Why RoHS Exemptions Assessment Matters

RoHS compliance is not only about checking whether a product is “RoHS compliant.” For many electrical and electronic products, the real challenge is understanding whether a restricted substance is present, whether a legal exemption applies, whether that exemption is still valid, and whether the company can prove its decision with reliable technical evidence.

The EU RoHS Directive restricts hazardous substances in electrical and electronic equipment to protect human health and the environment. The European Commission explains that RoHS currently restricts ten substances, including lead, cadmium, mercury, hexavalent chromium, PBB, PBDE and four phthalates: DEHP, BBP, DBP and DIBP.

This matters because many products still rely on RoHS exemptions for specific technical applications, such as lead in alloys, lead in solders, lead in glass or ceramics, mercury in certain lamps, and applications in medical devices or monitoring and control instruments.

A RoHS exemption is not a general permission to use a restricted substance. It is specific, conditional, application-based and time-limited. If the exemption is applied incorrectly, expires, or is not supported by proper evidence, the product may face market access risk, customer rejection, technical file gaps or redesign pressure.

What Is a RoHS Exemptions Assessment?

A RoHS Exemptions Assessment is the process of checking whether a product, component, material or technical application can legally rely on an exemption from the substance restrictions under the EU RoHS Directive.

A proper assessment should answer four practical questions:

1- Is the product in scope of RoHS?

2- Is a restricted substance present above the permitted threshold in a homogeneous material?

3- Does the exact Annex III or Annex IV exemption apply to the specific use?

4- Is the exemption still valid and supported by current evidence?

ComplyMarket describes a RoHS Exemptions Assessment as a way to confirm whether a product can legally rely on a RoHS Annex III or Annex IV exemption for a restricted substance in a specific application, while documenting the proof needed for audits and market surveillance.

Annex III vs Annex IV: What Is the Difference?

RoHS exemptions are mainly listed in Annex III and Annex IV of Directive 2011/65/EU.

Area	What it covers	Why it matters
Annex III	General RoHS exemptions for applications in electrical and electronic equipment	Relevant for many electronics, industrial products, components, solders, alloys, glass, ceramics and lamps
Annex IV	Exemptions specific to medical devices and monitoring and control instruments	Relevant for medical equipment, laboratory devices, measurement equipment and industrial monitoring systems

ECHA explains that Annex III contains application exemptions from the Article 4(1) restrictions, while Annex IV lists exemptions specific to medical devices and monitoring and control instruments.

This distinction is important because an exemption must match the product category and the exact technical use. A product cannot rely on an exemption simply because a similar substance or material appears somewhere in the RoHS exemption list.

Latest RoHS Exemption Updates Companies Should Know

1. RoHS exemptions are time-limited and regularly reassessed

The European Commission explains that RoHS exemptions are limited in time and reassessed regularly. The assessment considers the availability, practicability and reliability of substitutes, the environmental and health impact of substitution, socioeconomic impacts and possible adverse impacts on innovation.

For companies, this means exemption management must be an ongoing process. A declaration collected years ago may no longer be enough if the exemption wording, scope, renewal status or expiry date has changed.

2. Renewal applications must be planned early

The European Commission states that an application for renewal of a RoHS exemption must be made no later than 18 months before the exemption expires. It also explains that existing exemptions with a submitted renewal request remain valid until the Commission takes a decision.

This is critical for manufacturers and importers because missed deadlines can affect product planning, redesign timelines, customer commitments and market access.

3. Major lead-related Annex III exemptions were updated in 2025

Several important lead-related RoHS exemptions were updated in 2025. Commission Delegated Directive (EU) 2025/2364 concerns lead as an alloying element in steel, aluminium and copper.

EUR-Lex also lists Commission Delegated Directive (EU) 2025/1802 concerning lead in high melting temperature solders and Commission Delegated Directive (EU) 2025/2363 concerning lead in glass or ceramic components.

These updates are highly relevant for companies using exemptions such as 6(a), 6(b), 6(c), 7(a), 7(c)-I and 7(c)-II. Businesses should not assume that old supplier declarations or old exemption wording are still sufficient.

