The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019

(47) (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 48 (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 54(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 51 (restriction, suspension or withdrawal of approval). (3) In this Part— - “notified body” means a body— 1. which the Secretary of State had before IP completion day notified to the European Commission and the member State of the European Union, in accordance with Article 27 of the Directive; and 2. in respect of which no objections had been raised, as referred to in regulation 47(2)(b), as it had effect immediately before IP completion day; - “approved body requirements” means the requirements set out in Schedule 3. (48) (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 procedure in respect of which the conformity assessment body claims to be competent; (iii) the class of regulated non-automatic weighing instruments 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)(i), 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. (49) (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. (50) 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 48(6)(b); or (ii) in the case of an approved body which was a notified body immediately before IP completion day, in accordance with regulation 48(6)(b), as it applied immediately before IP completion day; and (c) carries out its functions in accordance with these Regulations. (51) (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 50(b), the Secretary of State must restrict, suspend or withdraw the body's status as an approved body under regulation 48 (approval of conformity assessment bodies). (2) With the consent of an approved body, or where the Secretary of State determines that an approved body no longer meets a condition in accordance with regulation 50(b), the Secretary of State may restrict, suspend or withdraw the body's status as an approved body under regulation 48 (approval of conformity assessment bodies). (3) In deciding what action is required under paragraph (1) or (2), the Secretary of State must have regard to the seriousness of the failure. (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 that 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— (a) on the request of the Secretary of State, transfer its files to another approved body or to the Secretary of State; or (b) in the absence of a request under sub-paragraph (a), ensure that its files relating to the activities it has undertaken as an approved body are kept available for the Secretary of State and competent 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 notified body. (7) The Secretary of State may impose a monetary penalty on an approved body that fails to comply with any requirement imposed by or under paragraph (5). (8) Schedule 5 has effect in relation to monetary penalties imposed under paragraph (7). (52) (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 . (53) (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. (54) (1) 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; and (b) monitoring approved bodies in accordance with regulation 50. (2) Where the Secretary of State authorises the UK national accreditation body pursuant to paragraph (1), the Secretary of State remains fully responsible for anything done pursuant to that authorisation.

Amendment to regulation 58

33

Regulation 58 (regulated non-automatic weighing instruments presenting a risk) is amended as follows—

• (a) in paragraph (5), for “notified” substitute “ approved ”;

• (b) omit paragraph (6);

• (c) in paragraph (7) for “on the market throughout the European Economic Area” substitute “ in the United Kingdom ”;

• (d) in paragraph (9) for “Commission and the other EEA States” substitute “ Secretary of State ”; and

• (e) in paragraph (10)(f)(ii) for “harmonised” substitute “ designated ”.

Amendment to regulation 59

34

Omit regulation 59 (EU safeguard procedure).

Amendment to regulation 60

35

In regulation 60 (compliant regulated non-automatic weighing instruments which present a risk) in paragraph (3), for “Commission and the other EEA states” substitute “ Secretary of State ”.

Amendment to regulation 63

36

In regulation 63 (compliance notice procedure) in paragraph (1)—

• (a) in sub-paragraphs (a) and (b), for “CE” substitute “ UK ” in both places in which it occurs;

• (b) in sub-paragraph (a) for “Article 30 of the RAMS Regulation or the requirements of these Regulations” substitute “ regulation 44 or regulation 45 ”;

• (c) in sub-paragraph (c) for “notified” substitute “ approved ”; and

• (d) in sub-paragraph (d) omit “EU”.

Amendment to regulation 64

37

In regulation 64 (enforcement notice procedure)—

• (a) in paragraph (5)—

• (i) for “a United Kingdom notified” substitute “ an approved ”;

• (ii) for “that notified” substitute “ that approved ”; and

• (b) omit paragraph (6).

Amendment to regulation 67

38

In regulation 67 (disqualification)—

• (a) in paragraph (1)—

• (i) in sub-paragraph (a) for “CE” substitute “ UK ”;

• (ii) in sub-paragraph (c) for “notified” substitute “ approved ”; and

• (b) in paragraph 2(b) omit “EU-”.

Amendment to regulation 68

39

In regulation 68 (requalification)—

• (a) in paragraph (3)(c)—

• (i) omit “notified”; and

• (ii) for “Annex II to the Directive” substitute “ Schedule 7 ”;

• (b) in paragraph (3)(d)—

• (i) for “notified” substitute “ approved ”; and

• (ii) for “Annex II to the Directive” substitute Schedule 7;

• (c) in paragraph (4)(b) omit “EU-”.

Amendment to regulation 71

40

In regulation 71 (unauthorised application of authorised marks) in paragraph (5)—

• (a) in sub-paragraph (a) for “CE” substitute “ UK ”; and

• (b) in sub-paragraph (c) for “notified” substitute “ approved ”.

Amendment to Schedule 1

41

In Schedule 1 (information to be marked on regulated non-automatic weighing instruments)—

• (a) in paragraph 1 omit “EU-”; and

• (b) in paragraph 9 for “the Annex III to the Directive” substitute “ Schedule 8 ”.

