標準簡介
有害物質限制指令（RoHS 3），正式名稱為歐盟指令 2011/65/EU（經 2015/863/EU 修訂），限制在歐盟銷售的電氣和電子設備（EEE）中使用十種有害物質。該指令最初於 2006 年推出時限制六種物質，2019 年更新後增加了四種鄰苯二甲酸酯，總數達到十種。該指令涵蓋十一個類別的產品，包括消費電子產品、IT 設備、照明、家用電器、醫療設備和監控儀器。
RoHS 合規要求製造商準備技術文件、簽發符合性聲明並加貼 CE 標誌。受限物質包括鉛（0.1%）、汞（0.1%）、鎘（0.01%）、六價鉻（0.1%）、PBB（0.1%）、PBDE（0.1%）以及四種鄰苯二甲酸酯——DEHP、BBP、DBP 和 DIBP（各 0.1%）。對於尚無技術可行替代方案的應用存在特定豁免，但這些豁免有到期日。RoHS 與 REACH 法規和 WEEE 指令共同構成歐盟管理產品中有害物質的整體方法。
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.