1. In order to demonstrate that a toy complies with the essential safety requirements, manufacturers shall, before placing a toy on the market, carry out a safety assessment, including an analysis of the hazards that the toy may present, as well as an assessment of any potential exposure to such hazards.
2. The safety assessment shall in particular:
(a) cover all the chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards and the potential exposure to such hazards;
(b) in relation to chemical hazards, take account of the possible exposure to individual chemicals, and any known additional hazards from combined exposure to the different chemicals present in the toy, taking into account the obligations set out in Regulation (EC) No 1907/2006 and the conditions set out therein;
(c) for toys falling within the scope of Regulation (EU) 2024/1689 or (EU) 2024/2847 or Directive 2014/53/EU, take account of the particular vulnerabilities of children in relation to the use of such toys as intended, when assessing and addressing the hazards that the toy may present; and
(d) be updated whenever additional relevant information is available.
For the purposes of the first subparagraph, point (b), the safety assessment shall consider the possible non-intended presence of substances subject to Part III, point 4, of Annex II and shall take into account any information provided to the manufacturer as regards the presence of substances or mixtures meeting the classification criteria of the categories set out in Part III, point 4, of Annex II.
3. The safety assessment shall be included in the technical documentation referred to in Article 27.
Text as published in the Official Journal, reproduced verbatim (including any typographical quirks of the source). For the authentic version, see EUR-Lex.