The Law On The Free Movement Of Goods In The Eea (Eea Vareloven)

Original Language Title: Lov om det frie varebytte i EØS (EØS-vareloven)

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The law on the free movement of goods in the EEA (EEA vareloven) date law-2013-04-12-13 Ministry industry and Fisheries Ministry last edited Published in 2013 booklet 5 entry into force 12.04.2013 Change Announced at 12.04.2013. 15.30 brief title EEA vareloven Chapter overview: the main part to the EEA Agreement-annex II, chap. XIX No. 3F (Regulation (EC) No. 764/2008) on the determination of procedures for the application of certain national technical re ...
Chapter 1. Purpose and scope Chapter 2. Procedure for the application of a technical regulation Chapter 3. Product contact points Chapter 4. The final provisions of the EEA Agreement-annex II, chap. XIX No. 3B (Regulation (EC) No. 765/2008) on the determination of the requirements for accreditation and market supervision for the marketing of ...
In the General provisions chapter. Chapter II. Accreditation Chapter III. Community framework for market supervision and control of the products introduced at Community market chapter IV. CE marking Chapter v. Community financing chapter VI. Provisions in the end Attachments to the organ. claims that be recognized in accordance with article 14 Annex II. CE marking section 1. The enforcement of technical rules on goods from other EEA State to the EEA Agreement-annex II, chap. XIX No. 3F (Regulation (EC) No. 764/2008) on the determination of procedures for the application of certain national technical rules on goods which are legally marketed in another EEA Member State, apply as law with the customizations that follows from annex II to the agreement, Protocol 1 and the agreement by the way.

§ 2. Accreditation and market supervision to the EEA Agreement-annex II, chap. XIX No. 3B (Regulation (EC) No. 765/2008) on the determination of the requirements for accreditation and market supervision for the marketing of goods, apply as law with the customizations that follows from annex II to the agreement, Protocol 1 and the agreement by the way.

§ 3. Accreditation National accreditation body in Norway is the Norwegian accreditation.
Individual decisions about accreditation may be appealed to the Norwegian accreditation complaint Committee.
The Ministry may provide regulations on the exercise of accreditation activities and on payment for services performed by the Norwegian accreditation.

§ 4. The scope of the Act does not apply to Svalbard.

§ 5. Entry into force and the law will take effect immediately. 

The EEA Agreement-annex II, chap. XIX No. 3F (Regulation (EC) No. 764/2008) on the determination of procedures for the application of certain national technical rules on goods which are legally marketed in another EEA State.

It's not made any "EEA adaptation" of forordnings text. It follows from the EEA Agreement Protocol in that "Member State" in the EEA context must read as "EEA State", "the community" as the "EUROPEAN ECONOMIC AREA", and that the Commission's tasks to a great extent performed by the EFTA surveillance authority to the EFTA States in the EUROPEAN ECONOMIC AREA. Make a note of which refers to the EEA, Norwegian laws or institutions are inserted by the editors of the Norwegian laws. Footnotes that refer to the EC and EU-tidende (EFT, OFFICIAL JOURNAL) or to the preparatory documents in the EU is inserted in connection with announcement of Commission regulations in the EU. 
The European Parliament and the Council of the European union-having regard to the Treaty establishing the European Community, in particular article 37 and 95, having regard to the proposal from the Commission, having regard to the opinion of the European economic and Social Committee, after consultation with the Committee of the regions, following the procedure set out in Treaty Article 251 and based on the following considerations: 1) the internal market constitutes an area without internal frontiers , where the free movement of goods is ensured in accordance with the Treaty, which prohibits measures having effect equivalent to quantitative restrictions on imports. The ban includes all national measures which, directly or indirectly, actually or potentially, can prevent trade within the community.

2) obstacles to the free varebyttet between Member States can be created illegally by that Member States ' competent authorities, in the absence of harmonised legislation, applying technical regulations with the requirements that these products must meet, such as the rules for designation, form, size, weight, composition, presentation, labelling and packaging, on products which are legally marketed in other Member States. The application of such rules to products which are legally marketed in another Member State, can be contrary to the Treaty's article 28 and 30, even if they apply to all products without that it distinguished between them.

3) the principle of mutual recognition, which is derived from the case law by The European communities, is one of the means to ensure the free movement of goods on the internal market. Mutual recognition applies to products that are not subject to Community harmonisation legislation, or on aspects of products falling outside the scope of such a policy. In accordance with the said principle, a Member State does not prohibit the sale on its territory of products which are lawfully marketed in another Member State, even if they are produced in accordance with the other technical regulations than those that domestic products are subject to. The only exceptions from this principle are restrictions which are justified with reference to the Treaty's article 30, or with other compelling public interest, and which stands in relation to the goal to be reached.

4) many problems still remain with regard to the right of the Member States the application of the principle of mutual recognition. It is therefore necessary to determine the procedures to reduce the possibility that technical regulations creates illegal obstacles to the free movement of goods between Member States. The absence of such procedures in the Member States creates additional obstacles for the free varebyttet, as it does not encourage enterprises to sell their products, which are legally marketed in another Member State, on the territory of the Member State which use such technical regulations. Surveys have shown that many enterprises, especially small and medium-sized enterprises (SMEs), either adapt their products to comply with the technical regulations of the Member States, or do not market them in these Member States.

5) competent authorities also lack appropriate procedures for the application of their technical regulations on certain products that are lawfully marketed in another Member State. The lack of such procedures make it difficult for them to assess the products ' compliance according to the Treaty.

6) in the Council resolution of 28. October 1999 on mutual recognition, it was pointed out that market participants and citizens do not always fully and properly taken advantage of the principle of mutual recognition because they were not sufficiently aware of the principle and its practical follows. In the resolution, Member States were urged to develop appropriate measures to give market participants and citizens an effective framework for mutual recognition, inter alia by effectively managing requests from market participants and the citizens and respond quickly to such requests.

7) the European Council underlined its meeting 8. and 9. March 2007 the importance of providing a boost in the internal market for goods by strengthening mutual recognition and at the same time ensure a high level of safety and consumer protection. The European Council emphasised at its meeting 21. and 22. June 2007 that the further strengthening of the four freedoms in the internal market (free movement of goods and the free movement of persons, services and capital) and an improvement of the internal market behavior is still of paramount importance for growth, competitiveness and employment.

8) that the internal market for goods to function in a satisfactory way, required adequate and open procedures to resolve the problems arising from the application of a Member State technical regulations on certain products that are lawfully marketed in another Member State.

9) this regulation should not preclude further harmonization of technical regulations, when it is appropriate, with a view to better the internal market behavior.

10) barriers to trade can also be a result of other types of measures that fall under the scope of the Treaty's article 28 and 30. Such measures may include, for example, technical specifications that are prepared for the procedures for public procurement or requirement to use official languages in the Member States. Such measures should not, however, constitute technical regulations according to this regulation and should, therefore, not covered by its scope.

11) Technical regulations according to this regulation are sometimes applied within the framework of procedures for the compulsory prior approval, set out in the legislation, where the competent authority in the said Member State, before a product or type of product can be brought in revenue in this Member State or in a part of it, after application should give its formal approval. That there are such procedures will in itself restrict the free varebyttet. To be eligible for the basic principle of the free movement of goods in the internal market, should a procedure for compulsory prior approval therefore pursue a goal that is in the public interest and recognised in Community law, which is not discriminatory and is relative to the target; that is, it should be suitable to ensure that the goals pursued, will be reached, but do not go beyond what is necessary to achieve this goal. Whether or not such a procedure is in accordance with the forholdsmessighetsprinsippet, should be considered in the light of the considerations made in the Court's case-law.


12) a requirement of prior approval to bring a product in revenue, should in itself does not constitute a technical regulation pursuant to this regulation, so that a decision to exclude or remove a product from the market solely for the reason that it does not have any valid prior approval, should not constitute a decision to which this Regulation applies. When an application for such compulsory prior approval of a product available, should, however, a planned decision to reject the application on the basis of a technical regulation is made in accordance with this regulation, so that the applicant can benefit from the procedural protection which this regulation provides.

13) Decisions by national courts about the legality of cases in which products that, on the basis of the application of a technical regulation, the legally marketed in one Member State, not be granted access to the market in another Member State, or where it applied sanctions, should not be covered by this forordnings scope.

14) weapons are products that can pose a serious risk to human health and safety and for the public security in the Member States. More specific types of weapons that are legally marketed in one Member State, for the sake of the protection of human health and safety and the prevention of crime, be subject to restrictive measures in another Member State. Such measures may consist of specific controls and approvals before the weapons that are being legally marketed in one Member State, being brought in revenue in another Member State. Member States should therefore be permitted to prevent weapons being brought in revenue of their market until the national procedural requirements are fully met.

15) in the European Parliament and Council Directive 2001/95/EC of 3. December 2001 on general product safety be turned it states that only safe products may be brought in revenue, and it is determined the obligations of producers and distributors with respect to product safety. According to the directive, the authorities can ban all dangerous products with immediate effect or temporarily ban a product that could be dangerous for the period of time that is necessary to carry out the various security reviews, surveys and controls. According to the directive the authorities have also the right to take appropriate measures such as those that are dealt with in article 8 Nr. 1 letter b)-f) in the said directive, in cases where products pose a serious risk. Measures that are hit by the competent authorities in the Member States in accordance with the national legislation adopted in implementation of article 8 Nr. 1 letter d)-f) and article 8 Nr. 3 in the said directive, should not be covered by this forordnings scope.

16) By European Parliament and Council Regulation (EC) No. 178/2002 of 28. January 2002 on the determination of the General principles and requirements of food regulations, on the establishment of the European authority for food safety and on the determination of procedures in connection with food safety, it was among other things, created a quick alert system for the notification of direct or indirect health risks for people because of the food or feed. Member States be ordered immediately to inform the Commission via the quick alert system of any measure they adopt to limit the turnover of, pulling back from the market or recalling food or feed in order to protect human health, in those cases where it is necessary to act quickly. Measures that are hit by the competent authorities in the Member States according to article 50 no. 3 letter a) and article 54 in the said regulation, should, therefore, not covered by the scope of this forordnings.

