List of Substances of Very High Concern (SVHC) Subject to Authorisation under the EU REACH regulation. The Candidate List contains SVHC identified by the European Commission in agreement with the Member States and assisted by the European Chemicals Agency (ECHA). Substances included in the Candidate List are afterwards prioritized for inclusion in Annex XIV List of Substances Subject to Authorisation (Authorisation List).
REACH is the Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1st June 2007 to streamline and improve the former legislative framework on chemicals of the European Union (EU). REACH places greater responsibility on industry to manage the risks that chemicals may pose to the health and the environment.
REACH establishes an Authorisation process by which a manufacturer, importer or downstream user shall not place a substance of very high concern (SVHC) on the European market for a use or use it himself without obtaining an authorisation. The aim is to ensure the good functioning of the internal market while assuring that the risks from SVHC are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable. REACH criteria for SVHC identification as defined in Article 57 are:
(a) substances meeting the criteria for classification in the hazard class carcinogenicity category 1A or 1B in accordance with section 3.6 of Annex I to Regulation (EC) No 1272/2008;
(b) substances meeting the criteria for classification in the hazard class germ cell mutagenicity category 1A or 1B in accordance with section 3.5 of Annex I to Regulation (EC) No 1272/2008;
(c) substances meeting the criteria for classification in the hazard class reproductive toxicity category 1A or 1B, adverse effects on sexual function and fertility or on development in accordance with section 3.7 of Annex I to Regulation(EC) No 1272/2008;
(d) substances which are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XIII of this Regulation;
(e) substances which are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII of this Regulation;
(f) substances — such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) or (e) — for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59.
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