Artifact GuideEU

EU RoHS Directive Annex III and IV Exemptions

RoHS exemptions are temporary, application-specific permissions for materials and components of electrical and electronic equipment that would otherwise breach Annex II substance restrictions.

This guide helps decide whether an Annex III or Annex IV entry can be relied on, when renewal timing matters, and what evidence belongs in the technical file.

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Author

Sorena AI

Published

May 9, 2026

Updated

Jul 25, 2026

Sections

Structured answer sets in this page tree.

Primary sources

Cited legal and guidance references.

Publication metadata

Sorena AI

Published May 9, 2026

Updated Jul 25, 2026

Overview

A under Directive 2011/65/EU permits only the application defined in its legal entry. Each Annex III or Annex IV entry is adopted through Article 5 to adapt the annexes to scientific and technical progress, with conditions, category limits, wording, and expiry dates that must be checked against the exact product and homogeneous material use case.

Section 1

What Annex III and Annex IV exemptions do

Article 4 says the RoHS substance restriction does not apply to applications listed in Annexes III and IV. Article 5 then explains how materials and components of EEE for specific applications can be included in those annexes by delegated acts.

Annex III contains application-specific exemptions that may cover one or more RoHS EEE categories. Annex IV is limited to applications specific to medical devices and monitoring and control instruments. A substance name or old exemption number is not enough: delegated acts can split, narrow, replace, or add dates to entries, so use the current consolidated text and match every condition.

Current Annex III entries show how precise the match must be. Entry 6(a) and its successor entries distinguish lead in steel for machining from lead in batch hot-dip galvanised steel, with different lead limits and dates. Entry 7(a) and its successor entries distinguish high-melting-temperature solders by semiconductor use and electrical or dimensional conditions. Annex IV examples include lead in portable emergency-defibrillator solders and cadmium in X-ray measurement filters. These are examples of entry structure, not permission for a different alloy, solder, device, or application.

Map the product to the relevant Annex I EEE category before relying on an exemption.
Match the material, component, substance, and function to the exact wording of the Annex III or IV entry.
Check whether the entry contains category-specific expiry dates or narrower application language.
Record why the restricted substance is present above the Annex II threshold in the relevant homogeneous material.
Record the legal status source used for the release: current Annex wording, applicable delegated act, and any timely renewal evidence. An assessment report, consultation, draft act, or supplier statement does not itself create an exemption.
Write a release outcome: exact entry applies and evidence is complete; entry may apply but a stated fact is unresolved and blocks release; no entry applies and the material must meet Annex II; or a new request is pending and gives no interim permission.

Sources for this answer

Directive 2011/65/EU on restriction of hazardous substances (RoHS)

Current consolidated text as of 1 July 2026 for Article 4, Article 5, Annex III, Annex IV, Annex V, and EEE category context.

European Commission - RoHS Directive implementation

Commission implementation page covering exemption procedure, timing, assessment studies, and links to current exemption resources.

Section 2

When an exemption can be granted, renewed, or deleted

Article 5 allows an exemption only where the inclusion does not weaken REACH environmental and health protection and at least one listed condition is met. The directive points to scientific or technical impracticability of elimination or substitution, reliability of substitutes, or cases where the negative environmental, health, and consumer-safety impacts of substitution are likely to outweigh the benefits.

The Commission must also consider substitute availability, socioeconomic impact, potential adverse impacts on innovation, and life-cycle thinking where relevant. Meeting one criterion does not create an exemption. Only an adopted delegated act can add the entry; assessment reports, consultations, and applications are evidence in the process rather than permission to place non-compliant EEE on the market.

For a new exemption, document the restricted substance, exact application, why substitution is not currently suitable, and the requested wording.
For a renewal, show that the Article 5 conditions still apply and that the application remains within the existing exemption wording.
For deletion or revocation, show why the Article 5 conditions are no longer fulfilled, such as available substitutes or changed risk evidence.
Separate evidence for technical feasibility, substitute reliability, health and environmental impacts, socioeconomic impacts, and innovation effects.

Sources for this answer

Directive 2011/65/EU on restriction of hazardous substances (RoHS)

Current binding criteria for including or deleting materials and components from Annex III and Annex IV.

Guidance document for RoHS exemption applications

Commission-linked guidance on exemption criteria, applications, renewals, amendments, deletions, and supporting documentation.

