REACH — Chemical RegulationREACH

REACH — the EU Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals, EC 1907/2006 — is the chemical regulation that put the burden of proof on the manufacturer and the importer, so a chemical is treated as unsafe until the company that places it on the market demonstrates otherwise. The registration obligation applies to substances manufactured or imported at or above one tonne per year, and the dossier has to cover the intrinsic properties, the uses, and the exposure scenarios. The Substances of Very High Concern — the carcinogens, the mutagens, the reproductive toxicants, the persistent and bioaccumulative — go on the Candidate List, and an article containing an SVHC above 0.1 per cent by weight has to be disclosed to the recipient and on request to the consumer.

REACH works in three layers that escalate with the risk. The Candidate List is the disclosure trigger; the Authorisation List is the list a company cannot use after the sunset date unless an authorisation was granted, which forces the substitution to a safer alternative; and the Restriction List is the EU-wide ban on a specific use. The compliance burden is the supply-chain communication — the SDS, the exposure scenario, and the SVHC disclosure cascade down the supply chain, and the article manufacturer a step removed from the chemical still has to know what is in the product it bought. The enforcement is by the member-state authorities and the ECHA, and the penalty for a non-compliant import is the market access. See SDS, GHS, and RoHS.