Chemicals are indispensable in our society. They play an important role in the economy. There are international rules to assess, control and reduce the risks of chemicals. On June 1, 2007, the ‘new’ European Chemicals Regulation (EC) 1907/2006 called REACH came into force. The REACH Regulation aims to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances. This is done by the four core processes of REACH, namely the Registration, Evaluation, Authorisation and Restriction of Chemicals.
Companies are responsible
All companies handling chemicals – as manufacturer, importer, distributor or downstream user – have to deal with the REACH Regulation. This relates to substances as such, in mixtures (preparations) and in articles. The aim of REACH is that all businesses across the supply chain of a substance can ensure the safest possible production, distribution and use for man and environment. The responsibility lies with the companies.
Registration is your license to do business with a substance within the EU
The REACH Regulation introduces a registration requirement for European manufacturers and importers of substances as such, in mixtures or in articles. Manufacturers outside Europe can take over the registration requirement for their European customers via a European-based “Only Representative”. Registrants must, according to clear criteria, in a joint process with other registrants prepare and submit a registration dossier using prescribed tools (IUCLID5 & REACH-IT) within rigid time frames legally set.
Relevant REACH compliance information is passed in the supply chain through the well-known main information carrier, the safety data sheet (SDS). No registration means no access to the EU market. Eventually, all uses of a substance in its supply chain (if not excluded) must be covered in the appropriate registration dossier(s). REACH is a business issue: registration is your license to do business and to apply a substance as such, within a mixture and/or article within the EU.
Efficient supply chain communication is crucial for suppliers and downstream users
The REACH Regulation introduces a chemical safety assessment requirement of the supplier SDS for downstream users of chemicals. If the SDS contains an registration number and exposure scenarios for covered uses an annex to the SDS (“extended SDS”), the downstream user has 12 months to ensure that its own applications are covered and, if the substance is passed unchanged further in the supply chain (e.g. as mixture), also the known applications in the supply chain are covered as well.
The European Chemicals Agency (ECHA) oversees the operation of the REACH Regulation, is the central contact point for registrations and other REACH obligations and can impose obligations on Authorisation or Restrictions on the use of substances of very high concern. ECHA has a forum to support the Member State Competent Authorities (MSCA). Although REACH is a Regulation directly in force within all European Member States, Inspection and Enforcement of REACH will be the conducted in the local language by the Member State Competent Authority within the Country of your local site(s).