S.L. 427.29 Art. 29Market surveillance.

(1) Article 15(3) and articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to pressure equipment and assemblies covered by regulation 3 of these regulations.

(2) (a) Where the Technical Regulations Division have sufficient reasons to believe that pressure equipment or assemblies covered by these regulations present a risk to the health or safety of persons or to domestic animals or property, they shall carry out an evaluation in relation to the pressure equipment or assembly concerned covering all relevant requirements laid down in these regulations. The relevant economic operators shall cooperate as necessary with the market surveillance authorities for that purpose.

(b) Where, in the course of the evaluation referred to in sub-regulation (2), the market Technical Regulations Division find that the equipment or assembly does not comply with the requirements laid down in these regulations, they shall without delay require the relevant economic operator to take all appropriate corrective actions to bring the pressure equipment or assembly into compliance with those requirements, to withdraw the equipment or assembly from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as they may prescribe.

(c) They shall also inform the relevant notified body accordingly.

(d) Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in sub-regulation (4).

(3) Where the Technical Regulations Division consider that non-compliance is not restricted to the Maltese territory, it shall inform the European Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take.

(4) The economic operator shall ensure that all appropriate corrective action is taken in respect of all the pressure equipment concerned that it has made available on the market throughout the European Union.

(5) Where the relevant economic operator does not take adequate corrective action within the period referred to in sub-regulation (2)(b), the Technical Regulations Division shall take all appropriate provisional measures to prohibit or restrict the placing on the Maltese market or the use of the pressure equipment or assembly concerned, or recall it.

(6) The Technical Regulations Division shall inform the European Commission and the other Member States, without delay, of those measures.

(7) The information referred to in the sub-regulation (6) shall include all available details, in particular the data necessary for the identification of the non-compliant equipment or assembly, the origin of the equipment or assembly, the nature of the non-compliance alleged 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 Technical Regulations Division shall indicate whether the non-compliance is due to either of the following:

(a) failure of the equipment or assembly to meet the requirements relating to the health and safety of persons or to the protection of domestic animals or property; or

(b) shortcomings in the harmonised standards referred to in regulation 14 conferring a presumption of conformity.

(8) When the procedure under these regulations is initiated by another Member State, the Technical Regulations Division, shall without delay inform the European 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 equipment or assembly concerned, and, in the event of disagreement with the adopted national measure, of their objections.

(9) Where, within three months of receipt of the information referred to in sub-regulation (6), no objection has been raised by either a Member State or the European Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified.

(10) In such cases, the Technical Regulations Division shall ensure that appropriate restrictive measures, such as withdrawal of the equipment or assembly from the Maltese market, are taken in respect of the equipment or assembly concerned without delay.

(11) Where on completion of the procedure set out in sub-regulations (4) and (5), objections are raised against the measures taken by Technical Regulations Division; the European Commission shall conduct an evaluation including appropriate consultations with these entities and the relevant economic operator or operators.

(12) If, on the basis of this evaluation, the national measure is considered justified, the Technical Regulations Division shall take the measures necessary to ensure that the placing on the market or use of the non-compliant equipment or assembly is withdrawn from the Maltese market and shall inform the European Commission accordingly. If, on the basis of this evaluation, the national measure is considered unjustified, the national measure shall be withdrawn.

(13) Where, having carried out an evaluation under sub-regulation (2), the Technical Regulations Division, finds that although pressure equipment or an assembly is in compliance with these regulations, it presents a risk to the health or safety of persons or to other aspects of public interest protection, it shall require the relevant economic operator to take all appropriate measures to ensure that the equipment or assembly concerned, when placed on the Maltese market, no longer presents that risk, to withdraw the equipment from the market or to recall it within a reasonable period, commensurate with the nature of the risk, as it may prescribe.

(14) The economic operator shall ensure that corrective action is taken in respect of all the equipment or assemblies concerned that he has made available on the market throughout the European Union.

(15) The Technical Regulations Division, upon consultation with the Commissioner of Police, shall immediately inform the European Commission and the other Member States. That information shall include all available details, in particular the data necessary for the identification of the equipment or assembly concerned, the origin and the supply chain of the equipment or assembly, the nature of the risk involved and the nature and duration of the national measures taken.

(16) Without prejudice to sub-regulations (2) to (10), where the Technical Regulations Division and, or the Commissioner of Police make one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned:

(a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of regulation 21 of these regulations;

(b) the CE marking has not been affixed;

(c) the identification number of the notified body involved in the production control phase, has been affixed in violation of regulation 21 or has not been affixed;

(d) the marking and labelling referred to in point 3.3. of Schedule I have not been affixed or have been affixed in violation of regulation 21 or point 3.3 of Schedule I;

(e) the EU declaration of conformity has not been drawn up;

(f) the EU declaration of conformity has not been drawn up correctly;

(g) technical documentation is either not available or not complete;

(h) the information referred to in regulation 8(9) or regulation 10(5) is absent, false or incomplete;

(i) any other administrative requirement provided for in regulation 8 or regulation 10 is not fulfilled.

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

(16) persists, the Technical Regulations Division shall take all appropriate measures to restrict or prohibit the equipment or assembly being made available on the Maltese market or ensure that it is recalled or withdrawn from the Maltese market.

(18) The powers of the Commissioner of Police under this regulation may be exercised by any officer or other entity as he may direct.