Textual Amendments
F1Pt. 4 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 28 para. 36 (with Sch. 28 para. 41) (as amended by S.I. 2020/676, regs. 1(1), 2; S.I. 2020/852, regs. 2(2), 4(2), Sch. 1 para. 1(q)(v)(vi)); 2020 c. 1, Sch. 5 para. 1(1)
55.—(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 56 (approval of conformity assessment bodies); or
(b)immediately before IP completion day was a notified body in respect of which the Secretary of State had taken no action under regulation 61(1) or (2) as they 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 regulation 59 (restriction, suspension or withdrawal of approval).
(3) In this Part—
“notified body” means a body—
which the Secretary of State had before IP completion day notified to the European Commission and the member States of the European Union in accordance with Article 26 of the Directive; and
in respect of which no objections had been raised, as referred to in regulation 55(b), as it had effect immediately before IP completion day;
“approved body requirements” means the requirements set out in Schedule 11.]
Extent Information
E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
55. For the purposes of this Part, a notified body is a conformity assessment body—
(a)which has been notified by the Secretary of State, to the European Commission and to the other [F2relevant states]—
(i)under regulation 56 (notification); or
(ii)before the date these Regulations come into force, in accordance with Article 26 of the Directive; and
(b)in respect of which no objections [F3, other than an immaterial objection,] were raised by the European Commission or other [F4relevant states]—
(i)within 2 weeks of the date of notification, where notification is accompanied by an accreditation certificate; or
(ii)within 2 months of the date of notification, where the notification is not accompanied by an accreditation [F5certificate;]
[F6(c)in sub-paragraph (b), an “immaterial objection” is an objection on the grounds that—
(i)the conformity assessment body is established in the United Kingdom; or
(ii)the accreditation certificate was issued by the United Kingdom Accreditation Service.]
Extent Information
E11This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Textual Amendments
F2Words in reg. 55(a) substituted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 15 para. 4(1)(a)
F3Words in reg. 55(b) inserted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 15 para. 4(1)(b)(i)
F4Words in reg. 55(b) substituted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 15 para. 4(1)(b)(ii)
F5Word in reg. 55(b) substituted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 15 para. 4(1)(b)(iii)
F6Reg. 55(c) inserted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 15 para. 4(1)(c)
Commencement Information
I1Reg. 55 in force at 3.8.2017, see reg. 1
56.—(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 the application is accompanied by—
(a)a description of—
(i)the conformity assessment activities that the conformity assessment body intends to carry out;
(ii)the relevant conformity assessment procedure in respect of which the conformity assessment body claims to be competent;
(iii)the product 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.
(8) 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.]
Extent Information
E2This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
56.—(1) The Secretary of State may notify to the European Commission and the other [F7relevant states] only those conformity assessment bodies that qualify for notification.
(2) A conformity assessment body qualifies for notification 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 a notified body and the 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 or modules in respect of which the conformity body claims to be competent; and
(iii)the product for which the conformity assessment body claims to be competent; and either—
(b)an accreditation certificate; or
(c)the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the conformity assessment body’s compliance with the notified body requirements.
(4) The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the notified 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 notified body requirements.
(6) When deciding whether to notify a conformity assessment body that qualifies for notification to the European Commission and the other [F7relevant states], 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) The Secretary of State must inform the European Commission of the United Kingdom’s procedures for the assessment and notification of conformity assessment bodies, and any changes to those procedures.
Extent Information
E12This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Textual Amendments
F7Words in reg. 56 substituted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 15 para. 4(2)
Commencement Information
I2Reg. 56 in force at 3.8.2017, see reg. 1
57.—(1) Where a conformity assessment body demonstrates its conformity with the criteria set out 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 the standard).
(2) The presumption in paragraph (1) is rebuttable.]
Extent Information
E3This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
57. A notification under regulation 56 (notification) must include—
(a)the details of—
(i)the conformity assessment activities in respect of which the conformity assessment body has made its application for notification;
(ii)the conformity assessment module or modules in respect of which the conformity assessment body has made its application for notification;
(iii)the product in respect of which the conformity assessment body has made its application for notification; and either
(b)an accreditation certificate; or
(c)documentary evidence which attests to—
(i)the conformity assessment body’s competence; and
(ii)the arrangements in place to ensure that the conformity assessment body will be monitored regularly and will continue to satisfy the notified body requirements.
