Legal provisions of COM(2013)75 - Amending a number of directives on the market surveillance of products

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dossier COM(2013)75 - Amending a number of directives on the market surveillance of products.
document COM(2013)75 EN
date February 13, 2013

Contents

CHAPTER I - General provisions

Article 1 - Subject matter

This Regulation lays down a framework for verifying that products meet requirements which safeguard, at a high level, the health and safety of persons in general, health and safety in the workplace, consumer protection, the environment, public security and other public interests.

Article 2 - Scope

1. Chapters I, II, III, V and VI of this Regulation shall apply to all products that are subject to Regulation (EU) No [… on Consumer Product Safety] or Union harmonisation legislation, including to products assembled or manufactured for the manufacturer's own use, and to the extent that Union harmonisation legislation does not contain a specific provision with the same objective.

2. Chapters I and IV and Article 23 shall apply to all products covered by Union legislation to the extent that other Union legislation does not contain specific provisions relating to the organisation of external border controls or to cooperation between authorities in charge of external border controls.

3. Chapters II, III, V and VI shall not apply to the following products:

(a) medicinal products for human or veterinary use;

(b) medical devices and in vitro diagnostic medical devices;

(c) blood, tissues, cells, organs and other substances of human origin.

4. Chapter III of this Regulation shall not apply to transportable pressure equipment subject to Directive 2010/35/EU.

5. Articles 11 and 18 of this Regulation shall not apply to the following products:

(a) products subject to Regulation (EC) No 1907/2006;

(b) fittings as defined in Article 1(2)(b) of Directive 2009/142/EC;

(c) pressure equipment subject to the provisions of Article 3(3) of Directive 97/23/EC;

(d) simple pressure vessels subject to the provisions of Article 3(2) of Directive 2009/105/EC.

6. This Regulation shall not apply in the areas governed by Union legislation on official controls and other official activities carried out for the verification of compliance with the following rules:

(a) rules governing food and food safety, at any stage of production, processing and distribution of food, including rules aimed at guaranteeing fair practices in trade and protecting consumer interests and information;

(b) rules governing the manufacture and use of materials and articles intended to come into contact with food;

(c) rules governing the deliberate release into the environment of genetically modified organisms;

(d) rules governing feed and feed safety, at all stages of production, processing and distribution of feed and the use of feed, including rules aimed at guaranteeing fair practices in trade and protecting consumer interests and information;

(e) rules laying down animal health requirements;

(f) rules aiming at preventing and minimising risks to human and animal health arising from animal by-products and derived products;

(g) rules laying down welfare requirements for animals;

(h) rules on protective measures against pests of plants;

(i) rules on the production, with a view to placing on the market, and placing on the market of plant reproductive material;

(j) rules laying down the requirements for placing on the market and the use of plant protection products and the sustainable use of pesticides;

(k) rules governing organic production and labelling of organic products;

(l) rules on the use and labelling of protected designations of origin, protected geographical indications and traditional specialities guaranteed.

Article 3 - Definitions

For the purposes of this Regulation the following definitions shall apply:

(1) ‘product’ means a product obtained through a manufacturing process;

(2) ‘making available on the market’ means any supply of a product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

(3) ‘placing on the market’ means the first making available of a product on the Union market;

(4) ‘manufacturer’ means any natural or legal person who manufactures a product or has a product designed or manufactured and markets that product under his name or trademark;

(5) ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;

(6) ‘importer’ means any natural or legal person established within the Union who places a product from a third country on the Union market;

(7) ‘distributor’ means any natural or legal person in the supply chain, other than a manufacturer or importer, who makes a product available on the market;

(8) ‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;

(9) ‘conformity assessment’ means conformity assessment as defined in Regulation (EC) No 765/2008;

(10) ‘conformity assessment body’ means conformity assessment body as defined in Regulation (EC) No 765/2008;

(11) ‘market surveillance’ means the activities carried out and measures taken by public authorities to ensure that products do not endanger health, safety or any other aspect of public interest protection and, in the case of products falling within the scope of Union harmonisation legislation, that they comply with the requirements set out in that legislation;

(12) ‘market surveillance authority’ means an authority of a Member State responsible for carrying out market surveillance on its territory;

(13) ‘product presenting a risk’ means a product having the potential to affect adversely health and safety of persons in general, health and safety in the workplace, consumer protection, the environment and public security as well as other public interests to a degree which goes beyond that considered reasonable and acceptable under the normal or reasonably foreseeable conditions of use of the product concerned, including the duration of use and, where applicable, its putting into service, installation and maintenance requirements;

(14) ‘product presenting a serious risk’ means a product presenting a risk requiring rapid intervention and follow-up, including cases where the effects may not be immediate;

(15) ‘recall’ means any measure aimed at achieving the return of a product that has already been made available to the end user;

(16) ‘withdrawal’ means any measure aimed at preventing a product in the supply chain from being made available on the market;

(17) ‘release for free circulation’ means the procedure laid down in Article 79 of Council Regulation (EEC) No 2913/92;

(18) ‘Union harmonisation legislation’ means Union legislation harmonising the conditions for the marketing of products;

(19) ‘European standard’ means a European standard as defined in Article 2(1)(b) of Regulation (EU) No 1025/2012 of the European Parliament and the Council;

(20) ‘harmonised standard’ means a harmonised standard as defined in Article 2(1)(c) of Regulation (EU) No 1025/2012.