Section 3

Timing rules that affect product releases

For exemptions granted under Article 5(1)(a), the directive sets validity periods of up to 5 years for Annex I categories 1 to 7, 10, and 11, and up to 7 years for categories 8 and 9. Annex III entries that existed on 21 July 2011 have category-specific maximum periods unless a shorter period is specified; Annex IV entries that existed on that date have a maximum 7-year period from the relevant Article 4(3) dates unless shorter timing is specified.

A renewal application must be made no later than 18 months before the exemption expires. A timely renewal request keeps the existing exemption valid until the Commission decides. If renewal is rejected or an exemption is revoked, the Directive sets an expiry 12 to 18 months after the decision. These protections concern an existing exemption; an application for a new exemption does not authorize market placement while it is pending.

Track the expiry date for every relied-on Annex III or IV entry in the product compliance record.
Flag renewal deadlines at least 18 months before expiry and keep evidence that the renewal was submitted if continued reliance depends on it.
For an application made to the Commission, retain the written acknowledgement due within 15 days and the decision timeline due within one month where available; these process records do not replace the adopted exemption.
Do not assume a past date in an annex entry means the entry is unusable without checking whether a timely renewal request keeps it valid pending a Commission decision.
For new exemption requests, plan around the Commission's stated 18 to 24 month decision timeframe and design for compliance unless and until the Commission grants the entry.

Sources for this answer

Directive 2011/65/EU on restriction of hazardous substances (RoHS)

Current binding source for Article 5 validity periods, renewal timing, continued validity during a renewal review, and transition periods after rejection or revocation.

European Commission - RoHS Directive implementation

Commission source for the current 18- to 24-month exemption-decision timing, practical renewal status, and the treatment of new requests.

Section 4

Evidence to keep when relying on an exemption

A usable exemption record should prove more than the fact that an annex entry exists. It should connect the entry to the product, EEE category, homogeneous material, substance, component function, supplier evidence, expiry status, and technical-documentation file.

Annex V identifies the minimum information for exemption applications, including applicant details, material or component information, specific substance uses, verifiable and referenced justification, alternatives analysis on a life-cycle basis, reuse or recycling information, actions and timetables for alternatives, confidentiality claims where appropriate, and proposed precise wording. Even when a company is only relying on an existing exemption, those fields are a useful evidence model.

Keep a register with exemption number, annex, wording relied on, EEE categories covered, expiry date, renewal status, and affected SKUs or BOM lines.
Link supplier declarations, material declarations, test reports, and engineering rationale to the specific homogeneous material and restricted substance.
For renewal or new requests, collect substitute availability, reliability, lifecycle, socioeconomic, and innovation evidence in separate referenced exhibits.
Record whether any application information is confidential and keep public and confidential materials separated when preparing a Commission submission.

Sources for this answer

Directive 2011/65/EU on restriction of hazardous substances (RoHS)

Current Annex V lists minimum information for applications to grant, renew, or revoke exemptions.

Guidance document for RoHS exemption applications

Guidance source for application documentation, consultation steps, and evidence categories such as substitutes and socioeconomic data.

Recommended next step

Turn exemption reliance into a controlled evidence record

Build a product-level RoHS exemption register that ties each Annex III or IV entry to the affected BOM item, substance, category, expiry status, supplier evidence, and review trigger.

Research workflow

Open Research Copilot

Answer RoHS scope, timing, and interpretation questions with cited outputs.

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Talk to Sorena

Talk through implementation

Review your scope, evidence model, controls, and next actions.

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Section 5

Common mistakes with Annex III and IV exemptions

Most mistakes come from treating an exemption as a general material allowance. RoHS exemptions attach to specific applications and often to specific EEE categories or subcategories. A lead, cadmium, or mercury use that fits one entry may still fail if the product category, component function, or expiry condition is different.

Stale monitoring also creates risk. The Commission page explains that exemptions are reassessed regularly, and the consolidated Directive shows many Annex entries with detailed category-specific expiry language. A product-release checklist should include exemption status review at release and after relevant legal changes.

Do not cite Annex III for category 8 or 9 equipment until the entry wording and dates are checked against the exact subcategory.
Do not use Annex IV for ordinary EEE outside medical devices or monitoring and control instruments.
Do not rely on a supplier's broad RoHS statement if it does not identify the exemption number, annex, substance, component, and applicable expiry status.
Do not submit or retain an exemption rationale without referenced evidence for alternatives, reliability, impacts, and planned substitution actions where relevant.

Sources for this answer

Directive 2011/65/EU on restriction of hazardous substances (RoHS)

Current consolidated source for application-specific annex entries and category-specific validity periods.

European Commission - RoHS Directive implementation

Commission source explaining regular reassessment, renewal, and current exemption procedure timing.

Primary sources