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

Made: 27th March 2019

Coming into force in accordance with regulation 1

The Secretary of State makes the following Regulations in exercise of the powers conferred by section 8(1) of, and paragraph 21 of Schedule 7 to, the European Union (Withdrawal) Act 2018 .

In accordance with paragraph 1(1) of Schedule 7 to the European Union (Withdrawal) Act 2018 a draft of this instrument has been laid before Parliament and approved by a resolution of each House of Parliament.

PART 1 — Introduction

Citation and Commencement

1

These Regulations may be cited as the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 and come into force on exit day.

Extent

2

Subject to regulation 3, these Regulations extend to England and Wales and Scotland only.

3

The following provisions extend to the United Kingdom—

• (a) Part 1;

• (b) regulation 4 and Schedule 1;

• (c) Part 5 and its related schedules, except—

• (i) paragraphs 29 to 40 of Schedule 34 (cosmetic product enforcement);

• (ii) paragraphs 1 and 2 of Schedule 35 (personal protective equipment enforcement);

• (iii) paragraph 1 of Schedule 36 (gas appliances enforcement);

• (d) Part 6 and its related schedule.

PART 2 — Amendment of primary legislation

Amendment of the Hallmarking Act 1973

4

Schedule 1 contains amendment of the Hallmarking Act 1973 .

Amendment of the Weights and Measures Act 1985

5

Schedule 2 contains amendment of the Weights and Measures Act 1985 .

Amendment of the Consumer Protection Act 1987

6

Schedule 3 contains amendment of the Consumer Protection Act 1987 .

PART 3 — Amendment of subordinate legislation

Amendment of the Measuring Container Bottles (EEC Requirements) Regulations 1977

7

Schedule 4 contains amendment of the Measuring Container Bottles (EEC Requirements) Regulations 1977 .

Amendment of the Measuring Instruments (EEC Requirements) Regulations 1988

8

Schedule 5 contains amendment of the Measuring Instruments (EEC Requirements) Regulations 1988 .

Amendment of the Weights and Measures (Intoxicating Liquor) Order 1988

9

Schedule 6 contains amendment of the Weights and Measures (Intoxicating Liquor) Order 1988 .

Amendment of the Lifting Operations and Lifting Equipment Regulations 1998

10

Schedule 7 contains amendment of the Lifting Operations and Lifting Equipment Regulations 1998 .

Amendment of the Noise Emission in the Environment by Equipment for use Outdoors Regulations 2001

11

Schedule 8 contains amendment of the Noise Emission in the Environment by Equipment for use Outdoors Regulations 2001 .

Amendment of the General Product Safety Regulations 2005

12

Schedule 9 contains amendment of the General Product Safety Regulations 2005 .

Amendment of the Offshore Installations (Safety Case) Regulations 2005

13

Schedule 10 contains amendment of the Offshore Installations (Safety Case) Regulations 2005 .

Amendment of the Weights and Measures (Packaged Goods) Regulations 2006

14

Schedule 11 contains amendment of the Weights and Measures (Packaged Goods) Regulations 2006 .

Amendment of the Supply of Machinery (Safety) Regulations 2008

15

Schedule 12 contains amendment of the Supply of Machinery (Safety) Regulations 2008 .

Amendment of the Aerosol Dispensers Regulations 2009

16

Schedule 13 contains amendment of the Aerosol Dispensers Regulations 2009 .

Amendment of the Accreditation Regulations 2009

17

Schedule 14 contains amendment of the Accreditation Regulations 2009 .

Amendment of the Toys (Safety) Regulations 2011

18

Schedule 15 contains amendment of the Toys (Safety) Regulations 2011 .

Amendment of the Explosives Regulations 2014

19

Schedule 16 contains amendment of the Explosives Regulations 2014 and associated provision relating to retained direct EU legislation.

Amendment of the Weights and Measures (Revocations) Regulations 2015

20

Schedule 17 contains amendment of the Weights and Measures (Revocations) Regulations 2015 .

Amendment of the Offshore Installations (Offshore Safety Directive) (Safety Case etc.) Regulations 2015

21

Schedule 18 contains amendment of the Offshore Installations (Offshore Safety Directive) (Safety Case etc.) Regulations 2015 .

Amendment of the Pyrotechnic Articles (Safety) Regulations 2015

22

Schedule 19 contains amendment of the Pyrotechnic Articles (Safety) Regulations 2015 .

Amendment of the Electromagnetic Compatibility Regulations 2016

23

Schedule 20 contains amendment of the Electromagnetic Compatibility Regulations 2016 .

Amendment of the Simple Pressure Vessels (Safety) Regulations 2016

24

Schedule 21 contains amendment of the Simple Pressure Vessels (Safety) Regulations 2016 .

Amendment of the Lifts Regulations 2016

25

Schedule 22 contains amendment of the Lifts Regulations 2016 .

Amendment of the Electrical Equipment (Safety) Regulations 2016

26

Schedule 23 contains amendment of the Electrical Equipment (Safety) Regulations 2016 .

Amendment of the Pressure Equipment (Safety) Regulations 2016

27

Schedule 24 contains amendment of the Pressure Equipment (Safety) Regulations 2016 .

Amendment of the Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016

28

Schedule 25 contains amendment of the Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016 .

Amendment of the Non-automatic Weighing Instruments Regulations 2016

29

Schedule 26 contains amendment of the Non-automatic Weighing Instruments Regulations 2016 .

Amendment of the Measuring Instruments Regulations 2016

30

Schedule 27 contains amendment of the Measuring Instruments Regulations 2016 .

Amendment of the Recreational Craft Regulations 2017 and related amendment

31

Schedule 28 contains amendment of the Recreational Craft Regulations 2017 and of Commission Implementing Regulation (EU) 2017/1 of 3 January 2017 on procedures for watercraft identification under Directive 2013/53/EU of the European Parliament and of the Council on recreational and personal watercraft.

Amendment of the Radio Equipment Regulations 2017 and related amendments

32

Schedule 29 contains amendment of the Radio Equipment Regulations 2017 and of Commission Implementing Regulation specifying how to present the information provided for in Article 10(10) of Directive 2014/53/EU of the European Parliament and the Council (EU) 2017/1354.

PART 4 — Amendment of subordinate legislation relating to Northern Ireland

Amendment of the Identification and Traceability of Explosives Regulations (Northern Ireland) 2013

33

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

Amendment of the Making Available on the Market and Supervision of Transfers of Explosives Regulations (Northern Ireland) 2016

34

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

Amendment of the Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations (Northern Ireland) 2017

35

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

PART 5 — Amendment of retained direct EU legislation

Amendment of Regulation (EC) No 765/2008

36

Schedule 33 contains amendment of Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93.

Amendment of Regulation (EC) No 1223/2009 and related amendments

37

Schedule 34 contains amendment of Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products, and amendment of the Cosmetic Products Enforcement Regulations 2013 , and amendment of related direct EU tertiary legislation.

Amendment of Regulation (EU) 2016/425 and the Personal Protective Equipment (Enforcement) Regulations 2018

38

Schedule 35 contains amendment of Regulation (EU) 2016/425 of the European Parliament and of the Council of on personal protective equipment and repealing Council Directive 89/686/EEC, and amendment of the Personal Protective Equipment (Enforcement) Regulations 2018 .

Amendment of Regulation (EU) 2016/426 and the Gas Appliances (Enforcement) and Miscellaneous Amendments Regulations 2018

39

Schedule 36 contains amendment of Regulation (EU) 2016/426 of the European Parliament and of the Council on appliances burning gaseous fuels and repealing Directive 2009/142/EC, and amendment of the Gas Appliances (Enforcement) and Miscellaneous Amendments Regulations 2018 .