CHAPTER II - Union market surveillance framework

Article 4 - Market surveillance obligation

1. Member States shall carry out market surveillance in respect of products covered by this Regulation.

2. Market surveillance shall be organised and carried out in accordance with this Regulation with a view to ensuring that products presenting a risk are not made available on the Union market and, where such products have been made available, effective measures are taken to remove the risk presented by the product.

3. The implementation of market surveillance activities and external border controls shall be monitored by the Member States which shall report on these activities and controls to the Commission every year. The information reported shall include statistics regarding the number of controls carried out and shall be communicated to all Member States. Member States may make a summary of the results accessible to the public.

4. The results of the monitoring and assessment of market surveillance activities carried out pursuant to paragraph 3 shall be made available to the public, electronically and, where appropriate, by other means.

Article 5 - Market surveillance authorities

1. Each Member State shall establish or designate market surveillance authorities and define their duties, powers and organisation.

2. Market surveillance authorities shall be given the powers and entrusted with the resources and means necessary for the proper performance of their tasks.

3. Each Member State shall establish appropriate mechanisms to ensure that the market surveillance authorities that it has established or designated exchange information, cooperate and coordinate their activities both among themselves and with the authorities in charge of controls of products at the external borders of the Union.

4. Each Member State shall inform the Commission about its market surveillance authorities and their areas of competence, providing the necessary contact details, and the Commission shall transmit this information to the other Member States and publish a list of market surveillance authorities.

5. Member States shall inform the public of the existence, responsibilities and identity of national market surveillance authorities and how those authorities may be contacted.

Article 6 - General obligations of market surveillance authorities

1. Market surveillance authorities shall perform appropriate checks on the characteristics of products on an adequate scale and with adequate frequency, by means of a documentary check and, where necessary, a physical and laboratory check on the basis of an adequate sample. They shall record these checks in the information and communication system for market surveillance referred to in Article 21.

In cases of known or emerging risk related to the objectives set out in Article 1 of this Regulation and concerning a particular product or a category of products, the Commission may adopt implementing acts to establish uniform conditions for the carrying out of the checks performed by one or several market surveillance authorities in relation to that particular product or category of products and the characteristics of that known or emerging risk. These conditions may include requirements for a temporary increase of the scale and frequency of checks to be carried out and the adequacy of samples to be checked. These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 32(2).

2. Where appropriate, market surveillance authorities shall alert users in their territories within an adequate timeframe of products that those authorities have identified as presenting a risk.

They shall cooperate with economic operators to prevent or reduce risks caused by products made available by those operators. For this purpose, they shall encourage and promote voluntary action by economic operators including, where applicable, through the development of and adherence to codes of good practice.

3. Market surveillance authorities shall carry out their duties independently, impartially and without bias and shall fulfil their obligations under this Regulation; they shall exercise their powers in relation to economic operators in accordance with the principle of proportionality.

4. Where it is necessary and justified for carrying out their duties, market surveillance authorities may enter the premises of economic operators and take any necessary samples of products.

5. Market surveillance authorities shall:

(a) provide consumers and other interested parties with the opportunity to submit complaints on issues relating to product safety, market surveillance activities and risks arising in connection with products and follow up those complaints as appropriate;

(b) verify that corrective action has been taken;

(c) follow and keep up to date with developments in scientific and technical knowledge concerning the safety of products.

6. Adequate procedures shall be established and made known to the public to enable market surveillance authorities to fulfil these obligations.

7. Without prejudice to national legislation in the area of confidentiality, the safeguarding of confidentiality with regard to information received and collated by market surveillance authorities shall be ensured. Information exchanged between national market surveillance authorities and between them and the Commission on condition of confidentiality shall remain confidential unless the originating authority has agreed to its disclosure.

8. The protection of confidentiality shall not prevent the dissemination to market surveillance authorities of information necessary to ensure effective market surveillance.

Article 7 - Market surveillance programmes

1. Each Member State shall draw up a general market surveillance programme and shall review that programme, and update it if necessary, at least every four years. The programme shall cover market surveillance organisation and related activities and take into account the specific needs of business generally, and SMEs in particular, when implementing Union harmonisation legislation and Regulation (EU) No […/…] [on consumer product safety], and provide for guidance and assistance. It shall include the following:

(a) the sectoral and geographical competence of the authorities designated under Article 5(1);

(b) the financial resources, staff, technical and other means attributed to the authorities;

(c) an indication of the priority areas of work of the different authorities;

(d) the mechanisms of coordination among the different authorities and with customs authorities;

(e) the participation of the authorities in the exchange of information under Chapter V;

(f) the participation of the authorities in sectoral or project-oriented cooperation at Union level;

(g) the means to fulfil the requirements of Article 6(5).

2. Each Member State shall draw up sector-specific programmes and shall review these programmes, and update them if necessary, every year. These programmes shall cover all sectors in which authorities conduct market surveillance activities.

3. The general and sector-specific programmes and their updates shall be communicated to the other Member States and the Commission and, subject to Article 6(6), shall be made accessible to the public electronically and, where appropriate, by other means.

Article 8 - General obligations of economic operators

1. On request, economic operators and, where applicable, conformity assessment bodies, shall make available to market surveillance authorities any documentation and information that those authorities require for the purpose of carrying out their activities, in a language which can be easily understood by them.

2. Economic operators shall provide all necessary information to market surveillance authorities including information that enables the precise identification of the product and facilitates the tracing of the product.

CHAPTER III - Control of products within the Union

Article 9 - Products presenting a risk

1. Where, in the course of carrying out the checks referred to in Article 6(1) or as a result of information received, market surveillance authorities have sufficient reason to believe that a product that is placed or made available on the market or is used in the course of the provision of a service may present a risk, they shall carry out a risk assessment in relation to that product taking account of the considerations and criteria set out in Article 13.

