What is the RoHS Directive?

The RoHS Directive (2011/65/EU) restricts the use of specific hazardous substances in electrical and electronic equipment (EEE) placed on the EU market to protect human health and the environment.

Which substances are restricted under RoHS?

Annex II of the RoHS Directive restricts 10 substances: Lead, Mercury, Cadmium, Hexavalent chromium, PBB, PBDE, and four phthalates (DEHP, BBP, DBP, DIBP). Most have a maximum concentration limit of 0.1% by weight, except Cadmium which is limited to 0.01%.

Does RoHS require CE marking?

Yes. Under Article 15 of the RoHS Directive, manufacturers must affix the CE marking to the finished EEE or its data plate before placing it on the market, signifying compliance with the restricted substance limits.

What are the penalties for RoHS non-compliance?

Under Article 23, Member States determine specific penalties, which must be effective, proportionate, and dissuasive. Penalties can include product recalls, market withdrawal, and criminal sanctions for serious infringements.

Who is responsible for RoHS compliance?

Under Article 7, manufacturers bear the primary responsibility for ensuring EEE is designed and manufactured without restricted substances, drawing up technical documentation, and affixing the CE marking. Importers and distributors also have verification obligations.

RoHS Directive (2011/65/EU) Compliance Guide

The Restriction of Hazardous Substances (RoHS) Directive is the European Union's regulatory framework governing the use of specific hazardous materials in electrical and electronic equipment (EEE). Established by Directive 2011/65/EU [1], often referred to as RoHS 2, the legislation aims to protect human health and the environment by preventing hazardous substances from entering the waste stream.

Compliance with the RoHS Directive is a mandatory prerequisite for placing electrical and electronic products on the EU market. It is closely linked to the REACH Regulation and the WEEE Directive (Waste Electrical and Electronic Equipment).

Legal Basis and Scope

Directive 2011/65/EU was adopted on 8 June 2011, replacing the original 2002 RoHS Directive. Under Article 4 (Prevention) [2], Member States must ensure that EEE placed on the market—including cables and spare parts for repair, reuse, or upgrading—does not contain the substances listed in Annex II above their maximum tolerated concentration values.

The scope of RoHS 2 is "open," meaning it applies to all EEE unless explicitly exempted. The rollout was phased, with the final category (all other EEE outside the scope of the original directive) coming under restriction on 22 July 2019 [3].

Restricted Substances and Limits

Annex II of the Directive [4], as amended by Delegated Directive (EU) 2015/863 (often called RoHS 3), restricts ten specific substances. The maximum concentration values tolerated by weight in homogeneous materials are:

Lead (Pb): 0.1%
Mercury (Hg): 0.1%
Cadmium (Cd): 0.01%
Hexavalent chromium (Cr VI): 0.1%
Polybrominated biphenyls (PBB): 0.1%
Polybrominated diphenyl ethers (PBDE): 0.1%
Bis(2-ethylhexyl) phthalate (DEHP): 0.1%
Butyl benzyl phthalate (BBP): 0.1%
Dibutyl phthalate (DBP): 0.1%
Diisobutyl phthalate (DIBP): 0.1%

Key Obligations for Manufacturers

Article 7 [5] outlines the strict obligations placed on manufacturers. Before placing EEE on the market, manufacturers must:

Ensure the equipment is designed and manufactured in compliance with the Article 4 substance restrictions.
Draw up the required technical documentation and carry out the internal production control procedure.
Draw up an EU declaration of conformity.
Keep the technical documentation and declaration of conformity for 10 years after the EEE has been placed on the market.
Ensure the EEE bears a type, batch, or serial number for identification.
Indicate their name, registered trade name, and a single contact address on the EEE or its packaging.

CE Marking Requirements

Unlike the original RoHS Directive, RoHS 2 is a CE marking directive. Under Article 15 [6], the CE marking must be affixed visibly, legibly, and indelibly to the finished EEE or its data plate before it is placed on the market. By affixing the CE marking, the manufacturer assumes responsibility for the compliance of the product with all applicable EU requirements, including RoHS.

Penalties and Enforcement

Enforcement of the RoHS Directive is handled at the national level by individual EU Member States. Under Article 23 (Penalties) [7], Member States are required to lay down rules on penalties applicable to infringements. The directive mandates that these penalties must be "effective, proportionate and dissuasive."

While specific fines vary by country, Member States may impose criminal sanctions where they consider it appropriate for serious infringements. Enforcement actions commonly include forced product recalls, withdrawal from the market, and prohibition of future sales.

References

[1] European Parliament and Council. (2011). Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment. EUR-Lex. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32011L0065
[2] Directive 2011/65/EU, Article 4(1).
[3] Directive 2011/65/EU, Article 4(3).
[4] Directive 2011/65/EU, Annex II (as amended by Delegated Directive (EU) 2015/863).
[5] Directive 2011/65/EU, Article 7.
[6] Directive 2011/65/EU, Article 15.
[7] Directive 2011/65/EU, Article 23.