Regulation (EC) No 765/2008 of the European Parliament and of the CouncilDangos y teitl llawn

SECTION 2 Community market surveillance framework

Article 17 Information obligations

1. Member States shall inform the Commission of their market surveillance authorities and their areas of competence. The Commission shall transmit that information to the other Member States.

2. Member States shall ensure that the public is aware of the existence, responsibilities and identity of national market surveillance authorities, and of how those authorities may be contacted.

Article 18 Obligations of the Member States as regards organisation

1. Member States shall establish appropriate communication and coordination mechanisms between their market surveillance authorities.

2. Member States shall establish adequate procedures in order to:

(a) follow up complaints or reports on issues relating to risks arising in connection with products subject to Community harmonisation legislation;

(b) monitor accidents and harm to health which are suspected to have been caused by those products;

(c) verify that corrective action has been taken; and

(d) follow up scientific and technical knowledge concerning safety issues.

3. Member States shall entrust market surveillance authorities with the powers, resources and knowledge necessary for the proper performance of their tasks.

4. Member States shall ensure that market surveillance authorities exercise their powers in accordance with the principle of proportionality.

5. Member States shall establish, implement and periodically update their market surveillance programmes. Member States shall draw up either a general market surveillance programme or sector specific programmes, covering the sectors in which they conduct market surveillance, communicate those programmes to the other Member States and the Commission and make them available to the public, by way of electronic communication and, where appropriate, by other means. The first such communication shall be effected by 1 January 2010. Subsequent updates of the programmes shall be made public in the same manner. Member States may cooperate with all relevant stakeholders to those ends.

6. Member States shall periodically review and assess the functioning of their surveillance activities. Such reviews and assessments shall be carried out at least every fourth year and the results thereof shall be communicated to the other Member States and the Commission and be made available to the public, by way of electronic communication and, where appropriate, by other means.

Article 19 Market surveillance measures

1. Market surveillance authorities shall perform appropriate checks on the characteristics of products on an adequate scale, by means of documentary checks and, where appropriate, physical and laboratory checks on the basis of adequate samples. When doing so they shall take account of established principles of risk assessment, complaints and other information.

Market surveillance authorities may require economic operators to make such documentation and information available as appear to them to be necessary for the purpose of carrying out their activities, and, where it is necessary and justified, enter the premises of economic operators and take the necessary samples of products. They may destroy or otherwise render inoperable products presenting a serious risk where they deem it necessary.

Where economic operators present test reports or certificates attesting conformity issued by an accredited conformity assessment body, market surveillance authorities shall take due account of such reports or certificates.

2. Market surveillance authorities shall take appropriate measures to alert users within their territories within an adequate timeframe of hazards they have identified relating to any product so as to reduce the risk of injury or other damage.

They shall cooperate with economic operators regarding actions which could prevent or reduce risks caused by products made available by those operators.

3. Where the market surveillance authorities of one Member State decide to withdraw a product manufactured in another Member State, they shall inform the economic operator concerned at the address indicated on the product in question or in the documentation accompanying that product.

4. Market surveillance authorities shall carry out their duties independently, impartially and without bias.

5. Market surveillance authorities shall observe confidentiality where necessary in order to protect commercial secrets or to preserve personal data pursuant to national legislation, subject to the requirement that information be made public under this Regulation to the fullest extent necessary in order to protect the interests of users in the Community.

Article 20 Products presenting a serious risk

1. Member States shall ensure that products which present a serious risk requiring rapid intervention, including a serious risk the effects of which are not immediate, are recalled, withdrawn or that their being made available on their market is prohibited, and that the Commission is informed without delay thereof, in accordance with Article 22.

2. The decision whether or not a product represents a serious risk shall be based on an appropriate risk assessment which takes account of the nature of the hazard and the likelihood of its occurrence. The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering that a product presents a serious risk.

Article 21 Restrictive measures

1. Member States shall ensure that any measure taken, pursuant to the relevant Community harmonisation legislation, to prohibit or restrict the product's being made available on the market, to withdraw it from the market or to recall it, is proportionate and states the exact grounds on which it is based.

2. Such measures shall be communicated without delay to the relevant economic operator, which shall at the same time be informed of the remedies available under the law of the Member State concerned and of the time limits to which such remedies are subject.

