Registration, Evaluation, Authorisation and Restriction of Chemicals

REACH is the European regulation No. 1907/2006 dated 18 December 2006, made by the European Parliament and Council, concerning the Registration, Evaluation, Authorization and Restriction of Chemicals. This regulation has considerably improved the EU legislative framework for chemicals, holding Industry responsible for knowing the chemicals they place on the market and for making the appropriate risk management regarding each use, bearing in mind the protection of human health and of the environment.

With REACH entering into force, manufacturers and importers of chemical substances, on their own, in mixtures and in articles, in quantities above 1 ton per year, are required to submit a registration to the European Chemicals Agency (ECHA), located in Helsinki.

The registration dossier is the compilation of a chemical substance’s phys-chem, tox and eco-toxicological data. According to Article 5 of the REACH regulation, “No data, no market”, which means the absence of a REACH registration submitted by the manufacturer in due time to ECHA, equals to the inability to continue manufacturing it or placing it on the European market in a legal manner.

The REACH regulation also provides for a Restriction process to regulate the manufacture, placing on the market or use of certain substances on their own, in mixtures and in articles, where they pose a risk to human health or to the environment, that is not adequately controlled. The list of chemical substances subject to Restrictions is sett out in Annex XVII of REACH.

Likewise, all substances of very high concern for human health or the environment (SVHC), once included in Annex XIV of REACH, may only be used after an Authorization is granted by ECHA following manufacturer’s, importer’s or downstream user’s request. This procedure ensures that the risks associated with these substances are adequately controlled and that there is a progressive substitution of alternative substances or technologies where these are economically and technically viable.