rec_22

(22) The European positive lists are the lists of starting substances, compositions or constituents, depending on the type of materials, namely organic, cementitious, metallic, enamels and ceramic or other inorganic materials, authorised for use in the manufacture of materials, and those lists should include, where appropriate, conditions for their use and migration limits. For the inclusion of a starting substance, composition or constituent in the European positive lists, a risk assessment of the starting substance, composition or constituent itself, as well as relevant impurities and foreseeable reaction and degradation products in the intended use, should be required. The risk assessment by the applicant or national authority should cover health risks arising from the potential migration under worst foreseeable conditions of use and from the toxicity. Based on the risk assessment, the European positive lists should, if necessary, set out specifications for the starting substance, composition or constituent and restrictions of use, quantitative restrictions or migration limits for the starting substance, composition or constituent, possible impurities and reaction products or constituents in order to ensure the safety of the final material to be used in a product in contact with water intended for human consumption. For the purpose of establishing the first European positive lists, national positive lists of starting substances, compositions and constituents or other national provisions, the methodologies that led to the establishment of such national lists and provisions, and the accompanying risk assessments for each of the starting substances, compositions and constituents should be made available to the European Chemicals Agency set up under Regulation (EC) No 1907/2006 of the European Parliament and of the Council Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1). (‘ECHA’). ECHA should, on that basis, recommend compiled lists to the Commission. ECHA should review and deliver an opinion on the substances, compositions and constituents on the first European positive lists in time for the Commission to review the lists by 15 years after their adoption. For the purposes of updating the European positive lists, ECHA should deliver opinions on the inclusion or removal of substances, compositions or constituents.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-28 · Text as adopted (Official Journal); later amendments are not incorporated in this text.