1. RoHS and REACH – Why Are They Often Confused?

RoHS and REACH are two of the most important pieces of EU legislation affecting manufacturers and suppliers of electrical and electronic products. Both address hazardous substances, both can create obligations throughout the supply chain, and both require manufacturers to understand what substances are present in their products.

Because of these similarities, RoHS and REACH are often treated as if they were two versions of the same requirement. They are not.

The two regulations have different purposes, different scopes, different compliance mechanisms, and different ways of determining whether a product meets the applicable requirements. A product can be compliant with RoHS while still requiring action under REACH — and compliance with REACH does not automatically demonstrate compliance with RoHS.

Understanding this distinction is essential for manufacturers who want to avoid unnecessary testing, incomplete supplier documentation, or incorrect compliance declarations.

1.1 Both Deal With Hazardous Substances — But in Different Ways

The most obvious reason for the confusion is simple: both RoHS and REACH are concerned with chemical substances that can pose risks to people or the environment.

RoHS is specifically focused on electrical and electronic equipment (EEE). Its primary mechanism is to restrict the concentration of specific substances in homogeneous materials used in covered electrical and electronic equipment. The current RoHS substance list contains ten restricted substances or substance groups, including lead, mercury, cadmium, hexavalent chromium, certain flame retardants, and four phthalates.

REACH has a much broader chemical scope. It applies, in principle, to chemical substances placed on the EU market, including substances on their own, in mixtures, and in articles. It establishes requirements covering areas such as registration, evaluation, authorisation, communication, and restrictions.

This means that a manufacturer of an electrical product may encounter both regimes when assessing the same product.

For example, a plastic housing may contain a substance that is relevant under RoHS because it is one of the RoHS-restricted substances. The same housing may also contain a substance that is relevant under REACH because it is on the REACH Candidate List or because a REACH restriction applies to its particular use.

The fact that the same material can therefore be relevant under both frameworks does not mean that the two requirements are interchangeable.

1.2 RoHS Is Product-Specific

RoHS is fundamentally linked to the product category.

Its purpose is to restrict the use of certain hazardous substances in electrical and electronic equipment. The requirements are therefore closely connected to whether a product falls within the scope of the RoHS legislation and, if it does, whether the applicable substance restrictions are met.

This makes RoHS particularly important during product design and technical compliance activities.

A manufacturer typically needs to understand:

• whether the product is within the scope of RoHS;
• which RoHS restrictions apply;
• whether an exemption is applicable;
• which materials and components contain restricted substances;
• whether the concentration limits are respected at the homogeneous-material level; and
• what technical documentation is required to demonstrate compliance.

RoHS therefore becomes part of the technical compliance process for an electrical or electronic product.

1.3 REACH Is a Broader Chemicals Regulation

REACH operates from a different perspective.

Rather than being limited to electrical and electronic equipment, REACH covers chemical substances across a very broad range of products and industries. ECHA describes REACH as applying in principle to all chemical substances, including substances used in industrial processes as well as substances present in everyday products and articles such as clothing, furniture, and electrical appliances.

For an electrical product manufacturer, relevant REACH questions can therefore include:

• Does the product contain a substance of very high concern (SVHC)?
• Is an SVHC present above the applicable concentration threshold?
• Is information required to be communicated to customers or recipients?
• Does a REACH restriction apply to a substance or use?
• Are there obligations associated with importing substances, mixtures, or articles?
• Does the company have additional obligations because of its role in the supply chain?

These questions are fundamentally different from simply asking whether the product passes the RoHS substance limits.

1.4 The Same Product Can Be Subject to Both

One of the easiest ways to understand the relationship is to look at a typical electronic product.

Consider a connected industrial controller containing:

• a plastic enclosure;
• a printed circuit board;
• electronic components;
• cables;
• connectors;
• metal parts;
• solder;
• adhesives; and
• labels or other polymer-based materials.

For RoHS, the manufacturer must determine whether the applicable restricted substances exceed the permitted concentrations in the relevant homogeneous materials, taking applicable exemptions into account.

For REACH, the manufacturer may need to determine whether relevant substances are present in the article and whether those substances trigger communication or other obligations.

The same component can therefore require two different compliance assessments.

This is one of the most important principles to understand:

RoHS compliance does not automatically mean REACH compliance, and REACH compliance does not automatically mean RoHS compliance.

The two assessments may use information from the same suppliers, but the regulatory questions being answered are different.

1.5 Why Supplier Declarations Can Cause Confusion

Another major source of confusion is supplier documentation.

Manufacturers often receive statements such as:

• “RoHS compliant”
• “REACH compliant”
• “RoHS & REACH compliant”
• “RoHS/REACH declaration”
• “Free of hazardous substances”

These statements can look similar, but they do not necessarily provide the same level of regulatory evidence.

A supplier declaration stating that a component is “RoHS compliant” primarily addresses the RoHS requirements identified by the supplier. It does not automatically establish that all relevant REACH obligations have been assessed.

Likewise, a general “REACH compliant” declaration does not necessarily provide the material-specific evidence required for a RoHS technical assessment.

Manufacturers therefore need to understand what exactly a supplier has declared, for which product, under which legislation, and based on what evidence.

This becomes particularly important when products contain complex supply chains with components sourced from multiple countries.

1.6 RoHS and REACH Can Overlap

Although RoHS and REACH are separate legal frameworks, their substance-related requirements can overlap.

The European Commission’s review of RoHS specifically identified potential and observed overlap between RoHS substance restrictions and REACH mechanisms. At the same time, the Commission highlighted important differences in the nature and objectives of the two pieces of legislation.

This overlap can create practical challenges for manufacturers.

A substance may be restricted under RoHS for a particular application in electrical and electronic equipment while also being subject to controls under REACH. Conversely, a substance can be highly relevant under REACH without being one of the substances restricted under RoHS.

Therefore, manufacturers should not maintain a single generic “hazardous substance compliance” assessment and assume that it covers everything.

Instead, the applicable requirements should be assessed separately and then combined into the overall product compliance process.

1.7 The Key Difference in Mindset

A useful way to remember the distinction is:

RoHS asks:
Does this covered electrical or electronic equipment comply with the applicable restrictions on specific hazardous substances?

REACH asks:
What chemical substances are involved, what regulatory requirements apply to them, and what obligations arise from their manufacture, import, use, or presence in products?

These questions can overlap, but they are not the same question.

For manufacturers, this distinction has practical consequences.

A RoHS assessment normally focuses strongly on:

Product → Material → Homogeneous Material → Restricted Substance → Concentration Limit → Exemption

A REACH assessment may instead involve:

Product/Article → Substance → Regulatory Status → Concentration/Use → Communication, Restriction or Other Obligation

The resulting compliance evidence can therefore look very different.

1.8 Why the Distinction Matters in Practice

Confusing RoHS and REACH can lead to several common problems.

A manufacturer may:

• assume that a RoHS declaration is sufficient for REACH;
• assume that a REACH declaration proves RoHS compliance;
• request unnecessary laboratory testing;
• fail to request relevant substance information from suppliers;
• overlook an applicable REACH restriction;
• overlook an SVHC communication obligation;
• use outdated supplier declarations;
• fail to assess exemptions under RoHS;
• treat “halogen-free” or “lead-free” claims as equivalent to RoHS compliance; or
• include a generic “RoHS/REACH compliant” statement in technical documentation without knowing what evidence supports it.

These problems are particularly common when compliance responsibility is distributed across purchasing, engineering, quality, regulatory affairs, and suppliers.

A structured process is therefore much more effective than relying on a single supplier statement.

1.9 RoHS and REACH Should Be Assessed Together — But Not as One Requirement

For an electrical or electronic product, RoHS and REACH should normally be considered as part of the same broader chemical compliance strategy, while still being assessed as separate regulatory requirements.

This approach provides a better balance:

• RoHS determines whether the product meets the specific substance restrictions applicable to covered EEE.
• REACH determines which broader chemical obligations may apply to substances, mixtures, articles, and supply-chain relationships.
• Supplier information provides important input for both assessments.
• Technical documentation should retain sufficient evidence to support the conclusions reached.
• Testing should be used where it is technically and commercially justified rather than automatically treating laboratory testing as the default solution.

The goal is not simply to collect as many declarations and test reports as possible. The goal is to build a defensible compliance assessment based on the actual product, its materials, its supply chain, and the applicable legal requirements.

1.10 A Simple Example

Imagine a manufacturer purchases a plastic connector from a supplier.

The supplier provides a document stating:

“The connector is RoHS compliant.”

The manufacturer should not automatically conclude:

“Therefore, the connector is also fully compliant with REACH.”

The RoHS statement and the REACH assessment answer different questions.

The manufacturer may still need to determine whether the connector contains substances relevant under REACH, including whether an SVHC is present above the applicable threshold and whether any communication obligation applies.

Conversely, if the supplier provides a REACH statement, the manufacturer should not automatically assume that the connector satisfies all applicable RoHS substance restrictions and exemptions.

The correct approach is to identify the requirements separately and then determine what evidence is necessary for each.

1.11 The Practical Rule for Manufacturers

The safest approach is simple:

Do not treat “RoHS and REACH compliance” as one single compliance requirement.

Treat them as two related but distinct regulatory assessments.

For every electrical or electronic product, manufacturers should first determine:

1. Does RoHS apply to the product?
2. Which RoHS substance restrictions and exemptions are relevant?
3. What materials and components need to be assessed?
4. What supplier evidence is available?
5. Does REACH create additional obligations for the product or supply chain?
6. Are SVHCs or REACH restrictions relevant?
7. Is additional information or testing necessary?

This distinction forms the foundation for everything that follows in this article.

The next chapters will therefore examine RoHS in detail, beginning with what RoHS actually is, which substances are restricted, which products fall within its scope, and how manufacturers can demonstrate compliance.

2. What Is RoHS?

RoHS stands for Restriction of Hazardous Substances. In the European Union, RoHS is established through Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment, commonly referred to as the RoHS Directive.

The purpose of RoHS is to restrict the use of certain hazardous substances in electrical and electronic equipment (EEE), helping to protect human health and the environment and supporting the environmentally sound recovery and disposal of electronic waste.

For manufacturers, however, RoHS is more than simply a list of banned substances. It is a product compliance requirement that has to be considered during product design, material selection, purchasing, supplier management, technical documentation, and conformity assessment.

2.1 RoHS Is an EU Product Regulation

RoHS is an EU Directive rather than an EU Regulation.

This distinction is important. A directive establishes requirements that must be implemented into the national legislation of the EU Member States. Manufacturers placing products on the EU market therefore need to comply with the applicable national implementation of the RoHS requirements.

The current framework is based on Directive 2011/65/EU, which replaced the original RoHS Directive 2002/95/EC. The 2011 recast substantially expanded the scope of covered electrical and electronic equipment.

RoHS has also been amended several times since its adoption. These amendments include changes to exemptions, product scope, and other provisions. The applicable version of the legislation and the status of relevant exemptions therefore need to be considered when assessing a product.

2.2 What Is the Objective of RoHS?

The fundamental objective of RoHS is to reduce the use of certain hazardous substances in electrical and electronic equipment.

The Directive states that these restrictions are intended to contribute to:

• the protection of human health;
• the protection of the environment; and
• environmentally sound recovery and disposal of waste electrical and electronic equipment.

The underlying idea is straightforward.

Electrical and electronic products contain a wide variety of materials and components. Some of these materials historically relied on substances that can create environmental or health concerns during manufacturing, use, recycling, or disposal.

By restricting the concentration of specified substances in covered products, RoHS aims to reduce the amount of these substances entering the electrical and electronic product stream.

2.3 What Does RoHS Actually Restrict?

RoHS does not prohibit all hazardous chemicals from being used in electrical products.

Instead, it restricts specific substances and substance groups identified by the legislation.

The current RoHS framework restricts ten substances or substance groups:

1. Lead (Pb)
2. Mercury (Hg)
3. Cadmium (Cd)
4. Hexavalent chromium (Cr VI)
5. Polybrominated biphenyls (PBB)
6. Polybrominated diphenyl ethers (PBDE)
7. Bis(2-ethylhexyl) phthalate (DEHP)
8. Benzyl butyl phthalate (BBP)
9. Dibutyl phthalate (DBP)
10. Diisobutyl phthalate (DIBP)

The European Commission’s review of the RoHS Directive confirms these ten currently restricted substances and substance groups.

Each substance or substance group has a defined maximum concentration value under Annex II of the Directive.

For most of the restricted substances, the maximum concentration is 0.1% by weight, while the limit for cadmium is 0.01% by weight.

These limits are applied at the level of the homogeneous material, not simply to the complete finished product.

This distinction is fundamental to understanding how RoHS compliance works.

2.4 RoHS Is Based on Homogeneous Materials

A common misunderstanding is to compare the amount of a restricted substance with the total weight of the finished product.

That is generally not how RoHS works.

The concentration limits apply to the homogeneous materials contained in the product.

A homogeneous material is essentially a material that cannot be mechanically separated into different materials.

For example, consider a product containing:

• a painted metal housing;
• a plastic connector;
• a printed circuit board;
• solder;
• an insulated cable; and
• a metal screw.

These parts cannot simply be treated as one combined material for RoHS purposes.

The different materials may need to be assessed separately.

This is particularly important for materials such as:

• plastics;
• coatings;
• solder;
• metal alloys;
• cables;
• adhesives; and
• electronic component materials.

A restricted substance can therefore be present in a relatively small component and still be relevant for RoHS if its concentration in the applicable homogeneous material exceeds the permitted limit.

2.5 RoHS Does Not Mean “Zero Hazardous Substances”

Another important point is that RoHS does not mean that a product contains absolutely none of the restricted substances.

The legislation establishes concentration limits.

For example, a homogeneous material may contain a restricted substance below the applicable maximum concentration value and still comply with RoHS.

There are also specific exemptions that permit certain restricted substances to be used in defined applications where the conditions of the relevant exemption are met.

Therefore, the statement:

“RoHS prohibits hazardous substances.”

is too simplistic.

A more accurate description is:

RoHS restricts the concentration of specified substances in specified applications within covered electrical and electronic equipment, subject to applicable exemptions.

This distinction becomes particularly important when evaluating supplier declarations and laboratory test results.

2.6 Which Products Does RoHS Apply To?

RoHS applies to electrical and electronic equipment falling within the categories defined by the Directive.

The legislation defines EEE as equipment that depends on electric currents or electromagnetic fields to function properly, as well as equipment used to generate, transfer, or measure such currents or fields, within specified voltage limits.

The Directive applies to EEE designed for:

• up to 1,000 V AC, or
• up to 1,500 V DC.

The scope is broader than many manufacturers initially expect.

It covers numerous product types, including household appliances, IT and telecommunications equipment, consumer equipment, lighting equipment, electrical and electronic tools, toys and leisure equipment, medical devices, monitoring and control instruments, and other EEE categories.

The Directive also introduced an open-scope approach under which equipment not specifically excluded can fall within RoHS.

This means that manufacturers should not determine RoHS applicability simply by asking whether their product appears on a short list of regulated products.

A proper scope assessment is required.

2.7 There Are Also Explicit Exclusions

Although RoHS has broad coverage, the Directive specifically excludes certain types of equipment.

Examples include:

• equipment necessary for essential national security interests and specifically designed military equipment;
• equipment designed to be sent into space;
• certain equipment specifically designed as part of excluded equipment;
• large-scale stationary industrial tools;
• large-scale fixed installations;
• most means of transport;
• certain professional non-road mobile machinery;
• active implantable medical devices;
• certain permanently installed photovoltaic panels;
• equipment designed solely for business-to-business research and development; and
• pipe organs.

These exclusions are important because they demonstrate why a simple statement such as “all electrical products are RoHS regulated” is incorrect.

Scope has to be established product by product.

2.8 RoHS Is Part of the CE Compliance Framework

RoHS is closely connected to the CE marking system.

For products falling within the scope of RoHS, the manufacturer must establish conformity with the applicable RoHS requirements and prepare the required technical documentation and EU Declaration of Conformity.

The manufacturer is responsible for ensuring that the product complies with the applicable requirements before placing it on the EU market.

RoHS therefore should not be treated as a purely purchasing or supplier-management topic.

It is part of the manufacturer’s overall product compliance responsibility.

A manufacturer cannot simply transfer this responsibility to a component supplier by collecting a few declarations and assuming that the finished product is automatically compliant.

Supplier information is important evidence, but the manufacturer remains responsible for the conformity of the finished product.

2.9 RoHS and Other EU Legislation

RoHS does not exist in isolation.

The Directive explicitly states that it applies without prejudice to other EU legislation concerning areas such as safety, health, chemicals, and waste management. It specifically refers to REACH as an example of other applicable chemicals legislation.

This is important in practice because a single electrical product can be subject to several regulatory frameworks at the same time.

Depending on the product, these may include:

• RoHS;
• REACH;
• the EMC Directive;
• the Radio Equipment Directive;
• the Low Voltage Directive;
• the Machinery Regulation or other machinery legislation;
• the WEEE Directive;
• the Ecodesign framework;
• battery legislation; and
• other product-specific requirements.

Compliance with one piece of legislation does not automatically establish compliance with the others.

For example, completing a RoHS assessment does not replace an EMC assessment, and a CE marking under another applicable directive does not by itself prove RoHS compliance.

2.10 Why RoHS Matters During Product Development

RoHS should ideally be considered before the product reaches the testing or final certification stage.

Material selection can have a significant influence on compliance.

If an engineering team selects a material or component that contains a restricted substance above the applicable limit, the issue may only become visible later when documentation is reviewed or testing is performed.

At that stage, replacing the component may result in:

• redesign work;
• new validation activities;
• additional testing;
• supplier changes;
• production delays;
• additional costs; or
• difficulties meeting a planned market-launch date.

A structured RoHS assessment during product development can therefore prevent problems later in the product lifecycle.

2.11 RoHS Is a Compliance Process, Not Just a Test

One of the most important concepts for manufacturers is that RoHS compliance cannot be reduced to a laboratory test.

Laboratory analysis can be valuable, but a test report only represents the samples and materials that were actually tested.

A robust RoHS assessment normally combines several types of evidence, such as:

• supplier declarations;
• material declarations;
• component specifications;
• bills of materials;
• technical drawings;
• information about material composition;
• exemption assessments;
• risk assessments; and
• laboratory test reports where appropriate.

The manufacturer then uses this information to establish whether the finished product complies with the applicable RoHS requirements.

This is why RoHS compliance is best understood as a technical documentation and supply-chain management process supported by testing where necessary, rather than as a simple pass/fail laboratory exercise.

2.12 The Practical Definition of RoHS

For manufacturers, the following definition is useful:

RoHS is an EU product compliance framework that restricts specified hazardous substances in covered electrical and electronic equipment, based on defined concentration limits at the homogeneous-material level and subject to applicable exemptions.

This definition captures the key elements:

EU framework → Covered EEE → Specified substances → Homogeneous materials → Concentration limits → Exemptions → Technical evidence

Understanding these elements is essential before moving to the next question:

Which substances are actually restricted under RoHS, what are their limits, and where do manufacturers encounter them in real products?

That is the focus of the next chapter.

3. Which Substances Are Restricted Under RoHS?

RoHS does not restrict hazardous substances in general. It specifically restricts a defined list of substances and substance groups in electrical and electronic equipment covered by the Directive.

Under the current RoHS framework, ten substances or substance groups are restricted. The maximum concentration values are generally 0.1% by weight in homogeneous materials, with a lower limit of 0.01% for cadmium. These values are specified in Annex II of Directive 2011/65/EU, as amended by Commission Delegated Directive (EU) 2015/863.

Understanding the ten restricted substances is important, but manufacturers should not stop at memorising the list. The practical challenge is determining where these substances can occur, which materials need to be assessed, whether an exemption applies, and what evidence is sufficient to demonstrate compliance.

3.1 The Ten RoHS Restricted Substances

The current RoHS substance restrictions are:

No.	Substance / Substance Group	Abbreviation	Maximum Concentration in Homogeneous Material
1	Lead	Pb	0.1%
2	Mercury	Hg	0.1%
3	Cadmium	Cd	0.01%
4	Hexavalent chromium	Cr VI	0.1%
5	Polybrominated biphenyls	PBB	0.1%
6	Polybrominated diphenyl ethers	PBDE	0.1%
7	Bis(2-ethylhexyl) phthalate	DEHP	0.1%
8	Butyl benzyl phthalate	BBP	0.1%
9	Dibutyl phthalate	DBP	0.1%
10	Diisobutyl phthalate	DIBP	0.1%

The limits are expressed by weight in homogeneous materials. The four phthalates — DEHP, BBP, DBP and DIBP — were added through Commission Delegated Directive (EU) 2015/863.

This means that the list has evolved over time. The original RoHS restrictions covered six substances or substance groups; the four phthalates were added later.

3.2 Lead (Pb)

Lead is one of the best-known RoHS substances.

It has historically been widely used in electrical and electronic products because of its useful technical properties. In particular, lead has traditionally been used in:

• solder;
• metal alloys;
• electronic component terminations;
• cable materials;
• coatings;
• certain glass and ceramic applications;
• connectors; and
• other metal components.

Under RoHS, the maximum concentration value for lead is 0.1% by weight in homogeneous materials.

The restriction does not mean that every occurrence of lead in an electrical product automatically makes the product non-compliant. The relevant question is whether the concentration exceeds the applicable limit in the relevant homogeneous material and whether a valid RoHS exemption applies.

This is particularly important for manufacturers using specialised components or applications where lead remains technically necessary and an exemption may be available.

Practical example

Consider a metal component containing a small amount of lead as part of an alloy.

The manufacturer should not simply ask:

“Does this product contain lead?”

The correct questions are:

• In which homogeneous material is the lead present?
• What is the concentration?
• Is the applicable concentration below 0.1%?
• If it exceeds the limit, is a specific RoHS exemption applicable?
• Is the exemption valid for the particular product and application?

This illustrates why a simple “lead-free” or “lead-containing” statement is not sufficient for every RoHS assessment.

3.3 Mercury (Hg)

Mercury is another substance restricted under RoHS, with a maximum concentration of 0.1% by weight in homogeneous materials.

Mercury has historically been used in applications such as:

• certain lamps;
• switches;
• relays;
• sensors;
• specialised electrical equipment; and
• other applications requiring mercury’s electrical or physical properties.

Many traditional applications have been replaced by alternative technologies, but mercury remains relevant because specific applications and exemptions have existed under RoHS.

This is particularly important in lighting and specialised equipment.

A manufacturer should therefore not assume that mercury is irrelevant simply because modern consumer electronics generally contain little or no intentionally added mercury.

Where mercury is present, the manufacturer needs to establish whether the applicable restriction is met or whether a specific exemption applies.

3.4 Cadmium (Cd)

Cadmium has one of the strictest RoHS concentration limits.

The maximum concentration is:

0.01% by weight in homogeneous materials.

This corresponds to 100 mg/kg.

Cadmium has historically been used in areas such as:

• pigments;
• coatings;
• batteries;
• electrical contacts;
• certain alloys;
• plastics;
• specialised electronic components; and
• other industrial applications.

Because the permitted concentration is only one-tenth of the general 0.1% limit, cadmium can be particularly important during material assessment.

For example, a material containing 0.05% cadmium would be below the general 0.1% threshold used for many other RoHS substances, but it would still exceed the specific cadmium limit of 0.01%.

This demonstrates why manufacturers must evaluate each restricted substance against its own applicable limit rather than applying one generic threshold to all substances.

3.5 Hexavalent Chromium (Cr VI)

Hexavalent chromium refers to chromium in the hexavalent oxidation state, commonly written as Cr(VI) or Cr VI.

The RoHS maximum concentration is 0.1% by weight in homogeneous materials.

Chromium compounds have been used in various industrial applications, including:

• surface treatments;
• coatings;
• corrosion protection;
• metal finishing; and
• certain pigments and other materials.

One important practical point is that RoHS does not restrict all chromium.

The restriction specifically concerns hexavalent chromium.

This distinction matters when evaluating metal components and surface treatments because chromium can exist in different chemical forms.

A supplier statement simply saying that a product contains “chromium” does not, by itself, establish whether the RoHS restriction is exceeded.

The manufacturer may need information about the chemical form and the relevant material or surface treatment.

3.6 Polybrominated Biphenyls (PBB)

PBB stands for polybrominated biphenyls.

These are brominated flame-retardant substances that were historically used in certain plastics and other applications.

The maximum RoHS concentration is 0.1% by weight in homogeneous materials.

PBBs are important to distinguish from other brominated substances.

A statement such as:

“The plastic is brominated.”

does not automatically establish that it contains PBBs.

Likewise, the presence of bromine itself does not mean that a material fails RoHS.

The RoHS restriction concerns the specific substance group PBB, not every bromine-containing compound.

This distinction is particularly relevant when manufacturers receive broad material declarations or laboratory reports that identify total bromine rather than the specific restricted substance.

3.7 Polybrominated Diphenyl Ethers (PBDE)

PBDE stands for polybrominated diphenyl ethers.

Like PBBs, PBDEs have been used historically as flame retardants, particularly in plastics and electronic products.

The maximum RoHS concentration is 0.1% by weight in homogeneous materials.

PBDEs should not be confused with all brominated flame retardants.

A material may contain bromine without containing PBDEs.

This is another reason why manufacturers should be careful when interpreting supplier declarations and test reports. A generic “halogen-free” declaration may provide useful information, but it is not necessarily the same thing as a complete RoHS substance assessment.

3.8 DEHP

DEHP stands for bis(2-ethylhexyl) phthalate.

It is a phthalate used primarily as a plasticiser, particularly in flexible plastics such as PVC.

The RoHS maximum concentration is 0.1% by weight in homogeneous materials.

DEHP can therefore be relevant in materials such as:

• flexible PVC;
• cables;
• insulation;
• flexible plastic parts;
• certain seals; and
• other polymer-based components.

The four phthalates covered by RoHS were added later than the original six restricted substances. Their restrictions became particularly important across a broader range of EEE from 22 July 2019, with specific provisions applying to medical devices and monitoring and control instruments from 22 July 2021.

Manufacturers should therefore pay particular attention to polymeric materials and flexible components when assessing phthalates.

3.9 BBP

BBP stands for butyl benzyl phthalate.

Like DEHP, BBP is a phthalate that has been used as a plasticiser.

Its maximum RoHS concentration is 0.1% by weight in homogeneous materials.

Potentially relevant applications include flexible polymer materials and other products where plasticisation is required.

For manufacturers, the practical challenge is often not identifying BBP by visual inspection. It is obtaining reliable information about the chemical composition of the material.

A plastic component may look completely ordinary while still requiring a chemical composition assessment.

3.10 DBP

DBP stands for dibutyl phthalate.

DBP is another plasticiser that can be found in polymer-related applications and other industrial materials.

The maximum RoHS concentration is 0.1% by weight in homogeneous materials.

As with the other phthalates, the practical assessment is often heavily dependent on the quality of supplier information and material declarations.

This is especially relevant where manufacturers purchase finished components rather than raw materials and therefore have limited direct visibility into the chemical formulation.

3.11 DIBP

DIBP stands for diisobutyl phthalate.

It is the fourth phthalate restricted under RoHS.

The maximum concentration is also 0.1% by weight in homogeneous materials.

DIBP illustrates an important point about modern RoHS compliance: the assessment is not limited to the traditional substances that manufacturers have been managing for many years.

A company may have a mature lead, mercury and cadmium control process while still having weaknesses in its management of phthalates.

For this reason, a current RoHS compliance process should explicitly address all ten restricted substances.

3.12 The Concentration Limit Is Not Applied to the Finished Product

The RoHS limits are not calculated against the total weight of the finished electrical product.

They apply to the relevant homogeneous material.

This is one of the most important practical principles in RoHS.

Imagine a product weighing 1 kg that contains a small plastic component weighing 10 g.

If that plastic component contains a restricted substance at a concentration above the applicable limit, the fact that the substance represents only a tiny percentage of the complete 1 kg product does not automatically make the product compliant.

The assessment must be performed at the appropriate homogeneous-material level.

The Directive expressly specifies the maximum concentration values by weight in homogeneous materials.

This is why bills of materials and supplier declarations alone may not always provide enough information. The manufacturer needs to understand the material composition of the relevant components.

3.13 The Four Phthalates Changed the RoHS Assessment

The addition of DEHP, BBP, DBP and DIBP significantly expanded the substance assessment manufacturers need to perform.

Before their introduction, RoHS compliance programmes often focused primarily on:

• lead;
• mercury;
• cadmium;
• hexavalent chromium;
• PBB; and
• PBDE.

The addition of the four phthalates created a stronger need to assess:

• plastics;
• PVC;
• cables;
• insulation;
• flexible components;
• seals;
• adhesives and other polymer-related materials.

The four phthalates are each subject to the same general 0.1% homogeneous-material concentration limit.

This is one reason why older supplier declarations should not automatically be treated as sufficient evidence of current RoHS compliance.

3.14 RoHS Does Not Restrict Every Substance of Concern

The ten RoHS substances should not be confused with the much larger number of substances regulated under other EU chemical legislation.

For example, a substance can be:

• classified as hazardous;
• listed under REACH;
• included on the REACH Candidate List;
• subject to a REACH restriction; or
• otherwise relevant from a chemical safety perspective,

without being one of the ten substances restricted by RoHS.

This is one of the fundamental reasons why RoHS and REACH must be assessed separately.

RoHS has a defined list of restricted substances with specific limits. REACH operates through a much broader chemical regulatory framework.

3.15 RoHS Exemptions Can Change the Assessment

The presence of a restricted substance above the standard concentration limit does not always mean that the product automatically fails RoHS.

RoHS provides specific exemptions for certain applications where the use of a restricted substance is permitted under defined conditions.

These exemptions are not general permissions.

An exemption normally has:

• a specific application;
• defined scope;
• a specific exemption number;
• conditions of use; and
• an expiry or review mechanism where applicable.

Therefore, manufacturers should never use a statement such as:

“Lead is allowed under RoHS.”

The more accurate statement is:

Lead may be permitted for specific applications where the conditions of an applicable RoHS exemption are fulfilled.

This distinction is critical during technical documentation and compliance reviews.

3.16 What Manufacturers Should Look for in Real Products

The ten restricted substances can appear in very different parts of an electrical product.

A practical material-oriented assessment may therefore consider:

Product Material / Component	Potential RoHS Considerations
Solder	Lead
Metal alloys	Lead, cadmium
Surface coatings	Lead, hexavalent chromium
Plastics	PBB, PBDE, phthalates
Flexible PVC	DEHP and other phthalates
Cables	Lead, phthalates and other material-specific risks
Connectors	Lead, cadmium, coatings
Electronic components	Lead and other restricted substances depending on construction
Lamps	Mercury
Flame-retarded plastics	PBB/PBDE and other substances requiring differentiation
Specialised materials	Substance- and application-specific assessment

This table should not be interpreted as meaning that every material in the listed category contains the corresponding substance.

It simply identifies areas where manufacturers may need to pay particular attention.

The actual assessment must be based on the specific material, component, supplier information and applicable legal requirements.

3.17 Why a Simple “RoHS Test” Can Be Misleading

A laboratory may test a material or component for several RoHS substances and provide a pass/fail result.

That can be useful evidence, but manufacturers should understand what the test actually demonstrates.

For example:

• Was the correct homogeneous material tested?
• Was the entire relevant material tested?
• Which substances were included in the test?
• Was the analytical method suitable for the substance being assessed?
• Was the result below the applicable limit?
• Was a specific exemption considered?
• Does the tested sample represent current production?
• Has the material formulation changed since the test?

A laboratory result is therefore one part of the compliance assessment rather than an automatic replacement for technical documentation and supply-chain control.

3.18 The Practical Meaning of the Ten Substances

For manufacturers, the most useful way to view the RoHS substance list is not simply as ten names.

It is a chain of questions:

What substance is restricted?

↓

Where could it occur in the product?

↓

In which homogeneous material is it present?

↓

What is its concentration?

↓

What is the applicable RoHS limit?

↓

Does an exemption apply?

↓

What evidence supports the conclusion?

This approach turns the substance list into a practical compliance process.

3.19 The Key Takeaway

RoHS currently restricts ten substances or substance groups:

Pb → Hg → Cd → Cr VI → PBB → PBDE → DEHP → BBP → DBP → DIBP

The general concentration limit is 0.1% by weight in homogeneous materials, while cadmium has a stricter limit of 0.01%. The four phthalates were added through Commission Delegated Directive (EU) 2015/863.

However, knowing the list alone is not enough.

A manufacturer must also understand:

• where the substances may occur;
• how homogeneous materials are defined;
• which concentration limits apply;
• whether an exemption is relevant;
• what supplier evidence is available; and
• when laboratory testing is justified.

The next chapter addresses the first of these questions in more detail:

Which electrical and electronic products are actually covered by RoHS?

4. Which Products Are Covered by RoHS?

One of the most important questions in a RoHS assessment is also one of the easiest to get wrong:

Does RoHS actually apply to this product?

RoHS is often described simply as legislation for “electronic products.” That description is too broad to be useful.

The scope of RoHS is defined by the legal definition of electrical and electronic equipment (EEE), the product categories listed in Annex I, and a number of specific exclusions. Since the introduction of the open-scope approach, the fact that a product does not appear in a traditional product list does not necessarily mean that it is outside RoHS.

Today, the scope is deliberately broad. The European Commission describes the current framework as covering all EEE within scope, from household appliances to medical devices, subject to specific exclusions.

For manufacturers, this means that a proper RoHS scope assessment should be performed before deciding what documentation, supplier evidence, or testing is required.

4.1 What Is “Electrical and Electronic Equipment”?

The starting point is the definition of EEE in Article 3 of the RoHS Directive.

EEE means equipment that:

• depends on electric currents or electromagnetic fields to work properly; or
• is used for the generation, transfer, or measurement of such currents or fields;

and is designed for operation at a voltage rating of no more than:

• 1,000 V AC, or
• 1,500 V DC.

The word “depends” is particularly important.

The equipment must need electrical currents or electromagnetic fields to perform at least one intended function.

This means that not every product containing a metal part, plastic part, or electrical accessory is automatically EEE. The actual function and design of the product need to be considered.

For example, a purely mechanical product that happens to be used next to electrical equipment is not automatically an EEE product.

On the other hand, a product can clearly fall within RoHS even if electricity is not its only important function. If electrical energy or electromagnetic fields are necessary for at least one intended function, the product can meet the EEE definition.

4.2 The Eleven RoHS Product Categories

Annex I of the RoHS Directive defines eleven categories of EEE:

1. Large household appliances
2. Small household appliances
3. IT and telecommunications equipment
4. Consumer equipment
5. Lighting equipment
6. Electrical and electronic tools
7. Toys, leisure and sports equipment
8. Medical devices
9. Monitoring and control instruments, including industrial monitoring and control instruments
10. Automatic dispensers
11. Other EEE not covered by categories 1–10

The eleventh category is particularly important.

It means that manufacturers cannot rely on the argument:

“Our product does not fit into one of the first ten categories, so RoHS does not apply.”

The opposite may be true.

If the product qualifies as EEE and is not specifically excluded, it may fall into Category 11 – Other EEE.

This is the basis of the modern open-scope approach.

4.3 The Open-Scope Principle

The open-scope approach is one of the most important changes introduced by RoHS 2.

Under the original RoHS framework, the scope was more closely tied to defined equipment categories. The recast Directive gradually expanded coverage, and since 22 July 2019, the open-scope approach has applied to the remaining EEE categories.

In practical terms:

If a product is EEE, falls within one of the Annex I categories, and is not covered by an exclusion, it can be subject to RoHS even if it is a highly specialised or unusual product.

This has significant consequences for manufacturers developing new products.

A product does not need to look like a traditional consumer electronic device.

Industrial equipment, specialised control equipment, professional equipment and many other products can fall within RoHS.

4.4 Large Household Appliances

Category 1 covers large household appliances.

Typical examples include products such as:

• refrigerators;
• freezers;
• washing machines;
• tumble dryers;
• dishwashers;
• electric ovens;
• large cooking appliances; and
• air-conditioning equipment.

The important point is not the word “household” alone.

The scope assessment should consider whether the product falls within the relevant EEE category and whether any specific exclusion applies.

Large appliances can also contain numerous different materials and components, making RoHS assessment particularly relevant during product design and supplier management.

4.5 Small Household Appliances

Category 2 covers small household appliances.

Examples can include:

• vacuum cleaners;
• coffee machines;
• electric kettles;
• toasters;
• irons;
• hair dryers;
• electric shavers; and
• similar electrically operated household products.

These products are generally straightforward examples of EEE.

However, the same principles apply to more specialised household equipment. The manufacturer should assess the product based on its actual design and function rather than relying solely on marketing terminology.

4.6 IT and Telecommunications Equipment

Category 3 covers IT and telecommunications equipment.

Examples include:

• computers;
• servers;
• routers;
• network equipment;
• telecommunications equipment;
• certain data-processing equipment;
• peripherals; and
• other equipment whose primary function is related to information processing or telecommunications.

This category is particularly relevant for modern connected products because many devices combine computing, communication, control and other functions.

A product that includes Wi-Fi, Bluetooth, cellular connectivity or another communication technology does not automatically become a Category 3 product. The classification depends on the nature and intended function of the equipment.

Nevertheless, many connected products will fall within RoHS either under Category 3 or Category 11.

4.7 Consumer Equipment

Category 4 covers consumer equipment.

This category includes many products used for entertainment and audiovisual purposes, such as:

• televisions;
• radios;
• audio equipment;
• video equipment;
• cameras;
• music equipment; and
• other similar consumer products.

Modern consumer products increasingly combine several technologies.

For example, a smart television may simultaneously provide:

• audiovisual functionality;
• network connectivity;
• data processing;
• wireless communication; and
• user-interface functions.

The presence of multiple functions does not necessarily create multiple RoHS classifications. The product should be assessed as the relevant EEE based on its intended function and applicable category.

4.8 Lighting Equipment

Category 5 covers lighting equipment.

This includes electrical and electronic equipment designed for lighting applications.

Examples can include:

• luminaires;
• LED lighting products;
• professional lighting equipment;
• certain lamps and lighting control equipment; and
• other electrical equipment specifically associated with lighting.

Lighting products have historically been particularly relevant to RoHS because mercury restrictions affected certain lamp technologies.

For modern LED products, mercury may be less relevant, but the other RoHS substance restrictions still need to be considered.

Manufacturers should therefore avoid assuming that a change from conventional lighting technology to LED automatically eliminates the need for a RoHS assessment.

4.9 Electrical and Electronic Tools

Category 6 covers electrical and electronic tools.

Examples include:

• drills;
• saws;
• grinding equipment;
• screwdrivers;
• soldering equipment;
• cutting tools;
• gardening tools; and
• other electrically powered tools.

However, the existence of a motor or electrical system does not automatically mean that every industrial machine is covered.

RoHS contains specific exclusions for certain large-scale stationary industrial tools and large-scale fixed installations.

This distinction can be extremely important for industrial manufacturers.

A relatively small electrical tool may clearly fall within RoHS, while a large permanently installed industrial machine may fall within an exclusion depending on its design, scale, installation and use.

4.10 Toys, Leisure and Sports Equipment

Category 7 covers toys, leisure and sports equipment.

Examples can include:

• electrically operated toys;
• electronic games;
• electric exercise equipment;
• electronic sports equipment;
• certain amusement equipment; and
• other electrically powered leisure products.

Modern children’s products can combine electrical, wireless and mechanical functions.

For manufacturers, this can create several simultaneous compliance obligations.

RoHS may apply alongside other legislation, such as toy safety legislation, radio equipment requirements or EMC requirements.

A manufacturer should therefore avoid treating RoHS as the only regulatory assessment required for such products.

4.11 Medical Devices

Category 8 covers medical devices.

This is particularly important because medical equipment was not treated in exactly the same way during the original implementation of RoHS 2.

The RoHS requirements were introduced progressively for medical devices, and RoHS now covers relevant medical equipment unless a specific exclusion applies. The EU framework also contains a specific exclusion for active implantable medical devices.

Examples of potentially covered medical EEE can include:

• diagnostic equipment;
• monitoring equipment;
• electrically operated medical devices;
• medical imaging equipment; and
• other medical EEE.

Medical manufacturers therefore need to coordinate RoHS with their broader medical-device compliance system.

A product being classified as a medical device does not automatically mean that it is outside RoHS.

4.12 Monitoring and Control Instruments

Category 9 covers monitoring and control instruments, including industrial monitoring and control instruments.

This can include:

• measurement equipment;
• control equipment;
• sensors;
• monitoring systems;
• laboratory instruments;
• industrial control devices;
• measuring instruments; and
• other equipment used to monitor or control processes.

This category is particularly important for industrial manufacturers because many products that historically were considered specialised industrial equipment are now within the broader RoHS framework.

The fact that a product is intended exclusively for professional or industrial use does not by itself remove it from RoHS.

The manufacturer must examine the actual product and the applicable exclusions.

4.13 Automatic Dispensers

Category 10 covers automatic dispensers.

Examples can include electrically operated systems that automatically dispense:

• food;
• beverages;
• cash;
• tickets;
• products; or
• other goods.

The category illustrates another important feature of RoHS: the scope is based on the function and characteristics of the equipment, not simply on whether the product is traditionally considered an “electronic device.”

4.14 Category 11 – Other EEE

Category 11 is one of the most important categories for modern product development.

It covers:

Other EEE not covered by categories 1 to 10.

This is effectively the catch-all category.

It means that many modern products can fall within RoHS even when they do not resemble traditional products covered by the first ten categories.

This is particularly relevant for:

• smart products;
• connected devices;
• industrial electronics;
• specialised electrical equipment;
• professional equipment;
• sensors;
• electronic control systems;
• smart home products; and
• other newly developed EEE.

For manufacturers, Category 11 means that the question is no longer:

“Which traditional RoHS product category does my product belong to?”

It is often:

“Is my product EEE, and is there a specific exclusion?”

If the answer is yes and no respectively, RoHS may apply.

4.15 Cables and Spare Parts

RoHS is not limited to the original finished equipment.

The current framework also addresses cables and spare parts for covered EEE. EUR-Lex summarises the scope as applying to all EEE within scope as well as cables and spare parts, subject to the applicable exclusions and provisions.

This matters because manufacturers and service organisations may otherwise assume that a replacement component is outside RoHS simply because it is not sold as a complete product.

The specific circumstances still matter, including whether the spare part is intended for equipment covered by RoHS and whether the relevant provisions or exemptions apply.

4.16 Components Are Not Automatically Separate RoHS Products

A common misconception is:

“Every electronic component must have its own RoHS CE marking.”

That is not how the system works.

RoHS primarily regulates EEE placed on the market, while components and materials can become relevant because they are incorporated into covered EEE.

For example, a manufacturer of a finished electronic device may purchase:

• resistors;
• capacitors;
• integrated circuits;
• connectors;
• cables;
• switches;
• displays; and
• mechanical parts.

The finished product manufacturer needs to assess the materials and components used in the product, but that does not mean every individual component must independently carry a RoHS CE marking.

Supplier declarations and material information are therefore important inputs into the finished product’s compliance assessment.

4.17 Important RoHS Exclusions

RoHS has a broad scope, but Article 2(4) contains important exclusions.

These include:

• equipment necessary for essential national security interests and specifically designed military equipment;
• equipment designed to be sent into space;
• certain specifically designed equipment that forms part of excluded or non-covered equipment;
• large-scale stationary industrial tools;
• large-scale fixed installations;
• most means of transport;
• certain professional non-road mobile machinery;
• active implantable medical devices;
• certain permanently installed photovoltaic panels;
• equipment designed solely for business-to-business research and development; and
• pipe organs.

These exclusions are not general exemptions from the substance restrictions.

They are scope exclusions.

That distinction is important.

If a product is excluded from the scope of RoHS, the manufacturer does not need to demonstrate compliance with RoHS for that product.

If the product is within scope but benefits from a specific substance exemption, the situation is completely different: RoHS applies, but a particular restricted substance may be permitted under defined conditions.

4.18 Large-Scale Stationary Industrial Tools

Large-scale stationary industrial tools are frequently misunderstood.

The term does not mean simply:

“Any large machine used in a factory.”

The legal definition contains specific characteristics concerning the scale, installation, professional assembly/disassembly, intended location and industrial or R&D use.

A manufacturer should therefore not exclude a machine from RoHS solely because:

• it is large;
• it is expensive;
• it is used by professionals;
• it is installed in a factory; or
• it is permanently connected to electrical power.

The legal criteria need to be assessed.

This is a good example of why a product-by-product scope assessment is preferable to broad internal assumptions.

4.19 Large-Scale Fixed Installations

Large-scale fixed installations are another important exclusion.

These can include complex installations made up of multiple types of equipment and systems that are assembled and installed permanently at a defined location.

However, the exclusion should not be interpreted as:

“Anything installed permanently is outside RoHS.”

The legal definition and conditions must be considered.

Individual equipment incorporated into an installation may need to be assessed separately depending on the circumstances and whether the equipment itself falls within the RoHS scope.

This is particularly important for manufacturers supplying electrical or electronic equipment that is later incorporated into industrial installations.

4.20 Photovoltaic Panels

Certain photovoltaic panels are specifically excluded from RoHS.

The exclusion applies to photovoltaic panels intended for use in systems that are:

• designed, assembled and installed by professionals;
• intended for permanent use at a defined location; and
• used to generate energy from sunlight for public, commercial, industrial or residential applications.

This exclusion is specific.

It should not be interpreted as meaning that all electrical equipment associated with a photovoltaic system is automatically outside RoHS.

For example, other electrical equipment used in or around a photovoltaic installation may need its own scope assessment.

4.21 Transport Equipment

RoHS generally excludes means of transport for persons or goods, subject to the specific wording of the Directive and the stated exception for certain electric two-wheel vehicles that are not type-approved.

This exclusion is important for manufacturers operating in automotive, aviation, marine, rail and other transport sectors.

However, the exclusion should not be applied blindly to every electrical product used in a transport environment.

The relevant question is whether the product itself falls within the excluded equipment category or is separate EEE placed on the market in its own right.

This distinction can become particularly important for aftermarket equipment, accessories and specialised electronic products.

4.22 Professional Use Does Not Automatically Mean Exclusion

Another common mistake is assuming:

“The product is only for professional use, so RoHS does not apply.”

That is incorrect.

RoHS covers numerous professional and industrial products.

Professional use becomes relevant only in connection with certain specific scope provisions or exclusions.

For example, certain professional non-road mobile machinery is excluded, and certain business-to-business research and development equipment is excluded under defined conditions.

But professional use alone is not a general RoHS exclusion.

4.23 Research and Development Equipment

Equipment specifically designed solely for research and development and made available only on a business-to-business basis is excluded under Article 2(4).

The wording is important.

The equipment must be:

• specifically designed;
• solely for research and development; and
• made available only in a business-to-business context.

A manufacturer should therefore be careful when applying this exclusion.

A general-purpose laboratory instrument that happens to be used for R&D is not automatically excluded merely because one customer uses it for research.

The intended design and market placement need to be considered.

4.24 The Product’s Intended Function Matters

When determining whether a product is EEE, the intended function is fundamental.

For example, consider a mechanical valve with an integrated electronic actuator.

The assessment should not simply ask:

“Is the product mechanical?”

Instead, the manufacturer should determine whether the equipment depends on electrical currents or electromagnetic fields to perform at least one intended function.

Similarly, a product can contain mechanical, optical, hydraulic and electrical elements simultaneously.

Modern products are increasingly hybrid systems, which makes simplistic product classification unreliable.

4.25 Why Scope Assessment Should Come Before Material Assessment

The correct order of a RoHS assessment is important.

A manufacturer should not start by asking:

“Which RoHS test should we perform?”

The first question should be:

“Is the product within the scope of RoHS?”

Only after the scope has been established does it make sense to determine:

• which substance restrictions apply;
• whether exemptions are relevant;
• which materials require assessment;
• what supplier evidence should be collected;
• whether testing is necessary; and
• what technical documentation must be maintained.