PART 6 — Revocations

Revocation of retained direct EU and EEA legislation

40

Schedule 37 contains revocation of retained direct EU and EEA legislation.

SCHEDULE 1 — Amendment of the Hallmarking Act 1973

General

1

The Hallmarking Act 1973 is amended as follows.

2

In section 2—

• (a) in subsection (1)(d), after “United Kingdom” insert “ before exit day ”;

• (b) for subsection (2A), substitute—

(2A) In this section “EEA state” has the meaning which it had under Schedule 1 to the Interpretation Act 1978 before exit day.

3

In section 22(1), in paragraph (c) of the definition of “sponsor's mark”, after “EEA state” insert “ other than the United Kingdom before exit day ”.

SCHEDULE 2 — Amendment of the Weights and Measures Act 1985

General

1

In the Weights and Measures Act 1985 omit section 76 (fees for performance of EU obligations) .

SCHEDULE 3 — Amendment of the Consumer Protection Act 1987

Introduction

1

The Consumer Protection Act 1987 is amended in accordance with paragraphs 2 to 6.

Amendment of section 1

2

In section 1(1)—

• (1) for “shall have effect” substitute “ was enacted ”;

• (2) for “is” substitute “ was ”.

Amendment of section 2

3

In section 2(2)(c) for the words from “a member State” to “member States” substitute “ the United Kingdom ”.

Amendment of section 4

4

In section 4(1)(a) before “EU” insert “ retained ”.

Omission of section 8

5

Omit section 8.

Saving for Orders in Council made under section 8

6

An Order in Council made under section 8 continues to have effect despite the repeal of that section by paragraph 5.

SCHEDULE 4 — Amendment of the Measuring Container Bottles (EEC Requirements) Regulations 1977

Introduction

1

The Measuring Container Bottles (EEC Requirements) Regulations 1977 are amended in accordance with paragraphs 2 to 11.

Amendment to regulation 2

2

• (1) Regulation 2 (interpretation) is amended as follows.

• (2) In paragraph (1)—

• (a) in the definition of “batch”—

• (i) for “paragraph 1 of Annex II of the Directive” substitute “ Schedule 3 ”;

• (ii) for “the Directive” in the second place in which it occurs substitute “ these Regulations ”;

• (b) for the definition of “importer” substitute—

“importer” means any person who— (a) is established in the UK; and (b) places a measuring container bottle (marked with the UK marking) from a country outside the United Kingdom onto the market;

• (c) in the definition of “manufacturer” for “EEC sign” substitute “ UK marking ”;

• (d) after “production control records” insert—

“UK marking” means the marking in the form set out in Annex 2 of Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products;

• (3) After paragraph (1) insert—

(1A) Schedules 2 and 3 reproduce provisions of Annexes I and II (respectively) to the Directive with amendments to correct deficiencies in retained EU law. (1B) A reference to a provision of Schedules 2 and 3 is a reference to the equivalent provision of Annexes I and II to the Directive as set out in that Schedule.

• (4) In paragraph (3), for “the schedule” substitute “ Schedule 1 ”.

Amendment to regulation 3

3

In regulation 3 (application), for the words from “only” to the end of the regulation, substitute—

to bottles made of glass, or any other substance having the rigidity and stability that offers the same metrological guarantees as glass, when such bottles— (a) are stoppered or designed to be stoppered and are intended for the storage, transport or delivery of liquids, (b) have a nominal capacity of between 0.05 litre and five litres inclusive, and (c) have metrological characteristics (design characteristics and uniformity of manufacture) such that they can be used as measuring containers, i.e. when they are filled up to a specified level or to a specified percentage of their brim capacity their contents can be measured with sufficient accuracy.

Amendment to regulation 4

4

In regulation 4 (weights and measures acts) for “EEC sign” substitute “ UK marking ”.

Amendment to regulation 5

5

For regulation 5 substitute—

(5) (1) Only measuring container bottles— (a) complying with paragraph 3 of Schedule 2; (b) the actual capacity of which has been checked in accordance with paragraph 4 of Schedule 2; and (c) marked in accordance with paragraph 5.1.1 and 5.1.2 of Schedule 2; shall be marked with the UK marking. (2) The UK marking on a measuring container bottle , or where paragraph (2A) applies, on a label affixed to the bottle or on a document accompanying the bottle shall be at least 3mm high and shall be indelible, easily legible and visible. (2A) For a period of 24 months beginning with IP completion day, the UK marking may be affixed to a label affixed to, or a document accompanying, a measuring container bottle. (3) It is the responsibility of the manufacturer to affix the UK marking to certify that a measuring container bottle meets the requirements of these Regulations, including Schedule 2.

Amendment to regulation 6

6

In regulation 6 (manufacturer's identification mark) omit paragraph (3).

Insertion of regulation 7A

7

After regulation 7 insert—

(7A) (1) In this regulation any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive. (2) Paragraph (3) applies where, before a measuring container bottle is sold or supplied on the UK market, the manufacturer— (a) has complied with the requirements of the Directive in accordance with Article 2 and Annex 1; and (b) marks the bottle with the EEC sign in accordance with the third subparagraph of paragraph 5 of Annex 1. (3) Where this paragraph applies— (a) the requirements of regulations 5 and of Schedule 2 are to be treated as being satisfied; (b) the definitions of importer and manufacturer in regulation 2(1) apply subject to the modification that the references to “UK marking” are to be read as references to the EEC sign; and (c) regulations 4, 9 and 10 apply subject to the modifications that— (i) any reference to “UK marking” is to be read as a reference to the EEC sign; (ii) any reference to “these Regulations” is to be read as a reference to the Directive. (7B) (1) Subject to paragraphs (2) and (3), regulation 7A ceases to have effect at the end of the period of 12 months beginning with IP completion day. (2) Notwithstanding the expiry of regulation 7A— (a) any measuring container bottle to which paragraph (3) applies may be sold or supplied on the market of Great Britain on or after the expiry of regulation 7A; (b) any obligation to which a person was subject under regulation 7A(2) in respect of a measuring container bottle to which paragraph (3) applies continues to have effect after the expiry of regulation 7A. (3) This paragraph applies to a measuring container bottle which— (a) was sold or supplied on the market of Great Britain prior to the expiry of regulation 7A; and (b) in respect of which the requirements in regulation 7A were met. (7C) (1) Where paragraph (2) applies— (a) the requirements of regulation 5 and of Schedule 2 are treated as being satisfied; (b) the definition of “importer” and “manufacturer” in regulation 2(1) apply subject to the modification that the references to “UK marking” are to be read as references to the EEC sign. (2) This paragraph applies where a measuring container bottle— (a) complies with regulation 5, as it applies in Northern Ireland; and (b) is qualifying Northern Ireland goods. (3) In this regulation “qualifying Northern Ireland goods” has the meaning given to it in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018.

Amendment to regulation 9

8

In regulation 9 (individual measuring container bottles), for “EEC sign” in each place in which it occurs substitute “ UK marking ”.

Amendment to regulation 10

9

In regulation 10 (offences)—

• (a) in paragraphs (1)(a) and (b) and paragraph (7), for “EEC sign” substitute “ UK marking ”;

• (b) in paragraph (1)( c), for “in section 2 of Annex I of the Directive” substitute “ at paragraph 1 of Schedule 2 ”.

Amendment to Schedule

10

For the heading “Schedule” substitute “ Schedule 1 ”.

