Capital overview :
SECTION 1.
enforcement of technical rules on goods from other EDS state
The EES deal Attachment II kep. XIX # 3f (Regulation (EC) # 764/2008) about determining the applicability of the applicability of certain national technical rules on goods that are legally marketable in another EES state, applies as law with the adaptations as follows by attachment II, protocol 1 to the agreement and the agreement for Incidentally.
Part Article SECTION 2.
Accreditation and market vision
The EES deal Attachment II kep. XIX # 3b (Regulation (EC) # 765/2008) about determining the requirements of accreditation and market vision for marketing of goods, applies as law with the adaptations as follows by attachment II, protocol 1 to the agreement and agreement of the otherwise.
Part Article SECTION 3.
Accreditation
National accreditation organ in Norway is Norwegian accreditation.
Single-charge of accreditation can be incurred to the Norwegian accreditation of the Norwegian accreditation.
The Ministry can provide regulations on the exercise of accreditation business and about payment for services performed by Norwegian accreditation.
Part Article SECTION 4.
Scope
The law does not apply to Svalbard.
Part Article SECTION 5.
Ipower trekation and
The law takes effect immediately.
Part Article
The EES deal Attachment II kep. XIX # 3f (Regulation (EC) # 764/2008) about determining the procedures for the applicability of certain national technical rules on goods that are legally marketable in a different EES state.
There is no "EES adaptable" of the foreword text. It follows by the EES agreement protocol in that "Member State" in the EES context must read as "EES", and that the Commission's tasks in large extent are conducted by the EFTA monitoring organ across the EFTA states in EPS. The record that refers to the EDS, Norwegian laws or institutions are inserted by the editorial staff of Norway's Lover. Footnotes that refer to the EC and EU-time (EFT, EUT) or to the forage of the EU have been put into connection with the announcement of the foreverings of the EU.
The European Union and the Council of the European Union have-
under reference to the Treaty of Creation of the European Community, especially Article 37 and 95,
under reference to proposals from the Commission,
under reference to the statement from the European Economic and Social Committee,
after contemporary with the Regional Committee,
after the procedure determined in the treaty article 251 and
out from the following consideration :
| 1) The interior market constitutes an area without internal borders, in which free commodity quarters are secured in accordance with the treaty, which prohibit measures that have equivalent impact as quantitative restrictions on import. The bid includes all national measures that, directly or indirectly, in fact or potentially, can prevent commodity trade within the community. |
| 2) Obstacles of the free commodity-line between member states may be created illegal by the Member States of the Member, in the absence of harmonized regulations, invoking technical regulations with requirements that these products must meet, such as rules for designation, shape, size, weight, compound, presentation, marking and embaling, on products that are legally marketled in other member states. The review of such rules on products that are legally markeled in another member state may be in violation of the treaty's article 28 and 30, although they are given the Applicability of all products without the separation of separation between them. |
| 3) The principle of mutual recognition, which is derived from judicial practice at the European Community Court, is one of the means to secure free heat-swap on the inner market. Mutual recognition gets Applicability on products that are not subject to the Co-Company harmonics regulations, or on pages of products that fall outside the scope of such a rule of work. In accordance with the mentioned principle, a member state cannot ban sales on its territory of products that are legally markeled in a different member state, though they are manufactured in accordance with other technical regulations than them as domestic products are subject to. The only exceptions from this principle are restrictions that are due to reference to the treaty's article 30, or with other force-based public consideration, and that stands in relation to the aim of the goal to be reached. |
| 4) Many issues remain still with respect to the Member States appropriate Applicability of the principle of mutual recognition. It is therefore necessary to determine the future of procedures to reduce the possibility that technical regulations create illegal obstacles for free heat exchange between member states. The absence of such advances in the Member States creates further obstacles for the free heat-switched, as it does not encourage enterprises to sell their products, which are legally marketled in a different member state, on the territory of the member state that faces such technical regulations. Examinations have shown that many enterprises, especially small and medium-sized enterprises (SMB), either adapt their products to conform to member state technical regulations, or do not market them in these member states. |
| 5) The individual government also lacks egedown prospects for the Applicability of its technical regulations on specific products that are legally marketled in a different member state. The lack of such frameis makes it difficult for them to assess the product compliance according to the treaty. |
| 6) In Council resolution of 28. October 1999 of mutual recognition it was pointed out that market participants and citizens not always fully taken advantage of the principle of mutual recognition because they were not adequately aware of the principle and its practical follow. In the resolution, member states were encouraged to develop egedown measures to provide market participants and citizens an effective frame for mutual recognition, among other things by effectively processing requests from market participants and citizens and respond quickly on such requests. |
| 7) The European Council emphasized at its meeting 8. and 9. March 2007 The significance of ensuring a new giv in the interior market for goods by strengthenact mutual recognition and at the same time ensuring a high level of security and consumer protection. The European Council emphasized at its meeting 21. and 22. June 2007 that further strengthening of the four proposals in the inner market (free commodity and free mobility for people, services and capital) and an improvement of the interior market behavior is still of utmost importance for growth, competitive ability and employment. |
| 8) In order for the interior market for goods to work in a satisfying manner, adequate and open approach is required to address the problems that follow the applicability of a member state's technical regulations on specific products that are legal markeled in a different member state. |
| 9) This Regulation should not be an obstacle to further harmonization of technical regulations, when appropriate, with aim to better the interior market behavior. |
| 10) Trade obstacles can also be a result of other types of measures that fall into the scope of the treaty for the treaty article 28 and 30. Such measures may include technical specifications that have been worked out for the approach of public purchases or claims to take advantage of official languages in the Member States. Such measures, however, should not constitute technical regulations in accordance with this Regulation and should therefore not be reselected by its scope. |
| 11) Technical regulations pursuant to this Regulation are sometimes applied within the frame of the framework of mandatory pre-approval, stipulating in a member state legislation, in which the authority of the mentioned Member State, before a product or a product type can be brought in revenue in this Member State or in part of it, after application should give its formal approval. That there are such procedures will in itself limit the free heat-switched. In order to be justified after the basic principle of free commodity swap in the inner market, a approach for mandatory preapproval should therefore pursue a target that is in the public interest and recognised in the community court, which did not implies difference processing and stands in relation to the goal ; it would say that it should be suitable to ensure that the target being pursued will be reached, but do not go out over what is necessary to reach this goal. Whether such a approach is in accordance with the relationship signature principle, should be considered in light of the consideration made in the Court of Domensisis. |
| 12) A requirement for pre-approval to bring a product in revenue should itself not constitute a technical regulation in accordance with this Regulation, so that an ordinance to rule out or remove a product from the market exclusively for the reason that it do not have any valid pre-approval, should not constitute a ordinance that this Regulation gets the inquiry on. However, when an application for such mandatory pre-approval of a product is put forward, however, a planned ordinance should decline the application on the basis of a technical regulation be made in accordance with this Regulation, allowing the applicant to enjoy good of it procedural protection that this Regulation provides. |
| 13) Decisions at national courts about the legality of the law where products such as, on the basis of the use of a technical regulation, are legally marketable in one member state, are not granted access to the market in another member state, or where it uses sanctions, should not be retaken by this foreword scope. |
| 14) Guns are products that can pose a serious risk of human health and security and for the public safety of the Member States. Several specific types of weapons that become legally marketable in one member state can of regard to the protection of human health and safety and prevention of crime, be subject to restrictive measures in another member state. Such measures may consist of straight controls and approvals before weapons that become legally markeled in one member state are brought in revenue in another member state. The member states should therefore be permitted to prevent weapons from being brought in revenue at their market until the national procedural requirements are completely met. |
| 15) In the europe parliamentary and Council of Council, 2001 /95/EF of 3. December 2001 on average product safety, it is determined that only secure products can be brought in revenue, and it is determined obligations for manufacturers and distributors with respect to product safety. According to the directive, the government can ban all dangerous products with immediate effect or temporarily ban a product that may be hazardous to the amount of time needed to conduct the various security urderings, examinations and controls. According to the directive, the government also has the right to hit egedown measures as those who are reacted in Article 8 number 1 letter b)-f) in mentioned directive, in cases where products pose a serious risk. The roof that has been hit by the person authorities in the Member States in accordance with national legislation enacted by the review of Article 8 number 1 letter d)-f) and Article 8 # 3 in mentioned directive, should not be retaken by this foreword scope. |
| 16) By the europe parliaments and Council Regulation (EC) 178/2002 by 28 January 2002 on determining of public principles and requirements of the nutritional regulations, about the creation of the European Authority for nutritional safety and whether determining of the future of the future of nutrition was among other created a quick-warning system for message of direct or indirect health care companies for human beings due to nutritional or lining. Member States are immediately placed to inform the Commission via the quick-warning system of any measures they pass to limit the restatement of, withdraw from the market or recall nutrition or lining to protect people's health, in those cases where it is necessary to act quickly. The roof that has been hit by the person authorities in the Member States according to Article 50 No. 3 letter a) and Article 54 of the mentioned Regulation, therefore, should not be remarked by this foreword scope. |
| 17) In the europe parliaments and Council Regulation (EC) 882/2004 of 29 April 2004 on public control to ensure that the feeding and nutritional regulations as well as regulations on animal health and welfare are being imposed on public control to ensure compliance with rules that particularly take aim on prevention or removing the risk of human beings and animals either directly or through the environment, or reduce it to an acceptable level, and guarantee good business custom by trade with feeding goods and nutrient and protect consumers ' interests, herders marking the feeding of feeding and nutritional funds and other forms of consumer enlightenment. In the arrangement, a particularly frameworks are determined to ensure that market participants are helping a situation in which the feeding and nutritional regulations as well as the provisions of the animal health and welfare are not overheld. The measures met by the person in the Member States in accordance with Article 54 of the mentioned Regulation should therefore not be remarked by this foreword scope. The measures that have been hit or planned by the person on the basis of national technical regulations should be subject to this Regulation, in the extent they do not touch the measures determined in Regulation (EC) 882/2004. |
| 18) In the europe parliamentary and Council of Council 2004 /49/F of 29. April 2004 about security on the Joint Company's railroads (the railway security directive) is determined to provide the permission of the iuse of existing rolling materials, in which it is given the possibility of the Applicability of certain national rules. The roof that has been hit by the person authorities in accordance with Article 14 of the mentioned directive should not be retaken by this foreword scope. |
| 19) In Council Directive 96 //8/EC of 23. July 1996 about the intericity of the trans-European railway system for high-speed trains and eurolamoents and Council Directive 2001 /16/EC of 19. March 2001 about the contemporary European railway system for conventional trains, it is determined a gradual harmonization of systems and operation through a gradual ordinance of technical specifications for the Commonwealth of Engineering (TSI). Systems and interpersonal traffic components that fall into the scope of the mentioned Directives should therefore not be retaken by this foreword scope. |
