Regulation (EC) No 765/2008 of the European Parliament and of the CouncilShow full title

Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (Text with EEA relevance)

CHAPTER IU.K.GENERAL PROVISIONS

Article 1U.K.Subject matter and scope

1.This Regulation lays down rules on the organisation and operation of accreditation of conformity assessment bodies performing conformity assessment activities.

2.This Regulation provides a framework for the market surveillance of products to ensure that those products fulfil requirements providing a high level of protection of public interests, such as health and safety in general, health and safety at the workplace, the protection of consumers, protection of the environment and security.

3.This Regulation provides a framework for controls on products [F1entering the market of Great Britain].

[F24.This Regulation provides the requirements as to the form of the UK marking.]

Article 2U.K.Definitions

For the purposes of this Regulation the following definitions F3... apply:

1.

‘making available on the market’ [F4means] any supply of a product for distribution, consumption or use on the [F5market of Great Britain] in the course of a commercial activity, whether in return for payment or free of charge [F6and related expressions must be construed accordingly];

2.

‘placing on the market’ [F4means] the first making available of a product on the [F7market of Great Britain ] [F8and related expressions must be construed accordingly];

3.

‘manufacturer’ [F4means] any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark;

4.

[F9authorised representative” means a person who—

(a)

is established in the United Kingdom; and

(b)

has received a written mandate from a manufacturer to act on that manufacturer's behalf in relation to specified task with regard to the manufacturer's obligation under any relevant enactment;]

5.

[F10importer” means any person established in the United Kingdom who places a product from a country outside of the United Kingdom on the market;]

6.

‘distributor’ [F11means] any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;

7.

‘economic operators’ [F12means] the manufacturer, the authorised representative, the importer and the distributor;

8.

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9.

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10.

[F14accreditation” means an attestation by a national accreditation body conveying formal recognition that a conformity assessment body is competent to carry out a specific conformity assessment activity;]

11.

[F15UK national accreditation body” means the body appointed by the Secretary of State in accordance with Article 4;]

12.

‘conformity assessment’ [F16means] the process demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled;

13.

‘conformity assessment body’ [F16means] a body that performs conformity assessment activities including calibration, testing, certification and inspection;

14.

‘recall’ [F16means] any measure aimed at achieving the return of a product that has already been made available to the end user;

15.

‘withdrawal’ [F16means] any measure aimed at preventing a product in the supply chain from being made available on the market;

16.

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17.

‘market surveillance’ [F18means] the activities carried out and measures taken by public authorities to ensure that products comply with the requirements set out in [F19any relevant enactment] and do not endanger health, safety or any other aspect of public interest protection;

18.

[F20market surveillance authority” means an authority responsible for carrying out market surveillance in the United Kingdom;]

19.

[F21the free circulation procedure” means the procedure set out in Schedule 1 to the Taxation (Cross-border Trade) Act 2018;]

20.

[F22conformity marking” means a marking, such as the UK marking, by which the manufacturer indicates that a product is in conformity with the applicable requirements of any enactment providing for the affixing such a marking;]

21.

[F23relevant enactment” means any retained EU law, as it applies in Great Britain, derived from an EU instrument harmonising the conditions for the marketing of products in the EU;]

22.

[F24UK marking” means the marking in the form set out in Annex 2.]

Textual Amendments

CHAPTER IIU.K.ACCREDITATION

Article 3U.K.Scope

This Chapter [F25applies] to accreditation, used on a compulsory or voluntary basis, relating to conformity assessment, whether that assessment is compulsory or not, and irrespective of the legal status of the body performing the accreditation.

[F26Article 4U.K. UK national accreditation body

1.The Secretary of State must by regulations appoint a single UK national accreditation body.

2.The appointment of the UK national accreditation body under regulation 3 of the Accreditation Regulations 2009 is to be treated on and after IP completion day as having been made in pursuance of the duty on the Secretary of State to appoint a UK national accreditation body set out in paragraph 1.