Market surveillance authorities shall take due consideration of any readily available test result and risk assessment that has already been carried out or issued in relation to the product by an economic operator or any other person or authority including the authorities of other Member States.

2. In relation to a product that is subject to Union harmonisation legislation, formal non-compliance with that legislation shall give market surveillance authorities sufficient reason to believe that the product may present a risk in any of the following cases:

(a) the CE marking or other markings required by Union harmonisation legislation have not been affixed or have been affixed incorrectly;

(b) the EU declaration of conformity, where required, has not been drawn up or has been drawn up incorrectly;

(c) the technical documentation is incomplete or unavailable;

(d) the required labelling or instructions for use are incomplete or missing.

Regardless whether the risk assessment shows that the product in fact presents a risk, market surveillance authorities shall require the economic operator to rectify the formal non-compliance. If the economic operator fails to do so, market surveillance authorities shall ensure that the product is withdrawn or recalled.

3. Without prejudice to Article 10(4), where market surveillance authorities find that a product does present a risk they shall without delay specify the necessary corrective action to be taken by the relevant economic operator to address the risk within a specified period. Market surveillance authorities may recommend or agree with the relevant economic operator the corrective action to be taken.

The economic operator shall ensure that all necessary corrective action is taken in respect of all the products concerned that it has made available on the market throughout the Union.

The economic operator shall provide all necessary information to market surveillance authorities pursuant to Article 8, and in particular the following information:

(a) a full description of the risk presented by the product;

(b) a description of any corrective action undertaken to address the risk.

Where possible, market surveillance authorities shall identify the manufacturer or importer of the product and take action in relation to that economic operator in addition to the distributor.

4. Corrective action to be taken by economic operators in relation to a product presenting a risk may include:

(a) in the case of a product subject to the requirements laid down in or pursuant to Union harmonisation legislation, taking the measures necessary to bring the product into compliance with those requirements;

(b) in the case of a product that is liable to present a risk only in certain conditions or only to certain persons and where such risk is not addressed by requirements of Union harmonisation legislation:

(i)      affixing to the product suitable, clearly worded, easily comprehensible warnings of the risks it may present, in the official language or languages of the Member State in which the product is made available on the market ;

(ii)      making the marketing of the product subject to prior conditions;

(iii)     alerting the persons at risk to the risk, in good time and in an appropriate form, including by publication of special warnings;

(c) in the case of a product that may present a serious risk, temporarily preventing the product from being placed or made available on the market pending a risk assessment;

(d) in the case of a product that presents a serious risk:

(i)      preventing the product from being placed or made available on the market;

(ii)      withdrawing or recalling the product and alerting the public to the risk presented;

(iii)     destroying the product or otherwise rendering it inoperable.

5. The Commission may adopt implementing acts establishing the modalities for the provision of information in accordance with the third subparagraph of paragraph 3, while ensuring the effectiveness and proper functioning of the system. These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 32(2).

Article 10 - Measures taken by market surveillance authorities

1. Where the identity of the relevant economic operator cannot be ascertained by the market surveillance authorities or where an economic operator has not taken the necessary corrective action pursuant to Article 9(3) within the period specified, market surveillance authorities shall take all necessary measures to deal with the risk presented by the product.

2. For the purpose of paragraph 1, market surveillance authorities may oblige the relevant economic operators to take, inter alia, any of the corrective action referred to in Article 9(4) or take such measures themselves, as appropriate.

Market surveillance authorities may destroy or otherwise render inoperable a product presenting a risk where they deem it necessary and proportionate. They may require the relevant economic operator to bear the cost of such action.

The first subparagraph shall not prevent Member States from enabling market surveillance authorities to take other, supplementary measures.

3. Prior to taking any measure under paragraph 1 in relation to an economic operator who has failed to take the necessary corrective action, market surveillance authorities shall allow him at least 10 days within which to be heard.

4. Where market surveillance authorities consider that a product presents a serious risk, they shall take all necessary measures and may do so without first requiring the economic operator to take corrective action pursuant to Article 9(3) and without giving the operator the opportunity to be heard beforehand. In such cases the economic operator shall be heard as soon as practicable.

5. Any measure taken pursuant to paragraphs 1 or 4 shall:

(a) be communicated without delay to the economic operator together with information about the remedies available under the law of the Member State concerned;

(b) state the exact grounds on which it is based;

(c) be lifted without delay where the economic operator has demonstrated that he has taken the required action.

For the purposes of point (a) of the first subparagraph, where the economic operator to whom the measure has been communicated is not the economic operator concerned, the manufacturer located within the Union or the importer shall be informed of the measure, provided market surveillance authorities know his identity.

6. Market surveillance authorities shall publish information about product identification, the nature of a risk and the measures taken to prevent, reduce or eliminate that risk on a dedicated website to the fullest extent necessary to protect the interests of users of products in the Union. This information shall not be published where it is imperative to observe confidentiality in order to protect commercial secrets, preserve personal data pursuant to national and Union legislation or avoid undermining monitoring and investigation activities.

7. Any measure taken in accordance with paragraphs 1 or 4 shall be subject to legal remedies, including recourse to the competent national courts.

8. Market surveillance authorities may charge fees on economic operators which wholly or partly cover the costs of their activities, including testing carried out for the risk assessment, where they take measures in accordance with paragraphs 1 or 4.