| 20) By europe Parliaments and Council Regulation (EC) 765/2008 of 9. July 2008 About determining the requirements of accreditation and market vision for marketing of products introduced an accreditation arrangement that ensures mutual approval of the skill level of compliance monitoring organs. The individual government of the Member States should therefore no longer reject trial reports and certificates issued by an accredited compliance organ for reasons related to the organics of the organ. Further, member states may also accept trial reports and certificates issued by other compliance rating organs in accordance with the community court. |
| 21) According to the europe parliamentary and Council Directive 98 /34/EC of 22. June 1998 about an information procedure for standards and technical regulations are the Member States committed to overpassing the Commission and the other member states all suggestions for technical regulations on any product, herder agricultural and fisheries, as well as a message for the reasons it is necessary to impose such a regulation. However, it is necessary to ensure, after the ordinance of such a technical regulation, that the principle of mutual recognition has been applied correctly in individual cases on specific products. By this Regulation, it is determined for the purposes of the applicability of the principle of mutual recognition in individual cases, that the person's authority is obliged to indicate the technical or scientific reasons that it decided The product in its present form cannot be markeed in the Member State, in accordance with the treaty's Article 28 and 30. In this settlement, documentation should not be understood as legal evidence. The Member States government is within the frame of this Regulation not committed to the framework of the technical forewriting itself. They should, however, be shallow, as determined in this Regulation, a possible application of the technical forewriting on a product that becomes legally markeled in another member state. |
| 22) In accordance with the principle of mutual recognition, the approach should be established by this Regulation determining that the person authorities in each case basis on the basis of the relevant technical or scientific elements that are available, to inform the market participant that forced public consideration dictates that national technical regulations impose their product or product type and that less restrictive measures cannot be used. The written message should give the market participant the ability to comment on all relevant pages of the planned ordinance to limit the adhall to the market. There is nothing to obstacle that the person's authority is hitting measures after the deadline for receipt of such notes, if the market participant has not responded. |
| 23) The term forced public consideration has been developed gradually by the Court of the Court in its judicial practice in association with the treaty's Article 28 and 30. The concepts include among other effective tax control, good business custom, consumer protection, environmental protection, the preservation of a diverse press and the risk of serious undermining the financial stability of the Social Security arrangement. Such forced public concerns may justify the fact that the government is invoking technical regulations. However, such an Applicability should not be a means of arbitrary difference processing or a hidden trade obstruction between the Member States. Further, the relationship signature principle should always be overheld, as it is taken into consideration whether the authority has actually chosen the least restrictive ceiling. |
| 24) At the applicability of the framework determined in this Regulation, the authority in a member state should not withdraw or limit the turnover of a product or product type that is legally markeled in another member state. However, it is appropriate that the person's authority can pass temporary measures in which it takes quick efforts to prevent users from security and health be compromised. Such temporary measures can also be passed by the person's authority to prevent the turnover of a product being reauthored by a general ban on the issue of consideration of public morality or public safety, herding prevention of crime. The member states should therefore at any stage in the approach set in this Regulation under such circumstances could temporarily ban marketing on its territory of products or product types. |
| 25) In any ordinance that this Regulation gets the Applicability on, it should be indicated which clectation access is available, so that a market participant can bring in the case of the person's national court. |
| 26) It is appropriate that the market participant is also informed that there has been overseas legal arrangements for problem solving, such as the SOLVIT system, to prevent legal uncertainty and costs of court cases. |
| 27) When the authority has made a decision to rule out a product on the basis of a technical regulation in accordance with the procedural requirements of this Regulation, should further measures that meet in association with this product on the basis of this ordinance and the same technical regulation, not be subject to the requirements of this Regulation. |
| 28) It is important for the interior market for goods that the safeties accessibility to national technical regulations, such that enterprises, and especially small and medium-sized enterprises, can collect reliable and accurate information about current legislation. |
| 29) It is therefore necessary to conduct principles of administrative enclave, among other things by creating a system of product contact points. The system should be designed so that it ensures that enterprises can access information in an open and correct manner, such that delays, costs and deterrent effects that follow national technical regulations can be avoided. |
| 30) To facilitate free commodity exchange, product contact points should be cost-free provide information on their national technical regulations and the applicability of the principle of mutual recognition when it comes to products. The product contact points should have adequate equipment and adequate resources and also be encouraged to make information available on a website and in other community languages. The product contact points can also give market participants additional information or opinions under the approach set in this Regulation. For such additional information, the product contact points may require fees that stand in relation to the costs of these information. |
| 31) As the creation of product contact points should not affect the distribution of tasks between the person within the Member States legislature, it should be possible for Member States to create product contact points in accordance with regional or local authority. Member states should be able to leave the role of product contact point to existing contact points established in accordance with other community arrangements to avoid far too many points of contact and to simplify administrative procedures. Member states should also be able to leave the role of product contact point not only to existing services within public management, but also to national SOLVIT centers, trade chambers, occupational organizations and private organs, to not increase administrative costs of enterprise and the person authorities. |
| 32) Member States and Commission should be encouraged to cooperate closely to facilitate training of staff at product contact points. |
| 33) In light of the development and creation of a field-read European electronic public service and underlying interacting telematics, the ability to create an electronic system for information exchange between product contact points examined, in accordance with the europe parliamentary and council decision 2004 /387/EF of 21. April 2004 about merging of the field-reading European electronic public physician tensts to the public physician stewards, pre-case and borgarar (IDABC). |
| 34) Reliable and effective monitoring and assessment arrangements should be created to provide information on the applicability of this Regulation, to better the knowledge of the behavior of the inner market for goods in sectors that are not subject to harmonization, and to ensure that the principle of mutual recognition is being duly applied by the person authorities in the Member States. Such arrangements should not go further than what is necessary to achieve these goals. |
| 35) This Regulation gets the Applicability only on products or candid characteristic of products that are not subject to the Joint Court's harmonics measures, which are intended to remove trade obstacles between member states that are due to differences between national technical regulations. The provisions of such harmonics measures are often exhaustive, so that the member states cannot ban, limit or prevent products that comply with these measures, are brought in revenue on their territory. However, some of the Joint Court's harmonics measures provide the Member States the ability to determine further technical terms for the inflow of a product at their market. Such additional terms should be subject to the treaty's article 28 and 30 and the provisions of this Regulation. With aim at an effective Applicability of this Regulation, it is therefore appropriate that the Commission creates a guiding and non-exhaustive list of products that are not subject to harmonization on the community plan. |
| 36) The monitoring arrangement that was created at the europe parliamentary and council maintenance number 3052 /95/EC of 13 December 1995 about the introduction of a future approach for the exchange of information on national measures that the absence of free heat-swap within the community has largely proved not to be successful as the review of the ordinance has not given the Commission sufficient information to designate sectors where harmonization would be appropriate. It also has not led to rapid resolution of certain problems for the free commodity-switched. Attaches No. 3052 /95/EC should therefore be repea-made. |
| 37) It will be appropriate to impose a transition period for the applicability of this Regulation so that the person of the government can adapt to the requirements determined in the settlement. |
| 38) As the goal of this Regulation, which is to remove technical obstacles for free heat exchange between member states, cannot be reached in sufficient extent by the Member States and therefore due to the scope of the scope and effects better be reachable on community plan, the community can hit measures in accordance with the proximity principle as stipuled in the treaty's Article 5. In accordance with the relationship signature principle stipulated in mentioned article, this settlement is no longer going to be any longer than what is necessary to reach this goal. |
| 39) The measures necessary to conduct this Regulation should be passed in accordance with the Council decision 1999 /40/8/F of 28. June 1999 on determining further rules for the exercise of the Transparency Authority that is attributed to the Commission- |
passed this Regulation :
Chapter 1. Foretarget and scope
Art 1.
Formal
| 1. The goal of this Regulation is to strengthen the inner market behavior by better the free commodity-switched. |
| 2. In this Regulation, there are determined rules and procedures that the person in a member state should follow when they do or intends to make a ordinance that was reacted in Article 2 # 1, which will be able to prevent free trade of a product that becomes legally markeled in a different member state and is subject to the treaty of the Article 28. |
| 3. In this Regulation, it is also stipulate that it should be created product contact points in the Member States to help reach this foreword measure, as stipulate in the No. 1. |
Part Article Art 2.
Scope
| 1. This Regulation gets the Applicability of Management Act aimed at market participants, either the ordinance made or shall be made, on the basis of a technical regulation as defined in the No. 2. With respect to all products, herunder agricultural and fisheries, which are legally markeled in a different member state, where the direct or indirect effect of the above mentioned ordinance is |
| a) |
a ban on the fact that the product or product type is brought in revenue, |
| b) |
a change or further trial of the person product or product type before it can be brought in revenue the first time or remain in the market, |
| c) |
a withdrawal of the person product or product type from the market. |
In the first clause, letter b) means of change of product or product type any modification of one or more of the properties by a product or product type, listed in No. 2 letter b) in).
| 2. In this Regulation, with technical regulation any provision in a member state laws and regulations |
| a) |
which are not subject to harmonization on the community plan, and |
| b) |
which prohibit marketing of a product or product type on this member state territory, or as it is mandatory to comply with when a product or product type is markeled on this member state's territory, and which determines either |
| in) |
those properties required by the product or product type, such as quality, performance, safety, or dimensions, herders requirements of the product or product type with respect to the name it is sold under, terminology, symbols, sampling and trial methods, empressing or marking, or |
| ii) |
all other requirements that impose the product or product type with the purpose of protecting the consumers or environment, and affecting the product's life cycle after it is brought in revenue, such as conditions for use, recycling, reuse, or resettlement, where such terms in significant extent can affect the product or product type, species, or marketing. |
| 3. This Regulation is not allowed to be Applicability |
| a) |
court decisions hit by national courts, |
| b) |
court decisions struck by authorities with liability for enforcement of the law in connection with investigation or prosecution of a criminal offence concerning terminology, symbols or other significantly reference to the constitution of the constitution or criminal organizations or criminal conditions of racial or alienally hostile species |
Part Article Art 3.