This avoids spending time and money on compliance activities that may not actually be required.

4.26 A Practical Scope Assessment

A useful internal decision process can look like this:

Step 1 – Is the product electrical or electronic equipment?

Does it depend on electric currents or electromagnetic fields for at least one intended function?

↓

Step 2 – Is it within the voltage limits?

Maximum design rating:

1,000 V AC / 1,500 V DC

↓

Step 3 – Does it fall within an Annex I category?

Categories 1–10 or:

Category 11 – Other EEE

↓

Step 4 – Is there a specific exclusion?

Check Article 2(4).

↓

Step 5 – Is the exclusion actually applicable?

Do the legal conditions match the product?

↓

Step 6 – If not excluded, RoHS applies.

The manufacturer can then continue with the substance and documentation assessment.

This sequence is much more reliable than relying on product names or internal assumptions.

4.27 Example: A Connected Industrial Controller

Consider an industrial controller with:

• a power supply;
• microprocessor;
• Ethernet;
• Wi-Fi;
• sensors;
• digital outputs;
• a display; and
• control software.

The product is clearly dependent on electrical currents and electromagnetic fields.

It is within the RoHS voltage limits.

It may not fit neatly into one of the traditional consumer-oriented categories.

However, that does not mean it is outside RoHS.

Depending on its characteristics and intended function, it can fall under monitoring and control equipment or, where appropriate, the broader Category 11 – Other EEE.

The manufacturer should then assess whether any exclusion applies.

If no exclusion applies, the product is within RoHS.

This example demonstrates why Category 11 and the open-scope principle are so important for modern industrial electronics.

4.28 Example: A Large Industrial Machine

Now consider a large automated manufacturing machine permanently installed in a factory.

It contains:

• motors;
• drives;
• sensors;
• PLCs;
• displays;
• safety controls; and
• communication interfaces.

At first glance, it is clearly electrical and electronic equipment.

However, the manufacturer cannot immediately conclude that RoHS applies.

The next question is whether the machine qualifies for an applicable exclusion, such as the exclusion for a large-scale stationary industrial tool or, depending on its configuration and installation, whether it forms part of a large-scale fixed installation.

The legal definitions and conditions need to be assessed.

This is precisely the type of product where a formal scope assessment can prevent an incorrect compliance conclusion.

4.29 Example: A Smart Home Device

Consider a smart home sensor containing:

• a battery;
• a microcontroller;
• Bluetooth;
• temperature and humidity sensors; and
• a plastic housing.

The product depends on electrical energy and electromagnetic fields for its intended functions.

It is therefore EEE.

It does not obviously fall under an exclusion.

Even if it does not fit neatly into Categories 1–10, Category 11 can bring it within RoHS.

The fact that the product is small, low-power and inexpensive does not remove it from the scope.

4.30 Scope Is Not the Same as Substance Compliance

It is important to distinguish two separate questions:

Question 1: Is the product within RoHS?

This is a scope assessment.

Question 2: Does the product comply with the RoHS substance restrictions?

This is a substance compliance assessment.

A product can therefore be:

• outside RoHS scope → RoHS substance assessment is not required;
• within RoHS scope and compliant → applicable substance restrictions are met;
• within RoHS scope and non-compliant → one or more restrictions are exceeded without an applicable exemption; or
• within RoHS scope with an applicable exemption → a restricted substance may be permitted under defined conditions.

Keeping these concepts separate makes the overall compliance process much clearer.

4.31 The Manufacturer’s Responsibility

The manufacturer placing a covered product on the EU market is responsible for establishing conformity with the applicable RoHS requirements.

This means that the manufacturer should be able to explain:

• why RoHS applies or does not apply;
• which category or scope provision is relevant;
• which exclusions were considered;
• which materials and components were assessed;
• which substance restrictions apply;
• which exemptions are used, if any; and
• what evidence supports the conclusion.

A supplier may provide important information, but the manufacturer should not outsource the final scope determination without understanding the basis for it.

4.32 The Practical Rule

For modern electrical and electronic products, the most useful rule is:

Do not ask only whether the product is on a RoHS list. Ask whether it is EEE, whether it falls within the open scope, and whether a specific exclusion applies.

The current RoHS framework covers a very broad range of EEE and includes an open catch-all category. At the same time, several specific exclusions can remove otherwise electrical products from the scope.

For manufacturers, the practical sequence is therefore:

EEE definition → Annex I category → Open-scope assessment → Exclusions → RoHS applicability

Only after that should the assessment move to materials and substances.

4.33 Key Takeaways

The most important points are:

• RoHS applies to electrical and electronic equipment (EEE) within the defined scope.
• EEE is generally equipment dependent on electric currents or electromagnetic fields for at least one intended function.
• The voltage limits are 1,000 V AC and 1,500 V DC.
• Annex I contains eleven EEE categories.
• Category 11 creates an important open-scope catch-all for other EEE.
• Since July 2019, the open-scope approach has significantly broadened RoHS coverage.
• Cables and relevant spare parts are also addressed within the RoHS framework.
• Several important exclusions exist, including certain military equipment, space equipment, large-scale stationary industrial tools, large-scale fixed installations, transport equipment, professional non-road mobile machinery, active implantable medical devices, certain photovoltaic panels, specific R&D equipment, and pipe organs.
• Professional or industrial use alone does not automatically exclude a product from RoHS.
• Scope assessment should be completed before deciding on material evidence or laboratory testing.

Once it has been established that a product falls within RoHS, the next practical question is:

What does RoHS mean for the actual materials, components and construction of that product?

That is the focus of the next chapter.

5. RoHS and Materials – What Does This Mean in Practice?

Once a product has been established as being within the scope of RoHS, the next question is much more practical:

Where exactly do the RoHS requirements apply within the product?

For manufacturers, RoHS compliance is ultimately a material-level assessment. A finished electrical product may contain hundreds or even thousands of individual parts, but the legal concentration limits are not normally assessed against the complete product as one unit.

Instead, the restrictions apply to homogeneous materials.

This is why a manufacturer needs visibility into the materials used in components, assemblies and finished products.

A product can look completely compliant from the outside while containing a non-compliant material hidden inside a connector, cable, coating, solder joint or plastic component.

5.1 The Homogeneous Material Principle

The RoHS Directive defines a homogeneous material as:

one material of uniform composition throughout, or a material consisting of a combination of materials that cannot be separated into different materials by mechanical actions.

This definition is fundamental.

Mechanical separation includes processes such as:

• unscrewing;
• cutting;
• crushing;
• grinding;
• abrasive processes; and
• similar mechanical actions.

The practical consequence is that a product generally needs to be broken down conceptually into its individual homogeneous materials rather than simply being assessed as a complete assembly.

For example, a cable may contain:

• copper conductor;
• metallic plating;
• polymer insulation;
• outer jacket; and
• other layers.

These materials may need to be considered separately.

The fact that they are supplied together as one finished cable does not make them one homogeneous material.

5.2 A Component Is Not Necessarily One Material

This is one of the most common sources of misunderstanding.

Manufacturers sometimes treat a component such as a connector, PCB or cable as a single material for RoHS purposes.

That is usually too simplistic.

Consider a connector consisting of:

• a plastic body;
• metal contacts;
• a plating layer;
• solder;
• a sealing material; and
• a label or marking.

The connector is one component, but it contains multiple materials.

Each relevant material can have its own chemical composition and therefore its own RoHS assessment.

The same principle applies to:

• printed circuit boards;
• cables;
• switches;
• relays;
• displays;
• motors;
• power supplies;
• transformers;
• housings; and
• mechanical assemblies.

This distinction between component and material is essential.

5.3 Why the Finished Product Weight Is Not Enough

Imagine a 2 kg electronic product containing a small 5 g plastic component.

Suppose that plastic component contains a RoHS-restricted substance at a concentration above the applicable limit.

It does not become compliant simply because the restricted substance represents only a very small percentage of the total 2 kg product.

The relevant concentration must be assessed at the appropriate homogeneous-material level.

This is why a calculation such as:

“The product contains only 0.001% lead overall.”

does not, by itself, demonstrate RoHS compliance.

The relevant question is:

What is the concentration of lead in the homogeneous material containing the lead?

This is one of the most important practical differences between RoHS and many general product-level chemical assessments.

5.4 What Counts as a Homogeneous Material?

Consider a painted metal housing.

It may contain:

1. the underlying metal;
2. a primer;
3. a coating;
4. printing or marking.

If these layers can be mechanically separated, they should not automatically be treated as one homogeneous material.

The metal itself may therefore need to be assessed separately from the coating.

Similarly, a plastic housing with a separately applied coating or decorative layer may contain more than one relevant material.

The exact assessment depends on the construction and whether the materials can be mechanically separated.

The key principle is:

If two materials can be mechanically separated, they should not automatically be treated as one homogeneous material.

5.5 Printed Circuit Boards

Printed circuit boards are a good example of why material-level assessment matters.

A typical PCB can contain:

• copper;
• copper surface finishes;
• solder;
• solder mask;
• laminate;
• resin;
• adhesives;
• component materials; and
• other coatings or layers.

The PCB as a complete assembly is therefore not one homogeneous material.

A manufacturer should consider the relevant individual materials when determining RoHS compliance.

For example, the solder used on a PCB can have a completely different chemical composition from the PCB laminate.

Likewise, a surface finish can contain different substances from the underlying copper.

This is why a supplier statement saying simply:

“The PCB is RoHS compliant”

can be useful but should not be confused with a detailed material assessment.

5.6 Cables

Cables are another area where manufacturers frequently encounter material complexity.

A typical cable can include:

• conductor metal;
• insulation;
• shielding;
• jacket;
• fillers;
• tapes;
• coatings;
• connectors; and
• strain-relief materials.

Different materials can therefore have different RoHS risks.

For example:

• metal alloys may require assessment for lead or cadmium;
• polymer materials may require assessment for phthalates;
• specialised coatings may require assessment for particular restricted substances.

RoHS explicitly addresses cables associated with covered EEE.

Manufacturers should therefore avoid treating a cable simply as a single line item in a bill of materials without understanding what material information is available.

5.7 Plastics and Polymer Materials

Polymeric materials deserve particular attention because several RoHS-restricted substances have historically been associated with plastics.

Potential areas of concern include:

• flame-retardant systems;
• plasticisers;
• flexible PVC;
• cable insulation;
• cable jackets;
• seals;
• gaskets;
• flexible housings;
• adhesives; and
• other polymer-based components.

The four RoHS phthalates — DEHP, BBP, DBP and DIBP — are particularly relevant to polymer materials.

However, manufacturers should not assume that every plastic contains phthalates.

The correct approach is to obtain reliable information about the material formulation and, where appropriate, use targeted analytical testing.

5.8 Metals and Metal Alloys

Metal parts can also require detailed assessment.

Potentially relevant materials include:

• copper alloys;
• aluminium alloys;
• steel;
• brass;
• solder;
• surface finishes;
• plating materials; and
• other specialised alloys.

Lead and cadmium can occur in certain metal alloys, while specific surface treatments can create additional assessment requirements.

Again, the important point is not simply:

“This is a metal part.”

The manufacturer needs to understand:

Which alloy or coating is used, and what is its composition?

A supplier material specification can therefore be much more useful than a generic declaration that the component is “RoHS compliant.”

5.9 Surface Treatments and Coatings

Surface treatments can be particularly challenging because they are often very thin and easy to overlook.

Examples include:

• corrosion-protection coatings;
• plating;
• decorative coatings;
• paints;
• conversion coatings;
• primers; and
• printed markings.

The underlying material and the surface treatment may constitute separate homogeneous materials if they can be mechanically separated.

This is particularly relevant when evaluating metal parts.

A manufacturer may receive a declaration for the base metal while having little information about the coating applied later in the supply chain.

This creates a potential documentation gap.

5.10 Solder

Solder deserves special attention because lead has historically been widely used in soldering applications.

Modern electronics frequently use lead-free solder, but lead can still be present in certain applications, particularly where a specific RoHS exemption is relevant.

The manufacturer therefore needs to know:

• which solder alloy is used;
• where it is used;
• whether the material exceeds the applicable lead limit;
• whether an exemption applies; and
• whether the exemption is valid for the specific application.

A general statement such as “lead-free solder process” may be useful evidence, but it should not automatically be interpreted as proving that every solder-related material in every product is compliant.

5.11 Glass and Ceramic Materials

Glass and ceramic materials can also be relevant.

Certain electronic components and specialised electrical equipment contain:

• glass;
• ceramic bodies;
• ceramic coatings;
• ceramic capacitors;
• specialised glass compositions; or
• other inorganic materials.

Lead can historically occur in some glass and ceramic applications, while certain specific RoHS exemptions address specialised uses.

This means that a manufacturer should not assume that a material is automatically low-risk simply because it is inorganic or non-polymeric.

The applicable material composition and exemption status still need to be understood.

5.12 Adhesives, Sealants and Potting Materials

Adhesives and sealants are often overlooked because they are used in relatively small quantities.

However, they can constitute separate homogeneous materials.

Examples include:

• structural adhesives;
• pressure-sensitive adhesives;
• silicone materials;
• epoxy resins;
• polyurethane materials;
• potting compounds;
• sealing compounds; and
• encapsulation materials.

A small quantity does not automatically make the material irrelevant.

If the material is a separate homogeneous material, its chemical composition still needs to be considered.

This is particularly important for products containing many small bonded or sealed components.

5.13 Labels, Markings and Inks

Labels and markings can also require attention.

A product may contain:

• printed labels;
• coloured markings;
• identification inks;
• decorative printing;
• barcodes; or
• other applied materials.

Depending on the construction, these may constitute separate materials.

Manufacturers should therefore avoid assuming that anything applied in a very thin layer can automatically be ignored.

The correct assessment depends on the material, its construction and whether it can be mechanically separated.

5.14 Why the Bill of Materials Is Not Enough

A bill of materials (BOM) is an essential starting point, but it does not automatically provide the information required for a RoHS assessment.

A typical BOM may tell the manufacturer:

BOM Information	What It Does Not Necessarily Tell You
Part number	Chemical composition
Supplier	Restricted substance content
Quantity	Homogeneous-material structure
Component name	Applicable exemption
Revision	Current material formulation
Description	Evidence supporting RoHS compliance

For example:

BOM line: Connector – Part No. ABC123

This identifies the component.

It does not necessarily identify:

• the plastic formulation;
• metal alloy;
• plating;
• solder;
• adhesives;
• coatings; or
• restricted substance concentrations.

The BOM therefore needs to be supported by material and supplier information.

5.15 Supplier Information Becomes Critical

Because manufacturers often do not formulate every material themselves, supplier information is one of the most important sources of RoHS evidence.

Useful supplier documentation can include:

• RoHS declarations;
• material declarations;
• full material composition information;
• component specifications;
• laboratory reports;
• declarations of conformity;
• exemption statements;
• information about material changes; and
• controlled product specifications.

However, the quality of supplier information varies considerably.

A manufacturer should therefore assess whether the information is:

• product-specific;
• current;
• traceable;
• sufficiently detailed;
• applicable to the supplied revision;
• consistent with the actual component; and
• supported by appropriate evidence.

The objective is not to collect paperwork for its own sake.

The objective is to establish a reliable chain of evidence from supplier material → component → product.

5.16 Material Changes Can Affect Compliance

RoHS compliance is not necessarily permanent simply because a component was compliant when it was originally assessed.

Suppliers can change:

• raw materials;
• formulations;
• manufacturing processes;
• coatings;
• plating;
• component suppliers;
• sub-suppliers; or
• production locations.

A material change can therefore affect the RoHS status of a component.

This is why effective RoHS management should include change control.

For example, if a supplier replaces the plastic formulation of a connector, the manufacturer should determine whether the existing RoHS evidence remains valid.

Similarly, a change in metal plating or solder alloy may require a reassessment.

5.17 Material Risk Is Not the Same for Every Component

Not every component requires the same level of investigation.

A practical RoHS process should be risk-based.

Higher-risk materials may include:

• flexible PVC;
• flame-retarded plastics;
• solder;
• metal alloys;
• surface coatings;
• cables;
• specialised electronic components; and
• materials supplied with incomplete chemical information.

Lower-risk materials may still require documentation, but the depth of verification can be different.

The manufacturer can therefore prioritise resources based on:

• material type;
• supplier reliability;
• component complexity;
• historical risk;
• regulatory changes;
• previous non-conformities; and
• the quality of available evidence.

This is generally more efficient than testing every material indiscriminately.

5.18 Why “RoHS Compliant” Alone Can Be Too Vague

Consider a supplier statement:

“Our component is RoHS compliant.”

This is useful information, but several questions remain.

For example:

• Which RoHS version was considered?
• Does the declaration cover all ten restricted substances?
• Which product revision does it cover?
• Is it based on supplier knowledge, material declarations or testing?
• Are any exemptions used?
• If exemptions are used, which ones?
• Does the declaration cover all materials in the component?
• When was the declaration issued?
• Has the supplier committed to notifying customers of material changes?

A manufacturer should therefore consider the quality and scope of the evidence, not just the existence of a declaration.

5.19 RoHS Compliance as a Material Chain

A useful way to think about RoHS is as a chain:

Raw material

↓

Material formulation

↓

Component

↓

Subassembly

↓

Finished product

↓

Technical documentation

The further a manufacturer is from the original material formulation, the more dependent it becomes on supplier information.

For example, a manufacturer purchasing a simple aluminium screw may have relatively straightforward material information.

A manufacturer purchasing a complex electronic module may depend on several tiers of suppliers to understand the materials inside that module.

The complexity of the supply chain therefore directly influences the complexity of the RoHS evidence.

5.20 The Role of IEC 63000

For manufacturers, this material assessment is closely connected to EN IEC 63000:2018, the harmonised standard addressing technical documentation for assessing electrical and electronic products with respect to restricted hazardous substances.

The European Commission recognised EN IEC 63000:2018 as the relevant harmonised standard replacing EN 50581:2012.

IEC 63000 provides a structured approach to technical documentation and the evaluation of materials, components and products.

It does not mean that every material must automatically be laboratory tested.

Instead, it supports an evidence-based assessment in which manufacturers determine what information is needed to demonstrate compliance.

The practical application of IEC 63000 will be examined in much greater detail in Chapter 7.

5.21 What This Means for Product Design

The most effective time to address RoHS is during product development, not after production has started.

Engineering teams can reduce compliance risks by:

• selecting known-compliant materials;
• specifying acceptable material grades;
• controlling approved suppliers;
• identifying restricted-substance risks during component selection;
• documenting relevant exemptions;
• including RoHS requirements in purchasing specifications; and
• establishing change-notification requirements.

This can prevent a common situation:

Engineering selects a component → Purchasing changes the supplier → Production starts → Compliance discovers a material problem.

A good RoHS process moves the compliance assessment upstream.

5.22 Example: A Cable Assembly

Consider a cable assembly containing:

• copper conductor;
• tin-plated conductor;
• PVC insulation;
• shielding;
• outer PVC jacket;
• connector;
• strain relief.

It should not be treated simply as:

“Cable – RoHS compliant.”

A stronger assessment would consider the relevant materials individually.

For example:

Copper conductor → metal composition

Plating → surface material

PVC insulation → polymer composition

Shielding → metal composition

Outer jacket → polymer composition

Connector → multiple materials

Strain relief → polymer composition

The manufacturer can then combine the available evidence into the overall RoHS assessment for the cable assembly.

This approach provides significantly better traceability.

5.23 Example: An Electronic Control Module

Consider an industrial control module containing:

• PCB;
• plastic housing;
• aluminium heat sink;
• connectors;
• display;
• cables;
• solder;
• adhesive;
• labels.

The module is one product or subassembly.

But from a RoHS perspective it contains many different materials.

A robust assessment therefore asks:

Which homogeneous materials are present?

↓

What evidence exists for each relevant material?

↓

Are any restricted substances above the applicable limits?

↓

Are any exemptions applicable?

↓

Is additional testing necessary?

This is much more meaningful than simply attaching a single supplier declaration to the BOM.

5.24 Material Selection Can Prevent Compliance Problems

One of the most cost-effective RoHS strategies is to address material compliance during design.

For example, if an engineering team is choosing between two functionally equivalent polymers, selecting a material with:

• established supplier documentation;
• known chemical composition;
• stable supply;
• controlled formulation; and
• strong RoHS evidence

can significantly reduce future compliance work.

The cheapest component is not necessarily the cheapest component from a compliance perspective.

A component with poor documentation may create:

• additional testing;
• supplier investigations;
• redesign;
• production delays;
• qualification work; or
• market-access problems.

Material selection therefore has a direct impact on compliance cost.

5.25 What Manufacturers Should Document

For each relevant material or component, manufacturers should ideally be able to establish:

• what the material or component is;
• who supplies it;
• which product or revision it belongs to;
• what material information is available;
• which RoHS substances have been assessed;
• what concentration limits apply;
• whether an exemption is relevant;
• what evidence supports the conclusion; and
• whether the evidence remains current.

The exact level of documentation should be proportionate to the product and risk.

The key objective is traceability.

5.26 The Practical Material Assessment

A practical RoHS material assessment can therefore follow this sequence:

1. Identify the component

↓

2. Break the component down into relevant materials

↓

3. Identify the potential RoHS substance risks

↓

4. Obtain supplier/material evidence

↓

5. Evaluate the evidence

↓

6. Check applicable exemptions

↓

7. Identify evidence gaps

↓

8. Perform targeted testing where justified

↓

9. Record the conclusion

↓

10. Maintain the assessment through change control

This process provides a much stronger basis for compliance than simply collecting generic supplier declarations.

5.27 The Key Takeaway

RoHS compliance is ultimately about the materials inside the product, not simply the product name or BOM line item.

The most important principles are:

• RoHS concentration limits are assessed at the homogeneous-material level.
• A component can contain multiple homogeneous materials.
• The complete product weight is not the basis for determining whether a material exceeds a RoHS limit.
• Plastics, PVC, cables, solder, metal alloys, coatings and other materials may require specific attention.
• Supplier information is a critical part of the evidence chain.
• Material and formulation changes can affect an existing compliance assessment.
• A risk-based approach is generally more effective than automatically testing every material.
• EN IEC 63000:2018 provides the recognised framework for the technical documentation used to assess materials, components and EEE for RoHS purposes.
• The best time to address RoHS is during product development, before material choices become difficult or expensive to change.

The next chapter moves from materials to evidence:

How can manufacturers demonstrate that their products actually comply with RoHS, and what should a defensible compliance file contain?

6. How Do Manufacturers Demonstrate RoHS Compliance?

Once a manufacturer has established that a product falls within the scope of RoHS and has identified the relevant materials and substances, the next question is:

How can the manufacturer demonstrate that the product actually complies?

This is where RoHS compliance becomes a documentation and evidence process.

A manufacturer does not normally demonstrate RoHS compliance simply by obtaining one laboratory report or collecting a single supplier declaration. The manufacturer needs to establish a reasonable and technically justified chain of evidence showing that the finished electrical and electronic equipment complies with the applicable substance restrictions.

The RoHS Directive places the responsibility for conformity on the manufacturer. By drawing up the EU Declaration of Conformity, the manufacturer assumes responsibility for compliance with the Directive.

The practical objective is therefore not to produce as much documentation as possible. It is to create documentation that is relevant, traceable, current and sufficient to support the compliance conclusion.

6.1 The Manufacturer Is Responsible

The manufacturer is ultimately responsible for ensuring that covered EEE complies with RoHS before it is placed on the EU market.

This remains true even when the manufacturer purchases components from suppliers that provide RoHS declarations.

A supplier may manufacture:

• a PCB;
• a connector;
• a cable;
• a power supply;
• a plastic housing; or
• another subassembly.

The supplier’s information can be an important part of the evidence.

However, the finished-product manufacturer still needs to determine whether the complete product complies with the applicable RoHS requirements.

This is particularly important when a product combines components from many suppliers.

A manufacturer therefore cannot simply argue:

“All of our suppliers told us that their components are RoHS compliant.”

The relevant question is whether the manufacturer has sufficient evidence to support the conformity of the finished product.

6.2 RoHS Compliance Is an Evidence-Based Process

A robust RoHS assessment can be visualised as a chain:

Product scope

↓

Bill of materials

↓

Components and materials

↓

Supplier information

↓

Material risk assessment

↓

Exemption assessment

↓

Additional testing where justified

↓

Technical documentation

↓

EU Declaration of Conformity

↓

CE marking

Each step supports the next.

The manufacturer should be able to explain how the information used to make the final compliance decision was obtained and how it relates to the actual product placed on the market.

This is why RoHS compliance should be established systematically rather than through isolated documents.

6.3 The Role of Technical Documentation

Technical documentation is central to demonstrating RoHS compliance.

The manufacturer needs to maintain documentation that supports the conclusion that the applicable requirements have been met.

The RoHS framework provides for an EU Declaration of Conformity and requires the relevant documentation to be maintained for ten years after the EEE has been placed on the market.

The technical documentation should therefore not be viewed as paperwork created only when an authority requests it.

It should be built as part of the product compliance process.

A well-structured technical file allows the manufacturer to answer questions such as:

• Why is the product within the scope of RoHS?
• Which RoHS requirements apply?
• Which materials were assessed?
• What information was obtained from suppliers?
• Which exemptions are used?
• Was testing performed?
• Why was testing considered necessary or unnecessary?
• How were evidence gaps addressed?
• How does the evidence relate to the production version of the product?

6.4 EN IEC 63000 Provides the Documentation Framework

For RoHS, the key harmonised standard for technical documentation is EN IEC 63000:2018 – Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances.

The European Commission published the reference to EN IEC 63000:2018 as the harmonised standard supporting Directive 2011/65/EU. It replaced EN 50581:2012, whose reference was subsequently withdrawn.

EN IEC 63000 is important because it provides a structured methodology for compiling the technical documentation needed to assess RoHS compliance.

It does not mean:

“Every component must be laboratory tested.”

Instead, it supports an evidence-based approach in which the manufacturer identifies the information needed to demonstrate compliance and evaluates the reliability of that information.

This distinction is fundamental.

6.5 What Should the Technical Documentation Contain?

The exact structure of a manufacturer’s technical documentation can vary depending on the product and the wider conformity assessment process.

For RoHS, however, a practical technical file will generally contain information such as:

• product identification;
• product description;
• product variants and model numbers;
• bill of materials;
• identification of relevant components and materials;
• supplier information;
• material declarations;
• supplier RoHS declarations;
• relevant specifications and drawings;
• assessment of restricted substances;
• applicable RoHS exemptions;
• supporting test reports where relevant;
• risk-based evaluation of evidence;
• change-control information; and
• the final RoHS conformity assessment.

Where RoHS is assessed together with other EU legislation, the manufacturer may maintain a broader technical file covering several requirements.

The RoHS information can then form one part of that overall technical documentation.

6.6 The Bill of Materials Is the Starting Point

The bill of materials is usually one of the first documents needed for a RoHS assessment.

It identifies the components used to manufacture the product.

A useful BOM should provide sufficient traceability to identify:

• component number;
• manufacturer;
• supplier;
• part number;
• revision;
• quantity;
• product location where relevant; and
• applicable specification.

However, the BOM alone is not sufficient.

A line such as:

C-1023 – Connector – Supplier XYZ

does not reveal the chemical composition of the connector.

The manufacturer must therefore connect the BOM to supporting supplier and material evidence.

This creates the essential relationship:

BOM item → supplier → material information → RoHS assessment

6.7 Supplier Declarations Are Important Evidence

Supplier declarations are one of the most commonly used sources of RoHS evidence.

A supplier may provide a declaration stating that a component complies with Directive 2011/65/EU and applicable amendments.

Such a declaration can be useful, especially when it is:

• product-specific;
• dated;
• traceable to a part number;
• linked to a specific revision;
• issued by an identifiable supplier;
• clear about applicable exemptions; and
• supported by an established supplier quality process.

However, manufacturers should not assume that every document carrying the words “RoHS compliant” has the same evidentiary value.

A one-line generic statement is fundamentally different from a controlled material declaration supported by technical information.

6.8 The Quality of the Evidence Matters

Consider two supplier documents.

Supplier A

“All products supplied by our company are RoHS compliant.”

Supplier B

A product-specific declaration identifying:

• manufacturer;
• part number;
• product revision;
• applicable RoHS requirements;
• restricted substances;
• applicable exemptions;
• declaration date; and
• responsible signatory.

Both documents say “RoHS compliant.”

But the second provides substantially better traceability.

The manufacturer should therefore evaluate not only whether evidence exists, but also how reliable and relevant that evidence is.

This is one of the central principles behind a risk-based RoHS documentation process.

6.9 What Makes Supplier Evidence Stronger?

Supplier information becomes more useful when it is:

Specific

It identifies the actual component or material.

Current

It reflects the material and product revision currently supplied.

Traceable

The manufacturer can connect the declaration to a specific BOM item.

Complete

It addresses the relevant RoHS substances and any applicable exemptions.

Controlled

The supplier has a process for managing material and product changes.

Supported

Where necessary, declarations are supported by material information or analytical data.

The manufacturer does not necessarily need the same level of evidence for every component.

The level of verification should be proportionate to the risk.

6.10 Supplier Declarations Are Not Automatically Sufficient

A supplier declaration can be an appropriate part of a RoHS assessment, but there are circumstances where additional verification may be justified.

Examples include:

• high-risk materials;
• unclear declarations;
• outdated documentation;
• significant supplier changes;
• new suppliers;
• unusual materials;
• suspected non-compliance;
• missing exemption information;
• inconsistent supplier information; or
• components with a history of RoHS problems.

In these situations, the manufacturer may need additional information or laboratory testing.

The objective should be to close a specific evidence gap rather than testing simply because testing is available.

6.11 Material Declarations Can Provide More Detail

A material declaration can provide more detailed information than a simple RoHS statement.

Depending on the supplier and industry, it may identify:

• material types;
• material composition;
• restricted substances;
• concentrations;
• homogeneous materials;
• exemptions; and
• other chemical information.

This can be particularly valuable for complex components.

For example, a connector supplier might provide information for:

• housing plastic;
• contact metal;
• plating;
• seal;
• solder;
• adhesive.

The manufacturer can then incorporate this information into its product-level RoHS assessment.

6.12 Full Chemical Composition Is Not Always Necessary

A common misconception is that a manufacturer must obtain the complete chemical formulation of every material.

That is not necessarily practical or necessary.

Suppliers may legitimately treat detailed formulations as confidential business information.

The manufacturer therefore needs sufficient information to demonstrate compliance, not necessarily unrestricted access to every proprietary formulation.

This is another reason why a risk-based evidence strategy is useful.

Where a reliable supplier declaration and appropriate supporting information provide sufficient confidence, demanding a complete proprietary formulation may add little practical value.

Where the evidence is weak or the material is high-risk, additional verification may be justified.

6.13 Exemptions Must Be Documented

RoHS exemptions are an important part of the compliance assessment.

If a product contains a restricted substance above the standard concentration limit but relies on a valid exemption, the manufacturer should document:

• the exemption number;
• the specific application;
• why the exemption applies;
• which product or component uses it;
• any relevant conditions;
• the current validity/status of the exemption; and
• the evidence supporting its use.

An exemption should never simply appear as:

“RoHS exemption applies.”

That statement is incomplete.

The manufacturer should be able to explain which exemption applies and why.

This is particularly important because RoHS exemptions can have specific scopes, conditions and validity periods.

6.14 Exemptions Need Ongoing Monitoring

An exemption is not necessarily permanent.

RoHS exemptions can be amended, renewed, replaced or allowed to expire.

Therefore, a manufacturer that relies on an exemption should monitor its regulatory status.

This is particularly important for products with long lifecycles.

For example, an industrial product may remain in production for ten or fifteen years.

An exemption used when the product was originally designed may not have exactly the same legal status years later.

A mature compliance process therefore includes exemption monitoring and change management.

6.15 When Should Manufacturers Use Laboratory Testing?

Laboratory testing can provide valuable evidence, but it should generally be used strategically.

Testing may be appropriate when:

• supplier evidence is unavailable;
• supplier evidence is insufficient;
• a material is considered high-risk;
• a supplier’s declaration is questionable;
• a new supplier is introduced;
• the material formulation has changed;
• regulatory uncertainty exists;
• a customer requires independent testing; or
• there is a specific reason to verify a material analytically.

Testing can also be useful as part of a supplier-monitoring programme.

However, the existence of a laboratory report does not automatically make the complete product RoHS compliant.

The test must be relevant to the material and compliance question being assessed.

6.16 Testing the Wrong Material Does Not Solve the Problem

Consider a product with:

• metal housing;
• plastic connector;
• PVC cable;
• PCB;
• solder;
• coating.

If a laboratory tests only the external housing, the test result says very little about the RoHS status of the other materials.

Similarly, testing a complete product without understanding the homogeneous-material structure may make the result difficult to interpret.

The manufacturer should therefore define the testing objective before sending samples to a laboratory.

The question should be:

What specific evidence gap are we trying to close?

rather than:

Can we test the product for RoHS?

This distinction can prevent unnecessary testing costs.

6.17 Analytical Testing Has Technical Limitations

RoHS testing involves analytical methods with different capabilities.

Some substances can be screened effectively using techniques such as X-ray fluorescence (XRF), while others require more specific analytical methods.

For example, XRF can be useful for screening elements such as:

• lead;
• mercury;
• cadmium;
• total chromium; and
• total bromine.

However, total chromium is not automatically equivalent to hexavalent chromium, and total bromine is not automatically equivalent to PBB or PBDE.

This means that a screening result must be interpreted correctly.

Where the restricted substance is defined by a specific chemical form, further analytical work may be required to establish the relevant concentration.

Testing strategy therefore needs to consider the substance definition, analytical method and regulatory limit.

6.18 Test Reports Should Be Traceable

A useful RoHS test report should allow the manufacturer to establish:

• what was tested;
• which sample was tested;
• which component or material it represented;
• the sample identification;
• the test date;
• the analytical methods;
• the substances or parameters tested;
• the measured results; and
• the applicable limits.

A report stating only:

“Product XYZ – RoHS Pass”

provides less useful evidence than a report with detailed sample and material identification.

Traceability is particularly important when a product has multiple revisions.

6.19 Testing Is a Snapshot

A laboratory test represents the sample that was tested.

It does not automatically prove that every future production unit contains exactly the same materials.

This is why laboratory testing should be integrated with:

• supplier control;
• material specifications;
• change management;
• production controls; and
• technical documentation.

If a supplier changes a plastic formulation after testing, the old test report may no longer fully represent the current material.

Testing therefore provides evidence at a particular point in the product lifecycle.

6.20 Risk-Based Assessment Is More Efficient

A manufacturer with 2,000 components could theoretically attempt to test every material.

That would often be expensive, slow and unnecessary.

A better approach is to classify materials according to risk.

For example:

Higher-risk

• flexible PVC;
• flame-retarded plastics;
• metal alloys;
• solder;
• coatings;
• complex imported components;
• components with weak supplier documentation.

Medium-risk

• standard plastic parts;
• connectors;
• cables with controlled material specifications;
• components from established suppliers.

Lower-risk

• materials with well-controlled specifications;
• components supported by strong, current supplier evidence;
• materials with low historical risk.

The precise classification should be determined by the manufacturer based on its products and supply chain.

The important principle is that verification effort should follow risk.

6.21 Combining Different Evidence Sources

A strong RoHS assessment may therefore combine several types of evidence.

For example:

Evidence	Typical Purpose
BOM	Identifies components
Supplier declaration	Provides supplier conformity statement
Material declaration	Provides material-level information
Component specification	Identifies construction/materials
Technical drawing	Supports material and construction assessment
Exemption assessment	Supports use of restricted substance exemptions
Laboratory report	Provides analytical verification
Change notification	Confirms continued validity
Risk assessment	Determines level of verification needed

No single document necessarily proves everything.

The strength comes from the combination of relevant evidence.

6.22 Building a RoHS Evidence Matrix

For complex products, an evidence matrix can be extremely useful.

A manufacturer could maintain a table such as:

BOM Item	Component	Supplier	Material Risk	Supplier Evidence	Test Report	Exemption	Status
C001	Connector	Supplier A	Medium	Yes	No	No	Compliant
C002	Cable	Supplier B	High	Yes	Yes	No	Compliant
C003	PCB	Supplier C	High	Yes	No	Yes	Compliant
C004	Housing	Supplier D	Medium	Yes	No	No	Compliant
C005	Solder	Supplier E	High	Yes	Yes	No	Compliant

The exact format can vary.

The important feature is traceability from the product BOM to the evidence supporting each relevant material or component.

This can make internal reviews and regulatory inspections significantly easier.

6.23 Managing Evidence Through Product Changes

RoHS documentation should be connected to the manufacturer’s change-control process.

Changes that may require a RoHS review include:

• new supplier;
• alternative component;
• new material;
• changed material formulation;
• revised coating;
• changed plating;
• new manufacturing location;
• revised component design;
• supplier process change; or
• regulatory change affecting a substance or exemption.

The manufacturer should define when a change triggers:

• document review;
• supplier confirmation;
• risk reassessment;
• laboratory testing; or
• a new compliance assessment.

This prevents the technical file from becoming outdated while the product continues to change.

6.24 The EU Declaration of Conformity

After the manufacturer has established conformity, it must prepare an EU Declaration of Conformity.

The RoHS Directive provides a specific model structure in Annex VI.

The declaration includes information such as:

• a unique identification of the EEE;
• manufacturer information;
• identification of the product;
• the statement of conformity with Directive 2011/65/EU;
• applicable harmonised standards or technical specifications, where relevant;
• additional information;
• place and date of issue; and
• the name, function and signature of the authorised person.

The declaration is not merely a supplier document.

It is the manufacturer’s formal statement of responsibility for the conformity of the EEE.

6.25 The EU Declaration Must Be Kept Up to Date

The RoHS Directive requires the EU Declaration of Conformity to be updated where necessary.

This means that the declaration should not simply be created once and forgotten.

Changes to:

• product design;
• product identification;
• applicable legislation;
• harmonised standards;
• exemptions; or
• other relevant technical information

may require the compliance documentation to be reviewed.

The manufacturer should therefore have a process for maintaining the declaration alongside the technical documentation.

6.26 CE Marking

RoHS is part of the CE-marking framework.

For covered EEE, the CE marking must be affixed before the product is placed on the market and must be visible, legible and indelible on the finished equipment or its data plate where practicable. Where that is not possible or warranted because of the nature of the EEE, it may be placed on the packaging and accompanying documents.

The CE marking indicates conformity with the applicable EU harmonisation legislation for which the manufacturer is responsible.

It should therefore not be interpreted as a symbol that means simply:

“This product is RoHS compliant.”

A product may be subject to several pieces of EU legislation that all contribute to its CE conformity.

6.27 RoHS Does Not Normally Require a Notified Body

RoHS conformity is generally based on the manufacturer’s own assessment and technical documentation.

A manufacturer does not normally need to obtain a certificate from a notified body simply to demonstrate RoHS compliance.

This is an important practical distinction from regulatory frameworks where third-party conformity assessment may be mandatory.

The manufacturer remains responsible for determining the appropriate evidence and establishing conformity.

Where other applicable EU legislation requires a conformity assessment procedure that is at least as stringent, RoHS conformity can, under the Directive, be demonstrated within that procedure, and a single technical documentation file may be used.

6.28 Market Surveillance

RoHS compliance documentation is particularly important in the context of market surveillance.

Authorities can request information and documentation necessary to demonstrate conformity.

A manufacturer should therefore be able to retrieve the relevant evidence efficiently rather than reconstructing the compliance assessment after receiving a request.

This is another reason why a structured technical file is valuable.

A good compliance system should allow the manufacturer to move from:

Product → BOM → Component → Supplier → Evidence

without significant gaps.

6.29 Keeping Documentation for Ten Years

The RoHS framework requires the relevant EU Declaration of Conformity and technical documentation to be kept for ten years after the EEE has been placed on the market.

This has practical implications for document management.

Manufacturers should consider:

• document retention;
• version control;
• access rights;
• supplier-document archiving;
• test-report storage;
• product revision history; and
• long-term traceability.

A supplier declaration stored only in an employee’s email account is not a robust long-term compliance system.

6.30 A Practical RoHS Compliance Workflow

A manufacturer can structure the process as follows:

Step 1 – Determine RoHS scope

↓

Step 2 – Identify the product and applicable category

↓

Step 3 – Identify exclusions and exemptions

↓

Step 4 – Create or review the BOM

↓

Step 5 – Identify relevant homogeneous materials

↓

Step 6 – Request supplier evidence

↓

Step 7 – Evaluate the quality and relevance of the evidence

↓

Step 8 – Perform a material and supplier risk assessment

↓

Step 9 – Conduct targeted testing where evidence gaps remain

↓

Step 10 – Document exemptions and their applicability

↓

Step 11 – Compile the technical documentation

↓

Step 12 – Prepare the EU Declaration of Conformity

↓

Step 13 – Affix CE marking

↓

Step 14 – Maintain compliance through change control and regulatory monitoring

This process is scalable from relatively simple products to complex industrial equipment.

6.31 What a Defensible RoHS File Looks Like

A strong RoHS technical file should allow an independent reviewer to follow the logic from the product to the final conclusion.

For example:

Product: Industrial wireless controller
RoHS scope: Category 9 / Category 11 assessment
BOM: Revision 4
Components assessed: 146
Supplier evidence: 138 components
Additional material declarations: 8 components
Laboratory testing: 6 high-risk materials
Exemptions: 2 documented applications
Evidence gaps: None outstanding
RoHS conclusion: Conforming
EU DoC: Issued
Technical file: Controlled and archived

The exact numbers are only illustrative.

The important principle is that the conclusion can be traced back to the underlying evidence.

6.32 What Manufacturers Should Avoid

Manufacturers should be cautious about relying on:

• generic undated supplier declarations;
• declarations that do not identify the relevant product;
• outdated RoHS versions;
• unexplained exemption references;
• test reports that cannot be linked to the production material;
• tests performed on the wrong material;
• one test report being used to represent unrelated components;
• assumptions that “lead-free” means fully RoHS compliant;
• assumptions that “halogen-free” means fully RoHS compliant; or
• a CE mark being treated as a substitute for technical documentation.

These approaches may create the appearance of compliance without providing a sufficiently defensible evidence base.

6.33 The Key Takeaway

Demonstrating RoHS compliance is fundamentally about building a credible chain of evidence.

The most important principles are:

• The manufacturer is responsible for demonstrating conformity.
• Supplier declarations are useful but should be evaluated for quality, relevance and traceability.
• The BOM provides the connection between the finished product and its components.
• Material-level information is important because RoHS limits apply at the homogeneous-material level.
• EN IEC 63000:2018 provides the harmonised technical-documentation framework for RoHS assessment.
• Laboratory testing can strengthen the evidence but should be targeted at specific risks or evidence gaps.
• RoHS exemptions must be identified, justified and monitored.
• The EU Declaration of Conformity formalises the manufacturer’s responsibility for compliance.
• CE marking is part of the overall EU conformity framework and does not replace the underlying technical documentation.
• Technical documentation and the EU Declaration of Conformity must generally be retained for ten years after the EEE is placed on the market.
• Compliance must be maintained when products, suppliers, materials or regulatory requirements change.

The next chapter goes deeper into the technical-documentation framework itself:

What is IEC 63000, what does it actually require, and how should manufacturers use it to structure their RoHS compliance documentation?

7. IEC 63000 and Technical Documentation

Once a manufacturer has identified the applicable RoHS requirements and assessed the relevant materials and components, the next question is:

How should all of this evidence be structured and documented?

This is where EN IEC 63000:2018 becomes particularly important.

EN IEC 63000:2018 is the harmonised standard used in the EU framework for the technical documentation required to assess materials, components and electrical and electronic equipment with respect to the restriction of hazardous substances.

It replaced EN 50581:2012. The European Commission published the reference to EN IEC 63000:2018 in the Official Journal through Commission Implementing Decision (EU) 2020/659, while the reference to EN 50581:2012 was withdrawn with effect from 18 November 2021.

For manufacturers, the important point is that IEC 63000 is not a laboratory-testing standard. It provides a structured approach for compiling and evaluating the technical evidence used to support a RoHS conformity assessment.

7.1 What Is IEC 63000?

IEC 63000:2016 is an international standard addressing the technical documentation needed to assess electrical and electronic products with respect to restricted hazardous substances.

The European version is:

EN IEC 63000:2018

The European Commission recognised EN IEC 63000:2018 as the harmonised standard supporting Directive 2011/65/EU. The Commission’s decision specifically states that the standard establishes specifications for the technical documentation required for assessing materials, components and EEE with respect to RoHS.

In practical terms, IEC 63000 helps a manufacturer answer:

• What materials and components are used?
• What information is available about them?
• Which suppliers provided that information?
• How reliable is the information?
• What additional evidence is necessary?
• How is the evidence connected to the finished product?
• How can the manufacturer demonstrate that the RoHS assessment is technically justified?

It therefore provides a framework for evidence management.

7.2 IEC 63000 Does Not Mean “Test Everything”

One of the biggest misconceptions about IEC 63000 is that it requires laboratory testing of every component.

It does not.

The standard is based on the principle that manufacturers can use different forms of technical evidence to establish conformity.

Depending on the product and supply chain, evidence may include:

• supplier declarations;
• material declarations;
• component specifications;
• technical drawings;
• material data;
• supplier quality information;
• existing test reports;
• analytical test results;
• exemption information; and
• other relevant technical documentation.

Laboratory testing can therefore be part of the assessment, but it is not automatically required for every material.

This is consistent with the European Commission’s recognition of EN IEC 63000 as the standard for the technical documentation used to assess materials, components and EEE.

7.3 Why IEC 63000 Matters

Without a structured approach, a RoHS technical file can quickly become a collection of unrelated documents.

A manufacturer may have:

• 500 supplier declarations;
• 30 test reports;
• several spreadsheets;
• hundreds of emails;
• component specifications; and
• various versions of material declarations.

The problem is not necessarily a lack of information.

The problem is lack of structure and traceability.

IEC 63000 provides a framework for connecting the evidence to the product.

The objective is essentially:

Product

↓

Components

↓

Materials

↓

Supplier information

↓

Technical evidence

↓

RoHS assessment

This makes the final compliance conclusion much easier to defend.

7.4 IEC 63000 and EN 50581

Before EN IEC 63000:2018, manufacturers commonly used EN 50581:2012 for RoHS technical documentation.

EN IEC 63000:2018 replaced that standard.

The European Commission explicitly states that EN IEC 63000:2018 was developed as the successor to EN 50581:2012 and that the reference to EN 50581 was withdrawn from the Official Journal on 18 November 2021.

Therefore, manufacturers preparing current RoHS technical documentation should refer to the applicable current framework rather than treating EN 50581:2012 as the current harmonised standard.

A document that still refers to EN 50581 is not automatically evidence of non-compliance, but manufacturers should understand that EN IEC 63000:2018 is the relevant harmonised standard reference in the EU framework.

7.5 Harmonised Standard vs. Legal Requirement

Another important distinction is the relationship between the RoHS Directive and IEC 63000.

The legal requirement comes from:

Directive 2011/65/EU

The harmonised standard provides a recognised technical methodology for supporting conformity.

In other words:

The Directive establishes the legal requirements; EN IEC 63000 provides a recognised way of structuring the technical documentation used to demonstrate conformity.

A manufacturer should therefore not confuse the standard with the legislation itself.

The legal obligation to comply with RoHS exists because the product falls within the scope of the Directive.

IEC 63000 helps the manufacturer build the evidence supporting that conclusion.

7.6 Presumption of Conformity

The European Commission’s Implementing Decision explains that compliance with a harmonised standard can provide a presumption of conformity with the corresponding requirements covered by that standard, from the date its reference is published in the Official Journal.

This is an important benefit of using the recognised standard.

