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Document 02008R0765-20210716
Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93 (Text with EEA relevance)Text with EEA relevance
Consolidated text: Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93 (Text with EEA relevance)Text with EEA relevance
Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93 (Text with EEA relevance)Text with EEA relevance
02008R0765 — EN — 16.07.2021 — 001.001
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►M1 REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93 ◄ (OJ L 218 13.8.2008, p. 30) |
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REGULATION (EU) 2019/1020 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 |
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25.6.2019 |
REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 9 July 2008
setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93
(Text with EEA relevance)
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter and scope
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Article 2
Definitions
For the purposes of this Regulation the following definitions shall apply:
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‘manufacturer’ shall mean 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;
‘authorised representative’ shall mean any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks with regard to the latter's obligations under the relevant Community legislation;
‘importer’ shall mean any natural or legal person established within the Community who places a product from a third country on the Community market;
‘distributor’ shall mean any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;
‘economic operators’ shall mean the manufacturer, the authorised representative, the importer and the distributor;
‘technical specification’ shall mean a document that prescribes technical requirements to be fulfilled by a product, process or service;
‘harmonised standard’ shall mean a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services ( 1 ) on the basis of a request made by the Commission in accordance with Article 6 of that Directive;
‘accreditation’ shall mean an attestation by a national accreditation body that a conformity assessment body meets the requirements set by harmonised standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a specific conformity assessment activity;
‘national accreditation body’ shall mean the sole body in a Member State that performs accreditation with authority derived from the State;
‘conformity assessment’ shall mean the process demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled;
‘conformity assessment body’ shall mean a body that performs conformity assessment activities including calibration, testing, certification and inspection;
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‘peer evaluation’ shall mean a process for the assessment of a national accreditation body by other national accreditation bodies, carried out in accordance with the requirements of this Regulation, and, where applicable, additional sectoral technical specifications;
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‘CE marking’ shall mean a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Community harmonisation legislation providing for its affixing;
‘Community harmonisation legislation’ shall mean any Community legislation harmonising the conditions for the marketing of products.
CHAPTER II
ACCREDITATION
Article 3
Scope
This Chapter shall apply 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.
Article 4
General principles
Article 5
Operation of accreditation
Article 6
Principle of non-competition
Article 7
Cross-border accreditation
Where a conformity assessment body requests accreditation it shall do so with the national accreditation body of the Member State in which it is established or with the national accreditation body to which that Member State has had recourse in accordance with Article 4(2).
However, a conformity assessment body may request accreditation by a national accreditation body other than those referred to in the first subparagraph in any one of the following situations:
where the Member State in which it is established has decided not to establish a national accreditation body and has not had recourse to the national accreditation body of another Member State in accordance with Article 4(2);
where the national accreditation bodies referred to in the first subparagraph do not perform accreditation in respect of the conformity assessment activities for which accreditation is sought;
where the national accreditation bodies referred to in the first subparagraph have not successfully undergone peer evaluation under Article 10 in respect of the conformity assessment activities for which accreditation is sought.
Article 8
Requirements for national accreditation bodies
A national accreditation body shall fulfil the following requirements:
it shall 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;
it shall be organised and operated so as to safeguard the objectivity and impartiality of its activities;
it shall ensure that each decision relating to the attestation of competence is taken by competent persons different from those who carried out the assessment;
it shall have adequate arrangements to safeguard the confidentiality of the information obtained;
it shall identify the conformity assessment activities for which it is competent to perform accreditation, referring, where appropriate, to relevant Community or national legislation and standards;
it shall set up the procedures necessary to ensure efficient management and appropriate internal controls;
it shall have a number of competent personnel at its disposal sufficient for the proper performance of its tasks;
it shall document the duties, responsibilities and authorities of personnel who could affect the quality of the assessment and of the attestation of competence;
it shall establish, implement and maintain procedures for monitoring the performance and competence of the personnel involved;
it shall 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;
it shall publish audited annual accounts prepared in accordance with generally accepted accounting principles.
Article 9
Compliance with requirements
Article 10
Peer evaluation
Article 11
Presumption of conformity for national accreditation bodies
Article 12
Information obligation
Article 13
Requests to the body recognised under Article 14
The Commission may also, following the procedure laid down in paragraph 1:
request the body recognised under Article 14 to lay down evaluation criteria and procedures for peer evaluation and to develop sectoral accreditation schemes;
accept any existing scheme that already lays down evaluation criteria and procedures for peer evaluation.
Article 14
European accreditation infrastructure
CHAPTER III
COMMUNITY MARKET SURVEILLANCE FRAMEWORK AND CONTROLS OF PRODUCTS ENTERING THE COMMUNITY MARKET
CHAPTER IV
CE MARKING
Article 30
General principles of the CE marking
CHAPTER V
COMMUNITY FINANCING
Article 31
Body pursuing an aim of general European interest
The body recognised under Article 14 shall be considered a body pursuing an aim of general European interest within the meaning of Article 162 of Commission Regulation (EC, Euratom) No 2342/2002 of 23 December 2002 laying down detailed rules for the implementation of Regulation (EC, Euratom) No 1605/2002 ( 2 ).