17) in European Parliament and Council Regulation (EC) No. 882/2004 of 29. April 2004 on public control to ensure that the fôrvare and food regulations as well as the provisions relating to animal health and welfare are observed, it is laid down common rules for Government control to ensure compliance with the rules that especially aims to prevent or remove the risk to humans and animals, either directly or through the environment, or reduce it to an acceptable level, and to guarantee good business when trading with livestock feed and food safety and consumer interests , including the marking of livestock feed and food, and other forms of consumer information. In the Regulation stipulate a particular procedure to ensure that market participants remedies a situation where fôrvare and food regulations as well as the provisions relating to animal health and welfare are not met. Measures that are hit by the competent authorities in the Member States according to article 54 in the said regulation, should, therefore, not covered by the scope of this forordnings. Measures that are hit or planned by the competent authorities on the basis of national technical regulations should, however, be subject to this regulation, to the extent that they do not touch the objectives set out in Regulation (EC) No. 882/2004.

18) in the European Parliament and Council Directive 2004/49/EC of 29. April 2004 on safety on the community's railways (railway safety directive), it is set out a procedure to give permission to ibruktaking of existing rolling stock, where there is opportunity for the application of certain national rules. Measures that are hit by the competent authorities pursuant to article 14 of the said directive, should not be covered by this forordnings scope.

19) in Council Directive 96/48/EC of 23. July 1996 about the samtrafikkevnen trans-European rail system for high speed trains and European Parliament and Council Directive 2001/16/EC of 19. March 2001 about the samtrafikkevnen trans-European rail system for conventional trains, it is laid down a gradual harmonisation of systems and operations through a gradual adoption of technical specifications for samtrafikkevne (TSI). Systems and samtrafikkomponenter that fall under the scope of the said directives, should, therefore, not covered by the scope of this forordnings.

20) by the European Parliament and Council Regulation (EC) No. 765/2008 of 9. July 2008 on the determination of the requirements for accreditation and market supervision for the marketing of products introduced there a accreditation scheme that ensures mutual authentication of the competence level of the compliance assessment bodies. The competent authorities in the Member States should therefore no longer refuse test reports and certificates issued by an accredited conformity assessment body for reasons related to the competent organ. Furthermore, the Member States also accept test reports and certificates issued by other compliance assessment bodies in accordance with Community law.

21) according to the European Parliament and Council Directive 98/34/EC of 22. June 1998 about an information procedure for standards and technical regulations are the Member States are obliged to send the Commission and the other Member States all the suggestions to the technical regulations on any product, including agricultural and fisheries goods, as well as a message about the reasons why it is necessary to impose such a regulation. However, it is necessary to ensure, after the adoption of such a technical regulation, that the principle of mutual recognition is correctly applied in individual cases to specific products. By this regulation are determined that a procedure for the application of the principle of mutual recognition in individual cases, in that the competent authority imposed a duty to indicate the technical or scientific reasons why the specific product in its current form cannot be marketed in the Member State, in accordance with treaty article 28 and 30. In this regulation should not be understood as legal documentation evidence. Member States ' authorities is within the framework of this regulation are not obligated to state the technical regulations. They should, however, the State, as provided for in this regulation, a possible application of the technical regulations on a product that is lawfully marketed in another Member State.

22) in accordance with the principle of mutual recognition should be the procedure created by this regulation provide that the competent authorities in each individual case on the basis of the relevant technical or scientific elements available, to announce the market participant that compelling public interest dictates that national technical regulations imposed on the person concerned product or type of product, and that less restrictive measures cannot be used. The written message should provide the market participant the opportunity to comment on all relevant pages of the planned decision to restrict access to the market. There is nothing to impede the competent authority take action after the deadline for the receipt of such comments, if the market participant has not responded.

23) the concept of overriding reasons relating to the Court is gradually developed in the case law of its practice in relation to the Treaty's article 28 and 30. The term includes effective tax control, good business, consumer protection, environmental protection, the maintenance of a diversified press and the risk of seriously undermining the financial stability of the social security scheme. Such overriding reasons relating to the competent authorities can state applying technical regulations. Such an application should not, however, be a means of arbitrary discrimination or a disguised trade barrier between the Member States. Moreover, forholdsmessighetsprinsippet always has to be observed, as the consideration given to whether the competent authority has actually chosen the least restrictive measure.


24) By application of the procedure laid down in this regulation should be the competent authority in a Member State does not withdraw or restrict the marketing of a product or type of product which is lawfully marketed in another Member State. However, it is appropriate that the competent authority may adopt temporary measures which it required quick efforts to prevent users ' safety and health is put at risk. Such interim measures may also be adopted by the competent authority to prevent the marketing of a product which is covered by a general prohibition against revenue in the interests of public morality or public security, including the prevention of crime. Member States should therefore at any stage of the procedure laid down in this regulation under such circumstances could temporarily prohibit the marketing on its territory of products or product types.

25) in any decision to which this Regulation applies on, it should be specified which complaint is available, access to a market participant may bring into the matter for the competent national court.

26) it is appropriate that the market participant also be informed that there are utenrettslige arrangements for problem solving, such as the SOLVIT system, in order to prevent legal uncertainty and the costs of litigation.

27) When the competent authority has made a decision to exclude a product on the basis of a technical regulation in accordance with the procedural requirements of this regulation, should additional measures adopted in relation to this product on the basis of this decision and the same technical regulations, not be subject to the requirements of this regulation.

28) it is important for the internal market for goods that it ensured access to national technical regulations, so that enterprises, and especially small and medium-sized businesses, can gather reliable and precise information on the current legislation.

29) it is therefore necessary to implement principles of administrative simplification, inter alia, by creating a system of product contact points. The system should be designed so that it ensures that enterprises can gain access to information in an open and correct manner, so that the delays, costs and deterrent effects arising out of national technical regulations, can be avoided.

30) to facilitate the free movement of goods should the product contact points free of charge provide information about their national technical regulations and the application of the principle of mutual recognition as regards products. Product contact points should have adequate equipment, and sufficient resources and, moreover, are encouraged to make information available on a website and in other Community languages. Product contact points may also provide the market participants additional information or views under the procedure laid down in this regulation. For such additional information may contact product points require fees related to the cost of these information.

the creation of 31) as the product contact points should not affect the distribution of tasks between competent authorities within the Member States ' legislative systems, it should be possible for Member States to set up product contact points according to regional or local authority. Member States should be able to entrust the role of product contact points to existing contact points established in accordance with other Community schemes to avoid too many contact points and to simplify administrative procedures. Member States should also be able to entrust the role of product contact points not only to existing services within the public administration, but also to national SOLVIT centres, chambers of Commerce, professional associations and private bodies, in order not to increase the administrative costs for enterprises and competent authorities.

32) Member States and the Commission should be encouraged to work together closely to facilitate the training of staff of product contact points.

33) in the light of the development and the establishment of a pan-European electronic government service and underlying inter-dependent telematics network, the ability to create an electronic system for the exchange of information between product contact points should be examined, in accordance with European Parliament and Council decision 2004/387/EC of 21. April 2004 on samverkande activities of the Pan-European electronic public tenester to public forvaltingar, føretak and borgarar (IDABC).

34) reliable and efficient monitoring and assessment arrangements should be established to provide information on the application of this regulation, to improve the knowledge about the behavior of the internal market for goods in sectors that are not subject to harmonisation and to ensure that the principle of mutual recognition is duly applied by the competent authorities in the Member States. Such arrangements should not go further than is necessary to achieve these goals.

35) this Regulation applies only to products or particular characteristics of the products which are not subject to Community harmonisation measures, which are intended to remove barriers to trade between Member States due to differences between national technical regulations. The provisions of such harmonisation measures are often exhaustive, so that the Member States may not prohibit, restrict or prevent the products in accordance with these measures, brought in revenue on their territory. Some of the Community harmonisation measures, however, gives Member States the opportunity to fix the further technical conditions for sales of a product on their market. Such additional criteria should be subject to the Treaty's article 28 and 30 and the provisions of this regulation. With the aim of an effective application of this regulation, it is therefore appropriate that the Commission create an illustrative and non-exhaustive list of products that are not subject to harmonisation at Community level.

36) The monitoring scheme that was created by European Parliament and Council decision No. 3052/95/EC of 13. December 1995 on the introduction of a procedure for the exchange of information on national measures that the derogation from the principle of free movement of goods within the community, have mostly been shown not to be successful since the implementation of the decision has not given the Commission sufficient information to be able to designate sectors where harmonisation would be appropriate. It has also not led to quick solution of certain problems for the free varebyttet. Decision Nr. 3052/95/EC should therefore be repealed.

37) it will be appropriate to introduce a transitional period for the application of this regulation so that the competent authorities can adapt to the requirements that are set out in the regulation.

38) As the target of the this regulation, which is to remove the technical obstacles to the free movement of goods between Member States, cannot be reached to a sufficient degree by the Member States and, therefore, because of the scope and effects of the action better can be reached at Community level, the community can take measures in accordance with the subsidiarity principle as set out in the Treaty's article 5. In accordance with the forholdsmessighetsprinsippet set out in the said article, this Regulation no longer than is necessary to achieve this goal.

39) the measures necessary for implementing this regulation, should be adopted in accordance with Council decision 1999/468/EC of 28. June 1999 on the determination of modalities for the conduct of the enforcement authority that is attributed to the Commission-adopted this Regulation: Chapter 1. Purpose and scope 1. Purpose 1. The objective of this regulation is to strengthen the internal market behavior by better the free varebyttet.

2. in this regulation, it is laid down rules and procedures which the competent authorities in a Member State to follow when they make or intend to make a decision as referred to in article 2 No. 1, which will be able to prevent free exchange of a product that is lawfully marketed in another Member State and is subject to the Treaty's article 28.

3. in this regulation, it is also stipulated that to create the product contact points in the Member States to contribute to reaching this goal, forordnings as set out in no. 1. species 2. Work area 1. This regulation applies to the administrative decisions directed to the market participants, whether the decision that is made or to be made, on the basis of a technical regulation as defined in the No. 2, with respect to all products, including agricultural and fisheries goods, which are legally marketed in another Member State, where the direct or indirect impact of the said decision is a) a ban on the product or type of product is brought in revenue, b) a change or further trial by the product or type of product before it can be brought in revenue the first time or remain on the market , c) a withdrawal of the product or type of product from the market.