However, this does not mean:

“If I mention IEC 63000 in my technical file, the product is automatically RoHS compliant.”

The manufacturer still needs to actually apply the relevant methodology and maintain appropriate technical evidence.

Simply writing:

“RoHS assessed according to EN IEC 63000:2018.”

does not replace the underlying assessment.

7.7 What Is the Manufacturer Actually Trying to Demonstrate?

The purpose of the RoHS technical documentation is to support the manufacturer’s conclusion that the applicable substance restrictions have been met.

This means the documentation should allow the manufacturer to establish:

1. which product was assessed;
2. which components and materials are included;
3. which evidence was used;
4. how that evidence was evaluated;
5. which exemptions were considered;
6. whether additional verification was necessary; and
7. why the final conclusion is justified.

The technical file should therefore tell a coherent story.

It should not simply contain a large number of documents.

7.8 Product Identification

The first requirement of good technical documentation is knowing exactly which product has been assessed.

The documentation should normally allow the manufacturer to identify:

• product name;
• model number;
• part number;
• product family;
• variants;
• hardware revision;
• software or firmware version where relevant;
• BOM revision; and
• production version.

This becomes particularly important for products that exist in multiple variants.

For example, if a manufacturer has:

• Model A;
• Model A-W;
• Model A-EU;
• Model A-US; and
• Model A-Pro,

it should be clear which configurations are covered by the RoHS assessment.

7.9 The Bill of Materials

The BOM is one of the central documents connecting the finished product to its underlying materials.

A useful BOM should ideally contain enough information to identify:

• component number;
• manufacturer;
• supplier;
• part number;
• revision;
• description;
• quantity; and
• relevant configuration information.

For complex products, the BOM may contain several levels.

For example:

Finished Product

→ Main PCB

→ Power supply

→ Display assembly

→ Cable assembly

→ Housing

Each of these assemblies can then contain further components and materials.

The technical documentation should provide sufficient traceability to understand the relevant material chain.

7.10 Supplier Information

IEC 63000 is particularly relevant where manufacturers depend on information from their suppliers.

A manufacturer does not necessarily formulate every material itself.

Instead, the supply chain may look like:

Raw material supplier

↓

Material manufacturer

↓

Component manufacturer

↓

Subassembly manufacturer

↓

Finished-product manufacturer

The further the manufacturer is from the original material formulation, the more important supplier evidence becomes.

The manufacturer should therefore establish a process for collecting and evaluating relevant information.

7.11 Types of Supplier Evidence

Supplier evidence can take many forms.

Examples include:

RoHS declarations

A supplier formally declares that a component complies with applicable RoHS requirements.

Material declarations

The supplier provides information about the materials and substances contained in a component.

Test reports

The supplier provides analytical test results for relevant materials.

Product specifications

Technical specifications identify the material grade or construction of the component.

Engineering drawings

Drawings can provide information about coatings, materials and construction.

Certificates or declarations

Additional conformity documents may support the material assessment.

Change notifications

Supplier notifications can demonstrate that the material or manufacturing process has remained unchanged or identify a new material requiring reassessment.

The manufacturer should consider how each document contributes to the overall evidence.

7.12 Evidence Quality Matters

IEC 63000 does not make all evidence equally valuable.

Consider two declarations.

Declaration A

“Our products are RoHS compliant.”

Declaration B

A signed declaration identifying:

• supplier;
• manufacturer;
• exact part number;
• product revision;
• applicable RoHS requirements;
• applicable exemptions;
• declaration date; and
• responsible person.

Both documents contain a RoHS statement.

However, the second provides significantly stronger traceability.

A good technical documentation process therefore evaluates the quality and relevance of evidence, not merely its existence.

7.13 Evidence Should Be Linked to the Product

One of the most important principles is traceability.

A manufacturer should be able to answer:

Which document supports the RoHS assessment of this particular component?

For example:

BOM Item C1023

↓

Supplier: ABC Electronics

↓

Part Number: ABC-4456

↓

Revision: B

↓

Supplier RoHS Declaration: RD-2026-018

↓

Material Declaration: MD-2026-018

↓

RoHS Assessment: Compliant

This is much stronger than storing a folder called:

“RoHS Supplier Documents”

containing thousands of unrelated files.

7.14 Risk-Based Evidence

IEC 63000 supports a practical approach in which manufacturers determine the information necessary to demonstrate compliance based on the available evidence and the product.

This allows manufacturers to allocate verification effort intelligently.

For example:

Low-risk component

A standard component from a long-term supplier with:

• current declaration;
• identifiable part number;
• controlled material specification; and
• established change-control process.

Additional laboratory testing may provide little additional value.

High-risk component

A complex plastic component from a new supplier with:

• generic declaration;
• unclear material composition;
• no exemption information; and
• limited traceability.

Additional information or testing may be justified.

This approach prevents compliance from becoming unnecessarily expensive.

7.15 The Importance of Homogeneous Materials

IEC 63000 must ultimately support the assessment of the relevant materials against the RoHS restrictions.

This means that manufacturers need to understand the relationship between:

Component → Homogeneous Material → Restricted Substance

For example:

Connector

→ Plastic housing

→ Metal contact

→ Plating

→ Seal

Each material may require different evidence.

A single declaration for the connector can be useful, but the manufacturer should understand what the declaration actually covers.

7.16 Material Declarations

Material declarations can be particularly valuable for complex products.

Depending on the supplier and industry, they can provide information such as:

• material type;
• material composition;
• restricted substances;
• concentration information;
• homogeneous materials;
• applicable exemptions; and
• material identification.

The manufacturer can then use this information to build the product-level assessment.

A material declaration is therefore often more informative than a generic statement that a component is “RoHS compliant.”

7.17 Laboratory Test Reports

Laboratory reports can form part of the technical documentation where testing is necessary or useful.

However, the manufacturer should ensure that the test report is relevant to the material being assessed.

Important information includes:

• sample identification;
• component identification;
• material identification;
• test date;
• analytical method;
• substances tested;
• measured concentrations;
• applicable limits; and
• laboratory identification.

A test report should be traceable to the product configuration being assessed.

7.18 Testing Should Address an Evidence Gap

A useful principle is:

Testing should answer a compliance question.

For example:

“The supplier has provided insufficient information about the composition of the plastic housing. We need to verify whether relevant RoHS substances are present above the applicable limits.”

That is a clear testing objective.

By contrast:

“We test everything because RoHS requires testing.”

is generally a poor compliance strategy.

The first approach is targeted and evidence-driven.

7.19 Exemptions in the Technical File

Where an exemption is used, the technical documentation should make the reasoning clear.

The file should allow a reviewer to determine:

• which exemption is being used;
• which component or material uses it;
• which application is covered;
• why the exemption applies;
• whether its conditions are fulfilled; and
• whether the exemption is still applicable.

For example:

Component: High-temperature ceramic component

Restricted substance: Lead

Exemption: [Applicable exemption]

Application: [Defined application]

Reason for use: [Technical application]

Evidence: Supplier declaration + technical specification

Status: Valid / under review

The exact details depend on the exemption.

The important principle is that exemptions should be documented and traceable.

7.20 Change Control Is Part of Technical Documentation

A technical file should not be treated as a static document.

Products change.

Suppliers change.

Materials change.

Regulatory requirements change.

Examples include:

• alternative components;
• new suppliers;
• new manufacturing locations;
• changed plastic formulations;
• different coatings;
• new solder alloys;
• revised PCB materials;
• component substitutions; and
• regulatory changes affecting exemptions.

A change-control process should determine whether the RoHS assessment needs to be updated.

7.21 The Relationship Between Engineering and Compliance

RoHS documentation should not be created only by the regulatory department.

Engineering, purchasing, quality and regulatory functions may all contribute important information.

For example:

Engineering

provides:

• BOM;
• drawings;
• specifications;
• product revisions.

Purchasing

provides:

• supplier information;
• supplier declarations;
• change notifications.

Quality

provides:

• supplier qualification;
• quality records;
• change-control information.

Regulatory / Compliance

provides:

• RoHS assessment;
• exemption evaluation;
• evidence review;
• final conformity conclusion.

A structured process connects these functions.

7.22 A Practical IEC 63000 Documentation Structure

A manufacturer could structure its RoHS documentation as follows:

1. Product Identification

• product name;
• model;
• part number;
• revision;
• product family.

2. RoHS Scope Assessment

• EEE classification;
• applicable category;
• exclusions considered;
• RoHS applicability conclusion.

3. Product Structure

• BOM;
• assemblies;
• components;
• relevant materials.

4. Supplier Evidence

• RoHS declarations;
• material declarations;
• specifications;
• supplier certificates;
• change notifications.

5. Material Assessment

• homogeneous materials;
• restricted substances;
• concentration information;
• risk classification.

6. Exemption Assessment

• exemption number;
• application;
• applicability;
• supporting evidence.

7. Laboratory Evidence

• test reports;
• analytical results;
• sample identification;
• test methods.

8. Final Assessment

• evidence review;
• outstanding gaps;
• conformity conclusion.

9. Declaration of Conformity

• signed EU Declaration of Conformity.

This is not a mandatory folder structure prescribed word-for-word by the Directive.

It is a practical way to organise the evidence.

7.23 Example: Simple Product

Consider a simple electronic temperature sensor containing:

• PCB;
• plastic housing;
• connector;
• cable;
• display.

The manufacturer could establish:

PCB

→ Supplier RoHS declaration
→ Material declaration

Housing

→ Material specification
→ Supplier declaration

Connector

→ Supplier declaration
→ Material declaration

Cable

→ Cable specification
→ Supplier declaration

Display

→ Supplier declaration
→ Material information

If the evidence is sufficiently reliable and no significant gaps remain, additional laboratory testing may not be necessary.

The manufacturer can document the evidence assessment and establish the RoHS conclusion.

7.24 Example: Complex Industrial Product

Now consider a complex industrial controller containing:

• 4 PCBs;
• 12 cable assemblies;
• 40 connectors;
• 8 power modules;
• 3 displays;
• 2 cooling systems;
• numerous metal parts;
• several polymer components.

The manufacturer may have hundreds or thousands of individual materials.

Testing everything would be impractical.

Instead, the manufacturer can establish:

• product structure;
• material risks;
• supplier evidence;
• evidence quality;
• identified gaps;
• targeted testing;
• applicable exemptions; and
• final assessment.

This is where a structured IEC 63000 approach becomes particularly valuable.

7.25 IEC 63000 Does Not Replace Supplier Management

A manufacturer cannot simply purchase components and then expect IEC 63000 to solve missing supplier information.

Effective compliance still requires a functioning supply-chain process.

Purchasing specifications can require suppliers to provide:

• current RoHS declarations;
• material information;
• exemption information;
• change notifications; and
• supporting documentation upon request.

Supplier agreements can also define obligations for communicating relevant material changes.

This turns RoHS from a one-time documentation exercise into an ongoing supply-chain process.

7.26 IEC 63000 and the Technical File

The RoHS technical documentation can be part of the manufacturer’s broader technical file.

A modern electrical product may simultaneously require evidence for:

• RoHS;
• EMC;
• electrical safety;
• radio requirements;
• cybersecurity;
• WEEE;
• REACH;
• batteries;
• energy efficiency; and
• other applicable legislation.

The manufacturer does not necessarily need completely separate technical files for each requirement.

Instead, evidence can be organised within an integrated technical documentation system.

RoHS-specific evidence can then form one clearly identifiable part of the overall product compliance file.

7.27 What a Good Technical File Should Allow

A well-designed technical file should allow a reviewer to start with the finished product and work backwards.

For example:

Product

↓

Product revision

↓

BOM

↓

Component

↓

Material

↓

Supplier evidence

↓

RoHS substance assessment

↓

Exemption, if applicable

↓

Final conclusion

If this chain can be followed without major gaps, the manufacturer has a strong foundation for demonstrating compliance.

7.28 What a Weak Technical File Looks Like

A weak technical file may contain:

• generic supplier declarations;
• outdated documents;
• missing product revisions;
• test reports without sample identification;
• unexplained exemptions;
• duplicate documents;
• supplier documents that cannot be linked to BOM items;
• no evidence of change control; or
• a final “RoHS compliant” statement without a documented assessment.

The problem is not necessarily that the manufacturer has no evidence.

The problem is that the evidence cannot be reliably connected to the product.

7.29 IEC 63000 and Long-Term Compliance

The value of structured documentation becomes even greater when products remain on the market for many years.

Consider an industrial product with a ten-year lifecycle.

During that period:

• suppliers may change;
• components may become obsolete;
• materials may change;
• exemptions may change;
• new RoHS amendments may be introduced.

A structured technical documentation system allows the manufacturer to identify what needs to be reassessed.

Without traceability, every change can become a manual investigation.

With traceability, the manufacturer can identify affected components and evidence much more efficiently.

7.30 The Practical IEC 63000 Workflow

A manufacturer can translate the standard’s documentation principles into a practical workflow:

Step 1 – Identify the product

↓

Step 2 – Determine RoHS applicability

↓

Step 3 – Establish the product structure and BOM

↓

Step 4 – Identify relevant materials and components

↓

Step 5 – Collect supplier and material information

↓

Step 6 – Evaluate the quality and relevance of the evidence

↓

Step 7 – Identify evidence gaps

↓

Step 8 – Perform targeted testing where justified

↓

Step 9 – Assess exemptions

↓

Step 10 – Document the conformity assessment

↓

Step 11 – Prepare the EU Declaration of Conformity

↓

Step 12 – Maintain the file through change control

This creates a repeatable compliance process rather than a one-time paperwork exercise.

7.31 The Key Takeaway

EN IEC 63000:2018 is the key harmonised standard for RoHS technical documentation in the EU framework. It replaced EN 50581:2012, with the latter’s reference withdrawn from the Official Journal on 18 November 2021.

The most important principles are:

• IEC 63000 is about technical documentation, not simply laboratory testing.
• It provides a structured approach to assessing materials, components and EEE.
• Supplier declarations and material information can form important parts of the evidence.
• The quality, relevance and traceability of evidence matter.
• Testing can be used where necessary to close specific evidence gaps.
• Exemptions should be documented and linked to the relevant application.
• Product, component and material information should remain traceable.
• Change control is essential for maintaining the validity of the assessment.
• A well-structured RoHS file should allow the manufacturer to trace the final conclusion back to the underlying evidence.
• Using a harmonised standard can provide a recognised route for supporting conformity with the corresponding requirements covered by the standard.

Ultimately, IEC 63000 helps turn RoHS compliance from a collection of supplier documents into a structured, traceable and defensible technical assessment.

The next chapter focuses on one of the most important practical parts of that process:

What evidence should manufacturers actually request from their suppliers, and how can they distinguish useful compliance evidence from weak or generic declarations?

8. What Evidence Should Manufacturers Request from Suppliers?

Supplier information is one of the most important sources of evidence in a RoHS compliance assessment.

Most manufacturers do not manufacture every material and component used in their products themselves. A finished electrical product may contain hundreds or thousands of components sourced from multiple suppliers, countries and supply-chain levels.

The manufacturer therefore needs a practical way to obtain enough information from suppliers to assess whether the final product complies with the RoHS substance restrictions.

However, there is an important distinction:

Collecting supplier declarations is not the same as demonstrating RoHS compliance.

The manufacturer needs to determine whether the information received is relevant, current, traceable and sufficient for the specific product and material being assessed.

This chapter explains what manufacturers should request from suppliers, how supplier evidence should be evaluated, and when a simple RoHS declaration may not be enough.

8.1 Why Supplier Evidence Is So Important

A finished product manufacturer often has limited visibility into the chemical composition of purchased components.

Consider a manufacturer producing an industrial controller.

The final product may contain:

• 4 printed circuit boards;
• 35 connectors;
• 12 cable assemblies;
• 150 electronic components;
• several plastic parts;
• metal housings;
• coatings;
• adhesives;
• displays; and
• power supplies.

The manufacturer knows which components are used, but it may not know the detailed material composition of every component.

The relevant information therefore needs to come from the supply chain.

A typical evidence chain looks like this:

Finished Product

↓

BOM

↓

Purchased Component

↓

Supplier

↓

Material Information

↓

RoHS Assessment

This is one of the reasons why supplier management is an integral part of RoHS compliance.

8.2 The Manufacturer Remains Responsible

The fact that a supplier provides a RoHS declaration does not transfer the manufacturer’s legal responsibility for the finished product.

The supplier can provide evidence.

The manufacturer must evaluate that evidence and establish conformity for the product it places on the market.

For example:

Supplier A declares its connector to be RoHS compliant.

The finished-product manufacturer still needs to determine:

• whether the declaration applies to the exact connector used;
• whether the relevant product revision is covered;
• whether any exemptions are involved;
• whether the declaration is current;
• whether the component has changed;
• and whether the evidence is sufficient for the manufacturer’s overall assessment.

This distinction is essential.

8.3 What Should a Manufacturer Request?

There is no single document that is universally sufficient for every supplier and every component.

Depending on the component and risk, manufacturers may request:

1. RoHS Declaration of Conformity
2. Material Declaration
3. Full or partial material composition information
4. Component specifications
5. Technical drawings
6. Information about applicable RoHS exemptions
7. Laboratory test reports
8. Supplier change notifications
9. Manufacturing or material revision information
10. Confirmation of compliance with current RoHS requirements

The appropriate combination depends on the product, component and quality of the available evidence.

8.4 RoHS Supplier Declaration

The most common document is a supplier RoHS declaration.

A typical declaration may state that a component complies with:

Directive 2011/65/EU and applicable amendments.

This can be useful evidence.

However, manufacturers should look beyond the headline statement.

A strong supplier declaration should ideally identify:

• supplier name;
• supplier address;
• product or component name;
• exact part number;
• product revision where applicable;
• applicable RoHS legislation;
• relevant amendments;
• applicable exemptions;
• declaration date;
• responsible person; and
• signature or other controlled approval.

The more clearly the declaration is connected to the actual supplied component, the more useful it becomes.

8.5 Generic vs. Product-Specific Declarations

There is a significant difference between:

“All products supplied by Company XYZ are RoHS compliant.”

and:

“Part No. ABC-123, Revision B, supplied by Company XYZ, complies with Directive 2011/65/EU and applicable amendments. Exemption X is used for application Y.”

The second declaration provides considerably more traceability.

A manufacturer should therefore be cautious about accepting generic declarations as the sole evidence for complex or high-risk components.

Generic statements may still have value, particularly when combined with:

• controlled supplier relationships;
• material specifications;
• change-control procedures; and
• other supporting evidence.

But their evidentiary strength should be assessed rather than assumed.

8.6 The Exact Part Number Matters

One of the simplest but most important checks is:

Does the supplier document identify the exact component being used?

For example:

BOM: ABC-123 Rev. C

Supplier declaration:

ABC-123

This may be acceptable depending on the supplier’s document-control system, but the manufacturer should understand whether the declaration covers all revisions.

A declaration for:

ABC-120

does not automatically prove compliance for:

ABC-123.

Similarly, a declaration covering a product family may or may not cover every variant within that family.

The manufacturer should understand the supplier’s scope.

8.7 Product Families Can Be Useful — But Need Definition

Suppliers sometimes provide declarations covering an entire product family.

For example:

“The ABC connector series is compliant with RoHS.”

This can be efficient.

However, the manufacturer should establish:

• which part numbers belong to the family;
• whether all material variants are covered;
• whether different plating options are included;
• whether different housing materials are included;
• whether different manufacturing locations are included; and
• whether all revisions are covered.

A product-family declaration can be strong evidence if its scope is clearly defined.

8.8 Declaration Date and Currency

A declaration should not be treated as permanently valid simply because it has a signature.

The manufacturer should consider:

• when it was issued;
• which legislation it references;
• whether the product has changed;
• whether the supplier has changed its materials;
• whether the applicable RoHS requirements have changed; and
• whether the supplier has a formal change-notification process.

For long-life products, this becomes particularly important.

A declaration issued ten years ago may still be useful historical evidence, but it should not automatically be treated as sufficient evidence for today’s production without considering whether the underlying component remains unchanged.

8.9 Ask Suppliers About Exemptions

If a supplier’s component contains a restricted substance that is permitted under a RoHS exemption, the manufacturer should request information about the exemption.

The supplier should ideally identify:

• exemption number;
• application;
• component or material concerned;
• reason for use;
• relevant conditions; and
• status or validity information where applicable.

For example:

RoHS exemption used: Exemption X

is much more useful than:

“Lead is present but permitted under RoHS.”

The manufacturer needs to know why it is permitted.

8.10 Exemption Information Should Be Traceable

An exemption should be connected to a specific material or application.

For example:

BOM item: PWR-001

↓

Material: Ceramic component

↓

Restricted substance: Lead

↓

RoHS exemption: [specific exemption]

↓

Application: [specific application]

↓

Supplier evidence: [document reference]

This makes the exemption traceable within the technical file.

A generic supplier statement that “RoHS exemptions may apply” is not sufficient for a final compliance assessment.

8.11 Material Declarations

A material declaration provides more detailed information than a basic RoHS declaration.

Depending on the supplier and industry, a material declaration can identify:

• material categories;
• homogeneous materials;
• substances;
• concentrations;
• material composition;
• restricted substances; and
• applicable exemptions.

Material declarations can be particularly valuable for:

• connectors;
• cables;
• plastic components;
• PCBs;
• power supplies;
• mechanical assemblies;
• displays;
• complex electronic modules.

They can help the manufacturer understand what is actually inside a purchased component.

8.12 Full Chemical Formulation Is Usually Not the Goal

Manufacturers sometimes assume they need the complete chemical formulation of every material.

That is often unrealistic.

Suppliers may consider detailed formulations proprietary or confidential.

The practical objective is therefore not necessarily:

“Give us your complete chemical recipe.”

It is:

“Provide sufficient information and evidence for us to assess the relevant RoHS requirements.”

Depending on the material and risk, this could be achieved through:

• a controlled RoHS declaration;
• material declaration;
• specification;
• test report;
• supplier certification;
• or a combination of these.

The manufacturer should focus on sufficient evidence, not unnecessary disclosure of proprietary information.

8.13 Component Specifications

Technical specifications can provide useful supporting evidence.

For example, a specification may identify:

• plastic type;
• metal alloy;
• plating;
• solder alloy;
• cable insulation;
• coating;
• material grade;
• manufacturing process; or
• component construction.

Consider a metal connector.

A generic RoHS declaration says:

“RoHS compliant.”

The technical specification says:

“Contact material: CuZn alloy; plating: Ni/Au.”

The second document provides additional information that can help the manufacturer assess material risk.

8.14 Technical Drawings

Technical drawings can also contribute to the evidence.

A drawing may identify:

• material;
• coating;
• plating;
• surface treatment;
• adhesive;
• seal;
• plastic grade; or
• other construction details.

This is particularly useful for mechanical components.

For example:

Housing

→ Aluminium alloy

→ Surface coating

→ Printed marking

A drawing can help identify that the housing contains more than just the base metal.

8.15 Supplier Test Reports

For higher-risk components, manufacturers may request laboratory test reports.

A useful report should identify:

• tested component;
• part number;
• sample identification;
• material;
• test date;
• analytical methods;
• substances tested;
• measured concentrations;
• applicable limits; and
• laboratory information.

The report should be traceable to the actual component supplied.

A test report simply stating:

“RoHS PASS”

provides significantly less information than a detailed analytical report.

8.16 Do Not Automatically Require Testing from Every Supplier

Requiring a laboratory report for every purchased component may sound like a robust compliance strategy.

In practice, it can create enormous cost and administrative burden.

Imagine a product containing 2,000 purchased components.

Testing every component could be:

• expensive;
• time-consuming;
• technically unnecessary;
• difficult to maintain after component changes.

A more effective approach is to combine different forms of evidence.

For example:

Standard low-risk component

→ Current supplier declaration

Complex connector

→ Supplier declaration + material declaration

High-risk PVC cable

→ Supplier declaration + material information + targeted testing

This allows verification effort to be focused where it provides the greatest value.

8.17 Supplier Risk Classification

Manufacturers can establish a supplier/component risk classification.

For example:

Low Risk

• established supplier;
• stable component;
• current product-specific declaration;
• controlled change notification;
• well-known material;
• strong historical compliance.

Medium Risk

• limited material information;
• generic declaration;
• moderately complex component;
• new product;
• limited supplier history.

High Risk

• complex material structure;
• weak or missing documentation;
• high-risk polymer;
• unusual alloy;
• coating or plating concerns;
• new or unknown supplier;
• previous compliance issues;
• significant recent material change.

The exact criteria should be defined by the manufacturer.

The objective is to determine how much evidence is appropriate.

8.18 Supplier Change Notifications

One of the most valuable documents a manufacturer can receive is not a certificate at all.

It is a change notification.

A supplier should ideally notify the manufacturer when it changes:

• raw material;
• formulation;
• component design;
• plating;
• coating;
• manufacturing location;
• sub-supplier;
• material grade;
• production process; or
• other characteristics that could affect compliance.

This allows the manufacturer to determine whether its existing RoHS assessment remains valid.

Without change notification, a perfectly valid declaration can gradually become disconnected from the actual product.

8.19 Supplier Change Control Is Critical for Long-Life Products

Consider an industrial controller expected to remain in production for 15 years.

In Year 1:

Supplier declaration received → Component assessed → RoHS compliant.

In Year 7:

Supplier changes plastic formulation.

If the manufacturer is not informed, the original evidence may no longer represent the current component.

This is why supplier compliance management should include:

Initial assessment

•  

Ongoing change control

•  

Periodic review where appropriate

RoHS compliance is therefore not simply a one-time supplier-document collection exercise.

8.20 Ask Suppliers to Confirm the Current Revision

Where components are revision-controlled, manufacturers should request evidence that relates to the current revision.

For example:

BOM: Part ABC-123 Rev. D

Supplier evidence:

ABC-123 Rev. D

This is ideal.

If the supplier document only identifies:

ABC-123

the manufacturer should understand whether the supplier declaration covers all revisions.

This becomes particularly important where the component has undergone:

• material changes;
• redesign;
• supplier changes;
• manufacturing-location changes; or
• changes in coatings or plating.

8.21 Evidence Should Be Connected to the BOM

A good compliance system should allow a manufacturer to answer:

Which evidence supports this BOM item?

For example:

BOM Item	Supplier	Evidence	Status
C001	Supplier A	RoHS Declaration RD-101	Current
C002	Supplier B	Material Declaration MD-221	Current
C003	Supplier C	Test Report TR-045	Current
C004	Supplier D	Declaration + Exemption Statement	Current

This is far more useful than having a folder containing hundreds of supplier PDFs without any clear connection to the product.

8.22 Supplier Evidence Should Have a Defined Scope

A declaration should ideally answer:

What exactly does this document cover?

For example:

Product: Connector ABC-123

Part family: ABC-100 series

Revision: A–D

Applicable legislation: Directive 2011/65/EU and amendments

Exemptions: None

Declaration date: 2026

This gives the manufacturer a much stronger basis for assessing whether the document is relevant.

8.23 What About “RoHS 3”?

Suppliers sometimes use terminology such as:

• RoHS 2;
• RoHS 3;
• RoHS 2011/65;
• RoHS 2015/863;
• RoHS 10 substances.

These terms are not always used consistently.

Manufacturers should therefore focus on the actual legal references and substance requirements, rather than relying solely on informal labels such as “RoHS 3.”

For example, a useful declaration should identify the relevant Directive and amendments rather than simply stating:

“RoHS 3 compliant.”

This reduces ambiguity.

8.24 What About “Lead-Free”?

“Lead-free” is useful information, but it does not automatically mean:

Fully RoHS compliant.

RoHS covers ten substances or substance groups.

A component can be lead-free while still requiring assessment for:

• mercury;
• cadmium;
• hexavalent chromium;
• PBB;
• PBDE;
• DEHP;
• BBP;
• DBP; or
• DIBP.

Similarly, a supplier’s declaration that a component is “cadmium-free” does not establish complete RoHS compliance.

Specific substance claims should therefore be treated as partial evidence unless the manufacturer has established that the relevant claim covers the full RoHS assessment.

8.25 What About “Halogen-Free”?

“Halogen-free” is another frequently misunderstood claim.

The term generally concerns halogens such as:

• chlorine;
• bromine;
• fluorine;
• iodine.

RoHS does not prohibit halogens as a general category.

For example, RoHS restricts PBB and PBDE, but it does not simply prohibit every bromine-containing material.

Therefore:

Halogen-free ≠ automatically RoHS compliant.

A halogen-free declaration may be useful additional information, but it should not replace the RoHS assessment.

8.26 What About REACH Declarations?

A supplier may provide a combined:

“RoHS & REACH Declaration.”

This can be convenient.

However, the manufacturer should still determine what the document actually covers.

For RoHS, the manufacturer needs evidence relevant to:

• the RoHS restricted substances;
• homogeneous materials;
• applicable concentration limits;
• exemptions.

For REACH, the manufacturer may need information about:

• SVHCs;
• Candidate List status;
• applicable restrictions;
• communication obligations; and
• other REACH requirements.

A combined document does not automatically mean that both assessments have been performed to the same depth.

8.27 Ask Suppliers for SVHC Information Separately Where Appropriate

Because REACH and RoHS are different regulatory frameworks, a supplier should not necessarily be asked only:

“Is this component RoHS compliant?”

Where REACH is relevant, the manufacturer may also need to ask:

“Does the supplied article contain any Candidate List substances above the applicable threshold, and what information is required under Article 33?”

This is especially important for complex articles and supply chains.

RoHS and REACH information can be collected together, but the questions should remain clearly separated.

8.28 Supplier Evidence and Confidentiality

Sometimes suppliers will refuse to provide detailed chemical composition because it is commercially sensitive.

This does not automatically mean that compliance cannot be demonstrated.

Possible approaches include:

• controlled supplier declarations;
• third-party test reports;
• material declarations;
• confidential information agreements;
• supplier audits;
• targeted laboratory testing;
• certification from qualified third parties.

The manufacturer should determine what evidence is reasonably necessary for the risk involved.

The goal is not to obtain confidential information simply for completeness.

The goal is to obtain sufficient evidence to support the conformity conclusion.

8.29 Supplier Evidence Should Be Evaluated, Not Just Collected

A common failure mode is:

Supplier sends document → Document saved → Component marked “RoHS compliant.”

That process is too simplistic.

A better process is:

Supplier sends document

↓

Document reviewed

↓

Product/part number verified

↓

Revision verified

↓

Legislation checked

↓

Exemptions checked

↓

Date checked

↓

Material risk evaluated

↓

Evidence accepted / additional evidence requested

↓

Assessment recorded

This creates an actual compliance process.

8.30 A Practical Supplier Evidence Hierarchy

Manufacturers can think of supplier evidence in levels.

Level 1 – Generic Statement

“Our products comply with RoHS.”

Useful as an initial indication, but weak as standalone evidence.

Level 2 – Product-Specific Declaration

Identifies the actual component and applicable legislation.

Stronger.

Level 3 – Product-Specific Declaration + Material Information

Provides additional visibility into the relevant materials.

Stronger again.

Level 4 – Material Information + Supporting Test Evidence

Provides analytical or technical verification for relevant risks.

Very strong for higher-risk materials.

Level 5 – Controlled Evidence + Change Management

Evidence is connected to the product revision and supported by a controlled supplier change process.

This provides a strong long-term compliance foundation.

This is not a formal legal hierarchy of evidence. It is a practical way for manufacturers to think about evidence quality.

8.31 What Should Be Included in a Supplier Request?

A manufacturer can establish a standard supplier questionnaire or documentation request.

For example:

Product Information

• Supplier name
• Manufacturer name
• Part number
• Product family
• Revision
• Manufacturing location

RoHS Information

• RoHS declaration
• Applicable Directive
• Applicable amendments
• Confirmation of all relevant restricted substances
• Applicable exemptions

Material Information

• Material declaration
• Homogeneous-material information where available
• Material specifications
• Relevant composition information

Testing

• Existing laboratory reports
• Test date
• Test methods
• Tested materials
• Sample identification

Change Management

• Material change notification process
• Product change notification process
• Commitment to notify customer of changes affecting compliance

This creates a consistent supplier-information process.

8.32 Example Supplier Request

A practical request could be:

Please provide current RoHS compliance documentation for the following supplied component: Part No. ABC-123, Revision C.

Please include, where available:

• current RoHS Declaration;
• applicable Directive and amendments;
• applicable RoHS exemptions;
• material declaration or relevant material information;
• supporting test reports for relevant high-risk materials; and
• confirmation that Scope and material information correspond to the current supplied revision.

Please also notify us of any material, component, manufacturing or supplier changes that could affect RoHS compliance.

This is much more useful than simply asking:

“Please send us your RoHS certificate.”

8.33 Why “RoHS Certificate” Can Be the Wrong Request

There is often confusion around the term RoHS certificate.

RoHS does not generally require a manufacturer to obtain a universal third-party “RoHS certificate” before placing EEE on the EU market.

The manufacturer’s conformity assessment is based on its technical documentation and EU Declaration of Conformity.

Therefore, asking every supplier for a “RoHS certificate” can result in suppliers sending:

• generic certificates;
• outdated documents;
• unrelated certifications;
• third-party certificates with unclear scope; or
• documents that do not identify the actual component.

A better request is:

“Please provide current RoHS compliance evidence for the exact supplied part.”

This focuses the supplier on the evidence actually needed.

8.34 Supplier Evidence and IEC 63000

The importance of supplier information is closely connected with EN IEC 63000:2018.

The harmonised standard provides the technical-documentation framework used to assess materials, components and EEE with respect to restricted substances. The European Commission has formally listed EN IEC 63000:2018 as the harmonised standard supporting the RoHS Directive.

The practical implication is that supplier information can form a significant part of the manufacturer’s technical evidence.

However, IEC 63000 does not turn every supplier declaration into automatically sufficient evidence.

The manufacturer still needs to evaluate the information and determine whether it provides adequate confidence for the specific assessment.

8.35 A Supplier Declaration Is Evidence — Not the Conclusion

This distinction is worth repeating.

A supplier declaration says:

“The supplier states that this component complies.”

The manufacturer’s technical file needs to establish:

“Based on the available evidence and assessment, we conclude that our product complies.”

Those are not the same statement.

The supplier provides input.

The manufacturer makes the product-level conformity assessment.

8.36 What If a Supplier Does Not Provide Evidence?

This situation occurs frequently.

The manufacturer has several possible options.

Option 1 – Request Additional Documentation

Ask for:

• updated declaration;
• material declaration;
• specification;
• exemption information;
• test report.

Option 2 – Escalate Through Purchasing

Make RoHS documentation a formal supplier requirement.

Option 3 – Perform Risk Assessment

Determine whether the component can reasonably be assessed using existing information.

Option 4 – Perform Targeted Testing

Where the evidence gap is significant, laboratory testing may provide additional verification.

Option 5 – Replace the Supplier or Component

If compliance evidence cannot be established and the risk is unacceptable, an alternative component may be necessary.

The appropriate solution depends on the product and risk.

8.37 Supplier Compliance Should Be Built Into Purchasing

The strongest approach is to address RoHS requirements before purchasing, rather than after components have already entered production.

Purchase specifications can require suppliers to:

• comply with applicable RoHS requirements;
• provide relevant declarations;
• provide material information when requested;
• identify exemptions;
• notify the manufacturer of relevant changes;
• maintain supporting evidence; and
• cooperate with compliance investigations.

This makes RoHS part of supplier qualification rather than a last-minute documentation exercise.

8.38 Example: Weak Supplier Process

A manufacturer purchases 500 components.

Six months before market launch, the compliance department asks:

“Do we have RoHS documentation?”

Purchasing contacts suppliers.

Several suppliers provide declarations.

Others provide old documents.

Some documents cover product families.

Some do not identify revisions.

Several components have changed since the original purchase.

The compliance team now has to investigate everything under time pressure.

This is expensive and inefficient.

8.39 Example: Strong Supplier Process

The manufacturer establishes RoHS requirements during supplier qualification.

For each component:

Supplier approved

↓

RoHS evidence requested

↓

Part number verified

↓

Material risk classified

↓

Evidence stored against BOM

↓

Changes require notification

↓

High-risk changes trigger reassessment

Now RoHS becomes part of the normal product-development process.

This significantly reduces last-minute compliance work.

8.40 Supplier Evidence Should Follow the Product Lifecycle

A good system operates throughout the lifecycle:

Product Development

Collect initial evidence.

Design Freeze

Confirm the evidence corresponds to the final BOM.

Production

Monitor material and supplier changes.

Product Updates

Reassess affected components.

Regulatory Changes

Review impacted materials and exemptions.

Market Surveillance

Retrieve the evidence quickly if requested.

This lifecycle approach is much stronger than collecting declarations once and never reviewing them.

8.41 A Practical Supplier Evidence Matrix

For a complex product, manufacturers can maintain a matrix such as:

BOM	Part	Supplier	RoHS Declaration	Material Data	Test Report	Exemption	Change Control	Status
C001	Connector	Supplier A	✓	✓	–	–	✓	Complete
C002	Cable	Supplier B	✓	✓	✓	–	✓	Complete
C003	PCB	Supplier C	✓	✓	–	✓	✓	Complete
C004	Housing	Supplier D	✓	–	–	–	✓	Review
C005	Power Module	Supplier E	✓	✓	✓	–	✓	Complete

This matrix gives the compliance team immediate visibility into evidence gaps.

8.42 What Should Trigger Additional Supplier Evidence?

Additional evidence should generally be considered when:

• a supplier declaration is missing;
• a declaration is outdated;
• the exact part cannot be identified;
• the supplier changed the material;
• the component changed revision;
• the material is high-risk;
• the supplier is new;
• the supplier information is inconsistent;
• an exemption is claimed without details;
• a customer has additional requirements;
• a market-surveillance request is received; or
• there is reason to suspect non-compliance.

This creates a clear connection between risk and documentation effort.

8.43 The Goal Is Not Maximum Documentation

More documents do not automatically mean better compliance.

A manufacturer could collect:

• 5,000 supplier declarations;
• 2,000 test reports;
• hundreds of spreadsheets;

and still have a weak compliance system if the evidence cannot be connected to the actual product.

The objective should instead be:

The right evidence, for the right component, linked to the right product revision, and maintained over time.

That is the essence of effective supplier evidence management.

8.44 Practical Supplier Evidence Checklist

For each relevant supplier/component, ask:

Identification

• Supplier identified
• Manufacturer identified
• Exact part number identified
• Revision identified where applicable
• Product family scope understood

RoHS

• Current RoHS declaration available
• Relevant legislation identified
• Current amendments considered
• Exemptions identified
• Exemption applicability understood

Materials

• Relevant material information available
• High-risk materials identified
• Material specifications reviewed where appropriate
• Homogeneous-material considerations understood

Testing

• Existing test reports reviewed
• Tested sample identified
• Test scope understood
• Results compared with applicable limits

Change Control

• Supplier change-notification process established
• Material changes communicated
• Component revisions monitored
• Compliance reassessment triggered where necessary

Traceability

• Evidence linked to BOM
• Evidence linked to product revision
• Documents controlled and retained

8.45 The Key Takeaway

Supplier information is a fundamental part of a practical RoHS compliance system, but a supplier declaration should be treated as evidence rather than as the final compliance conclusion.

Manufacturers should aim to obtain evidence that is:

• specific to the actual component;
• current;
• traceable;
• relevant to the RoHS requirements;
• clear about exemptions;
• supported by material information where necessary; and
• maintained through supplier change control.

The most useful supplier documentation can include:

• RoHS declarations;
• material declarations;
• technical specifications;
• drawings;
• test reports;
• exemption information; and
• change notifications.

The appropriate level of evidence should be risk-based. A simple, well-controlled component from a reliable supplier may require relatively little additional verification, while a complex or high-risk material with weak supplier information may justify additional documentation or laboratory testing.

Most importantly, the manufacturer should be able to establish a clear chain:

Product → BOM → Component → Supplier → Material → Evidence → RoHS Assessment

That chain is what turns supplier paperwork into meaningful technical evidence.

The next chapter addresses the question that naturally follows:

When is supplier documentation sufficient, and when should a manufacturer perform laboratory testing for RoHS?

9. RoHS Testing – When Are Laboratory Tests Required?

Once a manufacturer has collected supplier declarations, material information and other technical evidence, an important question remains:

When is laboratory testing actually necessary for RoHS compliance?

This is one of the most misunderstood aspects of RoHS.

Some manufacturers assume that every product must undergo a RoHS laboratory test before it can be placed on the EU market. Others take the opposite approach and assume that supplier declarations are always sufficient.

Neither approach is generally appropriate.

RoHS conformity is based on the manufacturer’s overall conformity assessment and technical documentation. The RoHS Directive requires manufacturers to establish technical documentation and carry out the internal production control procedure. It does not prescribe a universal requirement to laboratory-test every product or every component. (EUR-Lex)

Laboratory testing can nevertheless be extremely valuable when it provides evidence that cannot be obtained reliably through other means.

The practical question is therefore not:

“Do we need a RoHS test?”

but:

“What evidence do we need to demonstrate conformity, and is laboratory testing necessary to close any remaining evidence gaps?”

9.1 Is RoHS Laboratory Testing Mandatory?

There is no general rule under the RoHS Directive stating that every covered EEE product must undergo a laboratory test before being placed on the EU market.

The manufacturer’s conformity assessment is based on internal production control, supported by technical documentation. The manufacturer must ensure that the EEE complies with the substance restrictions and must maintain the documentation supporting that conclusion. (EUR-Lex)

This means a manufacturer can potentially establish RoHS compliance using a combination of:

• supplier declarations;
• material declarations;
• technical specifications;
• drawings;
• bills of materials;
• manufacturing information;
• exemption assessments;
• supplier change-control information; and
• laboratory testing where appropriate.

Testing is therefore one possible source of evidence, not automatically the entire conformity assessment.

9.2 Why Do Manufacturers Still Perform RoHS Tests?

If testing is not universally mandatory, why do manufacturers use laboratories?

Because supplier and material information does not always provide enough confidence.

A laboratory test can provide independent analytical evidence about the presence and concentration of relevant substances in a specific material or sample.

Testing can therefore be particularly useful when:

• supplier documentation is missing;
• supplier information is unclear;
• a material is considered high-risk;
• a new supplier is being qualified;
• a supplier has changed the material;
• there is contradictory information;
• an exemption is being investigated;
• previous compliance problems have occurred; or
• the manufacturer wants additional verification.

The key is that the test should answer a specific compliance question.

9.3 Testing Should Be Risk-Based

A manufacturer with a product containing 2,000 components does not necessarily need to send all 2,000 components to a laboratory.

Doing so could create enormous:

• testing costs;
• lead times;
• sample-management requirements;
• administrative work; and
• interpretation challenges.

A more effective approach is to assess the risk of the materials and components first.

For example:

Low-risk component

• established supplier;
• current product-specific declaration;
• stable material;
• good supplier history;
• effective change control.

Potential approach: supplier documentation may provide sufficient evidence.

Medium-risk component

• limited material information;
• generic declaration;
• moderate material complexity.

Potential approach: request additional supplier information or material declaration.

High-risk component

• incomplete documentation;
• complex polymer;
• unusual alloy;
• questionable supplier;
• recent material change;
• previous compliance issue.

Potential approach: additional technical evidence and potentially laboratory testing.

This approach allows testing resources to be directed where they provide the greatest value.

9.4 Testing Should Close an Evidence Gap

A useful principle is:

Do not test simply because testing is available. Test because there is a defined reason to test.

For example:

A supplier provides a current, product-specific RoHS declaration for a standard connector.

There may be little value in automatically testing the connector simply because it is an electrical component.

Now consider a different situation:

A supplier provides a generic declaration for a complex plastic component, but the manufacturer has no information about the plasticiser or flame-retardant system.

There is a clear evidence gap.

Laboratory testing may therefore be justified.

The difference is not the component itself.

The difference is the quality and reliability of the available evidence.

9.5 What Should a RoHS Test Actually Determine?

Before testing begins, the manufacturer should define the question.

For example:

“Does the homogeneous plastic material contain DEHP above the applicable RoHS limit?”

or:

“Does this metal alloy contain lead above the applicable RoHS concentration limit?”

or:

“Does this surface treatment contain a relevant concentration of a restricted substance?”

These are much better test objectives than:

“Please test this product for RoHS.”

The laboratory needs to understand:

• what material is being tested;
• which substances are relevant;
• what concentration limits apply;
• what analytical method is appropriate; and
• how the result will be used in the technical documentation.

9.6 Test the Relevant Material

RoHS concentration limits apply at the homogeneous-material level.

Therefore, the manufacturer should understand what material the laboratory is actually testing.

For example, consider a connector containing:

• plastic housing;
• copper contact;
• nickel plating;
• gold plating;
• seal.

A test performed on the entire connector may not provide the same information as testing the relevant homogeneous materials separately.

The manufacturer should therefore define the sampling and testing strategy based on the product construction.

This is particularly important when a restricted substance could be concentrated in a specific layer or material.

9.7 Whole-Product Testing Can Be Misleading

A laboratory may be able to test a complete product.

However, a complete-product result does not automatically answer every RoHS question.

Consider a product containing:

• 500 g aluminium;
• 300 g plastic;
• 100 g PCB;
• 50 g cables;
• 50 g connectors.

If a complete-product analysis finds a low overall concentration of a substance, this does not necessarily demonstrate that every relevant homogeneous material is below its applicable RoHS limit.

The regulatory assessment is based on the relevant homogeneous materials.

Therefore, manufacturers should not assume:

“The complete product passed the laboratory test, therefore every material complies.”

The sampling and analytical strategy must be consistent with the compliance question being answered.

9.8 XRF Screening

X-ray fluorescence, commonly referred to as XRF, is widely used as a screening technique for RoHS-related materials.

XRF can be particularly useful for detecting or screening for elements such as:

• lead;
• mercury;
• cadmium;
• chromium; and
• bromine.

It can therefore be very useful for identifying potential issues quickly.

For example, XRF can be used to screen:

• plastics;
• metal alloys;
• coatings;
• connectors;
• cables;
• solder;
• electronic components.

However, XRF results must be interpreted correctly.

9.9 XRF Does Not Directly Answer Every RoHS Question

One of the most important limitations is that XRF generally measures elements, whereas RoHS sometimes restricts specific chemical forms or substance groups.

For example:

Chromium detected ≠ automatically hexavalent chromium detected.

The RoHS restriction concerns hexavalent chromium, not chromium in every oxidation state.

Similarly:

Bromine detected ≠ automatically PBB or PBDE detected.

Bromine can be present in many compounds that are not restricted under RoHS.

Therefore, an XRF result showing bromine does not by itself demonstrate that the material exceeds the RoHS limit for PBB or PBDE.

The analytical method must be appropriate to the regulatory substance being assessed.

9.10 Screening vs. Confirmatory Testing

It is useful to distinguish between:

Screening

A rapid assessment used to identify potential problems.

Examples:

• XRF screening;
• supplier material screening;
• document review.

Confirmatory analysis

A more specific analytical investigation used to establish the concentration or presence of a particular substance or substance group.

The two approaches serve different purposes.

A manufacturer may use screening to identify a potential risk and then perform more specific testing where the screening result requires further investigation.

This can be significantly more efficient than performing the most complex analytical method on every material from the beginning.

9.11 Example: Chromium

Consider a metal component with a surface treatment.

XRF detects chromium.

The result is:

Chromium: detected

This does not automatically mean:

RoHS non-compliant.

The manufacturer still needs to determine:

• what form of chromium is present;
• whether it is hexavalent chromium;
• what concentration is relevant;
• which homogeneous material is being assessed;
• whether the applicable limit is exceeded; and
• whether an exemption applies.

This is a good example of why laboratory results must be interpreted within the legal and technical context.

9.12 Example: Bromine

Now consider a plastic housing.

XRF detects:

Bromine: 1,500 mg/kg

Again, this does not automatically mean that the material contains restricted PBDE or PBB above the applicable limit.