The relationship with other provisions of the community court
| 1. This Regulation does not get the Applicability of systems or intertraffic components that fall into the scope of the Directive 96 //8/F and Directive 2001 /16/EF. |
| 2. This Regulation does not get the Applicability of measures hit by the government in the Member States according to |
| a) |
Article 8 # 1 letter d)-f) and Article 8 # 3 in Directive 2001 /95/EF, |
| b) |
Article 50 # 3 letter a) and Article 54 in Regulation (EC) # 178/2002, |
| c) |
Article 54 of Regulation (EC) No. 882/2004, |
| d) |
Article 14 of Directive 2004 /49/F. |
Part Article
Chapter 2. Framway for the Applicability of a Technical Regulation
Art 4.
Information about the product
When a person authority wants to consider a product or product type to determine whether it should make a decision that was reacted in Article 2 # 1, it can, as it is taken to the relationship of the relationship signature, the requesters market participant identified in accordance with Article 8 very much about the following :
| a) |
relevant information about the individual product or product types of properties, |
| b) |
relevant and easily accessible information about legal marketing of the product in a different member state. |
Part Article Art 5.
Mutual recognition of the skill level of accredited compliance organs
Member States should not reject certificates or trial reports issued by a compliance rating organ accredited for compliance rating business on the applicable area in accordance with Regulation (EC) 765/2008 for reasons related to the person's competence.
Part Article Art 6.
Assessment of the need to estimate a technical regulation
| 1. When a person's authority intends to make a decision that was reacted in Article 2 # 1, shall the sending market participant identified in accordance with Article 8 a written message of its intent, where it is indicated which technical regulation is to build on, as well as technical or scientific documentation that shows that |
| a) |
The planned ordinance is justified from the public consideration set in the treaty's article 30, or other public consideration, and |
| b) |
The planned ordinance is appropriate to reach the desired goal and will no longer go beyond what is necessary to reach this goal. |
A planned ordinance shall be made on the basis of the properties of the person product or product type.
The affected market participant should after receiving such a message is given a due date of at least 20 real time days to come with notes. In the message, the deadline for the future of notes is indicated.
| 2. A ordinance that was reacted in article 2 # 1 shall be made and co-share the market participant and the Commission within a range of 20 reality days rained from the expiration of the deadline for receipt of notes from the market participant that reacted in No. 1 1 in this article. The betting shall take full consideration of these notes and it shall be given a justification, hernials to reject any arguments that are induced by the market participant, as well as the technical or scientific documentation that has been re-acted in No. 1 in this article. |
The authority of the authority can, when there is an audible due in the composite nature of the case, extending the time period indicated in the first clause once with a maximum of 20 reality days. The desire shall be bescohesion and shall co-share the market participant before the expiration of the original deadline.
In an ordinance that reacted in Article 2 # 1 shall it also be specified which cleccl. is available after applicable law in the person's member state as well as the fristas for such clageentry. Such an ordinance can be brought in for national courts or other clashinees.
| 3. If the person authority, after providing written message in accordance with # 1, decides not to make the ordinance that reacted in Article 2 # 1, it shall immediately inform the affected market participant about this. |
| 4. If the person authority fails to inform the market participant of an ordinance that was reacted in Article 2 # 1 within the amount of time indicated in the # 2 In this article, the product shall be deemed legally markeled in the person's member state when it comes to the applicability of the technical regulation of the 1 in this article. |
Part Article Art 7.
Temporary ban on marketing of a product
| 1. The authority shall not temporarily ban the marketing of the person product or product type during the approach set in this chapter, except there |
| a) |
the product or product type under regular or reasonably predictable usage terms constitutes a serious risk of users security and health, or |
| b) |
The marketing of the individual product or product type has been reauthored by a general ban in a member state of regard to public morality or public safety. |
| 2. The authority shall immediately inform the market participant identified in accordance with Article 8 and the Commission on an optionally temporary ban that reacted in No. 2 1 in this article. In the cases that are reacted in number 1 letter a) in this article, the message shall be accompanied by a technical or scientific justification. |
| 3. A temporary ban on marketing of a product according to this article can be brought in for national or other clashinees. |
Part Article Art 8.
Information to the market participant
References to market participants in Article 4, 6 and 7 should be understood as referrals
| a) |
to the manufacturer of the product, if this is established in the Community, or the person who has brought the product in revenue or requestor the authority that the product is brought in revenue, |
| b) |
if the authority cannot determine the identity and contact information of any of the market participants who are reacted in the letter a), to the manufacturer's representative, when the manufacturer is not established in the community or, if it does not exist a representative established in the community, to the importer of the product, |
| c) |
If the authority cannot determine the identity and contact information of any of the market participants who are reacted in the letter a) and b), to any occupational practitioner in the restatement chain whose business can affect properties of the product reauthored by the technical regulation that is applied to the product, |
| d) |
if the authority cannot determine the identity and contact information of any of the market participants who are reacted in letter a), b) and c), to any occupational practitioner in the restatement chain whose business does not affect properties of the product which are reauthored by the technical regulation that is applied to the product. |
Part Article
Chapter 3. Product-pin
Art 9.
Product-pin creation
| 1. Member States shall designate product contact points on its territory and overpass contact information for these to the other Member States and to the Commission. |
| 2. The Commission shall devise and periodically reconcile a list of product contact points and announce it in The European Union's time-end . The Commission shall also make the information available on a website. |
Part Article Art 10.
Tasks
| 1. Product contact points should at request from among other a market participant or the authority in a different member state, provide the following details : |
| a) |
the technical regulations that gain the Applicability of a specific product type on the territory in which these product contact points have been created, and information about whether or not this product type is reauthored by a requirement of preapproval in accordance with the legislation in this Member State, together with information on the principle of mutual recognition and the applicability of this settlement on this Member State territory, |
| b) |
contact information for the person in this member state so that they can be contacted directly, hereunder further details of which authorities are responsible for the supervision of the applicable technical regulations on this member state territory, |
| c) |
The clawn admission in general is available on this member state's territory in case of a dispute between the person and a market participant. |
| 2. The product contact points shall respond to inquiries within 15 business days after receiving a request that reacted in number 1. |
| 3. Product contact points in the Member State where the person market participant legally has marketable the appropriate product, can provide the market participant or the authority that reacted in Article 6, all relevant information or opinions. |
| 4. Product contact points should not require fees to provide information that reacted in No. 1. |
Part Article Art 11.
Telemeikknett
The Commission can after the procedure of the advisory committee reacted in Article 13 number 2 create a telematics for review of the provisions of this Regulation on information exchange between product contact points and / or the person in the Member States.
Part Article
Chapter 4. End regulations
Art 12.
The report-liked
| 1. Each member state shall each year submit the Commission a report on the applicability of this Regulation. The report should at least contain the following information : |
| a) |
number of written messages submitted in accordance with Article 6 # 1, as well as the affected product type, |
| b) |
adequate information on all passes made according to Article 6 No. 2. therunder a justification for the wood ceiling as well as the affected product type, |
| c) |
the number of passes made in accordance with Article 6 # 3. As well as the affected product type. |
| 2. In light of the information that is presented by the Member States according to No. 1, shall the Commission analyze the measures made in accordance with Article 6 No. 2. And consider the justification for them. |
| 3. The Commission shall be at the latest 13. May 2012 and then each fifth year review the applicability of this Regulation and advance a report on this for the European Parliament and the Council. The Commission may optionally attach the report appropriate suggestions for the improvement of the free commodity-switched. |
| 4. The Commission shall devise, public and periodically reconcile a non-exhaustive list of products that are not subject to the Co-Company harmonics. The Commission shall make the list available on a website. |
Part Article Art 13
Committee of Committee
| 1. The Commission shall biosteel of a committee composed of representative of the Member States and led by a representative from the Commission. |
| 2. When it is shown to this number, the approach gets the advisory committee set in Article 3 in decision 1999 /4/8/F Applicability, in accordance with the decisive Article 7 # 3 and Article 8. |
Part Article Art 14.
Uprise
Attaches No. 3052 /95/EF repeats with effect from 13 May 2009.
Part Article Art 15.
Ipowertrecation and Applicability
This Regulation takes effect on 20. day after it is announced in The European Union's time-end .
It gets the Applicability from 13. May 2009.
This Regulation is binding in all parts and comes directly to the Applicability of all Member States.
Ufinet in Strasbourg, 9. July 2008.
Part Article
The EES deal Attachment II kep. XIX # 3b (Regulation (EC) # 765/2008) about determining the requirements of accreditation and market vision for marketing of goods.