Amendment to Schedule 2

42

In Schedule 2 (operational obligations of notified bodies)—

• (a) in paragraphs 3, 4 and 6 for “a notified” substitute “ an approved ”;

• (b) in all places in which it occurs (other than the paragraphs referred to in sub-paragraph (a)), including in the heading, for “notified” substitute “ approved ”;

• (c) in paragraph 7 for “notifying authority” substitute “ Secretary of State ”;

• (d) in paragraph 7(b) for “notification” substitute “ approval ”;

• (e) in paragraph 8 for “this Directive” substitute “ these Regulations ”; and

• (f) omit paragraph 9.

Amendments to Schedule 3

43

In Schedule 3 (requirements related to notified bodies)—

• (a) for the heading, substitute— “ SCHEDULE 3 Approved Body requirements ”;

• (b) in paragraph 1 for “under the national law of an EEA state” substitute “ in the United Kingdom ”;

• (c) in paragraph 8 for “Annex II to the Directive” substitute “ Schedule 7 ”;

• (d) in paragraph 9(c) for “a notified” substitute “ an approved ”;

• (e) in all places in which it occurs (other than the paragraph referred to in sub-paragraph (d)), including in the heading, for “notified” substitute “ approved ”;

• (f) in paragraph 11(c)—

• (i) for “Annex I to the Directive” substitute “ Schedule 6 ”;

• (ii) for “harmonised” substitute “ designated ”; and

• (iii) for “European harmonisation legislation and of national legislation” substitute “ these Regulations ”;

• (g) in paragraph 16 for “under the European Union harmonisation legislation” substitute “ by the Secretary of State ”.

Amendments to Schedule 4

44

In Schedule 4 (use for trade of regulated non-automatic weighing instruments in Great Britain) in paragraphs 1(3) and 1(5) for “Annex I to the Directive” substitute “ Schedule 6 ”.

Insertion of Schedule 6

45

After Schedule 5 (monetary penalties) insert—

SCHEDULE 6 Where an instrument includes, or is connected to, more than one indicating or printing device used for the applications listed in sub-paragraphs (a) to (f) of regulation 3(2), those devices which repeat the results of the weighing operation and which cannot influence the correct functioning of the instrument shall not be subject to the essential requirements if the weighing results are printed or recorded correctly and indelibly by a part of the instrument which meets the essential requirements and the results are accessible to both parties concerned by the measurement. However, in the case of instruments used for direct sales to the public, display and printing devices for the vendor and the customer must fulfil the essential requirements. (1) Units of mass The units of mass used shall be the legal units within the meaning of the Weights and Measures Act 1985 relating to units of measurement . Subject to compliance with this condition, the following units are permitted— (a) SI units: kilogram, microgram, milligram, gram, tonne; (b) imperial unit: troy ounce, if weighing precious metals; (c) other non-SI unit: metric carat, if weighing precious stones. For instruments that make use of the imperial unit of mass referred to above, the relevant essential requirements specified below shall be converted to that unit, using simple interpolation. (2) Accuracy classes (2) The following accuracy classes have been defined— (a) I special (b) II high (c) III medium (d) IIII ordinary The specifications of these classes are given in Table 1.

The minimum capacity is reduced to 5 e for instruments in classes II and III for determining a conveying tariff.

(2) Scale intervals (2) The actual scale interval (d) and the verification scale interval (e) shall be in the form— - 1 x 10k, 2 x 10k, or 5 x 10k mass units, - k being any integer or zero. (2) For all instruments other than those with auxiliary indicating devices— d = e. (2) For instruments with auxiliary indicating devices the following conditions apply— - e = 1 x 10kg; - d < e ≤ 10 d. Those conditions do not apply for instruments of class I with d < 10–4 g, for which e = 10–3 g. (3) Classification (3) Instruments with one weighing range Instruments equipped with an auxiliary indicating device shall belong to class I or class II. For these instruments the minimum capacity lower limits for these two classes are obtained from Table 1 by replacement in column 3 of the verification scale interval (e) by the actual scale interval (d). If d < 10–4 g, the maximum capacity of class I may be less than 50 000 e. (3) Instruments with multiple weighing ranges Multiple weighing ranges are permitted, provided they are clearly indicated on the instrument. Each individual weighing range is classified according to point 3.1. If the weighing ranges fall into different accuracy classes the instrument shall comply with the severest of the requirements that apply for the accuracy classes in which the weighing ranges fall. (3) Multi-interval instruments (3) Instruments with one weighing range may have several partial weighing ranges (multi-interval instruments). Multi-interval instruments shall not be equipped with an auxiliary indicating device. (3) Each partial weighing range i of multi-interval instruments is defined by—

Where:
- i = 1, 2, …r,
- i = partial weighing range number,
- r = the total number of partial weighing ranges
All capacities are capacities of net load, irrespective of the value of any tare used.

(3) The partial weighing ranges are classified according to Table 2. All partial weighing ranges shall fall into the same accuracy class, that class being the instrument's accuracy class.

(4) Accuracy (4) On implementation of the procedures laid down in regulation 36, the error of indication shall not exceed the maximum permissible error of indication as shown in Table 3. In the case of digital indication the error of indication shall be corrected for the rounding error. The maximum permissible errors apply to the net value and tare value for all possible loads, excluding preset tare values.