標準簡介
REACH（化學品的註冊、評估、授權和限制）是歐盟法規 (EC) No 1907/2006，是世界上最全面的化學品法規之一。它管轄歐盟境內化學物質的製造、進口和使用，將舉證責任置於企業身上，要求其證明化學品和產品的安全性。REACH 由歐洲化學品管理局（ECHA）管理，適用於投放歐盟市場的幾乎所有產品。
REACH 透過四個關鍵機制運作：註冊（製造商和進口商必須註冊年產量超過 1 噸的物質）、評估（ECHA 評估測試提案）、授權（附件 XIV 中的高度關注物質需要獲得授權）和限制（附件 XVII 列出了具體條件或禁令）。對於物品生產商和進口商，主要義務是 SVHC 通訊——如果物品中含有的候選清單物質超過重量的 0.1%，供應商必須應要求告知客戶。候選清單目前包含 240 多種物質，每年至少更新兩次。
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.