Legal provisions of COM(2007)36 - Procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2007)36 - Procedures relating to the application of certain national technical rules to products lawfully marketed in another Member ... |
|---|---|
| document | COM(2007)36  |
| date | July 9, 2008 |
CHAPTER 1
SUBJECT MATTER AND SCOPE
Article 1
Subject matter
1. The aim of this Regulation is to strengthen the functioning of the internal market by improving the free movement of goods.
2. This Regulation lays down the rules and procedures to be followed by the competent authorities of a Member State when taking or intending to take a decision, as referred to in Article 2(1), which would hinder the free movement of a product lawfully marketed in another Member State and subject to Article 28 of the Treaty.
3. It also provides for the establishment of Product Contact Points in the Member States to contribute to the achievement of the aim of this Regulation, as set out in paragraph 1.
Article 2
Scope
1. This Regulation shall apply to administrative decisions addressed to economic operators, whether taken or intended, on the basis of a technical rule as defined in paragraph 2, in respect of any product, including agricultural and fish products, lawfully marketed in another Member State, where the direct or indirect effect of that decision is any of the following:
| (a) | the prohibition of the placing on the market of that product or type of product; |
| (b) | the modification or additional testing of that product or type of product before it can be placed or kept on the market; |
| (c) | the withdrawal of that product or type of product from the market. |
For the purposes of point (b) of the first subparagraph, modification of the product or type of product shall mean any modification of one or more of the characteristics of a product or a type of product as listed in point (b)(i) of paragraph 2.
2. For the purposes of this Regulation, a technical rule is any provision of a law, regulation or other administrative provision of a Member State:
| (a) | which is not the subject of harmonisation at Community level; and |
| (b) | which prohibits the marketing of a product or type of product in the territory of that Member State or compliance with which is compulsory when a product or type of product is marketed in the territory of that Member State, and which lays down either:
|
3. This Regulation shall not apply to:
| (a) | decisions of a judicial nature taken by national courts or tribunals; |
| (b) | decisions of a judicial nature taken by law enforcement authorities in the course of the investigation or prosecution of a criminal offence as regards the terminology, symbols or any material reference to unconstitutional or criminal organisations or offences of a racist or xenophobic nature. |
Article 3
Relationship with other provisions of Community law
1. This Regulation shall not apply to systems or interoperability constituents falling within the scope of Directives 96/48/EC and 2001/16/EC.
2. This Regulation shall not apply in the case of measures taken by the authorities of the Member States pursuant to:
| (a) | Article 8(1)(d) to (f) and Article 8(3) of Directive 2001/95/EC; |
| (b) | Article 50(3)(a) and Article 54 of Regulation (EC) No 178/2002; |
| (c) | Article 54 of Regulation (EC) No 882/2004; |
| (d) | Article 14 of Directive 2004/49/EC. |
CHAPTER 2
PROCEDURE FOR THE APPLICATION OF A TECHNICAL RULE
Article 4
Information on the product
Where a competent authority submits a product or type of product to an evaluation to determine whether or not to adopt a decision as referred to in Article 2(1), it may request from the economic operator identified in accordance with Article 8, with due regard to the principle of proportionality, any of the following in particular:
| (a) | relevant information concerning the characteristics of the product or type of product in question; |
| (b) | relevant and readily available information on the lawful marketing of the product in another Member State. |
Article 5
Mutual recognition of the level of competence of accredited conformity-assessment bodies
Member States shall not refuse certificates or test reports issued by a conformity-assessment body accredited for the appropriate field of conformity-assessment activity in accordance with Regulation (EC) No 765/2008 on grounds related to the competence of that body.
Article 6
Assessment of the need to apply a technical rule
1. Where a competent authority intends to adopt a decision as referred to in Article 2(1), it shall send the economic operator identified in accordance with Article 8 written notice of that intention, specifying the technical rule on which the decision is to be based and setting out technical or scientific evidence to the effect that:
| (a) | the intended decision is justified on one of the grounds of public interest set out in Article 30 of the Treaty or by reference to other overriding reasons of public interest; and |
| (b) | the intended decision is appropriate for the purpose of achieving the objective pursued and does not go beyond what is necessary in order to attain that objective. |
Any intended decision shall be based on the characteristics of the product or type of product in question.
The economic operator concerned shall, following receipt of such notice, be allowed at least 20 working days in which to submit comments. The notice shall specify the time limit within which comments may be submitted.
2. Any decision as referred to in Article 2(1) shall be taken and notified to the economic operator concerned and to the Commission within a period of 20 working days from the expiry of the time limit for the receipt of comments from the economic operator referred to in paragraph 1 of this Article. It shall take due account of those comments and shall state the grounds on which it is based, including the reasons for rejecting the arguments, if any, put forward by the operator, and the technical or scientific evidence as referred to in paragraph 1 of this Article.
Where duly justified by the complexity of the issue, the competent authority may, once only, extend the period specified in the first subparagraph by a maximum of 20 working days. That extension shall be duly reasoned and shall be notified to the economic operator before the expiry of the initial period.
Any decision as referred to in Article 2(1) shall also specify the remedies available under the law in force in the Member State concerned and the time limits applying to such remedies. Such a decision may be challenged before national courts or tribunals or other instances of appeal.
3. Where, after giving written notice in accordance with paragraph 1, the competent authority decides not to adopt a decision as referred to in Article 2(1), it shall immediately inform the economic operator concerned accordingly.