Article 11 - Union assessment for products controlled within the Union and subject to harmonisation legislation

1. Within 60 days of communication by the Commission to the Member States, pursuant to Article 20(4), of measures taken pursuant to paragraphs 1 or 4 of Article 10 by the original notifying Member State, a Member State may object to those measures where they relate to a product subject to Union harmonisation legislation. The Member State shall state its reasons for objecting, indicate any difference in its assessment of the risk presented by the product and mention any special circumstances and any additional information relating to the product in question.

2. If no objection is raised by a Member State pursuant to paragraph 1 and the Commission does not consider that the national measures are contrary to Union legislation, the measures taken by the original notifying Member State shall be deemed justified and each Member State shall ensure that restrictive measures are taken without delay in respect of the product concerned.

3. Where an objection is raised by a Member State pursuant to paragraph 1 or the Commission considers that the national measures may be contrary to Union legislation, the Commission shall without delay enter into consultation with the relevant economic operator(s) and shall evaluate the national measures, taking account of all available scientific or technical evidence.

4. On the basis of the results of the evaluation conducted pursuant to paragraph 3, the Commission may decide by implementing acts whether the national measures are justified and similar measures should be taken by all Member States that have not already done so. In this case, it shall address the decision to the Member States concerned and immediately communicate it to all Member States and the relevant economic operator or operators.

5. If the Commission decides that the national measures are justified, each Member State shall take the necessary restrictive measures without delay. If it decides that the national measure is not justified, the original notifying Member State and any other Member State that has taken a similar measure shall withdraw the measure and the notification made under the rapid information exchange system pursuant to Article 20.

6. Where a national measure is considered justified and the product is found not to be in compliance with Union harmonisation legislation because of shortcomings in the relevant harmonised standards, the Commission shall inform the relevant European standardisation organisation and may make an appropriate request pursuant to Article 11 of Regulation (EU) No 1025/2012.

Article 12 - Union action against products presenting a serious risk

1. Where it is evident that a product, or a specific category or group of products, when used in accordance with the product's intended purpose or under conditions which can be reasonably foreseeable, presents a serious risk the Commission may, by means of implementing acts, take any appropriate measures depending on the gravity of the situation, including measures prohibiting, suspending or restricting the placing or making available on the market of such products or laying down special conditions for their marketing, in order to ensure a high level of protection of the public interest, provided that the risk cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned or by any other procedure under Union legislation. By those implementing acts, the Commission may lay down the appropriate control measures to be taken by Member States to ensure their effective implementation.

The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 32(2).

On duly justified imperative grounds of urgency relating to the health and safety of persons in general, health and safety in the workplace, consumer protection, the environment and public security and other public interests, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 32(3).

2. For products and risks subject to Regulation (EC) No 1907/2006, a decision taken by the Commission pursuant to paragraph 1 of this Article shall be valid for up to two years and may be extended for additional periods of up to two years. Such a decision shall be without prejudice to procedures provided in that Regulation.

3. The exportation from the Union of a product that has been prohibited to be placed or made available on the Union market pursuant to a measure adopted in accordance with paragraph 1 shall be prohibited, unless the measure expressly so permits.

4. Any Member State may submit a substantiated request to the Commission to examine the need for the adoption of a measure referred to in paragraph 1.

Article 13 - Risk assessment

1. Risk assessment shall be based on available scientific or technical evidence.

For products subject to Regulation (EC) No 1907/2006, risk assessment shall be carried out as appropriate in accordance with the relevant parts of Annex I to that Regulation.

2. In the context of the risk assessment, market surveillance authorities shall take into account the extent to which the product complies with the following:

(a) any requirements laid down in or pursuant to Union harmonisation legislation that apply to the product and relate to the potential risk under consideration, taking full account of test reports or certificates attesting conformity and issued by a conformity assessment body;

(b) in the absence of requirements laid down in or pursuant to Union harmonisation legislation, specific rules laying down health and safety requirements for such products in the national law of the Member State where it is made available on the market, provided that such rules are in accordance with Union law;

(c) any European standards the references of which have been published in the Official Journal of the European Union.

3. Compliance with the criteria referred to in points (a), (b) and (c) of paragraph 2 shall raise a presumption that the product adequately safeguards the public interests to which those criteria relate. However, this shall not prevent market surveillance authorities from taking action under this Regulation where there is new evidence that, despite such conformity or compliance, the product presents a risk.

4. The feasibility of obtaining higher levels of protection of the public interest concerned and the availability of other products presenting a lesser risk shall not be a reason to consider that a product presents a risk.

CHAPTER IV - Control of products entering the Union

Article 14 - Checks and suspension of release

1. The authorities of the Member States in charge of the control of products at the external borders of the Union shall have the powers and resources necessary for the proper performance of their tasks. They shall carry out appropriate documentary and, where necessary, physical and laboratory checks on products before those products are released for free circulation.

2. Where more than one authority is responsible for market surveillance or external border controls in a Member State, those authorities shall cooperate with each other, by sharing information relevant to their functions.

3. Subject to Article 17, the authorities in charge of external border controls shall suspend release of a product for free circulation on the Union market when, in the course of the checks referred to in paragraph 1, they have reason to believe that the product may present a risk.

In relation to a product which must comply with Union harmonisation legislation when it is released for free circulation, formal non-compliance with that legislation shall give the authorities of Member States sufficient reason to believe that the product may present a risk in any of the following cases:

(a) is not accompanied by the documentation required by the legislation;

(b) is not marked or labelled in accordance with that legislation;

(c) bears a CE marking or other marking required by Union harmonisation legislation which has been affixed in a false or misleading manner.