3.The UK national accreditation body must perform its functions in accordance with the provisions of this Chapter.

4.Regulations made under this Article may—

(a)terminate the appointment of a UK national accreditation body; and

(b)appoint a different body as the UK national accreditation body

where the Secretary of State considers that a UK national accreditation body is not performing its functions in accordance with this Chapter.

5.Regulations made under this Article must establish procedures for the resolution of appeals against accreditation decisions made by the appointed UK national accreditation body.

6.Regulation 5 of the Accreditation Regulations 2009 is to be treated as meeting the requirements of paragraph 5.

7.The UK national accreditation body must operate on a not-for-profit basis.

8.The UK national accreditation body must not—

(a)offer or provide any activities or services that are provided by conformity assessment bodies,

(b)provide consultancy services; and

(c)own shares in, or otherwise have any financial or managerial interest in, a conformity assessment body.

9.The UK national accreditation body must establish and maintain appropriate structures to ensure—

(a)consultation on its activities with interested parties; and

(b)responses of interested parties to consultation are adequately taken into account.

10.The Secretary of State must ensure that the UK national accreditation body has the appropriate financial and personnel resources for the proper fulfilment of its tasks, including—

(a)the fulfilment of special tasks such as activities related to international accreditation cooperation; and

(b)activities that are required to support public policy and which are not self-financing.

11.Regulations made under this Article must be made by statutory instrument.

12.Regulations made under this Article may make such transitional, transitory, consequential or saving provision as the Secretary of State considers appropriate.

13.A statutory instrument containing regulations made under this Article is subject to annulment in pursuance of a resolution of either House of Parliament.]

Article 5U.K.Operation of accreditation

1.[F27The UK national accreditation body must], when requested by a conformity assessment body, evaluate whether that conformity assessment body is competent to carry out a specific conformity assessment activity. Where it is found to be competent, [F28the UK national accreditation body must] issue an accreditation certificate to that effect.

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3.[F30The UK national accreditation body must] monitor the conformity assessment bodies to which [F31it has] issued an accreditation certificate.

4.Where [F32the UK national accreditation body] ascertains that a conformity assessment body which has received an accreditation certificate is no longer competent to carry out a specific conformity assessment activity or has committed a serious breach of its obligations, [F33the UK national accreditation body must] take all appropriate measures within a reasonable timeframe to restrict, suspend or withdraw the accreditation certificate.

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Textual Amendments

Article 6U.K.Principle of non-competition

1.[F35The UK national accreditation body must] not compete with conformity assessment bodies.

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F37Article 7U.K.Cross-border accreditation

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Article 8U.K.Requirements for [F38the UK national accreditation body]

[F39The UK national accreditation body must] fulfil the following requirements:

1.

it [F40must] be organised in such a manner as to make it independent of the conformity assessment bodies it assesses and of commercial pressures, and to ensure that no conflicts of interest with conformity assessment bodies occur;

2.

it [F40must] be organised and operated so as to safeguard the objectivity and impartiality of its activities;

3.

it [F40must] ensure that each decision relating to the attestation of competence is taken by competent persons different from those who carried out the assessment;

4.

it [F40must] have adequate arrangements to safeguard the confidentiality of the information obtained;

5.

it [F40must] identify the conformity assessment activities for which it is competent to perform accreditation, referring, where appropriate, to [F41any enactment] and standards;

6.

it [F40must] set up the procedures necessary to ensure efficient management and appropriate internal controls;

7.

it [F40must] have a number of competent personnel at its disposal sufficient for the proper performance of its tasks;

8.

it [F40must] document the duties, responsibilities and authorities of personnel who could affect the quality of the assessment and of the attestation of competence;

9.

it [F40must] establish, implement and maintain procedures for monitoring the performance and competence of the personnel involved;

10.

it [F40must] verify that conformity assessments are carried out in an appropriate manner, meaning that unnecessary burdens are not imposed on undertakings and that due account is taken of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process;

11.

it [F40must] publish audited annual accounts prepared in accordance with generally accepted accounting principles.