The European Union and the Council of the European Union have-
under reference to the Treaty of the Creation of the European Community, especially Article 95 and 133,
under reference to proposals from the Commission,
under reference to the statement from the European Economic and Social Committee,
after contemporary with the Regional Committee,
after the procedure determined in the treaty article 251 and
out from the following consideration :
| 1) It is necessary to ensure that products that are reauthored by the free commodity in the community meet requirements that provide a high level for protection of public interests such as health and safety in general health, health and safety in the workplace, Consumer protection, environmental protection and security, and at the same time ensure that free heat-switched is not limited more than what is permitted in accordance with the Joint Court harmonics or other relevant community rules. It should therefore be determined rules for accreditation, market vision, control of products from third-stage and CE marking. |
| 2) It is necessary to create a holistic frame for rules and principles of accreditation and market vision. This frame should not affect the material rules of the current regulations of regulations to be followed to protect public interests such as health, security, consumer protection and environmental protection, but should have as goals to better the applicability of them. |
| 3) This Regulation should be seen as a padding of europe Parliaments and Council Decision 768 /2008/EF of 9. July 2008 about a joint frame for marketing of products. |
| 4) It is very difficult to pass the community regulations for all products that exist, or that can be developed. There is a need for a comprehensive rules of horizontal character for such products to be retaken and to dense again the holes, especially in anticipation of the revision of the existing sHonest Regulatory Regulations, and to outfill the provisions of the present or future especially regulations, especially in order to ensure a high level of protection of health and security as well as environmental protection and consumer protection in accordance with the treaty's Article 95. |
| 5) The frame of market vision created by this Regulation should outfill and strengthen current regulations on market vision in the Joint Court harmonics or enforcement of such provisions. However, in accordance with the lex specalis principle, however, this Regulation should be given only in the extent that there are no specific provisions of the same purpose, of the same species or with the same effect in other current or future regulations in The community harmonics harmonics. Examples can be found in the following areas : exit drugs for drugs, medical equipment, drugs and veterinary preparates, motorcars and aerospace. The corresponding provisions of this Regulation should therefore not be able to obtain the Applicability of those areas that are reselected by such particular regulations. |
| 6) In the europe parliamentary and Council of the Council, 2001 /95/EF of 3. December 2001 about ordinary product safety is the set rules to better consumer safety. Market health authorities should have the opportunity to meet the particularly separate measures they have at their disposal in accordance with the mentioned directive. |
| 7) To achieve a higher security level of consumer goods, however, the market measures stipulated in Directive 2001 /95/EF are dikes with respect to products that pose a serious risk, in accordance with the principles determined by this Regulation. Directive 2001 /95/EC should therefore be changed. |
| 8) Accreditation is part of a parent system that includes compliance assessment and market vision, and that have as purpose to assess and ensure that the current requirements are met. |
| 9) Accreditation's honest value lies in the fact that it is an authoritative statement of the technical competency of organs that have been tasked with ensuring that current requirements are met. |
| 10) Accreditation uses in all Member States, but have thus far not been reauthored by rules on the community plan. The lack of joint rules for such business has led to various approaches and arrangements in the community, with the result that the member states have not been as strict at accreditation. It is therefore necessary to develop a comprehensive frame for accreditation and on the community plan determine principles of how accreditation is to be carried out and organized. |
| 11) The creation of a singular national accreditation organ should not touch the distribution of tasks within the Member States. |
| 12) If it for the feats of the Joint Assembly Regulatory Regulatory Regulatory Regulatory regulations, the national public authorities of the community should consider open accreditation, as determined in this Regulation, which ensures the necessary confidence in compliance certificates, as the preferred way of showing these organises technical competence. The National Government, however, can mean that they themselves have egedown ways to carry out this assessment. In such cases, the national authorities should, to ensure that assessments conducted by other national authorities have the necessary credibility, lay out for the Commission and the other member states necessary documentation that they considered The compliance rating organs comply with relevant requirements. |
| 13) An accreditation arrangement that builds on binding rules helps strengthen the mutual trust between the Member States when it comes to the competences of compliance organs and also when it comes to those certificates and trial reports as they issue. It strengthens the principle of mutual recognition, and therefore, the provisions of accreditation in this Regulation should be given the application of organs that carry out compliance considerations in areas where there are set rules, and in areas where it is not set rules. The crucial is the quality of the certificates and trial reports, whether they fall under an area where there are stipulation rules or an area where there is no set rules, and therefore, no distinction should be made between these areas. |
| 14) In this Regulation, it should with national accreditation organizers ideal business means a business that does not have the purpose of providing financial profits that increase the resources of the organ's owners or members. Although national accreditation organs do not have as goals to increase profits most or distribute profits, they can provide services against payment or receive revenue. All excess income from such services can be used for investment to develop the organ's business further, as long as this is unily compatible with their main business. It should therefore be emphasise that the most important goal for national accreditation organs should be to support or actively exercise business that is not intended to provide profits. |
| 15) As the purpose of accreditation is to provide an authoritative statement of an organ's competency to exercise compliance business, the Member States should not have more than one national accreditation organ and note that this organ is organized on a such way that business is objective and impartial. Such national accreditation organs should exercise their business regardless of commercial compliance business. It is therefore appropriate to determine that the Member States ensure that national accreditation organs, when they perform their tasks, are deemed to exercise public authority, regardless of the organist's legal status. |
| 16) To be able to assess and lead ongoing supervision with a compliance assessment organ's competence, it is very important to determine the organ's technological knowledge and experience and its ability to perform assessments. It is therefore necessary that the National Accreditation of the National Accreditation Agency has the relevant knowledge and skills and the necessary means to be able to perform their tasks in a satisfactory manner. |
| 17) Accreditation should in principle be a self-financing business. The member states should ensure that it is given financial support to straight-up tasks. |
| 18) In those cases where it is not economically meaningful or sustainable for a member state to create a national accreditation organ, the member state should have the opportunity to take advantage of the national accreditation organ in another member state and are encouraged to in the greatest extent to use this opportunity. |
| 19) Competition between national accreditation organs will be able to lead to a commercialization of their business, which will not be unification with their role as the final control level in the compliance assessment chain. The purpose of this Regulation is to ensure that within the European Union is sufficient with one accreditation evidence for the entire Union territory, and to avoid double taxation, which provide additional costs without additional value. National accreditation organs can compete on the third-party markets, but this must not affect their business within the community or cooperation and craft assessment that is organized by the organ recognized in accordance with this Regulation. |
| 20) To avoid double taxation, increase acceptance and approval of accreditation evidence and lead effective supervision of accredited compliance organs, the organs should apply for accreditation of the national accreditation organ in the Member State where they are established. Nevertheless, it is necessary to ensure that a compliance rating organ has the ability to apply for accreditation in another member state in cases where it in the organ's own member state does not exist any national accreditation organ, or where such an organ is not competent to te the accreditation services the requesters about. In such cases, the national compliance organs should cooperate and exchange information. |
| 21) To ensure that national accreditation organs meet the requirements and obligations stipulation in this Regulation, it is important that member states contribute to the accreditation arrangement in a satisfactory manner, leads regular supervision with their national accreditation organs and within reasonable time meet the appropriate corrective action when needed. |
| 22) To ensure that compliance rating organs have an equal skill level, ease mutual recognition and promote general acceptance of accreditation and compliance results issued by accredited organs, it is necessary that National accreditation organs have a strict and open craft field assessment arrangement and regularly undercasts such assessment. |
| 23) This Regulation should include provisions of the recognition of a single organization on EU plan with respect to certain tasks on the accreditation area. The European cooperation for accreditation (EA), which has as the main task to promote an open and quality managed arrangement for assessment of the competency of compliance organs throughout Europe, manage a craft-field assessment arrangement that includes national accreditation organs from member states and other European states. The arrangement has proven to be effective and contributes to mutual trust. The EA should therefore be the first organ to be recognized in accordance with this Regulation, and member states should ensure that their national accreditation organs seek and retain membership in the EA as long as EA is recognised. At the same time, it should be determined an opportunity to change the affected organ that is recognized in accordance with this Regulation, in cases where there is a need for this in the future. |
| 24) Efficient cooperation between national accreditation organs is necessary for the craft field assessment and accreditation across the country's borders should be successfully performed in a appropriate manner. For purposes of disclosure, it is therefore necessary with a commitment for national accreditation organs to exchange information and to provide national authorities and the Commission relevant information. Reconcile and accurate information on the availability of accreditation services offered by national accreditation organs, should also be released and thus be made available, especially for compliance rating organs. |
| 25) The seccreditation accreditation orders should include the enterprise areas where common requirements of compliance organizers are not sufficient to ensure the required level of protection when it faces particularly detailed requirements to technology or health and safety. As the EA has extensive technical sake knowledge at the disposal, the organist should be requested to develop such arrangements, especially in areas that are retaken by the Joint Regulatory Regulatory Regulatory. |
| 26) To ensure a peer-to-peer and singular enforcement of the Joint Court harmonics, it is introduced by this Regulation a community frame for market vision, in which it is determined minimum requirements on the background of the measures to be reached by the Member States, and a frame for administrative cooperation, herunder exchange of information between the Member States. |
| 27) In cases where market participants have trial reports or certificates confirming compliance and are issued by an accredited compliance organ, and where the Co-Company's current harmonics regulations do not require such reports or certificates, the market health authorities should take the attention of them when they control product properties. |
| 28) Cooperation between the government on national plan and across the country borders on exchange of information, examination of violations and measures to bring them to termination, even before dangerous products are brought in revenue, by strengthits measures for identifying them, especially in ports, is crucial for the protection of health and security and for the interior market to work in a satisfactory manner. The National Consumer Protection Government should on national plan cooperation with national market health authorities and exchange information with them about products that they believe could pose a risk. |
| 29) Risk assessment should take into account all relevant information, therunder information of risk that has occurred with respect to the person's product, if such information is present. It should also be taken into account of all measures that the affected market participants had to have struck to reduce this risk. |
| 30) Situations where a product constitutes a serious risk requires that it be inserted quickly, which may cause the product to be withdrawn from the market, recalled, or that it is forbidden to make the product available in the market. In such situations, it is necessary to have access to a system for rapid exchange of information between the Member States and the Commission. The system reacted in Article 12 in Directive 2001 /95/EF has proven to be effective and effective for consumer use. In order to avoid unnecessary overlap, the said system should be used for this foreword purpose. A singular market vision of the entire community requires extensive exchange of information on national business in this context, which runs longer than this system. |
| 31) Information exchanged between the person authorities should be subject to the strictest guarantees of privacy and confidentiality and processed in accordance with privacy rules in current national legislation or, when it comes to the Commission, europe Parliaments and Council Regulation (EC) 1049/2001 of 30. May 2001 about public access to the European Parliament, the Council and the Commission's documents, to ensure that the investigations do not be troubled and that the market participants ' reputation is not harmed. Europarliaments and Council Directive 95 /46/EC of 24 October 1995 about the protection of physical persons in connection with the treatment of personal information and on free exchange of such information and europe parliamentary and Council Regulation (EC) 45/2001 of 18. December 2000 about the Privacy Policy in the context of the processing of personal information in the community institutions and organs and whether free exchange of such information is given the Applicability within the frame of this Regulation. |