The bromine could originate from a different brominated compound.

The manufacturer therefore needs to determine what the analytical result actually demonstrates.

This distinction is particularly important when manufacturers use screening reports as if they were complete RoHS conformity assessments.

9.13 Testing Lead and Cadmium

Lead and cadmium are often more straightforward targets for elemental screening.

However, the same fundamental principles still apply.

The manufacturer needs to know:

• which homogeneous material was tested;
• what concentration was measured;
• which limit applies;
• whether the result is above or below that limit;
• whether measurement uncertainty is relevant;
• whether the tested sample represents production material; and
• whether an exemption applies.

For example:

Cadmium result: 0.005%

The general 0.1% limit should not be used.

The applicable RoHS limit for cadmium is:

0.01% by weight.

The correct interpretation therefore depends on the substance-specific limit.

9.14 Testing Phthalates

The four RoHS-restricted phthalates are:

• DEHP;
• BBP;
• DBP; and
• DIBP.

They are particularly relevant to polymeric materials.

Potentially relevant materials include:

• flexible PVC;
• cable insulation;
• cable jackets;
• flexible plastics;
• seals;
• gaskets;
• certain adhesives; and
• other polymer-based materials.

For these substances, elemental screening is not enough.

The laboratory needs an analytical method capable of identifying and quantifying the relevant phthalates.

This is a good example of why the analytical method must match the substance being assessed.

9.15 Testing PBB and PBDE

PBB and PBDE are specific brominated substance groups.

Simply measuring total bromine does not establish the concentration of PBB or PBDE.

Where there is a specific reason to investigate these substances, the laboratory needs an appropriate analytical method capable of addressing the relevant compounds.

This can be particularly important for:

• older components;
• legacy products;
• flame-retarded plastics;
• unknown material formulations; and
• suppliers with limited chemical information.

Again, the question is not:

“Is bromine present?”

It is:

“Are the RoHS-restricted PBB or PBDE substances present above the applicable limit?”

9.16 Mercury Testing

Mercury can be relevant to:

• certain lamps;
• switches;
• relays;
• specialised equipment;
• legacy products; and
• particular technical applications.

Where mercury is a realistic risk, laboratory analysis can provide useful verification.

However, the need for testing should still be based on the product’s materials, technology and available supplier evidence.

A modern LED product with strong material documentation may present a very different testing requirement from an older specialised lighting technology.

9.17 Laboratory Testing Does Not Replace Supplier Management

A manufacturer should not use laboratory testing as an excuse to ignore supplier controls.

Consider a supplier that changes a plastic formulation every year.

The manufacturer performs one laboratory test in 2026.

The result is compliant.

In 2027, the supplier changes the formulation without notifying the manufacturer.

The 2026 test does not automatically prove that the 2027 material is compliant.

Supplier change control is therefore still essential.

Testing provides evidence about the tested material and sample.

Supplier management helps maintain the relationship between that evidence and ongoing production.

9.18 Testing Is a Snapshot in Time

A laboratory test generally represents a particular:

• component;
• material;
• formulation;
• production revision;
• sample;
• and point in time.

This means that testing should be connected to product lifecycle management.

For example:

2026

Material A tested → compliant.

2027

Supplier changes formulation.

↓

Existing evidence reviewed.

↓

New material assessment.

↓

Additional testing if required.

This is much stronger than assuming that one historical laboratory report remains permanently representative.

9.19 When Is Testing Particularly Valuable?

Laboratory testing can be especially useful in the following situations.

New Supplier

The manufacturer has limited confidence in the supplier’s compliance processes.

Missing Documentation

The supplier cannot provide sufficient material information.

High-Risk Material

The material is historically associated with RoHS substance risks.

Material Change

A supplier has changed a formulation or manufacturing process.

Contradictory Evidence

Supplier declarations conflict with other information.

Suspected Non-Compliance

There is a reason to believe that a material may contain a restricted substance above the limit.

Market Surveillance

An authority or market-surveillance investigation requires clarification of the material composition.

Customer Requirement

A customer contract requires independent analytical evidence.

Internal Verification

The manufacturer wants to verify the effectiveness of its supplier-control system through periodic sampling.

These are all legitimate reasons to consider testing.

9.20 When Testing May Not Add Much Value

Testing may add relatively little value where:

• the supplier is well controlled;
• the exact component is identified;
• current material documentation is available;
• the material is well characterised;
• the supplier has effective change control;
• historical compliance is strong; and
• there is no specific indication of elevated risk.

In such a case, automatically testing the component may simply duplicate evidence that is already sufficient.

The manufacturer should therefore consider:

What new information will this test provide?

If the answer is “none,” testing may not be the most efficient use of resources.

9.21 A Practical Evidence Hierarchy

A manufacturer can think of RoHS evidence as a combination of different sources.

Level 1 – Supplier Statement

Useful initial evidence.

Level 2 – Product-Specific Declaration

Better traceability.

Level 3 – Material Declaration

Provides material-level information.

Level 4 – Technical Specifications

Supports material and construction assessment.

Level 5 – Analytical Testing

Provides independent analytical evidence for specific materials or substances.

Level 6 – Combined Evidence

Supplier information + material information + risk assessment + targeted testing.

The goal is not to reach the highest level for every component.

The goal is to reach a sufficient level of confidence for the specific compliance risk.

9.22 A Practical Testing Decision Tree

A manufacturer can use a simple decision process:

Is the component/material within the RoHS product?

↓

Yes

↓

Is reliable, current supplier/material evidence available?

Yes

↓

Is the evidence sufficiently specific and traceable?

Yes

↓

Is the material considered low or controlled risk?

Yes

↓

Additional testing may not be necessary.

If the answer is No at any of these stages:

↓

Is there a significant evidence gap or elevated risk?

Yes

↓

Request additional supplier/material evidence.

↓

If the evidence gap remains:

↓

Consider targeted laboratory testing.

This approach avoids both extremes:

Testing everything

and

Testing nothing.

9.23 Example: Plastic Housing

Consider a plastic housing supplied by an established manufacturer.

The supplier provides:

• exact part number;
• current revision;
• material specification;
• RoHS declaration;
• material declaration;
• change notification commitment.

The material is a standard engineering polymer with a known formulation.

The manufacturer may reasonably conclude that additional laboratory testing is not necessary, provided the overall risk assessment supports that conclusion.

Now consider a different housing.

The supplier provides:

“RoHS compliant.”

No material specification.

No material declaration.

No information about plasticisers or flame retardants.

The supplier is new.

In this case, additional information or targeted testing may be appropriate.

The difference is the evidence quality and risk, not simply the fact that both components are plastic.

9.24 Example: Cable

A manufacturer purchases a flexible cable.

The supplier provides:

• exact part number;
• current technical specification;
• material declaration;
• RoHS declaration;
• controlled manufacturing process;
• change notification.

This may provide a strong evidence basis.

Now consider an imported cable from an unknown supplier.

The only document available is:

“RoHS compliant.”

The cable contains several polymer layers and the supplier cannot provide detailed material information.

Because cables can contain multiple homogeneous materials and polymeric materials may require attention to phthalates, the manufacturer may have a stronger reason to request additional information or perform targeted testing.

9.25 Example: Metal Alloy

A manufacturer purchases a brass connector.

The supplier provides the exact alloy specification and a current RoHS declaration.

The manufacturer can assess the material based on the available evidence.

Now imagine the supplier cannot identify the alloy composition and the component has a different surface treatment from the previously approved version.

This creates uncertainty about the material.

A targeted analytical test may therefore be useful.

The objective would be to determine the relevant substance concentration in the applicable material, rather than simply obtaining a generic “RoHS pass.”

9.26 Testing and Measurement Uncertainty

Laboratory results are measurements, not absolute mathematical truths.

Where a measured concentration is close to the applicable regulatory limit, the manufacturer should consider:

• analytical method;
• measurement uncertainty;
• laboratory competence;
• sample preparation;
• detection limits;
• quantification limits;
• material heterogeneity; and
• interpretation of borderline results.

For example, a result very close to a legal limit deserves more careful consideration than a result comfortably below the limit.

This is one reason why laboratory selection and report interpretation matter.

A manufacturer should avoid treating:

“0.099%”

and

“0.001%”

as equivalent simply because both are technically below a 0.1% limit.

The compliance assessment should consider the reliability of the measurement and the surrounding evidence.

9.27 Selecting a Laboratory

Where laboratory testing is required, manufacturers should consider whether the laboratory is competent for the intended analytical work.

Relevant considerations can include:

• experience with RoHS-related testing;
• appropriate analytical capabilities;
• suitable test methods;
• sample preparation capability;
• quality management;
• accreditation where relevant;
• clear reporting;
• traceable sample identification; and
• ability to explain limitations of the method.

A laboratory report is only as useful as the relationship between:

sample → method → result → regulatory requirement.

The cheapest test is therefore not necessarily the best compliance evidence.

9.28 What Should a Test Report Contain?

A useful test report should identify, as appropriate:

• laboratory;
• customer;
• product;
• part number;
• sample identification;
• sample description;
• material tested;
• date received;
• test date;
• analytical method;
• substances tested;
• results;
• units;
• applicable limits;
• measurement information;
• deviations or limitations; and
• final interpretation where provided.

The report should allow the manufacturer to trace the result back to the actual component or material used in the product.

9.29 Test Reports Should Be Linked to the BOM

A test report should not simply sit in a laboratory folder.

The manufacturer should be able to establish:

Test Report TR-2026-001

↓

Part ABC-123

↓

BOM Revision D

↓

Product XYZ Revision 5

This creates traceability.

If the same component is later replaced by:

ABC-124

the manufacturer can immediately see that the old test report may no longer apply.

This is a simple but powerful part of compliance document management.

9.30 Testing as Part of Supplier Qualification

Laboratory testing can also be used strategically when qualifying suppliers.

For example:

New supplier

↓

Documentation review

↓

Risk assessment

↓

Sample testing

↓

Supplier approval

↓

Production monitoring

This can be particularly useful where a manufacturer is entering a new supply chain or sourcing components from suppliers with limited compliance history.

Testing can therefore be used as a supplier-control tool, not just as a final product certification activity.

9.31 Periodic Verification

Some manufacturers may also use periodic or random testing.

For example:

• annually;
• after major supplier changes;
• for selected high-risk components;
• during supplier audits;
• after compliance incidents.

This can help verify that the supplier documentation continues to reflect actual production.

Again, the frequency should be based on risk.

There is generally little justification for treating every component identically if their risks are fundamentally different.

9.32 What About Existing Test Reports?

Manufacturers often receive test reports from suppliers.

These can be useful, but they should be reviewed.

Ask:

• Is the tested part the exact part used?
• Is the material identical?
• Is the revision current?
• Is the sample representative?
• Which substances were tested?
• Was the correct analytical method used?
• How old is the report?
• Has the supplier changed the material since the test?
• Can the report be traced to the production component?

An old report can still provide valuable evidence, but its relevance should be assessed rather than assumed.

9.33 Do All Ten RoHS Substances Need to Be Tested?

Not necessarily in every analytical programme.

The appropriate testing scope depends on:

• the material;
• potential substance risks;
• supplier information;
• previous evidence;
• product construction;
• analytical capabilities; and
• the purpose of the test.

For example, testing a homogeneous metal alloy for phthalates may be of little practical relevance, while testing a flexible polymer for phthalates may be highly relevant.

The testing programme should therefore be technically justified.

The question should always be:

Which restricted substances could realistically be present in this material, and what evidence do we need to assess them?

9.34 Testing Does Not Create an Exemption

This point is important.

Suppose laboratory testing identifies lead above the standard RoHS concentration limit.

The test does not somehow make the material compliant.

The manufacturer must determine whether:

• the result is correct;
• the material has been correctly identified;
• an applicable exemption exists;
• the exemption conditions are fulfilled; and
• the evidence supports the use of that exemption.

Testing provides information.

It does not change the legal status of the substance.

9.35 Testing Does Not Replace the Technical File

A laboratory report is not a substitute for the manufacturer’s technical documentation.

The RoHS Directive requires manufacturers to prepare technical documentation and perform the internal production control procedure. (EUR-Lex)

The technical documentation should therefore explain the overall basis for the conformity conclusion.

For example:

BOM

•  

Supplier evidence

•  

Material assessment

•  

Exemption assessment

•  

Targeted test reports

•  

Risk assessment

=

RoHS conformity conclusion

The laboratory report is one part of this chain.

9.36 What If a Test Fails?

A failed or borderline test result should trigger an investigation.

The manufacturer should determine:

1. What material was tested?
2. Was the sample representative?
3. Was the correct analytical method used?
4. Was the concentration correctly interpreted?
5. Is an exemption applicable?
6. Is the supplier information incorrect?
7. Has the material changed?
8. Are other products affected?
9. Is production affected?
10. What corrective action is required?

Possible corrective actions can include:

• supplier investigation;
• additional testing;
• material replacement;
• component redesign;
• supplier replacement;
• exemption assessment;
• production containment; or
• product correction.

The correct response depends on the circumstances.

9.37 Testing Can Reveal Supply-Chain Problems

One unexpected benefit of targeted testing is that it can identify weaknesses in supplier control.

Suppose a manufacturer receives compliant declarations from a supplier but repeated laboratory tests identify unexpected substance concentrations.

This could indicate:

• inadequate supplier controls;
• inaccurate declarations;
• sub-supplier changes;
• uncontrolled formulations;
• poor document management; or
• a misunderstanding of the applicable requirements.

In such a situation, the issue is larger than one failed test.

The manufacturer should review the supplier relationship itself.

9.38 A Strong Testing Strategy

A mature RoHS testing strategy can therefore follow this structure:

Step 1 – Identify product scope

Determine whether RoHS applies.

Step 2 – Identify materials

Break components down into relevant homogeneous materials.

Step 3 – Collect supplier evidence

Obtain declarations and material information.

Step 4 – Evaluate evidence quality

Assess specificity, currency and traceability.

Step 5 – Perform risk assessment

Identify high-risk materials and evidence gaps.

Step 6 – Define testing objectives

Determine exactly what needs to be verified.

Step 7 – Select appropriate analytical methods

Ensure the method addresses the relevant substance.

Step 8 – Test representative samples

Ensure sample identity and traceability.

Step 9 – Interpret the results

Compare results with the applicable RoHS limits and exemptions.

Step 10 – Update the technical documentation

Record the evidence and final conclusion.

Step 11 – Maintain through change control

Reassess when materials, suppliers or designs change.

This provides a structured and defensible approach.

9.39 A Practical Testing Matrix

Manufacturers can maintain a simple testing matrix:

Component	Material	Risk	Supplier Evidence	Testing	Result	Action
Connector	Plastic	Medium	Complete	None	–	Accept
Cable	PVC	High	Limited	Phthalates	Pass	Accept
PCB	Solder	High	Complete	XRF	Pass	Accept
Metal housing	Alloy	Medium	Limited	XRF	Review	Additional assessment
Coating	Surface layer	High	Missing	Targeted analysis	Pass	Accept

The exact matrix will depend on the manufacturer’s products.

The important feature is that the decision to test is visible and traceable.

9.40 The Most Common Testing Mistakes

Manufacturers should avoid several common mistakes.

Testing Everything

This can create unnecessary cost without improving the compliance conclusion.

Testing Nothing

This can leave significant evidence gaps.

Testing the Complete Product Without Understanding Materials

The result may not answer the relevant homogeneous-material questions.

Treating XRF as a Complete RoHS Analysis

XRF is a powerful screening tool but does not directly identify every restricted substance or chemical form.

Using Old Test Reports Without Verification

The tested material may no longer represent current production.

Testing the Wrong Revision

A test report for an older component does not automatically cover a new revision.

Ignoring Supplier Changes

Testing does not compensate for uncontrolled material changes.

Treating “Pass” as the End of the Assessment

The test result still needs to be incorporated into the technical documentation.

9.41 The Practical Rule

For most manufacturers, the most useful rule is:

Use laboratory testing where it adds meaningful evidence — not as an automatic substitute for supplier management and technical documentation.

A well-designed RoHS compliance system might therefore look like:

Supplier evidence first

↓

Risk assessment

↓

Identify evidence gaps

↓

Targeted laboratory testing

↓

Document the conclusion

This is generally more efficient than either:

“Test everything.”

or:

“Never test anything.”

9.42 What a Defensible Testing Decision Looks Like

A manufacturer should ideally be able to explain why a component was or was not tested.

For example:

Part ABC-123 was not laboratory tested because the component is supplied by an approved supplier, the current part revision is covered by a product-specific RoHS declaration, the material declaration identifies the relevant homogeneous materials, no applicable evidence gaps were identified, and the component was assessed as low risk under the manufacturer’s RoHS risk-assessment procedure.

Or:

Part XYZ-456 was laboratory tested because the supplier could not provide sufficient material information for the flexible polymer used in the component. The material was considered high risk for phthalates, and targeted analytical testing was therefore performed to close the identified evidence gap.

These explanations are much stronger than simply recording:

“Tested.”

or:

“Not tested.”

9.43 RoHS Testing and Market Surveillance

Laboratory testing can also become relevant after a product is already on the market.

The European Commission’s 2026 reporting on coordinated EU market-surveillance activities illustrates that authorities can select products for testing and investigate hazardous-substance compliance. The Commission also emphasises the importance of manufacturers maintaining and being able to provide relevant product documentation and test reports when requested. (Internal Market Hub)

This reinforces an important point:

Compliance evidence should remain accessible throughout the product lifecycle.

A manufacturer should not have to reconstruct its RoHS assessment from scratch when a market-surveillance authority asks questions.

9.44 The Key Takeaway

RoHS laboratory testing is an important compliance tool, but it should not be confused with the RoHS conformity assessment itself.

The most important principles are:

• There is no general requirement to laboratory-test every RoHS product.
• RoHS conformity is based on the manufacturer’s technical documentation and internal production control procedure. (EUR-Lex)
• Testing should be risk-based and linked to a defined compliance question.
• Supplier declarations and material information can provide important evidence.
• Laboratory testing is particularly useful where supplier evidence is missing, unclear, outdated or insufficient.
• Testing should focus on the relevant homogeneous materials.
• Whole-product testing does not automatically demonstrate that every homogeneous material complies.
• XRF can be an effective screening technique, but elemental results must not automatically be interpreted as specific restricted substances.
• Chromium is not automatically hexavalent chromium, and bromine is not automatically PBB or PBDE.
• Phthalates require analytical methods capable of addressing the specific substances.
• Test results should be traceable to the exact component, material and product revision.
• A laboratory report does not replace supplier management, change control or the technical documentation.
• A failed test should trigger an investigation rather than simply being recorded as a “failed product.”
• The objective is not maximum testing. The objective is sufficient, reliable and technically justified evidence.

In practice, the strongest approach is:

Supplier evidence → Material assessment → Risk assessment → Targeted testing where necessary → Technical documentation

The next chapter looks at the documentation framework that ties these elements together:

10. What Is REACH?

REACH is one of the most important pieces of EU chemicals legislation and is particularly relevant to manufacturers of electrical and electronic products.

The name REACH stands for:

Registration, Evaluation, Authorisation and Restriction of Chemicals

REACH is established through Regulation (EC) No 1907/2006 and entered into force on 1 June 2007. Unlike RoHS, REACH is an EU Regulation, meaning that it applies directly across the EU Member States rather than requiring national implementation through separate transposing legislation.

REACH has a much broader scope than RoHS.

While RoHS specifically addresses certain hazardous substances in electrical and electronic equipment, REACH establishes a comprehensive framework for the manufacture, import, placing on the market and use of chemical substances.

For manufacturers of electrical and electronic products, this means that REACH can become relevant not only because of the chemicals deliberately used during manufacturing, but also because certain substances may be present in materials, components, mixtures or finished articles.

10.1 What Does REACH Stand For?

The four letters in REACH describe the main regulatory mechanisms of the Regulation:

R – Registration

E – Evaluation

A – Authorisation

R – Restriction

These mechanisms work together to control chemical substances and their risks.

REACH places significant responsibility on companies to identify and manage the risks associated with substances they manufacture, import or use.

The underlying principle is that companies, rather than public authorities alone, are responsible for demonstrating that chemicals can be used safely.

This is an important difference in philosophy compared with older chemical legislation.

10.2 Why Was REACH Introduced?

REACH was introduced to improve the protection of:

• human health;
• workers;
• consumers;
• the environment; and
• the wider population

from risks associated with chemical substances.

At the same time, the Regulation aims to support the functioning of the EU internal market and encourage innovation and the substitution of particularly hazardous substances with safer alternatives.

ECHA describes REACH as a framework intended to improve protection from chemical risks while also supporting the competitiveness of the European chemicals industry.

The fundamental idea is:

Companies that manufacture or place chemicals on the EU market must understand the properties and risks of those chemicals and take appropriate measures to control them.

10.3 REACH Is Much Broader Than RoHS

This is perhaps the most important point for manufacturers.

RoHS is focused specifically on:

Electrical and electronic equipment + defined restricted substances

REACH is focused much more broadly on:

Chemical substances + their manufacture, import, use and placing on the market

REACH can therefore affect products far beyond the electronics industry.

It applies, in principle, to chemical substances used in:

• industrial processes;
• paints;
• coatings;
• adhesives;
• cleaning products;
• plastics;
• textiles;
• furniture;
• consumer products;
• electrical equipment; and
• many other products and materials.

ECHA explicitly notes that REACH can affect everyday articles such as clothing, furniture and electrical appliances.

For an electrical-product manufacturer, REACH is therefore not simply another version of RoHS.

10.4 REACH Is an EU Regulation

RoHS and REACH differ in their legal form.

RoHS is established through:

Directive 2011/65/EU

REACH is established through:

Regulation (EC) No 1907/2006

This distinction matters.

An EU Regulation is directly applicable throughout the EU Member States.

Manufacturers therefore work directly with the obligations established by the REACH Regulation and its amendments rather than relying on national legislation transposing REACH into domestic law.

The current REACH framework is continuously amended as substances are:

• added to regulatory lists;
• restricted;
• authorised;
• evaluated;
• or otherwise subject to regulatory action.

Manufacturers therefore need to consider the current status of the legislation when performing a REACH assessment.

10.5 What Does REACH Actually Regulate?

REACH regulates chemical substances.

The term “substance” is important because it is a defined regulatory concept.

A substance can be:

• a chemical element;
• a naturally occurring substance;
• a manufactured chemical;
• a substance used as a raw material;
• a substance used in a formulation; or
• a substance present in certain articles.

REACH can therefore become relevant at multiple stages of a supply chain.

For example:

Raw chemical

↓

Material formulation

↓

Component

↓

Finished product

↓

Customer

At each stage, different REACH obligations may potentially arise depending on the company’s role and the substance involved.

10.6 Substances, Mixtures and Articles

One of the most important concepts for electrical-product manufacturers is the distinction between:

Substances

Individual chemical substances.

Examples include:

• solvents;
• plasticisers;
• metals;
• flame retardants;
• monomers;
• additives.

Mixtures

Combinations of two or more substances.

Examples include:

• paints;
• adhesives;
• inks;
• lubricants;
• cleaning agents;
• sealants.

Articles

Objects whose shape, surface or design determines their function to a greater degree than their chemical composition.

Examples can include:

• cables;
• connectors;
• housings;
• switches;
• printed circuit boards;
• appliances;
• tools;
• electronic devices.

This distinction is particularly important because REACH obligations can differ depending on whether a company manufactures or imports a substance, uses a mixture, or places an article on the market.

10.7 REACH and Electrical Products

An electrical product is often an article under REACH.

However, that does not mean REACH becomes irrelevant simply because the manufacturer is selling an article rather than a chemical substance.

The article may contain substances that are relevant under REACH.

For example, an electronic product could contain:

• plasticisers;
• flame retardants;
• coatings;
• adhesives;
• pigments;
• lubricants;
• metals;
• batteries;
• solder;
• or other chemical substances.

Some of these substances may be relevant because they are:

• restricted under REACH;
• included on the Candidate List;
• subject to authorisation;
• relevant to supply-chain communication;
• or otherwise regulated.

Therefore, the manufacturer needs to consider the chemical content of the article.

10.8 REACH Is Not a “Banned Substance List”

Another common misunderstanding is:

“REACH is a list of banned chemicals.”

That is incorrect.

REACH is a comprehensive regulatory system containing several different mechanisms.

Depending on the substance and circumstances, REACH can involve:

• registration;
• evaluation;
• information requirements;
• communication obligations;
• authorisation;
• restrictions;
• supply-chain information;
• risk management;
• and substitution of substances of concern.

A substance being listed somewhere within the REACH framework does not automatically mean:

“This substance is banned.”

The specific regulatory mechanism and conditions must be examined.

10.9 Registration

Registration is one of the central mechanisms of REACH.

Companies manufacturing or importing substances into the EU/EEA above the applicable tonnage threshold generally have registration obligations.

For many substances, the threshold is:

1 tonne per year

subject to the detailed rules and exemptions contained in REACH.

Registration requires companies to collect information about the substance’s:

• identity;
• properties;
• hazards;
• uses;
• exposure;
• and safe handling.

This information is submitted to the European Chemicals Agency (ECHA) through a registration dossier.

The registration system is therefore primarily concerned with substances rather than finished electrical products.

10.10 Who Normally Has to Register?

The registration obligation generally falls on companies that:

• manufacture substances in the EU/EEA; or
• import substances into the EU/EEA

above the applicable threshold.

This distinction is important for electrical-product manufacturers.

A company buying a component from an EU supplier is not automatically responsible for registering every chemical substance contained in that component.

The company’s obligations depend on its specific role in the supply chain.

For example:

EU chemical manufacturer

→ may have registration obligations.

EU component manufacturer

→ may have downstream-user or article-related obligations.

EU electrical-product manufacturer

→ may have article-related and supply-chain obligations.

Non-EU manufacturer

→ may have no direct REACH registration obligation simply because its product is sold to an EU customer, but its EU importer may have obligations.

The exact legal situation depends on the supply-chain structure.

10.11 What Does Registration Achieve?

Registration is intended to ensure that sufficient information exists about chemical substances placed on the EU market.

Companies must provide information about the substance’s properties and, where relevant, its risks and safe-use conditions.

ECHA receives and evaluates registration information, while Member State authorities can evaluate selected substances to investigate potential concerns.

This creates a large information base about chemicals used in Europe.

The information can then support further regulatory action.

For example:

Registration data

↓

Evaluation

↓

Identification of concerns

↓

Risk assessment

↓

Possible authorisation or restriction

This is one of the fundamental mechanisms through which REACH operates.

10.12 Evaluation

The second major element of REACH is Evaluation.

Authorities and ECHA evaluate information submitted under REACH.

The objective is to determine whether:

• registration information is adequate;
• additional information is necessary;
• a substance requires further investigation; or
• regulatory action may be necessary.

ECHA explains that Member States evaluate selected substances to clarify initial concerns for human health or the environment.

Evaluation therefore acts as an important control mechanism within the REACH system.

10.13 Authorisation

Another major REACH mechanism is Authorisation.

Authorisation is particularly relevant to substances of very high concern.

The objective is to ensure that substances presenting particularly serious risks are progressively replaced by safer alternatives where technically and economically feasible.

If a substance is included in Annex XIV of REACH, certain uses may require an authorisation unless another applicable provision applies.

This does not necessarily mean that the substance itself is completely banned.

Instead, the use may only be permitted under defined conditions or with an appropriate authorisation.

For manufacturers, this means that a substance’s presence alone is not always enough to determine the legal conclusion.

The specific use can be critical.

10.14 Restriction

REACH also contains a separate mechanism called Restriction.

Restrictions can limit or prohibit:

• manufacture;
• placing on the market;
• import;
• or use

of substances where unacceptable risks exist.

A restriction can apply to:

• substances on their own;
• substances in mixtures;
• substances in articles.

ECHA notes that restrictions can apply even to substances that do not require registration, including certain substances manufactured or imported below the one-tonne threshold.

This is an important distinction:

Registration and restriction are separate mechanisms.

A substance not requiring registration can still be subject to a REACH restriction.

10.15 Annex XVII

REACH restrictions are contained in Annex XVII.

This annex contains restrictions adopted under REACH and earlier chemical legislation.

As of the current ECHA database update in July 2026, the restriction database contains 79 unique substances/entries.

However, the number of entries should not be confused with a simple list of banned substances.

Each entry can contain specific:

• substances;
• products;
• concentration limits;
• uses;
• conditions;
• exemptions; and
• dates.

A manufacturer therefore needs to examine the actual restriction entry rather than simply checking whether a substance appears in Annex XVII.

10.16 The Candidate List

One of the most important REACH concepts for electrical-product manufacturers is the Candidate List of substances of very high concern (SVHCs).

A substance can be identified as an SVHC and added to the Candidate List because it meets specific hazard criteria.

Examples of characteristics that can lead to SVHC identification include:

• carcinogenicity;
• mutagenicity;
• reproductive toxicity;
• persistence;
• bioaccumulation;
• toxicity; or
• other equivalent levels of concern.

Being placed on the Candidate List does not automatically mean that the substance is banned.

Instead, Candidate List inclusion can trigger specific information and communication obligations and may be an important step toward possible future regulatory action.

The Candidate List is therefore fundamentally different from the RoHS list of restricted substances.

A detailed discussion of SVHCs and the Candidate List follows in Chapter 12.

10.17 Communication in the Supply Chain

REACH places significant emphasis on communication throughout the supply chain.

Information may need to move:

Substance manufacturer

↓

Chemical supplier

↓

Component supplier

↓

Product manufacturer

↓

Distributor

↓

Professional customer / consumer

This is particularly important when substances present specific hazards or regulatory concerns.

For electrical-product manufacturers, this means that compliance is not simply a matter of obtaining one annual “REACH declaration.”

The manufacturer needs to understand what information is relevant to its products and what information it must communicate downstream.

10.18 Safety Data Sheets

Safety Data Sheets (SDS) are an important REACH communication mechanism for hazardous substances and mixtures.

An SDS can provide information such as:

• substance or mixture identification;
• hazards;
• composition;
• first-aid measures;
• handling and storage;
• exposure controls;
• physical and chemical properties;
• toxicological information;
• ecological information;
• disposal;
• transport;
• regulatory information.

However, an important distinction must be made:

An SDS is generally associated with substances and mixtures, not with every finished article.

An electrical appliance sold as an article does not automatically require an SDS simply because it contains chemicals.

The applicable REACH information and communication obligations need to be assessed based on the product and substance involved.

10.19 REACH and Articles

For manufacturers of electrical and electronic products, the concept of an article is particularly important.

Many finished products are articles under REACH.

Examples can include:

• smartphones;
• computers;
• electrical connectors;
• cables;
• power supplies;
• household appliances;
• industrial controllers;
• sensors;
• tools;
• lighting products.

An article can contain substances that trigger specific REACH obligations.

This means that manufacturers should not conclude:

“We only sell articles, so REACH does not apply to us.”

REACH can apply to companies dealing with articles in several ways.

10.20 Substances in Articles

A manufacturer or importer of an article may need to assess whether the article contains certain substances of regulatory concern.

One particularly important situation is the presence of an SVHC above the applicable concentration threshold.

Where the relevant conditions are met, REACH can create obligations to provide information to recipients of the article.

The purpose is to allow downstream users and recipients to understand how substances of concern are present and how the article can be used safely.

This is one of the areas where REACH becomes highly relevant to electrical-product manufacturers.

10.21 The 0.1% Threshold Is Often Misunderstood

The figure:

0.1%

appears frequently in REACH discussions.

However, it should not be confused with the RoHS 0.1% limit.

Under RoHS, 0.1% is generally a maximum concentration value for specified restricted substances in homogeneous materials.

Under REACH, a 0.1% threshold can have a different legal function, particularly in relation to SVHCs in articles.

The regulatory context is therefore completely different.

This is one of the most important reasons why manufacturers should never copy a RoHS calculation directly into a REACH assessment.

10.22 REACH Uses Different Regulatory Concepts

The difference can be summarised as follows.

RoHS

Restricted substance

↓

Homogeneous material

↓

Maximum concentration

↓

Product conformity

REACH

Substance

↓

Regulatory status

↓

Use / presence / concentration

↓

Registration, communication, authorisation, restriction or other obligation

The two systems can use similar terminology while applying it in different ways.

Manufacturers need to understand the legal context behind the numbers.

10.23 REACH and Supply-Chain Responsibility

REACH follows the concept of different roles within the supply chain.

A company may be:

• manufacturer;
• importer;
• downstream user;
• distributor;
• producer of an article;
• supplier of an article;
• or another defined actor.

The obligations depend significantly on that role.

For example, a company that manufactures a chemical substance has fundamentally different REACH responsibilities from a company that purchases an electronic component and incorporates it into a finished product.

This is why a generic statement such as:

“Our company is REACH compliant.”

can be difficult to interpret without understanding the company’s role.

10.24 Importing from Outside the EU

REACH can become particularly important when electrical products or components are sourced from outside the EU/EEA.

Consider a German manufacturer purchasing an electronic module from:

China

The Chinese supplier may provide:

“REACH compliant.”

However, the EU manufacturer should still determine what its own REACH responsibilities are.

The supplier’s declaration may provide useful evidence, but it does not automatically transfer the EU manufacturer’s legal responsibilities to the Chinese supplier.

The manufacturer should understand:

• what is being imported;
• whether it is a substance, mixture or article;
• whether substances are present;
• whether an SVHC is present;
• whether a restriction applies;
• whether registration obligations could arise;
• and what information must be communicated.

This becomes particularly important where the EU company is the importer under REACH.

10.25 The “Only One Tonne” Misunderstanding

Another common misunderstanding is:

“If we import less than one tonne, REACH does not apply.”

This is incorrect.

The one-tonne threshold is primarily relevant to certain registration obligations.

Other REACH mechanisms can apply regardless of that threshold.

For example, restrictions under Annex XVII can apply even when a substance does not require registration.

Likewise, specific information and communication obligations can arise from the presence of SVHCs in articles.

Therefore:

No registration obligation ≠ no REACH obligations.

This distinction is essential for product manufacturers.

10.26 REACH and Chemicals Used During Manufacturing

REACH can also affect substances used during production.

For example, a manufacturer may use:

• cleaning solvents;
• lubricants;
• adhesives;
• paints;
• coatings;
• process chemicals;
• sealants;
• or other chemical mixtures.

The company may have obligations as a downstream user.

The manufacturer therefore needs to distinguish between:

Chemicals used in manufacturing

and

Substances contained in the finished product

These can create different REACH considerations.

A company may therefore have REACH obligations even when the finished electrical product itself contains no substance that triggers a specific article-related obligation.

10.27 Downstream Users

A downstream user is generally a company that uses a substance or mixture as part of its industrial or professional activities, rather than manufacturing or importing that substance.

For example:

Chemical supplier

↓

Supplies adhesive

↓

Electrical-product manufacturer

Uses adhesive to assemble products.

The electrical-product manufacturer may be a downstream user.

It therefore needs to consider whether the substance is used according to the conditions communicated through the supply chain and whether additional obligations arise.

ECHA specifically identifies downstream users as companies that may need to check restrictions, authorisation requirements, safety information and risk-management measures.

10.28 REACH and Product Design

REACH can influence product design in much the same way that RoHS does, but through different mechanisms.

During product development, manufacturers may need to consider:

• chemical composition;
• SVHC content;
• restricted substances;
• authorised uses;
• available alternatives;
• supplier transparency;
• customer information requirements;
• and future regulatory developments.

This can influence material selection.

For example, an engineering team might have two technically equivalent materials.

One has:

• strong supplier documentation;
• no relevant SVHC;
• stable formulation;
• good regulatory history.

The other contains a substance of concern and requires additional communication and monitoring.

The first material may therefore be preferable even if both are technically suitable.

10.29 REACH Is Dynamic

One of the major practical differences between REACH and a static product specification is that REACH changes over time.

The regulatory status of a substance can evolve.

For example:

Substance identified

↓

Regulatory evaluation

↓

Candidate List

↓

Potential inclusion in Annex XIV

or

↓

Potential restriction under Annex XVII

This means that a product that was assessed several years ago may require reassessment when the regulatory status of a substance changes.

For manufacturers with long product lifecycles, regulatory monitoring is therefore important.

10.30 REACH Does Not Mean Every Product Must Be Laboratory Tested

Another common misconception is:

“REACH requires manufacturers to test their products for every chemical substance.”

That is not how REACH works.

REACH establishes different obligations depending on:

• substance;
• role;
• quantity;
• use;
• product type;
• regulatory status;
• and applicable provisions.

Manufacturers should therefore first determine the applicable regulatory question.

Only then should they determine whether additional information or testing is necessary.

This is similar to the risk-based approach discussed for RoHS, but the legal framework is different.

10.31 Information First, Testing Where Necessary

A sensible REACH assessment often starts with:

Product identification

↓

Supply-chain identification

↓

Substance information

↓

Candidate List check

↓

Restriction check

↓

Authorisation check

↓

Assessment of applicable obligations

↓

Additional information/testing where necessary

This avoids using laboratory testing as a substitute for regulatory analysis.

ECHA itself emphasises that registrants should first evaluate available information and only seek additional testing where the available information is inadequate.

10.32 REACH and RoHS Can Use the Same Supplier Information

Although RoHS and REACH are different, the same supplier data can sometimes support both assessments.

For example, a supplier may provide:

• material declaration;
• chemical composition;
• RoHS declaration;
• REACH/SVHC information;
• test reports;
• exemption information;
• change notifications.

The manufacturer can then use the information for different regulatory assessments.

However, the manufacturer should still ask:

Does this information actually answer the specific legal question?

A material declaration might support a RoHS assessment while still being insufficient to establish the manufacturer’s complete REACH obligations.

10.33 A Practical Example

Consider a plastic housing for an industrial controller.

The supplier provides:

“RoHS compliant according to Directive 2011/65/EU.”

For RoHS, the manufacturer can evaluate this statement as part of its material evidence.

For REACH, however, additional questions may be necessary:

• Does the housing contain an SVHC?
• Is any relevant substance present above the applicable threshold?
• Is the substance restricted?
• Is information required to be communicated?
• Has the supplier assessed the current Candidate List?
• Has the material formulation changed?

The same component therefore requires two different compliance questions.

10.34 Another Example: Adhesive

An electrical manufacturer uses an adhesive during production.

The adhesive supplier provides an SDS.

The SDS identifies several chemical substances.

The manufacturer should then determine:

• Is the adhesive classified as hazardous?
• What REACH obligations apply to its use?
• Are there restrictions?
• Is authorisation relevant?
• Are exposure controls required?
• Are the conditions of safe use being followed?

This is different from asking whether the finished electrical product complies with RoHS.

The adhesive could be fully compliant with REACH requirements while containing none of the RoHS-restricted substances.

10.35 REACH and the Environment

REACH is not limited to worker or consumer protection.

Environmental protection is one of its central objectives.

The regulatory framework addresses risks associated with:

• persistence;
• bioaccumulation;
• toxicity;
• environmental exposure;
• and other chemical hazards.

This is particularly important for substances that can remain in the environment for long periods or accumulate in organisms.

RoHS also has environmental objectives, but REACH approaches chemical risks much more broadly.

10.36 REACH and Substitution

One of the long-term objectives of REACH is to encourage the substitution of substances of very high concern with safer alternatives where technically and economically feasible.

For manufacturers, this can create an important product-development consideration.

A material may technically be legal today but become strategically undesirable because:

• its regulatory status is becoming more restrictive;
• customers are demanding alternatives;
• future authorisation may become necessary;
• supply may become more difficult; or
• safer alternatives are available.

A mature compliance strategy therefore looks beyond:

“Is it legal today?”

and also asks:

“Is this a material we want to depend on for the next ten years?”

10.37 REACH Is a Supply-Chain Regulation as Much as a Chemical Regulation

For electrical-product manufacturers, REACH compliance is often heavily dependent on supply-chain transparency.

The manufacturer may not know the detailed chemical composition of every:

• plastic;
• coating;
• adhesive;
• cable;
• connector;
• PCB;
• seal;
• or electronic module.

Instead, the manufacturer depends on suppliers and sub-suppliers for information.

This makes supplier management essential.

A robust process should therefore define:

• what information suppliers must provide;
• how often it is updated;
• how changes are communicated;
• how Candidate List updates are handled;
• how restrictions are checked;
• and how evidence is stored.

10.38 What Manufacturers Should Ask Suppliers

Instead of simply asking:

“Is this product REACH compliant?”

a manufacturer can ask more useful questions.

For example:

• Does the product contain any substances on the current REACH Candidate List?
• If yes, which substances?
• At what concentration?
• In which article or material are they present?
• Does the product contain substances subject to Annex XVII restrictions?
• Are any substances subject to authorisation relevant to the supplied use?
• Is the declaration applicable to the exact part number and revision?
• When was the information last reviewed?
• Will the supplier notify us of relevant chemical or regulatory changes?

These questions produce much more useful compliance information than a generic declaration.

10.39 REACH Compliance Is Not One Document

A manufacturer should therefore avoid thinking:

“We have our REACH certificate.”

There is generally no universal REACH certificate that proves all obligations for every product and every company.

Instead, REACH compliance is based on the obligations applicable to the company’s:

• role;
• substances;
• products;
• quantities;
• uses;
• supply chain;
• and regulatory situation.

The appropriate evidence can therefore include:

• supplier declarations;
• SDS;
• material information;
• Candidate List assessments;
• restriction assessments;
• authorisation information;
• technical documentation;
• communication records;
• and other supporting information.

10.40 A Practical REACH Compliance Workflow

For an electrical-product manufacturer, a practical process can look like this:

Step 1 – Identify the product

Determine whether the product is:

• substance;
• mixture;
• article;
• or a combination of these.

↓

Step 2 – Identify the company’s REACH role

Determine whether the company acts as:

• manufacturer;
• importer;
• downstream user;
• distributor;
• article producer;
• or another defined actor.

↓

Step 3 – Identify relevant substances

Obtain information from suppliers and internal manufacturing processes.

↓

Step 4 – Check regulatory status

Review:

• Candidate List;
• Annex XIV;
• Annex XVII;
• and other relevant REACH provisions.

↓

Step 5 – Determine applicable obligations

Assess:

• registration;
• communication;
• restriction;
• authorisation;
• downstream-user obligations;
• and other requirements.

↓

Step 6 – Identify evidence gaps

Determine what information is missing.

↓

Step 7 – Request additional information or perform targeted investigation

Only where justified.

↓

Step 8 – Document the conclusion

Maintain traceable evidence.

↓

Step 9 – Monitor changes

Update the assessment when:

• suppliers change;
• materials change;
• the Candidate List changes;
• restrictions change;
• or other relevant regulatory developments occur.

10.41 RoHS and REACH Require Different Questions

At this point, the difference between the two frameworks can be summarised very simply.

RoHS

Is this covered electrical/electronic product compliant with the specified substance restrictions at the homogeneous-material level?

REACH

What REACH obligations arise from the substances, materials, products, uses and supply-chain roles involved?

These questions may concern the same product.

But they lead to different assessments.

10.42 Why Manufacturers Need Both Assessments

Consider a modern wireless industrial device.

It contains:

• PCB;
• plastic enclosure;
• cables;
• connectors;
• display;
• adhesives;
• coatings;
• metal parts;
• battery;
• electronic components.

The manufacturer may need to perform:

RoHS assessment

• scope;
• ten restricted substances;
• homogeneous materials;
• exemptions;
• supplier evidence;
• testing where necessary.

REACH assessment

• substances in articles;
• SVHC status;
• Candidate List;
• Annex XVII restrictions;
• authorisation;
• supply-chain communication;
• importer/downstream-user obligations.

The same BOM can therefore support two different regulatory assessments.

This is one reason why an integrated chemical-compliance process can be highly valuable.

10.43 The Most Important REACH Principle

For manufacturers, perhaps the most important principle is:

REACH is not simply a list of substances to test for. It is a regulatory system that determines different obligations depending on the substance, product, use and role of the company in the supply chain.

This means that a manufacturer should not start with:

“Which REACH test should we order?”

It should start with:

“Which REACH obligations apply to us and to this product?”

Only after that question has been answered can the manufacturer determine what evidence is actually required.

10.44 The Key Takeaway

REACH is the EU’s comprehensive framework for the Registration, Evaluation, Authorisation and Restriction of Chemicals.

The most important principles for electrical and electronic product manufacturers are:

• REACH is established by Regulation (EC) No 1907/2006.
• It entered into force on 1 June 2007.
• It has a much broader scope than RoHS.
• REACH applies, in principle, to chemical substances and can affect substances, mixtures and articles.
• Registration generally concerns companies manufacturing or importing substances above the applicable thresholds, commonly 1 tonne per year, subject to specific rules and exemptions.
• Evaluation allows authorities to examine registration information and investigate potential concerns.
• Authorisation controls certain uses of substances of very high concern.
• Restrictions under Annex XVII can limit or prohibit the manufacture, placing on the market or use of substances.
• REACH restrictions can apply even where a substance does not require registration.
• Electrical and electronic products are often articles under REACH, meaning that article-related obligations can become relevant.
• The REACH Candidate List is particularly important for manufacturers because SVHC presence can trigger information and communication obligations.
• The 0.1% threshold used in certain REACH article obligations must not be confused with the 0.1% RoHS homogeneous-material limit.
• There is no universal “REACH certificate” that automatically proves compliance with every REACH obligation.
• Supplier information is extremely important, particularly for complex electrical products.
• REACH is dynamic, so regulatory status can change during the lifetime of a product.
• A robust REACH assessment should therefore be based on the company’s role, substances, products, uses and supply chain, rather than on a generic declaration.

In short:

RoHS asks whether specific hazardous substances are restricted in covered electrical and electronic equipment. REACH establishes a much broader system for managing chemical substances throughout the supply chain.

11. REACH and Electrical and Electronic Products

REACH is particularly relevant to electrical and electronic products because modern EEE is made from a large number of different materials, components and subassemblies.

A typical electronic product may contain:

• plastics;
• metals and alloys;
• cables;
• printed circuit boards;
• coatings;
• adhesives;
• sealants;
• flame-retardant materials;
• displays;
• batteries;
• connectors; and
• many other components.

Each of these can involve different substances and different positions in the REACH supply chain.

This creates an important practical distinction:

A product can be an article under REACH while still containing substances that create specific REACH obligations.

For manufacturers, REACH compliance therefore cannot be assessed simply by asking whether the finished product is “REACH compliant.” The manufacturer needs to understand what the product contains, what regulatory status those substances have, and which obligations arise from the company’s role in the supply chain.

11.1 Why REACH Matters for Electrical Products

Electrical and electronic products are often complex assemblies.

A single finished product can contain hundreds or thousands of individual materials and components sourced from suppliers around the world.

Consider an industrial controller containing:

• a plastic housing;
• PCB assemblies;
• connectors;
• cables;
• display;
• metal brackets;
• adhesives;
• thermal interface materials;
• labels;
• coatings; and
• electronic modules.

The manufacturer may not directly formulate any of these materials.

Instead, it depends on its supply chain for information about their chemical composition.

This makes REACH fundamentally different from simply checking a product against a fixed list of substances.

The manufacturer needs a process that connects:

Product → Component → Material → Substance → Regulatory status → Applicable obligation

11.2 Electrical Products Are Often “Articles” Under REACH

One of the most important REACH concepts for electrical-product manufacturers is the definition of an article.

REACH defines an article as an object whose:

shape, surface or design determines its function to a greater degree than its chemical composition.

Many electrical and electronic products fall within this definition.

Examples can include:

• computers;
• smartphones;
• routers;
• industrial controllers;
• sensors;
• power supplies;
• cables;
• connectors;
• switches;
• lighting equipment;
• household appliances; and
• electronic control units.

Being an article does not mean that REACH is irrelevant.

On the contrary, REACH contains specific provisions concerning substances present in articles.

ECHA specifically identifies obligations for producers, importers and suppliers of articles containing Candidate List substances. (Chemicals in Our Life)

11.3 Article vs. Substance or Mixture

A manufacturer must first understand what it is dealing with.

