- Official source for EN IEC 63000 as the harmonised standard for RoHS technical documentation.
"technical documentation required for assessing materials"
RoHS exemptions are temporary, application-specific exceptions in Annex III and Annex IV for materials and components of electrical and electronic equipment.
This page helps structure a register for exemption scope, category coverage, expiry dates, renewal status, substitution evidence, and technical-file records.
Structured answer sets in this page tree.
Cited legal and guidance references.
Track every relied-on so an old Annex III or Annex IV entry is not treated as permanent clearance. The register should tie the exemption to the exact material or component, EEE category, expiry or renewal status, Article 5 justification, substitution evidence, and technical documentation used for market placement.
Track RoHS exemptions at the level where the legal exception is written: the specific material or component, its use, the restricted substance, the covered EEE category, and the Annex III or Annex IV entry. Annex III entries may cover one or more EEE categories; Annex IV is limited to applications specific to medical devices and monitoring and control instruments.
Do not store an exemption as a generic product approval. The register should show why that entry applies to the homogeneous material or component in the marketed product and where the supporting declaration, supplier statement, test evidence, or engineering assessment sits in the technical file. It should also identify the current consolidated Annex or delegated act used for the legal-status check.
Use the current Annex wording as a matching test. For example, Annex III now separates several lead-in-steel, lead-in-aluminium, copper-alloy, and high-melting-temperature-solder uses into entries with different composition limits, technical conditions, category coverage, and dates. A register row that says only '6(a)' or '7(a)' can miss a successor entry or narrowed condition.
Each exemption row needs a live status supported by more than an expiry date copied from an Annex. Under RoHS Article 5, new exemptions have validity periods decided case by case, up to five years for categories 1 to 7, 10 and 11 and up to seven years for categories 8 and 9. Renewal applications must be made no later than 18 months before expiry.
The Commission states that exemption decisions currently take 18 to 24 months from the application date. A timely renewal request keeps the existing exemption valid until the Commission decides; if renewal is rejected or an exemption is revoked, the expiry occurs 12 to 18 months after the decision. A pending request for a new exemption has no equivalent market-placement effect.
A record should explain both the legal fit and the engineering fit. Annex V requires exemption applications to identify the material or component, specific substance uses, verifiable justification under Article 5, alternatives analysis on a lifecycle basis where available, reuse or recycling information, proposed alternative-development actions and timing, proprietary-information justification where needed, proposed exemption wording, and an application summary.
For products already relying on an exemption, use the same evidence structure internally. It gives procurement, quality, engineering, and regulatory teams a shared file for supplier changes, technical-file updates, and release decisions.
Turn exemption entries, supplier evidence, renewal status, substitution analysis, and technical-file records into a register product and regulatory teams can review before market placement.
Treating an exemption as permanent or product-wide breaks the control. RoHS exemptions are limited in time, tied to Annex wording, and reassessed against substitutes, impacts, socioeconomic factors, and innovation effects. A product release should not rely on an exemption unless the row still matches the material, component, category, application, and timing.
Another failure is confusing an application for a new exemption with permission to place non-compliant EEE on the market. The Commission implementation page states that after submitting a request for a new exemption, equipment must still comply with the Directive until the Commission adopts a decision granting the exemption.
"technical documentation required for assessing materials"
"must comply with the Directive"
"check whether an existing exemption either applies"