REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is the regulation underpinning the new EU chemicals legislation, by which Europe-wide harmonization is to be achieved. It was finally adopted on 18 December 2006, and came into force on 1 June 2007.
Under the REACH system, enterprises must register a chemical substance in a central database should they wish to produce this substance or import it into the EU in quantities of 1 t per annum or over. A time schedule phased according to quantities (transitional arrangement) is in place for registration.
Between 1 June 2008 and 1 December 2008, pre-registration took place. Pre-registration is a criterion for use of the following transitional arrangements:
* CMR = carcinogenic, mutagenic or reprotoxic substances in Categories 1 or 2
(REACH Regulation, Article 23)
At registration proper, a technical dossier must be submitted to the Agency containing data on the substance and information on risk management measures. The information requirements vary according to the quantities produced or imported each year. A registration number and registration date are assigned for each registration. A chemical safety report is required for substances in quantities of 10 t and over per annum.
Registration of a substance also includes the corresponding applications. Manufacturers and importers must therefore consider the risks of all applications of which they have been informed by the downstream users. The manufacturer is however not obliged to register a substance for an application which is not intended by him.
Certain substances are exempted from the obligation to register; others are deemed to be already registered. Isolated intermediates must be registered, but only a limited amount of information is generally required. Substances release of which is intentional during normal use of an article must be registered, and the Agency must be notified of unintentionally released substances should they be classified as dangerous and exceed the corresponding quantity thresholds.
Substances of very high concern must be authorized.
Reporting obligations for the classification and labelling inventory apply as of 1 December 2010.
(GHS Regulation (EC) No. 1272/2008).