Extent Information
E13This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Commencement Information
I3Reg. 57 in force at 3.8.2017, see reg. 1
58. 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 condition set—
(i)in accordance with regulation 56(6)(b); or
(ii)in the case of an approved body that was a notified body immediately before IP completion day, in accordance with regulation 56(6)(b) as it applied immediately before IP completion day; and
(c)carries out its functions in accordance with these Regulations.]
Extent Information
E4This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
58.—(1) Where a conformity assessment body demonstrates its conformity with the criteria laid down in a harmonised standard (or part of such a standard), the reference of which has been published in the Official Journal of the European Union, the Secretary of State is to presume that the conformity assessment body meets the notified body requirements covered by that standard (or part of that standard).
(2) The presumption in paragraph (1) is rebuttable.
Extent Information
E14This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Commencement Information
I4Reg. 58 in force at 3.8.2017, see reg. 1
59.—(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 58(b),
the Secretary of State must restrict, suspend or withdraw the body's status as an approved body under regulation 55 (approved bodies).
(2) With the consent of the approved body or where the Secretary of State determines that an approved body no longer meets a condition referred to in regulation 58(b), the Secretary of State may restrict, suspend or withdraw the body's status as an approved body under regulation 55.
(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) 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 activities, the approved body must—
(a)at the request of the Secretary of State, 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)in the absence of a request under sub-paragraph (a), keep its files relating to the activities it has undertaken as an approved body available for inspection by the Secretary of State and the market surveillance authorities for a period of 10 years from the date they were created.
(5) The activities undertaken as an approved body referred to in paragraph (4) include any activities that the body has undertaken as a notified body.]
Extent Information
E5This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
59.—(1) The Secretary of State must monitor each notified body with a view to verifying that the notified body—
(a)continues to meet the notified body requirements;
(b)complies with any condition set in accordance with regulation 56(6)(b); and
(c)carries out its functions in accordance with these Regulations.
(2) The Secretary of State must inform the European Commission of the United Kingdom’s procedures for the monitoring of notified bodies, and any changes to those procedures.
Extent Information
E15This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Commencement Information
I5Reg. 59 in force at 3.8.2017, see reg. 1
60.—(1) Where the Secretary of State proposes to restrict, suspend or withdraw a body's status as an approved body in accordance with regulation 59 (restriction, suspension or withdrawal of approval), the Secretary of State must give notice in writing to the approved body that its approval will be restricted, suspended or withdrawn.
(2) A notice provided in accordance with paragraph (1) must—
(a)state the date on which the notice is issued;
(b)state the reasons why the approval is being restricted, suspended or withdrawn;
(c)state the date on which the restriction, suspension or withdrawal of the approval is to take effect;
(d)where an approval is being restricted or suspended, state what the effect of that restriction or suspension is on the approved body;
(e)inform the approved body of its right to make written representations to the Secretary of State against the proposal within 14 days of the date of the notice.
(3) Where an approved body submits written representations to the Secretary of State within 14 days of the notice in accordance with paragraph (2)(e), the Secretary of State must respond to the representations within 21 days of the date on which the representations are received, stating whether, having considered the representations, the notice issued under paragraph (1) will be modified or withdrawn.]
Extent Information
E6This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
60. The Secretary of State may authorise the United Kingdom Accreditation Service (a company limited by guarantee incorporated in England and Wales under number 03076190) to carry out the following activities on behalf of the Secretary of State—
(a)assessing applications for designation as a notified body made under regulation 56 (application for designation as a notified body); and
(b)monitoring notified bodies required by regulation 59 (monitoring of notified bodies).
Extent Information
E16This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Commencement Information
I6Reg. 60 in force at 3.8.2017, see reg. 1
61. When an approved body carries out a relevant conformity assessment procedure, Schedule 12 (operational requirements of approved bodies) has effect.]
Extent Information
E7This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
61.—(1) Where the Secretary of State determines that a notified body no longer meets a notified body requirements or that it is failing to fulfil its obligations under these Regulations other than a condition set in accordance with regulation 56(6)(b), the Secretary of State must restrict, suspend or withdraw the body’s status as a notified body under regulation 55.
(2) With the consent of the notified body, or where the Secretary of State determines that a notified body no longer meets a condition set in accordance with regulation 56(6)(b), the Secretary of State may restrict, suspend or withdraw the body’s status as a notified body under regulation 55.
(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) Where the Secretary of State takes action under paragraph (1) or (2), the Secretary of State must immediately inform the European Commission and the other [F8relevant states].