4. The authorities in charge of external border controls shall immediately notify the market surveillance authorities of any suspension under paragraph 3.

5. In the case of perishable products, the authorities in charge of external border controls shall, as far as possible, seek to ensure that any requirements they may impose with regard to the storage of products or the parking of vehicles used for transport are not incompatible with the preservation of those products.

6. Where, in relation to products that are not declared for free circulation, the authorities in charge of external border controls have reason to believe that those products present a risk, they shall transmit all relevant information to the authorities in charge of external border controls in the Member State of final destination.

Article 15 - Release

1. A product the release of which has been suspended by the authorities in charge of external border controls pursuant to Article 14 shall be released if, within three working days of the suspension of release, those authorities have not been requested by the market surveillance authorities to continue the suspension or they have been informed by the market surveillance authorities that the product does not present a risk, and provided that all the other requirements and formalities pertaining to such release have been fulfilled.

2. If the market surveillance authorities conclude that a product the release of which was suspended due to formal non-compliance in accordance with the second sub-paragraph of paragraph 3 of Article 14 does not in fact present a risk, the economic operator shall nevertheless rectify the formal non-compliance before the product is released.

3. Compliance with the requirements of any Union harmonisation legislation that apply to the product upon its release which relate to the potential risk under consideration, taking full account of test reports or certificates attesting conformity and issued by a conformity assessment body, shall raise a presumption on the part of market surveillance authorities that the product does not present a risk. However, this shall not prevent those authorities from instructing the authorities in charge of external border controls not to release the product where there is evidence that, despite such compliance, the product does in fact present a risk.

Article 16 - Refusal to release

1. Where the market surveillance authorities conclude that a product does present a risk, they shall instruct the authorities in charge of external border controls not to release the product for free circulation and to include the following endorsement on the commercial invoice accompanying the product and on any other relevant accompanying document:

“Product presents a risk — release for free circulation not authorised — Regulation (EU) No XXX/XXXX”.

2. Where that product is subsequently declared for a customs procedure other than release for free circulation and provided that the market surveillance authorities do not object, the endorsement set out in paragraph 1 shall also be included, under the conditions set out in paragraph 1, on the documents used in connection with that procedure.

3. Market surveillance authorities or the authorities in charge of external border controls, as the case may be, may destroy or otherwise render inoperable a product presenting a risk where they deem it necessary and proportionate. The cost of such action shall be borne by the person declaring the product for free circulation.

4. Market surveillance authorities shall provide the authorities in charge of external border controls with information on product categories in which a risk has been identified pursuant to paragraph 1.

5. Any measure taken in accordance with paragraphs 1 or 3 shall be subject to legal remedies, including recourse to the competent national courts.

6. Market surveillance authorities may charge fees which wholly or partly cover the costs of their activities, including testing carried out for the risk assessment, where they take measures in accordance with paragraph 1.

Article 17 - Personal imports

1. Where a product enters the Union accompanied by, and in the physical possession of, a natural person and reasonably appears to be destined for the personal use of that person, its release shall not be suspended pursuant to Article 14(3) except where the use of the product can endanger the health and life of persons, animals or plants.

2. A product shall be deemed to be destined for the personal use of a natural person bringing it into the Union if it is of an occasional nature and exclusively intended for use by that person or his family and does not by its nature or quantity indicate any commercial intent.

Article 18 - Union assessment for products entering the Union and subject to harmonisation legislation

1. Within 60 days of communication by the Commission to the Member States, pursuant to Article 20(4), of any refusal to release a product for free circulation by the original notifying Member State, a Member State may object to that refusal where it relates to a product subject to Union harmonisation legislation. The Member State shall state its reasons for objecting, indicate any difference in its assessment of the risk presented by the product and mention any special circumstances and any additional information relating to the product in question.

2. If no objection is raised by a Member State under paragraph 1 and the Commission does not consider that the national measures are contrary to Union legislation, the refusal by the original notifying Member State shall be deemed justified and each Member State shall ensure that restrictive measures are taken without delay in respect of the product concerned.

3. Where an objection is raised by a Member State under paragraph 1 or the Commission considers that the refusal may be contrary to Union legislation, the Commission shall without delay enter into consultation with the relevant economic operator(s) and shall evaluate the refusal, taking account of all available scientific or technical evidence.

4. On the basis of the results of the evaluation conducted pursuant to paragraph 3, the Commission may decide by implementing acts whether the refusal is justified and similar action should be taken by all Member States that have not already done so. In this case, it shall address the decision to the Member States concerned and immediately communicate it to all Member States and the relevant economic operator or operators.

5. If the Commission decides that the refusal is justified, each Member State shall take the necessary restrictive measures without delay. If it decides that the refusal is not justified, the original notifying Member State and any other Member State that has taken a similar measure shall withdraw it and the notification made under RAPEX pursuant to Article 20.

6. Where a refusal is considered justified and the product is found not to be in compliance with Union harmonisation legislation because of shortcomings in the relevant harmonised standards, the Commission shall inform the relevant European standardisation organisation and may make an appropriate request pursuant to Article 11 of Regulation (EU) No. 1025/2012.

CHAPTER V - Exchange of information

Article 19 - Union Rapid Information Exchange System - RAPEX

1. The Commission shall maintain the system for rapid exchange of information (RAPEX). Member States shall use RAPEX for exchanging information about products presenting a risk in accordance with this Regulation.