Article 32
Activities eligible for Community financing
The Community may finance the following activities in connection with the application of this Regulation:
the production and revision of sectoral accreditation schemes referred to in Article 13(3);
the activities of the secretariat of the body recognised under Article 14, such as the coordination of accreditation activities, the processing of technical work linked to the operation of the peer evaluation system, the provision of interested parties with information and the participation of the body in the activities of international organisations in the field of accreditation;
the drawing up and updating of contributions to guidelines in the fields of accreditation, notification to the Commission of conformity assessment bodies and conformity assessment;
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the performance of preliminary or ancillary work in connection with the implementation of the conformity assessment, metrology and accreditation activities linked to the implementation of Community legislation, such as studies, programmes, evaluations, guidelines, comparative analyses, mutual joint visits, research work, the development and maintenance of databases, training activities, laboratory work, proficiency testing, inter-laboratory tests and conformity assessment work;
activities carried out under programmes of technical assistance, cooperation with third countries and the promotion and enhancement of European conformity assessment and accreditation policies and systems among interested parties in the Community and at international level.
Article 33
Bodies eligible for Community financing
Community financing may be granted to the body recognised under Article 14 for the implementation of the activities set out in Article 32.
However, Community financing may also be granted to other bodies for the carrying out of the activities set out in Article 32, except those set out in paragraph 1(a) and (b) of that Article.
Article 34
Financing
The appropriations allocated to the activities referred to in this Regulation shall be determined each year by the budgetary authority within the limits of the financial framework in force.
Article 35
Financing arrangements
Community financing shall be provided:
without a call for proposals, to the body recognised under Article 14 to carry out those activities referred to in Article 32(1)(a) to (g) for which grants can be awarded in accordance with the Financial Regulation;
in the form of grants after a call for proposals, or by public procurement procedures, to other bodies to carry out the activities referred to in Article 32(1)(c) to (g).
Article 36
Management and monitoring
Article 37
Protection of the Community's financial interests
CHAPTER VI
FINAL PROVISIONS
Article 38
Technical guidelines
In order to facilitate the implementation of this Regulation, the Commission shall draw up non-binding guidelines in consultation with stakeholders.
Article 39
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.
Article 40
Review and reporting
By 2 September 2013, the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation, of Directive 2001/95/EC and of any other relevant Community instrument addressing market surveillance. That report shall, in particular, analyse the consistency of Community rules in the field of market surveillance. If appropriate, it shall be accompanied by proposals to amend and/or consolidate the instruments concerned, in the interests of better regulation and simplification. It shall include an evaluation of the extension of the scope of Chapter III of this Regulation to all products.
By 1 January 2013, and every five years thereafter, the Commission, in cooperation with the Member States, shall produce and submit to the European Parliament and to the Council a report on the implementation of this Regulation.
Article 41
Penalties
The Member States shall lay down rules on penalties for economic operators, which may include criminal sanctions for serious infringements, applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive and may be increased if the relevant economic operator has previously committed a similar infringement of the provisions of this Regulation. The Member States shall notify the Commission of those provisions by 1 January 2010 and shall notify it without delay of any subsequent amendment affecting them.
Article 42
Amendment to Directive 2001/95/EC
Article 8(3) of Directive 2001/95/EC shall be replaced by the following:
Article 43
Repeal
Regulation (EEC) No 339/93 is hereby repealed with effect from 1 January 2010.
References to the repealed Regulation shall be construed as references to this Regulation.
Article 44
Entry into force
This Regulation shall enter into force on the 20th day after its publication in the Official Journal of the European Union.
It shall apply from 1 January 2010.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
Requirements applicable to the body to be recognised under Article 14
1. The body recognised under Article 14 of the Regulation (the body), shall be established within the Community.
2. Under the body's constitution, national accreditation bodies from within the Community shall be entitled to be members of it, provided that they comply with the rules and objectives of the body and with the other conditions set out herein and as agreed with the Commission in the framework agreement.
3. The body shall consult all relevant stakeholders.
4. The body shall provide its members with peer evaluation services satisfying the requirements of Articles 10 and 11.
5. The body shall cooperate with the Commission in accordance with this Regulation.
ANNEX II
CE marking
1. The CE marking shall consist of the initials ‘CE’ taking the following form:
2. If the CE marking is reduced or enlarged, the proportions given in the graduated drawing in paragraph 1 shall be respected.
3. Where specific legislation does not impose specific dimensions, the CE marking shall be at least 5 mm high.
( ) OJ L 204, 21.7.1998, p. 37. Directive as last amended by Council Directive 2006/96/EC (OJ L 363, 20.12.2006, p. 81).
( ) OJ L 357, 31.12.2002, p. 1. Regulation as last amended by Regulation (EC, Euratom) No 478/2007 (OJ L 111, 28.4.2007, p. 13).
( ) OJ L 312, 23.12.1995, p. 1.