Insertion of Schedules 2 and 3

11

After Schedule 1, insert—

SCHEDULE 2 (1) Measuring container bottles shall be characterized by the following capacities which are always specified for a temperature of 20C: (1) the nominal capacity Vn is the volume which is marked on the bottle; it is the volume of liquid which the latter is deemed to contain when it is filled in the conditions of use for which it is intended; (1) the brim capacity of a bottle is the volume of liquid it contains when filled to the brim; (1) the actual capacity of a bottle is the volume of liquid it in fact contains when it is filled exactly under the conditions corresponding theoretically to the nominal capacity; (2) There are two methods of filling measuring container bottles: (1) to a constant level, (2) to a constant vacuity. The distance between the theoretical filling level for the nominal capacity and the brim level and the difference between the brim capacity and the nominal capacity, known as the volume of expansion or vacuity, shall be perceptibly constant for all bottles of the same type, that is, for all bottles made to the same design. (3) The maximum permissible errors (positive or negative) in the capacity of a measuring container bottle, i.e. the greatest differences permitted (positive or negative) at a temperature of 20°C and under the control conditions laid down in Schedule 3, between the actual capacity and the nominal capacity Vn shall be in accordance with the following table:

Normal capacity Vₙ in millilitres	Maximum permissible errors	Maximum permissible errors
	as a % of Vₙ	in millilitres
from 50 to 100		3
from 100 to 200	3
from 200 to 300		6
from 300 to 500	2
from 500 to 1 000		10
from 1 000 to 5 000	1

The maximum permissible error in the brim capacity shall be the same as the maximum permissible error in the corresponding nominal capacity. The systematic exploitation of tolerances shall be prohibited.

(4) In practice, the actual capacity of a measuring container bottle shall be checked by determining the quantity of water at 20°C which the bottle actually contains when filled to the level theoretically corresponding to the nominal capacity. It may also be checked indirectly by a method of equivalent accuracy. (5) A measuring container bottle shall bear the following indelible, easily legible and visible indications : (5) on its side, on the bottom rim or on the bottom: (5) an indication of its nominal capacity in litres, centilitres or millilitres in figures at least 6 mm high, if the nominal capacity is greater than 100 cl, 4 mm high if it is from 100 cl down to but not including 20 cl and 3 mm high if it is not more than 20 cl, followed by the symbol for the unit of measurement used or, where appropriate, by the name of the unit in accordance with the Units of Measurement Regulations 1986 ; (5) the manufacturer's identification mark referred to in regulation 6; (5) the UK marking; (5) On the bottom or on the bottom rim, in such a manner as to avoid confusion with the previous indication, in figures of the same minimum height as those expressing the corresponding nominal capacity, according to the method or methods of filling for which the bottle is intended: (5) an indication of the brim capacity expressed in centilitres and not followed by the symbol cl, and/or (5) an indication of the distance in millimetres from the brim level to the filling level corresponding to the nominal capacity, followed by the symbol mm. (5) Other indications may appear on the bottle provided they do not give rise to confusion with the compulsory indications. SCHEDULE 3 (1) A sample of measuring container bottles of the same design and the same manufacture shall be drawn from a batch corresponding, in principle, to an hour's production. If the result of the check on a batch corresponding to an hour's production is not satisfactory, a second test can be carried out, based either on another sample from a batch corresponding to a longer period of production or, where production has been subject to a check recognized by the Secretary of State, on the results recorded on the manufacturers' check-cards. The number of measuring container bottles constituting the sample shall be 35 or 40 as determined by an inspector. (2) The measuring container bottles shall be weighed empty. They shall be filled with water at 20C of a known density, up to the filling level appropriate to the method of checking used. They shall then be weighed in full. The check shall be carried out by means of a legal measuring instrument, suitable for effecting the necessary operations. Error in measuring the capacity shall not be greater than one-fifth of the maximum permissible error corresponding to the nominal capacity of the measuring container bottle. (3) (3) Use of the standard deviation method The number of measuring container bottles in the sample is 35. (3) Calculate as follows (see 3.1.4.): (3) the average (3) estimated standard deviation s of the actual capacities Xi of the bottles in the batch. (3) Calculate as follows: (3) The upper limit T s : the sum of the indicated capacity (see Schedule 2 paragraph 5) and of the maximum permissible error corresponding to this capacity. (3) The lower limit Ti : the difference between the indicated capacity (see Schedule 2 paragraph 5) and the maximum permissible error corresponding to this capacity. (3) Acceptance criteria: The batch shall be declared to comply with the Regulations if the numbers - where k = 1·57 - and F = 0·266 (3) Calculation of the mean value Calculate as follows: — the sum of the 35 actual capacity measurements — the mean value of the 35 measurements — the sum of the squares of the 35 measurements — the square of the sum of the 35 measurements — the corrected sum: — the estimated variance: Hence the estimated standard deviation: (3) Use of the average range method The number of measuring container bottles in the sample is 40. (3) Calculate as follows (see 3.2.4): (3) the average (3) the average range value (3) Calculate as follows: (3) The upper limit T s : the sum of the indicated capacity (see Schedule 2 paragraph 5) and of the maximum permissible error corresponding to this capacity. (3) The lower limit Ti : the difference between the indicated capacity (see Schedule 2 paragraph 5) and the maximum permissible error corresponding to this capacity. (3) Acceptance criterion: The batch shall be declared to comply with the Regulations if the numbers - where k′ = 0·668, - and F′ = 0·628. (3) Calculation of the mean value (3) to obtain — the sum of the 40 actual capacity measurements Xi: — the mean value of these 40 measurements of the 40 actual capacity measurements: (3) To obtain Divide the sample, in chronological order of selection, into eight sub-samples of five measuring container bottles each. Calculate as follows: - — the range of each of the sub-samples, i.e. the difference between the actual capacity of the largest and the smallest of the five bottles in the sub-sample; eight ranges are thus obtained: R1 ; R2 ; . . . . . . R₈ - — the sum of the ranges of the eight sub-samples: The average range

SCHEDULE 5 — Amendment of the Measuring Instruments (EEC Requirements) Regulations 1988

General

1

• (1) The Measuring Instruments (EEC Requirements) Regulations 1988, so far as they continue in force by virtue of paragraph 5 of the Schedule to the Weights and Measures (Revocations) Regulations 2015 , are amended as follows.

• (2) In the following, omit “other than the United Kingdom”—

• (a) regulation 2(1) in the definition of “use for trade”;

• (b) regulations 10, 12(1) and (2), 13(8), 17(1) and (5), 18, 19(1) and (2), 20(1)(a) and (3) and 21(5);

• (c) paragraph 1(e) of Schedule 5.

• (3) In regulation 2 after paragraph (3) insert—

(3A) For the purposes of these Regulations but subject to paragraphs (3B) and (3C), any reference to a member State in an Annex to a relevant Directive is to be read as including a reference to the United Kingdom. (3B) Paragraph (3A) does not apply to a reference contained in a reference to the title of a Directive. (3C) For the purposes of these Regulations, the references to the metrological service of a member State in point 5.2.3 of the Annex to the Directive on cold-water meters are to be read, in relation to the conduct of EEC pattern approval by the Secretary of State, as references to the Secretary of State.

• (4) In regulation 8(3) for “any other member State” substitute “ a member State ”.

• (5) In regulation 9(2) after sub-paragraph (b) insert—

(ba) a condition requiring such notice to be given to the Secretary of State if such instruments are to be installed in the United Kingdom;

• (6) After regulation 15 insert—

(15A) (1) This regulation applies where an EEC pattern approval granted before IP completion day is subject to a condition requiring notice of the place of installation to be given to the competent authorities of member States in which instruments of the pattern in question are to be installed. (2) For the purposes of these Regulations the condition is to be treated as including a requirement for such notice to be given to the Secretary of State if any such instrument is to be installed in the United Kingdom.