2. Each Member State shall designate a single contact point for RAPEX.

3. The Commission may, by means of implementing acts, prescribe the modalities and procedures for the exchange of information through RAPEX. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 32(2).

4. Participation in RAPEX shall be open to applicant countries, third countries or international organisations within the framework of and in accordance with agreements between the Union and those countries or organisations. Any such agreements shall be based on reciprocity and include provisions on confidentiality corresponding to those applicable in the Union.

Article 20 - Notification through RAPEX of products presenting a risk

1. The RAPEX contact point shall immediately notify to the Commission information on any of the following:

(a) any corrective action taken by economic operators pursuant to Article 9(3);

(b) any measure taken by market surveillance authorities pursuant to Article 10(1) or (4), unless it concerns a product subject to a notification pursuant to point (a);

(c) any refusal to release a product for free circulation pursuant to Article 16.

The first subparagraph shall not apply where the RAPEX contact point has reason to believe that the effects of the risk presented by a product do not go beyond the territory of its Member State.

The RAPEX contact point shall inform the Commission without delay of any relevant update, modification or withdrawal of the corrective action or measures referred to in the first subparagraph.

2. The information provided in accordance with paragraph 1 shall include all available details relating to the risk and at least the following information:

(a) the nature and level of the risk, including a summary of the results of the risk assessment;

(b) the nature of any non-compliance with Union harmonisation legislation;

(c) the data necessary to identify the product;

(d) the origin and the supply chain of the product;

(e) the date on which the measure or corrective action was taken and its duration;

(f) the nature of the measure or corrective action taken and whether voluntary, approved, required;

(g) whether the economic operator has been given the opportunity to be heard.

The information referred to in the first subparagraph shall be transmitted using the standard notification form made available by the Commission in the RAPEX system.

3. Where a notification relates to a product found not to comply with Union harmonisation legislation, the information provided shall also indicate whether the non-compliance is due to any of the following:

(a) the failure of the product to satisfy the requirements of the applicable legislation;

(b) shortcomings in the harmonised standards referred to in that legislation which confer a presumption of conformity with those requirements.

Where a measure or corrective action referred to in paragraph 1 relates to a product that has undergone conformity assessment by a notified body, the market surveillance authorities shall ensure that the relevant notified body is informed of the corrective action or measures taken.

4. On receiving a notification, the Commission shall communicate it to the other Member States. If the notification does not satisfy the requirements set out in paragraphs 1, 2 and 3, the Commission may suspend it.

5. The Member States shall immediately inform the Commission of the action or measures taken following receipt of a notification and shall provide any supplementary information, including the results of any tests or analyses carried out or possible differences in views. The Commission shall immediately transmit this information to other Member States.

Article 21 - Information and communication system for market surveillance

1. The Commission shall maintain an information and communication system for market surveillance (ICSMS) for the collection and structured storage of information on issues relating to market surveillance, in particular the following information:

(a) market surveillance authorities and their areas of competence;

(b) market surveillance programmes;

(c) the monitoring, review and assessment of market surveillance activities;

(d) complaints or reports about issues relating to risks arising from products;

(e) any non-compliance with Union harmonisation legislation other than measures or corrective action notified under RAPEX in accordance with Article 20;

(f) any objection raised by a Member State in accordance with Articles 11(1) or 18(1) and the follow-up.

ICSMS shall contain a record of references to the notifications of measures or corrective action made under RAPEX in accordance with Article 20.

ICSMS may also be made available, where necessary or appropriate, for use by the authorities in charge of controls at the external borders.

2. For the purposes of paragraph 1, Member States shall enter into ICSMS any information at their disposal and not already notified under Article 20 about products presenting a risk regarding, in particular, the identification of risks, results of testing carried out, restrictive measures taken, contacts with the economic operators concerned and justification for action or inaction.

3. Market surveillance authorities shall recognise the validity and make use of test reports prepared by or for their counterparts in other Member States and entered into ICSMS.

Article 22 - International exchange of confidential information

The Commission and Member States may exchange confidential information, including information exchanged through RAPEX, with regulatory authorities of third countries or international organisations with which the Commission and the Member State or group of Member States have concluded bilateral or multilateral confidentiality arrangements based on reciprocity.

CHAPTER VI - Cooperation

Article 23 - Mutual assistance

1. There shall be efficient cooperation and exchange of information among the market surveillance authorities of the Member States, among the different authorities within each Member State and between market surveillance authorities and the Commission and the relevant Union agencies regarding market surveillance programmes and all issues relating to products presenting a risk.

2. Market surveillance authorities shall, on receipt of a duly motivated request from a market surveillance authority in another Member State, provide any relevant information or documentation and carry out checks, inspections or investigations and report on them and on any follow-up action taken to the requesting authority.

The information, documentation and reporting referred to in the first subparagraph shall be used only in respect of the matter for which it was requested and shall be processed as quickly as possible, by electronic means.

Article 24 - 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 Union information exchange systems including the RAPEX system in accordance with Article 19(4), and promoting activities relating to conformity assessment and market surveillance.

2. Cooperation with the competent authorities of third countries shall take the form of, inter alia, the types of activities referred to in Article 27. Member States shall ensure that their competent authorities participate in those activities.

Article 25 - European Market Surveillance Forum

1. A European Market Surveillance Forum (EMSF) is established.

2. Each Member State shall be represented in meetings of the EMSF by a person or persons selected by the Member State having the particular knowledge and experience required in accordance with the subject matter of the meeting in question.

