The EU's new chemicals policy is one of the most complex pieces of European legislation ever drafted
At the start of June, the European Chemicals Agency (ECHA) began the task of substantively administering what has been described by EU Commission officials as the EU’s most complex and complicated piece of legislation to date. REACH, the Regulation on the Registration, Evaluation and Authorisation of Chemicals, came into force a year ago and will require the scrutiny of some 30,000 of the more than 100,000 chemical substances currently on the EU market.
Replacing around 40 pieces of existing legislation, REACH requires producers and other users of chemicals to register, and potentially test, substances manufactured in or imported into the EU in quantities greater than one tonne per annum. Registration with ECHA is also required for chemical substances in certain ‘articles’, where the chemical substances in those articles are intended to be released during normal conditions of use. There are, however, some substances that are exempt from REACH, such as those that are naturally occurring and which are thought to have low hazard properties (such as water) and those which have existing targeted EU regulatory controls (such as waste). As part of the general ‘no data, no market’ rule, failure to register substances subject to REACH with ECHA will result in their continued manufacture or import becoming unlawful.
To make the new policy administratively workable (for regulated and regulator alike), there are phased deadlines for registration of substances with ECHA, staggered between 2010 and 2018 depending on the tonnage band in which the chemical substance is manufactured or imported and the relative toxicity of the substance. In order to take advantage of these deadlines, manufacturers and importers must pre-register their so-called ‘phase-in substances’ between 1 June, 2008, and 30 November, 2008. The EU Commission has estimated that somewhere in the region of 200,000 pre-registration dossiers will be submitted over the course of the next six months (with ECHA disclosing at its inauguration ceremony on 3 June that some 2,000 pre-registrations had been filed in the first two days of the system going live).
On a practical level, pre-registration comprises the electronic transmission of certain information via the REACH-IT portal on the ECHA website by each individual legal entity within a business. Companies can either:
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