Safety assessment
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.
Conformity assessment procedures
1. Manufacturers shall use the conformity assessment procedures referred to in paragraph 2 or 3.
2. If the manufacturer has applied harmonised standards the references of which have been published in the Official Journal of the European Union or common specifications covering all relevant safety requirements for the toy identified in the safety assessment referred to in Article 25 the manufacturer shall use the internal production control procedure set out in Part I of Annex IV.
3. In the following cases, the manufacturer shall use the EU-type examination procedure set out in Part II of Annex IV together with the conformity-to-type procedure set out in Part III of that Annex:
(a)
where harmonised standards the references of which have been published in the Official Journal of the European Union or common specifications covering all relevant safety requirements for the toy, do not exist;
(b)
where harmonised standards or common specifications referred to in point (a) exist but the manufacturer has not applied them or has applied them only in part;
(c)
where one or more of the harmonised standards referred to in point (a) have been published with a restriction and the restriction is applicable to the toy in question;
(d)
where the manufacturer considers that the nature, design, construction or purpose of the toy necessitates third-party verification.
4. The EU-type examination certificate issued in accordance with Part II, point 6, of Annex IV shall be reviewed whenever necessary, in particular in the case of a change to the manufacturing process, the raw materials or the components of the toy, and, in any case, every five years.
Technical documentation
1. The technical documentation shall contain all relevant data or details of the means used by the manufacturer to ensure that the toy complies with the essential safety requirements. It shall, in particular, contain the documents listed in Annex V.
2. The technical documentation shall be drawn up in one of the official languages of the Union.
3. Following a reasoned request from the market surveillance authority of a Member State, the manufacturer shall provide a translation of the relevant parts of the technical documentation into the language of that Member State.
When a market surveillance authority requests the technical documentation or a translation of parts thereof from a manufacturer, it may fix a deadline for receipt of such file or translation, which shall be 30 days, unless a shorter deadline is justified in the case of a serious and immediate risk to health and safety.
4. If the manufacturer does not comply with the requirements set out in paragraphs 1, 2 and 3, the market surveillance authority may require the manufacturer to have a test performed by a notified body at its own expense within a specified period in order to verify compliance with the essential safety requirements.