Consider a manufacturer purchasing three different products:

Product A – Adhesive

The adhesive is primarily a mixture.

Product B – Plastic housing

The housing is generally an article.

Product C – Chemical solvent

The solvent is a substance or mixture, depending on its composition and supply form.

These classifications matter because REACH obligations can differ significantly.

A manufacturer may therefore have several different REACH roles within the same production process.

For example:

Chemical supplier

→ supplies adhesive

↓

Electrical-product manufacturer

→ uses adhesive

↓

Finished electrical product

→ becomes an article

REACH needs to be considered at each relevant stage.

11.4 A Finished Product Can Contain Many Articles

Modern electronic products are often complex objects made from many individual articles.

For example:

Industrial controller

• plastic housing;
• connector;
• cable;
• PCB;
• display;
• mounting bracket;
• screws;
• fan.

Each individual component may itself be an article.

This matters because a Candidate List substance may be present in an individual component even though its concentration in the complete finished product is much lower.

ECHA’s guidance and SCIP framework recognise that complex objects can contain multiple articles and that information concerning Candidate List substances can need to be tracked through the article hierarchy. (ECHA)

11.5 REACH Does Not Work Like RoHS

This distinction is critical.

RoHS generally asks:

Does a restricted substance exceed the applicable concentration limit in the relevant homogeneous material?

REACH asks a broader series of questions.

For example:

• What substances are present?
• What is their regulatory status?
• Is the substance on the Candidate List?
• Is it subject to a restriction?
• Is authorisation relevant?
• Is information required to be communicated?
• Is an ECHA notification required?
• Does the company’s role as producer, importer or downstream user create additional obligations?

The same material can therefore produce very different conclusions under the two frameworks.

11.6 The Candidate List Is Particularly Important for EEE

For electrical and electronic products, the REACH Candidate List of substances of very high concern (SVHCs) is one of the most important areas to monitor.

When a substance is added to the Candidate List, specific legal obligations can arise for companies dealing with:

• substances;
• mixtures; and
• articles containing those substances.

For articles, the key threshold for several obligations is:

more than 0.1% by weight (w/w)

However, the meaning of this threshold is different from the RoHS 0.1% limit.

The REACH 0.1% threshold is associated with specific obligations concerning Candidate List substances in articles. It is not a general REACH “maximum concentration limit.”

ECHA confirms that suppliers of articles containing Candidate List substances above 0.1% w/w have information obligations, while producers and importers may also have notification obligations when additional conditions are met. (ECHA)

11.7 Article 33 – Communication to Customers

One of the most important provisions for electrical-product manufacturers is Article 33 of REACH.

Where an article contains a Candidate List substance above 0.1% w/w, suppliers must provide sufficient information to allow safe use of the article.

At minimum, the name of the substance must be communicated.

This obligation applies to recipients such as:

• industrial customers;
• professional users; and
• distributors.

The obligation applies from the point at which the substance is included in the Candidate List. (ECHA)

For an electrical-product manufacturer, this means that an SVHC declaration can become an important part of the product information supplied to customers.

11.8 Consumer Requests

REACH also provides information rights to consumers.

If a consumer asks whether an article contains a Candidate List substance above 0.1% w/w, the supplier must provide sufficient information for safe use.

The response must be provided:

within 45 days

and free of charge. (ECHA)

This can be particularly relevant for consumer electronics manufacturers.

A company selling:

• appliances;
• smart-home products;
• consumer electronics;
• lighting;
• personal electronics; or
• other consumer products

may therefore need a process for handling such requests.

11.9 Article 7(2) – Notification to ECHA

REACH also contains a separate notification obligation for certain producers and importers of articles.

Notification to ECHA is required when both of the following conditions are met:

1. the Candidate List substance is present in the relevant articles above 0.1% w/w; and
2. the total amount of the substance in those articles exceeds one tonne per year per producer or importer.

The notification generally has to be submitted within six months after the substance is included in the Candidate List. (ECHA)

This is an important distinction:

The 0.1% threshold alone does not automatically mean that an ECHA notification is required.

The one-tonne-per-year condition is also relevant to the Article 7(2) notification obligation.

11.10 The 0.1% Threshold Must Be Understood Correctly

This is one of the areas where manufacturers most often confuse RoHS and REACH.

RoHS

The 0.1% value is generally a maximum concentration limit for specified substances in homogeneous materials.

REACH

The 0.1% value can trigger information and communication obligations for Candidate List substances in articles.

These are fundamentally different concepts.

For example:

RoHS

Lead = 0.12% in a homogeneous material

→ potentially non-compliant unless an exemption applies.

REACH

Candidate List substance = 0.12% in an article

→ does not automatically mean that the article is prohibited.

Instead, specific REACH obligations may arise.

This distinction should be clearly reflected in internal compliance procedures.

11.11 An SVHC Does Not Automatically Mean the Product Is Illegal

Another important misconception is:

“If an electronic product contains an SVHC, it cannot be sold.”

That is not generally correct.

A Candidate List substance can be present in an article.

Its presence can trigger:

• communication obligations;
• potentially ECHA notification obligations;
• SCIP obligations;
• additional supply-chain information requirements; and
• potentially future regulatory action.

But Candidate List inclusion itself does not automatically constitute a ban on the article.

ECHA explicitly notes that articles containing Candidate List substances are not necessarily prohibited or necessarily hazardous to consumers merely because the substance is present. (ECHA)

The manufacturer therefore needs to determine the actual regulatory consequences of the substance’s status.

11.12 SCIP – Substances of Concern In Products

For electrical and electronic manufacturers, another important obligation is the SCIP database.

SCIP stands for:

Substances of Concern In Products

It was established under the EU Waste Framework Directive.

Companies placing articles containing Candidate List substances above 0.1% w/w on the EU market can have obligations to submit information to ECHA’s SCIP database.

The purpose is to make information about substances of concern available throughout the product lifecycle, including at the waste stage. (Chemicals in Our Life)

This is particularly relevant to electrical and electronic products because complex electronic products can contain many individual articles.

11.13 SCIP Is Not the Same as REACH

SCIP and REACH are closely connected but should not be treated as identical.

REACH

Focuses on:

• chemical substances;
• risks;
• registration;
• authorisation;
• restrictions;
• supply-chain communication; and
• substances in articles.

SCIP

Focuses on:

• articles containing Candidate List SVHCs;
• information for the product lifecycle;
• waste treatment;
• recycling;
• and the circular economy.

The SCIP obligation arises from the Waste Framework Directive, even though it uses the REACH Candidate List as its substance trigger.

This distinction is important when building a compliance database.

11.14 SCIP Is Particularly Relevant to Electronics

Electrical and electronic products are often complex objects.

A single product may contain:

Finished product

↓

PCB assembly

↓

Connector

↓

Cable

↓

Plastic housing

↓

Individual material

If a Candidate List substance above the relevant threshold is present in one of these articles, the information may need to be reflected in the product’s SCIP assessment.

The ECHA SCIP database explicitly supports complex objects and their article hierarchies. (Chemicals in Our Life)

This makes SCIP data management particularly relevant for manufacturers with complex BOM structures.

11.15 The Supply Chain Is Essential

Electrical manufacturers often cannot determine the chemical composition of every component independently.

They rely on suppliers.

A typical information chain can look like:

Raw-material supplier

↓

Component manufacturer

↓

Subassembly manufacturer

↓

Electrical-product manufacturer

↓

Distributor

↓

Customer

Information about Candidate List substances therefore needs to move through the supply chain.

ECHA specifically notes that producers and importers of articles can obtain information about substances and their concentrations from actors further up the supply chain, including suppliers outside the EU. (Chemicals in Our Life)

11.16 Non-EU Suppliers Are Particularly Important

This becomes especially important when an EU manufacturer sources components from:

• China;
• Taiwan;
• South Korea;
• Japan;
• the United States;
• India;
• Vietnam; or
• other non-EU countries.

A non-EU supplier may provide a declaration saying:

“REACH compliant.”

But the EU importer still needs to understand its own obligations.

ECHA specifically recommends that non-EU article producers be aware of the Candidate List because EU importers may need information about SVHCs present in imported articles. (ECHA)

Therefore, a good purchasing specification should require meaningful substance information rather than simply requesting a generic “REACH certificate.”

11.17 The EU Importer Can Carry the Legal Obligation

Consider a German company importing a finished electronic device from China.

The Chinese manufacturer produces the product.

The German company imports it into the EU and places it on the EU market.

The German company may therefore become the relevant importer under REACH.

The fact that the Chinese supplier manufactured the product does not automatically remove the EU company’s obligations.

The importer may need to assess:

• Candidate List substances;
• concentration;
• annual quantities;
• notification obligations;
• Article 33 communication;
• SCIP;
• and other applicable REACH requirements.

This is why global supply chains need to be incorporated into the compliance assessment.

11.18 The One-Tonne Threshold Is Not Universal

The one-tonne threshold creates another frequent misunderstanding.

A manufacturer may think:

“We import less than one tonne, so REACH does not apply.”

That conclusion is too broad.

The one-tonne threshold is relevant to certain obligations, such as the Article 7(2) notification to ECHA.

It does not remove all other obligations.

For example, the Article 33 information obligation for an article containing a Candidate List substance above 0.1% does not have the same one-tonne trigger. ECHA explicitly notes that this communication obligation also applies below one tonne per year. (ECHA)

Therefore:

No Article 7(2) notification does not necessarily mean no REACH action.

11.19 Substances in Components

One of the most difficult practical issues for electronics manufacturers is determining whether a substance is present in a component.

For example, a supplier may provide a connector.

The connector may contain:

• plastic;
• brass;
• plating;
• lubricant;
• adhesive;
• seal;
• marking ink.

The manufacturer may only see:

Part number ABC123 – Connector

But the REACH assessment may require information about the individual materials inside that connector.

This is why component-level declarations can sometimes be insufficient.

The manufacturer needs to establish whether the supplier’s statement actually covers the relevant article and its constituent materials.

11.20 Complex Products Require Hierarchical Data

For a simple product, REACH data can be relatively straightforward.

For a complex electronic system, it can become hierarchical.

For example:

Product A

• Module B
  • PCB C
    • Component D
    • Connector E
  • Cable F
• Housing G
• Display H

If a Candidate List substance exists in Connector E, the manufacturer needs a way to associate that information with the overall product.

This is one reason why structured compliance databases are increasingly useful.

A flat spreadsheet containing only:

“Product A – REACH compliant”

does not provide the same level of traceability.

11.21 REACH and the Bill of Materials

The BOM therefore becomes an important starting point for REACH.

A useful BOM can identify:

• internal part number;
• supplier;
• manufacturer;
• manufacturer part number;
• revision;
• material;
• component type;
• quantity;
• product position;
• and applicable documentation.

The BOM can then be connected to:

SVHC information

REACH restrictions

Supplier declarations

Material information

SCIP information

Change notifications

This creates a structured compliance chain.

11.22 Supplier Declarations Need a Defined Scope

A supplier declaration should ideally identify what it covers.

For example:

Part number: ABC-123
Revision: Rev. 04
Supplier: XYZ GmbH
Assessment: REACH Candidate List status
Date: 15 August 2026
SVHC status: No Candidate List substances above applicable threshold
Change notification: Supplier commits to notify customer of relevant material changes.

This is much more useful than:

“Our products are REACH compliant.”

The second statement is difficult to audit because the scope and basis of the declaration are unclear.

11.23 Candidate List Monitoring Is Essential

The Candidate List is not static.

ECHA can add substances to the list as substances are identified as meeting the relevant SVHC criteria.

For example, ECHA announced an update in February 2026 that brought the Candidate List to 253 entries, noting that some entries cover groups of chemicals. (ECHA)

For manufacturers with long product lifecycles, this means that an assessment performed once may become outdated.

A product that was assessed as having no relevant SVHCs in 2023 may require reassessment after later Candidate List updates.

11.24 A Change in Candidate List Status Can Trigger New Work

Consider a plastic component.

January 2026

Supplier confirms:

No Candidate List substance above 0.1%.

February 2026

A substance relevant to the component is added to the Candidate List.

The supplier’s old declaration does not necessarily become meaningless, but it may no longer answer the current regulatory question.

The manufacturer should determine:

• Is the substance present?
• At what concentration?
• Is the concentration above 0.1%?
• Does Article 33 apply?
• Does SCIP apply?
• Is Article 7(2) notification relevant?
• Does another restriction apply?

This is why Candidate List monitoring should be connected to supplier and product data.

11.25 REACH Restrictions Can Also Affect Electrical Products

Candidate List substances are not the only REACH concern.

A substance can also be subject to a restriction under Annex XVII.

A restriction may apply to:

• the substance itself;
• a mixture;
• a specific product;
• a particular use;
• or an article.

The manufacturer therefore needs to consider both:

Candidate List status

and

Restriction status

These are separate regulatory questions.

A substance can be relevant under Annex XVII even if the compliance question is completely different from an SVHC communication assessment.

11.26 Authorisation Can Also Become Relevant

Some substances of very high concern can progress from the Candidate List toward the Authorisation List in Annex XIV.

Authorisation concerns whether certain uses of specified substances can continue.

This creates an important product-development consideration.

A material may be available today but become strategically problematic because:

• its use requires authorisation;
• its regulatory status is changing;
• customers demand substitution;
• alternative materials become available; or
• the supply chain becomes more difficult.

For long-life electrical products, manufacturers should therefore consider not only current compliance but also future material availability.

11.27 REACH and Material Selection

Material selection can therefore be influenced by REACH.

Imagine two technically suitable plastics.

Material A

• no relevant SVHC;
• strong supplier documentation;
• stable formulation;
• no known restriction concerns.

Material B

• contains an SVHC;
• requires Article 33 communication;
• requires SCIP assessment;
• supplier information is incomplete.

Both may technically perform the same function.

Material A may nevertheless be the better long-term choice because it reduces:

• documentation effort;
• customer communication;
• regulatory monitoring;
• SCIP management;
• supply-chain dependency;
• and future substitution risk.

Compliance should therefore be considered during product design rather than only after the design is frozen.

11.28 REACH Does Not Require Testing Every Component

As with RoHS, REACH compliance should not automatically be translated into:

“Send the product to a laboratory.”

Laboratory testing can be useful, but the first step is normally information gathering and regulatory assessment.

A practical sequence is:

Identify product

↓

Identify articles/components

↓

Obtain supplier information

↓

Check Candidate List

↓

Check restrictions

↓

Assess applicable obligations

↓

Identify information gaps

↓

Perform targeted investigation/testing where justified

This prevents unnecessary analytical testing.

11.29 When Testing May Be Useful

Additional investigation or testing may be justified where:

• supplier information is unavailable;
• supplier information is contradictory;
• a high-risk material is involved;
• a supplier refuses to provide sufficient information;
• the material formulation is unknown;
• a supplier has changed the material;
• an SVHC declaration appears unreliable;
• a customer requires independent verification; or
• regulatory uncertainty remains.

The purpose should be clearly defined.

For example:

“We need to determine whether DEHP is present above the relevant threshold in this PVC material.”

is a meaningful analytical question.

“Test the entire product for REACH.”

is generally too vague.

11.30 REACH and Batteries

Electrical products frequently contain batteries.

This creates an additional layer of regulatory complexity.

Depending on the product and battery type, manufacturers may need to consider:

• REACH;
• the EU Batteries Regulation;
• transport requirements;
• waste legislation;
• and other applicable legislation.

A REACH assessment therefore should not automatically be considered the complete chemical assessment for a battery-containing product.

The manufacturer should identify the other applicable legislation separately.

11.31 REACH and Cables

Cables are particularly relevant because they combine multiple materials.

A cable may contain:

• copper;
• aluminium;
• insulation;
• polymer jackets;
• shielding;
• fillers;
• adhesives;
• connectors.

Some polymer materials can contain substances that are relevant under REACH.

For example, certain phthalates have historically been used in flexible PVC.

A manufacturer should therefore request meaningful material information from cable suppliers rather than relying solely on a generic declaration.

11.32 REACH and Plastics

Plastics are another important area.

Manufacturers should consider:

• base polymer;
• plasticisers;
• flame retardants;
• pigments;
• stabilisers;
• additives;
• coatings;
• fillers.

The presence of a substance of concern does not automatically mean the plastic cannot be used.

Instead, the manufacturer must determine the relevant legal status and resulting obligations.

This is why a statement such as:

“Plastic is REACH compliant.”

provides limited information without knowing what was actually assessed.

11.33 REACH and Flame Retardants

Flame-retardant systems deserve particular attention.

Electrical products often require fire-performance properties, which can involve chemical flame retardants.

Some flame retardants have historically been subject to significant regulatory scrutiny.

A manufacturer should therefore determine:

• which flame-retardant system is used;
• which substances are present;
• whether any are on the Candidate List;
• whether restrictions apply;
• whether customer communication is required; and
• whether safer alternatives are available.

This can be particularly important for:

• housings;
• connectors;
• cable insulation;
• PCB materials;
• power supplies; and
• industrial equipment.

11.34 REACH and Coatings

Coatings can also introduce substances that are not obvious from the underlying material.

Examples include:

• paints;
• corrosion protection;
• plating;
• decorative coatings;
• protective films;
• conversion coatings.

A metal component can therefore have a different REACH assessment depending on its surface treatment.

This is another reason why material information should extend beyond the base material.

11.35 REACH and Adhesives

Adhesives can contain multiple chemical substances.

They may be used in:

• PCB assemblies;
• displays;
• housings;
• labels;
• cable assemblies;
• sensors;
• batteries;
• sealing applications.

The manufacturer may be a downstream user of the adhesive before the final article is produced.

Therefore, the company should distinguish between:

REACH obligations associated with using the adhesive

and

REACH obligations associated with the finished article

These are related but not necessarily identical.

11.36 A Practical Example – Industrial Sensor

Consider an industrial sensor containing:

• stainless-steel housing;
• plastic connector;
• PCB;
• cable;
• epoxy potting compound;
• adhesive;
• protective coating.

The manufacturer should consider REACH at several levels.

Housing

Assess material and surface treatment information.

Connector

Obtain information about plastics, metals and coatings.

Cable

Assess polymer materials and other relevant substances.

Potting compound

Consider the REACH status of the mixture during manufacturing.

Adhesive

Assess downstream-user obligations where applicable.

Finished sensor

Determine whether any Candidate List substances in the article trigger Article 33, Article 7(2) or SCIP obligations.

This demonstrates why REACH compliance cannot be reduced to one product-level declaration.

11.37 A Practical Example – Consumer Electronics

Consider a smart-home device sold directly to consumers.

It contains:

• plastic housing;
• PCB;
• cable;
• battery;
• display;
• adhesive;
• rubber seal.

The manufacturer should consider:

1. Which substances are present?
2. Are any Candidate List substances present above 0.1%?
3. Is Article 33 information required?
4. Is SCIP notification required?
5. Is Article 7(2) notification relevant?
6. Are any Annex XVII restrictions applicable?
7. Are additional obligations triggered by the battery or other legislation?

This illustrates how REACH fits into the broader product-compliance system.

11.38 A Practical Example – Imported Electronic Module

Now consider a German manufacturer importing a preassembled wireless module from outside the EU.

The supplier provides:

“REACH compliant – no SVHC.”

The German manufacturer should establish:

• which exact module revision the declaration covers;
• when the declaration was issued;
• which Candidate List version was assessed;
• whether the declaration covers the complete module;
• whether constituent articles were assessed;
• whether any Annex XVII restrictions apply;
• and whether SCIP information is required.

The declaration can be a useful starting point, but it should be integrated into the manufacturer’s own compliance assessment.

11.39 What a Good REACH Evidence Package Looks Like

For a complex electrical product, a useful REACH evidence package can contain:

• product identification;
• BOM;
• component list;
• supplier declarations;
• material declarations;
• Candidate List assessment;
• Annex XVII assessment;
• SVHC concentration information;
• Article 33 assessment;
• Article 7(2) assessment where relevant;
• SCIP assessment;
• SDS for relevant substances and mixtures;
• supplier change notifications;
• internal risk assessment;
• and records of regulatory reviews.

The exact documentation should be proportionate to the product and applicable obligations.

The objective is not maximum paperwork.

The objective is:

A traceable and defensible regulatory assessment.

11.40 A Practical REACH Assessment Matrix

A manufacturer could maintain a matrix such as:

BOM Item	Component	Supplier	Article / Mixture	SVHC Status	>0.1%?	Article 33	SCIP	Annex XVII	Evidence
C001	Connector	Supplier A	Article	None identified	No	No	No	Checked	Declaration
C002	Cable	Supplier B	Article	DEHP	Yes	Yes	Yes	Checked	Material declaration
C003	Adhesive	Supplier C	Mixture	None identified	N/A	N/A	N/A	Checked	SDS
C004	Housing	Supplier D	Article	None identified	No	No	No	Checked	Supplier declaration
C005	PCB	Supplier E	Article	SVHC identified	Yes	Yes	Yes	Checked	Material data

The exact fields should be adapted to the manufacturer’s products and obligations.

The important point is that the manufacturer can see which regulatory question applies to which component.

11.41 REACH Compliance Should Be Linked to Change Management

A REACH assessment should not end when the product is launched.

The manufacturer should review the assessment when:

• a supplier changes;
• a component is replaced;
• a material formulation changes;
• a new Candidate List version is published;
• an Annex XVII restriction changes;
• a supplier issues new substance information;
• a new manufacturing site is introduced;
• a product revision is released; or
• the product enters a new market.

This turns REACH from a one-time document exercise into an ongoing compliance process.

11.42 The Importance of Product Revision Control

Consider an electronic device:

Product Rev. A

Supplier declaration dated 2024.

Later:

Product Rev. B

The plastic housing changes.

If the manufacturer continues using the Rev. A REACH declaration without checking the new material, the compliance documentation may no longer accurately represent the product.

Therefore, REACH evidence should ideally be linked to:

• product revision;
• BOM revision;
• supplier part number;
• material revision; and
• date of assessment.

This creates much stronger traceability.

11.43 What Manufacturers Should Ask Suppliers

For electrical and electronic products, useful supplier questions include:

1. Does the supplied part contain any Candidate List substances?
2. Which substances are present?
3. What is the concentration?
4. Does the concentration exceed 0.1% w/w?
5. Which constituent article contains the substance?
6. Has the current Candidate List been checked?
7. Are any Annex XVII restrictions relevant?
8. Does the supplier provide SCIP information where required?
9. Is the declaration applicable to the exact part number and revision?
10. When was the information last reviewed?
11. Will the supplier notify the manufacturer of relevant material changes?

These questions provide substantially more useful evidence than simply asking:

“Is this REACH compliant?”

11.44 The Difference Between “No SVHC” and “REACH Compliant”

These two statements should not be treated as equivalent.

“No SVHC”

Usually means:

No Candidate List substance was identified above a specified threshold under the supplier’s assessment.

“REACH compliant”

Could potentially refer to a much broader assessment involving:

• restrictions;
• authorisation;
• supply-chain obligations;
• registration;
• downstream use;
• articles;
• mixtures;
• and other requirements.

Therefore, a supplier’s “no SVHC” declaration can be very useful, but it does not necessarily demonstrate compliance with every possible REACH obligation.

11.45 The Difference Between “REACH Compliant” and “REACH Relevant”

A substance can be relevant under REACH without making the product illegal.

For example:

Candidate List substance >0.1%

may create an information obligation.

That does not automatically mean:

Product cannot be sold.

Similarly, a substance can be subject to an Annex XVII restriction that does affect whether a product can legally be placed on the market.

The manufacturer therefore needs to identify the exact regulatory mechanism involved.

11.46 REACH Compliance Is Context-Dependent

The same substance can have different regulatory consequences depending on:

• concentration;
• product;
• use;
• physical form;
• company role;
• annual quantity;
• supply-chain position;
• and regulatory listing.

This makes REACH inherently more contextual than a simple fixed substance limit.

For electrical-product manufacturers, this is one of the most important concepts to understand.

11.47 A Practical REACH Workflow for EEE Manufacturers

A structured workflow can look like this:

Step 1 – Identify the product

↓

Step 2 – Determine whether it is an article, mixture, substance or complex object

↓

Step 3 – Identify the company’s REACH role

↓

Step 4 – Build the BOM/component structure

↓

Step 5 – Obtain supplier chemical information

↓

Step 6 – Check the current Candidate List

↓

Step 7 – Identify SVHCs in relevant articles

↓

Step 8 – Assess the 0.1% threshold

↓

Step 9 – Assess Article 33 communication

↓

Step 10 – Assess Article 7(2) notification where applicable

↓

Step 11 – Assess SCIP obligations

↓

Step 12 – Check Annex XVII restrictions

↓

Step 13 – Consider authorisation and other relevant REACH provisions

↓

Step 14 – Identify evidence gaps

↓

Step 15 – Obtain additional information or perform targeted testing where justified

↓

Step 16 – Document the conclusion

↓

Step 17 – Monitor regulatory and product changes

This provides a much more reliable process than maintaining a single “REACH compliant” checkbox.

11.48 REACH and Product Lifecycle Management

REACH should ideally be integrated into the entire product lifecycle.

Design

Select materials with strong regulatory profiles.

Procurement

Include chemical information requirements in supplier specifications.

Development

Assess components and materials.

Production

Control material changes.

Market launch

Complete the applicable REACH assessments and communications.

Maintenance

Monitor Candidate List and restriction changes.

End of life

Maintain relevant substance information for waste and recycling processes, including SCIP where applicable.

This approach connects chemical compliance with normal product lifecycle management.

11.49 Why This Matters for Global Manufacturers

A manufacturer selling the same product globally may need to maintain different chemical assessments for different markets.

For example:

EU

→ REACH

→ RoHS

→ SCIP

→ other EU requirements

USA

→ federal and state chemical requirements

Canada

→ applicable Canadian chemical requirements

Other markets

→ local chemical substance legislation

Therefore, a global compliance database should not simply contain a field called:

“REACH compliant: Yes/No”

It should ideally capture the underlying substance and material information so that it can be reused for different market assessments.

11.50 The Key Takeaway

For electrical and electronic products, REACH is primarily a substance and supply-chain information framework, not simply another product certification.

The most important principles are:

• Many electrical and electronic products are articles under REACH.
• Articles can contain substances that create specific REACH obligations.
• The REACH Candidate List is particularly important for electrical and electronic products.
• A Candidate List substance above 0.1% w/w in an article can trigger information obligations under Article 33.
• Consumers can request relevant information and must generally receive it within 45 days. (ECHA)
• Producers and importers can have an ECHA notification obligation where the substance exceeds 0.1% w/w and the total quantity exceeds one tonne per year, subject to the applicable conditions and exemptions. (ECHA)
• SCIP creates an additional information obligation for relevant articles placed on the EU market. (Chemicals in Our Life)
• The 0.1% REACH threshold must not be confused with the 0.1% RoHS homogeneous-material limit.
• An SVHC in an article does not automatically mean that the product is prohibited.
• Non-EU suppliers are an important source of information, but EU importers and other EU supply-chain actors may retain their own legal obligations. (ECHA)
• REACH assessments should be linked to the BOM, supplier information, product revisions and change management.
• Candidate List and restriction monitoring is essential because REACH is continuously evolving.

In practical terms:

For an electrical or electronic product, REACH compliance means understanding which substances are present, where they are present, what their regulatory status is, and what obligations that creates for the manufacturer, importer, supplier and customer.

12. SVHCs and the REACH Candidate List

For manufacturers of electrical and electronic products, one of the most important parts of REACH is the Candidate List of Substances of Very High Concern (SVHCs).

The Candidate List is particularly relevant because a substance does not need to be prohibited for it to create legal obligations.

Once a substance is added to the Candidate List, specific REACH obligations can arise for companies that manufacture, import, supply or place articles containing that substance on the EU market. ECHA explicitly notes that these obligations can take effect from the date of inclusion. (ECHA)

For manufacturers, this means that monitoring the Candidate List should be part of an ongoing product-compliance process rather than a one-time REACH assessment.

12.1 What Is an SVHC?

SVHC stands for:

Substance of Very High Concern

Under Article 57 of REACH, substances can be identified as SVHCs because they have particularly hazardous properties.

These include substances that are:

• carcinogenic, mutagenic or toxic for reproduction (CMR);
• persistent, bioaccumulative and toxic (PBT);
• very persistent and very bioaccumulative (vPvB); or
• substances that give rise to an equivalent level of concern because of their effects on human health or the environment.

The purpose of identifying these substances is to ensure that particularly concerning chemicals receive increased regulatory attention.

An SVHC is therefore not simply another name for a “hazardous substance.”

The designation reflects a specific legal process and specific criteria under REACH.

12.2 What Is the REACH Candidate List?

The Candidate List is the official list of substances that have been identified as SVHCs and are candidates for possible inclusion in the REACH Authorisation List.

ECHA maintains the official Candidate List.

The list is not static.

New substances can be added as the regulatory evaluation process develops.

As of August 2026, the ECHA Candidate List contains 253 entries, including substances and substance groups. For example, n-hexane was added on 4 February 2026. (ECHA)

This illustrates an important point:

REACH compliance is not a one-time exercise.

A product that was assessed against the Candidate List several years ago may require reassessment after new substances are added.

12.3 Being on the Candidate List Does Not Mean the Substance Is Banned

This distinction is extremely important.

A common misunderstanding is:

“If a substance is on the Candidate List, it is prohibited.”

That is not correct.

Inclusion in the Candidate List does not itself constitute a general ban on the substance.

Instead, it triggers specific information, communication and, under certain conditions, notification obligations.

A Candidate List substance may subsequently be considered for inclusion in the Authorisation List under REACH.

If a substance is eventually subject to an authorisation requirement, its continued use may require an authorisation unless an applicable exemption or other provision applies.

Therefore, the regulatory progression can broadly be understood as:

Substance identified as SVHC

↓

Candidate List

↓

Potential further regulatory action

↓

Possible inclusion in the Authorisation List

The Candidate List should therefore be understood as a significant regulatory warning and compliance trigger, not as an automatic prohibition.

12.4 Why the Candidate List Matters for Electrical Products

Electrical and electronic products can contain a large number of materials that are potentially relevant under REACH.

Examples include:

• plastics;
• rubber and elastomers;
• cables;
• adhesives;
• coatings;
• flame-retardant materials;
• soldering materials;
• metal alloys;
• electronic components;
• displays;
• batteries;
• seals;
• housings; and
• mechanical components.

A manufacturer may therefore receive a supplier declaration stating:

“No substances are restricted under RoHS.”

That statement does not answer the question:

“Does this product contain an SVHC on the REACH Candidate List?”

The two assessments are different.

A substance can be completely acceptable under RoHS while still being relevant under REACH.

12.5 The REACH Article Concept

For electrical and electronic products, the concept of an article is particularly important.

REACH defines an article as an object which, during production, is given a special shape, surface or design that determines its function to a greater degree than its chemical composition.

Examples relevant to electronics can include:

• housings;
• cables;
• connectors;
• printed circuit boards;
• electronic assemblies;
• plastic parts;
• metal parts;
• displays;
• switches;
• mechanical components; and
• finished electrical products.

A complex electrical product can therefore contain numerous individual articles.

This matters because certain REACH obligations relating to SVHCs in articles are assessed with reference to those articles.

ECHA specifically identifies obligations for producers, importers and suppliers of articles containing Candidate List substances. (Chemicals in Our Life)

12.6 The 0.1% Threshold Is Frequently Misunderstood

One of the biggest sources of confusion between RoHS and REACH is the 0.1% threshold.

Both regulatory frameworks use a 0.1% value in certain contexts, but they do not mean the same thing.

Under RoHS, the relevant concentration limits are generally assessed at the level of the homogeneous material.

For REACH Article 33, the relevant threshold for Candidate List substances in articles is generally:

More than 0.1% by weight in the article.

This is a fundamentally different assessment basis.

For example, consider a finished electronic controller containing a plastic housing and a cable.

If an SVHC is present at 0.2% in a particular article, the manufacturer cannot simply calculate the concentration against the total weight of the complete product and assume that the obligation disappears.

The correct REACH assessment requires understanding the relevant article structure and the applicable legal interpretation.

12.7 Article 33 – Communication in the Supply Chain

Article 33 of REACH creates an important communication obligation.

If an article contains a Candidate List substance in a concentration above 0.1% by weight, the supplier of the article must provide sufficient information to allow safe use of the article.

At a minimum, the name of the substance must be communicated.

The obligation applies to relevant suppliers in the EU and EEA supply chain.

This means that a manufacturer receiving a component containing an SVHC above the applicable threshold should receive the necessary information from its supplier.

The information can then become part of the manufacturer’s own REACH assessment and downstream communication.

ECHA confirms that suppliers of articles containing Candidate List substances above 0.1% w/w must provide sufficient information for safe use. (ECHA)

12.8 Consumers Have a Right to Information

Article 33 also creates a consumer information mechanism.

If a consumer asks whether an article contains a Candidate List substance above 0.1% by weight, the supplier must provide sufficient information to allow safe use.

ECHA states that the information must be provided within 45 days of receiving the consumer’s request. (ECHA)

This is important because REACH is not limited to business-to-business communication.

Depending on the product and supply chain, manufacturers and suppliers may therefore need processes for responding to consumer requests.

12.9 Article 7(2) – Notification to ECHA

REACH can also create a notification obligation for producers and importers of articles.

Under Article 7(2), notification to ECHA can be required where:

• the article contains a Candidate List substance above 0.1% w/w;
• the total quantity of that substance in the articles exceeds one tonne per producer or importer per year; and
• the applicable conditions for notification are met.

ECHA explains that the notification is generally due within six months of the substance being included in the Candidate List. (ECHA)

There are specific exceptions.

For example, notification is not required where the producer or importer can exclude exposure of humans or the environment during normal or reasonably foreseeable conditions of use and disposal, provided appropriate instructions are supplied.

Notification may also not be required where the substance has already been registered for that use.

These conditions should be assessed carefully rather than assumed.

12.10 The One-Tonne Threshold Is Not a General Exemption

Another common misunderstanding is:

“If we use less than one tonne, we have no REACH obligation.”

That is incorrect.

The one-tonne threshold relates specifically to the Article 7(2) notification obligation for producers and importers of articles.

It does not eliminate other REACH obligations.

For example, Article 33 communication obligations can apply where an SVHC is present above 0.1% in an article even when the total quantity is far below one tonne per year.

Therefore:

0.1% threshold → relevant to article communication

1 tonne/year threshold → relevant to Article 7(2) notification under specified conditions

These should not be confused.

12.11 SCIP and the Waste Framework Directive

For articles containing Candidate List substances above 0.1% by weight, another important obligation can arise through the SCIP database.

SCIP stands for:

Substances of Concern In Products

EU suppliers of relevant articles must submit information to ECHA for inclusion in the SCIP database.

The objective is to make information about SVHC-containing articles available further down the product lifecycle, particularly to:

• waste operators;
• recyclers;
• other professionals handling waste; and
• consumers.

ECHA confirms that articles placed on the EU market containing Candidate List substances above 0.1% w/w are subject to SCIP information requirements. (ECHA)

This creates another important connection between REACH, product information and end-of-life management.

12.12 What Information Is Needed for a SCIP Assessment?

A manufacturer may need information such as:

• article identification;
• article category;
• Candidate List substance;
• concentration range;
• material category;
• location of the substance within the article;
• information relevant to safe use;
• information needed for waste treatment; and
• information concerning components or complex objects.

This is another reason why a manufacturer needs more than a generic statement such as:

“REACH compliant.”

A meaningful assessment requires product-specific substance information.

12.13 Candidate List Monitoring Is Essential

The Candidate List can change during the lifetime of a product.

A substance may be added after:

• the product was designed;
• supplier declarations were collected;
• the technical documentation was completed;
• the product was launched; or
• the manufacturer last reviewed its REACH assessment.

This creates an ongoing compliance requirement.

A manufacturer should therefore establish a process for monitoring:

• Candidate List additions;
• changes to substance identities;
• regulatory restrictions;
• authorisation developments;
• supplier declarations;
• material changes; and
• changes in the composition of relevant components.

ECHA’s Candidate List is the authoritative source for the list itself. (ECHA)

12.14 A New Candidate List Substance Can Trigger a New Assessment

Consider a manufacturer that completed a REACH assessment in 2024.

In 2026, a new substance is added to the Candidate List.

The manufacturer should not simply retain the old assessment.

Instead, it should determine:

Is the substance present in our products?

↓

Which components or materials contain it?

↓

At what concentration?

↓

Which articles are affected?

↓

Does Article 33 communication apply?

↓

Does SCIP information need to be submitted or updated?

↓

Does Article 7(2) notification apply?

↓

Do customers need updated information?

This is why regulatory monitoring is an essential part of product compliance.

12.15 Supplier Declarations and SVHC Information

Manufacturers frequently request a document from suppliers stating:

“The supplied product contains no SVHC above 0.1%.”

This can be useful.

However, the manufacturer should still evaluate:

• which Candidate List version was used;
• when the declaration was issued;
• which product or part number it covers;
• which revision it covers;
• whether the declaration applies to all materials;
• whether any substances were intentionally excluded;
• whether the supplier monitors regulatory changes; and
• whether the supplier has a change-notification process.

A declaration without a clear date or scope can become difficult to defend several years later.

12.16 The Candidate List Is Dynamic — Supplier Data Must Be Dynamic Too

Imagine that a manufacturer has 1,500 components.

Each supplier has provided a REACH declaration.

If the Candidate List changes, the manufacturer potentially needs to know which of those 1,500 components are affected.

A mature compliance system therefore connects:

Candidate List

↓

Substance database

↓

Supplier information

↓

Component

↓

Product

This allows the manufacturer to identify affected products much faster when regulatory changes occur.

Without this connection, every Candidate List update can become a manual investigation.

12.17 Example: A Plastic Housing

Consider a plastic housing supplied to an electronics manufacturer.

The supplier informs the manufacturer that the housing contains an SVHC at:

0.25% by weight

The manufacturer should not simply record:

“REACH non-compliant.”

That conclusion is too simplistic.

Instead, it should determine:

• What is the substance?
• Is it currently on the Candidate List?
• Is the concentration above 0.1% in the relevant article?
• What Article 33 information must be provided?
• Is SCIP information required?
• Is the manufacturer itself a producer or importer of the relevant article?
• Does Article 7(2) notification apply?
• Are there other REACH restrictions or authorisation requirements?

This illustrates the difference between identifying an SVHC and determining the legal consequences of its presence.

12.18 Example: A Sealing Gasket

Consider an electronic control unit containing a sealing gasket.

The supplier reports:

SVHC present: 0.4%

The manufacturer now needs to establish:

Where is the substance?

↓

What is the relevant article?

↓

What is the concentration in that article?

↓

Is the threshold exceeded?

↓

What information must be communicated?

↓

Is SCIP relevant?

↓

Is an ECHA notification required?

The existence of the SVHC is therefore only the beginning of the assessment.

12.19 SVHCs and Complex Products

Complex electronic products can contain hundreds or thousands of individual components.

For example:

Product	Component	Material	SVHC	Concentration	REACH Assessment
Controller X	Housing	Plastic	None identified	<0.1%	No Article 33 trigger
Controller X	Gasket	Elastomer	SVHC A	0.4%	Article 33 assessment
Controller X	Cable	PVC	None identified	<0.1%	No Candidate List trigger
Controller X	PCB	Laminate	SVHC B	0.08%	Below 0.1% threshold

This kind of structure allows the manufacturer to connect regulatory information directly to the physical product.

It is much more useful than maintaining a generic statement that the entire product is “REACH compliant.”

12.20 REACH and RoHS Use Different Material Logic

This chapter also reinforces one of the central themes of this article.

Under RoHS, the manufacturer asks:

Which homogeneous material contains the restricted substance, and does it exceed the applicable RoHS concentration limit?

Under REACH, the manufacturer may need to ask:

Which article contains the Candidate List substance, at what concentration, and which REACH obligations result?

These are not interchangeable assessments.

The same component can therefore have:

• a RoHS assessment;
• a REACH SVHC assessment;
• a REACH restriction assessment; and
• potentially other chemical compliance assessments.

12.21 A Practical SVHC Assessment Process

A manufacturer can structure the process as follows:

Step 1 – Obtain the current Candidate List

↓

Step 2 – Identify relevant substances

↓

Step 3 – Map Candidate List substances to supplier information

↓

Step 4 – Map substances to components and articles

↓

Step 5 – Determine concentration

↓

Step 6 – Determine the relevant article structure

↓

Step 7 – Assess Article 33 communication

↓

Step 8 – Assess SCIP requirements

↓

Step 9 – Assess Article 7(2) notification where applicable

↓

Step 10 – Update customer and supply-chain information

↓

Step 11 – Record the assessment

↓

Step 12 – Monitor future Candidate List changes

This creates an ongoing process rather than a one-time declaration.

12.22 What Manufacturers Should Request from Suppliers

For relevant components and materials, manufacturers should consider requesting:

• current REACH declaration;
• Candidate List status;
• substance name and identifier where applicable;
• concentration or concentration range;
• affected material or component;
• affected article;
• date of declaration;
• product/part number;
• product revision;
• applicable restrictions;
• information required for safe use;
• SCIP-related information where relevant; and
• notification of future material or regulatory changes.

The exact information required depends on the component and the manufacturer’s role in the supply chain.

The objective is to obtain enough information to perform a defensible assessment.

12.23 Why “REACH Compliant” Is Not Enough

A statement such as:

“REACH compliant.”

does not tell the manufacturer:

• which Candidate List version was assessed;
• whether SVHCs are present;
• which articles were evaluated;
• whether the 0.1% threshold was considered;
• whether Article 33 information is required;
• whether SCIP information is relevant;
• whether a REACH restriction applies;
• whether the product has changed since the declaration; or
• whether the declaration is still current.

For this reason, manufacturers should treat generic REACH declarations as supporting evidence, not as a substitute for a product-specific assessment.

12.24 REACH Compliance Requires Regulatory Monitoring

A strong REACH process therefore has two dimensions.

Product monitoring

The manufacturer monitors:

• new components;
• material changes;
• supplier changes;
• product revisions;
• new formulations; and
• changes in the supply chain.

Regulatory monitoring

The manufacturer monitors:

• Candidate List updates;
• new SVHCs;
• Annex XVII restrictions;
• authorisation developments;
• changes affecting existing substances; and
• relevant SCIP requirements.

The two processes should be connected.

A regulatory change should trigger a product-impact assessment.

A product change should trigger a regulatory reassessment.

12.25 A Useful Internal Data Structure

Manufacturers can make this process much more efficient by linking regulatory information directly to product data.

For example:

Product

↓

Component

↓

Material

↓

Supplier

↓

Substance

↓

Candidate List status

↓

Concentration

↓

REACH obligation

↓

Required action

This structure makes it possible to answer practical questions such as:

“Which of our products contain a newly added Candidate List substance?”

or:

“Which suppliers need to provide updated information?”

or:

“Which products may require a SCIP update?”

That is far more effective than maintaining isolated declarations in separate folders.

12.26 What Manufacturers Should Do When an SVHC Is Identified

Finding an SVHC does not automatically mean that a product must be redesigned.

The manufacturer should first determine the actual regulatory consequence.

The assessment should consider:

1. Substance identity
2. Candidate List status
3. Article identity
4. Concentration
5. Quantity
6. Supplier role
7. Producer/importer status
8. Article 33 communication
9. SCIP requirements
10. Article 7(2) notification
11. Other REACH restrictions
12. Potential future authorisation requirements

Only after this assessment should the manufacturer decide whether:

• additional information is required;
• customers must be informed;
• SCIP information must be submitted;
• the supplier must provide additional evidence;
• the material should be replaced; or
• the product design should be changed.

12.27 The Strategic Importance of the Candidate List

For manufacturers, the Candidate List should therefore not be viewed simply as a database of chemicals.

It is better understood as a regulatory trigger mechanism.

A new entry can potentially affect:

• supplier declarations;
• product documentation;
• customer communication;
• SCIP submissions;
• ECHA notifications;
• material selection;
• purchasing decisions;
• product design; and
• future market access.

This is why Candidate List monitoring becomes increasingly important for companies with large product portfolios and long product lifecycles.

12.28 The Key Takeaway

The REACH Candidate List identifies Substances of Very High Concern (SVHCs) and plays a central role in the REACH framework for products and supply chains.

The most important principles are:

• An SVHC is a substance meeting specific high-concern criteria under REACH.
• Inclusion on the Candidate List does not itself mean that the substance is banned.
• Inclusion can nevertheless create immediate legal obligations.
• For articles, the 0.1% w/w threshold is particularly important for Article 33 communication obligations.
• Article 7(2) can create an additional ECHA notification obligation when the applicable conditions are met, including the more-than-one-tonne-per-year threshold.
• Relevant articles containing Candidate List substances above 0.1% can also trigger SCIP information requirements.
• Consumers can request information about Candidate List substances in relevant articles, with a 45-day response period.
• The Candidate List is dynamic and must be monitored throughout the product lifecycle.
• Supplier declarations are important but should be evaluated for scope, date, substance coverage and traceability.
• RoHS and REACH use different assessment concepts and thresholds and should not be treated as one compliance assessment.
• Identifying an SVHC is only the beginning; the manufacturer must determine the actual legal consequences for the product and supply chain.

The next chapter brings the two regulatory frameworks together:

RoHS vs. REACH – what are the key differences, and how should manufacturers decide which requirements apply to their products?

13. RoHS vs. REACH – The Key Differences

RoHS and REACH are closely related pieces of EU legislation, and manufacturers of electrical and electronic products often have to deal with both. However, they are not interchangeable.

Both regulations address substances that may pose risks to human health or the environment, but they do so from very different regulatory perspectives.

For manufacturers, the distinction is important because a product can comply with RoHS while still creating obligations under REACH — and a REACH assessment does not automatically demonstrate RoHS compliance.

The most useful way to understand the relationship is:

RoHS is primarily a product-specific substance restriction regime for electrical and electronic equipment, while REACH is the EU’s broader chemicals regulation covering substances, mixtures and articles.

13.1 RoHS and REACH Have Different Objectives

RoHS stands for Restriction of Hazardous Substances and is established by Directive 2011/65/EU.

Its central purpose is to restrict specific substances in covered electrical and electronic equipment.

RoHS therefore asks a relatively specific product-compliance question:

Does this electrical or electronic product comply with the applicable restrictions on RoHS substances?

REACH — the Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (EC) No 1907/2006 — has a much broader objective.

It establishes a comprehensive framework for the manufacture, placing on the market and use of chemical substances in the EU.

REACH can therefore address:

• substances on their own;
• substances in mixtures;
• substances present in articles;
• restrictions on particular uses;
• substances of very high concern (SVHCs);
• authorisation requirements;
• registration obligations; and
• information and communication obligations throughout the supply chain.

The two systems consequently start from different regulatory questions.

13.2 RoHS Is Specifically Focused on Electrical and Electronic Equipment

RoHS is directly connected to electrical and electronic equipment (EEE).

Where the Directive applies, it restricts the substances listed in Annex II and sets maximum concentration values in homogeneous materials. (EUR-Lex)

The current RoHS substance restrictions cover ten substances or substance groups:

• Lead (Pb)
• Mercury (Hg)
• Cadmium (Cd)
• Hexavalent chromium (Cr VI)
• PBB
• PBDE
• DEHP
• BBP
• DBP
• DIBP

For most of these substances, the maximum concentration is 0.1% by weight in homogeneous materials, while cadmium has a limit of 0.01%.

This creates a relatively defined compliance structure:

EEE → applicable RoHS scope → homogeneous material → restricted substance → concentration limit → exemption

The manufacturer then needs to establish conformity and maintain the relevant technical documentation.

13.3 REACH Has a Much Broader Chemical Scope

REACH is not limited to electrical and electronic products.

It applies broadly to chemical substances, including substances used in industrial processes and substances present in everyday products and articles.