In the first paragraph, LITRA b) meant by changing the product or product type any modification of one or more of the characteristics of a product or type of product, as listed in the No. 2 letter b) in).

2. in this regulation is meant by technical regulations any provision in a Member State laws and regulations a) that are not subject to harmonisation at Community level, and b) which prohibits the marketing of a product or type of product in this Member State's territory, or that it is mandatory to comply with when a product or type of product is being marketed on this Member State's territory, and that determines whether i) the properties required by the product or product type , such as the level of quality, performance, safety or dimensions, including the requirements to the product or product type as regards the name it sold under, terminology, symbols, testing and test methods, packaging or labeling, or ii)

all other requirements as imposed on the product or product type with the purpose of protecting consumers or the environment, and which affects the life cycle of the product after it has been brought in revenue. terms of use, recycling, reuse or disposal, where such conditions can significantly influence the product or product type's composition, art or marketing.

3. This Regulation shall not apply on a) Court decisions taken by national courts, b) Court decisions taken by authorities responsible for the enforcement of the law in connection with the investigation or prosecution of a criminal offense relationship that comes to terminology, symbols or other significant reference to forfatningsstridige or criminal organizations or criminal matters of racist or xenophobic nature.

Art 3. The relationship with other provisions of Community law 1. This Regulation shall not apply to systems or samtrafikkomponenter that fall under the scope of Directive 96/48/EC and Directive 2001/16/EC.

2. This Regulation shall not apply to measures taken by the authorities in the Member States according to a) article 8 Nr. 1 letter d)-f) and article 8 Nr. 3 of Directive 2001/95/EC, b) Article 50 no. 3 letter 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 regulation Art 4. Information about the product when a competent authority would like to review a product or type of product to determine whether it should render a decision as referred to in article 2 No. 1, it can, as it will be taken duly into account, ask the participant forholdsmessighetsprinsippet market identified in accordance with article 8 in particular on the following: a) the relevant information about the person the product or product type properties, b) relevant and readily available information on the lawful marketing of the product in another Member State.

Art 5. Mutual recognition of the competence level of accredited conformity assessment bodies Member States shall not refuse certificates or test reports issued by a conformity assessment body which is accredited for compliance assessment activities at that site in accordance with Regulation (EC) No. 765/2008 for reasons related to the competent organ.

Art 6. Assessment of the need to apply a technical regulations 1. When a competent authority intends to render a decision as referred to in article 2 No. 1, it should send the market participant identified in accordance with article 8 a written notice of its intent, where it entered the technical regulations the decision to build on, as well as the technical or scientific evidence that shows that a) the planned decision is justified from the public interest as set out in the Treaty's article 30, or other public interest, and b) the planned decision is appropriate to reach the desired objectives and does not go beyond what is necessary for to achieve this goal.

A planned decision to be made on the basis of the characteristics of the concerned product or product type.
The affected market participant shall, after receiving such a message is given a time limit of at least 20 business days to come with annotations. In the message to be the deadline for laying out notes be provided.

2. A decision as referred to in article 2 No. 1 to be made and notified to the person concerned the market participant and the Commission within a period of 20 working days counted from the expiry of the time limit for the receipt of comments from the market participant who referred 1 of this article. The decision shall take duly into account these comments and it is to be given a rationale, including the reasons for rejecting any arguments put forth by market participant, as well as the technical or scientific evidence as discussed in no. 1 of this article.
The competent authority may, when it is duly justified in the compound nature, extend the time period specified in the first paragraph one time with most 20 working days. The extension shall be duly reasoned and shall be notified to the market participant before the expiry of the original deadline.
In a decision that dealt with in article 2 No. 1 it shall also be specified which complaint available access under current legislation in the Member State concerned and the time limits for such complaint. Such a decision can be brought before national courts or other complaint agencies.

3. If the competent authority, after giving written notice in accordance with no. 1, decides not to make the decision as referred to in article 2 No. 1, it should immediately notify the affected market participant at this.

4. If the competent authority fails to notify the market participant a decision as referred to in article 2 No. 1 within the time period that is specified in the Nr. 2 in this article, will the product be considered legally marketed in the Member State concerned when it comes to the application of the technical regulation referred 1 of this article.

Art 7. Temporary ban on the marketing of a product 1. The competent authority shall not temporarily prohibit the marketing of the product or type of product under the procedure set out in this chapter, except where a) that person product or type of product under normal or reasonably predictable terms poses a serious risk to the users safety and health, or b the marketing of the product) that person or type of product is covered by a general prohibition in a Member State in the interests of public morality or public security.

2. The competent authority shall immediately notify the market participant identified in accordance with article 8 and the Commission on the temporary bans as referred 1 of this article. In the cases that are referred 1 letter a) of this article, to the message is followed by a technical or scientific justification.

3. A temporary ban on the marketing of a product pursuant to this article may be brought before national or other complaint agencies.

Art 8. Information to the market participant referrals to market participants in articles 4, 6 and 7 shall be understood as references a) to the manufacturer of the product, if this is established in the community, or the person who has brought the product in sales or requests the competent authority that the product be brought in revenue, b) if the competent authority cannot establish the identity and contact information for any of those market participants that are referred to in letter 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) if the competent authority cannot establish the identity and contact information for any of those market participants that are dealt with in the letter a) and b), to any professional in the revenue chain if the business can affect the characteristics of the product that is covered by the technical regulations which are applied on the product , d) if the competent authority cannot establish the identity and contact information for any of those market participants that are dealt with in the letter a), b) and c), to any professional in the revenue chain if the business does not affect the characteristics of the product that is covered by the technical regulations which are applied on the product.

Chapter 3. Product contact points Art 9. The creation of product contact points 1. Member States shall designate product contact points in its territory and send the contact information for these to the other Member States and to the Commission.

2. the Commission shall prepare and regularly updating a list of product contact points and publish it in the official journal of the European Union. The Commission should also make the information available on a website.

Art 10. Tasks 1. Product contact points shall at the request of a market participant or the competent authority in another Member State, provide the following information: a) the technical regulations that apply to a specific type of product in the territory in which those product contact points are established and information as to whether this product type is covered by a requirement of prior approval in accordance with the laws of the Member State, together with information concerning the principle of mutual recognition and the application of this regulation on this Member State's territory , b) contact information for the competent authorities in this Member State so that they can be contacted directly, including the details about the authorities that have responsibility for oversight of the implementation of the relevant technical regulations on this Member State's territory, c) the complaint that access is generally available on this Member State's territory in the event of a dispute between the competent authorities and a market participant.

2. Product contact points shall respond to inquiries within 15 working days after receiving a request as referred 1.3. Product contact points in the Member State where the person concerned market participant legal has marketed the product in question, can provide the market participant or the competent authority as referred to in article 6, all the relevant information or views.

4. Product contact points shall not charge any fees to provide information as referred 1. species 11. Telematics network the Commission may after the procedure with the Advisory Committee referred to in article 13 Nr. 2 create a telematics network for the implementation of the provisions of this regulation on Exchange of information between product contact points and/or competent authorities in the Member States.

Chapter 4. Final provisions Art 12. The reporting obligation 1. Each Member State shall each year send the Commission a report on the application of this regulation. The report shall at least contain the following information: a)

the number of written messages sent pursuant to article 6 Nr. 1, as well as the affected product type, b) have sufficient information about all decisions made pursuant to article 6 Nr. 2, including a justification for the decision as well as the affected product type, c) the number of decisions that are made in accordance with article 6 Nr. 3, as well as the affected product type.

2. In the light of the information provided by the Member States according to the No. 1, the Commission shall analyse the decisions that are made in accordance with article 6 Nr. 2, and consider the rationale for them.

3. the Commission shall no later than 13. may 2012 and then every five years to review the application of this regulation and present a report on this to the European Parliament and the Council. The Commission may, where appropriate, attach the report appropriate suggestions to the improvement of the free varebyttet.

4. The Commission shall draw up, publish and regularly updating a non-exhaustive list of products that are not subject to Community harmonisation legislation. The Commission shall make the list available on a Web site.

Art 13. Committee procedure 1. The Commission shall be assisted by a Committee composed of representatives of the Member States and chaired by a representative from the Commission.

2. When referring to this number, the procedure with Advisory Committee provided for in article 3 of decision 1999/468/EC, the application, in accordance with article 7 of the decision No. 3 and article 8.

Art 14. Repealing Decision Nr. 3052/95/EC is repealed with effect from 13. May 2009.

Art 15. Entry into force and application this Regulation shall enter into force on the 20th. the day after it is announced in the official journal of the European Union.
It is applicable from 13. May 2009.
This regulation is binding in all parts and come directly to the application in all Member States.
  Issued in Strasbourg, 9. July 2008. 

The EEA Agreement-annex II, chap. XIX No. 3B (Regulation (EC) No. 765/2008) on the determination of the requirements for accreditation and market supervision for the marketing of goods. 

The European Parliament and the Council of the European union-having regard to the Treaty establishing the European Community, in particular article 95 and 133, having regard to the proposal from the Commission, having regard to the opinion of the European economic and Social Committee, after consultation with the Committee of the regions, following the procedure set out in Treaty Article 251 and based on the following considerations: 1) it is necessary to ensure that products are in the scope of the free varebyttet in the community meet the requirements that provides a high level of protection of public interests such as health and safety in General, health and safety in the workplace, consumer protection, environmental protection and security, while ensuring that the free varebyttet not be restricted more than is allowed in accordance with the Community harmonisation legislation or any other relevant Community rules. It should therefore be determined rules for accreditation, market supervision, control of products from third States and CE marking.

2) it is necessary to create a coherent framework for the rules and principles of accreditation and market supervision. This frame should not affect the substantive policies in the current regulatory framework for provisions to be followed for the protection of public interests such as health, safety, consumer protection and environmental protection, but should aim to improve the application of them.

3) this regulation should be seen as a filling of European Parliament and Council decision No. 768/2008/EC of 9. July 2008 on a common framework for the marketing of products.