4. Pack 29 consultation is active in 2026

A RoHS Pack 29 stakeholder consultation is running from 6 June to 1 August 2026. It covers ten exemption requests and three revocation requests under the RoHS Directive. The consultation includes mercury exemptions under Annex III and lead-related revocation requests under Annex IV.

This is especially important for companies dealing with special-purpose lamps, mercury-containing applications, medical devices, monitoring instruments, detectors and ion selective electrodes.

5. EN IEC 63000 remains central for RoHS technical documentation

EN IEC 63000:2018 is the harmonised standard used for technical documentation to assess materials, components and electrical and electronic equipment with respect to RoHS restricted substances. Commission Implementing Decision (EU) 2020/659 confirms the adoption of EN IEC 63000:2018 for this purpose.

For companies, this means RoHS exemption decisions should be supported by structured documentation, supplier evidence, risk assessment, material data and clear technical justification.

Who Needs a RoHS Exemptions Assessment?

A RoHS Exemptions Assessment is useful for any company placing electrical and electronic equipment on the EU market where restricted substances may be present in parts, materials or components.

You may need an assessment if you are:

Business Type	Why It Matters
Manufacturer	You need evidence that your product meets RoHS requirements before placing it on the market
Importer	You need confidence that imported products are supported by valid technical documentation
Distributor	You may need to respond to customer or authority requests for compliance evidence
OEM or brand owner	You may carry compliance responsibility for products sold under your name
Component supplier	Your customers may ask for precise exemption information and supporting evidence
Medical device company	Annex IV exemptions may apply, but only under specific conditions
Industrial equipment company	Exemptions may affect solders, alloys, coatings, glass, ceramics and control systems
Lighting manufacturer or supplier	Mercury lamp exemptions are under active review in 2026

A product may need a RoHS Exemptions Assessment when a part or material exceeds a RoHS limit in a homogeneous material, when engineering believes an exemption applies, when an exemption is close to expiry, or when supplier or process changes could affect the exemption claim. ComplyMarket lists these as typical triggers for a RoHS Exemptions Assessment.

How to Know If Your Product Is at Risk

Your product may be at higher RoHS exemption risk if it contains or relies on any of the following:

Risk Area	Why It Needs Attention
Lead in steel, aluminium or copper alloys	Updated 2025 exemption wording may affect how exemption 6-series entries are applied
Lead in high melting temperature solders	Exemption 7(a) must be checked against the current wording and conditions
Lead in glass or ceramic components	Exemption 7(c) entries have been updated and may need reassessment
Mercury in special-purpose lamps	Pack 29 is reviewing several mercury-related Annex III exemption requests
Medical devices or monitoring equipment	Annex IV exemptions are specific and may not apply to general EEE
Older supplier declarations	Old declarations may refer to outdated exemption wording or expired validity periods
Complex BOMs with many suppliers	Missing part-level evidence can create technical file gaps
Product redesigns or supplier changes	A new material, solder, coating, adhesive, resin or plating can invalidate previous assumptions

A practical rule is simple: if your product relies on restricted substances and the exemption is important for market access, the exemption should be actively tracked, documented and reassessed.

RoHS Exemptions Assessment Decision Flow

Use this decision flow to understand whether your product can rely on a RoHS exemption.

Step	Question	Action
1	Is the product electrical or electronic equipment under RoHS?	Confirm scope, product category and exclusions
2	Does the product contain a restricted substance?	Review supplier declarations, material declarations and test reports
3	Is the substance above the RoHS threshold in a homogeneous material?	Assess at material level, not only finished-product level
4	Is there a relevant Annex III or Annex IV exemption?	Identify the exact exemption number and wording
5	Does the technical application match the exemption wording?	Check the use case, material, component and product category
6	Is the exemption still valid or under review?	Check expiry dates, renewal status and recent delegated directives
7	Is the evidence strong enough?	Collect declarations, test reports, technical justification and change history
8	Is the technical file updated?	Align documentation with EN IEC 63000 expectations
9	Are there reassessment triggers?	Review after supplier, material, design or regulatory changes

This decision flow helps prevent one of the most common mistakes: treating an exemption as a product-level statement instead of a specific, evidence-based technical conclusion.

What Evidence Is Needed for a RoHS Exemption?