Article 9U.K.Compliance with requirements

1.Where [F42the UK national accreditation body] does not meet the requirements of this Regulation or fails to fulfil its obligations hereunder, the [F43Secretary of State must] take appropriate corrective action or [F44must ensure] that such corrective action is taken F45...

2.[F46The Secretary of State must] monitor [F47the UK national accreditation body] at regular intervals in order to ensure that [F48it fulfils] the requirements laid down in Article 8 on a continuing basis.

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4.[F50The UK national accreditation body must] have in place the necessary procedures to deal with complaints against the conformity assessment bodies [F51it has] accredited.

Textual Amendments

[F52Article 10U.K.Peer evaluation

1.The UK national accreditation body must—

(a) ensure that it is evaluated in accordance with the requirements of this Article by a body which is approved by the Secretary of State;

(b)set out the results of the evaluation in a report;

(c)make that report publicly available; and

(d)provide a copy of that report to the Secretary of State.

2.The evaluation referred to in paragraph 1(a) must—

(a)be based on evaluation criteria and procedures—

(i)agreed between the national accreditation body and the body undertaking the evaluation; and

(ii)approved by the Secretary of State; and

(b)evaluate whether the UK national accreditation body meets the requirements of Article 8.

3.The procedures referred to in paragraph 2(a) must include provision for appeal by the UK national accreditation body against the results of the evaluation.

4.The report paragraph (1)(c) must include the evaluation criteria and procedures referred to in paragraph (2)(a).

5.The first report under paragraph (1) must be made publicly available before the end of the period of five years beginning on IP completion day.

6.After the first report, reports made under this Article are to be made publicly available at intervals not exceeding five years]

F53Article 11U.K.Presumption of conformity for national accreditation bodies

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F53Article 12U.K.Information obligation

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F53Article 13U.K.Requests to the body recognised under Article 14

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F53Article 14U.K.European accreditation infrastructure

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CHAPTER IIIU.K.F54... MARKET SURVEILLANCE FRAMEWORK AND CONTROLS OF PRODUCTS ENTERING THE [F55MARKET OF GREAT BRITAIN]

SECTION 1U.K.General provisions

Article 15U.K.Scope

1.Articles 16 to [F5622 and] 26 F57... apply to products covered by [F58any relevant enactment].

2.Each of the provisions of Articles 16 to [F5922 and] 26 [F60applies] in so far as there are no specific provisions with the same objective in [F61any relevant enactment].

3.The application of this Regulation [F62does] not prevent market surveillance authorities from taking more specific measures as provided for in [F63the General Product Safety Regulations 2005].

4.For the purposes of Articles 16 to [F6422 and] 26, a ‘product’ [F65means] a substance, preparation or good produced through a manufacturing process other than food, feed, living plants and animals, products of human origin and products of plants and animals relating directly to their future reproduction.

5.Articles 27, 28 and 29 F66... apply to all products covered by [F67any relevant enactment] in so far as other [F68enactments do] not contain specific provisions relating to the organisation of border controls.

Textual Amendments

Article 16U.K.General requirements

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2.Market surveillance [F70authorities] [F71must] ensure that products covered by [F72any relevant enactment] which, when used in accordance with their intended purpose or under conditions which can be reasonably foreseen and when properly installed and maintained, are liable to compromise the health or safety of users, or which otherwise do not conform to applicable requirements set out in [F72any relevant enactment] are withdrawn or their being made available on the market is prohibited or restricted and that the public [F73and the Secretary of State] are informed accordingly.

[F743.The Secretary of State must ensure that there is a national market surveillance infrastructure and programme so that effective measures may be taken in relation to any product subject to any relevant enactment.]

4.Market surveillance [F75must] cover products assembled or manufactured for the manufacturer's own use where [F76any relevant enactment] provides that its provisions F77... apply to such products.

