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Directive 2010/35/EU of the European Parliament and of the CouncilShow full title

Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC (Text with EEA relevance)

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CHAPTER 5SAFEGUARD PROCEDURES

Article 30Procedure for dealing with transportable pressure equipment presenting a risk at national level

1.Where the market surveillance authorities of one Member State have taken action pursuant to Article 20 of Regulation (EC) No 765/2008 or where they have sufficient reason to believe that transportable pressure equipment covered by this Directive presents a risk to the health or safety of persons or to other aspects of public interest protection covered by this Directive, they shall carry out an evaluation in relation to the transportable pressure equipment concerned covering all the requirements laid down in this Directive. The relevant economic operators shall cooperate as necessary with the market surveillance authorities, including granting access to their premises and providing samples as appropriate.

Where, in the course of that evaluation, the market surveillance authorities find that the transportable pressure equipment does not comply with the requirements set out in the Annexes to Directive 2008/68/EC and in this Directive, they shall without delay require the relevant economic operator to take all appropriate corrective action to bring the transportable pressure equipment into compliance with those requirements, to withdraw the transportable pressure equipment from the market or to recall it within a reasonable period, commensurate with the nature of the risk, as they may prescribe.

The market surveillance authorities shall inform the relevant notified body accordingly.

Article 21 of Regulation (EC) No 765/2008 shall apply to the corrective action referred to in the second subparagraph of this paragraph.

2.Where the market surveillance authorities consider that non-compliance is not restricted to their national territory, they shall inform the 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.

3.The economic operator shall ensure that all appropriate corrective action is taken in respect of transportable pressure equipment that it has made available on the Union market.

4.Where the relevant economic operator does not take adequate corrective action within the period referred to in the second subparagraph of paragraph 1, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the transportable pressure equipment being made available on their national market, to withdraw the equipment from that market or to recall it.

They shall inform the Commission and the other Member States, without delay, of those measures.

5.The information referred to in paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant transportable pressure equipment, the origin of the equipment, 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 authorities shall indicate whether the non-compliance is due to either:

(a)failure of the transportable pressure equipment to meet requirements relating to the health or safety of persons or to other aspects of public interest protection set out in the Annexes to Directive 2008/68/EC and in this Directive, or

(b)shortcomings in the standards or technical codes referred to in the Annexes to Directive 2008/68/EC or in other provisions of that Directive.

6.Member States other than the Member State initiating the procedure 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 transportable pressure equipment concerned, and, in the event of disagreement with the notified national measure, of their objections.

7.Where, within two months of receipt of the information referred to in paragraph 4, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified.

8.Member States shall ensure that appropriate restrictive measures are taken in respect of the transportable pressure equipment concerned, such as withdrawal of the transportable pressure equipment from their market, without delay.

Article 31Union safeguard procedure

1.Where, on completion of the procedure set out in Article 30(3) and (4), objections are raised against a measure taken by a Member State or where the Commission considers a national measure to be contrary to a legally binding Union act, the Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall decide whether the national measure is justified or not.

The Commission shall address its decision to all Member States and shall immediately communicate it to them and to the relevant economic operator or operators.

2.If the national measure is considered justified, all Member States shall take the measures necessary to ensure that the non-compliant transportable pressure equipment is withdrawn from their markets, and shall inform the Commission accordingly.

If the national measure is considered unjustified, the Member State concerned shall withdraw it.

3.Where the national measure is considered justified and the non-compliance of the transportable pressure equipment is attributed to shortcomings in the standards as referred to in Article 30(5)(b), the Commission shall inform the relevant European standardisation body or bodies and may bring the matter before the Committee set up by Article 5 of Directive 98/34/EC(1). That Committee may consult the relevant European standardisation body or bodies before delivering its opinion.

Article 32Compliant transportable pressure equipment which presents a risk to health and safety

1.Where having performed an evaluation pursuant to Article 30(1) a Member State finds that although transportable pressure equipment is in compliance with Directive 2008/68/EC and this Directive, 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 transportable pressure equipment concerned, when placed on the 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.

2.The economic operator shall ensure that corrective action is taken in respect of all the transportable pressure equipment concerned that he has made available on the market or is using throughout the Union.

3.The Member State shall immediately inform the Commission and the other Member States. That information shall include all available details, in particular the data necessary for the identification of the transportable pressure equipment concerned, the origin and the supply chain of the equipment, the nature of the risk involved and the nature and duration of the national measures taken.

4.The Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall decide whether the measure is justified or not, and where necessary, propose appropriate measures.

5.The Commission shall address its decision to all Member States and shall immediately communicate it to them and to the relevant economic operator or operators.

Article 33Formal non-compliance

1.Without prejudice to Article 30, where a Member State 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 Pi marking has been affixed in violation of Article 12, 13, 14 or 15;

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

(c)that the technical documentation is either not available or not complete;

(d)that the requirements of the Annexes to Directive 2008/68/EC and of this Directive have not been complied with.

2.Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures to restrict or prohibit the transportable pressure equipment being made available on the market or shall ensure that it is recalled or withdrawn from the market.

(1)

Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (OJ L 204, 21.7.1998, p. 37).

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