RoHS Directive 2011/65/EU — Annex II restricted substances

The Restriction of Hazardous Substances Directive — "RoHS 2" — is the recast directive (Directive 2011/65/EU of 8 June 2011) that governs hazardous substances in electrical and electronic equipment (EEE) placed on the EU market. Annex II names the substances; Article 4 sets the prohibition; Article 7 sets the conformity assessment route; Annexes III and IV carve out application-specific exemptions.

For day-to-day engineering work, the consolidated text — CELEX:02011L0065-20240801 — is the version to read, because it folds in every Commission delegated directive that has amended Annex II, Annex III and Annex IV since 2011.

The 10 substances in Annex II

Article 4(1) of Directive 2011/65/EU states the rule plainly:

Member States shall ensure that EEE placed on the market, including cables and spare parts for its repair, its reuse, updating of its functionalities or upgrading of its capacity, does not contain the substances listed in Annex II.

Annex II of the consolidated text now lists ten substances with their maximum concentration values (MCVs) by weight in homogeneous materials:

The original six substances (lead through PBDE) were carried over from the previous RoHS directive (2002/95/EC) and bound from 1 July 2006. The four phthalates were added by Commission Delegated Directive (EU) 2015/863, titled in full "Commission Delegated Directive (EU) 2015/863 of 31 March 2015 amending Annex II to Directive 2011/65/EU of the European Parliament and of the Council as regards the list of restricted substances."

The 2015/863 amendment: timing of the phthalates

The phthalate restriction did not bite at the same time for every product category. Per Directive (EU) 2015/863:

• General EEE: phthalate restriction applied from 22 July 2019.
• Medical devices (including in vitro diagnostic medical devices) and monitoring and control instruments (including industrial monitoring and control instruments): phthalate restriction applied from 22 July 2021.

These dates align with the staggered scope-extension dates already built into Article 4(3) for the medical and industrial monitoring categories.

"Homogeneous materials" — the test that catches people out

Article 3(20) defines a "homogeneous material" as a material of uniform composition throughout, or a material consisting of a combination of materials that cannot be disjointed or separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding and abrasive processes.

The MCVs apply at the homogeneous-material level, not the finished-product level. A 0,1 % limit on lead does not mean "less than 0,1 % of total product weight" — it means less than 0,1 % in each homogeneous material the product is built from. Solder fillets, plating layers, plastic housings, cable jackets and adhesives are each separately assessed.

Annex I — the 11 product categories

The directive covers 11 categories of EEE (Annex I):

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 any of the categories above

Category 11 — the so-called "open scope" — was introduced by the 2011 recast and applied from 22 July 2019. Anything within the directive's definition of EEE that does not slot into categories 1–10 falls under category 11.

Article 7 — manufacturer obligations and CE marking

Article 7 of Directive 2011/65/EU sets the conformity assessment path. Manufacturers must:

• ensure EEE is designed and manufactured in accordance with Article 4 (the substance restrictions);
• prepare the technical documentation referred to in Annex VI and carry out the internal production control procedure in accordance with Module A of Annex II to Decision No 768/2008/EC;
• where compliance is demonstrated, draw up an EU Declaration of Conformity and affix the CE marking to the finished product;
• keep the technical documentation and the EU declaration of conformity for 10 years after the EEE has been placed on the market;
• ensure that procedures are in place for series production to remain in conformity;
• identify the product (type, batch or serial number) and provide manufacturer name and contact address on the EEE, or where this is not possible, on its packaging or accompanying documentation;
• where they consider an EEE they have placed on the market is non-compliant, immediately take corrective measures, withdraw or recall as appropriate, and inform the competent national authorities.

The conformity assessment module — Module A, internal production control — means RoHS does not require notified body involvement. The manufacturer self-declares.

Article 16 then states: "In the absence of evidence to the contrary, Member States shall presume EEE bearing the CE marking to comply with this Directive." Materials, components and EEE tested in accordance with harmonised standards published in the Official Journal benefit from a presumption of conformity (the most-cited harmonised standard for RoHS material testing is the EN IEC 63000 series).

Annex III and Annex IV — the exemption regime

RoHS has no general "trace contamination" allowance beyond the Annex II MCVs, but it does have an application-specific exemption regime:

• Annex III lists applications exempted from the Article 4(1) restriction (e.g. mercury in cold cathode fluorescent lamps for backlights, lead in solder for certain high-temperature applications). Each entry has a validity end date by category.
• Annex IV lists exemptions specific to category 8 (medical devices) and category 9 (monitoring and control instruments).

Both annexes are amended on a rolling basis by Commission delegated directives. The procedure for requesting, renewing and revoking exemptions is set out in Article 5. The two annexes drift continuously — always check the consolidated version dated to the moment you are placing the product on the market.