SCHEDULE 6 — Amendment of the Weights and Measures (Intoxicating Liquor) Order 1988

General

1

The Weights and Measures (Intoxicating Liquor) Order 1988 is amended as follows.

2

In article 3A(2), for “European Union” substitute “ United Kingdom ”.

SCHEDULE 7 — Amendment of the Lifting Operations and Lifting Equipment Regulations 1998

General

1

• (1) The Lifting Operations and Lifting Equipment Regulations 1998 are amended as follows.

• (2) In regulation 2(1) (interpretation)—

• (a) for “EC declaration of conformity” substitute “ declaration of conformity ” ;

• (b) for paragraph (b) of that definition, substitute—

1. the requirements for a declaration of conformity in Article 15 of Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC; or

• (3) In regulation 9(1)(b)(thorough examination and inspection), for “an EC declaration of conformity” substitute “ a declaration of conformity ”.

• (4) In regulation 11(1) (keeping of information), for “an EC declaration of conformity” substitute “ a declaration of conformity ”.

SCHEDULE 8 — Amendment of the Noise Emission in the Environment by Equipment for use Outdoors Regulations 2001

Introduction

1

The Noise Emission in the Environment by Equipment for use Outdoors Regulations 2001 are amended in accordance with paragraphs 2 to 27.

Amendment to regulation 2

2

Regulation 2 is amended as follows—

• (a) in paragraph (1)—

• (i) in sub-paragraph (a) after “equipment for use outdoors” insert “as it has effect immediately before IP completion day”;

• (ii) omit sub-paragraph (b); and

• (iii) for sub-paragraph (c) substitute—

(c) unless the context otherwise requires, a reference to a numbered regulation or Schedule is a reference to the regulation or Schedule so numbered in these Regulations and a reference to a paragraph in a regulation is a reference to a paragraph in that regulation.

• (b) in paragraph (2)—

• (i) before the definition of “CE marking” insert—

“approved body” has the meaning given to it in regulation 13

• (ii) in the definition of “CE marking”—

• (aa) for “regulation 11” substitute “ Article 3(c) of the Directive ”, and

• (bb) for “Schedule 7” substitute “ Annex IV to the Directive ”;

• (iii) omit the definition of “the Commission”;

• (iv) in the definition of “equipment for use outdoors”, omit from “all the kinds of machinery” to “that is to say”;

• (v) in the definition of “responsible person”—

• (aa) for “European Union” in the first two places in which it occurs substitute “ United Kingdom ”;

• (bb) for “the European Union” in sub-paragraph (c) in the second place in which it occurs substitute “Great Britain”;

• (vi) omit the definition of “notified body”; and

• (vii) after the definition of “sound power level LWA” insert—

“UK marking” means the marking in the form set out in Annex 2 of Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93;

Amendment to regulation 7

3

In regulation 7—

• (a) in paragraph (2)(c) for “CE” substitute “ UK ”;

• (b) in paragraph (2)(d) for “an EC” substitute “ a ”; and

• (ba) before paragraph (3) insert—

(2A) Where paragraph (2B) applies, paragraph (2)(c) is met where the UK marking is affixed to— (a) a label affixed to the equipment; or (b) a document accompanying the equipment. (2B) This paragraph applies to equipment that is placed on the market within a period of 24 months beginning with IP completion day.

• (c) in paragraph (3), omit “In respect of” to “Kingdom,”.

Amendment to regulation 9

4

In regulation 9, in paragraph (a)—

• (a) in sub-paragraph (i) for “the European Union” substitute “ Great Britain ”;

• (aa) for sub-paragraph (ii) substitute—

(ii) is imported into Great Britain for re-export to Northern Ireland or a country outside of the United Kingdom;

• (b) for “CE” substitute “ UK ”.

Amendment to regulation 11

5

In regulation 11—

• (a) for “CE” substitute “ UK ” in each place it occurs;

• (b) for “directives” substitute “ enactments ” in each place it occurs; ...

• (ba) at the end of paragraph (2) insert “ or, where regulation 7(2B) applies, to a label affixed to the equipment or to a document accompanying the equipment ”;

• (c) in paragraph (4), omit “as published in the Official Journal of the European Union”.

Amendment to regulation 12

6

In regulation 12 omit “and to the Commission”.

Insertion of regulation 12A

7

After regulation 12 insert—

(12A) (1) In this regulation— (a) any reference to an Article or an Annex is a reference to an Article of or an Annex to the Directive; (b) “conformity assessment procedure” has the meaning given to it in Article 3(b). (2) Paragraph (3) applies where, before placing equipment on the market or putting it into service in Great Britain, a responsible person— (a) ensures that the equipment satisfies the requirements of the Directive concerning noise emission in the environment; (b) ensures that the conformity assessment procedure that applies to the equipment in accordance with Article 14(1) or (2) has been carried out; (c) ensures that the technical documentation referred to in Article 14 and Annexes V to VIII, and any other records and correspondence relating to the relevant conformity assessment procedure set out in those provisions, are prepared in or translated into English; (d) ensures that the equipment bears a CE marking and an indication of the guaranteed sound power level in accordance with Article 11; (e) draws up an EC declaration of conformity, in accordance with Article 8; and (f) ensures that the EC declaration of conformity is prepared in or translated into English. (3) Where this paragraph applies— (a) the requirements of regulation 7(2) and (3) are to be treated as being satisfied; (b) regulations 7(4), 11, 12, 16(1), 17 and 18 and paragraph 8 of Schedule 13 apply subject to the modifications in paragraph (4); and (c) regulation 10 does not apply. (4) The modifications referred to in paragraph (3)(b) are that— (a) any reference to “declaration of conformity” is to be read as a reference to the EC declaration of conformity referred to in Article 8(1); (b) any reference to “technical documentation” is to be read as a reference to the technical documentation referred to in Article 8(3); (c) any reference to “UK marking” is to be read as a reference to the CE marking; and (d) for the purposes of regulation 16(1)— (i) the reference to regulation 7(2)(c) is to be read as a reference to Article 11(2); (ii) the reference to regulation 7(2)(d) is to be read as a reference to Article 8(1); and (iii) the reference to regulation 10 is to be read as a reference to Article 14(1) or (2). (12B) (1) Subject to paragraph (2), regulation 12A ceases to have effect at the end of the period of 12 months beginning with IP completion day. (2) Notwithstanding the expiry of regulation 12A— (a) any equipment which was placed on the market or put into service pursuant to regulation 12A may continue to be made available on the market on or after the expiry of regulation 12A; (b) any obligation to which a person was subject under regulation 12A(2) in respect of equipment placed on the market or put into service pursuant to regulation 12A continues to have effect after the expiry of regulation 12A, in respect of that equipment. (12C) (1) Where paragraph (2) applies the requirements in regulation 7(2) and (3) and regulations 10 and 11 are to be treated as being satisfied. (2) This paragraph applies where equipment is— (a) qualifying Northern Ireland goods; and (b) meets the requirements of regulation 16, as it applies in Northern Ireland. (3) In this regulation “qualifying Northern Ireland goods has the meaning given to it in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018.