4. When the competent authority fails to notify the economic operator of a decision as referred to in Article 2(1) within the period specified in paragraph 2 of this Article, the product shall be deemed to be lawfully marketed in that Member State insofar as the application of its technical rule as referred to in paragraph 1 of this Article is concerned.
Article 7
Temporary suspension of the marketing of a product
1. The competent authority shall not temporarily suspend the marketing of the product or type of product in question, during the procedure laid down in this Chapter, except where either:
| (a) | under normal or reasonably foreseeable conditions of use, the product or type of product in question poses a serious risk to the safety and health of the users; or |
| (b) | the marketing of the product or type of product in question is generally prohibited in a Member State on grounds of public morality or public security. |
2. The competent authority shall immediately notify the economic operator identified in accordance with Article 8 and the Commission of any suspension as referred to in paragraph 1 of this Article. In the cases referred to in paragraph 1(a) of this Article, that notification shall be accompanied by a technical or scientific justification.
3. Any suspension of the marketing of a product pursuant to this Article may be challenged before national courts or tribunals or other instances of appeal.
Article 8
Information to the economic operator
References to the economic operators in Articles 4, 6 and 7 shall be considered references:
| (a) | to the manufacturer of the product, if established in the Community, or the person who has placed the product on the market or requests to the competent authority that the product be placed on the market; |
| (b) | where the competent authority cannot establish the identity and contact details of any of the economic operators referred to in point (a), to the manufacturer's representative, when the manufacturer is not established in the Community or, if there is no representative established in the Community, to the importer of the product; |
| (c) | where the competent authority cannot establish the identity and contact details of any of the economic operators referred to in points (a) and (b), to any professional in the supply chain whose activity may affect any property of the product regulated by the technical rule which is being applied to it; |
| (d) | where the competent authority cannot establish the identity and contact details of any of the economic operators referred to in points (a), (b) and (c), to any professional in the supply chain whose activity does not affect any property of the product regulated by the technical rule which is being applied to it. |
CHAPTER 3
PRODUCT CONTACT POINTS
Article 9
Establishment of Product Contact Points
1. Member States shall designate Product Contact Points in their territories and shall communicate their contact details to the other Member States and to the Commission.
2. The Commission shall draw up and regularly update a list of Product Contact Points and publish it in the Official Journal of the European Union. The Commission shall also make that information available through a website.
Article 10
Tasks
1. Product Contact Points shall, at the request of, inter alia, an economic operator or a competent authority of another Member State, provide the following information:
| (a) | the technical rules applicable to a specific type of product in the territory in which those Product Contact Points are established and information as to whether that type of product is subject to a requirement for prior authorisation under the laws of their Member State, together with information concerning the principle of mutual recognition and the application of this Regulation in the territory of that Member State; |
| (b) | the contact details of the competent authorities within that Member State by means of which they may be contacted directly, including the particulars of the authorities responsible for supervising the implementation of the technical rules in question in the territory of that Member State; |
| (c) | the remedies generally available in the territory of that Member State in the event of a dispute between the competent authorities and an economic operator. |
2. Product Contact Points shall respond within 15 working days of receiving any request as referred to in paragraph 1.
3. Product Contact Points in the Member State in which the economic operator concerned has lawfully marketed the product in question may provide the economic operator or the competent authority as referred to in Article 6 with any relevant information or observations.
4. Product Contact Points shall not charge any fee for the provision of the information referred to in paragraph 1.
Article 11
Telematic network
The Commission may, in accordance with the advisory procedure referred to in Article 13(2), establish a telematic network for the implementation of the provisions of this Regulation concerning the exchange of information between Product Contact Points and/or the competent authorities of the Member States.
CHAPTER 4
FINAL PROVISIONS
Article 12
Reporting obligations
1. Each Member State shall send the Commission on a yearly basis a report on the application of this Regulation. That report shall include the following information at least:
| (a) | the number of written notices sent pursuant to Article 6(1) and the type of products concerned; |
| (b) | sufficient information concerning any decisions taken pursuant to Article 6(2), including the grounds on which those decisions were based and the type of products concerned; |
| (c) | the number of decisions taken pursuant to Article 6(3) and the type of products concerned. |
2. In the light of the information provided by Member States pursuant to paragraph 1, the Commission shall analyse the decisions taken pursuant to Article 6(2) and assess the grounds on which they were based.
3. By 13 May 2012, and every five years thereafter, the Commission shall review the application of this Regulation and shall submit a report thereon to the European Parliament and to the Council. The Commission may, where appropriate, accompany the report with proposals with a view to improving the free movement of goods.
4. The Commission shall draw up, publish and regularly update a non-exhaustive list of products which are not subject to Community harmonisation legislation. It shall make that list accessible through a website.
Article 13
Committee procedure
1. The Commission shall be assisted by a committee composed of representatives of the Member States and chaired by a representative of the Commission.
2. Where reference is made to this paragraph, the advisory procedure laid down in Article 3 of Decision 1999/468/EC shall apply, in accordance with Article 7(3) and Article 8 thereof.
Article 14
Repeal
Decision No 3052/95/EC is hereby repealed with effect from 13 May 2009.
Article 15
Entry into force and application
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
It shall apply from 13 May 2009.
This Regulation shall be binding in its entirety and directly applicable in all Member States.