Textual Amendments

SECTION 2U.K. [F78Market] surveillance framework

Article 17U.K.Information obligations

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2.[F80The Secretary of State must take appropriate measures to] ensure that the public is aware of the existence, responsibilities and identity of national market surveillance authorities, and of how those authorities may be contacted.

Article 18U.K.Obligations F81... as regards organisation

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2.[F83The Secretary of State must] establish adequate procedures in order to:

(a)follow up complaints or reports on issues relating to risks arising in connection with products subject to [F84any relevant enactment];

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

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

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

[F853.The Secretary of State may by regulations make such provision as the Secretary of State considers appropriate to ensure that market surveillance authorities have the powers necessary for the proper performance of their duties.

The Secretary of State must entrust market surveillance authorities with the resources and knowledge necessary for the proper performance of their duties.

Regulations made under this paragraph must be made by statutory instrument.

A statutory instrument containing regulations under this paragraph may not be made unless a draft of the instrument has been laid before, and approved by a resolution of, each House of Parliament.]

[F864.Market surveillance authorities must exercise their powers proportionately.]

[F875.The Secretary of State must establish, implement and periodically update the United Kingdom's market surveillance programme setting out the principles as to how market surveillance is to be organised and covering the sectors in which market surveillance is conducted in the United Kingdom. The Secretary of State must make this programme available to the public by way of electronic communication and, where appropriate, by other means.]

6.[F88The Secretary of State] [F89must] periodically review and assess the functioning of F90... surveillance activities [F91by market surveillance authorities]. Such reviews and assessments [F89must] be carried out at least every fourth year and the results thereof [F89must] F92... be made available to the public, by way of electronic communication and, where appropriate, by other means.

Textual Amendments

Article 19U.K.Market surveillance measures

1.Market surveillance authorities [F93must] perform appropriate checks on the characteristics of products on an adequate scale, by means of documentary checks and, where appropriate, physical and laboratory checks on the basis of adequate samples. When doing so they [F93must] take account of established principles of risk assessment, complaints and other information.

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

Where economic operators present test reports or certificates attesting conformity issued by an accredited conformity assessment body, market surveillance authorities [F93must] take due account of such reports or certificates.

2.Market surveillance authorities [F94must] take appropriate measures to alert users F95... within an adequate timeframe of hazards they have identified relating to any product so as to reduce the risk of injury or other damage.

They [F94must] cooperate with economic operators regarding actions which could prevent or reduce risks caused by products made available by those operators.

[F963.Where a market surveillance authority decides to withdraw a product manufactured in the United Kingdom, it must inform the economic operator concerned at the address indicated on the product in question or in the documentation accompanying the product.]

4.Market surveillance authorities [F97must] carry out their duties independently, impartially and without bias.

[F985.Market surveillance authorities must observe confidentiality where necessary in order to protect commercial secrets or to preserve personal data pursuant to national legislation, subject to the requirements that:

(a)information be made public under this Regulation to the fullest extent necessary in order to protect the users in the United Kingdom;

(b)the protection of confidentiality shall not prevent the dissemination to market surveillance authorities of information relevant to ensuring the effectiveness of market surveillance activities.]

Article 20U.K.Products presenting a serious risk

1.[F99Market surveillance authorities must] ensure that products which present a serious risk requiring rapid intervention, including a serious risk the effects of which are not immediate, are recalled, withdrawn or that their being made available on [F100the] market is prohibited, and that the [F101Secretary of State] is informed without delay thereof, in accordance with Article 22.

2.The decision whether or not a product represents a serious risk [F102must] be based on an appropriate risk assessment which takes account of the nature of the hazard and the likelihood of its occurrence. The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk [F103does] not constitute grounds for considering that a product presents a serious risk.

