In 2007 and shortly thereafter the European Parliament brought in two regulations: Rule (CE) 1907/2006 REACH (Registration, Evaluation, Authorization and Restriction of CHemicals) and Rule (CE) 1272/2008 CLP (Classification, Labelling and Packaging). These oblige manufacturers/importers to self-classify, characterize, register and perform toxicity testing on chemical substances produced or marketed in the European Community. CLP had immediate effect, while application of REACH was staggered:
30/11/2010: substances manufactured or imported in amounts ≥ 1,000 tonnes/year;
31/5/2013: substances manufactured or imported in amounts between 100 and 1,000 tonnes/year;
31/5/2018: substances manufactured or imported in amounts between 10 and 100 tonnes/year.
REACH and CLP inspectors have activated and are testing registration dossiers and safety files on hazardous substances/mixtures. Administrative, monetary and in some cases penal sanctions will apply to erroneous, incomplete or fraudulent registration or classification.
The European Chemical Agency (ECHA) was set up by the EU in 2007 to ensure that REACH and CLP regulations are correctly and uniformly enforced. Technological and scientific practice was brought under a “No data, no market” policy and dossiers substantiating experimental studies would be analysed. ECHA will only admit of GLP studies ensuring quality by criteria and methods common to all States belonging to OCSE (Organization for Economic Cooperation and Development).