REACH (EC 1907/2006)
Registration, Evaluation, Authorisation and Restriction of Chemicals
Standard Introduction
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is EU Regulation (EC) No 1907/2006, one of the most comprehensive chemical regulations in the world. It governs the manufacture, import, and use of chemical substances across the European Union, placing the burden of proof on companies to demonstrate that their chemicals and products are safe. REACH is administered by the European Chemicals Agency (ECHA) and applies to virtually all products placed on the EU market.
REACH operates through four key mechanisms: Registration (manufacturers and importers must register substances above 1 tonne per year), Evaluation (ECHA evaluates testing proposals), Authorisation (Substances of Very High Concern on Annex XIV require authorisation), and Restriction (Annex XVII lists specific conditions or bans). For article producers and importers, the primary obligation is SVHC communication — if an article contains a Candidate List substance above 0.1% by weight, the supplier must inform customers on request. The Candidate List currently includes over 240 substances and is updated at least twice yearly.
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.