Amendment to regulation 13

8

For regulation 13 substitute—

(13) (1) For the purposes of these Regulations, an approved body is a body which has been appointed to carry out one or more of the conformity assessment procedures mentioned or referred to in regulation 10(a) and which— (a) has been appointed as an approved body in the United Kingdom pursuant to regulation 14; 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 14(2)(e) as it had effect immediately before IP completion day, to terminate the appointment. (2) In this regulation “notified body” means a body which before IP completion day has been— (a) appointed as a notified body in the United Kingdom pursuant to regulation 14, as it had effect immediately before IP completion day; and (b) notified by the Secretary of State to the European Commission and other member States pursuant to Article 15 of the Directive.

Amendment to regulation 14

9

In regulation 14—

• (a) for “a notified” substitute “ an approved ” in each place it occurs;

• (b) in paragraph (1), after “such persons” insert “ which meet the approved body requirements, ”;

• (c) in paragraphs (1), (2)(d), (5)(a) and (5)(b) for “notified” substitute “ approved ”;

• (d) in paragraph (2)(e), after “any of” insert “ the approved body requirements or ”;

• (e) after paragraph (6) insert—

(7) In this regulation “approved body requirements” means the requirements set out in Schedule 12A.

Insertion of regulation 14A

10

After regulation 14 insert—

(14A) (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.

Amendment to regulation 15

11

In regulation 15—

• (a) in paragraph (1), for “a notified” in both places in which it occurs substitute “ an approved ”; and

• (b) in paragraph (1)(a), for “notified” substitute “ approved ”.

Amendment to regulation 16

12

In regulation 16—

• (a) in paragraph (1)(a), for “CE” substitute “ UK ”; and

• (b) in paragraph (1)(b) for “an EC” substitute “ a ”.

Amendment to regulation 17

13

In regulation 17—

• (a) in paragraph (2) for “CE” substitute “ UK ”;

• (b) in paragraph (2)(a) and (b) omit “established within the European Union”; and

• (c) in paragraph (3) for “CE” substitute “ UK ” in each place it occurs.

Transitional provision in relation to EU Exit

14

After regulation 22, insert—

(23) (1) In this regulation— - “pre-exit period” means the period beginning with 3rd July 2001 and ending immediately before IP completion day; - “product” means equipment to which these Regulations apply. (2) Subject to paragraph (3), where a product was made available on the market during the pre-exit period, despite the amendments made by Schedule 8 of the Product Safety and Metrology etc. (Amendments etc.) (EU Exit) Regulations 2019 , any obligation to which a person was subject under these Regulations as they had effect immediately before IP completion day, continues to have effect as it did immediately before IP completion day, in relation to that product. (3) Paragraph (2) does not apply to any obligation to take action outside of the United Kingdom in respect of that product. (4) Where, during the pre-exit period— (a) a product has not been placed on the market; and (b) a manufacturer has taken any action under regulation 7(2)(b) as it had effect immediately before IP completion day in relation to that product that action has effect as if it had been done under regulation 7(2)(b) as it has effect on and after IP completion day.

Amendment to Schedule 1

]15

In Schedule 1—

• (a) for “Annex I” substitute “ Schedule 4 ” in each place it occurs; and

• (b) for “Annex III” substitute “ Schedule 6 ” in each place it occurs.

Amendment to Schedule 2

16

In Schedule 2—

• (a) for “Annex I” substitute “ Schedule 4 ” in each place it occurs; and

• (b) for “Annex III” substitute “ Schedule 6 ” in each place it occurs.

Amendment to Schedule 3

17

In the heading to Schedule 3 after “(Extract from Article 12)” insert “ Permissible Sound Power Levels ”.

Amendment to Schedule 5

18

In Schedule 5—

• (a) omit “EC” in each place it occurs;

• (b) omit “established in the European Union” in each place it occurs;

• (c) for “notified” substitute “ approved ”;

• (d) for “this Directive” substitute “ these Regulations ” in each place it occurs; and

• (e) for “Community Directives” substitute “ other enactments ”.

Amendment to Schedule 6

19

In Schedule 6—

• (a) under the subheading “Scope”—

• (i) for “this Annex” substitute “ this Schedule ” in each place it occurs;

• (ii) for “this Directive” substitute “ these Regulations ” in each place it occurs;

• (iii) for “Article 2(1)” substitute “ regulation 3 (application) ” in each place it occurs; and

• (iv) omit “in the European Union”;

• (b) under the subheading “Part A Basic Noise Emission Standard”—

• (i) in the first line, for “Article 2(1)” substitute “ regulation 3 (application) ”;

• (ii) in paragraphs 5 and 6 for “this Directive” substitute “ these Regulations ”.

Amendment to Schedule 7

20

In Schedule 7—

• (a) for “CE” substitute “ UK ” in each place it occurs;

• (b) for “taking the following form” the first time it occurs, substitute “ taking the form set out in Annex 2 of Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 ” the first time it occurs; and

• (c) omit the first diagram.

Amendment to Schedule 8

21

In Schedule 8—

• (a) in paragraph 1—

• (i) for “Annex” substitute “ Schedule ”;

• (ia) omit “established within the European Union”;

• (ii) omit “established in the European Union” ...;

• (iii) for “this Directive” substitute “ these Regulations ”;

• (iv) for “CE” substitute “ UK ”;

• (v) for “in Article 11” substitute “ by regulation 7(2)(c), regulation 11 and Schedule 7 ”;

• (vi) omit “EC”; and

• (vii) for “in Article 8” substitute “ by regulation 7(2)(d) and Schedule 5 ”;

• (b) in paragraph 2—

• (i) omit “established in the European Union” in each place it occurs; and

• (ii) omit “EC”;

• (c) in paragraph 3—

• (i) for “this Directive” substitute “ these Regulations ” in each place it occurs; and

• (ii) omit “established in the European Union”; and

• (d) in paragraph 4 for “this Directive” substitute “ these Regulations ”.

Amendment to Schedule 9

22

In Schedule 9—

• (a) in paragraph 1—

• (i) for “Annex” substitute “ Schedule ”;

• (ii) omit “established in the European Union” in each place it occurs;

• (iii) for “this Directive” substitute “ these Regulations ”;

• (iv) for “CE” substitute “ UK ”;

• (v) for “Article 11” substitute “ regulation 7(2)(c), regulation 11 and Schedule 7 ”; and

• (vi) for “Article 8” substitute “ regulation 7(2)(d) and Schedule 5 ”;

• (b) in paragraph 2—

• (i) omit “established in the European Union” in each place it occurs; and

• (ii) omit “EC”;

• (c) in paragraph 3—

• (i) for “this Directive” substitute “ these Regulations ” in each place it occurs; and

• (ii) omit “established in the European Union”;

• (d) in paragraph 4 for “this Directive” substitute “ these Regulations ”;

• (e) in paragraph 5—

• (i) for “the notified” substitute “ the approved ” in each place it occurs;

• (ii) for “a notified” substitute “ an approved ”;

• (iii) omit “established in the European Union” in each place it occurs;

• (iiia) omit “established within the European Union”;

• (iv) for “CE” substitute “ UK ”;

• (v) for “an EC” substitute “ a ”; and

• (vi) for “Articles 11 and 8” substitute “ regulation 7(2)(c) and (d), regulation 11 and Schedules 5 and 7 ”;

• (f) in paragraph 6—

• (i) for “notified” substitute “ approved ” in each place it occurs;

• (ii) omit “established in the European Union” in each place it occurs;

• (iia) omit “established within the European Union”;

• (iii) for “this Directive” substitute “ these Regulations ” in each place it occurs;

• (iv) for “Article 11” substitute “ regulation 7(2)(c), regulation 11 and Schedule 7 ” in each place it occurs;

• (v) for “Article 8” substitute “ regulation 7(2)(d) and Schedule 5 ” in each place it occurs;

• (vi) for “Annex III” substitute “ Schedule 6 ” in each place it occurs; and

• (vii) for “notifying Member State” substitute “ Secretary of State ”.

