标准简介
有害物质限制指令（RoHS 3），正式名称为欧盟指令 2011/65/EU（经 2015/863/EU 修订），限制在欧盟销售的电气和电子设备（EEE）中使用十种有害物质。该指令最初于 2006 年推出时限制六种物质，2019 年更新后增加了四种邻苯二甲酸酯，总数达到十种。该指令涵盖十一个类别的产品，包括消费电子产品、IT 设备、照明、家用电器、医疗设备和监控仪器。
RoHS 合规要求制造商准备技术文件、签发符合性声明并加贴 CE 标志。受限物质包括铅（0.1%）、汞（0.1%）、镉（0.01%）、六价铬（0.1%）、PBB（0.1%）、PBDE（0.1%）以及四种邻苯二甲酸酯——DEHP、BBP、DBP 和 DIBP（各 0.1%）。对于尚无技术可行替代方案的应用存在特定豁免，但这些豁免有到期日。RoHS 与 REACH 法规和 WEEE 指令共同构成欧盟管理产品中有害物质的整体方法。
10 Restricted Substances
Restricts lead, mercury, cadmium, hexavalent chromium, PBB, PBDE, and four phthalates (DEHP, BBP, DBP, DIBP) in electrical and electronic equipment.
Maximum Concentration Values
Each restricted substance has a maximum concentration value (MCV) by weight in homogeneous materials — typically 0.1% (1000 ppm) except cadmium at 0.01% (100 ppm).
Broad Product Scope
Covers 11 categories of EEE including household appliances, IT equipment, lighting, toys, medical devices, and monitoring/control instruments.
list_alt Restricted Substances
- Lead (Pb) — max 0.1%
- Mercury (Hg) — max 0.1%
- Cadmium (Cd) — max 0.01%
- Hexavalent chromium (Cr VI) — max 0.1%
- Polybrominated biphenyls (PBB) — max 0.1%
- Polybrominated diphenyl ethers (PBDE) — max 0.1%
- Bis(2-ethylhexyl) phthalate (DEHP) — max 0.1%
- Butyl benzyl phthalate (BBP) — max 0.1%
Who Needs to Comply?
Manufacturers, importers, and distributors placing electrical and electronic equipment (EEE) on the EU market. Applies to all 11 EEE categories including large/small household appliances, IT equipment, lighting, and toys.
Key Requirements
Substance Testing & Compliance
Test products and components to verify restricted substance concentrations are below MCVs. Use XRF screening and confirmatory wet chemistry analysis per IEC 62321 test methods.
Technical Documentation
Maintain technical documentation demonstrating RoHS compliance for at least 10 years after the product is placed on the market. Include test reports, material declarations, and supply chain evidence.
EU Declaration of Conformity
Prepare and sign an EU Declaration of Conformity specifically referencing Directive 2011/65/EU. Affix the CE mark to the product indicating RoHS compliance alongside other applicable directives.
Supply Chain Due Diligence
Obtain material declarations and compliance certificates from component suppliers. Establish procedures to manage substance restrictions throughout the supply chain.
Penalties & Enforcement
Enforcement varies by EU member state. Penalties include product recalls, customs seizure, market withdrawal, and fines. In Germany, violations can result in fines up to EUR 100,000. Products may be listed on the EU RAPEX safety alert system.