A strong RoHS exemption file should create a traceable connection between the finished product, the component, the material, the restricted substance and the legal exemption.

Evidence Type	Purpose
Product scope assessment	Confirms whether the product is in scope of RoHS
RoHS category classification	Confirms the relevant product category
Bill of Materials	Links the exemption to the affected part or component
Material declarations	Shows whether restricted substances are present
Supplier declarations	Confirms supplier-level compliance or exemption reliance
Test reports	Supports risk-based verification where needed
Exemption applicability assessment	Explains why the exact exemption applies
Expiry and renewal tracker	Shows whether the exemption is still valid or under review
Technical justification	Explains technical need, reliability issues or substitute limitations
Change control history	Shows whether material, supplier or design changes were reviewed
Technical documentation file	Supports conformity assessment and market-surveillance readiness

EN IEC 63000 is important here because it provides the technical documentation framework used to assess materials, components and electrical and electronic equipment under RoHS.

Questions to Ask Your Suppliers

Supplier declarations are essential, but they must be specific enough to support your RoHS decision. A vague statement such as “RoHS compliant” may not be enough when a product relies on an exemption.

Ask suppliers:

Supplier Question	Why It Matters
Does the part contain any RoHS restricted substance above the threshold?	Confirms whether an exemption may be needed
Which homogeneous material contains the restricted substance?	RoHS thresholds apply at material level
Which exact Annex III or Annex IV exemption is being used?	Prevents broad or incorrect exemption claims
What is the exemption number and wording?	Supports legal traceability
Which product categories does the exemption apply to?	Prevents category mismatch
What is the exemption expiry date or renewal status?	Supports proactive compliance planning
Has the material, solder, coating, plating, adhesive or resin changed?	Identifies reassessment triggers
Can you provide supporting test reports or material declarations?	Strengthens the technical file
Is the declaration current and version-controlled?	Prevents reliance on outdated evidence
Who approved the declaration and when?	Supports audit readiness

For procurement and compliance teams, these questions help turn supplier communication into usable compliance evidence.

Common RoHS Exemption Mistakes

1. Using outdated exemption wording

Many RoHS exemptions have been renewed, split, narrowed or assigned different expiry dates. A supplier declaration that mentions an old exemption number may not be enough if the legal wording has changed.

2. Applying an exemption too broadly

RoHS exemptions are application-specific. A material containing lead, mercury or cadmium does not automatically qualify just because an exemption exists somewhere in Annex III or Annex IV.

3. Ignoring product category differences

Some exemptions apply differently depending on the RoHS category. This is especially important for medical devices and monitoring and control instruments under Annex IV.

4. Relying only on supplier self-declarations

Supplier declarations are useful, but they should be reviewed for completeness, version control, exemption wording, expiry date and supporting evidence.

5. Not tracking expiry dates

Because RoHS exemptions are time-limited and reassessed regularly, expiry tracking is a core compliance activity, not an administrative detail. The Commission confirms that exemptions with submitted renewal requests remain valid until a Commission decision is taken, while exemptions without timely renewal expire according to the applicable date.

6. Forgetting to update the technical file

If a product relies on a RoHS exemption, the technical file should show the exemption basis, supplier evidence, technical justification and review status.

When Is Testing Needed?

Testing is not always the first step. A practical RoHS assessment usually starts with supplier documentation, material declarations, engineering knowledge and risk-based review.

Testing may be needed when:

Supplier evidence is missing, old or inconsistent
The part contains high-risk materials such as solder, coatings, platings, PVC, pigments, glass, ceramics or metal alloys
The product relies on an exemption that is close to expiry or under review
A supplier changes a material, process or manufacturing location
Customer requirements demand stronger evidence
The company cannot confirm homogeneous material compliance through documentation alone

ComplyMarket’s material compliance software page explains that supplier engagement can help reduce testing cost and limit the amount of testing needed to manage high-risk supply chains.

Practical RoHS Exemption Action Plan

Step 1: Build a RoHS exemption register

Create a central register of every product, SKU, part and material relying on a RoHS exemption. Include the exemption number, exemption wording, product category, supplier, evidence owner, expiry date and review status.