For an electrical product manufacturer, this means that REACH can become relevant even when a substance is not restricted under RoHS.

For example, an electronic product may contain a substance that:

• is not one of the ten RoHS-restricted substances;
• is nevertheless identified as an SVHC under REACH;
• is subject to a REACH restriction for a particular use; or
• creates a communication or notification obligation.

The manufacturer therefore cannot use the RoHS substance list as a substitute for a REACH assessment.

13.4 The Scope of the Two Regulations Is Different

A useful comparison is:

	RoHS	REACH
Primary focus	Electrical and electronic equipment	Chemical substances
Main legal instrument	Directive 2011/65/EU	Regulation (EC) No 1907/2006
Product-specific?	Yes, specifically EEE	No, much broader
Restricted substances	Defined RoHS list	Much broader regulatory system
Homogeneous-material limits	Central to RoHS	Not the general basis of REACH
SVHC Candidate List	No	Yes
Authorisation system	No general RoHS equivalent	Yes
Article obligations	Through EEE/product requirements	Yes, including specific SVHC obligations
Technical documentation	Central to conformity assessment	Depends on the applicable REACH obligation
CE marking	Part of the RoHS conformity framework	REACH itself is not a CE-marking directive

This table illustrates why a single statement such as “RoHS/REACH compliant” can be misleading unless the manufacturer knows exactly what has been assessed.

13.5 RoHS Uses Specific Concentration Limits

One of the clearest differences is how RoHS determines whether a substance restriction has been exceeded.

RoHS establishes maximum concentration values for its restricted substances in homogeneous materials. Article 4 of the Directive explicitly refers to the maximum concentration values by weight in homogeneous materials. (EUR-Lex)

For example:

Lead → 0.1%

Cadmium → 0.01%

The manufacturer therefore needs to determine the concentration of the relevant restricted substance in the applicable homogeneous material.

This is why a RoHS assessment often involves:

• material declarations;
• component information;
• supplier declarations;
• BOM analysis;
• homogeneous-material assessment;
• targeted laboratory testing; and
• exemption assessment.

The compliance question is relatively specific.

13.6 REACH Uses Different Regulatory Mechanisms

REACH does not operate simply by applying the same type of ten-substance concentration table to every product.

Instead, it contains several different regulatory mechanisms.

These include:

Registration

Companies may have registration obligations for substances manufactured or imported above specified tonnage thresholds.

Restriction

Certain substances and uses can be restricted under Annex XVII.

Authorisation

Certain substances of very high concern can be placed on the Authorisation List in Annex XIV, meaning specific uses may require authorisation.

Candidate List

Substances identified as SVHCs can be added to the Candidate List, creating specific information and, in some cases, notification obligations.

Supply-chain communication

REACH can require information to be communicated to recipients and consumers concerning substances in articles.

The applicable mechanism therefore depends on the substance, its role in the supply chain, the way it is used and the regulatory status of that substance.

13.7 SVHCs Are a Major Difference

One of the most important concepts under REACH is the Substance of Very High Concern (SVHC).

SVHCs are substances identified under Article 57 of REACH because of properties such as:

• carcinogenicity;
• mutagenicity;
• reproductive toxicity;
• persistence, bioaccumulation and toxicity; or
• other properties giving rise to an equivalent level of concern.

These substances can be included on the REACH Candidate List.

The Candidate List is not the same thing as the RoHS restricted-substance list.

A substance can therefore be:

• restricted under RoHS but not on the REACH Candidate List;
• on the REACH Candidate List but not restricted under RoHS;
• relevant under both systems; or
• relevant under neither.

This distinction is critical for electrical and electronic manufacturers.

13.8 A REACH Candidate List Substance Does Not Automatically Mean the Product Is Banned

Another common misunderstanding is:

“If an SVHC is present, the product cannot be sold.”

That is not generally correct.

The inclusion of a substance on the Candidate List can trigger specific obligations, but the presence of the substance does not automatically mean that the article is prohibited.

For example, where an article contains a Candidate List substance above 0.1% w/w, suppliers generally have obligations to provide sufficient information to allow safe use. Producers and importers may also have a notification obligation to ECHA when the additional conditions are met. (European Chemicals Agency)

The regulatory consequence therefore depends on the substance, concentration, role of the company and applicable REACH provisions.

13.9 The 0.1% Threshold Can Be Confusing

Both RoHS and REACH can involve a 0.1% threshold, but the meaning is not the same.

Under RoHS, the 0.1% limit is a maximum concentration value for most restricted substances in homogeneous materials.

Under REACH, the 0.1% threshold is relevant to certain obligations concerning Candidate List substances in articles.

These are fundamentally different concepts.

For example:

RoHS:

Is the concentration of a restricted substance above the permitted limit in the relevant homogeneous material?

REACH:

Does an article contain a Candidate List substance above 0.1% w/w in a way that triggers a communication or notification obligation?

The same numerical value therefore does not mean the same regulatory requirement.

Manufacturers should be particularly careful when compliance databases use a single “0.1%” field without identifying which legislation it refers to.

13.10 RoHS Concentration Limits and REACH Article Obligations Should Not Be Mixed

Consider a plastic housing containing a substance at 0.15%.

For RoHS, the manufacturer would need to determine:

• Is the substance one of the RoHS-restricted substances?
• Is the 0.15% concentration measured in the relevant homogeneous material?
• What RoHS limit applies?
• Is there a valid exemption?

For REACH, the manufacturer may instead need to determine:

• Is the substance on the Candidate List?
• Is it an SVHC?
• Is the 0.15% concentration above the applicable REACH threshold?
• Is information required to be communicated?
• Does an ECHA notification obligation apply?
• Does a REACH restriction or authorisation requirement apply?

The same material can therefore produce two completely different regulatory assessments.

13.11 The Same Substance Can Be Relevant Under Both

There can also be direct overlap.

For example, some substances regulated under RoHS can also have a separate regulatory status under REACH.

Phthalates provide a useful example.

DEHP, DBP, BBP and DIBP are RoHS-restricted substances.

At the same time, several of these substances have also been identified as SVHCs under REACH and can therefore create additional REACH obligations depending on their presence and the applicable circumstances.

This demonstrates why manufacturers should not assume:

“We already assessed this substance for RoHS, so REACH is automatically covered.”

The same substance can have two different legal roles.

13.12 RoHS Exemptions and REACH Authorisations Are Different

Another common source of confusion is the word “exemption.”

RoHS contains specific exemptions that allow certain restricted substances to be used for defined applications under defined conditions.

For example, a manufacturer may rely on a RoHS exemption for a particular technical application of lead.

REACH has a different mechanism called authorisation.

An authorisation under REACH concerns the use of certain substances listed in Annex XIV and is subject to its own regulatory process.

These concepts should not be mixed.

A statement such as:

“The substance is exempt under REACH”

is usually too imprecise.

The manufacturer needs to identify the actual REACH mechanism involved.

Likewise:

“The substance has a RoHS exemption”

does not mean that the substance is generally permitted under all other EU chemical legislation.

13.13 RoHS Is Closely Connected to CE Marking

RoHS forms part of the EU product-conformity framework.

For covered EEE, the manufacturer must establish conformity with the applicable RoHS requirements and maintain the required technical documentation.

The CE marking is therefore relevant to RoHS compliance.

However, the CE marking does not mean:

“The product has passed a RoHS laboratory test.”

Nor does it mean that the product complies with REACH simply because the product carries a CE mark.

A single product can be subject to multiple pieces of EU legislation contributing to its CE conformity.

RoHS is one part of that wider conformity assessment.

13.14 REACH Is Not a CE-Marking Regulation

REACH operates differently.

REACH itself is not a CE-marking directive or regulation.

A manufacturer therefore should not use a CE mark as evidence of REACH compliance.

Instead, REACH obligations depend on the company’s role and the substances involved.

For an electrical product manufacturer, the practical process may therefore look like:

CE / Product Compliance

→ RoHS assessment
→ EMC assessment
→ RED/LVD/Machinery/etc., where applicable

while separately:

Chemical Compliance

→ REACH assessment
→ Candidate List
→ Restrictions
→ Authorisation
→ Supply-chain communication
→ SCIP, where applicable

The two systems interact, but they should not be collapsed into one assessment.

13.15 Supplier Declarations Can Support Both Assessments

The same supplier can provide information that is useful for both RoHS and REACH.

For example, a component supplier may provide:

• RoHS declaration;
• REACH declaration;
• material declaration;
• Candidate List statement;
• laboratory report;
• material composition information.

This can make supplier management more efficient.

However, the manufacturer still needs to determine whether the information actually answers the relevant regulatory question.

A single document titled:

“RoHS & REACH Declaration”

may be useful, but the manufacturer should check:

• Which legislation does it cover?
• Which product or part number does it cover?
• Which revision?
• Which substances?
• Which thresholds?
• Which exemptions?
• Which Candidate List version?
• What date was the assessment performed?
• What happens when the supplier changes materials?

The title of the document is not enough.

13.16 A Supplier’s “REACH Compliant” Statement Can Be Ambiguous

Consider this statement:

“Our products are REACH compliant.”

This sounds reassuring but does not necessarily provide enough information.

For an electrical component, the manufacturer may need to know:

• whether Candidate List substances are present;
• whether any exceed 0.1% w/w in the relevant article;
• whether information must be communicated;
• whether a restriction applies;
• whether the supplier is addressing only substances supplied on their own or also substances in articles;
• and which version/date of the Candidate List was considered.

The phrase “REACH compliant” therefore needs to be supported by more specific information.

13.17 A Supplier’s “RoHS Compliant” Statement Has Similar Limitations

The same applies to RoHS.

A supplier statement saying:

“RoHS compliant according to Directive 2011/65/EU.”

does not necessarily answer all questions.

The manufacturer may still need to know:

• Does it include the four phthalates?
• Which component revision is covered?
• Are any exemptions used?
• Which materials were assessed?
• Is the declaration current?
• Does it cover the complete component?
• Is there supporting material information?
• Does the supplier operate an appropriate change-control process?

The statement can be useful evidence, but it should be evaluated as part of the overall RoHS technical documentation.

13.18 Testing for RoHS Does Not Automatically Cover REACH

This is another critical distinction.

A laboratory test performed for RoHS may analyse:

• lead;
• mercury;
• cadmium;
• hexavalent chromium;
• PBB;
• PBDE;
• DEHP;
• BBP;
• DBP; and
• DIBP.

That test does not automatically establish the absence or presence of all substances relevant under REACH.

REACH covers a much broader chemical universe.

Likewise, a REACH-related chemical analysis does not automatically demonstrate that all applicable RoHS substances have been assessed at the correct homogeneous-material level.

The analytical programme must therefore be linked to the specific regulatory question.

13.19 One Product Can Require Two Evidence Chains

A useful way to visualise the difference is:

RoHS

Product

↓

EEE scope

↓

Components

↓

Homogeneous materials

↓

RoHS restricted substances

↓

Concentration limits

↓

Exemptions

↓

Technical documentation

REACH

Product / article / substance

↓

Chemical composition

↓

Candidate List / restrictions / authorisation status

↓

Concentration and use

↓

Supply-chain obligations

↓

Communication / notification / other requirements

The two chains can use the same supplier information, but they ultimately lead to different compliance conclusions.

13.20 SCIP Is Also Separate From RoHS

Where applicable, REACH-related substance information can also interact with obligations under the Waste Framework Directive, including SCIP notification requirements.

ECHA explains that EU suppliers of articles containing Candidate List substances above 0.1% w/w have obligations to submit information to the SCIP database. (European Chemicals Agency)

SCIP should therefore not be confused with RoHS.

A product may:

• be RoHS compliant;
• contain an SVHC above the applicable REACH threshold; and
• therefore require SCIP-related action.

This is another example of why a single “RoHS/REACH compliance” checkbox can be inadequate for a professional compliance system.

13.21 How the Manufacturer Should Approach Both

A practical compliance process can separate the two assessments while using common supplier data.

Step 1 – Establish RoHS scope

Determine whether the product is covered by RoHS.

Step 2 – Assess RoHS substances

Identify relevant materials, components, restricted substances and exemptions.

Step 3 – Establish REACH relevance

Determine the company’s role and whether REACH obligations arise for the substances, mixtures or articles involved.

Step 4 – Check Candidate List status

Determine whether relevant SVHCs are present and whether their concentration triggers obligations.

Step 5 – Check restrictions and authorisation

Determine whether the substance or its use is subject to a REACH restriction or authorisation requirement.

Step 6 – Determine communication and notification requirements

Assess whether customer communication, ECHA notification or SCIP reporting is required.

Step 7 – Maintain both assessments

Connect both assessments to supplier changes, product changes and regulatory updates.

This creates a much more robust chemical-compliance process.

13.22 Example: Industrial Control Cabinet

Consider an industrial control cabinet containing:

• steel housing;
• painted surfaces;
• PCB assemblies;
• cables;
• connectors;
• relays;
• plastic components;
• labels; and
• electronic modules.

RoHS assessment

The manufacturer needs to determine:

• whether the cabinet/equipment is within RoHS scope;
• which homogeneous materials are present;
• whether any of the ten RoHS substances exceed their applicable limits;
• whether exemptions apply;
• what supplier evidence is available; and
• whether additional testing is necessary.

REACH assessment

The manufacturer may additionally need to determine:

• whether any Candidate List substances are present;
• whether any exceed 0.1% w/w in relevant articles;
• whether communication obligations apply;
• whether SCIP information is required;
• whether any REACH restriction applies; and
• whether other obligations arise from the company’s role in the supply chain.

The result is not necessarily the same for both regulations.

13.23 Example: PVC Cable

Consider a flexible PVC cable.

For RoHS, the manufacturer may need to assess:

• lead;
• cadmium;
• the four restricted phthalates;
• other applicable RoHS substances;
• homogeneous-material concentrations; and
• applicable exemptions.

For REACH, the manufacturer may additionally need to determine whether the cable contains:

• Candidate List substances;
• substances subject to restrictions;
• substances creating communication obligations; or
• substances requiring other REACH-related action.

A RoHS test report alone cannot answer all of these questions.

13.24 What “RoHS & REACH Compliant” Should Mean

Manufacturers should be cautious when using the combined phrase:

“RoHS & REACH compliant.”

There is no single universal test or certificate that automatically establishes this statement for every product and every REACH obligation.

A technically meaningful statement should instead be supported by defined assessments.

For example:

RoHS

• scope assessed;
• ten restricted substances assessed;
• applicable concentration limits considered;
• exemptions assessed;
• technical documentation maintained.

REACH

• relevant REACH obligations assessed;
• Candidate List checked;
• applicable restrictions checked;
• SVHC communication obligations assessed;
• notification/SCIP requirements assessed where applicable.

This makes the statement much more defensible.

13.25 A Practical Comparison for Manufacturers

The distinction can be summarised as follows:

Question	RoHS	REACH
Is the product electrical/electronic equipment?	Central	Not generally the starting point
Is there a defined product scope?	Yes	No equivalent general EEE scope
Are there ten specifically restricted substances?	Yes	No
Are limits generally assessed in homogeneous materials?	Yes	Not as the general REACH mechanism
Are exemptions relevant?	Yes	Different mechanisms apply
Are SVHCs relevant?	No	Yes
Is the Candidate List relevant?	No	Yes
Are restrictions possible?	Yes, through RoHS substance restrictions	Yes, through REACH restrictions
Is authorisation relevant?	No equivalent mechanism	Yes
Can article communication obligations arise?	Not in the same way	Yes
Can SCIP obligations arise?	No	Yes, where applicable
Is CE marking directly relevant?	Yes	No
Is technical documentation central?	Yes	Depends on the obligation

The practical message is simple:

RoHS and REACH overlap, but they solve different regulatory problems.

13.26 Why Manufacturers Should Maintain Separate Compliance Fields

For companies managing hundreds or thousands of components, it is useful to avoid a single field such as:

Chemical Compliance: Yes/No

A better system can maintain separate information for:

RoHS

• RoHS scope;
• RoHS declaration;
• restricted-substance evidence;
• exemption;
• test report;
• evidence status;
• last review date.

REACH

• REACH status;
• Candidate List status;
• SVHC;
• SVHC concentration;
• communication required;
• restriction status;
• authorisation status;
• SCIP relevance;
• last review date.

This structure makes regulatory changes much easier to manage.

It also prevents a supplier’s general statement from being interpreted as evidence for requirements it was never intended to address.

13.27 The Key Takeaway

RoHS and REACH should be treated as two related but distinct compliance frameworks.

The most important differences are:

• RoHS is specifically focused on covered electrical and electronic equipment.
• REACH has a much broader chemicals scope.
• RoHS contains a defined list of ten restricted substances and concentration limits in homogeneous materials.
• REACH uses broader mechanisms including registration, restriction, authorisation and the Candidate List.
• The 0.1% threshold has different regulatory meanings under the two frameworks.
• A RoHS exemption is not the same as a REACH authorisation.
• A RoHS laboratory report does not automatically demonstrate REACH compliance.
• A REACH declaration does not automatically demonstrate RoHS compliance.
• A CE mark is relevant to RoHS conformity but is not evidence of REACH compliance.
• REACH SVHC obligations can apply even when a product is fully compliant with RoHS.
• SCIP obligations, where applicable, are separate from RoHS.
• Supplier declarations are useful for both assessments, but their scope and evidentiary value must be evaluated.

The practical rule for manufacturers is therefore:

Use common supplier and material information where possible, but maintain separate RoHS and REACH assessments and conclusions.

This becomes particularly important when products are sourced through complex international supply chains.

The next chapter addresses that practical problem:

Can manufacturers actually rely on RoHS and REACH supplier declarations, and what should they check before accepting them as compliance evidence?

14. Can Manufacturers Rely on RoHS and REACH Supplier Declarations?

Supplier declarations are one of the most common sources of compliance evidence for electrical and electronic products.

Manufacturers routinely receive statements such as:

“RoHS Compliant”

or:

“REACH Compliant”

and use these declarations as part of their technical documentation.

Supplier declarations can be extremely useful. However, a declaration is not automatically sufficient evidence simply because it carries a supplier’s signature or appears on company letterhead.

The manufacturer placing the finished product on the EU market remains responsible for determining whether the applicable legal requirements have been met.

This makes the quality, scope and traceability of supplier information particularly important.

14.1 Why Supplier Declarations Are So Important

Modern electrical products can contain hundreds or even thousands of individual components.

A manufacturer may source:

• PCBs;
• connectors;
• cables;
• resistors;
• capacitors;
• integrated circuits;
• displays;
• batteries;
• plastics;
• metal parts;
• adhesives;
• coatings;
• mechanical components; and
• complete electronic modules

from different suppliers around the world.

It would be impractical to independently test every material and every component for every potentially relevant substance.

Supplier information therefore plays an important role in the compliance process.

A manufacturer can use supplier documentation to build a compliance evidence chain from the individual component to the finished product.

The key word, however, is evidence.

A supplier declaration is evidence supporting an assessment. It is not necessarily the assessment itself.

14.2 The Manufacturer Remains Responsible for the Finished Product

For products covered by RoHS, the manufacturer placing the finished EEE on the EU market has to ensure conformity with the Directive’s requirements.

This means that the manufacturer cannot simply assume:

“All our suppliers said their parts are compliant, therefore our product is compliant.”

The manufacturer needs to understand:

• what components are included;
• what materials they contain;
• which supplier declarations apply;
• whether the declarations are current;
• whether exemptions are being used;
• whether any regulatory changes have occurred; and
• whether additional verification is necessary.

Supplier documentation therefore forms part of the manufacturer’s overall conformity assessment.

14.3 What a Good RoHS Declaration Should Contain

A useful RoHS declaration should identify the products or components to which it applies.

Ideally, it should include:

• supplier name;
• supplier address;
• product name;
• part number;
• product revision, where relevant;
• applicable RoHS legislation;
• statement of conformity;
• restricted substances covered;
• applicable exemptions;
• date of issue;
• responsible person or authorised signature;
• document revision;
• contact information; and
• change-control or validity information where available.

The more generic the declaration, the more carefully the manufacturer should evaluate it.

For example:

“All products manufactured by XYZ are RoHS compliant.”

is significantly less useful than:

“Part number ABC-123, revision B, complies with Directive 2011/65/EU and applicable delegated amendments. The following RoHS exemptions are used: …”

The second statement is far more traceable.

14.4 A Declaration Should Be Linked to a Specific Part

One of the most important principles in supplier compliance management is traceability.

If a manufacturer has a Bill of Materials containing:

Part number: ABC-123

the supporting RoHS declaration should ideally be clearly associated with:

ABC-123

rather than simply:

“Supplier XYZ – RoHS Declaration.”

This becomes particularly important when suppliers manufacture many different products.

Without part-number traceability, the manufacturer may not be able to demonstrate which evidence supports which component.

14.5 Product Revision Matters

A supplier may change:

• materials;
• manufacturing processes;
• component suppliers;
• plating;
• solder;
• plastic formulations;
• coatings;
• adhesives; or
• subcomponents.

The part number may remain unchanged.

A declaration from 2022 may therefore not necessarily represent the material composition of a component manufactured in 2026.

This is why compliance management should consider revision and change control, not merely document existence.

A strong process asks:

What exactly did the supplier’s declaration cover, and is that still true for the component currently being purchased?

14.6 The Date of the Declaration Matters

RoHS and REACH are not static.

Regulatory requirements can change through:

• amendments;
• new restricted substances;
• changes to exemptions;
• new Candidate List entries;
• changes to restrictions;
• changes in guidance; and
• changes to product composition.

A declaration issued many years ago may therefore require review.

This does not automatically mean that an old declaration is invalid.

It means that the manufacturer should understand which regulatory status and product configuration the declaration represents.

14.7 RoHS Declarations Should Address Exemptions

A supplier may state that a component is RoHS compliant while relying on one or more RoHS exemptions.

That is not necessarily a problem.

RoHS exemptions are part of the legal framework.

However, the manufacturer should know:

• which exemption applies;
• what application it covers;
• whether the exemption is applicable to the component;
• whether the exemption is still valid;
• whether an exemption expiry date is relevant; and
• whether the exemption is included in the manufacturer’s own technical documentation.

A generic statement of compliance can therefore hide an important technical detail.

For example:

“RoHS compliant.”

provides less information than:

“RoHS compliant under exemption 6(c).”

The latter allows the manufacturer to assess whether the exemption is actually relevant to the final product.

14.8 REACH Declarations Require a Different Review

A REACH declaration should not simply be evaluated using the same checklist as a RoHS declaration.

For REACH, the manufacturer may need to determine:

• whether the supplier is referring to substances, mixtures or articles;
• whether Candidate List substances are present;
• whether any exceed the relevant threshold;
• whether communication obligations arise;
• whether a restriction applies;
• whether authorisation is relevant;
• whether the declaration considers the current Candidate List; and
• whether the supplier is providing sufficient information for downstream obligations.

A statement such as:

“Our products comply with REACH.”

may therefore be too vague for a professional compliance process.

14.9 The Candidate List Version Should Be Considered

The REACH Candidate List is updated over time.

When a supplier provides an SVHC declaration, it is therefore useful to establish:

Which Candidate List version was considered?

For example, a declaration may state that the product does not contain substances on the Candidate List above 0.1%.

But if the declaration was issued before a substance was added to the Candidate List, the statement may need to be reassessed.

This is why date and regulatory-version control are important.

14.10 “No SVHC Above 0.1%” Is Not the Same as “No SVHC”

These statements are different:

Statement A:

“No SVHCs are present.”

Statement B:

“No Candidate List substances are present above 0.1% w/w.”

Statement B allows for the possibility that a Candidate List substance exists below the stated threshold.

That distinction can be important for compliance management.

A manufacturer should therefore avoid interpreting:

“No SVHC above 0.1%”

as:

“The product contains no SVHC.”

The wording matters.

14.11 Supplier Declarations Are Not Always Laboratory Reports

A declaration is generally a statement made by the supplier based on some underlying information.

That underlying information may include:

• material specifications;
• supplier declarations;
• upstream declarations;
• material composition data;
• analytical testing;
• production controls;
• engineering assessments; or
• a combination of these.

The declaration itself therefore does not necessarily prove that the supplier independently tested every material.

This is not inherently problematic.

A risk-based compliance system does not require every component to undergo identical laboratory testing.

Instead, the manufacturer should determine whether the available evidence is appropriate for the risk.

14.12 When Testing May Be Appropriate

Additional testing can be useful when:

• supplier documentation is missing;
• declarations are ambiguous;
• the component has a high compliance risk;
• the supplier is unable to provide sufficient material information;
• a material composition is unusual;
• the product contains substances historically associated with RoHS problems;
• there has been a material change;
• the supplier is considered high risk;
• regulatory requirements have changed; or
• contradictory information exists.

Testing should therefore be used strategically rather than automatically.

A good compliance system combines:

Supplier evidence + technical information + risk assessment + targeted testing

rather than relying exclusively on one source.

14.13 XRF Testing Has a Specific Role

For RoHS assessments, X-ray fluorescence (XRF) screening can be useful for certain elements.

It can provide rapid screening for elements such as:

• lead;
• mercury;
• cadmium;
• chromium;
• bromine.

However, XRF has limitations.

It does not automatically establish full RoHS compliance for every restricted substance and every material.

For example, the restricted phthalates are organic compounds and require different analytical methods.

Likewise, total chromium detected by XRF does not by itself distinguish chromium(VI) from other chromium forms.

This means:

XRF screening is a tool within a RoHS verification strategy, not a universal substitute for the complete compliance assessment.

14.14 Supplier Documentation Should Be Risk-Based

Not every component needs the same level of scrutiny.

Consider two examples.

Low-risk component

A standard resistor from a long-established supplier with:

• clear part number;
• current RoHS declaration;
• current REACH declaration;
• established quality system;
• stable material composition.

The manufacturer may reasonably rely heavily on supplier documentation.

Higher-risk component

A complex imported plastic assembly with:

• unclear material composition;
• several sub-suppliers;
• outdated declarations;
• unclear revision status;
• potentially relevant additives.

This component may justify deeper review or testing.

The objective is not to create unnecessary bureaucracy.

The objective is to place stronger verification where the compliance risk is higher.

14.15 Supplier Qualification Is Part of Compliance Management

The quality of compliance evidence is strongly influenced by supplier management.

A manufacturer can establish supplier requirements such as:

• mandatory RoHS declaration;
• mandatory REACH declaration;
• part-number identification;
• revision identification;
• regulatory date;
• exemption information;
• Candidate List status;
• notification of material changes;
• notification of regulatory changes; and
• defined response time for compliance requests.

These requirements can be incorporated into purchasing and supplier agreements.

This turns regulatory compliance from a one-time documentation exercise into an ongoing process.

14.16 Material Changes Should Trigger a Review

A supplier change notification can be a major compliance trigger.

For example:

Supplier changes plastic formulation

↓

New material composition

↓

Compliance evidence becomes outdated

↓

RoHS / REACH reassessment

This process can be automated within a compliance management system.

The same principle applies to:

• new PCB materials;
• new solder;
• new plating;
• new cable insulation;
• new adhesives;
• new coatings;
• replacement components;
• alternative suppliers.

A product should not be considered permanently compliant simply because it was compliant when originally assessed.

14.17 The BOM Is the Bridge Between Supplier Evidence and Product Compliance

For electrical products, the Bill of Materials (BOM) is one of the most important structures for compliance management.

A simplified compliance chain looks like this:

Finished Product

↓

BOM

↓

Component

↓

Supplier

↓

Compliance Declaration

↓

Material / Substance Information

↓

RoHS / REACH Assessment

This makes the BOM more than a purchasing document.

It can become the backbone of the product’s compliance evidence structure.

14.18 A Compliance Database Should Track Evidence Status

A manufacturer can assign a status to each component.

For example:

Component	RoHS	REACH	Evidence	Review
PCB Assembly	Confirmed	Confirmed	Current declarations	Current
Connector	Confirmed	Confirmed	Supplier declaration	Current
Plastic housing	Review	Confirmed	Old declaration	Required
Cable	Confirmed	Review	SVHC information missing	Required
Display	Confirmed	Confirmed	Test + declaration	Current

This immediately shows where compliance gaps exist.

It is much more useful than storing hundreds of PDF declarations in a folder without structured traceability.

14.19 Do Not Treat Missing Documentation as Automatic Non-Compliance

A missing supplier declaration does not automatically prove that a component is non-compliant.

It means:

The manufacturer currently lacks sufficient evidence to demonstrate compliance.

Those are different situations.

The appropriate response may be:

1. request updated documentation;
2. obtain material information;
3. perform a risk assessment;
4. conduct targeted testing;
5. obtain an alternative supplier;
6. restrict the component’s use; or
7. investigate further.

This distinction is important for professional compliance management.

14.20 But “No Evidence” Should Not Automatically Become “Compliant”

The opposite mistake is equally dangerous.

A manufacturer should not reason:

“We have no evidence of a problem, therefore the component is compliant.”

The correct logic is:

No evidence of non-compliance ≠ evidence of compliance.

This is especially important when managing large international supply chains.

14.21 What a Strong Supplier Compliance Package Looks Like

For a typical electronic component, a strong evidence package could contain:

RoHS

• current RoHS declaration;
• part number;
• revision;
• applicable exemptions;
• supporting material declaration where available;
• test report where appropriate.

REACH

• current REACH statement;
• Candidate List status;
• relevant SVHC information;
• concentration information where required;
• applicable restriction information;
• SCIP information where relevant.

Change control

• supplier change notification procedure;
• declaration validity;
• review date;
• regulatory update process.

This provides a much stronger basis for the finished-product assessment.

14.22 Practical Checklist for Manufacturers

Before accepting a supplier declaration, ask:

Identity

• Is the supplier clearly identified?
• Is the part number identified?
• Is the revision identified?

Regulatory scope

• Does the declaration explicitly identify RoHS or REACH?
• Is the relevant legislation clearly referenced?
• Are amendments or current requirements addressed?

Date

• When was the declaration issued?
• Is it still appropriate for the current product revision?

RoHS

• Are all applicable restricted substances covered?
• Are exemptions identified?
• Is the exemption actually applicable?

REACH

• Which Candidate List status was considered?
• Is the 0.1% threshold clearly defined?
• Are relevant restrictions addressed?
• Are communication obligations considered?

Traceability

• Can the declaration be linked to the exact BOM component?
• Is there a document revision?
• Is there a supplier change-control process?

Verification

• Is the evidence sufficient for the component’s risk?
• Is additional testing necessary?

If these questions cannot be answered, the declaration may still be useful, but it should not automatically be treated as complete compliance evidence.

14.23 The Key Takeaway

Supplier declarations are essential compliance evidence, but they should be treated as part of a structured evidence chain rather than as unquestionable proof.

A strong manufacturer process should:

• identify the exact component;
• maintain current supplier declarations;
• distinguish RoHS from REACH;
• document RoHS exemptions;
• track REACH Candidate List status;
• maintain revision and date information;
• monitor supplier changes;
• use testing where risk justifies it; and
• connect supplier evidence to the final product’s technical documentation.

The goal is not to collect as many declarations as possible.

The goal is to be able to answer a much more important question:

Can we demonstrate, with traceable evidence, why this product complies with the applicable substance requirements?

That is the foundation of a robust RoHS and REACH compliance process.

15. RoHS and REACH in the Supply Chain

RoHS and REACH compliance cannot be managed effectively by the manufacturer alone.

Modern electrical and electronic products are built from components, materials and subassemblies sourced from multiple suppliers and often from multiple countries. The manufacturer may know the final product extremely well while having limited visibility into the chemical composition of materials several levels upstream.

This makes the supply chain a critical part of the compliance process.

A manufacturer may purchase a connector from Supplier A, which purchases its plastic housing from Supplier B, while the metal contacts and plating come from Suppliers C and D.

The manufacturer therefore needs a process that connects:

Finished product → Component → Supplier → Material → Substance → Regulatory assessment

For RoHS, this chain is essential for demonstrating conformity.

For REACH, it can also determine whether information, communication or other obligations arise.

15.1 Why Supply-Chain Information Matters

Manufacturers frequently do not manufacture every component or material themselves.

Instead, they purchase:

• electronic components;
• PCB assemblies;
• cables;
• connectors;
• displays;
• batteries;
• plastic parts;
• metal parts;
• adhesives;
• coatings;
• power supplies;
• complete modules; and
• other subassemblies.

The manufacturer therefore depends heavily on suppliers for information about material composition and regulatory status.

This creates a fundamental principle:

A manufacturer’s product compliance is only as reliable as the information available about the materials and components incorporated into the product.

This does not mean that the manufacturer can simply transfer responsibility to suppliers.

The manufacturer remains responsible for its own finished product.

Supplier information is the input to the manufacturer’s compliance assessment.

15.2 RoHS and REACH Require Different Supply-Chain Information

Although the same supplier may provide information for both regulations, the information serves different purposes.

For RoHS, the manufacturer typically needs evidence concerning:

• the ten restricted substances;
• concentration limits;
• homogeneous materials;
• applicable exemptions;
• component and material composition; and
• evidence supporting the RoHS conformity assessment.

For REACH, the manufacturer may need information concerning:

• Candidate List substances;
• SVHCs;
• restrictions;
• substances in articles;
• safe-use information;
• communication obligations;
• supply-chain roles; and
• other REACH requirements depending on the material and business activity.

A supplier statement saying:

“RoHS and REACH compliant”

therefore needs to be treated carefully.

It may be useful, but the manufacturer should understand exactly what the supplier has assessed.

15.3 The Supply Chain Is an Information Chain

A useful way to view compliance is as an information flow.

Upstream

Raw material supplier

↓

Material manufacturer

↓

Component manufacturer

↓

Subassembly supplier

↓

Finished-product manufacturer

Downstream

Finished-product manufacturer

↓

Distributor

↓

Professional customer

↓

Consumer

Regulatory information may need to move in both directions.

For example, a manufacturer may need to request substance information from a supplier, while in another situation the manufacturer may need to communicate information about an SVHC to its own customer.

ECHA explicitly describes effective communication between actors at different stages of the supply chain as an important part of REACH compliance. (Chemicals in Our Life)

15.4 Supplier Declarations Are Part of the Evidence Chain

For RoHS, supplier declarations are often one of the most important sources of information.

A manufacturer may request:

• RoHS declaration;
• material declaration;
• component specification;
• test report;
• exemption information;
• change notification;
• manufacturing-site information; and
• other supporting documentation.

The manufacturer should then link that information to the actual component used.

For example:

BOM item: Connector ABC-123

↓

Supplier: Supplier X

↓

RoHS declaration: Document R-2026-04

↓

Part revision: Rev. B

↓

Assessment: Supported

This is significantly stronger than simply storing a document named:

RoHS_Compliance.pdf

in a general compliance folder.

15.5 Supplier Information Should Be Traceable

Traceability is one of the most important principles in supply-chain compliance.

A manufacturer should ideally be able to answer:

Which supplier document supports this specific component in this specific product revision?

For example:

Product	BOM Item	Supplier	Part Number	Evidence	Revision
Controller A	C102	Supplier X	ABC-123	RoHS Declaration	Rev. B
Controller A	C103	Supplier Y	DEF-456	Material Declaration	Rev. C
Controller A	C104	Supplier Z	GHI-789	Test Report	Rev. A

This allows compliance evidence to remain connected to the physical product.

15.6 Supplier Information Can Become Outdated

A supplier declaration is not necessarily valid forever.

A supplier may change:

• raw materials;
• material formulations;
• manufacturing processes;
• coatings;
• plating;
• component suppliers;
• production locations;
• subcomponents;
• adhesives;
• plastics; or
• other materials.

The supplier may keep the same commercial part number even though its material composition has changed.

This creates an important compliance risk:

The document may still exist, but the product it describes may no longer be identical to the product being supplied.

This is why supplier change control is an important part of RoHS and REACH management.

15.7 Change Notification Should Be Part of Supplier Management

Manufacturers should consider requiring suppliers to notify them of changes that could affect regulatory compliance.

Relevant changes may include:

• material changes;
• formulation changes;
• component substitutions;
• manufacturing-process changes;
• plating changes;
• coating changes;
• changes in sub-suppliers;
• changes in production location; and
• changes affecting regulatory status.

The manufacturer can then determine whether the change requires:

• no action;
• document review;
• updated declaration;
• new material information;
• risk assessment;
• laboratory testing; or
• a new product compliance assessment.

This is much more effective than discovering a material change months later during an audit.

15.8 Supplier Qualification Should Include Compliance

Supplier qualification is often focused on:

• price;
• quality;
• delivery;
• capacity;
• production capability; and
• financial stability.

Regulatory compliance should also be part of the qualification process.

A manufacturer can evaluate whether a supplier:

• understands RoHS requirements;
• understands REACH requirements;
• maintains material declarations;
• tracks regulatory changes;
• controls its own suppliers;
• has a documented change-notification process;
• can provide traceable compliance evidence; and
• responds reliably to compliance requests.

This is particularly important for components that represent a high compliance risk.

15.9 Not All Suppliers Represent the Same Risk

A manufacturer may have hundreds of suppliers.

It is rarely efficient to apply exactly the same level of scrutiny to every supplier.

A risk-based approach can consider factors such as:

Supplier risk

• new supplier;
• limited compliance history;
• unclear documentation;
• complex supply chain;
• poor change control.

Material risk

• flexible plastics;
• PVC;
• coatings;
• metal alloys;
• solder;
• flame-retarded materials;
• complex electronic modules.

Product risk

• large number of components;
• frequent engineering changes;
• long product lifecycle;
• high regulatory exposure;
• multiple markets.

The combination of these factors can determine how much evidence should be requested.

15.10 A Practical Supplier Risk Classification

A manufacturer could classify suppliers into three broad groups.

Low Risk

Characteristics may include:

• established supplier;
• strong compliance system;
• current declarations;
• stable materials;
• reliable change control.

Typical approach:

Supplier declaration + periodic review

Medium Risk

Characteristics may include:

• moderate material complexity;
• limited historical information;
• occasional documentation gaps.

Typical approach:

Declaration + material information + targeted review

High Risk

Characteristics may include:

• complex materials;
• unclear chemical composition;
• weak documentation;
• significant material changes;
• previous compliance issues.

Typical approach:

Detailed material information + additional verification + targeted testing where justified

The exact classification should be determined by the manufacturer.

The purpose is to direct resources where they provide the greatest compliance benefit.

15.11 REACH Requires Communication Along the Supply Chain

REACH contains specific information obligations concerning substances in articles.

Where an article contains a Candidate List substance above 0.1% by weight, suppliers have obligations to provide sufficient information to allow safe use of the article. At minimum, the name of the substance must be communicated. Consumers can also request this information, which must be provided free of charge within 45 days. (European Chemicals Agency)

This means that REACH information can follow the article through the supply chain.

The manufacturer therefore needs processes for both:

Receiving information from suppliers

and:

Providing relevant information to customers.

15.12 The 0.1% REACH Threshold Must Be Understood Correctly

The REACH Article 33 communication obligation is associated with a Candidate List substance being present in an article above 0.1% w/w.

This should not be confused with the RoHS concentration limits.

For RoHS:

0.1% or 0.01% applies to specified substances in homogeneous materials.

For the REACH Article 33 communication obligation:

0.1% w/w applies to a Candidate List substance in an article.

These are different regulatory calculations serving different purposes.

This distinction becomes particularly important for complex products made up of multiple articles.

The Court of Justice of the European Union has confirmed that the REACH Article 33 information obligation follows the relevant article and is not simply eliminated because that article has been incorporated into a more complex product. (EUR-Lex)

15.13 REACH Information Can Continue Through Multiple Supply-Chain Levels

Consider a manufacturer purchasing a display module.

The module contains a plastic housing with an SVHC above the relevant REACH threshold.

The module supplier may need to provide the required information to the manufacturer.

The manufacturer then needs to consider whether the same information must be communicated further downstream when supplying its own product.

The purpose is to ensure that relevant information about substances in articles is not lost simply because an article becomes part of a more complex product. (EUR-Lex)

This is one reason why supply-chain traceability is particularly important for REACH.

15.14 REACH Notification to ECHA Is a Separate Issue

Communication to customers should not be confused with notification to ECHA.

Under Article 7(2), producers and importers of articles may have to notify ECHA when a Candidate List substance is:

• present above 0.1% w/w in the relevant articles; and
• present in quantities totalling more than one tonne per year per producer or importer,

subject to the applicable conditions and exemptions.

ECHA states that notification generally has to be made within six months after inclusion of the substance in the Candidate List. (European Chemicals Agency)

This creates an important distinction:

Customer communication

and

ECHA notification

are two different obligations.

A manufacturer should therefore not assume that satisfying one automatically satisfies the other.

15.15 The Importer Can Have Additional Responsibilities

Supply chains become particularly important when products or components originate outside the EU.

For example:

Non-EU manufacturer

↓

EU importer

↓

EU distributor/customer

The EU importer may have its own REACH obligations depending on the product, substance and role in the supply chain.

ECHA specifically notes that non-EU producers of articles may be contacted by EU importers for information about Candidate List substances. (European Chemicals Agency)

This means that a manufacturer outside the EU should not assume that REACH is irrelevant simply because it is established outside the European Union.

Its EU customer or importer may require detailed substance information to fulfil its own obligations.

15.16 Non-EU Suppliers Need to Provide Usable Information

A supplier outside the EU may not be directly subject to every EU obligation in the same way as an EU-established supplier.

Nevertheless, its information can be essential to the EU importer’s compliance.

A non-EU supplier may therefore be asked to provide:

• Candidate List status;
• SVHC information;
• material declarations;
• substance concentrations;
• relevant restrictions;
• RoHS declarations;
• test reports;
• material specifications; and
• change notifications.

For global manufacturers, it is therefore useful to establish a standardised supplier compliance package that can be used across international supply chains.

15.17 A Generic “REACH Compliant” Statement May Be Insufficient

Consider the statement:

“This product complies with REACH.”

The manufacturer should ask:

• Which REACH requirements were assessed?
• Which Candidate List version was considered?
• Were SVHCs assessed?
• Were substances in articles considered?
• Was the assessment based on supplier information or testing?
• Is the statement linked to a specific part number?
• Which revision does it cover?
• When was it issued?
• How are changes managed?

The phrase “REACH compliant” can therefore have very different evidentiary value depending on the underlying assessment.

15.18 Candidate List Updates Create a Supply-Chain Trigger

The REACH Candidate List changes over time.

When a new substance is added, manufacturers may need to reassess affected products and supplier information.

A robust process can therefore work like this:

Candidate List update

↓

Identify affected substances

↓

Search supplier/material database

↓

Identify affected components

↓

Identify affected finished products

↓

Assess obligations

↓

Update documentation

↓

Communicate information where required

This is far more efficient than manually reviewing every supplier document from the beginning.

15.19 Supplier Questionnaires Can Standardise the Process

A manufacturer can establish a standard supplier questionnaire covering both RoHS and REACH.

For example:

RoHS

• Is the part compliant with Directive 2011/65/EU?
• Are all ten restricted substances covered?
• Are any exemptions used?
• Which exemptions?
• Which part number and revision are covered?
• What is the declaration date?
• Are material changes controlled?

REACH

• Does the article contain Candidate List substances above 0.1% w/w?
• Which substances?
• What is the concentration?
• Which Candidate List version was assessed?
• Are there relevant REACH restrictions?
• Can the supplier provide safe-use information?
• How are regulatory changes communicated?

This makes supplier responses easier to compare and process.

15.20 Supplier Information Should Be Version Controlled

A manufacturer may receive several declarations from the same supplier over several years.

For example:

• RoHS Declaration – 2023
• RoHS Declaration – 2024
• RoHS Declaration – 2025
• RoHS Declaration – 2026

The manufacturer needs to know which declaration applies to which product revision.

A controlled system can track:

Supplier	Part	Declaration	Date	Revision	Status
Supplier A	ABC-123	RoHS-2026-04	2026	B	Current
Supplier A	ABC-123	RoHS-2024-01	2024	A	Superseded
Supplier A	DEF-456	REACH-2026-02	2026	C	Current

This prevents older documentation from accidentally being used as evidence for newer product revisions.

15.21 Supplier Changes Should Trigger Product Impact Analysis

When a supplier announces a material change, the manufacturer should not automatically assume that every product is affected equally.

Instead:

Supplier change

↓

Identify affected component

↓

Identify products using the component

↓

Identify material affected

↓

Assess RoHS impact

↓

Assess REACH impact

↓

Determine required action

This can prevent unnecessary reassessment of unrelated products.

It also makes regulatory change management much more scalable.

15.22 The BOM Should Connect to the Supplier Database

A mature compliance system can connect three important datasets:

Product database

Product → BOM

Supplier database

BOM → Supplier → Part

Regulatory evidence database

Part → RoHS/REACH evidence

This creates a structured compliance chain:

Product

→ Component

→ Supplier

→ Material

→ Substance

→ Regulatory requirement

→ Evidence

This structure is particularly useful for manufacturers with large product portfolios.

15.23 A Compliance Gap Should Be Visible

A manufacturer should not hide incomplete supplier information.

Instead, the system should show the current status.

For example:

Component	RoHS	REACH	Evidence Gap	Action
Connector	Complete	Complete	None	None
Cable	Complete	Review	SVHC information missing	Supplier request
Housing	Review	Complete	Old declaration	Update required
PCB	Complete	Complete	None	None
Display	Review	Review	Supplier documentation incomplete	Detailed assessment

This makes compliance management proactive rather than reactive.

15.24 What Happens When a Supplier Does Not Respond?

This is a common real-world problem.

A manufacturer may request a declaration and receive no response.

The appropriate action depends on the component risk.

Possible responses include:

1. Send a formal compliance request.
2. Escalate through purchasing.
3. Contact the supplier’s regulatory or quality department.
4. Request alternative evidence.
5. Perform a risk assessment.
6. Conduct targeted testing where justified.
7. Qualify an alternative supplier.
8. Restrict use of the component until sufficient evidence is available.

The manufacturer should avoid automatically marking the component as compliant simply because the supplier has not reported a problem.

At the same time, it is not necessarily appropriate to treat every missing declaration as proof of non-compliance.

The correct classification is generally:

Compliance evidence incomplete — further assessment required.

15.25 Contractual Supplier Requirements Can Help

For strategically important suppliers, compliance requirements can be incorporated into purchasing or supplier agreements.

The agreement may specify that the supplier must:

• maintain regulatory compliance;
• provide requested substance information;
• maintain current declarations;
• notify the manufacturer of relevant material changes;
• provide information about Candidate List substances;
• provide information required for safe use;
• cooperate with regulatory investigations; and
• retain supporting records.

This turns compliance from an informal request into an established supplier obligation.

15.26 The Supply Chain Should Be Considered During Product Design

Supply-chain compliance should not begin after the product has already been designed.

During component selection, engineering teams should consider:

• supplier reliability;
• material transparency;
• regulatory documentation;
• availability of alternatives;
• change-control capability;
• expected product lifetime; and
• regulatory risk.

A technically excellent component can create significant compliance problems if its supplier cannot provide reliable regulatory information.

This is why design-for-compliance can reduce long-term cost.

15.27 Compliance Information Is Also a Business Continuity Issue

Supply-chain compliance is not only about regulatory audits.

If a critical supplier suddenly changes a material and the manufacturer cannot demonstrate continued compliance, the manufacturer may face:

• production interruptions;
• additional testing;
• component requalification;
• redesign;
• delayed product launches;
• customer complaints; or
• market-access problems.

A structured compliance database can therefore provide value beyond regulatory compliance.

It can help manufacturers understand:

Which products depend on which materials and suppliers?

That information can become important when regulations, suppliers or materials change.

