REACH is the European Community regulation for the Registration, Evaluation, Authorization and Restriction of Chemical substances. The aim of this new law, which entered into force on Ju1, 2007 and introduced a new European policy for the management of chemical substances, is to improve our understanding of the intrinsic properties (hazards) of chemical substances and to improve the management of risks for human health and the natural environment on the basis of risk appraisal throughout the product’s life cycle.
Approximately 30,000 existing chemical substances manufactured or imported into the European Union in quantities of at least one metric ton per year should gradually be registered over an eleven-year period depending upon their tonnage, on the basis of a schedule starting from the moment the new law came into force :
• Three and a half years for substances > 1000 metric tonnes/year, CMR¹ 1&2 > one metric tonne/year and R50¬53² substances> 100 metric tonnes/year
• Six years for substances > 100 metric tonnes/year
• Eleven years for substances > one metric tonne/year
The Registration process involves submitting a file to the European Chemicals Agency (ECHA) in Helsinki. This file must include information about the physico-chemical, toxicological and eco-toxicological properties of the substance, and an appraisal of the risks for human health and the environment for all the different ways in which the chemical is used in the chain of product usage.
The Evaluation of the files is entrusted to the Agency, with the assistance of the relevant authorities of the Member States.
An Authorization for so-called substances “of very high concern” (CMR 1&2, PBT, vPvB, etc.) is provided by the Agency if the requesting party manages to demonstrate that the risks inherent in the use of the substance are effectively controlled or, if not, that the socio-economic advantages outweigh the risks involved in its use, and that no alternative substance is available.
The regulation also provides for Restrictions liable to be imposed the conditions of manufacture, limits on the use and/or sale of a particular substance or, simply, an outright ban on the use of the chemical in question.
ECHA
European Chemicals Bureau.
(1) CMR: Carcinogenic, Mutagenic or toxic for Reproduction
(2) R 50/53: environmental hazard classification -> very toxic to aquatic organisms