Common mistakes

• Treating MCVs as product-level limits. The 0,1 % / 0,01 % thresholds apply to homogeneous materials, not the finished product weight.
• Forgetting that solder, plating and adhesives count. Every homogeneous material is in scope, including the bits engineers don't usually think of as "the product".
• Using stale Annex III/IV exemptions. Exemptions have explicit expiry dates per product category. An exemption valid for category 1 last year may not be valid for category 9 today.
• Assuming a notified body is required. RoHS uses Module A — internal production control. The manufacturer self-declares; no NB involvement is needed for RoHS conformity itself.
• Conflating RoHS and REACH. Both restrict chemicals, but RoHS is product-scoped (EEE) with fixed Annex II MCVs, while REACH applies horizontally across articles and substances under different rules.
• Missing the cables-and-spare-parts wording. Article 4(1) explicitly extends to cables and spare parts for repair, reuse, functionality update or capacity upgrade — not just the original product.

How Cenitia helps

Cenitia maintains a continuously-refreshed mirror of Annex II MCVs, Annex III/IV exemptions and their expiry dates, alongside the harmonised standards cited in the Official Journal for RoHS. When the Commission publishes a delegated directive that amends Annex II, III or IV, Cenitia flags every active Declaration of Conformity for products in affected categories so the engineering team can decide whether a re-test, a documentation update or a design change is required.

For new products, the Cenitia wizard walks through the Article 7 internal production control path: assembling Annex VI technical documentation, drafting the EU DoC with the required directive references, and producing the conformity package that supports the CE marking decision. The result is a defensible, evidence-graded RoHS file rather than a one-off PDF.

Frequently asked questions

What are the 10 restricted substances under RoHS Annex II?

Lead, mercury, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE) at 0,1 % maximum concentration; cadmium at 0,01 %; plus the four phthalates DEHP, BBP, DBP and DIBP added by Directive (EU) 2015/863, each at 0,1 %. See Annex II of consolidated Directive 2011/65/EU.

Do the maximum concentration values apply to the whole product?

No — Article 4(2) specifies the limits apply "in homogeneous materials". A homogeneous material is one that cannot be mechanically disjoined into different materials, so the test is applied at the level of solder, plastic housing, plating, etc., not the assembled product.

When did the four phthalates become restricted?

Directive (EU) 2015/863 added DEHP, BBP, DBP and DIBP to Annex II. The restriction applied to most EEE from 22 July 2019, and to medical devices (including in vitro diagnostic medical devices) and monitoring and control instruments from 22 July 2021.

What product categories does RoHS cover?

Annex I lists 11 categories: large household appliances, small household appliances, IT and telecommunications equipment, consumer equipment, lighting equipment, electrical and electronic tools, toys, leisure and sports equipment, medical devices, monitoring and control instruments (including industrial), automatic dispensers, and other EEE not covered by any of the above (category 11 — the open scope that took effect 22 July 2019).

How does a manufacturer demonstrate conformity with RoHS?

Article 7 of Directive 2011/65/EU requires manufacturers to apply the internal production control procedure of Module A in Annex II to Decision 768/2008/EC, draw up an EU Declaration of Conformity and affix the CE marking before placing the product on the EU market. See our DoC 101 and CE marking 101 guides.

Are there exemptions to the substance restrictions?

Yes. Annex III lists applications exempted from the restrictions (e.g. mercury in certain lamps, lead in specific solder applications), each with a validity end date. Annex IV lists exemptions specific to medical devices and monitoring and control instruments. Both annexes are maintained by Commission delegated directives that periodically add, amend or revoke entries.

Related from the Library

• CE marking 101 — how the CE marking framework binds RoHS, EMC, LVD and RED together
• Declaration of Conformity 101 — drafting the EU DoC referenced by RoHS Article 7
• Conformity assessment modules A to H — Module A internal production control explained
• Technical file 101 — what goes into the Annex VI technical documentation
• Updating a DoC after amendment — what to do when Annex II, III or IV changes

Further reading

• Directive 2011/65/EU on EUR-Lex (ELI) — base RoHS 2 directive
• Consolidated Directive 2011/65/EU (CELEX:02011L0065-20240801) — version with all delegated amendments folded in
• Commission Delegated Directive (EU) 2015/863 — the phthalate amendment
• Decision 768/2008/EC — common framework for the marketing of products, including Module A
• Regulation (EC) No 765/2008 — accreditation and market surveillance, including CE marking principles
• European Commission — RoHS Directive policy page — Commission overview and FAQ
• EN IEC 63000 (harmonised standard) — IEC catalogue — technical documentation for assessing EEE with respect to RoHS substances

Last reviewed: 5 July 2026. Cited regulations watched continuously by Cenitia — when one amends, this article is flagged for update.