(5) Where the Secretary of State has taken action under paragraph (1) or (2), or where the notified body has ceased its activity, the notified body must—
(a)at the request of the Secretary of State, transfer its files relating to the activities it has undertaken as a notified body to another notified body or to the Secretary of State; or
(b)in the absence of a request under sub-paragraph (a), keep its files relating to the activities it has undertaken as a notified body available for inspection by the Secretary of State and the market surveillance authorities for a period of 10 years from the date they were created.
Extent Information
E17This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Textual Amendments
F8Words in reg. 61(4) substituted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 15 para. 4(3)
Commencement Information
I7Reg. 61 in force at 3.8.2017, see reg. 1
62.—(1) Where an approved body subcontracts specific tasks connected with conformity assessment, or has such tasks carried out by a subsidiary, the tasks are to be treated as having been carried out by an approved body for the purposes of regulations 44 to 47 only where the conditions in paragraphs (2) and (3) are satisfied.
(2) The approved body must—
(a)ensure that the subcontractor or subsidiary meets the approved body requirements; and
(b)inform the Secretary of State accordingly.
(3) The approved body must have obtained the agreement of the client economic operator to the use of a subcontractor or subsidiary.
(4) Where an approved body subcontracts specific tasks connected with conformity assessment, or has such tasks carried out by a subsidiary, the approved body must, for a period of 10 years beginning on the day on which the tasks are carried out, keep at the disposal of the Secretary of State the documentation concerning—
(a)the assessment of the qualifications of the subcontractor or subsidiary; and
(b)the conformity assessment activities carried out by the subcontractor or subsidiary.
(5) When monitoring an approved body in accordance with regulation 58 (monitoring of approved bodies), the Secretary of State must treat the approved body as responsible for the tasks performed by a subcontractor or subsidiary, wherever the subcontractor or subsidiary is established.
(6) In this regulation “subsidiary” has the meaning given to it in section 1159 of the Companies Act 2006.]
Extent Information
E8This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
62. When a notified body carries out a relevant conformity assessment procedure, Schedule 12 (operational requirements of notified bodies) has effect.
Extent Information
E18This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Commencement Information
I8Reg. 62 in force at 3.8.2017, see reg. 1
63.—(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.]
Extent Information
E9This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
63.—(1) Where a notified body subcontracts specific tasks connected with conformity assessment, or has such tasks carried out by a subsidiary, the tasks are only to be treated as having been carried out by a notified body for the purposes of regulations 44 to 47 where the conditions in paragraphs (2) and (3) are satisfied.
(2) The notified body must—
(a)ensure that the subcontractor or subsidiary meets the notified body requirements; and
(b)inform the Secretary of State accordingly.
(3) The notified body must have obtained the agreement of the client economic operator to the use of a subcontractor or subsidiary.
(4) Where a notified body subcontracts specific tasks connected with conformity assessment, or has such tasks carried out by a subsidiary, the notified body must, for a period of 10 years beginning on the day on which the tasks are carried out, keep at the disposal of the Secretary of State the documentation concerning—
(a)the assessment of the qualifications of the subcontractor or the subsidiary; and
(b)the conformity assessment activities carried out by the subcontractor or subsidiary.
(5) When monitoring a notified body in accordance with regulation 59 (monitoring of notified bodies), the Secretary of State must treat the notified body as responsible for the tasks performed by a subcontractor or subsidiary, wherever the subcontractor or subsidiary is established.
Extent Information
E19This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Commencement Information
I9Reg. 63 in force at 3.8.2017, see reg. 1
64. 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 58;
(c)compiling and maintaining the register of approved bodies in accordance with regulation 63.]
Extent Information
E10This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
64.—(1) Where the Secretary of State intends to restrict, suspend or withdraw a notification in accordance with regulation 61 (changes to notifications) the Secretary of State must give notice in writing to the notified body concerned that its notification will be restricted, suspended or withdrawn.
(2) A written notice provided in accordance with paragraph (1) must—
(a)state the date on which the notice is issued;
(b)state of the reasons why the notification is being restricted, suspended or withdrawn;
(c)state the date on which the restriction, suspension or withdrawal of the notification is to take effect;
(d)where a notification has been restricted or suspended, state what the effect of that restriction or suspension is upon the notified body;
(e)inform the notified body of its right to make representations to the Secretary of State, in writing, within 14 days of the date on the notice, against this decision.
(3) Where a notified body submits written representations to the Secretary of State, the Secretary of State must respond to those representations within 21 days of the date on which those representations are received, stating whether, having considered those representations, the notice issued under paragraph (1) will be modified or withdrawn.
Extent Information
E20This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Commencement Information
I10Reg. 64 in force at 3.8.2017, see reg. 1