3. The EMSF shall meet at regular intervals and, where necessary, at the request of the Commission or a Member State.

4. The EMSF shall use its best endeavours to reach consensus. If consensus cannot be reached, the EMSF shall adopt its position by a simple majority of its members. Members may request that their positions and the grounds on which they are based are officially recorded.

5. The EMSF may invite experts and other third parties to attend meetings or provide written contributions.

6. The EMSF may establish standing or temporary sub-groups which shall include the administrative cooperation groups for market surveillance set up for the implementation of Union harmonisation legislation. Organisations representing the interests of industry, small and medium-sized enterprises, consumers, laboratories and conformity assessment bodies at Union level may be invited to participate in such sub-groups as observers.

7. The EMSF shall establish its rules of procedure which shall enter into force after receiving a favourable opinion from the Commission.

8. The EMSF shall cooperate with the Forum for Exchange of Information on Enforcement established by Regulation (EC) No 1907/2006.

Article 26 - Commission support and executive secretariat

1. The Commission shall support cooperation between market surveillance authorities. It shall participate in the meetings of the EMSF and its sub-groups.

2. To perform the tasks set out in Article 27, the EMSF shall be assisted by an executive secretariat that provides technical and logistic support to the EMSF and its sub-groups.

Article 27 - Tasks of the EMSF

The EMSF shall have the following tasks:

(a) to facilitate the exchange of information on products presenting a risk, risk assessment, test methods and results, recent scientific developments and other aspects relevant to control activities;

(b) to coordinate the preparation and implementation of the general and sector-specific market surveillance programmes referred to in Article 7;

(c) to organise joint market surveillance and joint testing projects;

(d) to exchange expertise and best practices;

(e) to organise training programmes and exchanges of national officials;

(f) to assist in monitoring activities as described in Article 4(3);

(g) to organise information campaigns and joint visit programmes;

(h) to improve cooperation at Union level with regard to the tracing, withdrawal and recall of products presenting a risk;

(i) to ensure the easy access, retrieval and sharing of product safety information collected by market surveillance authorities, including information on complaints, accidents, injury reports and investigation and test results;

(j) to contribute to the development of guidance to ensure the effective and uniform implementation of this Regulation, taking due account of the interests of business, in particular small and medium-sized enterprises, and other stakeholders;

(k) to provide advice and assist the Commission, at its request, in its assessment of any issue relating to the implementation of this Regulation;

(l) to contribute to uniform administrative practices with regard to market surveillance in the Member States.

Article 28 - European Union reference laboratories

1. For specific products or a category or group of products or for specific risks related to a category or group of products, the Commission may by means of implementing acts designate Union reference laboratories that satisfy the criteria set out in paragraph 2.

2. Each Union reference laboratory shall satisfy the following criteria:

(a) have suitably qualified staff with adequate training in the analytical techniques used in their area of competence and an adequate knowledge of standards and practices;

(b) possess the equipment and reference material needed to carry out the tasks assigned to them;

(c) act in the public interest in an impartial and independent manner;

(d) ensure that the staff respect the confidential nature of certain subjects, results or communications.

3. Within the area of their designation, Union reference laboratories shall where appropriate have the following tasks:

(a) carrying out product testing in relation to market surveillance activities and investigations;

(b) contributing to the resolution of disputes between the authorities of Member States, economic operators and conformity assessment bodies;

(c) providing independent technical or scientific advice to the Commission and the Member States;

(d) developing new techniques and methods of analysis;

(e) disseminating information and providing training.

CHAPTER VII - Financing

Article 29 - Financing activities

1. The Union may finance the following activities in relation to the application of this Regulation:

(a) the drawing up and updating of contributions to guidelines on market surveillance;

(b) the making available to the Commission of technical or scientific expertise for the purpose of assisting the Commission in its implementation of market surveillance administrative cooperation and the Union assessment procedures referred to in Articles 11 and 18;

(c) the performance of preliminary or ancillary work in connection with the implementation of market surveillance activities linked to the application of Union legislation such as studies, programmes, evaluations, guidelines, comparative analyses, mutual joint visits, research work, the development and maintenance of databases, training activities, laboratory work, proficiency testing, inter-laboratory tests and conformity assessment work, and European market surveillance campaigns and similar activities;

(d) activities carried out under programmes of technical assistance, cooperation with third countries and the promotion and enhancement of European market surveillance policies and systems among interested parties at European and international levels;

(e) the functioning of cooperation among market surveillance authorities and the technical and logistic support by the Executive Secretariat to the EMSF and its sub-groups.

2. The Union's financial assistance to the activities under this Regulation shall be implemented in accordance with Regulation (EU, Euratom) No 966/2012, either directly, or indirectly by delegating budget implementation tasks to the entities listed in Article 58(1)(c) of Regulation (EU, Euratom) No 966/2012.

3. The appropriations allocated to activities referred to in this Regulation shall be determined each year by the budgetary authority within the limits of the financial framework in force.

4. The appropriations determined by the budgetary authority for the financing of market surveillance activities may also cover expenses pertaining to preparatory, monitoring, control, audit and evaluation activities which are required for the management of the activities pursuant to this Regulation and the achievement of their objectives; in particular, studies, meetings of experts, information and communication actions, including corporate communication of the political priorities of the Union as far as they are related to the general objectives of market surveillance activities, expenses linked to information technology networks focusing on information processing and exchange, together with all other technical and administrative assistance expenses incurred by the Commission for the management of the activities pursuant to this Regulation.

5. The Commission shall evaluate the relevance of the market surveillance activities that receive Union financing in the light of the requirements of Union policies and legislation and inform the European Parliament and the Council of the outcome of that evaluation by [five years following the date of application] and every five years thereafter.

