Article 57 of REACH lists the properties that make a substance eligible for the authorisation regime: classification as carcinogenic, germ cell mutagenic or toxic to reproduction in category 1A or 1B under the CLP Regulation; persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to Annex XIII; or, case by case, substances such as endocrine disruptors for which there is scientific evidence of probable serious effects giving rise to an equivalent level of concern. Article 59 sets out the identification procedure: a Member State or ECHA at the Commission’s request prepares an Annex XV dossier, it is subject to comments, and the substance is placed on the candidate list for eventual inclusion in Annex XIV. Substances on that list are the substances of very high concern in everyday usage.
Listing has immediate consequences for articles. Under Article 7(2) a producer or importer of articles must notify ECHA where a candidate list substance is present above 0.1 % weight by weight and in quantities above one tonne per year. Under Article 33 any supplier of an article containing such a substance above 0.1 % must give the recipient enough information for safe use, at least the name of the substance, and must answer a consumer’s request for the same information free of charge within 45 days. Those notifications feed ECHA’s SCIP database under the Waste Framework Directive.
Inclusion in Annex XIV under Article 58 then means that the substance may not be used or placed on the market for a use after the sunset date without an authorisation. For a manufacturer or importer the practical task is to obtain declarations from suppliers, screen bills of materials against each new candidate list, and keep the results in the technical documentation.