S.L. 427.40 Art. 20Market surveillance.

(1) When the Market Surveillance Directorate takes measures as provided for in these regulations, and in particular those referred to in sub-regulation (2), it shall take due account of the precautionary principle.

(2) The Market Surveillance Directorate shall organise and perform surveillance of toys placed on the market in accordance with Articles 15 to 29 of Regulation (EC) No 765/2008. In addition to those Articles, sub-regulations (3) to (5) shall apply.

(3) The Market Surveillance Directorate may request a notified body to provide information relating to any EC-type examination certificate which that body has issued or withdrawn, or which relates to any refusal to issue such a certificate, including the test reports and technical documentation.

(4) Where the Market Surveillance Directorate finds that a toy is not in conformity with the requirements set out in regulation 9 and Schedule I, it shall, where appropriate, instruct the notified body to withdraw the EC-type examination certificate in respect of that toy.

(5) Where necessary, and in particular in the cases specified in the regulation 13(12), the Market Surveillance Directorate shall instruct the notified body to review the EC-type examination certificate.

(6) Where the Market Surveillance Directorate has taken action pursuant to Article 20 of Regulation (EC) No 765/2008, or where it has sufficient reason to believe that a toy covered by these regulations presents a risk to the health or safety of persons, it shall carry out an evaluation in relation to the toy concerned covering all the requirements laid down in these regulations. The relevant economic operators shall cooperate as necessary with the Market Surveillance Directorate.

(7) (a) Where, in the course of that evaluation, the Market Surveillance Directorate finds that the toy does not comply with the requirements laid down in these regulations, it shall without delay require the relevant economic operator to take appropriate corrective action to bring the toy into compliance with those requirements, to withdraw the toy from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as they may prescribe.

(b) The Market Surveillance Directorate shall inform the relevant notified body accordingly.

(c) Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred in the preceding paragraph.

(8) Where the Market Surveillance Directorate considers that non-compliance is not restricted to the local territory, it shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the relevant economic operator to take.

(9) The relevant economic operator shall ensure that appropriate corrective action is taken in respect of toys which that operator has made available on the local or Community market.

(10) (a) Where the relevant economic operator does not take adequate corrective action within the period referred to in the second sub-paragraph of sub-regulation (7), the Market Surveillance Directorate shall take appropriate provisional measures to prohibit or restrict the toy being made available on the local market, to withdraw the toy from that market or to recall it.

(b) The Market Surveillance Directorate shall inform the Commission and the other Member States, without delay, of those measures.

(11) The information referred to in sub-regulation (10) shall include all available details, in particular the data necessary for the identification of the non-compliant toy, the origin of the toy, the nature of the alleged non-compliance and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, the Market Surveillance Directorate shall indicate whether the non-compliance is due to either:

(a) failure of the toy to meet requirements relating to the health or safety of persons; or

(b) shortcomings in the harmonised standards referred to in regulation 13(1) conferring a presumption of conformity.

(12) Where market surveillance procedures are initiated in another Member State other than Malta, the Market Surveillance Directorate shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the toy concerned, and, in the event of disagreement with the notified national measure, of their objections.

(13) Where, within three months of receipt of the information referred to in sub-regulation (10), no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by the Market Surveillance Directorate, that measure shall be deemed to be justified.

(14) The Market Surveillance Directorate shall take appropriate restrictive measures in respect of the toy concerned, such as withdrawal of the toy from their market, without delay.

(15) Where, on completion of the procedure set out in sub-regulations (9) and (10), the national measure is considered justified, irrespective of whether the national measure was initiated in Malta or in another Member State, the Market Surveillance Directorate shall take the measures necessary to ensure that the non-compliant toy is withdrawn from their market, and shall inform the Commission accordingly.

(16) Where the national measure is considered unjustified by the Commission, the Market Surveillance Directorate shall withdraw it.

(17) If a measure referred to in sub-regulation (10) is a type of measure which is required under Article 22 of Regulation (EC) No 765/2008 to be notified through the Community Rapid Information Exchange System, it shall not be necessary to make a separate notification under sub-regulation (10), provided that the following conditions are met:

(a) the Community Rapid Information Exchange notification indicates that the notification of the measure is also required by these regulations;

(b) the supporting evidence referred to in sub-regulation

(11) is enclosed with the Community Rapid Information Exchange notification.

(18) Without prejudice to sub-regulations (6) to (14), where the Market Surveillance Directorate makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned:

(a) that the CE marking has been affixed in violation of regulations 9 or 11;

(b) that the CE marking has not been affixed;

(c) that the EC declaration of conformity has not been drawn up;

(d) that the EC declaration of conformity has not been drawn up correctly;

(e) that technical documentation is either not available or not complete.

(19) Where the non-compliance referred to in sub-regulation

(18) persists, the Market Surveillance Directorate shall take appropriate measures to restrict or prohibit the toy being made available on the market, or shall ensure that it is recalled or withdrawn from the market.

(20) By the 20th July 2014 and every five years thereafter, the Market Surveillance Directorate shall send the Commission a report on the application of these regulations. That report shall contain an evaluation of the situation concerning the safety of toys and of the effectiveness of these regulations, as well as a presentation of the market surveillance activities performed by the Market Surveillance Directorate.

(21) When the Market Surveillance Directorate adopts measures under these regulations, the requirements of transparency and confidentiality provided for in article 22 of the Act shall apply.

(22) (a) Any measure taken pursuant to these regulations to prohibit or restrict the placing on the market of a toy, to withdraw a toy or to recall a toy from the market shall state the exact grounds on which it is based.

(b) Such a measure shall be notified without delay to the party concerned, which shall at the same time be informed of the remedies available to it under local laws and of the time limits applicable to them.