REACH is designed to achieve the following:
- Registration of basic information on chemical substances submitted by companies to a central database.
- Evaluation of the registered information to determine hazards and risks.
- Authorisation requirements imposed on the use of high-concern substances.
- Restriction of a substance’s use if it poses an unacceptable risk to health or the environment.
REACH (Registration, Evaluation, Authorisation and Restriction of Chemical substances, EC1907/2006) requires registration over a tiered timescale of all chemicals produced or imported into the EU at ≥1 tpa.
Producers or importers must submit a dossier to ECHA that includes substance property information. The amount of hazard data required is dependent on the tonnage of the substance and whether it meets the ECHA definition of an intermediate under Strictly Controlled Conditions. The hazard data are used to classify the substance, and for substances ≥10 tpa a PBT assessment must be carried out. If the substance is classified as hazardous or PBT/vPvB then an exposure assessment needs to be included in the dossier.
Safe use needs to be demonstrated for manufacture and each downstream use, and risk management measures must be identified. Substances must be registered with ECHA by the relevant deadlines or manufacture and import must cease.