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Regulation (EU) No 305/2011 of the European Parliament and of the CouncilShow full title

Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC (Text with EEA relevance)

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CHAPTER VIIU.K.[F1APPROVED BODIES]

F2Article 39U.K.Notification

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[F3Article 39AU.K. Approved bodies

1.An “approved body” is a body which:

(a)is approved by the Secretary of State under Article 48 as a body authorised to carry out third party tasks in the process of assessment and verification of constancy of performance under this Regulation; or

(b)immediately before IP completion day was a notified body in respect of which the Secretary of State had taken no action under Article 50(1) (as it had effect immediately before IP completion day) to suspend or withdraw the body's status as a notified body.

2.Paragraph 1 has effect subject to Article 50(1) (restriction, suspension or withdrawal of approval).

3.Where an approved body was a notified body before IP completion day:

(a)it is to be treated on or after IP completion day as approved in respect of the same activities in relation to a harmonised standard in respect of which it was notified immediately before IP completion day where that standard becomes designated under Article 18B(2);

(b)any horizontal notification which was in force immediately before IP completion day in relation to a case set out in point 3 of Annex 5 to the EU Construction Products Regulation is to be treated on or after IP completion day as a horizontal approval under this Regulation.]

Article 40U.K.[F4Assessment, approval and monitoring of approved bodies]

1.[F5The Secretary of State] shall be responsible for setting up and carrying out the necessary procedures for the assessment and [F6approval] of the bodies to be authorised to carry out third-party tasks in the process of assessment and verification of constancy of performance for the purposes of this Regulation, and for the monitoring of [F7approved] bodies, including their compliance with Article 43.

2.[F8The Secretary of State] may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by [F9the UK national accreditation body].

[F103.Where the Secretary of State delegates or otherwise entrusts the assessment, approval or monitoring referred to in paragraph 1 to a body which is not a governmental entity, that body must be a legal entity and must comply with the following requirements:

(a)it must be established in such a way that no conflicts of interest with approved bodies occur;

(b)it must be organised and operated so as to safeguard the objectivity and impartiality of its activities;

(c)it must be organised in such a way that each decision relating to approval of a body to be authorised to carry out third party tasks in the process of assessment and verification of constancy of performance is taken by competent persons different from those who carried out the assessment;

(d)it must not offer or provide activities performed by approved bodies, or consultancy services on a commercial or competitive basis;

(e)it must safeguard the confidentiality of the information obtained;

(f)it must have a sufficient number of competent personnel at its disposal for the proper performance of its tasks;

(g)it must have arrangements to cover liabilities arising from its activities.]

4.The [F11Secretary of State] shall take full responsibility for the tasks performed by the body referred to in paragraph 3.

Textual Amendments

F12Article 41U.K.Requirements relating to notifying authorities

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Article 42U.K.Information obligation for Member States

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Article 43U.K.Requirements for [F14approved] bodies

1.[F15An approved] body shall meet the requirements set out in paragraphs 2 to 11.

[F162.An approved body must have legal personality and must be established in—

(a)the United Kingdom; or

(b)the territory of a party to the CPTPP.]

3.[F17An approved] body shall be a third-party body independent from the organisation or the construction product it assesses.

A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of construction products which it assesses, can on condition that its independence and the absence of any conflict of interest are demonstrated, be considered to be such a body.

4.[F17An approved] body, its top-level management and the personnel responsible for carrying out the third party tasks in the process of assessment and verification of constancy of performance shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the construction products which it assesses, nor the authorised representative of any of those parties. This shall not preclude the use of assessed products that are necessary for the operations of the [F18approved] body or the use of products for personal purposes.

[F17An approved] body, its top-level management and the personnel responsible for carrying out the third party tasks in the process of assessment and verification of constancy of performance shall not become directly involved in the design, manufacture or construction, marketing, installation, use or maintenance of those construction products, nor represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement and integrity related to the activities for which they have been [F18approved]. This shall, in particular, apply to consultancy services.

[F17An approved] body shall ensure that activities of its subsidiaries or subcontractors do not affect the confidentiality, objectivity and impartiality of its assessment and/or verification activities.

5.[F17An approved] body and its personnel shall carry out the third party tasks in the process of assessment and verification of constancy of performance with the highest degree of professional integrity and requisite technical competence in the specific field and must be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their assessment and/or verification activities, especially from persons or groups of persons with an interest in the results of those activities.