| 32) In the Co-Company harmonics Regulatory Regulatory Regulatory Regulatory regulations, it is determined to determine whether a national measures that limit free heat-quarters are justified or not (frameworks for protection clauses). These advances are given the Applicability after a quick exchange of information about products that pose a serious risk. |
| 33) Introduce sites by the outer boundaries are well suited to detect dangerous products that do not meet the requirements, or products with incorrect or misleading CE marking, before they are brought in revenue. A commitment for government with responsibility to carry out the control of products that are introduced on the community market, to carry out controls in adequate magnitude, can therefore contribute to a more secure market. In order to make the controls more effective, these authorities in good time should get all the necessary information from the market authorities about dangerous products that do not meet the requirements. |
| 34) In Council Regulation (ELF) # 339/93 of 8. February 1993 on the control of compliance with the rules of product safety by the acquisition of products from third-testing regulations is set rules for the customs government's deferral of the release of products, and it is determined further measures, herders to draw into the market health authorities. It is therefore appropriate that these regulations, herunder it to draw in the market visibility of the government, are being reworked in this Regulation. |
| 35) Experience has shown that products that are not released are often reperformed and then come into the community market in other pre-state sites, and thus undermining customs authorities work. Market health authorities should therefore be given the means to self-destruct products if they consider it appropriate. |
| 36) Within one year after the announcement of this settlement in The European Union's time-end should the Commission put forward an in-depth analysis on the range of consumer safety marking, followed by suggestions of regulations in which this is necessary. |
| 37) CE marking, which shows that a product is in compliance with the requirements, is the visible result of an entire process that includes compliance assessment in wide meaning. The public principles of the CE marking should be determined in this Regulation so that they can be used immediately and thus simplify future regulations. |
| 38) CE marking should be the only form of compliance marking that a product is in compliance with the Joint Court harmonics. However, other forms of marking can be used as long as they contribute to better consumer privacy and not reselected by the Joint Society harmonics. |
| 39) Member States must provide egedown opportunities to complain to the person courts on measures struck by the person authorities who limit the restatement of a product, or require the product to be withdrawn or recalled. |
| 40) Member States can find it useful to create a collaboration with affected parties, herduring secre occupational organizations and consumer organizations, to take advantage of available market knowledge when they create, go-through and reconcile market vision programs. |
| 41) Member States should determine rules of 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 violation and appear daunting and can be display if the affected market participant earlier has committed a similar violation of the provisions of this Regulation. |
| 42) To reach this forestation goal, the community is necessary that the community contributes to the financing of the business required to conduct the company's policies on the range of accreditation and market vision. Financing should happen either in terms of the addition of the organ recognized in accordance with this Regulation without the impact of settlement, in terms of supplements after settlement or by granting contracts to this or other organs, depending on the species of the business to be funded and in accordance with the Council Regulation (EC, Euratom) # 1605/2002 by 25 June 2002 about the financial regulations that will be given the Applicability of the European Community's common budget ("financial regulations"). |
| 43) For certain specialized tasks, e.g., outwork and revision of secsectory accreditation arrangements, and for other tasks related to the control of laboratory as well as certifications or inspection organizations technical skills and equipment, EA in The exit point is entitled to community funding, as it is well suited to ensuring the technical sake of knowledge necessary for this. |
| 44) In consideration of the role of the organ recognized in relation to this Regulation in relation to the field of accreditation organs, and its ability to assist member states with the management of such assessment, the Commission should be able to provide The addition of the operation of the secretariat of the organ recognized in accordance with this Regulation, which should provide ongoing support to accreditation business on the community plan. |
| 45) It should comply with the provisions of the Financial regulations encapsued a partnership agreement between the Commission and the organ recognized in accordance with this Regulation, to determine the administrative and financial regulations on funding of accreditation business. |
| 46) In addition, funding should also be available to other organs than the organ recognized in accordance with this Regulation, to other business on the range of compliance assessment, metrology, accreditation and market vision, e.g., outwork and reconcile of guidelines, comparative business related to the completion of the safety clauses, preparative business or on-demand business in connection with the completion of the Joint Regulatory Regulatory regulations on the above mentioned areas as well as programs for technical assistance and cooperation with third-level testing and an improvement The policy of the mentioned areas of community plan and on international plan. |
| 47) This Regulation is unily with the fundamental rights and the principles recognized especially in the European Union's pact on fundamental rights. |
| 48) As the goal of this Regulation, which is to ensure that products in the market that are reselected by the Joint Regulatory Regulatory Service, meet requirements for a high level of protection and safety and other public interests, and at the same time ensuring the interior market works in a satisfactory way by determining a frame for accreditation business and market vision, cannot be reached in sufficient extent of the Member States and therefore due to the scope of the scope and effects better be reached on community plan, can The community hit measures in accordance with the proximity principle as stipuled in the treaty's Article 5. In accordance with the relationship response principle stipulated in mentioned article, this settlement goes no longer than what is necessary to reach this goal- |
passed this Regulation :
Chapter I. Almemorial regulations
Art 1.
Foretarget and scope
| 1. In this Regulation, rules are determined for organization and review of accreditation of compliance organs as exercising compliance business. |
| 2. In this Regulation, a frame of market vision is determined with products to ensure that these products meet requirements that provide a high level of protection of public interests such as health and safety in general health, health and safety in the workplace, consumer protection, environmental protection and security. |
| 3. In this Regulation, a frame is determined for control with products from third-place. |
| 4. In this Regulation, the public principles are determined for CE marking. |
Part Article Art 2.
Definitions
In this Regulation, it is meaning :
| 1. |
"make available on the market" any provision of a product for distribution, consumption or use on the community market in connection with commercial business, against payment or charge freely, |
| 2. |
"bring in revenue" make a product available in the community market for the first time, |
| 3. |
"manufacturer" any physical or legal person who produces a product, or that gets a product constructed or produced, and as market leads the product under its name or trademark, |
| 4. |
"Representative" any physical or legal person established in the community that has received written authorization from a manufacturer to perform on dennes's behalf in connection with respect to the latter's obligations in accordance with current community regulations, |
| 5. |
"importer" any physical or legal person established in the community that brings a product from a third-party business in the revenue of the Community, |
| 6. |
"distributor" any physical or legal person in the restatement chain, except the manufacturer or importer, which makes a product available in the market, |
| 7. |
"market participants" the manufacturer, the representative, the importer and distributor, |
| 8. |
"technical specification" a document in which it is determined what technical requirements are to be met by a product, a process or service, |
| 9. |
"harmonised the standard" a standard adopted by one of the European Standards organs listed in attachments I to the europe parliamentary 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 mentioned directive, |
| 10. |
"accreditation" an attestation from a national accreditation organ that a compliance rating organ meets the requirements stipulating in harmonized standards and, in which it is relevant, any additional requirements, herding them that are determined in relevant sector arrangements, to exercise a specific compliance rating business, |
| 11. |
"nationwide accreditation organ" the only organ in a member state that performs accreditation on missions from the state, |
| 12. |
"Compliance Assessment" a process to determine whether closer to the stated requirements of a product, a process, a service, a system, a person or organ is met, |
| 13. |
"Compliance Assessment organ" an organ that exercising compliance business, herding calibration, trial, certification and inspection, |
| 14. |
"recall" any measures with aim of backdelivery of a product that has already been made available to the end user, |
| 15. |
"Withdrawal" any measures with aim to prevent a product in the restatement chain is made available in the market, |
| 16. |
"craft field assessment" a process in which a national accreditation organ is considered by other national accreditation organs in accordance with the requirements of this Regulation and, in which it is relevant, further sectorting technical specifications, |
| 17. |
"market vision" business as athletes and measures that meet by public authorities to ensure that products meet the requirements of the Co-Company's current harmonics and do not put health, safety, or other pages by the privacy of public interests at risk, |
| 18. |
"market syndidity" a authority in a member state with responsibility to carry out market vision on member state territory, |
| 19. |
"release of free revenue" the approach determined in Article 79 of the Council Regulation (ELF) 2913/92 of 12. October 1992 about the introduction of the Joint Customs Code of the Company, |
| 20. |
"CE-marking" marking where the manufacturer indicates that the product meets the current requirements determined in the Joint Company's harmonics regulations for such marking, |
| 21. |
"The company harmonics harmonics" all community regulations harmonize the terms of marketing of products. |
Part Article
Chapter II. Accreditation
Art 3.
Scope
This chapter gets the Applicability on accreditation, on mandatory or voluntary basis, in connection with compliance assessment, whether this assessment is mandatory or not, and regardless of the legal status of the organ that performs accreditation, have.
Part Article Art 4.
Public principles
| 1. Each member state shall designate one national accreditation organ. |
| 2. If a member state considers that it is not economically meaningful or sustainable to have a national accreditation organ or to provide certain accreditation services, the member state shall be able to take advantage of the national accreditation organ in a other member state. |
| 3. A Member State shall inform the Commission and the other member states if it in accordance with the No. 2 use the national accreditation organ in a different member state. |
| 4. On the basis of the information mentioned in the 3 and in Article 12 The Commission will announce, reconcile, and announce a list of national accreditation organs. |
| 5. When accreditation is not performed directly by the public authorities themselves, a member state shall leave the review of accreditation to its national accreditation organ as a public government exercise and give it formal recognition. |
| 6. The national accreditation organization's responsibility and tasks shall be clear separate from the responsibility and the tasks of other national authorities. |
| 7. The national accreditation organ should exercise its business on ideal grounds. |
| 8. The national accreditation organ shall not run business or provide services such as compliance organs offer, and should not provide advisory services, own shares in or otherwise have economic interest or management of responsibility in a compliance rating organ. |
| 9. Each member state shall ensure that its national accreditation organ has edown economic and human resources to carry out their tasks in a satisfying manner, herunder to carry out shonest tasks such as business for European and international accreditation cooperation and business that is necessary to support public policy and who are not self-funded. |
| 10. The national accreditation organ shall be a member of the organ recognized in accordance with Article 14. |
| 11. National accreditation organs should create and maintain egedown structures to ensure an effective and balanced participation from all affected parties both within their organizations and within the organ recognized according to Article 14. |
Part Article Art 5.
Accreditation
| 1. A nationwide accreditation organ shall at the request of a compliance rating organ assess whether this compliance evaluation organ is competent to exercise a specific compliance rating business. If that is the case, the National Accreditation of the National Accreditation Agency shall issue an accreditation evidence. |
| 2. When a member state does not decide to apply accreditation, it shall give the Commission and the other member states all of the documentation necessary to verify the competency of the compliance rating organs it selects out for review The company's current harmonics regulations. |
| 3. National accreditation organs shall bring attention to the compliance of the compliance organs that they have issued accreditation evidence to. |
| 4. If a national accreditation organ determines that a compliance rating organ that has received an accreditation evidence, no longer is competent to exercise a specific compliance rating business or in a serious way has neglected to fulfill its obligations, the accreditation organ shall be within a reasonable deadline to meet all egedown measures to limit, temporarily repor withdraw the accreditation evidence. |
| 5. Member States shall determine the procedures for processing complaints, herdunder clavide in connection with accreditation decisions, or lack accreditation decisions, in which it is appropriate. |
Part Article Art 6.
The principle of the ban on competing business
| 1. National accreditation organs should not compete with compliance rating organs. |
| 2. Natale accreditation organs should not compete with other national accreditation organs. |
| 3. National accreditation organs can drive their business across the country's borders, within the territory of another member state, either at the request of a compliance rating organ under the circumstances indicated in Article 7 # 1, or, if they are requesters about this by a national accreditation organ in accordance with Article 7 # 3. In cooperation with the national accreditation organ in mentioned member state. |
Part Article Art 7.