4) it is very difficult to adopt Community legislation for every product which exists or which may be developed. There is a need for a comprehensive policy of horizontal character that such products will be covered and to plug the holes, especially in anticipation of the revision of the existing special regulations, and to complement provisions in current or future especially regulations, in particular to ensure a high level of protection of health and safety as well as environmental protection and consumer protection in accordance with treaty article 95.

5) Frame for market supervision created by this regulation should complement and strengthen the current provisions on market supervision in the Community harmonisation legislation or the enforceability of such provisions. In accordance with the lex specialis principle should, however, this Regulation apply only to the extent that there are no special provisions with the same purpose, of the same species or with the same effect in other current or future provisions of Community harmonisation legislation. Examples can be found in the following areas: the starting substances for drugs, medical devices, pharmaceuticals and veterinary preparations, motor vehicles and aviation. The corresponding provisions of this regulation should not therefore apply in the areas covered by such special provisions.

6) in the European Parliament and Council Directive 2001/95/EC of 3. December 2001 on general product safety is it laid down rules to better consumption cost of security. Market supervisory authorities should have the opportunity to take the special measures they have at their disposal according to the said directive.

7) in order to achieve a higher level of security for the consumer goods market, however, supervisory arrangements set out in the Directive 2001/95/EC be strengthened with regard to the products that pose a serious risk, in accordance with the principles laid down by this regulation. Directive 2001/95/EC should therefore be amended.

8) Accreditation is part of an overall system which includes compliance assessment and market supervision, and whose purpose is to review and to ensure that current requirements are met.

9) Akkrediteringens particular value lies in the fact that it is an authoritative statement of the technical competence of bodies whose task is to ensure that current requirements are met.

10) Accreditation be applied in all Member States, but has so far not been covered by the rules of the community. The lack of common rules for such activity has led to different approaches and arrangements in the community, with the result that the Member States have not been as strict by accreditation. It is therefore necessary to develop a comprehensive framework for accreditation and at Community fix principles for how the accreditation is to be conducted and organized.

11 creation of a) uniform national accreditation body should not affect the distribution of tasks within the Member States.

12) If for the implementation of the Community harmonisation legislation is laid down that there shall be appointed compliance assessment bodies, they should be national public authorities in the community consider open accreditation, as provided for in this regulation, ensuring the necessary confidence to compliance certificates, as the preferred way to view these bodies ' technical expertise. National authorities can, however, believe that they even have suitable ways to perform this assessment. In such cases, the national authorities, to ensure that the reviews carried out by other national authorities have the necessary credibility, put forward to the Commission and the other Member States the necessary documentation that shows that they reviewed the compliance assessment bodies comply with the relevant requirements.

13) An accreditation scheme that is based on binding rules, helps to strengthen the mutual confidence between Member States as regards the competence of conformity assessment bodies and consequently also in terms of the certificates and test reports to the issuer. It forces thus the principle of mutual recognition, and therefore, the provisions relating to accreditation in this Regulation apply to organs that perform compliance reviews in areas where it is laid down rules, and in areas where there is no established rules. What matters is the quality of certificates and test reports, regardless of whether they fall into an area where it is set out rules or an area where there is no fixed rules, and it should therefore not be made any distinction between those areas.

14) in this regulation it should with national accreditation organers ideal business refers to a business that does not have to provide financial profit that increase resources to organets owners or members. Although the national accreditation bodies do not have the aim to increase profits the most or distribute profits, they can provide services against payment, or receive income. All excess income from such services can be used for investment to develop their business further, as long as this is compatible with their main business. It should therefore be emphasized that the most important goal for national accreditation bodies should be to support or actively exercise the business that are not intended to provide a profit.

15) Because the purpose of accreditation is to provide an authoritative statement of an organ empowered to exercise compliance assessment activities, Member States should not have more than one national accreditation body and make sure that this body is organized in such a way that the business is objective and unbiased. Such national accreditation bodies should exercise its activities independently of commercial conformity assessment activities. It is therefore appropriate to provide that Member States ensure that national accreditation bodies, when they perform their duties, are deemed to exercise public authority, regardless of their legal status.

16) to be able to assess and lead a compliance audit of ongoing assessment expertise, the organ is very important to determine the organets technological knowledge and experience and its ability to perform reviews. It is therefore necessary that the national accreditation body has the appropriate knowledge and expertise and the necessary means to be able to perform their duties in a satisfactory manner.


17) Accreditation should in principle be a self-sustaining business. Member States should ensure that financial support is given to the particular tasks.

18) in those cases where it is not economically meaningful or durable for a Member State to establish a national accreditation body, the Member State concerned should be able to use the national accreditation body of another Member State and are encouraged to the extent possible to use this opportunity.

19) Competition between national accreditation bodies could lead to a commercialisation of their business, something that will not be consistent with their role as the last level of control in the conformity assessment chain. The purpose of this regulation is to ensure that within the European union is sufficient proof for the entire one Union accreditation territory, and to avoid double accreditations, which provide additional cost without additional value. National accreditation bodies can compete on tredjestaters markets, but this must not affect their business within the community or the cooperation and peer evaluation organised by the body recognised under this regulation.

20) to avoid double accreditation, increase and approval of the meeting acceptance architecture accreditation proves and lead effective supervision of accredited conformity assessment bodies, organs should apply for accreditation by the national accreditation body of the Member State where they are established. It is still necessary to ensure that a conformity assessment body has the opportunity to apply for accreditation in another Member State in cases where the Member State in its own organets is no national accreditation body or where such a body is not competent to provide the accreditation services requested. In such cases, the national compliance assessment bodies collaborate and exchange information.

21) to ensure that national accreditation bodies meet the requirements and obligations set out in this regulation, it is important that Member States contribute to the accreditation scheme works in a satisfactory way, leading with their regular supervision national accreditation bodies and within a reasonable time, hit the appropriate corrective action when necessary.

22) to ensure that the compliance assessment bodies have an equal skill level, facilitate mutual recognition and promote general meeting acceptance architecture accreditation proves and compliance assessment results issued by accredited bodies, it is necessary that national accreditation bodies have a string and open peer review arrangement and regularly submit himself to such a review.

23) this regulation should include provisions on the recognition of a single organisation at EU level with regard to certain tasks on the accreditation area. The European cooperation for accreditation (EA), which has as main task to promote an open and quality controlled scheme for assessment of the competence of conformity assessment bodies throughout Europe, manages a peer evaluation scheme that includes national accreditation bodies from the Member States and other European States. The scheme has been shown to be effective and contribute to mutual trust. The EA should, therefore, be the first body recognised under this regulation, and Member States should ensure that their national accreditation bodies apply for and retain membership in the EA for as long as the EA is acknowledged. At the same time there should be determined a possibility to change the affected organ that are recognized in accordance with this regulation, in the cases where there is a need for this in the future.

24) effective cooperation among national accreditation bodies is required for peer review and accreditation across borders should be able to be carried out in an appropriate manner. For the sake of transparency, it is therefore necessary with an obligation for national accreditation bodies to exchange information and to give national authorities and the Commission relevant information. Up-to-date and accurate information about the availability of accreditation services provided by national accreditation bodies should also be made public and thus be made available, especially for compliance assessment bodies.

25) The sectoral accreditation schemes should include the areas where the General requirements for the competence of conformity assessment is not sufficient organers to ensure the required safety level when there are especially detailed requirements to technology or health and safety. Because EA have extensive technical knowledge to the case disposal, should the body be requested to develop such schemes, especially in areas covered by Community regulations.

26) to ensure an equitable and consistent enforcement of Community harmonisation legislation, introduced by this regulation a Community framework for market supervision, where the minimum is determined on the basis of the goals to be achieved by the Member States, and a framework for administrative cooperation, including the exchange of information between Member States.

27) in cases where market participants have test reports or certificates confirming compliance and is issued by an accredited conformity assessment body, and where the community's current regulations do not require harmonisation such reports or certificates, market supervisory authorities take duly into account to them when they control the product properties.

28) cooperation between competent authorities at national level and across borders for the exchange of information, investigation of violations and measures to bring them to an end, even before the dangerous products brought in revenues, by strengthening measures to identify them, especially in ports, is critical for the protection of health and safety and for the internal market to function in a satisfactory way. National consumer protection authorities at national level should cooperate with national market regulators and exchange information with them about products that they believe may pose a risk.

29) risk assessment should take into account all relevant information, including information about the risks that have arisen with respect to the product concerned, if such information exists. It should also be taken into account all measures that the affected market participants had to have hit to reduce this risk.

30) situations where a product poses a serious risk requires that it be stopped in quickly, which may cause the product to be withdrawn from the market, be revoked or that it is forbidden to make the product available on the market. In such situations it is necessary to have access to a system for the rapid exchange of information between Member States and the Commission. The system dealt with in article 12 of Directive 2001/95/EC has been shown to be efficient and effective for consumer goods. To avoid unnecessary overlap should be used for the system mentioned this forordnings purposes. A uniform market supervision throughout the Community requires a comprehensive exchange of information on national activities in this context, which goes further than this system.

31) information exchanged between competent authorities, should be subject to the strictest guarantees of confidence and confidentiality and processed in accordance with the fortrolighetsregler in the current national legislation or, in the case of the Commission, European Parliament and Council Regulation (EC) No. 1049/2001 of 30. May 2001 regarding public access to European Parliament, Council and Commission documents, to ensure that the investigations are not complicated and that market participants ' reputation is not damaged. European Parliament and Council Directive 95/46/EC of 24. October 1995 on the protection of natural persons in relation to the processing of personal data and on the free exchange of such information and European Parliament and Council Regulation (EC) No. 45/2001 of 18. December 2000 regarding the privacy policy in connection with the processing of personal data in the Community institutions and bodies and on the free exchange of such information is applicable within the framework of this regulation.

32) in the Community harmonisation legislation stipulate special procedures to determine whether a national measure which restricts the free movement of goods, justified or not (procedures for protection clauses). These procedures apply following a rapid exchange of information on products that pose a serious risk.