6.[F17An approved] body shall be capable of carrying out all the third party tasks in the process of assessment and verification of constancy of performance assigned to it in accordance with Annex V in relation to which it has been [F18approved], whether those tasks are carried out by the [F18approved] body itself or on its behalf and under its responsibility.

At all times and for each system of assessment and verification of constancy of performance and for each kind or category of construction products, essential characteristics and tasks in relation to which it has been [F18approved], the [F18approved] body shall have the following at its disposal:

(a)the necessary personnel with technical knowledge and sufficient and appropriate experience to perform the third party tasks in the process of assessment and verification of constancy of performance;

(b)the necessary description of procedures according to which the assessment of performance is carried out, ensuring the transparency and the ability of reproduction of these procedures; it shall have appropriate policies and procedures in place that distinguish between the tasks it carries out as [F17an approved] body and other activities;

(c)the necessary procedures to perform its activities which take due account 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.

[F17An approved] body shall have the means necessary to perform the technical and administrative tasks connected with the activities for which it is [F18approved] in an appropriate manner and shall have access to all necessary equipment or facilities.

7.The personnel responsible for carrying out the activities in relation to which the body has been [F19approved], shall have the following:

(a)sound technical and vocational training covering all the third party tasks in the process of assessment and verification of constancy of performance within the relevant scope for which the body has been [F19approved];

(b)satisfactory knowledge of the requirements of the assessments and verifications they carry out and adequate authority to carry out such operations;

(c)appropriate knowledge and understanding of the applicable [F20designated] standards and of the relevant provisions of the Regulation;

(d)the ability required to draw up the certificates, records and reports to demonstrate that the assessments and the verifications have been carried out.

8.The impartiality of the [F21approved] body, its top-level management and assessment personnel shall be guaranteed.

The remuneration of the [F21approved] body’s top-level management and assessment personnel shall not depend on the number of assessments carried out or on the results of such assessments.

[F229.An approved body must have adequate liability insurance in respect of its activities.]

10.The personnel of the [F23approved] body shall be bound to observe professional secrecy with regard to all information gained in carrying out its tasks under Annex V, except in relation to [F24a competent authority, the UK national accreditation body or any other body to which the Secretary of State delegates or otherwise entrusts the monitoring of the approved body.] Proprietary rights shall be protected.

11.[F25An approved] body shall participate in, or ensure that its assessment personnel is informed of, the relevant standardisation activities and the activities of the [F26approved] body coordination group established under this Regulation and shall apply as general guidance the administrative decisions and documents produced as a work result of that group.

Textual Amendments

Article 44U.K.Presumption of conformity

[F27An approved] body to be authorised to carry out third party tasks in the process of assessment and verification of constancy of performance which demonstrates its conformity with the criteria laid down in the relevant [F28designated] standards or parts thereof F29... shall be presumed to comply with the requirements set out in Article 43 in so far as the applicable [F28designated] standards cover those requirements.

Article 45U.K.Subsidiaries and subcontractors of [F30approved] bodies

1.Where [F31an approved] body subcontracts specific tasks connected with the third party tasks in the process of assessment and verification of constancy of performance or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 43, and shall inform the [F32Secretary of State] accordingly.

2.The [F33approved] body shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established.

3.Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.

4.The [F34approved] body shall keep at the disposal of the [F35Secretary of State] the relevant documents concerning the assessment of the qualifications of any subcontractor or the subsidiary and the tasks carried out by such parties under Annex V.

Textual Amendments

Article 46U.K.Use of facilities outside the testing laboratory of the [F36approved] body

1.On request of the manufacturer and where justified by technical, economic or logistic reasons, [F37approved] bodies may decide to carry out the tests referred to in Annex V, for the systems of assessment and verification of constancy of performance 1+, 1 and 3 or have such tests carried out under their supervision, either in the manufacturing plants using the test equipments of the internal laboratory of the manufacturer or, with the prior consent of the manufacturer, in an external laboratory, using the test equipments of that laboratory.

[F37Approved] bodies carrying out such tests shall be specifically designated as competent to work away from their own accredited test facilities.

2.Before carrying out those tests, the [F37approved] body shall verify whether the requirements of the test method are satisfied and shall evaluate whether:

(a)test equipment has an appropriate calibration system and the traceability of the measurements is guaranteed;

(b)the quality of the test results is ensured.

Article 47U.K.Application for [F38approval]

1.A body to be authorised to carry out third party tasks in the process of assessment and verification of constancy of performance shall submit an application for [F39approval] to the [F40Secretary of State.]