Accreditation across the country borders
| 1. When a compliance rating organ is requesting accreditation, it shall do this with the national accreditation organ in the Member State where it has been established, or with the national accreditation organ that the member state has taken advantage in accordance with with Article 4 # 2. |
However, a compliance rating organ may apply for accreditation of another national accreditation organ than those who are reacted in the first clause, in the following circumstances :
| a) |
when the Member State where the organ is established, has decided not to create a national accreditation organ and has not taken advantage of a national accreditation organ in another member state in accordance with Article 4 No. 2. |
| b) |
when the national accreditation organs reacted in the first clause does not perform accreditation for the type of compliance rating business as the requestdes of accreditation for, |
| c) |
when the national accreditation organs reacted in the first clause did not meet the requirements that are faced by the craft field assessment in accordance with Article 10 for the type of compliance assessment business as the requestdes of accreditation for. |
| 2. When a national accreditation organ receives a request in accordance with the 1 letter b) or c), it shall inform the national accreditation organ in the Member State in which the requesting end-compliance organ is established. In such cases, the national accreditation of the national accreditation organ in the Member State may where the requesting compliance organ is established, participating as an observer. |
| 3. A national accreditation organ can request a different national accreditation organ to conduct a part of the assessment business. In such a case, the accreditation evidence shall be issued by the requesting organ. |
Part Article Art 8.
Requirements for national accreditation organs
A national accreditation organ shall meet the following requirements :
| 1. |
It is supposed to be organized in such a way that it is independent of the compliance rating organs it is considering and of commercially charged, and so that it is safeguards that it does not occur to the conflict of compliance organs. |
| 2. |
It is supposed to be organized and driven so that business is objective and impartial. |
| 3. |
It shall impose that any decision on attestation of competence is taken by other competent people than those who carried out the assessment. |
| 4. |
It shall have egedown arrangements to ensure confidential care of the information it receives. |
| 5. |
It shall map which compliance rating business is competent to carry out accreditation for, and, in which it is appropriate, wise to the relevant community regulations or national legislation and national standards. |
| 6. |
It shall introduce the procedures necessary to ensure effective management and suitable internet control. |
| 7. |
It shall have an adequate great qualified staff to be able to perform their tasks in a satisfactory manner. |
| 8. |
It shall document the obligations, the responsibility and authority of the staff that will be able to influence the quality of assessment and the attestation of competence. |
| 9. |
It is to impose, conduct and maintain the future of the procedures for conducting supervision of the affected personnel's work efforts and skills. |
| 10. |
It shall verify that compliance assessments are conducted in a suitable manner, so that enterprises do not impose unnecessary burdens and that it is taken into account the size of the enterprises, in which sector they run their business, their structure, where complex the appropriate product's technology is as well as the production process's character of mass or series production. |
| 11. |
It is supposed to announce revised year-end rainfall in accordance with ordinary recognized accounting policy. |
Part Article Art 9.
Compliance of Requirements
| 1. If a national accreditation organ does not meet the requirements of this Regulation, or fail to fulfill its obligations under this Regulation, the affected member state shall hit egedown corrective actions or ensure that such corrective measures meet, and inform the Commission on this issue. |
| 2. Member states shall bring regular attention to their national accreditation organs to ensure that the running meet the requirements of Article 8. |
| 3. Member States shall in the greatest extent take into account the results of the craft field assessment according to Article 10 when they conduct the Department of Health 2 in this article. |
| 4. National accreditation organs shall have instituted the necessary procedures for processing complaints against the compliance rate organs they have accredited. |
Part Article Art 10.
Craft Assessment
| 1. National accreditation organs shall submit to a craft-field assessment organized by the organ recognized in accordance with Article 14. |
| 2. Affected parties shall have the right to participate in the arrangement that has been introduced to the supervision of the craft field assessment, but not in individual frameworks for the craft-field assessment. |
| 3. Member States shall ensure that their national accreditation organs regularly undergo a craft-field assessment according to the claim in No. 1. |
| 4. The union assessment shall be conducted on the basis of defensible and open assessment criteria and approach, especially when it comes to structural requirements, requirements of human resources and processes as well as privacy and complaints. It shall be determined to be determined by complaint against decisions made as a result of the assessment. |
| 5. The union assessment shall determine whether the national accreditation organs meet the requirements of Article 8, as it is taken into account the relevant harmonized standard reacted in Article 11. |
| 6. The organ recognized in accordance with Article 14 shall announce the result of the craft field assessment and overpass it to all of the Member States and to the Commission. |
| The 7th Commission is due in cooperation with the Member States to conduct supervision with the rules and with that the craft-field evaluation arrangement works in a satisfactory manner. |
Part Article Art 11.
Compliance for national accreditation organs
| 1. National accreditation organs that show that they meet the criteria determined in the relevant harmonized standard that it has been released a referral to i The European Union's time-end , by fulfilling the requirements that are faced by the craft field assessment in accordance with Article 10 shall be foremet to meet the requirements of Article 8. |
| 2. The National Government shall acknowledge the equilibrium of the services that are totes by the accreditation organs that have fulfilled the requirements that are faced by the craft field assessment in accordance with Article 10, and thus on the basis of the assumption reacted in No. 2 1 in this article accept the accreditation evidence from these organs and attesters issued by the compliance rating organs accredited by them. |
Part Article Art 12.
Illumination alike
| 1. Each national accreditation organ shall inform the other national accreditation organs about the compliance rating business as it offers accreditation for, and about any changes of the business. |
| 2. Each Member State shall inform the Commission and the organ recognized in accordance with Article 14, about the identity of its national accreditation organ and about all compliance business as this organ offers accreditation for support for The community harmonics harmonics as well as about any changes. |
| 3. Each national accreditation organ shall regularly release information on the results of its craft-field assessment, whether the compliance rating business as it offers accreditation for as well as about any changes. |
Part Article Art 13
The requests for the organ recognized in accordance with Article 14
| 1. The Commission can, after the co-counsel with the committee impaired pursuant to Article 5 of Directive 98 /34/EC, requesters the organ recognized in accordance with Article 14, of contributing to development, preservation and review of accreditation in the community. |
| 2. The Commission can also after the procedure determined in the 1 |
| a) |
requesters the organ recognized in accordance with Article 14 about determining assessment criteria and frameways for craft-field assessment and developing secsecaccreditation arrangements, |
| b) |
agree to all existing arrangements that already include assessment criteria and the approach of craft-field assessment. |
| 3. The Commission shall note that sector-wise arrangements map the technical specifications necessary to achieve the skill level required in the Joint Company's harmonics regulations on areas of candid claims to technology, health and safety or environmental claims or other aspects of the privacy of public interests. |
Part Article Art 14.
European infrastructure for accreditation
| 1. The Commission shall by the Council of the Member States acknowledge an organ that meets the requirements of attachments I to this Regulation. |
| 2. An organ to be recognized according to number 1, shall make a deal with the Commission. The agreement shall among other include a detailed description of the organ's tasks, funding regulations and regulations on supervision of the organ. Both the Commission and organ should be able to state the agreement without specifying any reason at the expiration of a reasonable deadline to be determined in the agreement. |
| 3. The Commission and the organ shall announce the agreement. |
| 4. The Commission shall inform member states and national accreditation organs of the recognition of an organ in accordance with the No. 1. |
| 5. The Commission cannot acknowledge more than one organ at a time. |
| 6. The first organ to be recognized in accordance with this Regulation shall be the European cooperation for accreditation, provided that it has struck a deal in accordance with the No. 2. |
Part Article
Chapter III. Community frame of market vision and control of products that are introduced on the community market
Paragraph 1. Almemorial regulations
Art 15.
Scope
| 1. Article 16-26 gets the Applicability on products that are reselected by the Joint Court harmonics. |
| 2. All provisions of Article 16-26 get Applicability in the extent that there are no specific provisions of the same purpose in the Joint harmonics harmonics. |
| 3. The charge of this Regulation shall not prevent the market health authorities in meeting particularly separate measures as determined in Directive 2001 /95/EC. |
| 4. In Article 16-26 means of "product" a substance, a substance mix or commodity is induced by a production process, except for nutritional, living plants and animals, products that write from humans and products of plants and animals that are directly related to their future reproduction. |
| 5. Article 27, 28 and 29 will be given Applicability on all products that are reselected by the Joint Regulatory Regulations of the extent that other community regulations do not contain shonest regulations about the organization of border control. |
Part Article Art 16.
Almemorial requirements
| 1. Member States should organize and conduct market vision as determined in this chapter. |
| 2. Market vision shall ensure that products that be reselected by the Joint Court harmonics regulations, which, when used in accordance with their intended purpose or under conditions which with the equitable can be predicted and when properly installed and maintained, will be able to damage the health or safety of users, or otherwise not in compliance with the current requirements determined in the Joint harmonics Regulatory Regulatory Regulatory regulations, are withdrawn, forelight or made available on the market only in limited scope, and that The public, the Commission and the other member states are informed about this. |
| 3. The national infrastructure and programs for market vision should ensure that it can be met effective measures for any product category that is reauthored by the Joint Court harmonics. |
| 4. Market vision should include products mounted or manufactured to the manufacturer's own use when it in the Joint Company's harmonics regulations is determined that its regulations are given the Applicability of such products. |
Part Article
Paragraph 2. Community frame for market vision
Art 17.
Illumination alike
| 1. The Member States shall inform the Commission on its market value of their market authority and their responsible areas. The Commission shall overpass these information to the other member states. |
| 2. The Member States should be seen that the public is aware of the national market of the national market, responsible areas and identity as well as how they can be contacted. |
Part Article Art 18.
Member States obligations with respect to organization
| 1. Member States shall impose edown arrangements for communication and interarrangement between their market synhilities. |
| 2. Member States should determine egedown frameacts to |
| a) |
follow up complaints or reports of risks associated with products that are subject to the Joint harmonics Regulatory Regulatory Regulatory Regulatory Regulatory Regulatory |
| b) |
monitoring accidents and health damage as there are suspicions that these products may have caused, |
| c) |
verify that corrective measures have been hit and |
| d) |
follow up scientific and technical knowledge of security questions. |
| 3. Member States shall provide market health authorities the authority, the resources and the knowledge required for them to be able to perform their tasks in a satisfactory manner. |
| 4. Member States should impose the market health authorities exercising its authority in accordance with the relationship-health principle. |
| 5. Member States should create, conduct and regular reconcile their market vision programs. Member States should devise either a general market vision program or sector show programs for sectors in which they carry out market vision, inform the other member states and the Commission on these programs and make them publicly available electronic as well, where it is appropriate, in other ways. |
The first subdirection of this kind shall happen within 1. January 2010. Later reconcile of the programs should be released in the same way. Member states can cooperate with all affected parties for this purpose.
| 6. Member states should regularly revise and assess their probation worker. Such audits and assessments shall be conducted at least every four years, and the results shall co-share the other member states and Commission and be made publicly available electronically as well, in other ways. |
Part Article Art 19.