3. Prior to the adoption of a measure referred to in paragraph 1, the economic operator concerned shall be given the opportunity to be heard within an appropriate period of not less than 10 days, unless such consultation is not possible because of the urgency of the measure to be taken, as justified by health or safety requirements or other grounds relating to the public interests covered by the relevant Community harmonisation legislation. If action has been taken without the operator's being heard, the operator shall be given the opportunity to be heard as soon as possible and the action taken shall be reviewed promptly thereafter.

4. Any measure referred to in paragraph 1 shall be promptly withdrawn or amended upon the economic operator's demonstrating that he has taken effective action.

Article 22 Exchange of information — Community Rapid Information System

1. Where a Member State takes or intends to take a measure in accordance with Article 20 and considers that the reasons which prompted the measure or the effects of the measure go beyond its territory, it shall immediately notify the Commission of that measure, in accordance with paragraph 4 of this Article. It shall also inform the Commission without delay of the modification or withdrawal of any such measure.

2. If a product presenting a serious risk has been made available on the market, Member States shall notify the Commission of any voluntary measures taken and communicated by an economic operator.

3. The information provided in accordance with paragraphs 1 and 2 shall include all available details, in particular the data necessary for the identification of the product, the origin and the supply chain of the product, the related risk, the nature and the duration of the national measure taken and any voluntary measures taken by economic operators.

4. For the purposes of paragraphs 1, 2 and 3, the market surveillance and information exchange system provided for in Article 12 of Directive 2001/95/EC shall be used. Paragraphs 2, 3 and 4 of Article 12 of that Directive shall apply mutatis mutandis.

Article 23 General information support system

1. The Commission shall develop and maintain a general archiving and exchange of information system, using electronic means, on issues relating to market surveillance activities, programmes and related information on non-compliance with Community harmonisation legislation. The system shall appropriately reflect notifications and information provided under Article 22.

2. For the purposes of paragraph 1, Member States shall provide the Commission with information at their disposal and not already provided under Article 22 on products presenting a risk regarding, in particular, identification of risks, results of testing carried out, provisional restrictive measures taken, contacts with the economic operators concerned and justification for action or inaction.

3. Without prejudice to Article 19(5) or to national legislation in the area of confidentiality, the safeguarding of confidentiality with regard to the information content shall be ensured. The protection of confidentiality shall not prevent the dissemination to market surveillance authorities of information relevant to ensuring the effectiveness of market surveillance activities.

Article 24 Principles of cooperation between the Member States and the Commission

1. Member States shall ensure efficient cooperation and exchange of information between their market surveillance authorities and those of the other Member States and between their own authorities and the Commission and the relevant Community agencies regarding their market surveillance programmes and all issues relating to products presenting risks.

2. For the purposes of paragraph 1, the market surveillance authorities of one Member State shall give the market surveillance authorities of other Member States assistance on an adequate scale by supplying information or documentation, by carrying out appropriate investigations or any other appropriate measure and by participating in investigations initiated in other Member States.

3. The Commission shall collect and organise such data on national market surveillance measures as will enable it to fulfil its obligations.

4. Any information provided by an economic operator under Article 21(3) or otherwise shall be included when the reporting Member State notifies other Member States and the Commission of its findings and actions. Any subsequent information shall be clearly identified as relating to the information already provided.

Article 25 Sharing of resources

1. Market surveillance initiatives designed to share resources and expertise between the competent authorities of the Member States may be set up by the Commission or the Member States concerned. Such initiatives shall be coordinated by the Commission.

2. For the purposes of paragraph 1, the Commission shall, in cooperation with the Member States:

(a) develop and organise training programmes and exchanges of national officials;

(b) develop, organise and set up programmes for the exchange of experience, information and best practice, programmes and actions for common projects, information campaigns, joint visit programmes and the consequent sharing of resources.

3. Member States shall ensure that their competent authorities participate fully in the activities referred to in paragraph 2, where appropriate.

Article 26 Cooperation with the competent authorities of third countries

1. Market surveillance authorities may cooperate with the competent authorities of third countries with a view to exchanging information and technical support, promoting and facilitating access to European systems and promoting activities relating to conformity assessment, market surveillance and accreditation.

The Commission shall, in cooperation with Member States, develop appropriate programmes for that purpose.

2. Cooperation with the competent authorities of third countries shall take the form of, inter alia, the activities referred to in Article 25(2). Member States shall ensure that their competent authorities participate fully in those activities.