Amendment to Schedule 10

23

In Schedule 10—

• (a) in paragraph 1—

• (i) for “Annex” substitute “ Schedule ”;

• (ii) for “this Directive” substitute “ these Regulations ”;

• (iii) omit “established in the European Union” in each place it occurs;

• (iv) for “CE” substitute “ UK ”;

• (v) for “Article 11” substitute “ regulation 7(2)(c), regulation 11 and Schedule 7 ”

• (vi) omit “EC”; and

• (vii) for “Article 8” substitute “ regulation 7(2)(d) and Schedule 5 ”;

• (b) in paragraph 2—

• (i) omit “established in the European Union”;

• (ii) for “a notified” substitute “ an approved ”;

• (iii) for “other notified” substitute “ other approved ”; and

• (iv) for “this Directive” substitute “ these Regulations ”;

• (c) in paragraph 3—

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

• (ii) for “this Directive” substitute “ these Regulations ” in each place it occurs;

• (d) in paragraph 4—

• (i) for “this Directive” substitute “ these Regulations ”;

• (ii) for “notified” substitute “ approved ” in each place it occurs; and

• (iii) for “Annex X” substitute “ Schedule 12 ”;

• (e) in paragraph 5 omit “established in the European Union”.

Amendment to Schedule 11

24

In Schedule 11—

• (a) in paragraph 1—

• (i) for “Annex” substitute “ Schedule ”;

• (ii) for “this Directive” substitute “ these Regulations ”;

• (iii) omit “established in the European Union”;

• (iv) for “CE” substitute “ UK ”;

• (v) for “Article 11” substitute “ regulation 7(2)(c), regulation 11 and Schedule 7 ”;

• (vi) omit “EC”; and

• (vii) for “Article 8” substitute “ regulation 7(2)(d) and Schedule 5 ”;

• (b) in paragraph 3.1—

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

• (ii) omit “established in the European Union” ;

• (iii) for “this Directive” substitute “ these Regulations ” in each place it occurs; and

• (iv) omit “EC”;

• (c) in paragraph 3.2 for “Directives” substitute “ enactments ”;

• (d) in paragraph 3.3 for “notified” substitute “ approved ” the first time it occurs;

• (e) in paragraph 3.4—

• (i) omit “established within the European Union”;

• (ii) for “notified” substitute “ approved ” in each place it occurs;

• (f) in paragraph 4, for “notified” substitute “ approved ” in each place it occurs;

• (g) in paragraph 5—

• (i) for “Annex” substitute “ Schedule ”; and

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

• (h) in point 6, for “notified” substitute “ approved ” in each place it occurs.

Amendment to Schedule 12

25

In Schedule 12, in the model of conformity certificate—

• (a) omit “EC” in each place it occurs;

• (b) for “Issuing Directive Applicable” substitute “ Enactments Applicable ”; and

• (c) for “EC Directive Applicable .. ../.. .. ../EC” substitute “ Enactments Applicable … ”.

Insertion of Schedule 12A

26

After Schedule 12 insert—

SCHEDULE 12A (1) (1) The body, its director and its staff responsible for carrying out verification operations may be neither the designer, builder, supplier or installer of the equipment nor the authorised representative established in the United Kingdom of any of those parties. They may become involved neither directly nor as authorised representatives in the design, construction, marketing or maintenance of such equipment nor represent the parties engaged in these activities. (2) Sub-paragraph (1) does not preclude the possibility of exchange of technical information between the manufacturer and the body. (2) The body and its staff must carry out the assessments and verifications with the highest degree of professional integrity and technical competence and must be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their work, especially from persons or groups of persons with an interest in the results of verification. (3) The body must have at its disposal the necessary staff and possess the necessary facilities to enable it to perform properly the technical and administrative tasks connected with inspection and surveillance operations; it must also have access to the equipment required for any special verification. (4) The staff responsible for inspection must have— (a) sound technical and professional training; (b) satisfactory knowledge of the requirements for the assessment of technical documentation; (c) satisfactory knowledge of the requirements for the tests they carry out and adequate practical experience of such tests; (d) the ability to draw up the certificates, records and reports required to authenticate the performance of the tests. (5) The body must be able to demonstrate the impartiality of its inspection staff. (6) The remuneration of the inspection staff must not depend on the number of tests carried out or the results of such tests. (7) The body must have, and must satisfy the Secretary of State that it has, adequate civil liability insurance in respect of its activities. (8) The body must ensure that its staff observe professional secrecy with regard to all information gained in carrying out its tests under these Regulations. (9) Paragraph 8 does not prevent the staff from providing the information to the Secretary of State.

Amendment to Schedule 13

27

In Schedule 13, in paragraph 8 for “an EC” substitute “ a ” in each place it occurs.

SCHEDULE 9 — Amendment of the General Product Safety Regulations 2005

Introduction

1

The General Product Safety Regulations 2005 are amended in accordance with paragraphs 2 to 10.

Amendment of regulation 2

2

In regulation 2—

• (a) omit the definition of “EU law”;

• (b) omit the definition of “the GPS Directive”;

• (c) after the definition of “magistrates' court” insert—

• “the market” means the market of Great Britain;

• (d) omit the definition of “Member State”;

• (e) in the definition of “producer”—

• (i) for “a Member State”, in the first, second and third place it occurs, substitute “ the United Kingdom ”; and

• (ii) in paragraph (b)(ii), for the words “importer of the product from a state that is not a Member State into a Member State” substitute “ person established in the United Kingdom that places a product from a country outside the United Kingdom on the market ”;

• (f) after the definition of “record” insert—

“relevant enactment” means any retained EU law (as it applies in Great Britain) derived from an EU instrument harmonising the conditions for the marketing of products in the EU but does not include Regulation (EC) No 765/2008 of the European Parliament and the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93;

Amendment of regulation 3

3

In regulation 3—

• (a) for “rules of EU law” substitute “ any relevant enactment ”, in both places it occurs;

• (b) omit “other than the GPS Directive”, in both places it occurs; and

• (c) in paragraph (2)(a) for “rules” substitute “ provisions of the enactment ”.

Amendment of regulation 6

4

• (1) Regulation 6 is amended as follows.

• (2) In paragraph (1)—

• (a) for “rules of EU law” substitute “ any relevant enactment ”; and

• (b) for “the law” substitute “ any other law ”.

• (3) In paragraph (2)—

• (a) for the words from “giving” to “Directive”, substitute “ (“S”) which meets the conditions in paragraph (2A) ”;

• (b) for “that national standard” substitute “ S ”; and

• (c) omit the final sentence.

• (4) After paragraph (2) insert—

(2A) The conditions referred to in paragraph (2) are that— (a) the Secretary of State considers S appropriate for the purposes of giving rise to the presumption of conformity; and (b) the Secretary of State has published the reference to S in a manner the Secretary of State considers appropriate.

• (5) In paragraph (3)—

• (a) omit sub-paragraph (a);

• (b) in sub-paragraph (b) omit “other”; and

• (c) in sub-paragraph (c), for “European Commission” substitute “ Secretary of State ”.

Amendment of regulation 9

5

In regulation 9—

• (a) in paragraph (1)(a), omit “and”; and

• (b) omit paragraph (1)(b).

Amendment of regulation 33

6

• (1) Regulation 33 is amended as follows.

• (2) In the heading, omit “and Commission”.

• (3) At the beginning insert—

(A1) The Secretary of State must establish and operate a database containing information relating to market surveillance and product safety.