Market Style
| 1. Market Health Authority shall in adequate scope perform edown controls of product control and, in which it is appropriate, physical control and laboratory investigations on the basis of appropriate cue samples. In that connection, they shall take into account the current principles of risk assessment, complaints and other information. |
Market vision authorities may require the market participants to make the documentation and information available as the government considers necessary for them to be able to carry out their business, as well as, when necessary and warranted, to access The market participants ' premises and the right to take necessary stab samples of the products. They can be destroyed or otherwise make useless products that pose a serious risk, if they consider it necessary.
If the market participants put forward trial reports or certificates that confirm compliance and which have been issued by an accredited compliance organ, the market health authorities shall take the auditent consideration of such reports or certificates.
| 2. Market Health Authority shall within a reasonable deadline hit edown measures to notify users on their territory of dangers they have discovered in association with a product, so that the risk of personal injury or other damage is reduced. |
They will cooperate with the market participants about measures that can prevent or reduce risks caused by products that these market participants have made available.
| 3. If the market health authorities in one member state decide to withdraw a product produced in another member state, they shall inform the affected market participant at the address indicated on the affected product or in the documentation that follow the product. |
| 4. The Market Health Authority shall fulfill its obligations on an independent, impartial and objective manner. |
| 5. Market Health Authority shall safeguard privacy in which this is necessary to protect business secrets or personal information in accordance with national legislation, but with reservations for the requirement for the information to be released in accordance with to this Regulation in the extent necessary to protect users ' interests in the community. |
Part Article Art 20
Products that pose a serious risk
| 1. Member States shall ensure that products that pose a serious risk requiring it to be seized quickly, herunder a serious risk that has no immediate effects, being recalled or withdrawn from the market, or being banned from the market, or that it is forbidden to make them available in the market, and that the Commission immediately undercorrected this in accordance with Article 22. |
| 2. The decision of whether a product constitutes a serious risk is to build on a suitable risk assessment that takes into account the father's species and the likelihood that it occurs. The possibility of achieving a higher level of security or obtaining other products that involve less risk should not be sufficient reason for a product to be considered to pose a serious risk. |
Part Article Art 21
Reactive measures
| 1. Member States shall ensure that all measures that meet in accordance with the Co-Company's current harmonics regulations, with aim to ban 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 ceiling are indicated precisely. |
| 2. Such measures shall immediately be co-shared the relevant market participant, which at the same time shall be undercorrected on which claviate access is available in accordance with the member state legislation and what deadlines apply to such clawn access. |
| 3. Before a measure that was reacted in the 1 meet, shall the affected market participant within a suitable amount of time of at least ten days given the opportunity to comment, unless such contemporary advice is not possible because the intake is urgent on the background of health or safety requirements or for other reasons related to public interests that are reauthored by the Co-Company's current harmonics regulations. If a measure has been hit without the market participant to comment, the market participant should be given the opportunity to comment as soon as possible, and the measures that have been hit are then quickly taken up to assessment. |
| 4. All measures reacted in number 1 shall quickly be withdrawn or change if the market participant has made amends that it has been hit effective measures. |
Part Article Art 22
Exchange of information-the company's system for quick exchange of information
| 1. If a member state hits or intends to hit measures in accordance with article 20 and considers that the reasons for the ceiling or to the measures go out over the member state territory, it shall immediately inform the Commission on such measures in accordance with the No. 4 in this article. The Member State shall also promptly inform the Commission on Change or the raising of such measures. |
| 2. If a product that constitutes a serious risk has been made available in the market, the Member States shall inform the Commission on any voluntary measures that a market participant has hit and informed about. |
| 3. The information provided in accordance with the 1 and 2 shall contain all available detail information, especially those necessary to identify the product, product origin and restatement chain, associated risk, the species and duration of national measures that have been hit, as well as any voluntary measures that have been hit by the market participants. |
| 4. With respect to No. 1, 2 and 3 shall it system for market vision and information exchange determined in Article 12 of Directive 2001 /95/EF, is used. Number 2, 3 and 4 in Article 12 of the mentioned directive gets the equivalent of the Applicability. |
Part Article Art 23
General Information System
| 1. The Commission shall develop and maintain a general electronic system for archiving and exchange of information relating to market vision business, programs, and related information about the lack of compliance with the Joint Company harmonics regulations. The system shall in suitable manner reflect the messages and information provided in accordance with Article 22. |
| 2. With respect to No. 1 shall member states lay out for the Commission information that they have at their disposal and as they have not already given according to Article 22, about products that pose a risk, especially about the identification of risk, results of executed trials, Temporary restrictive measures, contacts with affected market participants and the justification for measures have been hit or have not been hit. |
| 3. Without it touching article 19 number 5 or national legislation on privacy, shall be confidant of the information content of information security. The considerations of privacy shall not prevent the availability of the market health authorities of information that is important to ensure an effective market vision. |
Part Article Art 24
Principles of cooperation between the Member States and the Commission
| 1. Member States shall ensure effective cooperation and exchange of information between their own market visibility and market visibility of the other member states, and between their own government and the Commission and relevant Community organs, about their market vision programs and about all questions concerning products that pose a risk. |
| 2. With respect to No. 1 shall market health authorities in one member state in appropriate scope assist market visibility in other Member States by providing them with information or documentation, by carrying out egedown examinations or hitting other egedown measures and by participating in investigations initiated in other member states. |
| 3. The Commission shall gather and organize the information on national market style measures that allow it to fulfill their obligations. |
| 4. All information provided by a market participant in accordance with Article 21 # 3 or otherwise, shall be included when the enact of enact member state undercourses other Member States and the Commission on its results and measures. All more recent information is to be clearly identified as associated with the information already provided. |
Part Article Art 25.
Sharing resources
| 1. The Commission or the affected Member States can take market vision initiative that has the purpose of sharing resources and the case knowledge between the government of the Member States. Such initiatives shall be intersettled by the Commission. |
| 2. With respect to No. 1 shall the Commission, in cooperation with the Member States, |
| a) |
develop and organize training programs and exchange of national officials, |
| b) |
develop, organize and create programs for exchange of experience, information and best practices, programs and measures of joint projects, information campaigns, joint visitor programs and sharing resources. |
| 3. Member States to ensure that their government is participating fully in the business that has been reacted in number 2. When it is appropriate. |
Part Article Art 26
Cooperation with the person authorities in the third-place
| 1. Market Health Authority can work together with the person in third-place authorities with aim to exchange information and technical assistance, promote and easy access to European arrangements and promote business in connection with compliance assessment, market vision and accreditation. |
The Commission shall in cooperation with the Member States develop egedown programs for this purpose.
| 2. Cooperation with the person authorities in third-quarter states can among other things happen in terms of business that reacted in Article 25 # 2. Member States should impose their claim that their person is participating fully in this business. |
Part Article
Paragraph 3. Control of products that are introduced on the community market
Art 27
Control of products that are introduced on the community market
| 1. Member States government with responsibility for control of products that are introduced on the community market shall have the authority and the resources necessary for them to be able to perform their tasks in a satisfactory manner. They shall in adequate scope perform edown controls of product properties in accordance with the principles of Article 19 # 1, before these products are released for free turnover. |
| 2. When it in a member state is several government officials who are responsible for market vision or control with external borders, these governments should cooperate with each other by exchanging information that is necessary for them to be able to perform their tasks, and in other ways of need. |
| 3. Authorities with responsibility for control of external borders shall suspend the release of a product for free revenue on the community market if those at the controls were reacted in the 1 determines the following : |
| a) |
The product shows properties that give reason to believe that the product, when properly installed, maintained and used, constitutes a serious risk of health, security, the environment or other public interests that reacted in Article 1. |
| b) |
The product is not accompanied by the written or electronic documentation required in accordance with the Co-Company's current harmonics regulations, or is not marked in accordance with such regulations. |
| c) |
The CE marking has been inflicted on the product in an incorrect or misleading manner. |
The authorities with the responsibility of external borders shall immediately inform the market health authorities about such delay of the release.
| 4. If it revolves around easily tainted products, the government shall bear responsibility for control with external limits so far it is possible to ensure that all requirements as they optionally impose with respect to the storage of products or parking of transport vehicles, are organisations with product durability. |
| 5. With respect to this paragraph, Article 24 Applicability is given to the government with the responsibility of external limits, without it touching the applicability of the provisions of the community court on more specific arrangements for cooperation between these authorities. |
Part Article Art 28.
Release of products
| 1. A product whose release has been temporarily suspended by the government with the responsibility of external limits in accordance with Article 27, shall be released if these authorities within three reality days after the release of the release has not been notified about any measures hit by the market health authorities, and provided that all other requirements and formality with respect to such release have been met. |
| 2. If the market health authorities determine that the product does not constitute any serious risk of health and safety or cannot be deemed to be in violation of the Joint Court's harmonics regulations, the product shall be released, provided that all others requirements and formalities with respect to such release have been met. |
Part Article Art 29
National measures
| 1. If responsible market authority determines that a product poses a serious risk, they will hit measures to ban the revenue of the product and demand that the government with the responsibility of external borders marks the bill that follows the product, and all other relevant follow documents or, if the data processing occurs electronically, the data processing system itself, in the following manner : |
" Dangerous product release for free revenue not allowed-Regulation (EC) 765/2008 "
| 2. If the market health authorities determine that a product is not in accordance with the Joint Court's harmonics regulations, they shall hit equity measures as if necessary can include the ban on the product being brought in revenue. |
If it is forbidden to bring a product in revenue according to the first clause, the market health authorities shall require the government with the responsibility of external borders not releasing the product for free turnover and that they mark the bill as follows the product, and all other relevant follow documents or, in which the data processing occurs electronically, the data processing system itself, in the following manner :
" The product does not meet the current requirements-releasing for free revenue not allowed-Regulation (EC) 765/2008 "
| 3. If the product is later clarified for a second customs procedure than releasing for free turnover, and provided that market health authorities do not make objections, the engravings shall be mentioned in the No. 1 and 2 on the same terms incurred the documents that are used in connection with the person's approach. |
| 4. Member States government can be destroyed or otherwise make useless products that pose a serious risk, if they consider it necessary and affordable. |
| 5. Market Health Authority shall provide government with responsibility for control with external limits on product categories that it has been established a serious risk or does not meet current requirements according to No. 1 and 2. |
Part Article
Chapter IV. CE marking
Art 30.