33) of entry at the external borders are well placed to detect dangerous products that do not meet the requirements, or products with false or misleading CE marking, before they brought in revenue. An obligation for the authorities with the responsibility to perform the control of the products introduced on the Community market, to carry out controls in sufficient large scale, can therefore contribute to a safer market. To make the controls more effective should these authorities in good time to get all the necessary information from the authorities about dangerous products that do not meet the requirements.

34) in Council Regulation (EEC) Nr. 339/93 of 8. February 1993 on the control of compliance with the rules on product safety by the importation of products from third States is that set out rules for customs authorities ' delay of the release of products, and it's set out further measures, including pulling in market supervisory authorities. It is therefore appropriate that those provisions, including that to pull in the market supervisory, will be incorporated in this regulation.

35) experience has shown that products which are not released, often return the executed and then come into the Community market at other points of entry, thus undermining the Customs authorities ' work. Market supervisory authorities should therefore be given the means to destroy products if they consider it appropriate.


36) within one year after the announcement of this regulation in the official journal of the European Union, the Commission should present an in-depth analysis in the field of consumer safety markings, followed by proposals for regulations where this is necessary.

37) CE marking, which indicates that a product is in compliance with the requirements, is the visible result of a whole process comprising conformity assessment in the broad meaning. The General principles of the CE marking should be determined in this regulation, so that they can be applied immediately and thus facilitate future regulations.

38) CE marking should be the only form of conformity marking indicates that a product is in conformity with the Community harmonisation legislation. Other forms of labeling, however, can be used as long as they contribute to better consumer protection and are not covered by Community harmonisation legislation.

39) Member States must provide for suitable opportunities to appeal to the competent courts on the measures taken by the competent authorities which restrict the sales of a product, or require that the product be withdrawn or cancelled.

40) Member States may find it useful to create a cooperation with the parties concerned, including sectoral professional organisations and consumer organisations, in order to take advantage of available market knowledge when creating, implementing and updating market regulatory programs.

41) Member States should determine the rules for sanctions to be applied by the violation of the provisions of this regulation and ensure that they are implemented. These sanctions should be effective, stand in relation to the infringement and daunting and can be strengthened if the affected market participant have previously committed a similar infringement of the provisions of this regulation.

42) to reach this forordnings goal is it necessary that the community contributes to the financing of the business that is required to implement the Community policy in the field of accreditation and market supervision. Funding should take place either in the form of grants to the body which is recognised under this regulation without proposal invitation, in the form of grants for proposal invitation or by assigning contracts to this or other bodies, depending on the nature of the business to be financed and in accordance with Council Regulation (EC, Euratom) No. 1605/2002 of 25. June 2002 on the financial regulation applicable to the general budget of the European Communities ("financial regulation").

43) For certain specialized tasks, such as drafting and revision of sectoral accreditation schemes, and for other tasks related to the control of the laboratoriers as well as certification or inspection organers technical expertise and equipment, the EA should initially be eligible for Community financing, since it is well suited to provide the technical case for knowledge that is necessary.

44) in view of the role of the body recognised under this regulation in the context of peer review by accreditation bodies and its ability to assist the Member States with the management of such a review, the Commission should be able to provide grants for the operation of the Secretariat of the body recognised under this regulation, which should provide ongoing support for accreditation activities at Community level.

45) it should in accordance with the provisions of the financial rules, entered into a partnership agreement between the Commission and the body recognised under this regulation, in order to fix the administrative and financial provisions relating to the financing of accreditation activities.

46) in addition, financing should also be available to bodies other than the body recognised under this regulation, to other business in the area of conformity assessment, accreditation of metrology, and market supervision, e.g. drafting and updating of guidelines, comparative business related to the implementation of security clauses, preparatory operations or additional business in connection with the implementation of Community regulations on the above mentioned areas as well as applications for technical assistance and cooperation with third States and an improvement of the policy on the above mentioned areas at community and at international level.

47) this regulation is compatible with the fundamental rights and principles which are acknowledged in particular in the European Union Charter of fundamental rights.

48) since the objective of this regulation, which is to ensure that products on the market covered by Community regulations, meet the requirement for a high level of protection of health and safety and other public interests, and at the same time ensure that the internal market works in a satisfactory way by determining a framework for accreditation and supervision, business market cannot be reached to a sufficient degree by the Member States and, therefore, because of the scope and effects of the action better can be reached at Community , the community can take measures in accordance with the subsidiarity principle as set out in the Treaty's article 5. In accordance with the forholdsmessighetsprinsippet set out in the said article, this regulation does not go further than what is necessary to reach this target-adopted this Regulation: chapter I General provisions 1. Art. Purpose and scope 1. In this regulation be fixed rules for the Organization and implementation of accreditation of conformity assessment bodies that athlete compliance assessment business.

2. in this regulation will be determined a framework for market supervision of products to ensure that these products meet the requirements that provides a high level of protection of public interests such as health and safety in General, health and safety in the workplace, consumer protection, environmental protection and security.

3. in this regulation will be determined a frame for the control of products from third States.

4. in this regulation will be determined the General principles of the CE marking.

Art 2. Definitions in this regulation means: 1. "making available on the market" any delivery of a product for distribution, consumption or use on the Community market in connection with commercial ventures, against payment or free of charge, 2. "bring in revenues" make a product available on the Community market for the first time, 3. "producer" any physical or legal person who manufactures a product or who get a product designed or manufactured , and marketing the product under his name or trademark, 4.
"delegate" any natural or legal person established in the community who has received a written mandate from a manufacturer to act on his behalf in connection with specified tasks with regard to the latter's obligations in accordance with applicable Community legislation, 5.
"importer" any natural or legal person established in the community that brings a product from a third in sales in the community, 6.
"distributor" any natural or legal person in the sales chain, other than the manufacturer or the importer, who makes a product available on the market, 7.
"market participants" manufacturer, representative, the importer and the Distributor, 8.
"technical specification" a document in which it set out the technical requirements to be met by a product, process, or service, 9.
"harmonised standard" a standard adopted by one of the European standardisation bodies listed in Annex i to the European Parliament and Council Directive 98/34/EC of 22. June 1998 about an information procedure for standards and technical regulations on the basis of a request from the Commission in accordance with article 6 of the said directive, 10.
"accreditation" a certification from a national accreditation body that a conformity assessment body meets the requirements laid down in harmonised standards and, where relevant, any additional requirements, including those set out in the relevant sector schemes, to exercise a particular compliance assessment business, 11.
"national accreditation body" the only body in a Member State that performs accreditation on behalf of the State, 12.
"compliance rating" a process to determine whether the specified requirements for a product, a process, a service, a system, a person or a body are met, 13.
"compliance assessment body" a body which carries on the compliance assessment activities, including calibration, testing, certification and inspection, 14.
"recall" any measures with a view to back the delivery of a product that has already been made available to the end user, 15.
"withdrawal" any measures aimed at preventing a product in the sales chain is being made available on the market, 16.
"peer review" process, where a national accreditation body be considered by other national accreditation bodies in accordance with the requirements of this regulation and, where applicable, additional sectoral technical specifications, 17.
"market attention" business that is exercised and measures taken by public authorities to ensure that the products meet the requirements of the current regulations and the community's harmonisation does not put health, safety, or other aspects of the protection of the public interest at risk, 18.
"the market supervisory authority" an authority in a Member State with responsibility to conduct market supervision on the Member State's territory, 19.
"release for free sales" the procedure set out in article 79 of Council Regulation (EEC) Nr. 2913/92 of 12. October 1992 on the introduction of the Community customs code, 20.
"CE marking" marking where the manufacturer indicates that the product meets the applicable requirements set out in Community harmonisation legislation for such labeling, 21.
"Community harmonisation legislation" all Community regulations which harmonizes the conditions for the marketing of products.

Chapter II. Accreditation


Art 3. Scope This chapter applies to the accreditation, on a mandatory or voluntary basis, in the context of the compliance assessment, whether that assessment is compulsory or not, and regardless of the legal status the organ that carries out the accreditation, has.

Art 4. General principles 1. Each Member State shall designate a single national accreditation body.

2. If a Member State considers that it is not economically meaningful or durable to have a national accreditation body or to provide certain accreditation services, the Member State shall as far as possible make use of the national accreditation body of another Member State.

3. A Member State shall notify the Commission and the other Member States if it is in accordance with no. 2 using the national accreditation body of another Member State.

4. On the basis of the information mentioned in Nr. 3 and in article 12, the Commission shall prepare, maintain and make public a list of national accreditation bodies.

5. When the accreditation is not done directly by the public authorities themselves, a Member State shall hand over the implementation of the accreditation to its national accreditation body that a public governance and giving it formal recognition.

6. The national accreditation organ responsibilities and tasks should be clearly separated from the responsibility and tasks to other national authorities.

7. The national accreditation body shall exercise his or her business on the ideal basis.

8. The national accreditation body shall not operate or provide services that match the rating agencies, and shall not provide provide consulting services, own shares in or otherwise have a financial interest or management responsibility in a compliance assessment body.

9. Each Member State shall ensure that its national accreditation body has the appropriate financial and human resources to carry out its tasks in a satisfactory way, including to perform particular tasks, such as activities for European and international accreditation cooperation and activities that are required to support public policy and which are not self-sustaining.

10. The national accreditation body shall be a member of the body that is recognised in accordance with article 14.

11. National accreditation bodies shall establish and maintain appropriate structures to ensure an effective and balanced participation from all parties concerned both within their organizations and within the body that is recognised in accordance with article 14.

Art 5. Accreditation 1. A national accreditation body shall at the request of a conformity assessment body to consider about this compliance assessment body is competent to exercise a particular compliance assessment business. If that is the case, the national accreditation body issue a proof of accreditation.

2. When a Member State decides not to use accreditation, it shall provide the Commission and the other Member States all the information that is required to verify the competence of the conformity assessment bodies it selects for the implementation of the community's current harmonisation legislation.

3. National accreditation bodies shall supervise the compliance assessment bodies to which they have issued accreditation evidence to.

4. If a national accreditation body determines that a compliance assessment body which has received an accreditation certificate, is no longer competent to exercise a particular compliance assessment business or on a serious way has failed to fulfil its obligations, the accreditation body within a reasonable time limit take all appropriate measures to restrict, temporarily suspend or withdraw the accreditation certificate.