• (4) Before paragraph (1) insert—

(B1) The database referred to in paragraph (A1) must be designed so as to enable notifications required under paragraph (1), (2) or (4), or under Article 22 of Regulation (EC) 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93, to be made to the Secretary of State through the database.

• (5) For paragraph (1), substitute—

(1) An enforcement authority which has received a notification of a risk under regulation 9(1) shall immediately notify the Secretary of State of the risk through the database referred to in paragraph (A1).

• (6) In paragraph (2), after “Secretary of State”, in the first place it occurs, insert “ of the action taken through the database referred to in paragraph (A1) ”;

• (7) Omit paragraph (3).

• (8) In paragraph (4)—

• (a) for “pharmaceutical” substitute “ medicinal ”;

• (b) after “Secretary of State”, in the first place it occurs, insert “ of the measure or action taken through the database referred to in paragraph (A1) ”; and

• (c) after “withdrawal of any such measure or action” insert “through the database referred to in paragraph (A1).

• (9) Omit paragraphs (5) to (9).

• (10) For paragraph (10)(b), substitute—

(b) “medicinal product” has the meaning given to it in regulation 2 of the Human Medicines Regulations 2012 .

Amendment of regulation 34

7

In regulation 34—

• (a) in paragraph (1)—

• (i) for “to (6), (8) or 27(9)”, substitute “ or (4) ”;

• (ii) omit “or the Commission”; and

• (iii) omit “be in writing and shall”; and

• (b) omit paragraphs (2) and (3).

Omission of regulation 35

8

Omit regulation 35.

Amendment of regulation 36

9

In regulation 36, omit “and competent authorities of other Member States”.

Amendment of regulation 38

10

In regulation 38, omit paragraph (2).

SCHEDULE 10 — Amendment of the Offshore Installations (Safety Case) Regulations 2005

Introduction

1

• (1) The Offshore Installations (Safety Case) Regulations 2005 are amended as follows.

• (2) For regulation 2(6)(b) substitute—

(b) examination of any design, specification, certificate, marking or other document, or standard relating to those elements or that plant by such persons;

SCHEDULE 11 — Amendment of the Weights and Measures (Packaged Goods) Regulations 2006

Introduction

1

The Weights and Measures (Packaged Goods) Regulations 2006 are amended in accordance with paragraphs 2 to 5.

Amendment to regulation 2

2

In regulation 2 (interpretation) omit the definition of “Member State”.

Amendment to regulation 3

3

In regulation 3 (scope of application)—

• (a) omit paragraph (5);

• (b) after paragraph (6) insert—

(7) The obligations on the importer set out in regulation 5(1)(b) and regulation 6(1)(c) to ensure the package or outer container is marked with specified contact information do not apply where— (a) the importer has imported the package or outer container from an EEA state within the period of 24 months beginning with IP completion day; and (b) it is marked with the contact information of the person in that EEA state who packed or imported the package or who arranged for the packer to make up or the importer to import the package.

Amendment to regulation 11

4

Omit regulation 11 (notices to local weights and measures authorities).

Amendment to regulation 15

5

In regulation 15 (offences relating to E-marks) omit paragraph (2).

SCHEDULE 12 — Amendment of the Supply of Machinery (Safety) Regulations 2008

Introduction

1

The Supply of Machinery (Safety) Regulations 2008 are amended in accordance with paragraphs 2 to 34.

Amendment to regulation 2

2

• (1) Regulation 2 (interpretation) is amended as follows.

• (2) In paragraph (1)(a) at the end insert “ (as it had effect immediately before IP completion day) ”;

• (3) In paragraph (2)—

• (a) after the definition of “applicable” insert—

“approved body” has the meaning given to it in regulation 16A;

• (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (c) omit the definition of “CE marking”;

• (d) omit the definition of “Commission”;

• (e) after the definition of “conformity assessment” insert—

“designated standard” has the meaning given to it in regulation 2A;

• (f) omit the definition of “harmonised standard”;

• (g) in the definition of “manufacturer” for “an EEA state” substitute “Great Britain”;

• (h) omit the definition of—

• (i) “notified body”;

• (ii) “notified body criteria”;

• (iii) “notified body designation”;

• (iv) “official Community language”;

• (v) “published harmonised standard”;

• (i) after the definition of “safety component” insert—

“UK marking” means the marking in the form set out in Annex 2 of Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93;

Insertion of regulation 2A

3

After regulation 2 insert—

(2A) (1) Subject to paragraphs (6) and (7), in these Regulations a “designated standard” means a technical specification which is— (a) adopted by a recognised standardisation body, for repeated or continuous application, with which compliance is not compulsory; and (b) designated by the Secretary of State by publishing the reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate. (2) For the purposes of paragraph (1), a “technical specification” means a document that prescribes technical requirements to be fulfilled by a product, process, service or system and which lays down one or more of the following— (a) the characteristics required of a product, including— (i) levels of quality, performance, interoperability, environmental protection, health, safety or dimensions; and (ii) the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures; and (b) production methods and processes relating to the product, where these have an effect on the characteristics of the product. (3) For the purposes of this regulation a “recognised standardisation body” means any one of the following organisations— (a) the European Committee for Standardisation (CEN); (b) the European Committee for Electrotechnical Standardisation (Cenelec); (c) the European Telecommunications Standards Institute (ETSI); (d) the British Standards Institution (BSI). (4) When considering whether the manner of publication of a reference is appropriate in accordance with paragraph (1)(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard. (5) Before publishing the reference to a technical specification adopted by the British Standards Institution, the Secretary of State must have regard to whether the technical specification is consistent with technical specifications adopted by the other recognised standardisation bodies. (6) The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph (1)(b). (7) Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard. (8) In this regulation, a reference to a “product” is a reference to machinery to which these Regulations apply. (9) The Secretary of State may by regulations amend paragraph (3) to reflect any changes in the name or structure of the recognised standardisation bodies. (10) Regulations made under paragraph (9) are to be made by statutory instrument. (11) A statutory instrument containing regulations made under paragraph (9) is subject to annulment in pursuance of a resolution of either House of Parliament.

Amendment to regulation 3

4

In regulation 3 (placing on the market and putting into service; supplies outside the EEA and showing at trade fairs not covered)—

• (a) in the heading for “the EEA” substitute “Great Britain”;

• (b) in each place in which it occurs for “an EEA state” substitute “Great Britain”; and

• (c) in paragraph (2)(a) in both places in which it occurs for “CE” substitute “ UK ”.

Amendment to regulation 5

5

In regulation 5 (disapplication where more specific Community safety rules apply)—

• (a) in the heading omit “Community”;

• (b) for “EU directives other than the Directive” substitute “ other enactments (as they apply in Great Britain) ”; and

• (c) in the second place in which it occurs for “the Directive” substitute “ these Regulations ”.

Amendment to regulation 7

6

In regulation 7 (supply of machinery: general obligations and prohibition)—

• (a) in paragraph (2)(e) omit “EC”;

• (b) in paragraph (2)(f)—

• (i) for “CE” substitute “ UK ”;

• (ii) after “machinery” insert “ or where paragraph (2A) applies, or on a label affixed to, or document accompanying, the machinery ”;

• (ba) after paragraph (2) insert—

(2A) For a period of 24 months beginning with IP completion day, the UK marking may be affixed to— (a) a label affixed to the machinery; or (b) a document accompanying the machinery.

• (c) in paragraph (4)—

• (i) for “harmonised” substitute “ designated ”;

• (ii) omit “the references to which have been published in the Official Journal of the European Union (a “published harmonised standard”)”.

