Regulation (EC) No. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemical Substances.
REACH came into force in June 2007 and imposes the following requirements for chemical manufacture, import and use within the EU:
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All chemical substances, new and existing, that are manufactured or imported in the European Economic Area in a quantity of ≥1 tonne per year must undergo registration
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Chemical products need to be assessed at the component level, i.e. each substance contained in a chemical product must be registered if it meets the 1 tonne per year threshold
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All potential routes of exposure of a substance must be assessed throughout its life-cycle for risks to human health and the environment; this requires comprehensive communication throughout each supply network to ensure that all uses are incorporated in the registration
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All existing substances must have been "pre-registered" between 1st June and 1st December 2008 to allow the manufacturer/importer to take advantage of the phase-in period (Figure 1)
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Depending on quantity of the substance being manufactured, and its classification, full registration must occur before the deadlines set out in the REACH phase-in timetable
In brief, full registration of an existing chemical under REACH will take place in the following steps following pre-registration:
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Formation of Substance Information and Exchange Fora (SIEFs) and Consortia for each chemical; potential registrants will work together to meet the requirements of REACH regarding "joint registration"
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Gathering and evaluation of existing data on chemical substances
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Data gap analysis and development of a testing strategy to fill existing data gaps
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Agreement on a classification and labelling scheme for the chemical substance consistent with the Globally Harmonised System for classification and labelling (GHS)
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Exposure, Hazard and Risk Assessments for all chemical exposure scenarios as required by the Regulation
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Preparation of a Technical Dossier for all chemical substances and a Chemical Safety Report for substance as required
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Submission of the REACH dossier to the European Chemicals Agency (ECHA)
After registration, dossiers must be updated whenever new information on the substance is available, if a manufacturer or importer moves into a higher annual tonnage bracket, or if requested to do so by ECHA.
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