Article 30 - Protection of the Union's financial interests

1. The Commission shall take appropriate measures ensuring that, when actions financed under this Regulation are implemented, the financial interests of the Union are protected by the application of preventive measures against fraud, corruption and any other illegal activities, by effective checks and, if irregularities are detected, by the recovery of amounts wrongly paid and, where appropriate, by effective, proportionate and dissuasive penalties.

2. The Commission or its representatives and the Court of Auditors shall have the power of audit, on the basis of documents and on-the-spot checks, over all grant beneficiaries, contractors and subcontractors and other third parties who have received Union funds under this Regulation.

3. The European Anti-fraud Office (OLAF) may carry out on-the-spot checks and inspections on economic operators concerned directly or indirectly by such funding in accordance with the procedures laid down in Council Regulation (Euratom, EC) No 2185/96 with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with a grant agreement or grant decision or a contract concerning Union funding.

4. Without prejudice to paragraphs 1 and 2, cooperation agreements with third countries and international organisations and grant agreements and grant decisions and contracts resulting from the implementation of this Regulation shall expressly empower the Commission, the Court of Auditors and OLAF to conduct audits, on-the-spot checks and inspections.

CHAPTER VIII - Final provisions

Article 31 - Penalties

The Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation that impose obligations on economic operators and to infringements of provisions of any Union harmonisation legislation on products covered by this Regulation that impose obligations on economic operators where that legislation does not provide for penalties, and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by [insert date - 3 months prior to the date of application of this Regulation] and shall notify it without delay of any subsequent amendment affecting them.

The penalties referred to in the first subparagraph shall have regard to the size of the undertakings and in particular to the situation of small and medium-sized enterprises. The penalties may be increased if the relevant economic operator has previously committed a similar infringement and may include criminal sanctions for serious infringements.

Article 32 - Committee procedure

1. The Commission shall be assisted by a Committee. That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.

Article 33 - Evaluation

No later than [five] years after the date of application, the Commission shall assess the application of this Regulation and transmit an evaluation report to the European Parliament and the Council. That report shall assess if this Regulation achieved its objectives, in particular with regard to ensuring more effective and efficient enforcement of product safety rules and Union harmonisation legislation, improving cooperation between market surveillance authorities, strengthening the controls of products entering the Union and better protecting the health and safety of persons in general, health and safety in the workplace, consumer protection, the environment, public security and other public interests, taking into account its impact on business and in particular on small and medium-sized enterprises.

Article 34 - Amendments

1. The following provisions are deleted:

(a) Article 18 of Directive 2011/65/EU;

(b) Article 7 of Council Directive 89/686/EEC;

(c) Paragraphs 2 and 3 of Article 7 and Article 8 of Directive 93/15/EEC;.

(d) Article 7 of Directive 94/9/EC;

(e) Article 7, paragraph 4 of Article 10 and Article 11 of Directive 94/25/EC;

(f) Articles 7 and 11 of Directive 95/16/EC;

(g) Articles 8, 16 and 18 of Directive 97/23/EC;

(h) Article 9 of Directive 1999/5/EC;

(i) Articles 14, 15 and 19 of Directive 2000/9/EC;

(j) Article 5 of Directive 2000/14/EC;

(k) Paragraphs 2 and 3 of Article 6 and Articles 8, 9, 10, 11, 12 and 13 of, and Annex II to, Directive 2001/95/EC;

(l) Articles 10 and 11 of Directive 2004/108/EC;

(m) Paragraphs 3 and 4 of Article 4 and Articles 11, 17 and 20 of Directive 2006/42/EC;

(n) Article 9 of Directive 2006/95/EC;

(o) Paragraphs 5 and 6 of Article 14 and Articles 15, 16 and 17 of Directive 2007/23/EC;

(p) Paragraph 5 of Article 13 and Article 14 of Directive 2008/57/EC;

(q) Articles 39, 40, 42 to 45 of Directive 2009/48/EC;

(r) Articles 7, 15 and 17 of Directive 2009/105/EC;

(s) Articles 7, 11 and 12 of Directive 2009/142/EC;

(t) Articles 56 to 59 of Regulation (EU) No 305/2011.

2. Point (a) of Article 3(2) of Regulation (EC) No 764/2008 is replaced by the following:

'(a) Article 10 of Regulation (EU) No […] [on market surveillance of products];'

3. Regulation (EC) No 765/2008 is amended as follows:

(a) Paragraphs 2 and 3 of Article 1, points 14, 15, 17, 18 and 19 of Article 2, Chapter III and Article 32(1)(e) of Regulation (EC) No 765/2008 are deleted;

(b) The title of Regulation (EC) No 765/2008 is replaced by the following:

'Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 laying down the requirements for accreditation of conformity assessment bodies and general principles of CE marking and repealing Regulation (EEC) No 339/93'

References to the provisions of Articles 15 to 29 of Regulation (EC) No 765/2008 shall be construed as references to this Regulation and shall be read in accordance with the correlation table in the Annex.

Article 35 - Transitional provisions

Procedures initiated at national or Union level pursuant to any of the provisions referred to in Article 34 of this Regulation or to Articles 6 to 9 of Directive 2001/95/EC shall continue to be governed by those provisions.

Article 36 - Entry into force This Regulation shall enter into force on [insert date - the same day as Regulation (EU) No […/…] [on Consumer Product Safety]

It shall apply from 1 January 2015.

This Regulation shall be binding in its entirety and directly applicable in all Member States.