5. Member States shall determine the procedures for handling appeals, including appeals in connection with access accreditation decisions or lack of accreditation decisions, where appropriate.

Art 6. The principle of prohibition of competing business 1. National accreditation bodies shall not compete with conformity assessment bodies.

2. National accreditation bodies shall not compete with other national accreditation bodies.

3. National accreditation bodies can conduct their business across borders, within the territory of another Member State, either at the request of a conformity assessment body under the circumstances specified in article 7 No. 1, or, if this is requested by a national accreditation body in accordance with article 7 No. 3, in collaboration with the national accreditation body in the said Member State.

Art 7. Accreditation across borders 1. When a compliance assessment body requests accreditation, it shall do so with the national accreditation body of the Member State in which it is established or with the national accreditation body of that Member State concerned have utilized in accordance with article 4 Nr. 2. A compliance assessment body may, however, apply for accreditation by a national accreditation body other than those referred to in the first paragraph, in the following situations: a) when Member State where the body is established, has decided not to establish a national accreditation body and has not used a national accreditation body of another Member State in accordance with article 4 Nr. 2, b) when the national accreditation bodies referred to in the first paragraph do not perform accreditation for the kind of business that the compliance assessment is requested accreditation for, c) when the national accreditation bodies referred to in the first paragraph have not met the requirements set by peer review according to article 10 for the kind of business that the compliance assessment is requested accreditation for.

2. When a national accreditation body receives a request pursuant to no. 1 letter b) or c), it shall inform the national accreditation body of the Member State in which the requesting conformity assessment body is established. In such cases, the national accreditation body of the Member State in which the requesting conformity assessment body is established, participate as an observer.

3. A national accreditation body can ask another national accreditation body to carry out part of the appraisal business. In such a case will be the proof of the accreditation is issued requesting body.

Art 8. Requirements for national accreditation bodies a national accreditation body shall fulfil the following requirements: 1. It shall be organised in such a way that it is independent of the conformity assessment bodies it assesses and of commercial pressure, and so that it be ensured that there is no conflicts of interest occur with conformity assessment bodies.

2. It shall be organised and operated so that the business is objective and unbiased.

3. it shall ensure that any decision on certification of competence is taken by other competent people than those who carried out the assessment.

4. it shall have suitable arrangements to ensure the confidential treatment of the information it receives.

5. It should map out the compliance assessment business it is competent to perform accreditation, and, where appropriate, refer to the relevant Community legislation or national legislation and national standards.

6. It should introduce procedures that are necessary to ensure efficient management and appropriate internal controls.

7. It should have a sufficiently large qualified staff to be able to perform their duties in a satisfactory manner.

8. It shall document the duties, responsibilities and powers of the staff that will be able to affect the quality of the assessment and attesteringen of expertise.

9. To introduce, implement and maintain procedures for supervising the affected staff's work effort and expertise.

10. It should ensure that compliance reviews will be conducted in a suitable way, so that the companies not be imposed unnecessary burdens and that it be taken duly into account enterprises ' size, in which sector they conduct their business, their structure, how complex the current product's technology is as well as the production process the character of mass or serial production.

11. It shall publish audited annual accounts prepared in accordance with generally recognized accounting principles.

Art 9. Compliance with requirements 1. If a national accreditation body does not meet the requirements of this regulation, or fails to fulfill its obligations under this regulation, the Member State concerned shall take appropriate corrective action or ensure that such corrective action taken, and inform the Commission about this.

2. Member States shall bring their national regular supervision of the accreditation bodies in order to ensure that they meet the requirements in article 8.

3. Member States shall as far as possible take account of the results of the peer review according to article 10 when they perform the audit referred 2 of this article.

4. National accreditation bodies shall have introduced the necessary procedures to handle complaints against the conformity assessment bodies they have accredited.

Art 10. Peer review 1. National accreditation bodies shall submit to a peer review organized by the body that is recognised in accordance with article 14.

2. Parties concerned shall have the right to participate in the scheme that has been introduced for the supervision of peer review, but not in individual procedures for peer review.

3. Member States shall ensure that their national accreditation bodies regularly undergo a peer review according to the requirement of the No. 1.4. Peer review should be made on the basis of fair and open assessment policies and procedures, especially when it comes to structural requirements, requirements for human resources and processes as well as familiarity and complaints. It is determined appropriate procedures for a complaint against the decisions that are taken as a result of the assessment.


5. Peer evaluation shall ascertain whether the national accreditation bodies meet the requirements of article 8, as giving effect to the relevant harmonized standard referred to in article 11.

6. Body that is recognised in accordance with article 14, to announce the results of the peer review and send it to all Member States and to the Commission.

7. the Commission shall, in cooperation with the Member States, oversee the rules and that the peer-review system works in a satisfactory way.

Art 11. Matching guess for national accreditation bodies 1. National accreditation bodies that demonstrate that they meet the criteria set out in the relevant harmonised standard as it is published a reference to in the European Union's official journal, by fulfilling the requirements set by peer review according to article 10, the assumption is to meet the requirements of article 8.

2. National authorities shall recognise the likeverdigheten to the services provided by the accreditation bodies that have fulfilled the requirements posed by peer review according to article 10, and thus on the basis of the presumption referred to in no. 1 in this article accept accreditation from these organs and evidence attesteringene issued by the conformity assessment bodies that are accredited by them.

Art 12. Disclosure 1. Each national accreditation body shall inform the other national accreditation bodies of the conformity assessment activities that it offers accreditation for, and of any changes of the business.

2. each Member State shall inform the Commission and the body recognised under article 14, about the identity of its national accreditation body and of all conformity assessment activities that this body offers accreditation for in support of the Community harmonisation legislation, and of any changes.

3. Each national accreditation body shall regularly make publicly available information about the results of its peer review, if the compliance rating business as it offers accreditation for as well as of any changes.

Art 13. Requests to the body that is recognised in accordance with article 14 1. The Commission may, after consultation with the Committee appointed according to article 5 of Directive 98/34/EC, request the body recognised under article 14, to contribute to the development, maintenance and implementation of accreditation in the community.

2. the Commission may also after the procedure set out in the No. 1 a) ask the body that is recognised under article 14 to determine evaluation criteria and procedures for peer evaluation and to develop sectoral accreditation schemes, b) accept all existing schemes that already includes the assessment criteria and procedures for peer review.

3. the Commission shall ensure that sectoral schemes mapped the technical specifications that are required to achieve the level of expertise required in the Community harmonisation legislation in areas with special requirements to technology, health and safety or environmental requirements or other aspects of the protection of the public interest.

Art 14. European accreditation infrastructure 1. The Commission shall after consultation with the Member States recognize a body that meets the requirements in Annex i to this regulation.

2. A body which should be recognized according to the No. 1, to enter into an agreement with the Commission. The agreement shall include a detailed description of the organets tasks, funding provisions and provisions for supervision of the Agency. Both the Commission and the body shall be able to terminate the agreement without specifying any reason by the expiration of a reasonable time limit to be determined in the agreement.

3. The Commission and the Agency shall make public the agreement.

4. The Commission shall inform the Member States and national accreditation bodies for the recognition of a body pursuant to no. 1.5. The Commission may not recognise more than one organ at a time.

6. The first body recognised under this Regulation shall be the European cooperation for accreditation, provided that it has entered into an agreement according to the No. 2. Chapter III. Community framework for market supervision and control of the products introduced on the Community market Section 1. General provisions Art 15. Work area 1. Article 16-26 apply to products covered by Community harmonisation legislation.

2. All the provisions of article 16-26 applies to the extent that there are no specific provisions with the same objective in Community harmonisation legislation.

3. The application of this Regulation shall not prevent market supervisory authorities in to meet special measures as provided for in Directive 2001/95/EC.

4. In article 16-26 is meant by "product" a fabric, a fabric blend or an item made by a manufacturing process, apart from food, feed, living plants and animals, products that originate from the people and products of plants and animals that are directly related to their future reproduction.

5. Article 27, 28 and 29 apply to all products covered by Community legislation insofar as other Community legislation does not contain specific provisions about the Organization of border control.

Art 16. General requirements 1. Member States shall organise and carry out market supervision as set out in this chapter.

2. Market supervision is to ensure that products covered by Community harmonisation legislation which, when used in accordance with its intended purpose or under conditions which can reasonably be predicted, and when properly installed and maintained, it will be able to harm the health or safety of users, or which otherwise do not comply with the current requirements set out in Community harmonisation legislation, retractable , be prohibited or made available on the market only to a limited extent, and that the public, the Commission and the other Member States will be informed of this.

3. The national infrastructures and applications for market supervision to ensure that it can be made effective measures for any product category which are covered by Community harmonisation legislation.

4. Market supervision shall include products that are assembled or manufactured for the manufacturer's own use when it is in the community's harmonisation rules laid down that its provisions apply to such products.

Section 2. Community framework for market supervision Art 17. Disclosure 1. Member States shall inform the Commission about their market regulatory authorities and their areas of responsibility. The Commission shall transmit this information to the other Member States.

2. Member States shall ensure that the public is aware of the national market Government existence, responsibilities and identity as well as how they can be contacted.

Art 18. Member States ' obligations with regard to organization 1. Member States shall introduce appropriate arrangements for communication and coordination between their market regulatory authorities.

2. Member States shall establish appropriate procedures to a) follow up complaints or reports on the risks associated with products subject to Community harmonisation legislation, monitor accidents and b) health damage as it is suspected that these products may have caused, c) verify that corrective action is hit and d) follow up scientific and technical knowledge about security issues.

3. Member States shall give the market supervisory authority, the resources and the knowledge that is required for them to perform their duties in a satisfactory manner.

4. Member States shall ensure that market supervisory exerts its authority in accordance with forholdsmessighetsprinsippet.

5. Member States shall establish, implement and regularly maintain their market regulatory programs. Member States shall draw up either a general market supervisory program or sectoral programs for the sectors in which they carry out market supervision, notify the other Member States and the Commission about these programs and make them available to the public online, as well as, where appropriate, in other ways.
The first underretningen of this type should happen within 1. January 2010. Later current guidance of the programs will be made public in the same way. The Member States can cooperate with all parties concerned for this purpose.