15.28 A Practical Supply-Chain Compliance Workflow

A manufacturer can structure the process as follows:

Step 1 – Identify critical suppliers

↓

Step 2 – Identify relevant components and materials

↓

Step 3 – Define RoHS evidence requirements

↓

Step 4 – Define REACH information requirements

↓

Step 5 – Request supplier documentation

↓

Step 6 – Evaluate evidence quality

↓

Step 7 – Link evidence to BOM and product revision

↓

Step 8 – Identify compliance gaps

↓

Step 9 – Perform additional assessment where required

↓

Step 10 – Monitor supplier and regulatory changes

↓

Step 11 – Reassess affected products

↓

Step 12 – Maintain communication downstream where required

This creates an ongoing compliance process rather than a one-time document collection exercise.

15.29 What a Strong Supplier Compliance Package Looks Like

For a typical electronic component, a manufacturer might request:

Product identification

• manufacturer;
• supplier;
• part number;
• product revision.

RoHS

• current RoHS declaration;
• applicable exemptions;
• material declaration where available;
• supporting test report where appropriate.

REACH

• Candidate List status;
• SVHC information;
• relevant concentration information;
• applicable restriction information;
• safe-use information where required.

Change management

• declaration validity;
• material-change notification;
• regulatory-change notification;
• supplier contact for compliance matters.

The exact requirements should be proportionate to the component and supplier risk.

15.30 The Difference Between Supplier Responsibility and Manufacturer Responsibility

A critical distinction should always be maintained.

Supplier responsibility

The supplier is responsible for the accuracy of the information and declarations it provides and for fulfilling the obligations applicable to its own role.

Manufacturer responsibility

The manufacturer is responsible for ensuring that the finished product it places on the market meets the requirements applicable to that product.

Therefore:

Supplier compliance evidence supports the manufacturer’s assessment; it does not eliminate the manufacturer’s responsibility.

This principle applies particularly strongly when a finished product combines components from many different suppliers.

15.31 RoHS and REACH Should Be Managed as Living Data

One of the biggest weaknesses in traditional compliance systems is that regulatory information is stored as static documents.

For example:

Supplier declaration PDF → folder → forgotten

A stronger system treats compliance information as structured data:

Supplier → Part → Material → Substance → Regulation → Evidence → Revision → Date → Status

This makes it possible to identify:

• expired or outdated evidence;
• missing declarations;
• affected products;
• affected suppliers;
• new Candidate List substances;
• changing exemptions;
• regulatory gaps; and
• components requiring review.

For manufacturers with large product portfolios, this can significantly reduce the effort required to maintain compliance.

15.32 The Key Takeaway

RoHS and REACH compliance extend far beyond the manufacturer’s own factory.

The supply chain provides much of the information needed to understand the materials and substances contained in a finished product.

The most important principles are:

• Supplier information is a critical part of the compliance evidence chain.
• RoHS and REACH require different types of regulatory information, even when the same supplier provides both.
• Supplier declarations should be specific, current and traceable to the actual component.
• Material and product changes should trigger an appropriate compliance review.
• Supplier qualification should include regulatory capability.
• A risk-based approach is more efficient than treating every supplier and component identically.
• REACH Article 33 can require communication of Candidate List substance information when the relevant threshold is exceeded. (European Chemicals Agency)
• REACH notification to ECHA is a separate obligation that can apply to producers and importers under defined conditions. (European Chemicals Agency)
• Non-EU suppliers can be an important source of information for EU importers and downstream manufacturers. (European Chemicals Agency)
• The strongest compliance systems connect products, BOMs, suppliers, materials, substances and regulatory evidence in a traceable structure.
• Compliance should be treated as living information, not as a collection of static PDFs.

The next chapter broadens the perspective beyond the European Union:

How do RoHS requirements differ around the world, and why is “RoHS compliant” not necessarily enough for global market access?

16. RoHS Around the World – Global Requirements and Market Access

RoHS is often associated with the European Union, but the concept of restricting hazardous substances in electrical and electronic equipment has spread to many markets around the world.

As a result, manufacturers selling electrical and electronic products internationally may encounter several different RoHS-type regulations.

This creates an important misconception:

EU RoHS compliance does not automatically mean worldwide RoHS compliance.

Many countries have introduced their own requirements, often inspired by the EU approach but with differences in:

• scope;
• restricted substances;
• concentration limits;
• exemptions;
• documentation;
• marking;
• registration;
• enforcement;
• responsible economic operator; and
• implementation dates.

A manufacturer therefore needs to distinguish between global compliance strategy and simply copying the European approach into other markets.

16.1 Why Global RoHS Requirements Exist

The basic objective behind RoHS-type legislation is broadly similar across many jurisdictions:

• reduce hazardous substances in electrical and electronic products;
• reduce exposure of workers and consumers;
• reduce environmental contamination;
• improve recycling and waste treatment; and
• encourage safer material choices.

However, governments implement these objectives through their own legal frameworks.

This means that two jurisdictions can have very similar substance restrictions while still having different compliance procedures.

16.2 EU RoHS Is Only One Regulatory Model

The EU’s RoHS framework is established through Directive 2011/65/EU, commonly known as RoHS 2, together with subsequent amendments.

The EU system restricts ten substances in homogeneous materials:

Substance	Maximum concentration
Lead (Pb)	0.1%
Mercury (Hg)	0.1%
Cadmium (Cd)	0.01%
Hexavalent chromium (Cr VI)	0.1%
PBB	0.1%
PBDE	0.1%
DEHP	0.1%
BBP	0.1%
DBP	0.1%
DIBP	0.1%

These limits apply at the level of the relevant homogeneous material.

However, another country may use a different legal mechanism even when the substance list looks almost identical.

16.3 RoHS-Type Regulations Exist in Many Markets

Examples of jurisdictions with RoHS-related requirements include:

• European Union;
• United Kingdom;
• China;
• Japan;
• South Korea;
• India;
• Turkey;
• United Arab Emirates and other Middle Eastern markets;
• several U.S. states;
• and various other jurisdictions.

The details differ significantly.

Some systems are closely aligned with EU RoHS.

Others combine hazardous-substance restrictions with:

• recycling obligations;
• product registration;
• labeling;
• information disclosure;
• producer responsibility;
• or waste-management requirements.

Therefore, a manufacturer should avoid treating the term RoHS as if it referred to one universal global regulation.

16.4 China RoHS

China has developed its own hazardous-substance framework commonly referred to as China RoHS.

The current framework is based on China’s Administrative Measures for the Restriction of the Use of Hazardous Substances in Electrical and Electronic Products.

China RoHS is similar to EU RoHS in several respects, including restrictions concerning substances such as:

• lead;
• mercury;
• cadmium;
• hexavalent chromium;
• PBB;
• PBDE;
• and certain phthalates.

However, the Chinese system has its own regulatory structure and compliance mechanisms.

One particularly important difference is that China RoHS also involves information disclosure and marking requirements.

Manufacturers therefore should not simply place an EU RoHS declaration on a product and assume that the Chinese requirements have been satisfied.

16.5 China RoHS and the Product Marking Concept

China RoHS can involve an environmental protection use-period marking and, depending on the product and substance situation, additional information concerning hazardous substances.

This means that the compliance process can involve more than substance assessment.

The manufacturer may also need to determine:

• whether the product requires a China RoHS mark;
• which marking applies;
• whether hazardous-substance information must be disclosed;
• what documentation is required; and
• whether the product falls within relevant Chinese catalogs or implementation requirements.

The exact requirements depend on the product and the applicable Chinese rules.

16.6 EU RoHS and China RoHS Should Be Mapped Separately

A practical compliance matrix might look like this:

Requirement	EU	China
Lead restriction	Yes	Yes
Mercury restriction	Yes	Yes
Cadmium restriction	Yes	Yes
Hexavalent chromium	Yes	Yes
PBB	Yes	Yes
PBDE	Yes	Yes
Certain phthalates	Yes	Yes
Homogeneous-material assessment	Yes	Relevant
Declaration requirements	Yes	Specific Chinese requirements
Product marking	CE framework	China RoHS marking/information requirements

The substance similarities are useful.

But the compliance process still needs to be assessed separately.

16.7 United Kingdom RoHS

Following Brexit, the United Kingdom established its own RoHS framework.

The UK RoHS Regulations are broadly aligned with the EU RoHS substance restrictions and technical concepts.

However, the UK is a separate regulatory market.

Manufacturers placing products on the Great Britain market therefore need to consider:

• UK RoHS applicability;
• UK economic-operator responsibilities;
• conformity assessment;
• technical documentation;
• declaration requirements;
• marking requirements where applicable;
• record retention; and
• enforcement.

This is another example of why:

EU compliance and UK compliance should be checked separately even where the technical requirements are very similar.

Northern Ireland can require a separate assessment because of the regulatory framework applicable there.

16.8 Japan

Japan has hazardous-substance requirements that are commonly associated with the J-MOSS system.

J-MOSS is related to the Japanese Act on the Promotion of Effective Utilization of Resources and concerns the disclosure/marking of certain hazardous substances in specified electrical and electronic products.

The Japanese approach is therefore not simply a copy of EU RoHS.

This distinction is important.

A manufacturer entering Japan should determine:

• whether the product is within the applicable product categories;
• which substances are covered;
• whether marking is required;
• what information must be disclosed; and
• what documentation is expected.

16.9 South Korea

South Korea has implemented restrictions on hazardous substances in electrical and electronic products through its own regulatory framework.

The Korean requirements can overlap substantially with the substance restrictions familiar from EU RoHS.

However, the legal basis, product categories, administrative requirements and enforcement mechanisms are Korean-specific.

Manufacturers should therefore avoid assuming that an EU technical file automatically satisfies Korean requirements.

16.10 India

India has introduced its own hazardous-substance restrictions for electrical and electronic equipment.

The framework is linked to India’s electronic-waste regulatory regime and includes restrictions on specified hazardous substances.

India is particularly important for global manufacturers because compliance may involve more than simply confirming substance concentrations.

Depending on the applicable rules, manufacturers may need to consider:

• product applicability;
• restricted substances;
• concentration limits;
• documentation;
• producer responsibilities;
• registration;
• labeling; and
• electronic-waste obligations.

This demonstrates an important principle:

RoHS-type compliance and e-waste compliance can overlap without being the same obligation.

16.11 Turkey

Turkey has implemented hazardous-substance restrictions through its own legislation, closely influenced by the EU framework.

For manufacturers already supplying the European market, much of the technical substance assessment may therefore be reusable.

Nevertheless, the manufacturer must still confirm:

• the applicable Turkish legislation;
• product scope;
• conformity requirements;
• responsible economic operator;
• documentation;
• and current implementation status.

Technical similarity does not eliminate the need for legal verification.

16.12 The United States Uses a Different Model

The United States does not have one federal law equivalent to EU RoHS covering all electrical and electronic equipment.

Instead, hazardous-substance requirements may arise from:

• federal legislation;
• state legislation;
• product-specific requirements;
• environmental regulations;
• chemical restrictions;
• and customer requirements.

Certain U.S. states have introduced requirements addressing hazardous substances in electronics.

California is a well-known example.

Therefore, a manufacturer selling into the United States should not ask only:

“Is the product RoHS compliant?”

It should ask:

“Which U.S. requirements apply to this product in the states where it will be sold?”

16.13 California Is Particularly Important

California’s electronic waste legislation introduced restrictions on certain hazardous substances in covered electronic devices.

The requirements are not simply a general American version of EU RoHS.

They have their own:

• product scope;
• legal definitions;
• restrictions;
• implementation rules; and
• enforcement structure.

A manufacturer selling nationally in the United States therefore needs to determine whether California-specific requirements apply in addition to other U.S. obligations.

16.14 Global RoHS Compliance Is Therefore a Mapping Exercise

A manufacturer selling a product in ten markets may have ten different regulatory questions.

A useful approach is to create a global compliance matrix.

For example:

Market	RoHS-Type Requirement	Substance Rules	Documentation	Marking	Registration
EU	EU RoHS	EU list	Technical documentation + DoC	CE	Product-dependent
UK	UK RoHS	UK list	UK documentation	UK requirements	Product-dependent
China	China RoHS	Chinese rules	Required disclosures	China RoHS	Product-dependent
Japan	J-MOSS	Japanese rules	Product information	J-MOSS where applicable	Product-dependent
South Korea	Korean requirements	Korean rules	Korean requirements	Product-dependent	Product-dependent
India	E-waste/RoHS-type rules	Indian rules	Regulatory documentation	Applicable marking	Registration may apply
USA	State/product-specific	State-specific	Depends on requirement	Depends on requirement	Depends on requirement

The table is intentionally high-level.

The actual compliance assessment must always be based on the current legislation applicable to the specific product and market.

16.15 The Same Material Assessment Can Often Be Reused

Although regulations differ, the underlying engineering information can often be shared.

For example, a manufacturer may already know that a specific connector contains:

• lead concentration below the applicable threshold;
• no intentionally added mercury;
• no cadmium;
• no hexavalent chromium;
• no restricted brominated flame retardants;
• and no relevant phthalates.

That information can potentially support assessments for several markets.

This is where a structured material database becomes extremely valuable.

Instead of creating:

EU assessment

China assessment

India assessment

Japan assessment

from scratch, the manufacturer can maintain one controlled material dataset and map individual regulatory requirements onto it.

16.16 One Material Database, Multiple Regulatory Rules

A strong global compliance architecture can therefore look like this:

Material

↓

Chemical composition

↓

Substance concentration

↓

Regulatory database

↓

EU RoHS

China RoHS

UK RoHS

Japan

India

Other markets

This allows the same underlying material information to be reused.

The regulatory conclusion, however, remains market-specific.

16.17 Why “RoHS Compliant” Is Not Enough

Imagine a supplier declaration stating:

“Part ABC is RoHS compliant.”

The manufacturer still needs to ask:

Which RoHS?

Does it mean:

• EU RoHS?
• China RoHS?
• UK RoHS?
• customer-specific requirements?
• a generic supplier interpretation?

And:

Which revision?

Which substances?

Which exemptions?

Which product revision?

Which date?

Without these details, the statement may have limited value as regulatory evidence.

16.18 Global Compliance Requires a Regulatory Baseline

A manufacturer should establish a defined baseline for its products.

For example:

“All materials used in our standard products shall meet the substance restrictions of EU RoHS, UK RoHS and China RoHS unless a documented exception is approved.”

This can create a strong internal engineering requirement.

However, this baseline should not be confused with the legal conclusion for every market.

Additional local requirements may still apply.

16.19 The “Strictest Common Denominator” Strategy

Some manufacturers intentionally design products to satisfy the most restrictive common material requirements across their target markets.

For example, if a material is acceptable under one jurisdiction but restricted under another, the manufacturer may choose the safer material for all products.

This can simplify:

• procurement;
• manufacturing;
• inventory;
• engineering;
• documentation; and
• market expansion.

However, this strategy has limits.

The strictest substance list does not automatically capture every country’s:

• marking;
• registration;
• reporting;
• documentation;
• recycling;
• importer;
• or administrative requirements.

Therefore:

A common material baseline can simplify product design, but it cannot replace market-specific regulatory analysis.

16.20 Exemptions Are Another Major Difference

RoHS exemptions can differ between jurisdictions.

A material may be permitted under an EU RoHS exemption but not necessarily receive identical treatment elsewhere.

Manufacturers should therefore maintain exemption information separately.

For every exemption, the compliance database should ideally record:

• exemption number;
• substance;
• technical application;
• affected component;
• legal jurisdiction;
• expiry date;
• renewal status; and
• supporting justification.

This becomes particularly important for long-life products.

16.21 Regulatory Updates Can Break a Global Compliance Strategy

Suppose a manufacturer has designed a product around an exemption.

Later:

Exemption changes

↓

Material no longer acceptable

↓

Component must be redesigned

↓

BOM changes

↓

Supplier documentation changes

↓

Technical documentation changes

↓

Potential market reassessment

This is why global RoHS compliance should be monitored continuously.

It should not be treated as a certification completed once at product launch.

16.22 Product Scope Can Also Differ

One of the most dangerous assumptions is:

“If the product is covered by EU RoHS, it must be covered everywhere.”

That is not necessarily true.

Different jurisdictions may define covered equipment differently.

A product could therefore be:

• in scope in the EU;
• outside the scope of one national system;
• subject to a different product-specific rule elsewhere; or
• subject to additional requirements beyond RoHS.

Scope determination should therefore be performed separately for each target market.

16.23 Global Market Access Requires More Than RoHS

RoHS is only one part of electrical and electronic product compliance.

A manufacturer may simultaneously need to address:

European Union

• RoHS;
• REACH;
• EMC;
• Radio Equipment Directive;
• Low Voltage Directive;
• Ecodesign;
• WEEE;
• cybersecurity requirements;
• battery requirements;
• and other product-specific legislation.

China

• China RoHS;
• CCC where applicable;
• SRRC for radio equipment where applicable;
• EMC and safety requirements;
• other product-specific regulations.

United States

• FCC;
• state environmental requirements;
• product-specific safety requirements;
• other federal/state regulations.

Therefore, RoHS should be viewed as one regulatory layer within the overall market-access strategy.

16.24 A Global Compliance Matrix Is Extremely Useful

For a product sold internationally, a manufacturer can create a matrix such as:

Market	Product Scope	RoHS	REACH Equivalent	WEEE/E-Waste	Marking	Registration	Status
EU	In scope	Required	Required	Required	CE	Product-dependent	Complete
UK	In scope	Required	UK requirements	Required	Applicable UK marking	Product-dependent	Review
China	In scope	Required	Separate assessment	Required	China RoHS	Product-dependent	Complete
Japan	Category-dependent	J-MOSS	Separate assessment	Separate rules	Product-dependent	Review
India	Category-dependent	Required	Separate assessment	E-waste rules	Applicable	Registration may apply	Open
USA	State/product-dependent	State-specific	Chemical rules	State/federal rules	Product-dependent	Product-dependent	Review

This matrix makes the distinction between technical compliance and market-access compliance visible.

16.25 Supplier Requirements Can Be Globalized

A global manufacturer can simplify procurement by creating a global supplier requirement.

For example:

Suppliers shall provide current material and substance information sufficient to evaluate applicable hazardous-substance requirements in all target markets.

The supplier package can then contain:

• RoHS declaration;
• material declaration;
• REACH/SVHC information;
• substance composition;
• applicable exemptions;
• change notification;
• and supporting test evidence where necessary.

This reduces the need to repeatedly contact suppliers whenever a new market is entered.

16.26 However, Supplier Data Should Not Become a “Global Compliance Certificate”

A supplier’s material declaration describes the component.

It does not automatically prove that the finished product satisfies every regulatory requirement in every country.

For example, the same component may be acceptable from a hazardous-substance perspective while the finished product still requires:

• different marking;
• registration;
• local documentation;
• importer information;
• recycling registration;
• or product-specific certification.

Therefore:

Component compliance ≠ finished-product market access

This distinction is fundamental.

16.27 A Better Global Compliance Architecture

A mature manufacturer can structure its compliance system into four layers.

Layer 1 – Material data

What substances are present?

Layer 2 – Component compliance

Does the component satisfy the relevant substance requirements?

Layer 3 – Product compliance

Does the complete product satisfy the applicable regulations?

Layer 4 – Market access

Can the product legally be placed on the market in the target country?

This architecture prevents the common mistake of treating a material declaration as a complete market-access assessment.

16.28 Practical Example

Imagine a wireless industrial sensor.

The product contains:

• PCB;
• radio module;
• antenna;
• plastic enclosure;
• display;
• cable;
• battery;
• metal mounting parts.

The manufacturer wants to sell it in:

• Germany;
• United Kingdom;
• China;
• Japan;
• India;
• United States.

The material database can establish the substance composition of the components.

The manufacturer can then assess:

EU

• RoHS;
• REACH;
• WEEE;
• RED;
• EMC;
• safety;
• other applicable legislation.

UK

• UK RoHS;
• UK REACH;
• WEEE;
• radio;
• EMC;
• safety.

China

• China RoHS;
• radio requirements;
• applicable product requirements.

Japan

• J-MOSS where applicable;
• radio;
• EMC;
• safety;
• other applicable rules.

India

• applicable hazardous-substance/e-waste requirements;
• wireless requirements;
• other applicable product rules.

United States

• applicable state substance restrictions;
• FCC;
• safety;
• other product-specific requirements.

The same underlying product data can support the assessments, but the regulatory conclusions remain market-specific.

16.29 Global RoHS Compliance Should Be Designed Into the Product

The best time to address global hazardous-substance requirements is before component selection is finalized.

Engineering teams can ask:

• Is the material suitable for all target markets?
• Is the supplier documentation sufficient?
• Is an exemption being relied upon?
• Could the exemption expire?
• Is there an alternative material?
• Can the same component be used globally?
• Will the supplier notify us of changes?

These questions can prevent expensive redesigns later.

16.30 The Key Takeaway

RoHS is not a single worldwide regulation.

Different jurisdictions have developed their own approaches to hazardous substances in electrical and electronic equipment. Some are strongly aligned with EU RoHS, while others differ in scope, documentation, marking, registration or implementation.

The most important principles are:

• EU RoHS compliance does not automatically equal global RoHS compliance.
• China, the UK, Japan, India, South Korea and other markets have their own regulatory frameworks.
• The United States generally requires a state- and product-specific approach rather than one federal RoHS regime.
• Substance data can often be reused across markets, but the regulatory assessment must remain market-specific.
• Exemptions and product scope can differ between jurisdictions.
• Product marking and administrative requirements can be just as important as substance restrictions.
• A global material database can significantly reduce duplicated compliance work.
• Supplier declarations are valuable evidence but do not constitute universal market-access approval.
• Global market access requires more than RoHS; other environmental, safety, EMC, radio and product-specific requirements may apply.
• A structured global compliance matrix helps manufacturers identify what is required in each target market.

The central idea is simple:

Build one reliable source of product and material data, then map the applicable regulatory requirements to each market.

That approach is far more robust than assuming that one “RoHS compliant” declaration covers the entire world.

17. UAE RoHS – A Different Compliance Approach

The United Arab Emirates has introduced requirements addressing hazardous substances in electrical and electronic equipment. While these requirements are influenced by international approaches to chemical restrictions, manufacturers should not assume that compliance with EU RoHS automatically satisfies the UAE requirements.

The UAE approach is particularly important for manufacturers supplying electrical and electronic products to the Gulf region because compliance may involve not only the technical substance restrictions themselves, but also local conformity, documentation and market-access requirements.

For manufacturers already working with EU RoHS, much of the underlying technical information may be reusable. However, the regulatory assessment still needs to be performed against the applicable UAE requirements.

17.1 Why UAE RoHS Is Important

The UAE is a major commercial and distribution hub for the Middle East.

Products entering the UAE market can be subject to a range of technical and regulatory requirements covering areas such as:

• electrical safety;
• electromagnetic compatibility;
• radio equipment;
• hazardous substances;
• energy efficiency;
• environmental requirements;
• conformity assessment;
• product registration; and
• labeling.

RoHS-type requirements form only one part of this broader regulatory environment.

For manufacturers, the important question is therefore not simply:

“Is my product RoHS compliant?”

It is:

“Does my product satisfy the applicable UAE requirements for hazardous substances and market access?”

17.2 The UAE Approach Is Not Simply EU RoHS

One of the most common mistakes is to treat UAE RoHS as an exact copy of EU RoHS.

The two systems may share similar concepts, but they are based on different legal frameworks.

A manufacturer should therefore verify:

• applicable product scope;
• restricted substances;
• concentration limits;
• exemptions;
• conformity requirements;
• documentation;
• labeling;
• registration requirements;
• responsible parties; and
• current implementation dates.

This is particularly important when a product was originally designed exclusively for the European market.

17.3 Product Scope Must Be Determined First

Before evaluating hazardous substances, the manufacturer should establish whether the product falls within the relevant UAE regulatory scope.

Typical electrical and electronic products can include:

• consumer electronics;
• IT equipment;
• household appliances;
• lighting equipment;
• electrical tools;
• monitoring and control equipment;
• telecommunications equipment;
• electronic components incorporated into larger products;
• and other electrical or electronic equipment.

The exact scope depends on the applicable UAE legislation and product classification.

Therefore, the first compliance question should always be:

Is the product in scope?

Only after this has been established should the detailed substance assessment be performed.

17.4 Hazardous-Substance Assessment

For a product within scope, the manufacturer needs reliable information about the materials and components used in the product.

Relevant information can include:

• material composition;
• supplier declarations;
• material declarations;
• laboratory test reports;
• certificates;
• technical specifications;
• bills of materials;
• and information concerning exemptions.

The objective is to determine whether restricted substances exceed the applicable limits.

This is fundamentally similar to the approach used for other RoHS-type systems.

17.5 The Importance of Homogeneous Materials

RoHS assessments are generally based on the concentration of restricted substances in relevant homogeneous materials rather than simply looking at the average concentration across an entire finished product.

For example, a PCB assembly may contain:

• solder;
• copper;
• laminate;
• coatings;
• plastics;
• adhesives;
• connectors;
• and electronic components.

These materials should not simply be treated as one averaged material.

A substance concentration that appears insignificant when averaged over the complete product can still exceed a regulatory threshold in an individual material.

This is why detailed material information is essential.

17.6 Supplier Data Is Critical

Manufacturers rarely manufacture every material themselves.

A typical electrical product may contain hundreds or thousands of individual parts.

The manufacturer therefore needs a systematic supplier-information process.

Suppliers may be asked to provide:

• RoHS declarations;
• material declarations;
• chemical composition information;
• laboratory reports;
• exemption references;
• change notifications;
• and confirmation of regulatory status.

The manufacturer can then consolidate this information into the product compliance file.

17.7 A Supplier Declaration Is Not the End of the Assessment

A supplier declaration can provide important evidence, but it should not automatically be treated as absolute proof.

A robust compliance process considers:

• who issued the declaration;
• which product or component it covers;
• which revision it applies to;
• which regulations are referenced;
• which substances were assessed;
• whether exemptions are used;
• and when the declaration was issued.

For high-risk components, additional evidence may be appropriate.

This can include laboratory testing or detailed material declarations.

17.8 Testing Versus Documentation

RoHS compliance does not necessarily mean that every product must undergo laboratory testing.

A risk-based approach can be used.

For example:

Low-risk component

A well-controlled component from a reliable supplier may be supported primarily through supplier documentation.

Medium-risk component

Additional material information or historical test evidence may be appropriate.

High-risk component

Independent laboratory testing may provide stronger evidence.

Examples of potentially higher-risk materials include:

• plastics containing additives;
• soldered assemblies;
• cables;
• coatings;
• metal finishes;
• batteries;
• and components from suppliers with insufficient material information.

The appropriate evidence depends on the product and compliance risk.

17.9 Documentation Should Be Structured

A manufacturer should be able to demonstrate how the hazardous-substance conclusion was reached.

A useful compliance file can contain:

1. product identification;
2. product description;
3. BOM;
4. component list;
5. material declarations;
6. supplier declarations;
7. test reports where applicable;
8. exemption information;
9. regulatory assessment;
10. applicable conformity documentation;
11. labeling information;
12. change-control records.

This creates a traceable chain from the physical product to the regulatory conclusion.

17.10 Change Management Is Essential

RoHS compliance can be affected by apparently small engineering changes.

For example:

Supplier changes solder

↓

Material composition changes

↓

Hazardous-substance assessment changes

↓

Existing compliance evidence may no longer apply

Similarly:

• a new PCB supplier;
• a new cable;
• a different connector;
• a different plastic;
• a new coating;
• or a different adhesive

can affect the compliance status.

Therefore, RoHS should be integrated into the manufacturer’s engineering change process.

17.11 BOM Changes Should Trigger Compliance Review

A practical internal rule can be:

Any material or component change that could affect chemical composition must trigger a compliance review.

The review does not necessarily mean complete retesting.

Instead, the compliance team should determine whether the change affects:

• restricted substances;
• exemptions;
• supplier evidence;
• technical documentation;
• declarations;
• or market access.

This prevents compliance documentation from becoming disconnected from the actual production product.

17.12 Exemptions Need Special Attention

As with other RoHS-type frameworks, exemptions can be important for certain technical applications.

A manufacturer relying on an exemption should record:

• the exemption reference;
• the affected substance;
• the affected component;
• the technical justification;
• the applicable product;
• and the validity of the exemption.

The manufacturer should also monitor whether the exemption remains applicable.

An exemption should never simply be copied from an old EU compliance document without checking the UAE requirements.

17.13 UAE Compliance and EU Compliance Can Share Data

There is, however, a major opportunity for manufacturers already operating under EU RoHS.

Much of the underlying product information can potentially be reused.

For example:

EU RoHS material database

↓

Component information

↓

Supplier declarations

↓

Material composition

↓

UAE assessment

This avoids repeating the entire information-gathering process.

But the final regulatory conclusion must still be based on the UAE requirements.

17.14 One Product, Multiple Regulatory Assessments

Consider a product containing:

• 500 electronic components;
• 20 mechanical components;
• 8 cables;
• 4 connectors;
• 3 plastic housings;
• and several coatings and adhesives.

The manufacturer should not create completely independent material databases for:

• EU;
• UK;
• China;
• UAE;
• India;
• Japan.

Instead, the manufacturer should maintain one controlled product and material dataset.

Regulatory rules can then be mapped onto that dataset.

This is significantly more efficient.

17.15 UAE RoHS Within a Global Compliance Database

A structured compliance platform could therefore store:

Component	Material	Substance Data	EU RoHS	UK RoHS	China RoHS	UAE	Status
PCB	FR-4	Available	Pass	Pass	Pass	Pass	Valid
Connector	PA + metal	Available	Pass	Pass	Pass	Pass	Valid
Cable	PVC	Available	Pass	Pass	Pass	Review	Open
Solder	Sn-based	Available	Pass	Pass	Pass	Pass	Valid
Coating	Polymer	Partial	Review	Review	Review	Review	Missing data

This approach immediately shows where additional supplier information is needed.

17.16 The UAE Market Requires More Than RoHS

A manufacturer should never interpret UAE RoHS compliance as complete product approval.

Depending on the product, additional requirements may apply.

For example:

• electrical safety;
• EMC;
• radio requirements;
• telecommunications requirements;
• energy efficiency;
• labeling;
• conformity assessment;
• registration;
• importer responsibilities;
• and product-specific technical regulations.

A wireless product, for example, may require both hazardous-substance assessment and radio-related approval.

The two assessments address completely different regulatory questions.

17.17 Example: Wireless Smart Sensor

Consider a smart industrial sensor containing:

• Wi-Fi;
• Bluetooth;
• a power supply;
• PCB;
• plastic enclosure;
• display;
• battery;
• cables.

The manufacturer may need to assess:

Environmental / chemical

• UAE hazardous-substance requirements;
• applicable battery requirements;
• other environmental obligations.

Radio

• applicable UAE radio requirements;
• frequency allocation;
• transmitter parameters;
• applicable conformity procedures.

EMC

• emissions;
• immunity;
• applicable standards.

Safety

• electrical safety;
• power supply;
• battery safety.

The product therefore requires a multi-dimensional compliance assessment.

RoHS is only one part of the overall picture.

17.18 Common Mistake: “We Already Have CE”

A European CE marking demonstrates conformity with applicable EU legislation.

It does not automatically establish conformity with UAE legislation.

A manufacturer may be able to reuse:

• test reports;
• technical documentation;
• material information;
• supplier declarations;
• and engineering data.

But the UAE market-access assessment must still be performed separately.

This distinction is especially important for manufacturers expanding from Europe into the Middle East.

17.19 Common Mistake: “Our Supplier Says RoHS Compliant”

Another common mistake is relying entirely on a supplier’s generic statement.

For example:

“Component is RoHS compliant.”

This statement does not necessarily tell the manufacturer:

• which regulation was considered;
• which version;
• which substances;
• which exemptions;
• which component revision;
• or whether the declaration remains current.

A stronger supplier requirement specifies exactly what evidence must be provided.

17.20 A Better Supplier Declaration

A useful supplier declaration should identify:

Supplier

Part number

Part revision

Applicable regulation

Substances assessed

Concentration limits

Applicable exemptions

Declaration date

Authorized signatory

Supporting evidence

This makes the information much more useful for a global compliance system.

17.21 UAE Compliance Should Be Monitored

Regulatory requirements can change.

Manufacturers should therefore monitor:

• new legislation;
• amendments;
• implementation dates;
• exemptions;
• guidance;
• product scope;
• conformity procedures;
• and authority publications.

A product that was compliant when originally launched may require reassessment after a regulatory change.

This is especially important for products with long market lifetimes.

17.22 A Practical UAE Compliance Workflow

A manufacturer can use the following process:

Step 1 – Identify the product

Determine the exact product model, configuration and intended market.

Step 2 – Determine scope

Establish whether the UAE RoHS-type requirements apply.

Step 3 – Identify components

Create a controlled BOM.

Step 4 – Collect supplier information

Obtain declarations and material information.

Step 5 – Evaluate substances

Compare the relevant materials against the applicable restrictions.

Step 6 – Evaluate exemptions

Identify and document any exemptions.

Step 7 – Determine evidence

Decide whether supplier declarations are sufficient or additional testing is required.

Step 8 – Prepare documentation

Create the necessary technical and conformity documentation.

Step 9 – Check additional UAE requirements

Assess safety, EMC, radio, energy and other applicable regulations.

Step 10 – Control changes

Ensure future BOM changes trigger compliance review.

17.23 Global Strategy: Build Once, Assess Many Times

The biggest efficiency gain comes from separating product data from regulatory rules.

The manufacturer maintains:

Product data

• BOM;
• materials;
• suppliers;
• components;
• revisions;
• test reports;
• declarations.

And separately:

Regulatory data

• EU requirements;
• UK requirements;
• China requirements;
• UAE requirements;
• India requirements;
• Japan requirements;
• other market requirements.

The system can then determine which regulatory requirements apply to which product.

This is much more scalable than manually creating separate compliance files for every market.

17.24 The Key Takeaway

The UAE represents an important example of why manufacturers should not treat RoHS as one universal global regulation.

The underlying technical work can often be reused, particularly when a manufacturer already has a mature EU RoHS process.

However:

• scope must be checked;
• applicable UAE requirements must be identified;
• substance restrictions must be evaluated;
• exemptions must be verified;
• documentation must be maintained;
• supplier evidence must be controlled;
• and additional UAE market-access requirements must be assessed.

The most effective strategy is therefore:

Maintain one reliable source of product and material information, then perform a separate regulatory mapping for the UAE market.

This approach provides both efficiency and regulatory traceability while avoiding the dangerous assumption that an EU RoHS declaration—or a CE marking—automatically provides UAE market access.

18. RoHS and REACH for Manufacturers Outside the EU

Manufacturers located outside the European Union often assume that EU chemical and product legislation does not directly concern them because they are not established within the EU.

That assumption is only partly correct.

A manufacturer in the United States, China, Japan, India, South Korea, Taiwan, the United Kingdom, or another non-EU country can place products on the EU market and therefore needs to understand the requirements that apply to those products.

The important distinction is between where the manufacturer is established and where the product is placed on the market.

For RoHS, the non-EU manufacturer can still have direct responsibilities as the manufacturer of covered EEE placed on the EU market.

For REACH, the legal responsibilities are structured differently. ECHA explains that REACH obligations generally fall on EU/EEA importers, although a non-EU manufacturer can appoint an Only Representative in the EU/EEA for certain REACH obligations. (European Chemicals Agency)

This difference is extremely important for companies selling electrical and electronic products from outside Europe into the EU.

18.1 Selling Into the EU Is What Matters

A manufacturer does not avoid EU requirements simply because the factory is located outside Europe.

For example, consider a manufacturer based in:

• China;
• the United States;
• India;
• Japan;
• South Korea;
• Taiwan;
• the United Kingdom; or
• another non-EU country.

If that manufacturer sells an electrical product into the EU, the product may be subject to EU requirements including:

• RoHS;
• REACH;
• EMC;
• Radio Equipment Directive requirements;
• Low Voltage Directive requirements;
• Ecodesign requirements;
• battery legislation;
• WEEE requirements; and
• other product-specific legislation.

The manufacturing location is therefore not the decisive factor.

The key question is:

What product is being placed on the EU market, and which EU requirements apply to it?

18.2 RoHS: Non-EU Manufacturers Still Need to Assess Compliance

RoHS is particularly important because it is a product compliance requirement for covered electrical and electronic equipment.

A non-EU manufacturer placing covered EEE on the EU market must establish conformity with the applicable RoHS requirements.

This means the manufacturer needs to address issues such as:

• RoHS scope;
• restricted substances;
• homogeneous materials;
• concentration limits;
• exemptions;
• technical documentation;
• EU Declaration of Conformity;
• CE marking; and
• document retention.

The fact that the factory is located outside the EU does not eliminate these requirements.

The manufacturer therefore needs an EU-compliant product before the product is placed on the EU market.

18.3 A Non-EU Factory Does Not Need to Be in Europe

There is no general requirement for the physical manufacturing facility to be located in the EU in order to manufacture RoHS-compliant products.

A company can manufacture a product in:

China → Germany

USA → France

Japan → Netherlands

India → Italy

UK → Spain

and still place the product on the EU market, provided the applicable EU requirements are fulfilled.

The compliance system therefore needs to operate across the entire supply chain.

This is particularly important for manufacturers using global contract manufacturing.

18.4 The Manufacturer Remains Responsible for the Product

A non-EU manufacturer should not assume that the European importer automatically takes over all product compliance responsibilities.

The importer has its own legal obligations, but the manufacturer still needs to ensure that the product it supplies is appropriately designed and documented for the EU market.

A manufacturer should therefore establish its own compliance process covering:

• product classification;
• applicable legislation;
• standards;
• materials;
• suppliers;
• testing;
• technical documentation;
• declarations; and
• changes.

The importer can then use the manufacturer’s documentation as part of its own market-access and due-diligence activities.

18.5 REACH Works Differently

REACH requires a more careful distinction.

ECHA states that companies established outside the EU/EEA generally do not have direct REACH obligations simply because they export products into the EU.

Instead, the responsibility for obligations such as registration generally falls on the EU/EEA importer or, where applicable, an Only Representative appointed by the non-EU company. (European Chemicals Agency)

This does not mean that a non-EU manufacturer can ignore REACH.

The EU importer will need information from the non-EU manufacturer to determine and fulfil its obligations.

Therefore, the practical situation is:

Non-EU manufacturer

↓

Provides product and substance information

↓

EU importer / Only Representative

↓

Fulfils applicable REACH obligations

The non-EU manufacturer therefore plays a critical role even where the formal legal obligation sits with another actor.

18.6 Why Non-EU Manufacturers Need Strong REACH Data

An EU importer cannot determine its REACH obligations without sufficient information about the products it imports.

The importer may need to know:

• what substances are present;
• whether substances are present in mixtures;
• whether articles contain SVHCs;
• the concentration of relevant substances;
• the quantity imported;
• whether a substance is subject to restriction;
• whether registration is required;
• and whether additional communication is necessary.

ECHA specifically advises EU importers to obtain the necessary information from their non-EU suppliers. (European Chemicals Agency)

This makes supplier communication an essential part of international market access.

18.7 Articles Are Particularly Important for Electronic Products

Most finished electrical products are treated as articles under REACH because their shape, surface or design determines their function more strongly than their chemical composition.

Examples include:

• smartphones;
• computers;
• routers;
• sensors;
• household appliances;
• control panels;
• electronic tools;
• cables;
• connectors; and
• other finished electrical products.

For non-EU manufacturers, the REACH assessment therefore often focuses on the substances contained in these articles.

One important area is the presence of Substances of Very High Concern (SVHCs) from the REACH Candidate List.

18.8 SVHC Information Can Be Critical

If an article contains a Candidate List substance above the applicable 0.1% w/w threshold, REACH can create information and communication obligations.

The recipient of the article must receive sufficient information to allow safe use of the article.

For non-EU manufacturers, this means they may need to provide their EU customers with information concerning the presence of relevant SVHCs. (European Chemicals Agency)

This can create a practical requirement for detailed material information even when the manufacturer is not itself the formal REACH importer.

The manufacturer therefore benefits from maintaining a reliable substance database for its products.

18.9 REACH Notification Can Also Become Relevant

Under Article 7(2) of REACH, producers and importers of articles may have to notify ECHA when a Candidate List substance is present in relevant articles above 0.1% w/w and the total amount of that substance exceeds one tonne per year. (European Chemicals Agency)

There are specific exceptions, including circumstances where exposure can be excluded or the substance has already been registered for that use.

For a non-EU manufacturer, this is another reason why its EU importer needs accurate substance and quantity information.

The manufacturer should therefore not simply ask:

“Is this product REACH compliant?”

It should ask:

“What REACH information does our EU supply chain need from us?”

18.10 The Only Representative Mechanism

One of the most important mechanisms for non-EU companies is the Only Representative (OR).

A non-EU manufacturer can, where the legal conditions permit, appoint an EU/EEA-based Only Representative to fulfil certain REACH obligations that would otherwise fall on importers.

The Only Representative must be established in the EU/EEA and must have sufficient knowledge and competence to perform the relevant REACH tasks. (European Chemicals Agency)

The mechanism can be useful for companies with multiple European customers.

Instead of each importer separately handling certain REACH obligations, an Only Representative can fulfil the applicable obligations for the represented non-EU company.

18.11 Only Representative Does Not Mean “REACH Representative for Everything”

The term can easily be misunderstood.

An Only Representative is not a general European representative for all regulatory matters.

It is a specific mechanism under REACH.

The OR can take over certain REACH obligations of the importer, depending on the substance, product and role of the non-EU company.

It does not automatically:

• replace the importer for all EU legislation;
• become the manufacturer’s authorised representative for every product regulation;
• perform RoHS conformity on behalf of the manufacturer;
• replace a radio-equipment representative where one is separately required; or
• take responsibility for unrelated CE legislation.

The legal role must therefore be defined carefully.

18.12 Who Can Appoint an Only Representative?

The Only Representative mechanism is particularly relevant to non-EU manufacturers, formulators and certain article producers under the conditions established by REACH.

ECHA notes that the OR takes over the relevant importer obligations for the represented non-EEA company. (European Chemicals Agency)

The exact legal position depends on the role of the non-EU company and the substance or article involved.

A non-EU distributor should therefore not assume that it can appoint an OR simply because it sells products into Europe.

The supply-chain role needs to be established first.

18.13 The Importer Still Matters

If there is no applicable Only Representative arrangement, the EU importer may have REACH obligations.

For example, an EU company importing products from a non-EU manufacturer can become the relevant importer for REACH purposes.

The importer may then need to evaluate:

• registration;
• article obligations;
• SVHC communication;
• notification;
• restrictions;
• substance information; and
• other applicable REACH requirements.

This is why the commercial relationship between the non-EU manufacturer and the EU importer matters.

18.14 A Non-EU Manufacturer Should Support Its Importer

A practical international compliance strategy is therefore:

Make the importer’s job easier by providing structured regulatory information.

A manufacturer should ideally be able to provide:

• product identification;
• BOM;
• material information;
• SVHC assessment;
• substance declarations;
• RoHS documentation;
• relevant REACH information;
• test reports;
• exemptions;
• supplier declarations;
• and change notifications.

This allows the importer to determine its own regulatory obligations much more efficiently.

18.15 RoHS and REACH Should Be Managed Separately

For non-EU manufacturers, the distinction between RoHS and REACH becomes even more important.

RoHS

The manufacturer needs to establish conformity of covered EEE with the RoHS requirements.

REACH

The manufacturer needs to determine what information and obligations arise within the EU/EEA supply chain, particularly for substances, mixtures and articles.

Therefore:

RoHS → Product conformity

REACH → Chemical and supply-chain obligations

The same material data can support both processes, but the legal assessment is different.

18.16 Example: Chinese Manufacturer Selling a Router in Germany

Consider a Chinese manufacturer producing a wireless router.

The product contains:

• PCB;
• plastic housing;
• connectors;
• cables;
• solder;
• Wi-Fi module;
• power supply.

The manufacturer wants to sell the product in Germany.

RoHS assessment

The manufacturer needs to establish:

• whether the router is within RoHS scope;
• which materials are present;
• whether the ten restricted substances comply with the applicable limits;
• whether exemptions apply;
• what evidence supports conformity;
• and what technical documentation is required.

REACH assessment

The manufacturer needs to determine:

• whether relevant SVHCs are present;
• whether communication obligations arise;
• whether the EU importer needs additional information;
• whether any REACH restrictions apply; and
• whether an Only Representative arrangement is relevant.

Other EU requirements

The manufacturer may additionally need to assess:

• RED;
• EMC;
• electrical safety;
• WEEE;
• battery requirements, if applicable;
• cybersecurity requirements, depending on the product and applicable legislation; and
• other product-specific legislation.

The result is not one “EU compliance certificate.”

It is a combination of regulatory assessments.

18.17 Example: US Manufacturer Selling Industrial Equipment

Consider a US manufacturer producing an industrial wireless controller.

The product contains:

• aluminium housing;
• PCB;
• RF module;
• cables;
• display;
• power supply;
• plastic connectors.

The company wants to sell the controller to an EU distributor.

The US manufacturer should establish the product’s EU compliance position before commercial launch.

For RoHS, it should maintain:

• product scope assessment;
• BOM;
• material evidence;
• supplier declarations;
• testing where justified;
• exemption assessment;
• technical documentation;
• EU Declaration of Conformity.

For REACH, it should provide the European supply chain with the substance information needed to fulfil applicable REACH obligations.

This is much more efficient than waiting for the distributor to discover missing information after the product has already entered the EU market.

18.18 The United Kingdom Requires Separate Consideration

The UK is particularly important for non-EU manufacturers.

Since Brexit, EU and UK product and chemical legislation have developed separately.

A manufacturer selling into:

• Germany;
• France;
• Italy;

and separately into:

• England;
• Scotland;
• Wales;

cannot simply assume that one regulatory assessment covers both markets.

The manufacturer may need to maintain separate:

• EU RoHS;
• UK RoHS;
• EU REACH; and
• UK REACH

assessments, depending on the product and market route.

The underlying product and material data can often be reused, but the applicable legislation and market-access assessment must be checked separately.

18.19 Global Manufacturers Should Avoid Separate Data Silos

A manufacturer selling globally may otherwise end up maintaining:

EU database

UK database

US database

China database

UAE database

India database

and so on.

This creates duplication and increases the risk of inconsistent information.

A better approach is:

One product database

Containing:

• components;
• materials;
• suppliers;
• revisions;
• declarations;
• test reports;
• substances;
• exemptions.

Multiple regulatory mappings

Such as:

• EU RoHS;
• UK RoHS;
• REACH;
• China RoHS;
• UAE requirements;
• other market-specific requirements.

This allows the same underlying product information to support multiple regulatory assessments.

18.20 The BOM Becomes a Global Compliance Asset

For international manufacturers, the BOM should not be viewed simply as a production document.

It can become the foundation of the company’s global compliance system.

For each component, the manufacturer can maintain:

Component	Supplier	Material	RoHS	REACH/SVHC	Test Evidence	Change Status
PCB	Supplier A	FR-4 / copper	Pass	Assessed	Available	Current
Connector	Supplier B	PA / metal	Pass	Assessed	Available	Current
Cable	Supplier C	PVC / copper	Review	Assessed	Available	Changed
Housing	Supplier D	ABS	Pass	Assessed	Not required	Current

The regulatory status can then be mapped to different markets.

This is much more scalable than requesting new declarations every time a customer asks for compliance information.

18.21 Non-EU Manufacturers Should Build Compliance Into Design

A common mistake is to design a product for the home market and only afterwards ask:

“What do we need to change to sell this in Europe?”

This can be expensive.

A better strategy is to consider EU requirements during product development.

For example:

During component selection

Check:

• RoHS status;
• REACH information;
• supplier reliability;
• material composition;
• relevant exemptions.

During RF design

Check:

• applicable EU radio requirements;
• frequency bands;
• transmitter parameters;
• harmonised standards.

During mechanical design

Check:

• materials;
• plastics;
• coatings;
• cables;
• labeling;
• environmental requirements.

During purchasing

Require:

• declarations;
• change notifications;
• updated material information.

