S.L. 427.40 Art. 4Responsibilities of manufacturers.

(1) When placing their toys on the market, manufacturers shall ensure that the toys have been designed and manufactured in accordance with the requirements set out in regulation 9 and Schedule I.

(2) (a) Manufacturers shall draw up the required technical documentation in accordance with regulation 14 and carry out or have carried out the applicable conformity assessment procedure in accordance with regulation 13.

(b) Where compliance of a toy with the applicable requirements has been demonstrated by that procedure, manufacturers shall draw up an EC declaration of conformity, as referred to in regulation 12, and affix the CE marking, as set out in regulation 11.

(3) Manufacturers shall keep the technical documentation and the EC declaration of conformity at the disposal of the Market Surveillance Directorate for a period of ten years after the toy has been placed on the market.

(4) Manufacturers shall ensure that procedures are in place for series production to remain in conformity. Changes in toy design or characteristics and changes in the harmonised standards by reference to which conformity of a toy is declared shall be adequately taken into account.

(5) When deemed appropriate with regard to the risks presented by a toy, manufacturers shall, to protect the health and safety of consumers, carry out sample testing of marketed toys, investigate and keep a register of complaints, of non-conforming toys and toy recalls, and shall keep distributors informed of any such monitoring. They shall keep such register at the disposal of the Market Surveillance Directorate.

(6) Manufacturers shall ensure that their toys bear a type, batch, serial or model number or other element allowing their identification, or, where the size or nature of the toy does not allow it, that the required information is provided on the packaging or in a document accompanying the toy.

(7) Manufacturers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the toy or, where that is not possible, on its packaging or in a document accompanying the toy. The address shall indicate a single point at which the manufacturer can be contacted.

(8) Manufacturers shall ensure that the toy is accompanied by instructions and safety information. All information accompanying the toy and on the toy itself must be in, at least, the English or Maltese language.

(9) Manufacturers who consider or have reason to believe that a toy which they have placed on the market is not in conformity with the relevant Community harmonisation legislation shall immediately take the corrective measures necessary to bring that toy into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the toy presents a risk, manufacturers shall immediately inform the Market Surveillance Directorate giving details, in particular, of the non-compliance and of any corrective measures taken.

(10) Manufacturers shall, further to a reasoned request from the Market Surveillance Directorate, provide that Directorate with all the information and documentation necessary to demonstrate the conformity of the toy, in the English or Maltese language. They shall cooperate with that Directorate, at its request, as regards any action taken to eliminate the risks posed by toys which they have placed on the market.