S.L. 427.40 ст. 13Conformity assessment.

(1) Toys which are in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements covered by those standards or parts thereof set out in regulation 9 and Schedule I.

(2) Manufacturers shall, before placing a toy on the local or Community market, carry out an analysis of the chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards that the toy may present, as well as an assessment of the potential exposure to such hazards.

(3) Before placing a toy on the local or Community market, manufacturers shall use the conformity assessment procedures referred to in sub-regulations (4) and (5) to demonstrate that the toy complies with the requirements set out in regulation 9 and Schedule I.

(4) If the manufacturer has applied harmonised standards, the reference number of which has been published in the Official Journal of the European Union, covering all relevant safety requirements for the toy, it shall use the internal production control procedure set out in Schedule VII.

(5) In the following cases, the toy shall be submitted to EC-type examination, as referred to in sub-regulations (6) to (15), together with the conformity to type procedure set out in Schedule IX:

(a) where harmonised standards, the reference number of which has been published in the Official Journal of the European Union, covering all relevant safety requirements for the toy, do not exist;

(b) where the harmonised standards referred to in paragraph (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 paragraph (a) has been published with a restriction;

(d) when the manufacturer considers that the nature, design, construction or purpose of the toy necessitate third party verification.

(6) An application for EC-type examination, performance of that examination and issue of the EC-type examination certificate shall be carried out in accordance with the procedures set out in Schedule VIII.

(7) EC-type examination shall be carried out in the manner specified in the second indent of point 2 of Schedule VIII.

(8) In addition to those provisions, the requirements laid down in sub-regulations (9) to (15) shall apply.

(9) The application for an EC-type examination shall include a description of the toy and an indication of the place of manufacture, including the address.

(10) When a conformity assessment body notified under regulation 15 (hereinafter referred to as "notified body") carries out the EC-type examination, it shall evaluate, if necessary together with the manufacturer, the analysis of the hazards that toy may present carried out by the manufacturer in accordance with sub-regulation (2).

(11) The EC-type examination certificate shall include a reference to these regulations, a colour image, a clear description of the toy, including its dimensions, and a list of the tests performed, together with a reference to the relevant test report.

(12) The EC-type examination certificate shall be reviewed whenever necessary, in particular in case of a change to the manufacturing process, the raw materials or the components of the toy, and, in any case, every five years.

(13) The EC-type examination certificate shall be withdrawn if the toy fails to comply with the requirements set out in regulation 9 and Schedule I.

(14) Notified bodies shall not grant an EC-type examination certificate for a toy in respect of which a certificate has been refused or withdrawn.

(15) When the notified body is established in Malta, the technical documentation and correspondence relating to the EC-type examination procedures shall be drawn up in at least, the English or Maltese language.