This turns EU compliance into part of product development rather than a final-stage obstacle.

18.22 Contract Manufacturers Need Clear Responsibilities

Non-EU manufacturers frequently use contract manufacturers or OEM suppliers.

This creates another important question:

Who owns the compliance evidence?

A contract manufacturing agreement should ideally define responsibilities for:

• component approval;
• material changes;
• supplier changes;
• RoHS declarations;
• REACH information;
• testing;
• document retention;
• change notification;
• and regulatory updates.

Otherwise, the final product manufacturer may discover that critical material information is controlled by another company.

That can create significant compliance risk.

18.23 Supplier Change Notification Is Particularly Important

A non-EU manufacturer can establish a compliant product and then unintentionally lose control of compliance when a supplier changes a material.

For example:

Original connector

→ RoHS evidence available

→ REACH assessment completed

→ Product launched

Then:

Supplier changes plastic formulation

↓

New material introduced

↓

Existing evidence may no longer represent the product

The manufacturer therefore needs a change-notification mechanism.

This should ideally be a contractual requirement for critical suppliers.

18.24 Documentation Should Be Available Before Shipment

One of the best practices for international manufacturers is to complete the compliance file before the first commercial shipment.

The manufacturer should ideally already know:

• which EU requirements apply;
• who the importer is;
• what documentation the importer needs;
• whether REACH information is required;
• whether RoHS evidence is complete;
• whether CE documentation is ready;
• and whether any market-specific requirements remain open.

Waiting until customs, a distributor, or a customer requests documentation can create unnecessary delays.

18.25 Common Mistake: “Our EU Distributor Handles Compliance”

An EU distributor can have important regulatory responsibilities, but the manufacturer should not assume that the distributor will create the manufacturer’s technical compliance system.

The distributor may request:

• DoC;
• CE documentation;
• RoHS information;
• REACH information;
• test reports;
• product specifications;
• labeling information.

If the manufacturer cannot provide these documents, the commercial relationship can become difficult.

The manufacturer therefore benefits from having its own controlled compliance package.

18.26 Common Mistake: “We Have a CE Certificate”

Another common misconception is that a generic “CE certificate” solves the EU compliance problem.

CE marking is a manufacturer’s declaration of conformity with applicable EU harmonisation legislation. There is no single universal “CE certificate” that covers every product and every EU requirement.

A manufacturer needs to determine which legislation applies and maintain the corresponding technical evidence.

For RoHS, that includes the substance assessment and technical documentation.

For REACH, the relevant chemical obligations must be assessed separately.

18.27 Common Mistake: “Our Supplier Says RoHS/REACH Compliant”

A single supplier statement saying:

“RoHS/REACH compliant”

should not automatically close the compliance assessment.

The manufacturer should determine:

• which product the statement covers;
• which revision;
• which legislation;
• which substances;
• which exemptions;
• what evidence supports the statement;
• whether the information is current;
• and whether the statement covers the manufacturer’s actual application.

A generic declaration can be a useful starting point, but it should not replace a structured compliance assessment.

18.28 A Practical Compliance Workflow for Non-EU Manufacturers

A practical process can look like this:

Step 1 – Define the EU product

Identify:

• product;
• model;
• variants;
• intended use;
• importer;
• supply chain.

Step 2 – Identify applicable EU legislation

Assess:

• RoHS;
• REACH;
• EMC;
• RED;
• safety;
• WEEE;
• batteries;
• and other applicable legislation.

Step 3 – Build the product BOM

Identify all relevant components and materials.

Step 4 – Collect supplier evidence

Request:

• RoHS declarations;
• material declarations;
• REACH/SVHC information;
• test reports;
• exemptions;
• change notifications.

Step 5 – Assess RoHS

Determine:

• restricted substances;
• homogeneous materials;
• concentration limits;
• exemptions;
• evidence gaps.

Step 6 – Assess REACH

Determine:

• relevant substances;
• SVHC status;
• Candidate List implications;
• restrictions;
• communication requirements;
• importer/OR responsibilities.

Step 7 – Complete additional EU assessments

Assess other applicable product legislation.

Step 8 – Prepare technical documentation

Create a controlled compliance file.

Step 9 – Prepare declarations

Issue the applicable declarations of conformity.

Step 10 – Maintain compliance

Monitor:

• product changes;
• supplier changes;
• regulatory changes;
• exemptions;
• Candidate List updates;
• and market requirements.

18.29 One Product Database, Multiple Market Requirements

The most efficient long-term strategy for a global manufacturer is to build a centralized product compliance database.

For example:

Product

↓

BOM

↓

Components

↓

Materials

↓

Substances

↓

Supplier evidence

↓

Regulatory mapping

Then the same data can support:

EU RoHS

EU REACH

UK RoHS

UK REACH

China RoHS

UAE requirements

Other national requirements

The manufacturer does not need to rebuild the product assessment for every market.

Instead, it needs to determine which regulatory rules apply to the same underlying product data.

18.30 The Key Takeaway

Being located outside the EU does not mean that a manufacturer can ignore EU compliance requirements.

For RoHS, the manufacturer of covered EEE needs to establish conformity before placing the product on the EU market.

For REACH, the legal responsibilities are structured differently, with many obligations falling on EU/EEA importers or, where applicable, an Only Representative. However, non-EU manufacturers still need to provide the substance and product information required to allow those obligations to be fulfilled. (European Chemicals Agency)

The most effective strategy is therefore:

• determine the EU requirements before market launch;
• build RoHS compliance into product design;
• maintain reliable material and supplier information;
• assess REACH separately;
• understand the role of the EU importer;
• use the Only Representative mechanism where appropriate;
• control supplier and material changes;
• maintain a structured technical file; and
• reuse the same product and material data across multiple markets.

The goal should not be to create a separate compliance process for every country.

Build one reliable product compliance database, then map the applicable regulatory requirements to it.

That approach is particularly valuable for manufacturers selling the same electrical or electronic product across Europe, the UK, the Middle East, Asia and other global markets.

19. Common Manufacturer Mistakes

RoHS and REACH compliance problems are often not caused by a lack of technical knowledge. In many cases, manufacturers make relatively simple process mistakes: relying on outdated supplier information, confusing different regulatory requirements, failing to control material changes, or assuming that a single declaration proves compliance.

These mistakes can remain invisible for years, particularly when products are manufactured through complex international supply chains.

The following are some of the most common mistakes manufacturers should avoid.

19.1 Treating RoHS and REACH as the Same Requirement

One of the most common mistakes is treating RoHS and REACH as a single chemical compliance requirement.

A manufacturer may request a document labelled:

“RoHS & REACH Compliance Declaration”

and consider the chemical assessment complete.

This can be misleading.

RoHS and REACH have different:

• scopes;
• substance lists;
• thresholds;
• legal mechanisms;
• exemptions and restrictions;
• documentation requirements; and
• supply-chain obligations.

A product can comply with RoHS while still creating obligations under REACH.

Manufacturers should therefore assess the two frameworks separately, even when the same supplier information is used for both.

19.2 Assuming a Supplier Declaration Automatically Proves Compliance

A supplier declaration can be valuable evidence, but it does not automatically eliminate the manufacturer’s responsibility.

A generic statement such as:

“Our products are RoHS compliant.”

may not identify:

• the relevant part number;
• product revision;
• applicable legislation;
• restricted substances assessed;
• exemptions;
• declaration date; or
• technical basis of the declaration.

The manufacturer should evaluate whether the declaration is sufficiently specific and reliable for the product being assessed.

The goal is not simply to collect declarations.

The goal is to establish a defensible chain of evidence.

19.3 Using Outdated Supplier Documentation

Another common problem is continuing to rely on supplier declarations that were issued several years ago.

This is particularly risky when:

• the component has changed;
• the supplier has changed materials;
• the supplier has changed manufacturing locations;
• the applicable RoHS requirements have changed;
• exemptions have changed; or
• REACH Candidate List substances have been added.

A document does not automatically become invalid simply because it is old, but its relevance needs to be evaluated.

Manufacturers should have a process for determining when supplier evidence needs to be renewed.

19.4 Ignoring Product Revisions

Compliance documentation must correspond to the actual product placed on the market.

A manufacturer may have a valid RoHS assessment for:

Product Revision A

but continue using it after introducing:

Product Revision B

with a different:

• PCB;
• connector;
• cable;
• housing;
• coating;
• supplier; or
• material.

If the change affects the chemical composition of the product, the previous assessment may no longer fully represent the new product.

Product revision control is therefore an important part of chemical compliance.

19.5 Treating the BOM as a Chemical Assessment

A BOM tells the manufacturer what components are used.

It does not necessarily tell the manufacturer what materials those components contain.

For example:

Connector – Part No. 12345

does not reveal:

• plastic formulation;
• metal alloy;
• plating;
• seal material;
• adhesive;
• solder; or
• other homogeneous materials.

The BOM should therefore be connected to appropriate supplier and material information.

A BOM without supporting material evidence is not, by itself, a complete RoHS assessment.

19.6 Assessing the Complete Product Instead of Homogeneous Materials

Another common mistake is calculating restricted-substance concentration against the total product weight.

RoHS concentration limits apply at the homogeneous-material level.

For example, a small plastic component containing a restricted substance above the applicable limit does not automatically become compliant simply because the restricted substance represents a very small percentage of the total finished product.

The manufacturer needs to identify the relevant homogeneous material and assess the concentration against the applicable RoHS limit.

This is particularly important for:

• coatings;
• solder;
• plastics;
• cables;
• metal alloys;
• plating;
• adhesives; and
• electronic components.

19.7 Assuming “Lead-Free” Means Fully RoHS Compliant

“Lead-free” is not synonymous with “RoHS compliant.”

A product can be free from lead while still containing another restricted substance above the applicable limit.

For example, lead-free solder does not automatically demonstrate that the product is compliant with restrictions concerning:

• mercury;
• cadmium;
• hexavalent chromium;
• PBB;
• PBDE; or
• the four restricted phthalates.

A lead-free statement can therefore be useful evidence for a specific material, but it should not be treated as a complete RoHS assessment.

19.8 Assuming “Halogen-Free” Means RoHS Compliant

The same principle applies to “halogen-free.”

RoHS does not prohibit halogens in general.

A material can contain halogenated substances without necessarily violating RoHS, while a halogen-free material can still contain a RoHS-restricted substance.

“Halogen-free” and “RoHS compliant” therefore answer different questions.

Manufacturers should avoid using one claim as a substitute for the other.

19.9 Relying on a Single Laboratory Test

Laboratory testing can be useful, but one test report rarely demonstrates complete product compliance by itself.

For example, testing the housing of a product does not establish the chemical status of:

• the PCB;
• cables;
• connectors;
• solder;
• coatings;
• adhesives; or
• internal components.

Testing needs to be connected to the material structure and the specific compliance question being addressed.

The right question is not:

“Did we test the product?”

It is:

“Did we obtain sufficient evidence for the relevant materials and risks?”

19.10 Misinterpreting XRF Results

XRF can be a powerful screening tool for RoHS-related materials, but manufacturers sometimes treat XRF results as if they directly identify every restricted substance.

This can lead to incorrect conclusions.

For example:

• total chromium is not automatically equivalent to hexavalent chromium;
• total bromine is not automatically equivalent to PBB or PBDE;
• elemental detection does not necessarily identify the precise chemical form regulated by RoHS.

Where the legal restriction concerns a specific chemical form, the analytical approach must be appropriate to that substance.

Testing methodology therefore needs to be considered alongside the legal requirement.

19.11 Testing Everything Instead of Using a Risk-Based Approach

The opposite mistake is testing every component regardless of risk.

For a complex product, this can result in:

• unnecessary laboratory costs;
• long lead times;
• excessive sample requirements;
• large amounts of documentation; and
• little additional compliance confidence.

A stronger approach is to evaluate:

• material risk;
• supplier reliability;
• quality of available evidence;
• historical risk;
• component complexity; and
• changes in the supply chain.

Testing should then be used strategically where it provides meaningful additional assurance.

19.12 Failing to Document RoHS Exemptions

A manufacturer may identify that a restricted substance is present and simply write:

“RoHS exemption applies.”

That is not sufficient.

The manufacturer should document:

• the exemption number;
• the specific application;
• the affected component or material;
• why the exemption applies;
• any applicable conditions; and
• the current regulatory status.

An exemption is not a general permission to use a restricted substance.

It applies only within its defined scope.

19.13 Assuming an Exemption Is Permanent

Another common mistake is treating an exemption as a permanent feature of the product.

RoHS exemptions can be:

• amended;
• renewed;
• narrowed;
• replaced; or
• allowed to expire.

This is particularly important for products with long lifecycles.

A manufacturer that relies on an exemption should therefore monitor its regulatory status and determine whether changes require:

• redesign;
• alternative materials;
• additional assessment; or
• an updated technical file.

19.14 Ignoring REACH Candidate List Updates

REACH introduces a different type of compliance challenge because the Candidate List can change over time.

A manufacturer may have assessed a product and found no relevant SVHC communication obligation at one point in time.

A substance can subsequently be added to the Candidate List.

The manufacturer may then need to reassess affected articles and supply-chain communication obligations.

This means REACH compliance cannot always be treated as a one-time product certification exercise.

Regular regulatory monitoring is important.

19.15 Confusing the Candidate List With REACH Restrictions

The REACH Candidate List and Annex XVII restrictions serve different purposes.

A substance being on the Candidate List does not automatically mean that its use is prohibited.

Candidate List inclusion can trigger information and communication obligations, including obligations concerning SVHCs in articles.

REACH Annex XVII, by contrast, contains restrictions on the manufacture, placing on the market or use of specified substances, mixtures or articles under defined conditions.

Manufacturers should therefore determine which REACH mechanism applies rather than treating every listed substance as “banned.”

19.16 Ignoring Articles in the REACH Assessment

Manufacturers of electrical products sometimes focus heavily on chemicals purchased as substances or mixtures and overlook the fact that REACH also applies to articles.

Electrical products are generally articles under the REACH framework.

This means that manufacturers may need to consider whether articles contain SVHCs and whether relevant communication or notification obligations apply.

For complex products, this can require information from several levels of the supply chain.

19.17 Assuming the Supplier Has Checked Everything

A manufacturer may assume that because a component supplier is located in the EU, all RoHS and REACH obligations have already been addressed.

That assumption is risky.

The supplier may have assessed only:

• its own product;
• its own legal obligations;
• a previous product revision; or
• a limited set of substances.

The finished-product manufacturer still needs to understand its own obligations.

Supply-chain information should therefore be treated as input to the manufacturer’s assessment, not as a substitute for it.

19.18 Failing to Control Supplier Changes

A supplier can change a material without changing the commercial part number.

For example, a supplier might change:

• plastic formulation;
• plating;
• adhesive;
• flame-retardant system;
• metal alloy;
• manufacturing process; or
• sub-supplier.

If the manufacturer is not notified, the original compliance evidence may no longer represent the current component.

Supplier change-notification requirements are therefore an important part of a mature compliance system.

19.19 Not Connecting Compliance Documentation to Purchasing

Compliance often becomes difficult when purchasing and regulatory teams operate separately.

Purchasing may select an alternative component because it is:

• cheaper;
• faster to obtain;
• more readily available; or
• technically equivalent.

From an engineering perspective, the replacement may appear acceptable.

From a compliance perspective, however, the new component may require:

• new supplier documentation;
• new material assessment;
• new testing;
• exemption review; or
• REACH reassessment.

Compliance requirements should therefore be integrated into the company’s purchasing and approved-supplier processes.

19.20 Ignoring Sub-Suppliers

A manufacturer may have a strong relationship with its direct supplier while having very limited visibility into the lower levels of the supply chain.

For complex components, the direct supplier may itself purchase:

• plastics;
• metals;
• coatings;
• electronic components;
• adhesives; or
• subassemblies

from other suppliers.

The manufacturer does not necessarily need complete visibility of every sub-supplier in every case.

However, it should understand where lower-tier information is necessary to support the compliance conclusion.

This is particularly important for high-risk materials and components.

19.21 Treating Compliance as a One-Time Exercise

A product may remain on the market for many years.

During that time:

• regulations can change;
• Candidate Lists can change;
• exemptions can change;
• suppliers can change;
• materials can change;
• product designs can change; and
• manufacturing locations can change.

A RoHS or REACH assessment performed once at product launch may therefore become outdated.

Compliance should be treated as a lifecycle process.

This does not mean that every product needs to be completely reassessed every month.

It means that the manufacturer needs defined triggers for reassessment.

19.22 Failing to Define Reassessment Triggers

A good compliance system should specify when a review is required.

Typical triggers can include:

• new supplier;
• new component;
• material change;
• product revision;
• manufacturing change;
• new RoHS exemption;
• exemption expiry;
• new REACH Candidate List substance;
• new REACH restriction;
• regulatory change; or
• credible information indicating a potential compliance problem.

Without defined triggers, reassessment tends to happen only after a problem has already appeared.

19.23 Keeping Documentation in Personal Emails

Another surprisingly common problem is poor document management.

A supplier declaration may exist only in:

• an employee’s email;
• a local computer;
• an individual spreadsheet;
• an old shared folder; or
• a supplier portal that nobody monitors.

This creates serious traceability problems when employees leave or products are transferred between teams.

Compliance evidence should be stored in a controlled system where it can be linked to:

• product;
• component;
• supplier;
• revision; and
• date.

19.24 Not Maintaining Version Control

A manufacturer may have several declarations for the same component.

Without version control, it can become unclear:

• which declaration was current;
• which product revision it covered;
• whether a newer declaration superseded it; or
• which document was used for the final compliance assessment.

Version control is therefore not merely an administrative issue.

It directly affects the credibility of the compliance evidence.

19.25 Failing to Distinguish Product Families

Manufacturers often sell several products based on a common platform.

It may be tempting to create one declaration covering the entire product family.

This can be appropriate where the products genuinely share the same relevant materials and construction.

However, differences in:

• housing;
• cables;
• PCB;
• connectors;
• power supply;
• coatings;
• batteries;
• suppliers; or
• optional modules

can change the chemical compliance assessment.

Manufacturers should therefore define clearly which products and variants are covered by a particular assessment.

19.26 Assuming Similar Products Have the Same Compliance Status

Two products can look almost identical while using different materials.

For example:

Product A: PVC cable from Supplier A

Product B: PVC-free cable from Supplier B

Or:

Product A: Connector with plating A

Product B: Connector with plating B

A compliance assessment should therefore be based on the actual product configuration rather than visual similarity.

19.27 Waiting Until Market Launch

One of the most expensive mistakes is leaving RoHS and REACH until the end of product development.

By the time the compliance review begins:

• components may already be approved;
• tooling may already be completed;
• suppliers may already be contracted;
• production may already be scheduled; and
• design changes may be expensive.

If a problematic material is discovered at this stage, the manufacturer may have very limited options.

Chemical compliance should therefore be integrated into the product-development process from the beginning.

19.28 Treating Compliance as Only a Regulatory Department’s Responsibility

RoHS and REACH compliance involve several functions.

Relevant teams can include:

• engineering;
• purchasing;
• quality;
• regulatory affairs;
• production;
• supplier management;
• logistics; and
• product management.

If responsibility sits entirely with one regulatory employee, important information can easily be missed.

For example, engineering knows about a component change.

Purchasing knows about a supplier change.

Regulatory knows about a new substance restriction.

A strong process connects all three.

19.29 Not Documenting the Reason for the Compliance Decision

A compliance file should not only contain the conclusion.

It should also explain the basis for the conclusion.

For example:

RoHS status: Compliant

is less useful than:

RoHS status: Compliant based on supplier material declarations for all high-risk components, targeted analytical verification of identified high-risk materials, and documented assessment of applicable exemptions.

The second statement provides an audit trail.

This is particularly valuable when a product is reviewed years after its original assessment.

19.30 The Biggest Mistake: Treating Compliance as Paperwork

Perhaps the most important mistake is viewing RoHS and REACH as documentation exercises rather than product and supply-chain control processes.

A manufacturer can possess hundreds of declarations and still have weak compliance if it does not know:

• which documents apply to which components;
• whether the materials have changed;
• whether exemptions remain valid;
• whether new REACH substances are relevant;
• whether the product configuration matches the documentation; or
• whether important evidence gaps remain.

Effective compliance is therefore not about collecting the largest possible number of documents.

It is about maintaining a controlled, traceable and continuously relevant evidence system.

19.31 A Practical Manufacturer Self-Check

Manufacturers can use the following questions to identify weaknesses:

RoHS

• Have we formally determined whether the product is within RoHS scope?
• Do we know the relevant homogeneous materials?
• Do we have evidence for the high-risk materials?
• Are supplier declarations current and product-specific?
• Are exemptions documented and monitored?
• Can we trace evidence to the current product revision?
• Do we have a process for supplier and material changes?
• Is laboratory testing used strategically where evidence gaps remain?

REACH

• Have we assessed the product as an article where applicable?
• Do we know whether relevant SVHCs are present?
• Are we monitoring Candidate List updates?
• Have we assessed relevant REACH restrictions?
• Can we fulfil applicable information or communication obligations?
• Do we obtain sufficient information from suppliers?

Overall compliance management

• Is compliance integrated into purchasing?
• Is compliance integrated into engineering change control?
• Is the evidence centrally controlled?
• Can we retrieve the technical documentation efficiently?
• Do we have defined reassessment triggers?
• Can we explain the basis for our compliance conclusion?

If several answers are “no,” the manufacturer likely has opportunities to strengthen its compliance process.

19.32 The Key Takeaway

Most RoHS and REACH problems do not begin with a dramatic regulatory failure.

They often begin with small weaknesses:

• an outdated supplier declaration;
• an uncontrolled component change;
• an undocumented exemption;
• an incomplete BOM;
• a misunderstood test report;
• an ignored REACH update;
• a missing material declaration; or
• a compliance file that nobody can trace.

Individually, these may appear minor.

Together, they can create significant compliance risk.

A strong compliance system therefore focuses on:

Scope → Materials → Suppliers → Evidence → Risk → Changes → Regulatory Updates → Documentation

The objective is not to eliminate every uncertainty.

The objective is to identify uncertainty early, address it proportionately, and maintain a clear evidence trail throughout the product lifecycle.

For manufacturers, this approach can reduce not only regulatory risk, but also the cost and disruption associated with late-stage compliance problems.

The next chapter looks at how ScopeRight can support manufacturers in structuring this process and reducing the effort required to manage RoHS, REACH and broader product-compliance activities.

20. How ScopeRight Can Support Manufacturers

ScopeRight is not a RoHS or REACH compliance platform. RoHS and REACH are not ScopeRight modules, and ScopeRight does not replace dedicated chemical-compliance expertise.

ScopeRight’s role is to support manufacturers with the overall product certification and market-access process, particularly in the technical compliance areas covered by the platform.

20.1 Where ScopeRight Fits

Modern electrical and electronic products are often subject to several compliance workstreams at the same time.

Depending on the product and target market, these may include:

• RF and radio compliance;
• EMC compliance;
• electrical safety;
• cybersecurity requirements where applicable;
• MPE calculations;
• global radio approvals;
• RoHS and REACH;
• product-specific regulatory requirements; and
• technical documentation and conformity assessment.

These requirements should not be treated as one single compliance activity. Each area needs the appropriate expertise and evidence.

ScopeRight can support the technical certification workstreams within its capabilities while RoHS and REACH remain separate chemical-compliance activities.

20.2 ScopeRight’s Certification Capabilities

ScopeRight is designed to help manufacturers structure and manage the certification process from the early planning stage through testing and documentation.

Depending on the product, ScopeRight can support:

• compliance scoping;
• test-plan development;
• RF and radio compliance planning;
• EMC compliance planning;
• electrical safety planning;
• cybersecurity scoping where applicable;
• MPE calculations;
• global radio approval planning;
• laboratory coordination;
• quotation support;
• test and report review;
• pre-compliance testing through partner laboratories; and
• certification project management.

The objective is to help manufacturers understand the required certification activities before testing begins, reducing the risk of unnecessary testing, unexpected costs and avoidable project delays.

20.3 RoHS and REACH Remain Separate Workstreams

If a product is subject to RoHS or REACH, the manufacturer still needs to address those requirements using appropriate chemical-compliance processes, supplier information, technical documentation and, where necessary, specialist assessment or laboratory testing.

ScopeRight should therefore not be presented as providing:

• RoHS assessments;
• REACH assessments;
• SVHC assessments;
• chemical composition analysis;
• chemical laboratory testing; or
• dedicated RoHS/REACH certification services.

Instead, RoHS and REACH can be considered as parallel compliance workstreams within the manufacturer’s overall product-certification project.

20.4 One Product, Multiple Compliance Disciplines

Consider a connected industrial device containing:

• Wi-Fi;
• Bluetooth;
• a mains power supply;
• a plastic enclosure;
• industrial electronics; and
• several interfaces.

The manufacturer may need to address multiple regulatory areas simultaneously.

RoHS and REACH may be relevant to the materials and chemical composition of the product. At the same time, the radio functionality may require radio compliance, the electronics may require EMC assessment, the power system may require safety assessment, and additional requirements may apply depending on the product and target markets.

ScopeRight can support the applicable RF, EMC, Safety, MPE, radio-approval and related certification activities within its capabilities.

The manufacturer can manage RoHS and REACH separately as chemical-compliance workstreams.

This creates a more realistic structure for the overall project:

Product

↓

Regulatory requirements

↓

Individual compliance workstreams

↓

Testing and documentation

↓

Overall certification and market access

20.5 Starting Before Laboratory Testing

One of the main purposes of ScopeRight is to help manufacturers define the technical compliance scope before approaching a laboratory.

The process can start with product-specific information such as:

• product type;
• intended markets;
• radio technologies;
• frequency bands;
• integrated radio modules;
• power supply characteristics;
• product interfaces;
• intended use; and
• other technical characteristics.

The resulting assessment can help identify the relevant technical requirements and develop a structured test plan.

This is particularly valuable because compliance problems discovered during laboratory testing can be expensive to correct.

An incorrect standard, incomplete test plan or unsuitable certification strategy can result in:

• additional laboratory time;
• repeated testing;
• redesign;
• additional samples;
• project delays; and
• unexpected costs.

ScopeRight’s focus is therefore on helping manufacturers control the scope before they control the test budget.

20.6 Supporting the Laboratory Process

ScopeRight is independent from testing laboratories.

The platform is not intended to replace laboratories. Instead, it can help manufacturers prepare for and manage laboratory work.

Depending on the project, this can include:

• defining the required testing;
• preparing a test plan;
• supporting laboratory quotation requests;
• comparing the proposed test scope with the required scope;
• coordinating testing;
• reviewing test reports; and
• identifying potential gaps before the project is closed.

Where pre-compliance testing is useful, ScopeRight can also support access to partner laboratory capabilities.

The goal is to make laboratory testing one controlled part of a broader certification process rather than the starting point for discovering what needs to be tested.

20.7 Supporting the Certification Process as a Whole

For manufacturers, the value of ScopeRight is not that one platform claims to perform every specialist compliance activity.

The value is in helping structure, coordinate and manage the certification process across the technical areas ScopeRight supports.

For example:

Product definition

→ Compliance scoping

→ Applicable standards and requirements

→ Test plan

→ Laboratory testing

→ Report review

→ Technical documentation

→ Certification / market access

RoHS and REACH can sit alongside this process as separate chemical-compliance workstreams.

20.8 What ScopeRight Does and Does Not Cover

For clarity, the distinction can be summarised as follows:

Area	ScopeRight
RF / Radio compliance	Supported
EMC compliance	Supported
Electrical safety	Supported
Cybersecurity	Supported where applicable
MPE calculations	Supported
Global radio approvals	Supported
Compliance scoping	Supported
Test-plan development	Supported
Laboratory coordination	Supported
Pre-compliance testing	Supported through partner laboratories
Test/report review	Supported
Certification project management	Supported
RoHS assessment	Not a ScopeRight capability
REACH assessment	Not a ScopeRight capability
SVHC assessment	Not a ScopeRight capability
Chemical composition analysis	Not a ScopeRight capability

This distinction is important because manufacturers should know exactly what evidence and expertise are being provided for each compliance area.

20.9 Why This Separation Matters

Compliance platforms should be clear about their capabilities.

A manufacturer should not assume that a tool covering RF, EMC, Safety and other technical certification activities automatically provides chemical compliance under RoHS or REACH.

At the same time, the absence of RoHS or REACH functionality does not mean those requirements need to be ignored or treated separately from the overall project plan.

They should be identified as part of the product’s overall regulatory landscape and assigned to the appropriate specialists or internal teams.

This creates a more robust compliance structure:

ScopeRight

→ RF / Radio

→ EMC

→ Safety

→ MPE

→ Global Radio Approvals

→ Certification support and project management

Chemical compliance process

→ RoHS

→ REACH

→ SVHC / chemical assessments

Both can contribute to the same overall market-access project without pretending to be the same service.

20.10 The Practical Benefit for Manufacturers

Manufacturers do not necessarily need one provider to perform every specialist compliance task.

What they need is a process in which the applicable requirements are identified, the responsibilities are clear, the evidence is collected and the different activities are completed in the right sequence.

ScopeRight can provide that structure for the certification areas within its capabilities.

For products that also require RoHS and REACH, those requirements can be managed as dedicated chemical-compliance workstreams while the wider certification process is coordinated around them.

This approach reflects how complex product compliance actually works:

One product can require multiple compliance disciplines — and each discipline needs the right expertise.

20.11 Key Takeaway

ScopeRight is not a RoHS or REACH compliance solution.

Its role is to support manufacturers with the broader certification and market-access process in the technical areas covered by the platform.

RoHS and REACH remain separate chemical-compliance requirements that should be addressed through the appropriate regulatory expertise, supplier information, technical documentation and testing where necessary.

At the same time, ScopeRight can help manufacturers structure and manage the wider certification process around those requirements — including RF, EMC, Safety, Cybersecurity, MPE, global radio approvals, test planning, laboratory coordination, report review and project management.

The goal is not to claim that one platform solves every compliance problem. The goal is to ensure that each compliance requirement is handled by the appropriate expertise while the overall certification process remains structured, efficient and controlled.

Once a product has been established as being within the scope of RoHS, the next question is much more practical:

Where exactly do the RoHS requirements apply within the product?

For manufacturers, RoHS compliance is ultimately a material-level assessment. A finished electrical product may contain hundreds or even thousands of individual parts, but the legal concentration limits are not normally assessed against the complete product as one unit.

Instead, the restrictions apply to homogeneous materials.

This is why a manufacturer needs visibility into the materials used in components, assemblies and finished products.

A product can look completely compliant from the outside while containing a non-compliant material hidden inside a connector, cable, coating, solder joint or plastic component.

21. Practical Compliance Checklist for Manufacturers

RoHS and REACH compliance can become difficult when manufacturers treat them as a collection of individual documents rather than as part of a structured product-compliance process.

The purpose of a compliance checklist is therefore not simply to confirm that paperwork exists. It is to make sure that the manufacturer has identified the applicable requirements, assigned responsibility, collected appropriate evidence and maintained that evidence throughout the product lifecycle.

This chapter provides a practical checklist that manufacturers can use when reviewing an electrical or electronic product for RoHS and REACH requirements alongside the wider certification process.

21.1 Start With the Product

Before requesting declarations or laboratory tests, establish exactly what product is being assessed.

Confirm:

• product name and model number;
• product family and variants;
• hardware revision;
• intended use;
• target markets;
• manufacturer and manufacturing location;
• relevant product configurations; and
• applicable product documentation.

The assessment should always be connected to a clearly identified product version.

21.2 Confirm Whether RoHS Applies

The first RoHS question is whether the product is within scope.

Check:

• whether the product qualifies as electrical and electronic equipment;
• whether it falls within the applicable voltage limits;
• which Annex I category applies;
• whether Category 11 is relevant;
• whether any Article 2(4) exclusion applies; and
• whether the conclusion is documented.

Do not begin with laboratory testing. First establish that RoHS applies and understand why.

21.3 Identify the RoHS Requirements

Once RoHS applicability has been established, confirm the substance restrictions relevant to the product.

The assessment should cover the ten currently restricted substances or substance groups:

• lead (Pb);
• mercury (Hg);
• cadmium (Cd);
• hexavalent chromium (Cr VI);
• PBB;
• PBDE;
• DEHP;
• BBP;
• DBP; and
• DIBP.

Confirm the applicable concentration limits and identify any RoHS exemptions that may be relevant to the product.

21.4 Review the Bill of Materials

The BOM should be sufficiently detailed to connect the finished product to its components and materials.

Check that it identifies, where applicable:

• internal part numbers;
• supplier part numbers;
• manufacturers;
• suppliers;
• component descriptions;
• revisions;
• quantities; and
• relevant material or construction information.

If the BOM cannot be linked to the supporting compliance evidence, the evidence chain is incomplete.

21.5 Identify Relevant Homogeneous Materials

Do not assess the product only at component level.

Identify relevant homogeneous materials within components such as:

• plastics;
• cables;
• solder;
• metal alloys;
• coatings and plating;
• PCB materials;
• adhesives;
• seals;
• labels and markings; and
• other relevant materials.

The RoHS concentration limits apply at the homogeneous-material level.

21.6 Collect Supplier Evidence

For each relevant component or material, determine what evidence is available.

Useful evidence can include:

• product-specific RoHS declarations;
• material declarations;
• component specifications;
• technical drawings;
• supplier test reports;
• exemption statements;
• chemical composition information where appropriate; and
• supplier change-notification commitments.

The objective is not to collect documents indiscriminately. The objective is to obtain evidence that is relevant to the actual component and product revision.

21.7 Evaluate the Quality of Supplier Declarations

A declaration should be reviewed rather than accepted automatically.

Ask:

1. Does it identify the supplier?
2. Does it identify the product or part number?
3. Does it identify the relevant revision?
4. Is it current?
5. Does it address the applicable RoHS requirements?
6. Are exemptions identified where relevant?
7. Can it be traced to the BOM?
8. Is there evidence of supplier change control?

A generic statement such as “RoHS compliant” may be useful, but it does not necessarily provide the same level of confidence as product-specific, traceable technical evidence.

21.8 Identify Evidence Gaps

Identify components where:

• the declaration is missing;
• the declaration is outdated;
• the product identification is unclear;
• the material composition is unknown;
• an exemption is mentioned without justification;
• supplier information is inconsistent; or
• a material change has occurred since the original assessment.

These are evidence gaps that should be addressed before the final compliance conclusion.

21.9 Decide Whether Additional Testing Is Necessary

Laboratory testing should be used strategically.

Consider additional testing where:

• supplier evidence is unavailable or unreliable;
• the material is considered high-risk;
• a supplier or material is new;
• a significant material change has occurred;
• there is conflicting information;
• non-compliance is suspected; or
• independent verification is otherwise justified.

Testing should answer a specific compliance question.

The right question is:

What evidence gap will this test close?

21.10 Check the Analytical Method

Where testing is performed, confirm that the analytical method is appropriate for the substance being assessed.

In particular, do not automatically equate:

• total chromium with hexavalent chromium; or
• total bromine with PBB or PBDE.

Screening techniques can be valuable, but the manufacturer needs to understand exactly what the test result demonstrates.

21.11 Review RoHS Exemptions

For every exemption used, document:

• exemption number;
• affected material or component;
• specific application;
• reason the exemption applies;
• relevant conditions; and
• current regulatory status.

An exemption should be linked directly to the product and application rather than recorded as a generic statement.

21.12 Establish REACH Applicability Separately

RoHS and REACH should be assessed together as part of the overall chemical-compliance process, but they should not be treated as the same requirement.

For REACH, determine whether relevant obligations arise from:

• substances;
• mixtures;
• articles;
• SVHCs;
• REACH restrictions;
• communication obligations; or
• the manufacturer’s role in the supply chain.

Do not use a RoHS assessment as a substitute for a REACH assessment.

21.13 Check the REACH Candidate List

For products that are articles, determine whether substances on the REACH Candidate List are present and whether the applicable conditions for communication or other obligations are met.

Where relevant, collect supplier information concerning SVHC content and monitor changes to the Candidate List.

The assessment should be based on the current regulatory status when the product is placed on the market and maintained when relevant regulatory changes occur.

21.14 Check the Supply Chain

Compliance information should be traceable through the supply chain.

Ask:

• Who manufactures the component?
• Who supplies it?
• Is the supplier information current?
• Are sub-suppliers controlled where necessary?
• Are material changes communicated?
• Are declarations linked to the correct part number and revision?
• Can the manufacturer retrieve the evidence later?

The deeper and more complex the supply chain, the more important traceability becomes.

21.15 Integrate Compliance Into Change Control

RoHS and REACH compliance should not stop once the first technical file is completed.

Trigger a compliance review when there is a:

• new supplier;
• alternative component;
• material change;
• formulation change;
• coating or plating change;
• manufacturing-location change;
• product redesign;
• new product variant; or
• relevant regulatory change.

The response can range from a simple document update to a complete reassessment, depending on the risk.

21.16 Check the Technical Documentation

Before concluding the assessment, verify that the technical documentation is complete and controlled.

The file should allow a reviewer to understand:

Product → BOM → Component → Material → Supplier Evidence → Assessment → Conclusion

For RoHS, the documentation should be consistent with the methodology described in EN IEC 63000:2018.

21.17 Verify the EU Declaration of Conformity

Where RoHS applies, confirm that the EU Declaration of Conformity:

• identifies the product correctly;
• identifies the manufacturer;
• references Directive 2011/65/EU as applicable;
• contains the required declaration information;
• is signed by the appropriate responsible person; and
• is consistent with the current product and technical documentation.

The declaration should be updated when necessary rather than treated as a one-time document.

21.18 Verify CE Marking

Where CE marking is applicable, confirm that the marking is correctly applied and that the underlying conformity documentation supports the applicable EU legislation.

Remember that CE marking is not a standalone RoHS certificate.

It represents conformity with the applicable EU harmonisation legislation for the product.

21.19 Retain the Evidence

Establish a controlled document-retention process.

For RoHS, the relevant technical documentation and EU Declaration of Conformity generally need to be retained for ten years after the EEE has been placed on the market.

Make sure that documents remain accessible even when:

• employees leave;
• suppliers change;
• products are revised; or
• the original project team is no longer available.

21.20 Final Compliance Review

Before the product is released, ask the following questions.

RoHS

• Is the product within scope?
• Is the scope conclusion documented?
• Are all relevant materials identified?
• Are the ten restricted substances addressed?
• Are the applicable concentration limits understood?
• Are exemptions documented and valid?
• Is supplier evidence sufficient?
• Are evidence gaps closed?
• Is additional testing justified and, where required, completed?
• Is the technical documentation complete?
• Is the EU Declaration of Conformity current?

REACH

• Has REACH been assessed separately from RoHS?
• Are relevant SVHC requirements considered?
• Are applicable REACH restrictions considered?
• Are supplier information and communication obligations addressed?
• Is the current Candidate List status considered?
• Are relevant changes monitored?

Overall Product Compliance

• Are RF/radio requirements identified where applicable?
• Are EMC requirements identified where applicable?
• Are electrical safety requirements identified where applicable?
• Are cybersecurity requirements considered where applicable?
• Are MPE/SAR requirements considered where applicable?
• Are global market-access requirements identified for the intended countries?
• Is the laboratory test plan consistent with the actual product?
• Are test reports reviewed and traceable?
• Are certification documents controlled?

21.21 A Simple Compliance Status Matrix

For larger projects, manufacturers can use a simple status matrix:

Compliance Area	Status	Evidence	Owner	Action Required
RoHS scope	Complete	Scope assessment	Regulatory	None
RoHS materials	Complete	BOM + supplier evidence	Engineering / Purchasing	None
RoHS exemptions	Review complete	Exemption assessment	Regulatory	Monitor status
RoHS testing	Risk-based	Test reports	Compliance	None
REACH	Complete / Review	Supplier information	Regulatory	As applicable
SVHC	Review complete	Supplier declarations	Purchasing / Regulatory	Monitor Candidate List
RF / Radio	Complete	Test plan / reports	Compliance	None
EMC	Complete	Test plan / reports	Compliance	None
Safety	Complete	Assessment / reports	Compliance	None
Technical file	Complete	Controlled documentation	Regulatory	None
EU DoC	Complete	Signed declaration	Regulatory	None

The exact responsibilities will differ between organisations, but the principle is the same: every requirement should have a clear owner, evidence and status.

21.22 What a Good Compliance Process Looks Like

A mature process can be summarised as:

1. Identify
Identify the product, markets and applicable regulations.

2. Scope
Determine exactly which requirements apply.

3. Map
Map requirements to the product, materials, components and suppliers.

4. Collect
Collect relevant supplier and technical evidence.

5. Evaluate
Evaluate evidence quality and identify gaps.

6. Verify
Use targeted testing or additional investigation where necessary.

7. Document
Compile and control the technical documentation.

8. Declare
Prepare the required conformity documentation.

9. Maintain
Monitor regulatory changes, suppliers, materials and product changes.

This process is much more robust than relying on a single declaration or certificate.

21.23 The Checklist in One Page

For practical use, the complete process can be reduced to:

Product identified

↓

RoHS scope confirmed

↓

REACH applicability assessed separately

↓

BOM reviewed

↓

Homogeneous materials identified

↓

Supplier evidence collected

↓

Evidence quality evaluated

↓

SVHC / REACH requirements checked

↓

RoHS exemptions checked

↓

Evidence gaps identified

↓

Targeted testing performed where justified

↓

Technical documentation completed

↓

EU Declaration of Conformity completed

↓

CE marking applied where applicable

↓

Compliance maintained through change control

21.24 The Key Takeaway

The most effective compliance process is not the one with the largest number of certificates or laboratory reports.

It is the one in which the manufacturer can clearly demonstrate:

What requirements apply, what evidence supports compliance, who is responsible for each activity, and how compliance is maintained over time.

For RoHS, this means understanding the product scope, identifying homogeneous materials, collecting and evaluating appropriate evidence, documenting exemptions and using laboratory testing where justified.

For REACH, it means performing a separate chemical assessment covering the obligations relevant to substances, articles, SVHCs, restrictions and the supply chain.

And for the product as a whole, these chemical requirements should be considered alongside the other applicable certification and market-access requirements.

The final chapter brings these elements together and summarises the practical approach manufacturers should take when managing RoHS, REACH and the wider product-compliance process.

22. Conclusion

RoHS and REACH are often discussed together because both address substances and chemicals in products. For manufacturers of electrical and electronic equipment, however, they represent different regulatory requirements with different objectives, mechanisms and compliance obligations.

Understanding that distinction is the foundation of a reliable compliance process.

22.1 RoHS and REACH Are Not the Same Requirement

RoHS is specifically focused on restricting certain hazardous substances in electrical and electronic equipment.

REACH is much broader. It regulates chemical substances through mechanisms covering substances, mixtures and articles and can create obligations throughout the supply chain.

The two frameworks can therefore apply to the same product without asking the same regulatory question.

A simple way to remember the distinction is:

RoHS:
Does this electrical or electronic product comply with the applicable restrictions on specified hazardous substances?

REACH:
What substances are present, what regulatory status do they have, and what obligations arise from their presence, use, manufacture, import or supply?

Neither question can simply be replaced by the other.

22.2 Compliance Starts With the Product

A robust assessment should always start with the actual product.

The manufacturer should understand:

• what the product is;
• which variants are covered;
• which components and materials it contains;
• which markets it will enter;
• which suppliers are involved; and
• which regulatory requirements apply.

For RoHS, this leads into the assessment of homogeneous materials, restricted substances, concentration limits and exemptions.

For REACH, the assessment may lead into SVHCs, Candidate List obligations, Article 33 communication, Annex XVII restrictions and other requirements depending on the product and the company’s role in the supply chain.

22.3 Supplier Information Is Important — But It Is Not Automatically Sufficient

Manufacturers depend heavily on their supply chains for chemical-compliance information.

Supplier declarations can be extremely useful, but the manufacturer should understand:

what has actually been declared, for which product, under which legislation, and based on what evidence.

A generic statement such as:

“RoHS & REACH compliant”

does not necessarily demonstrate that all relevant requirements have been assessed.

The quality of the evidence matters more than the title printed on the document.

22.4 Testing Is a Tool, Not the Compliance Strategy

Laboratory testing can provide valuable evidence, particularly where supplier information is incomplete or risk is high.

However, a successful laboratory test does not automatically create complete RoHS or REACH compliance.

Testing must be connected to a clearly defined compliance question.

The stronger approach is:

Identify the requirement → identify the risk → identify the evidence gap → perform appropriate verification → document the conclusion.

This avoids both unnecessary testing and unsupported assumptions.

22.5 Compliance Must Be Maintained

One of the most important lessons is that chemical compliance is not necessarily a one-time activity.

Products change.

Suppliers change.

Materials change.

Components are replaced.

Regulatory requirements change.

The REACH Candidate List can change, and RoHS exemptions can change or expire.

A product that was correctly assessed several years ago may therefore require reassessment after a relevant product, supplier or regulatory change.

A robust compliance process must therefore include:

• change control;
• supplier monitoring;
• document control;
• regulatory monitoring;
• periodic reassessment where appropriate; and
• traceability between product revisions and compliance evidence.

22.6 RoHS and REACH Should Be Separate but Connected

The most effective approach is not to manage RoHS and REACH as completely isolated activities.

Instead, they should be treated as separate regulatory layers built on shared product and supply-chain information.

For example:

Product

↓

BOM and components

↓

Materials and suppliers

↙　　　　　　　　　↘

RoHS assessment　　REACH assessment

↓　　　　　　　　　↓

RoHS evidence　　 REACH evidence

↘　　　　　　　　　↙

Overall product compliance

This allows manufacturers to reuse relevant information without incorrectly assuming that one assessment proves the other.

22.7 The Broader Product-Compliance Picture

RoHS and REACH are also only part of the compliance landscape for many electrical and electronic products.

Depending on the product and target markets, manufacturers may additionally need to consider:

• radio and RF requirements;
• EMC;
• electrical safety;
• cybersecurity;
• MPE or SAR;
• energy-related requirements;
• environmental requirements;
• national market-access requirements;
• technical documentation; and
• conformity assessment procedures.

The challenge is therefore not simply knowing individual regulations.

The challenge is identifying the complete compliance scope early enough to plan the project correctly.

22.8 The Manufacturer Remains Responsible

Perhaps the most important principle is that compliance responsibility ultimately remains with the manufacturer or other responsible economic operator as defined by the applicable legislation.

Certificates, supplier declarations, laboratory reports and software tools can all support the process.

They do not remove that responsibility.

A defensible compliance assessment should allow the manufacturer to explain:

1. Why the requirement applies.
2. What was assessed.
3. What evidence was used.
4. What assumptions were made.
5. Which exemptions or special provisions were applied.
6. What additional verification was performed.
7. Why the final compliance conclusion is justified.

That is the difference between having compliance documents and having a defensible compliance process.

22.9 The Practical Takeaway

For manufacturers of electrical and electronic products, the key lessons from this article can be summarised in ten points:

1. Do not treat RoHS and REACH as the same regulation.
2. Determine the applicable scope before collecting evidence.
3. Build the assessment around the actual product and its BOM.
4. Understand the relevant materials and supply chain.
5. Evaluate supplier declarations rather than accepting them blindly.
6. Use laboratory testing where it provides meaningful additional evidence.
7. Document RoHS exemptions and monitor their status.
8. Assess REACH obligations separately, including relevant SVHC and restriction requirements.
9. Maintain traceability when products, suppliers or regulations change.
10. Keep the final compliance conclusion connected to the evidence supporting it.

Ultimately, good chemical compliance is not about collecting the largest possible number of declarations or test reports.

It is about having the right information, for the right product, evaluated against the right requirement, with a clear and traceable justification for the final conclusion.

That principle applies not only to RoHS and REACH, but to product compliance more broadly.

For manufacturers, the goal should therefore be simple:

Know what applies. Know what evidence you have. Know what is missing. And know why you can conclude that the product complies.