6. Member States shall regularly revise and assess its supervisory activities. Such audits and reviews to be carried out at least every four years, and the results shall be notified to the other Member States and the Commission and be made publicly available online as well as, where appropriate, in other ways.

Art 19. Market regulatory measures 1. Market supervisory authorities to be in sufficient scope to perform appropriate checks of the properties of a product by document control and, where appropriate, physical control and laboratory investigations on the basis of appropriate samples. In that regard they shall take into account the current principles of risk assessment, complaints and other information.
Market supervisory authorities may require that market participants make the documentation and information available as the authorities deem necessary for them to carry out their business, as well as, when it is necessary and justified, to gain access to market participants ' premises and the right to take appropriate samples of the products. They can destroy or otherwise make unusable products that pose a serious risk, if they consider it necessary.
If market participants put forward research reports or certificates confirming compliance, and which is issued by an accredited conformity assessment body, market supervisory take duly into account such reports or certificates.


2. Market Supervisory shall, within a reasonable time limit to meet appropriate measures to alert users on their territory about the perils they have discovered in association with a product, so that the risk of injury or other damage is reduced.
They are going to collaborate with market participants on measures that can prevent or reduce risks caused by products that these market participants have made available.

3. If the market supervisory authorities of one Member State decide to withdraw a product manufactured in another Member State, they shall inform the affected market participant at the address specified on the affected product or in product documentation.

4. Market Supervisory to fulfill their obligations in an independent, impartial and objective way.

5. Market Supervisory to attend intimacy where this is necessary to protect trade secrets or personal information according to national legislation, but without prejudice to the requirement that the information be made public under this regulation to the extent it is necessary for the protection of users ' interests in the community.

Art 20. Products that pose a serious risk 1. Member States shall ensure that products which pose a serious risk that requires that it be stopped in quickly, including a serious risk that do not have immediate effects, being recalled or withdrawn from the market, or that it is forbidden to make them available on the market, and that the Commission immediately under the corrected about this in accordance with article 22.

2. The decision as to whether a product poses a serious risk, should build on an appropriate risk assessment which takes into account his father's art and the probability that it occurs. The possibility of achieving a higher level of security or obtain other products that require less risk, shall not be sufficient reason for a product shall be deemed to pose a serious risk.

Art 21. Restrictive measures 1. Member States shall ensure that all measures adopted in accordance with the current regulations, the community's harmonisation with a view to prohibit or limit the availability of a product on the market, withdraw it from the market or recall it, stands in relation to the purpose, and that the reasons for the measure be set exactly.

2. Such measures shall immediately be notified to the relevant market participant, which should be addressed at the same time under about the type of complaint available access according to the competent Member State legislation and the deadlines that apply to such complaint.

3. Before a measure that referred 1 hit, to the affected market participant within a suitable period of time of at least ten days be given the opportunity to make a statement, unless such consultation is not possible because the measure is urgent on the basis of health or safety requirements or for other reasons related to the public interests that are covered by the community's current harmonisation legislation. If a measure is hit without that the market participant has received a statement, to the market participant is given the opportunity to make a statement as soon as possible, and the measures that are hit, then quickly be taken up for review.

4. All the measures referred 1 should quickly be withdrawn or changed if the market participant has at issue that it is hit effective measures.

Art 22. Exchange of information-the Community system for the rapid exchange of information 1. If a Member State or intend to take measures in accordance with article 20 and considers that the reasons for the measure or action effects go beyond the competent Member State territory, it shall immediately inform the Commission of such measures in accordance with no. 4 of this article. The Member State shall immediately inform the Commission on the amendment or repeal of such measures.

2. If a product poses a serious risk, have been made available on the market, Member States shall notify the Commission of any voluntary measures that a market participant has met and advised of.

3. The information provided according to the No. 1 and 2, shall include all available details, in particular those that are necessary to identify the product, the product's origin and the revenue chain, associated with the risk, the nature and duration of the national measures that are struck, as well as any voluntary measures that are hit by market participants.

4. With regard to the No. 1, 2 and 3 to the system for market supervision and information exchange that are set out in article 12 of Directive 2001/95/EC, be used. No. 2, 3 and 4 of article 12 of the said directive get the corresponding application.

Art 23. General information system 1. The Commission shall develop and maintain a general archiving and electronic system for the exchange of information on issues related to the market supervisory operations, applications and associated information about the non-compliance of Community harmonisation legislation. The system will be in a suitable way reflect the messages and information that is given in accordance with article 22.

2. With regard to the No. 1 Member States shall submit to the Commission information that they have at their disposal and that they have not already given pursuant to article 22, on products that pose a risk, especially in the identification of risks, results of executed prøvinger, temporary restrictive measures, contacts with affected market participants and the rationale for that action is hit or not hit.

3. Without prejudice to article 19 No. 5 or national legislation on familiarity, to confidential treatment of the information content is secured. Consideration of confidence shall not prevent the dissemination to the market supervisory authorities of information that is important to ensure an effective market supervision.

Art 24. Principles of cooperation between Member States and the Commission 1. Member States shall ensure efficient cooperation and exchange of information between their own market regulatory authorities and market regulatory authorities in the other Member States, and between their own authorities and the Commission and relevant community agencies, about their market regulatory programs and about all the questions that apply to the products that pose a risk.

2. With regard to the No. 1 to market supervisory in one Member State in the appropriate scope assist market regulatory authorities in other Member States by providing them information or documentation, by carrying out appropriate investigations or meet other appropriate measures and by participating in investigations initiated in other Member States.

3. the Commission shall collect and organise the information on national market supervisory measures that make it possible for it to meet its obligations.

4. All information that is provided by a market participant in accordance with article 21 No. 3 or otherwise, should be included when the innberettende Member State under dishes other Member States and the Commission about their results and measures. All recent information should clearly be identified as associated with the information already given.

Art 25. Sharing of resources 1. The Commission or the Member States concerned can take market regulatory initiative whose purpose is to share resources and case knowledge between competent authorities in the Member States. Such initiatives will be coordinated by the Commission.

2. With regard to the No. 1 the Commission shall, in cooperation with Member States, a) develop and organise training programmes and exchange of national officials, b) develop, organize, and create applications for the exchange of experience, information and best practice, programmes and actions for common projects, information campaigns, joint visit programmes and the sharing of resources.

3. Member States shall ensure that their competent authorities participate fully in the business that is referred 2, when it is appropriate.

Art 26. Cooperation with the competent authorities of third States 1. Market supervisory authorities may cooperate with the competent authorities in third States with a view to exchanging information and technical assistance, promote and facilitate access to European schemes and promote business in connection with conformity assessment, market supervision and accreditation.
The Commission shall, in cooperation with the Member States develop appropriate programs for this purpose.

2. Cooperation with the competent authorities in third States can among other things happen in the form of business that dealt with in article 25 Nr. 2. Member States shall ensure that their competent authorities participate fully in this business.

Section 3. Control of products that are being introduced at Community market Art 27. Control of products that are being introduced at Community market 1. Member States ' authorities with responsibility for the control of products that are being introduced on the Community market, should have the authority and the resources that are necessary for them to perform their duties in a satisfactory manner. They should be in sufficient scope to perform appropriate checks of the properties of a product in accordance with the principles of article 19 No. 1, before those products are released for free sales.

2. When in a Member State is more authorities that have responsibility for market supervision or control with outer limits, these authorities shall cooperate with each other by exchanging information necessary for them to perform their tasks, and in other ways as needed.

3. The authorities with responsibility for the control of external borders to delay release of a product for free sales on the Community market if they by the controls referred to in no. 1 States the following: a) the product displays characteristics which give cause to believe that the product, when it is properly installed, maintained and used, poses a serious risk to health, safety, the environment or other public interests as referred to in article 1.

b)

The product isn't followed by the written or electronic documentation required under the current regulations, the community's harmonisation or is not marked in accordance with such regulations.

c) CE marking on a product is applied to the incorrect or misleading way.

The authorities responsible for the control of external borders shall immediately notify the market supervisory if such postponement of release.

4. If in the case of perishable products, the authorities with responsibility for the control of external borders as far it is possible to make sure that all of the requirements that they may impose with regard to the storage of products or the parking of transport vehicles, consistent with the products ' shelf life.

5. with respect to this paragraph gets the article 24 application of the authorities with responsibility for the control of external borders, without prejudice to the application of the provisions of Community law on more specific arrangements for cooperation between these authorities.

Art 28. Release of products 1. A product if the release is temporarily exposed by the authorities with responsibility for the control of external borders in accordance with article 27, should be released if these authorities within three working days after the postponement of the release has not been informed of any measures taken by the market supervisory, and provided that all the other requirements and formalities with respect to such a release are met.

2. If the market supervisory States that the competent product does not pose any serious risk to health and safety or cannot be considered to be in breach of Community harmonisation legislation, will the product be released, provided that all the other requirements and formalities with respect to such a release are met.

Art 29. National measures 1. If the responsible market regulatory authorities determine that a product poses a serious risk, they shall take measures to prohibit the marketing of the product and demand that the authorities responsible for the control of external borders, select the invoice that follows the product, and all other relevant following the documents or, if the data processing is happening online, the data management system, in the following way: "Dangerous product-release for free turnover not allowed-Regulation (EC) No. 765/2008 ".

2. If the market supervisory authorities determine that a product is not in conformity with the Community harmonisation legislation, they shall take suitable measures if necessary, include prohibiting the product from being brought in revenue.
If it is forbidden to bring a product in revenue according to the first paragraph, the market supervisory authorities require that with responsibility for the control of external borders is not releasing the product for free turnover and that they select the invoice that accompanies the product, and all other relevant result documents or, where data processing is happening online, the data management system, in the following way: "the product does not meet the current requirements-release for free turnover not allowed-Regulation (EC) No. 765/2008 ".

3. If the person in question be trusted for product later another Customs procedure than releasing for free revenue, and provided that the market supervisory do not make objections, to påtegningene mentioned in Nr. 1 and 2 on the same terms applied to the documents used in connection with the relevant procedure.

