ECHA Guidance on REACH
Guidance documents aim at facilitating the implementation of REACH by describing good practice on how to fulfil the obligations.
REACH, which stands for Registration, Evaluation, Authorisation and Restriction of Chemicals, entered into force on 1 June 2007 and applies to all (industrial and everyday) chemical substances. Companies must identify and manage the risks linked to the substances they manufacture and market in the EU. Companies need to register their substances by demonstrating to ECHA how the substance can be safely used. Scientific committees assess whether the risks of substances can be managed. Companies must communicate the risk management measures to the users.
Information on the properties and uses of and hazards and potential risks presented by a substance is communicated to ECHA. The manufacturing/miporting company must also detail in this registration dossier how these risks should be controlled.
Evaluation of the information submitted by the registrant under REACH focuses on the examination of testing proposals, the compliance check of the dossiers and the substance evaluation.
The authorisation process aims to ensure that substances of very high concern (SVHCs) are progressively replaced by less dangerous substances or technologies where technically and economically feasible alternatives are available.
Restrictions are an instrument to protect human health and the environment from unacceptable risks posed by chemicals. Restrictions are normally used to limit or ban the manufacture, placing on the market (including imports) or use of a substance, but can impose any relevant condition, such as requiring technical measures or specific labels.
Communiaction in the supply chain
When downstream users provide information regarding their uses and conditions of use to their suppliers, registrants can base the exposure scenarios in their chemical safety assessment on this information. Consequently, the advice on safe use that the registrant communicates to downstream users is likely to be relevant and realistic. A safety data sheet, whose format and content are specified in REACH, should be provided to downstream users.
Candidate List substances in articles
The identification of a substance as a Substance of Very High Concern (SVHC) and its inclusion in the Candidate List can trigger certain legal obligations for the importers, producers and suppliers of an article that contains such a substance.
Consolidated versions of the Regulation are available.
National authorities can verify the compliance of the duty holders with REACH Regulation. E.g. checking whether the substance has been registered or pre-registered or verifying the presence and correctness of the Safety Data Sheets.
Substances of potential concern
Those substances that potentially have certain hazardous properties (for human health and/or the environment) need to be identified. Regulatory steps make sure that the risks associated with their use are properly addressed.
Animal testing under REACH
REACH aims to keep the number of animal tests to an essential minimum by several means.