2.The application shall be accompanied by a description of the activities to be performed, the assessment and/or verification procedures for which the body claims to be competent, an accreditation certificate, where one exists, issued by the [F41UK] national accreditation body F42... , attesting that the body meets the requirements laid down in Article 43.

3.Where the body concerned cannot provide an accreditation certificate, it shall provide the [F43Secretary of State] with all documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 43.

Textual Amendments

Article 48U.K. [F44Approval] procedure

1.[F45The Secretary of State] may [F46approve] only bodies which have satisfied the requirements laid down in Article 43.

F472.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.The [F48approval] shall include full details of the functions to be performed, reference to the relevant harmonised technical specification and, for the purposes of the system set out in Annex V, the essential characteristics for which the body is competent.

However, reference to the relevant harmonised technical specification is not required in the cases set out in point 3 of Annex V.

F494.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F495.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F496.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 49U.K.Identification numbers and lists of [F50approved] bodies

1.The [F51Secretary of State] shall assign an identification number to each [F52approved] body.

It shall assign a single such number even where the body is [F52approved] under several [F53relevant enactments].

2.The [F54Secretary of State] shall make publicly available the list of [F55approved bodies], including the identification numbers that have been allocated to them and the activities for which they have been [F56approved.]

The [F57Secretary of State] shall ensure that this list is kept up-to-date.

[F583.The Secretary of State may authorise the UK national accreditation body to compile and maintain the list referred to in paragraph 2.]

Textual Amendments

[F59Article 50U.K. Changes to the approval

1.Where the Secretary of State considers that an approved body no longer meets the requirements in Article 43, or that it is failing to fulfil its obligations, the Secretary of State must restrict, suspend or withdraw the approval as appropriate, depending on the seriousness of the failure to meet those requirements or to fulfil those obligations.

2.In the event of withdrawal, restriction or suspension of approval or where the approved body has ceased its activity, the Secretary of State must take the appropriate steps to ensure that the files of that body are either processed by another approved body or kept available for the Secretary of State and other market surveillance authorities at their request.]

F60Article 51U.K.Challenge of the competence of notified bodies

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Article 52U.K.Operational obligations for [F61approved] bodies

1.[F62Approved] bodies shall carry out third party tasks in accordance with the systems of assessment and verification of constancy of performance provided for in Annex V.

2.Assessments and verifications of constancy of performance shall be carried out with transparency as regards the manufacturer, and in a proportionate manner, avoiding an unnecessary burden for economic operators. The [F63approved] bodies shall perform their activities taking due account of the size of the undertaking, the sector in which the undertaking operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.

In so doing, the [F63approved] bodies shall nevertheless respect the degree of rigour required for the product by this Regulation and the part played by the product for the fulfilment of all basic requirements for construction works.

3.Where, in the course of the initial inspection of the manufacturing plant and of factory production control, [F64an approved] body finds that the manufacturer has not ensured the constancy of performance of the manufactured product, it shall require the manufacturer to take appropriate corrective measures and shall not issue a certificate.

4.Where, in the course of the monitoring activity aiming at the verification of the constancy of performance of the manufactured product, [F65an approved] body finds that a construction product no longer has the same performance to that of the product-type, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw its certificate if necessary.

5.Where corrective measures are not taken or do not have the required effect, the [F66approved] body shall restrict, suspend or withdraw any certificates, as appropriate.

Textual Amendments

Article 53U.K.Information obligations for [F67approved] bodies

1.[F68Approved] bodies shall inform the [F69Secretary of State] of the following:

(a)any refusal, restriction, suspension or withdrawal of certificates;

(b)any circumstances affecting the scope of, and conditions for, [F70approval];

(c)any request for information on assessment and/or verification of constancy of performance activities carried out which they have received from market surveillance authorities;

(d)on request, third party tasks in accordance with the systems of assessment and verification of constancy of performance carried out within the scope of their [F71approval] and any other activity performed, including cross-border activities and subcontracting.

2.[F72Approved] bodies shall provide the other bodies [F72approved] under this Regulation carrying out similar third party tasks in accordance with the systems of assessment and verification of constancy of performance and for construction products covered by the same harmonised technical specification with relevant information on issues relating to negative and, on request, positive results from these assessments and/or verifications.

Textual Amendments

F73Article 54U.K.Exchange of experience

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F74Article 55U.K. Coordination of approved bodies

1.The Secretary of State must establish a group of approved bodies to ensure appropriate coordination and cooperation between approved bodies.

2.Approved bodies must participate in the work of that group, directly or by means of designated representatives, or ensure that their representatives are informed of the work of the group.]

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