The European Union Regulation No. 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) entered into force on June 1, 2007, replacing previous chemicals regulations in the EU, and is being implemented in the period 2008 – 2018. Under REACH, companies operating in the EU face obligations for substances that they manufacture, import, supply, and/or use. REACH was specifically designed to place the responsibility on industry to demonstrate safe use and show why hazardous substances should continue to be used. The European Chemicals Agency (ECHA) is administering the requirements.
REACH places substantial obligations on manufacturers and importers of substances (including importers of articles that contain substances intended to be released), including registering each substance manufactured or imported in quantities of 1 tonne or above per year. Unregistered substances may not be manufactured or imported after the applicable registration deadline.
Downstream users are also affected, both directly and indirectly. Although downstream users do not have direct registration obligations, they need to provide information to suppliers on use and exposure to support the registration process. They also must report to ECHA in certain circumstances and prepare their own chemical safety reports (CSRs) for any continued uses outside conditions described in the revised safety data sheet (SDS). Downstream users must communicate information up the supply chain when they gain new information on hazardous properties of the substance or the appropriateness of risk management measures in the SDS supplied to them. Downstream users may need to change some chemical management practices in order to comply with safety measure in news SDSs. Finally, many downstream users will be affected as supplies of chemicals are affected—some chemicals will become more expensive and others may disappear from the market altogether.
REACH contains provisions for a list known as Annex XIV, Substances of Very High Concern (SVHC). For these substances, authorization must be sought for their continued use, which requires a technical dossier, a socio-economic analysis, and proof that there is no suitable alternative for the application to be provided. An Annex XIV substance cannot be manufactured, used or placed on the market unless authorized, and the authorization, if granted, will be subject to time limits and conditions. REACH also imposes reporting and downstream communication requirements on suppliers of certain articles that contain SVHC.
Enforcement of REACH is on a country-by-country basis. All EU countries may impose Administrative penalties and fines for REACH violations, and many are prepared to use additional enforcement measure such as ordering suspension of business activity, closure of the premises, withdrawal of a permit, suspension or ban on use of a substance, suspension of placing on the market of a substance, destruction of a substance, and so forth. In some countries, REACH violations are subject to criminal penalties including fine and imprisonment.