Article 21U.K.Restrictive measures

1.[F104Market surveillance authorities must] ensure that any measure taken, pursuant to [F105any relevant enactment], to prohibit or restrict the product's being made available on the market, to withdraw it from the market or to recall it, is proportionate and states the exact grounds on which it is based.

2.Such measures [F106must] be communicated without delay to the relevant economic operator, which [F106must] at the same time be informed of the [F107legal] remedies available F108... and of the time limits to which such remedies are subject.

3.Prior to the adoption of a measure referred to in paragraph 1, the economic operator concerned [F109must] be given the opportunity to be heard within an appropriate period of not less than 10 days, unless such consultation is not possible because of the urgency of the measure to be taken, as justified by health or safety requirements or other grounds relating to the public interests covered by [F110any of the relevant enactments]. If action has been taken without the operator's being heard, the operator [F109must] be given the opportunity to be heard as soon as possible and the action taken [F109must] be reviewed promptly thereafter.

4.Any measure referred to in paragraph 1 [F111must] be promptly withdrawn or amended upon the economic operator's demonstrating that he has taken effective action.

Textual Amendments

Article 22U.K.[F112Notification of serious risk]

[F1131.Where a market surveillance authority takes or intends to take a measure in accordance with Article 20 it must immediately notify the Secretary of State of that measure.]

2.If a product presenting a serious risk has been made available on the market, [F114the market surveillance authority] [F115must] notify the [F116the Secretary of State] of any voluntary measures taken and communicated by an economic operator.

3.The information provided in accordance with paragraphs 1 and 2 [F117must] include all available details, in particular the data necessary for the identification of the product, the origin and the supply chain of the product, the related risk, the nature and the duration of the F118... measure taken and any voluntary measures taken by economic operators.

4.For the purposes of paragraphs 1, 2 and 3, the market surveillance [F119authority must notify the Secretary of State through the database containing information relating to market surveillance and product safety established by regulation 33(A1) of the General Product Safety Regulations 2005].

Textual Amendments

F120Article 23U.K.General information support system

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F120Article 24U.K.Principles of cooperation between the Member States and the Commission

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F120Article 25U.K.Sharing of resources

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Article 26U.K.Cooperation with the competent authorities of third countries

1.Market surveillance authorities may cooperate with the competent authorities of third countries with a view to exchanging information and technical support F121... and promoting activities relating to conformity assessment, market surveillance and accreditation.

F122...

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SECTION 3U.K.Controls of [F124imported] products F125...

Article 27U.K.[F126Controls of imported products]

[F1271.The authorities in charge of the control of products entering Great Britain must carry out appropriate checks on the characteristics of products on an adequate scale, in accordance with the principles set out in Article 19(1), before those products are discharged from the free-circulation procedure.]

2.Where F128... more than one authority is responsible for market surveillance or external border controls, those authorities [F129must] cooperate with each other, by sharing information relevant to their functions and otherwise as appropriate.

3.The authorities in charge of external border controls [F130must] suspend [F131the discharge of a product from the free-circulation procedure] when any of the following findings are made in the course of the checks referred to in paragraph 1:

(a)the product displays characteristics which give cause to believe that the product, when properly installed, maintained and used, presents a serious risk to health, safety, the environment or any other public interest referred to in Article 1;

(b)the product is not accompanied by the written or electronic documentation required by [F132any relevant enactment] or is not marked in accordance with that legislation;

(c)[F133a conformity] marking has been affixed to the product in a false or misleading manner.

The authorities in charge of external border controls [F130must] immediately notify the market surveillance authorities of any such suspension.

4.In the case of perishable products, the authorities in charge of external border controls [F134must], as far as possible, seek to ensure that any requirements they may impose with regard to the storage of products or the parking of vehicles used for transport are not incompatible with the preservation of those products.

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Textual Amendments

Article 28U.K. [F136Discharge] of products

1.A product the [F137discharge] of which has been suspended by the authorities in charge of external border controls pursuant to Article 27 [F138must] be [F139discharged from the free-circulation procedure] if, within three working days of the suspension of [F137discharge], those authorities have not been notified of any action taken by the market surveillance authorities, and provided that all the other requirements and formalities pertaining to such [F137discharge] have been fulfilled.

