PART 3U.K.[F1Designation of Notified Bodies][F1Approval of Conformity Assessment Bodies]

[F1Designation of UK notified bodiesN.I.

40.—(1) The Secretary of State may designate a person to carry out conformity assessment (a “notified body designation”).

(2) A person in respect of whom a notified body designation has been made is a UK notified body to the extent that the designation remains in effect provided that—

(a)the designation has been notified by the Secretary of State to the European Commission and the other [F2relevant states],

(b)no objections [F3, other than an immaterial objection,] have [F4been] raised by the Commission or the other [F2relevant states] within the time periods in Article 31 of the [F5Directive;]

[F6(c)in sub-paragraph (b), an “immaterial objection” is an objection on the grounds that—

(i)the person designated is established in the United Kingdom; or

(ii)an accreditation certificate attesting that the person meets the requirements laid down in paragraphs 2 to 11 of Article 26 of the Directive was issued by the United Kingdom Accreditation Service, in respect of that person.]

(3) A person wishing to be a UK notified body must apply to the Secretary of State for designation.

(4) A notified body designation must not be made unless the Secretary of State is satisfied that the person meets the requirements laid down in paragraphs 2 to 11 of Article 26 of the Directive (the “notified body criteria”).

(5) A person who meets the relevant assessment criteria laid down in a harmonised standard shall be presumed to meet that part of the notified body criteria which corresponds to the criteria in that standard.

(6) The presumption of compliance in paragraph (5) is rebuttable.

(7) A notified body designation—

(a)must be in writing;

(b)must specify the conformity assessment procedures that the person designated may carry out;

(c)may designate a person for a specified period; and

(d)may be made subject to such other conditions as are specified in the designation, including conditions which are to apply upon or following termination of the designation.

(8) In making a notified body designation the Secretary of State may have regard (in addition to the notified body criteria) to any other matter which appears to the Secretary of State to be relevant.

(9) A UK notified body must comply with any request of the Secretary of State to provide information relevant to determining its compliance with the notified body criteria, these Regulations, or any condition to which its designation is subject. ]

[F1Approved bodiesE+W+S

40A.—(1) An approved body is a conformity assessment body which—

(a)has been approved by the Secretary of State pursuant to the procedure set out in regulation 40B (approval of conformity assessment bodies); or

(b)immediately before IP completion day was a UK notified body in respect of which the Secretary of State has taken no action under regulation 41(4) as it had effect immediately before IP completion day to suspend or withdraw the body's status as a UK notified body.

(2) Paragraph (1) has effect subject to regulation 40E (restriction, suspension or withdrawal of approval).

(3) In this Part—

“UK notified body” means a body—

“approved body requirements” means the requirements set out in Schedule 7.]

[F1Approval of conformity assessment bodiesE+W+S

40B.—(1) The Secretary of State may approve only those conformity assessment bodies that qualify for approval.

(2) A conformity assessment body qualifies for approval if the first and second conditions below are met.

(3) The first condition is that the conformity assessment body has applied to the Secretary of State to become an approved body and that application is accompanied by—

(a)a description of—

(i)the conformity assessment activities that the conformity assessment body intends to carry out;

(ii)the conformity assessment module in respect of which the conformity assessment body claims to be competent;

(iii)the category of toys in respect of which the conformity assessment body claims to be competent; and

(b)either—

(i)an accreditation certificate; or

(ii)the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the conformity assessment body's compliance with the approved body requirements.

(4) The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the approved body requirements.

(5) For the purposes of paragraph (4), the Secretary of State may accept an accreditation certificate, provided in accordance with paragraph (3)(b), as sufficient evidence that the conformity assessment body meets the approved body requirements.

(6) When deciding whether to approve a conformity assessment body that qualifies for approval, the Secretary of State may—

(a)have regard to any other matter which appears to the Secretary of State to be relevant; and

(b)set conditions that the conformity assessment body must meet.

(7) For the purposes of this regulation “accreditation certificate” means a certificate issued by the UK national accreditation body attesting that a conformity assessment body meets the approved body requirements.]

[F1Presumption of conformity of approved bodiesE+W+S

40C.—(1) Where a conformity assessment body demonstrates its conformity with the criteria laid down in a designated standard (or part of such standard), the Secretary of State is to presume that the conformity assessment body meets the approved body requirements covered by that standard (or that part of that standard).

(2) The presumption in paragraph (1) is rebuttable.]

[F1MonitoringE+W+S

40D.  The Secretary of State must monitor each approved body with a view to verifying that the body—

(a)continues to meet the approved body requirements;

(b)meets any conditions set—

(i)in accordance with regulation 40B(6)(b); or

(ii)by the Secretary of State before IP completion day in that body's capacity as a UK notified body; and

(c)carries out its functions in accordance with these Regulations.]

[F1Restriction, suspension or withdrawal of approvalE+W+S

40E.—(1) Where the Secretary of State determines that an approved body—

(a)no longer meets an approved body requirement; or

(b)is failing to fulfil its obligations under these Regulations, other than a condition referred to in regulation 40D(b), the Secretary of State must restrict, suspend or withdraw the body's status as an approved body under regulation 40A (approved bodies).

(2) Where the Secretary of State determines that an approved body no longer meets a condition referred to in regulation 40D(b), the Secretary of State may restrict, suspend or withdraw the body's status as an approved body under regulation 40A.