Step 2: Prioritize high-risk exemptions

Start with exemptions affected by recent updates or active reviews, especially lead in alloys, lead in high melting temperature solders, lead in glass or ceramics, mercury in special-purpose lamps and Annex IV applications.

Step 3: Recheck supplier evidence

Request updated declarations that clearly identify the exact exemption number, the restricted substance, the affected material, the product category and the validity status.

Step 4: Map exemptions to parts, not just products

Avoid saying the whole product “uses exemption 7(a)” unless the evidence clearly maps the exemption to the specific part, material and use case.

Step 5: Review expiry and renewal status

Track all expiry dates and renewal decisions. Exemption monitoring should be part of product lifecycle management, not a one-time launch activity.

Step 6: Update the technical file

Make sure the technical file contains product identification, BOM evidence, supplier declarations, restricted substance assessment, exemption justification, expiry tracking and change control records.

Step 7: Create reassessment triggers

Reassess the exemption when a supplier, material, solder, coating, plating, adhesive, resin, component, manufacturing site or product version changes.

FAQ: RoHS Exemptions Assessment

What is a RoHS exemption?

A RoHS exemption is a specific legal allowance that permits a restricted substance to be used in a defined technical application when the exemption conditions are met. It does not apply generally to the whole product.

Can a product still be RoHS compliant if it uses an exemption?

Yes, a product may still be RoHS compliant if the restricted substance use is covered by a valid exemption and the company has proper evidence showing that the exemption applies.

What happens when a RoHS exemption expires?

If an exemption expires and no valid renewal or transition rule applies, the product can no longer rely on that exemption for EU RoHS compliance. The company may need to redesign the product, change materials, find alternatives or stop placing the affected product on the market.

How often should RoHS exemptions be reviewed?

RoHS exemptions should be reviewed whenever the law changes, an exemption is renewed or expires, a supplier changes, a material changes, a product is redesigned, or new customer evidence is requested.

Are supplier declarations enough?

Supplier declarations are important, but they should be specific, current and supported by additional evidence where needed. A strong technical file should show how supplier evidence supports the exemption decision.

What is the difference between Annex III and Annex IV?

Annex III covers general application exemptions, while Annex IV covers exemptions specific to medical devices and monitoring and control instruments. ECHA confirms this distinction in its RoHS exemption list.

Why is EN IEC 63000 important?

EN IEC 63000 is the harmonised standard for technical documentation used to assess electrical and electronic equipment, materials and components with respect to RoHS restricted substances.

How ComplyMarket Product Compliance Software Can Help

Managing RoHS exemptions manually can become difficult when a company has many products, complex BOMs, multiple suppliers, changing materials and different exemption expiry dates.

ComplyMarket helps companies manage RoHS exemption requirements in a structured, traceable and scalable way.

1. Exemption-to-part traceability

ComplyMarket helps compliance teams connect RoHS exemptions to the exact product, part, material, supplier and technical use case. This helps avoid broad, unsupported exemption claims.

2. Centralized supplier evidence

ComplyMarket supports supplier evidence collection, including declarations, attachments, validity windows and version control. Its RoHS compliance service highlights supplier evidence collection and technical file assembly aligned with EN IEC 63000 expectations.

3. Exemption expiry tracking

ComplyMarket can help teams manage exemption validity, renewal deadlines and SKU impact mapping, reducing the risk of relying on outdated or expired exemptions.

4. EN IEC 63000-aligned technical files

ComplyMarket supports technical file structure, supplier data, risk-based verification and controlled documentation aligned with RoHS technical documentation expectations.

5. Supplier collaboration

ComplyMarket supports structured supplier requests, reminders, revision control and a single source of truth for declarations and supporting files.

6. Risk-based compliance decisions

ComplyMarket’s material compliance software supports supplier risk assessment and helps companies apply IEC 63000 principles while reducing unnecessary testing costs.

7. Change-control triggers

When a supplier, material, component, process or product version changes, ComplyMarket helps create a controlled reassessment process so compliance evidence stays current.

8. Faster customer and authority responses

With structured product data, exemption mapping, supplier evidence and technical documentation in one system, companies can respond faster to customer RoHS questionnaires, audits and market-surveillance requests.