2.Where the market surveillance authorities find that the product in question does not present a serious risk to health and safety or cannot be regarded as being in breach of [F140any relevant enactment], that product [F141must be discharged from the free-circulation procedure], provided that all the other requirements and formalities pertaining to such [F142discharge] have been fulfilled.

Article 29U.K.National measures

1.Where [F143a market surveillance authority finds] that a product presents a serious risk, [F144it] [F145must] take measures to prohibit that product from being placed on the market and [F145must] require the authorities in charge of external border controls to include the following endorsement on the commercial invoice accompanying the product and on any other relevant accompanying document or, where data processing is carried out electronically, in the data-processing system itself:

Dangerous product — [F146discharge from the free-circulation procedure] not authorised — Regulation (EC) No 765/2008.

2.Where [F147a market surveillance authority finds] that a product does not comply with [F148any relevant enactment], [F149it] [F150must] take appropriate action, which may, if necessary, include prohibiting the product's being placed on the market.

Where placing on the market is prohibited pursuant to the first subparagraph, the market surveillance [F151authority] [F150must] require the authorities in charge of external border controls not to [F152discharge the product from the free-circulation procedure] and to include the following endorsement on the commercial invoice accompanying the product and on any other relevant accompanying document or, where data processing is carried out electronically, in the data-processing system itself:

Product not in conformity — [F153discharge from the free-circulation procedure] not authorised — Regulation (EC) No 765/2008.

3.Where that product is subsequently declared for a customs procedure other than [F154the free-circulation procedure] and provided that the market surveillance authorities do not object, the endorsements set out in paragraphs 1 and 2 [F155must] also be included, under the same conditions, on the documents used in connection with that procedure.

4.[F156Market surveillance] authorities may destroy or otherwise render inoperable products presenting a serious risk where they deem it necessary and proportionate.

5.Market surveillance authorities [F157must] provide authorities in charge of external border controls with information on product categories in which a serious risk or non-compliance within the meaning of paragraphs 1 and 2 has been identified.

Textual Amendments

[F158CHAPTER 4U.K.UK MARKING

Article 30U.K.

1.The Secretary of State must publish the form of the UK marking as set out in Annex 2 on the Gov.uk website (https://www.gov.uk).

2.Annex 2 has effect.

3.Any reference to the UK marking in any enactment is a reference to the UK marking in the form set out in Annex 2 and published in accordance with paragraph 1.

4.A requirement in any enactment to affix the UK marking is a requirement to affix the UK marking in accordance with the requirements in Annex 2.

5.The UK marking must not be affixed to a product unless an enactment provides for its affixing.

6.An economic operator must not affix any other marking, sign or inscription which is likely to mislead any person as to the meaning or form of the UK marking.

7.An economic operator must not affix any other marking if the visibility, legibility and meaning of the UK marking would be impaired as a result.

8.Where the UK marking is affixed to a product in breach of paragraph 4, the UK marking is affixed in a false or misleading manner and Article 27(3)(c) applies.]

F159CHAPTER VU.K.COMMUNITY FINANCING

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CHAPTER VIU.K.FINAL PROVISIONS

F160Article 38U.K.Technical guidelines

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Article 39U.K.Transitional provision

Accreditation certificates issued before 1 January 2010 may remain valid until the date of their expiry, but no later than 31 December 2014. This Regulation shall, however, apply in the case of their extension or renewal.

F161Article 40U.K.Review and reporting

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F162Article 41U.K.Penalties

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F163Article 42U.K.Amendment to Directive 2001/95/EC

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Article 43U.K.Repeal

Regulation (EEC) No 339/93 is hereby repealed with effect from 1 January 2010.

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F165Article 44U.K.Entry into force

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