(3) In deciding what action is required under paragraph (1) or (2), the Secretary of State must have regard to the seriousness of the non-compliance.

(4) Before taking action under paragraph (1) or (2), the Secretary of State must—

(a)give notice in writing to the approved body of the proposed action and the reasons for it;

(b)give the approved body an opportunity to make representations to the Secretary of State regarding the proposed action within a reasonable period from the date of the notice; and

(c)consider any such representations made by the approved body.

(5) Where the Secretary of State has taken action in respect of an approved body under paragraph (1) or (2), or where an approved body has ceased its activity, the approved body must, at the request of the Secretary of State—

(a)transfer its files relating to the activities it has undertaken as an approved body to another approved body or to the Secretary of State; or

(b)keep its files relating to the activities it has undertaken as an approved body available for the Secretary of State and other enforcement authorities for a period of 10 years from the date they were created.

(6) The activities undertaken as an approved body referred to in paragraph (5) include any activities that the body has undertaken as a UK notified body.]

[F1Operational matters in relation to approved bodiesE+W+S

40F.—(1) Subject to the terms of its appointment and to regulation 44, an approved body must carry out the conformity assessment activities and modules—

(a)in respect of which the body's approval was given under regulation 40B; or

(b)in respect of which body's notification as a notified body was made.

(2) Where an approved body carries out a conformity assessment procedure, it must do so in accordance with Schedule 6.]

[F1Subsidiaries and contractorsE+W+S

40G.—(1) An approved body may subcontract specific conformity assessment activities, or use a subsidiary to carry out such activities provided—

(a)the body is satisfied that the subcontractor or subsidiary meets the approved body requirements;

(b)the body has informed the Secretary of State that it is satisfied that the subcontractor or subsidiary meets those requirements; and

(c)the economic operator for whom the activities are to be carried out has consented to the activities being carried out by that person.

(2) The approved body which subcontracts specific conformity assessment activities or uses a subsidiary to carry out such activities remains responsible for the proper performance of those activities (irrespective of where the subcontractor or subsidiary is established).

(3) Where an approved body subcontracts, or uses a subsidiary to carry out, a specific conformity assessment activity, the approved body must, for a period of 10 years beginning on the day on which the activity is first carried out, keep available for inspection by the Secretary of State all relevant documentation concerning—

(a)the assessment of the qualifications of the subcontractor or the subsidiary; and

(b)the conformity assessment activity carried out by the subcontractor or subsidiary.

(4) In this regulation “subsidiary” has the meaning given to it in section 1159 of the Companies Act 2006.]

[F1Register of approved bodiesE+W+S

40H.—(1) The Secretary of State must—

(a)assign an approved body identification number to each approved body; and

(b)compile and maintain a register of—

(i)approved bodies;

(ii)their approved body identification numbers;

(iii)the activities for which they have been approved; and

(iv)any restrictions on those activities.

(2) The register referred to in paragraph (1) must be made publicly available.]

[F1UK national accreditation bodyE+W

41.  The Secretary of State may authorise the UK national accreditation body to carry out the following activities on behalf of the Secretary of State—

(a)assessing whether a conformity assessment body meets the approved body requirements;

(b)monitoring approved bodies in accordance with regulation 40D; and

(c)compiling and maintaining the register of approved bodies, in accordance with regulation 40H.]

UK national accreditation bodyN.I.

41.—(1) A notified body designation other than one which designates a person as a UK notified body for a specified period has effect unless it is suspended, restricted or withdrawn under paragraph (4).

(2) A notified body designation which designates a person as a UK notified body for a specified period expires in accordance with its terms unless the period so specified is extended or shortened under paragraph (3) before the date on which it had been due to expire.

(3)  The Secretary of State may vary any aspect of a notified body designation if—

(a)the UK notified body so requests;

(b)it appears to the Secretary of State necessary or expedient to do so; or

(c)upon a request of the European Commission.

(4) The Secretary of State may suspend, restrict or withdraw a notified body designation—

(a)on the expiry of 90 days' notice in writing at the request of the UK notified body;

(b)if it appears to the Secretary of State that any condition of the designation is not complied with;

(c)if the Secretary of State considers that the UK notified body no longer satisfies the notified body criteria; or

(d)upon a request of the European Commission.

(5) Where the Secretary of State is minded to vary a designation in accordance with paragraph (3)(b), or to suspend, restrict or withdraw a notified body designation under paragraph (4)(b) or (c), the Secretary of State must—

(a)give notice in writing to the UK notified body of the proposed variation or suspension, restriction or withdrawal and the reasons for it, stating that the body has 21 days from the date of the notice in which to make representations to the Secretary of State in respect of the proposed variation, suspension, restriction or withdrawal; and

(b)consider any representations received in accordance with the notice.

(6) If a designation is suspended, restricted or withdrawn under paragraph (4), the Secretary of State may, by notice in writing—

(a)authorise another UK notified body to take over the functions of the UK notified body whose designation has been suspended, restricted or withdrawn in respect of such cases as are specified in the notice; and

(b)give such directions as the Secretary of State considers appropriate (either to the UK notified body whose designation has been suspended, restricted or withdrawn or to another UK notified body) in respect of the UK notified body's files or any other matter which the Secretary of State considers expedient for the purposes of ensuring that another notified body carries out the functions of a notified body for the existing customers of the body whose designation has been suspended, restricted or withdrawn.