4. Member States ' authorities may destroy or otherwise make unusable products that pose a serious risk, if they consider it necessary and reasonable.

5. The market supervisory authorities shall provide for the control of outer limits information about product categories as it is determined poses a serious risk or do not meet the current requirements according to no. 1 and 2.

Chapter IV. CE marking Art 30. The General principles of the CE marking 1. The CE marking shall be applied only by the manufacturer or its representative.

2. CE marking as shown in annex II shall be applied to products only if the in the Community harmonisation legislation set out specific provisions that the product to be applied to the CE marking, and shall not be applied to any other product.

3. By applying or have inflicted on the CE label shows that the manufacturer assumes responsibility for the product is in compliance with all applicable requirements set out in the current regulatory framework for the community's harmonisation to the application.

4. The CE marking shall be the only marking which confirms that the product is in compliance with the current requirements set out in the current regulatory framework for the community's harmonisation to the application.

5. It is prohibited to inflict a product marking, signs or inscriptions which could mislead third parties as to the meaning or the CE-merkingens graphic design. Other marking can be applied to the product, provided that it does not do the CE label less visible or readable or change its meaning.

6. Without prejudice to article 41, Member States shall ensure correct implementation of the provisions relating to CE marking and take appropriate action in case of improper use of the marking. Member States shall also determine the sanctions for violations, which may include criminal sanctions for serious infringements. These sanctions shall be in relation to overtredelsens seriously and effectively prevent improper use.

Chapter v. Community funding Art 31. Bodies that work for a goal of general European interest in The body that is recognised in accordance with article 14, shall be considered as a body working for a goal of general European interest according to article 162 of Commission Regulation (EC, Euratom) No. 2342/2002 of 23. December 2002 on the determination of modalities for the implementation of Council Regulation (EC, Euratom) No. 1605/2002.

Art 32. Business that is eligible for Community financing 1. The community may finance the following activities in connection with the application of this Regulation: a) the drafting and revision of sectoral accreditation schemes referred to in article 13 Nr. 3, b) the business of the Secretariat to the body that is recognised in accordance with article 14, such as the coordination of accreditation activities, technical work tasks related to the operation of the scheme for peer review, information dissemination to affected parties and organets participation in international organizations in the area of accreditation, c) drafting and updating of contributions to guidelines in the areas of accreditation, notification to the Commission of conformity assessment bodies, conformity assessment and market supervision , d) comparative business related to the implementation of security clauses, e) technical disclosure case knowledge of the Commission to assist it in its implementation of the administrative cooperation on market supervision, including the financing of administrative cooperation groups, decisions on market supervision and matters concerning security clauses, f) execution of preparatory work or additional work in connection with the implementation of the conformity assessment, accreditation of metrology, and market supervision related to the implementation of Community regulations , such as surveys, programs, reviews, guidelines, comparative analyses, mutual joint visits, research work, the development and maintenance of databases, training activities, laboratory work, suitable hot crispy wing, comparative laboratory prøvinger and compliance assessment work as well as European market supervisory promotions and similar business, g) operations within the framework of applications for technical assistance, cooperation with third States and the promotion and enhancement of European principles and arrangements for compliance review, market supervision and accreditation among the parties concerned in the community and at international level.

2. the business that is referred 1 letter a), shall be eligible for Community financing only if the Committee appointed by article 5 of Directive 98/34/EC has been consulted on the requests to be submitted for the body that is recognised in accordance with article 14 of this regulation.

Art 33. Bodies that are eligible for Community financing Community financing may be granted to the body recognised under article 14, for the implementation of the activities as listed in article 32.
Community financing can, however, also be granted to other bodies for the business as provided for in article 32, with the exception of the business that is mentioned in Nr. 1 letter a) and b) in the said article.

Art 34. Funding Allocations to the business that will be covered in this regulation, to be determined each year by the budget authority within the current financial framework.

Art 35. Funding arrangements 1. Community funding is to be given a) without proposal invitation, to the body recognised under article 14, to exercise the business that is dealt with in article 32 No. 1 letter a)-g), as it can be given grants to in accordance with the financial rules, b) in the form of grants for proposal invitation, or by public procurement, to other bodies to exercise the business that is dealt with in article 32 No. 1 letter c)-g).

2. The activities of the Secretariat to the body that is recognised in accordance with article 14 and dealt with in article 32 No. 1 letter b), can be financed on the basis of operating grants. Upon renewal to the operating subsidy does not nedsettes automatically.

3. in the grant agreements may be allowed permanent contributions to the coverage of the recipient's General fixed costs up to at most 10% of the total direct eligible costs of the action, except in cases where the recipient's indirect costs are covered by an operating grants funded over the Community budget.


4. The common goal for the cooperation and the administrative and financial conditions for the grants given to the organ which is recognized in accordance with article 14, can be defined in a framework partnership agreement signed by the Commission and mentioned the organ, in accordance with the financial regulation and Regulation (EC, Euratom) No. 2342/2002. The European Parliament and the Council will be under about the making of correct such agreements.

Art 36. Management and follow-up 1. The appropriations determined by the budget authority for the financing of conformity assessment, accreditation and market supervision, may also cover the administrative expenses relating to the preparation, monitoring, inspection, auditing and evaluation which are directly necessary to reach the objectives of this regulation, and in particular studies, meetings, information and publicity, expenses linked to the information network for the exchange of information as well as other expenses for administrative and technical assistance which the Commission may take in connection with the compliance assessment and accreditation activities.

2. the Commission shall consider whether the compliance assessment, accreditation and market supervisory activities that receive Community funding, is relevant in the light of the requirements of the community's principles and regulations, and inform the European Parliament and the Council on the results of this review within 1. January 2013 and then every five years.

Art 37. The protection of the community's financial interests 1. The Commission shall upon completion of operations financed under this regulation to ensure the protection of the community's financial interests through preventive measures against fraud, corruption and other illegal activities, through effective control and enforcement of the amount wrongfully paid out, and if it detects irregularities, through sanctions that are effective, stands in relation to the infringement and are a deterrent, in accordance with Council Regulation (EC , Euratom) Nr. 2972/95 of 18. December 1995 on the protection of the European Communities financial interests, Council Regulation (Euratom, EC) No. 2185/96 of 11. November 1996 for control and inspection on site that are made by the Commission for the protection of the European Communities financial interests against fraud and other irregularities, and European Parliament and Council Regulation (EC) No. 1073/1999 of 25. May 1999 on investigations made by the European Office for fighting fraud (OLAF).

2. For the community activities financed pursuant to this regulation, is meant by the concept of irregularity referred to in article 1 No. 2 of Regulation (EC, Euratom) No. 2972/95 any violation of a provision of Community law or any breach of a treaty obligation as a result of a market participant's Act or omission, damage or will be able to harm the European Union's general budget or budgets as the Fund Manager, as a result of a wrongful expense record.

3. Agreements and contracts arising from this regulation to include the provisions on monitoring and financial control to be safeguarded by the Commission or an authorised representative for the Commission, and whether the revision made by the Court of Auditors, if necessary on the spot.

Chapter VI. Final provisions Art 38. Technical guidelines to facilitate the implementation of this regulation, the Commission shall draw up non-binding guidelines in consultation with the affected parties.

Art 39. Transitional provisions Accreditation proves issued before 1. January 2010 may remain valid until they expire, but at the latest until 31. December 2014. This regulation, however, apply in case of extension or renewal of such accreditation proves.

Art 40. The revision clause and reporting the Commission shall no later than 2. September 2013 put forward for the European Parliament and the Council a report on the application of this regulation, of Directive 2001/95/EC and of the other current Community legislation on market supervision. This report shall in particular include an analysis of the context of Community policies in the area of market supervision. If appropriate, the report shall be accompanied by proposals to amend and/or consolidate the concerned acts with the aim to achieve a better legislation and simplification. The report shall contain an assessment of the expansion of the scope of chapter III of this regulation to include all products.
At the latest 1. January 2013 and then every five years the Commission shall, in cooperation with the Member States, draw up and submit to the European Parliament and the Council a report on the implementation of this regulation.

Art 41. Sanctions Member States shall fix the rules for sanctions against market participants, including criminal sanctions for serious infringements, applicable to infringements of the provisions of this regulation, and shall take all the necessary measures to ensure that they are implemented. The sanctions determined, should be effective, stand in relation to the infringement and daunting and can be strengthened if the person has previously committed market participant a similar infringement of the provisions of this regulation. Member States shall within 1. January 2010 under the correct Commission on these provisions and immediately inform it about any subsequent changes.

Art 42. Amendment of Directive 2001/95/EC, new article 8 Nr. 3 of Directive 2001/95/EC should read as follows: "3. In the case of products that pose a serious risk, the competent authorities quickly hit the appropriate measures as referred 1 letter b)-f). Whether or not there exists a serious risk shall be settled by the Member States, to consider each individual case, as taking into account the guidelines referred to in annex II Nr. 8. "Art 43. Repealing Regulation (EEC) Nr. 339/93 is repealed with effect from the 1. January 2010.
References to the repealed Regulation shall be understood as references to this regulation.

Art 44. Entry into force this Regulation shall enter into force on the 20th. the day after it is announced in the official journal of the European Union.
It is applicable from 1. January 2010.
This regulation is binding in all parts and come directly to the application in all Member States.
  Issued in Strasbourg, 9. July 2008. 

Attachment in. Requirements for the body recognised under article 14 1. The body recognised under article 14 of this Regulation (governing body), to be created in the community.

2. In accordance with the articles of Association organets to national accreditation bodies from the community have the right to be a member of the governing body, provided that they are acting in accordance with the organets rules and goals and with the other conditions laid down in this regulation, and as agreed with the Commission in the framework agreement.

3. The body shall consult all relevant parties concerned.

4. The body shall provide its members the peer-assessment services that meet the requirements of article 10 and 11.

5. The governing body shall cooperate with the Commission in accordance with this regulation.

Annex II. CE marking 1. The CE marking shall consist of the letters "CE" in the following graphic design: 2. If the CE marking is reduced or enlarged, the aspect ratio as it emerges from the shape in the No. 1, is met.

3. If it is not in some higher set out specific goals, CE marking shall be at least 5 mm high.