Chemical substances (REACH): regulatory context

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REACH Regulation (EC) No.1907/2006 (Registration, Evaluation, Authorisation and Restriction of Chemicals) has applied to all substances manufactured or imported in quantities ≥ 1 ton/year in the European Union since 01/06/2007 (registration mandatory for pure substances or substances contained in products or articles before placement on the market). Distributors or downstream users also have obligations under REACH (communicating the SDS, checking covered uses and risk management measures, complying with restrictions and authorisation).

After the first two registration steps of 2010 (substances ≥ 1 000 ton/year, CMR 1 and 2 ≥ 1 ton/year, R50/R53 ≥ 100 ton/year) and 2013 (substances ≥ 100 ton/year), the final deadline is approaching for all other substances ≥ 1 ton/year with registration due by 31/05/2018.

Furthermore, the Safety Data Sheet (SDS)  is now a mandatory document according to REACH Regulation: its format and contents are defined in Regulation (EU) No.2015/830. Its preparation requires multi-disciplinary knowledge (classification, occupational safety and risk management, physical chemistry, (eco)toxicology, transport of dangerous goods, etc.) and must remain concise and comprehensible to the recipient. In addition, it must be regularly revised.

Furthermore, placement on the European market of a substance or mixture must also strictly comply with the CLP Regulation (EC) No.1272/2008. This regulation governs the classification, packaging and labelling of substances and products. Application of these new classification and labelling rules has been mandatory for substances since 2010, and for mixtures since 2015; these rules are constantly changing (adaptation to technical progress).

Finally, according to article 45 of CLP Regulation, for any hazardous product placed on the European market, a declaration must be submitted to the national bodies appointed for collecting information related to emergency health response in all Member States where the product is marketed.

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