Allright principles of CE marking
| 1. CE marking shall be incurred only by the manufacturer or dennes representative. |
| 2. CE marking as shown in attachment II shall be imposed on products only if it in the Joint harmonics Regulatory Regulatory Regulations is determined that the product should be imposed on CE marking, and shall not be imposed on any other product. |
| 3. By inflict or sustained CE marking the manufacturer that the person claims responsibility for the product is in compliance with all current requirements determined in the Joint Company's current harmonics regulations for such on-entry. |
| 4. CE marking shall be the only marking confirming that the product is in compliance with the current requirements determined in the Joint Company's current harmonics regulations for such on-entry. |
| 5. It is forbidden to impose a product marking, characters or inscriptions that can mislead third-person with respect to the CE brand's meaning or graphic design. Other marking can be incurred the product, provided that it does not make the CE marking less visible or readable or changes its meaning. |
| 6. Without it touching Article 41, Member States shall ensure proper review of the provisions of CE marking and hit egedown measures in case of the wrongful use of the marking. The member states should also determine sanctions for violations, which may include criminal sanctions for serious offenses. These sanctions should stand in relation to the violation of the offender's earnest and effective prevention of wrongful use. |
Part Article
Chapter V. Community Funding
Art 31.
Organised as working for a target of public European interest
The organ recognized in accordance with Article 14 shall be regarded as an organ working for a target of public European interest in accordance with Article 162 of Commission Regulation (EC, Euratom) 2342/2002 by 23 December 2002 on determining further rules for the execution of the Council Regulation (EC, Euratom) # 1605/2002.
Part Article Art 32.
Reality that is entitled to community funding
| 1. The community can fund the following business in the context of the applicability of this Regulation : |
| a) |
outwork and revision of secsectation accreditation arrangements reacted in Article 13 # 3. |
| b) |
the business of the secretariat of the organ recognized in accordance with Article 14, such as the arrangement of accreditation business, technical workloads related to the operation of the arrangement of craft-field assessment, information messaging to affected parties and the organising of the organising in international organizations on the area accreditation, |
| c) |
Exploring and reconciliation of contribution to guidelines on the areas accreditation, message to the Commission of Compliance Assessment organs, Compliance Assessment, and market vision, |
| d) |
comparative business related to the completion of the safety clauses, |
| e) |
The availability of technical case knowledge for the Commission to assist it in its review of the administrative cooperation of market vision, herding administrative cooperation groups, decisions about market vision and cases concerning security clauses, |
| f) |
execution of preparative work or additional work in connection with the feasance of compliance assessment, metrology, accreditation and market vision related to the feasance of the Joint Regulatory Regulatory, such as examinations, programs, programs, assessments, guidelines, comparable analyses, reciprocation joint visits, research work, development and maintenance of databases, training business, laboratory work, comparable laboratory trials and compliance rating work as well as European market vision campaigns and similar business, |
| g) |
business within the frame of programs for technical assistance, collaboration with third-party and enhancing and improvement of European principles and arrangements for compliance assessment, market vision and accreditation among affected parties in the community and on international plan. |
| 2. The business that has been reacted in the 1 letter a), shall be entitled to community funding only if the committee impaired at Article 5 of Directive 98 /34/EC is consulted on the requests to be presented for the organ recognized in accordance with Article 14 of this Regulation. |
Part Article Art 33.
Organs that are entitled to community funding
Community funding can be given to the organ recognized in accordance with Article 14, for the completion of business as listed in Article 32.
However, community funding can also be given to other organs for business as determined in Article 32, with the exception of the business mentioned in No. 1 letter a) and b) in mentioned article.
Part Article Art 34.
Financing
The willingness of the business as renegotiated in this Regulation shall be determined each year by the budget authority within the current financial frame.
Part Article Art 35
Financing arrangements
| 1. Community Funding shall be given |
| a) |
without the impact of the settlement, to the organ recognized in accordance with Article 14, to exercise the business that has been reacted in Article 32 No. 1 letter a)-g), which it can be given addition to in accordance with the financial regulations, |
| b) |
in terms of supplements after the impact of settlement, or by public purchases, to other organs to exercise the business that has been reacted in Article 32 No. 1 letter c)-g). |
| 2. The business of the secretariat of the organ recognized in accordance with Article 14 and reacted in Article 32 # 1 letter b), can be funded on the basis of operating style rounds. Upon renewal, the operating shot shall not be automatically dilased automatically. |
| 3. In-to-contract agreements, it can be permitted fixed contributions to coverage of the recipient's regular fixed costs up to the maximum of 10% of overall direct support entitlements, except in cases where the recipient's indirect costs are covered at an operating drive funded over the community budget. |
| 4. The joint goals of the cooperation and the administrative and financial terms of the deposits provided to the organ recognized in accordance with Article 14 may be set in a framework agreement on partnership signed by the Commission and mentioned organ, in compliance with the finance regulations and Regulation (EC, Euratom) # 2342/2002. The European Parliament and the Council shall be underfixed on the introduction of such agreements. |
Part Article Art 36.
Prevalence and follow-up
| 1. The appropriations that are determined by the budget authority of compliance assessment, accreditation and market vision, can also cover administrative expenses related to preparation, follow-up, inspection, revision and assessment that is direct necessary to reach the goals of this Regulation, and especially examinations, meetings, information and public disclosure, expenses related to information net exchange of information as well as other expenses of administrative and technical assistance as the Commission can use in connection with compliance deriding and accreditation business. |
| 2. The Commission shall assess whether the compliance of the compliance, accreditation and market vision business that receives community funding, is relevant in light of the requirements of the Joint Principles and Regulatory Commission, and the Council of the European Parliament and the Council of the result of this assessment within 1. January 2013 and then every five years. |
Part Article Art 37.
Vern of the community's economic interests
| 1. The Commission shall be at review of business funded in accordance with this Regulation ensuring the protection of the Joint Economic interests through preventative measures against fraud, corruption and other illegal business, through effective control and The incomes of charges that are unjustly paid off, and if detected irregulates, through sanctions that are effective, stands in relation to the violation and are daunting, in accordance with the Council Regulation (EC, Euratom) no 2988/95 of 18. December 1995 about the protection of the European Community's economic interests, Council Regulation (Euratom, EF) 2185/96 of 11. November 1996 on the control and inspection of the site as being conducted by the Commission to uphold the European Community's economic interests against fraud and other irregularities and europe parliamentary and Council Regulation (EC) 1073/1999 of 25. May 1999 about investigations conducted by the European Office for the fraud prevention (OLAF). |
| 2. For the community business that is funded in accordance with this Regulation, the term of the concept of irregularity was reacted in Article 1 # 2 in Regulation (EC, Euratom) # 2988/95 Any violation of a provision in the community court or any violation of a contractual obligation as a result of a market participant's action or avoidance, which damages or will be able to damage the European Union's average budget or budgets as the trustee, as a result of a wrongful expense record. |
| 3. Agreements and contracts that follow of this Regulation shall contain provisions of follow-up and financial control to be taken by the Commission or a belamented representative of the Commission, and about revision being made by the Audit Court, if needed on the site. |
Part Article
Chapter VI. End regulations
Art 38.
Technical guidelines
In order to facilitate the completion of this Regulation, the Commission shall not devise non-binding guidelines in co-counsel with the affected parties.
Part Article Art 39.
Overtime Regulations
Accreditation proves issued before 1. January 2010 may still be valid until they expire, but most recently until 31. December 2014. However, this settlement is given the Applicability in case of extension or renewal of such accreditation evidence.
Part Article Art 40
Audit Clause and Reporting
The Commission shall be at the latest 2. September 2013 lay forward for the European Parliament and the Council a report on the applicability of this Regulation, of Directive 2001 /95/F and of other current community litigation on market vision. This report should particularly contain an analysis of the context in the community rules on the range of market vision. If it is appropriate, the report should be accompanied by proposals to change and / or consolidate the affected litigation with aim to achieve a better regulatory and simplification. The report shall contain an assessment of the expansion of the scope of chapter III in this Regulation to include all products.
Sen. 1. January 2013 and then every five years shall the Commission, in cooperation with the Member States, outperforming and overpass to the European Parliament and the Council a report on the completion of this Regulation.
Part Article Art 41.
Sanctions
Member states shall determine rules of sanctions against market participants, herunder criminal sanctions for serious offenses, which are given the inquiry on violations of the provisions of this Regulation, and shall meet all necessary measures for to ensure that they are being conducted. The sanctions that are determined should be effective, stand in relation to the violation and appear daunting and can be screen-made if the person market participant has previously committed an equivalent violation of the provisions of this Regulation. The member states should within 1. January 2010 inform the Commission on these regulations and immediately inform it of any subsequent changes.
Part Article Art 42
Change of Directive 2001 /95/EF
New Article 8 # 3 in directive 2001 /95/F shall obey :
| " 3. In the case of products that make up a serious risk, the person is going to quickly hit egedown measures that reacted in number 1 letter b)-f). Whether or not there is a serious risk to be decided by the Member States, to consider each individual case, as it is taken into consideration of the guidelines about the attachments II 8. " |
Part Article Art 43.
Uprise
Regulation (EEEF) No. 339/93 repit with effect from 1. January 2010.
The reference to the unavenged settlement shall be understood as referrals to this Regulation.
Part Article Art 44
Istrontrecation
This Regulation takes effect on 20. day after it is announced in The European Union's time-end .
It gets the Applicability from 1. January 2010.
This Regulation is binding in all parts and comes directly to the Applicability of all Member States.
Ufinet in Strasbourg, 9. July 2008.
Part Article
Appendix I. Requirement of the organ that can be recognized according to Article 14
| 1. The organ that is recognized according to Article 14 of this Regulation (organet) shall be created in the Community. |
| 2. According to the organising of the organ, national accreditation organs from the community have the right to become a member of the organ, provided they perform in accordance with the organ rules and objectives and with the other terms determined in this Regulation, and as agreed with the Commission on the framework agreement. |
| 3. The organ shall counsel with all relevant affected parties. |
| 4. The organ shall offer its members craft field assessment services that meet the requirements in Article 10 and 11. |
| 5. The organ shall cooperate with the Commission in accordance with this Regulation. |
Appendix II. CE marking
| 1. CE marking shall consist of the letters "CE" in the following graphical design : |
| 2. If the CE marking is reduced or enlarged, the size ratio should thus progress by the figure in number 1, overheld. |
| 3. If not in any court set, the CE marking should be at least 5 mm high. |
