标准简介
REACH（化学品的注册、评估、授权和限制）是欧盟法规 (EC) No 1907/2006，是世界上最全面的化学品法规之一。它管辖欧盟境内化学物质的制造、进口和使用，将举证责任置于企业身上，要求其证明化学品和产品的安全性。REACH 由欧洲化学品管理局（ECHA）管理，适用于投放欧盟市场的几乎所有产品。
REACH 通过四个关键机制运作：注册（制造商和进口商必须注册年产量超过 1 吨的物质）、评估（ECHA 评估测试提案）、授权（附件 XIV 中的高度关注物质需要获得授权）和限制（附件 XVII 列出了具体条件或禁令）。对于物品生产商和进口商，主要义务是 SVHC 通信——如果物品中含有的候选清单物质超过重量的 0.1%，供应商必须应要求告知客户。候选清单目前包含 240 多种物质，每年至少更新两次。
Registration Required
Manufacturers and importers must register substances produced or imported above 1 tonne/year with ECHA, providing safety data based on tonnage band.
SVHC Candidate List
Substances of Very High Concern (SVHCs) — carcinogenic, mutagenic, persistent, bioaccumulative — are placed on the Candidate List with special communication and authorization requirements.
No Data, No Market
Core REACH principle: substances cannot be manufactured or imported into the EU without registering safety data with ECHA. The burden of proof is on industry, not regulators.
list_alt Key Processes
- Registration — substance safety dossiers to ECHA
- Evaluation — ECHA reviews dossier quality and substance risks
- Authorisation — SVHC substances require use-specific authorization
- Restriction — limits or bans on hazardous substance use
- SVHC Candidate List communication obligations
- Safety Data Sheets (SDS) in supply chain
- Downstream user obligations
Who Needs to Comply?
EU manufacturers and importers of chemical substances above 1 tonne/year. Also applies to producers/importers of articles containing SVHCs above 0.1% w/w and downstream users of registered substances.
Key Requirements
Substance Registration
Register all substances manufactured or imported above 1 tonne/year with ECHA. Submit a technical dossier with physicochemical, toxicological, and ecotoxicological data. Higher tonnages require more extensive data.
SVHC Communication
If an article contains an SVHC from the Candidate List above 0.1% w/w, provide sufficient information to allow safe use to downstream recipients. Notify ECHA if total quantity exceeds 1 tonne/year.
Safety Data Sheets
Provide Safety Data Sheets (SDS) to downstream users for hazardous substances and mixtures. SDS must include 16 mandatory sections covering identification, hazards, handling, exposure controls, and disposal.
Authorisation Applications
Substances on the Authorisation List (Annex XIV) cannot be used after the sunset date without an authorization. Apply to ECHA demonstrating adequate control or that socio-economic benefits outweigh risks.
Penalties & Enforcement
Enforcement varies by member state. Penalties include market bans, product recalls, and significant fines. In Germany, fines can reach EUR 50,000 per violation. In the UK (pre-Brexit), fines were unlimited with up to 2 years imprisonment for serious offences.