Amendment to regulation 11

7

In regulation 11 (Annex IV machinery manufactured fully in accordance with published harmonised standards and fully covered by such standards)—

• (a) in the heading and in paragraphs (1)(b)(i) and (1)(b)(ii) for “published harmonised” substitute “ designated ”;

• (b) in paragraph (2)(b) for “EC type-” substitute “ Type- ”.

Amendment to regulation 12

8

In regulation 12 (Annex IV machinery not manufactured fully in accordance with published harmonised standards or not fully covered by such standards)—

• (a) in the heading and in paragraphs (1)(b)(i) to (iii) for “published harmonised” substitute “ designated ”;

• (b) in paragraph (1)(b)(iv) for “harmonised” substitute “ designated ”;

• (c) in sub-paragraph (2)(a) for “EC type-” substitute “ Type- ”.

Insertion of regulation 12A

9

After regulation 12 insert—

(12A) (1) In this regulation— (a) any reference to an Article or an Annex is a reference to an Article of or an Annex to the Directive; (b) “CE marking” means the marking referred to in Article 16(1); (c) “harmonised standard” means a harmonised standard within the meaning of Article 2(l), the reference to which has been published in the Official Journal of the European Union. (2) Subject to paragraphs (6) and (7), paragraph (3) applies where, before placing machinery on the market or putting machinery into service, the responsible person— (a) ensures that the machinery satisfies the essential health and safety requirements set out in Annex I; (b) ensures that the technical file referred to in Annex VII, part A is available to the enforcement authorities on request; (c) provides the necessary information, referred to in Article 5(1)(c); (d) carries out the appropriate procedures for assessing conformity in accordance with Article 12; (e) ensures that the technical file, necessary information and records and correspondence relating to the conformity assessment procedures are prepared in or translated into English; (f) draws up the EC declaration of conformity in accordance with Annex II, part I, Section A and ensure that it accompanies the machinery; (h) ensures that the EC declaration of conformity is prepared in or translated into English; and (i) affixes the CE marking in accordance with Article 16. (3) Where this paragraph applies— (a) the requirements of regulation 7(2)(a), (b), (c), (e)(i) and (f) are to be treated as being satisfied; (b) regulations 7(2)(e)(ii), 15 and 21 apply subject to the modifications in paragraph (8); (c) Part 8 of Schedule 2 does not apply. (4) Subject to paragraphs (6) and (7) paragraph (5) applies where, before placing partly completed machinery on the market, the responsible person ensures that— (a) the relevant technical documentation referred to in Annex VII part B is prepared in or translated into English; (b) the assembly instructions referred to in Annex VI are prepared in or translated into English; and (c) a declaration of incorporation referred to in Annex II part 1, Section B has been drawn up in or translated into English. (5) Where this paragraph applies the requirements of regulation 8(1) are to be treated as being satisfied. (6) This paragraph applies to machinery listed in Annex IV where there is no designated standard or part of a designated standard which corresponds exactly to a harmonised standard or part of a harmonised standard referred to in Article 7(2). (7) Where paragraph (6) applies, paragraph (2)(d) is to be read as requiring the responsible person to have carried out the conformity assessment procedure in Article 12(4). (8) The modifications referred to in paragraph (3)(b) are that— (a) any reference to “declaration of conformity” is to be read as a reference to the EU declaration of conformity; (b) any reference to “UK marking” is to be read as a reference to the CE marking. (12B) (1) Subject to paragraph (2), regulation 12A ceases to have effect at the end of the period of 12 months beginning with IP completion day. (2) Notwithstanding the expiry of regulation 12A— (a) any machinery or partly completed machinery which was placed on the market or put into service pursuant to regulation 12A may continue to be made available on the market on or after the expiry of regulation 12A; (b) any obligation to which a person was subject under regulation 12A(2) in respect of machinery or partly completed machinery placed on the market or put into service pursuant to regulation 12A continues to have effect after the expiry of regulation 12A, in respect of that machinery or partly completed machinery. (12C) (1) Where paragraph (2) applies the requirements of Part 3, other than those in regulations 12A, 12B and this regulation, are treated as being satisfied. (2) This paragraph applies where— (a) the responsible person has complied with the requirements of Part 3, as that Part applies in Northern Ireland; and (b) the machinery or partly completed machinery is qualifying Northern Ireland goods. (3) In this regulation “qualifying Northern Ireland goods has the meaning given to it in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018.

Amendment to heading to Part 4

10

For the heading to Part 4 substitute— “ Part 4 UK Marking ”.

Amendment to regulation 13

11

In regulation 13 (CE marked machinery to be taken to comply with Regulations)—

• (a) in the heading for “CE” substitute “ UK ”;

• (b) in paragraph (1)—

• (i) for “CE” substitute “ UK ”;

• (ii) for “an EC” substitute “ a ”.

• (c) after paragraph (1) insert—

(1A) For the purposes of paragraph (1) machinery bears the UK marking if, in accordance with regulation 7(2A), the UK marking is affixed to — (a) a label affixed to the machinery; or (b) a document accompanying the machinery.

Amendment to regulation 14

12

• (1) Regulation 14 (machinery covered by more than one Directive) is amended as follows.

• (2) In the heading for “Directive” substitute “ enactment ”.

• (3) In paragraph (1)—

• (a) for “EU directive” substitute “ enactment ”;

• (b) for “the Directive” substitute “ these Regulations ”;

• (c) for “the other Directive” substitute “ the other enactment ” in both places in which it occurs;

• (d) for “CE” substitute “ UK ”.

• (4) In paragraph (2)—

• (a) in each place in which it occurs for “Directive” substitute “ enactment ”;

• (b) in sub-paragraph (c) omit—

• (i) “as published in the Official Journal of the European Union”;

• (ii) “EC”;

• (c) in the text following subparagraph (c) for “CE” substitute “ UK ”.

Amendment to regulation 15

13

In regulation 15 (protection of CE marking) in the heading and in each place where it occurs for “CE” substitute “ UK ”.

Amendment to the heading to Part 5

14

For the heading to Part 5 substitute— “ Part 5 Approved Bodies ”.

Omission of regulation 16

15

Omit regulation 16 (designation and monitoring of UK notified bodies).

Insertion of regulations 16A to 16C

16

Before regulation 17 insert—

(16A) (1) An approved body is a person who— (a) on or after IP completion day has been designated to carry out conformity assessment in accordance with regulation 16B, to the extent that the designation remains in effect; or (b) immediately before IP completion day was a UK notified body. (2) Paragraph (1) is subject to regulation 17. (3) In this Part a “UK notified body” means a person who immediately before IP completion day was a UK notified body as defined in regulation 16(3) of these Regulations as they had effect immediately before IP completion day. (16B) (1) The Secretary of State may only designate a person to carry out conformity assessment if that person qualifies for approval. (2) A person qualifies for approval if the Secretary of State— (a) is satisfied that the person meets the criteria specified in Annex XI (Part 11 of Schedule 2) (“approved body criteria”); and (b) makes a designation in respect of that person (an “approved body designation”). (3) Where a person meets the assessment criteria laid down in a designated standard (or part of such a standard) the Secretary of State is to presume that the person meets the approved body criteria covered by that standard (or that part of that standard). (4) Where the Secretary of States makes an approved body designation, that designation— (a) must be in writing; (b) must specify the conformity assessment procedures that the person designated may carry out; (c) may relate to all the categories of machinery listed in Annex IV (Part 4 of Schedule 2) or to such of those categories as are specified in the designation; (d) may designate a person for a specified period; and (e) 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. (5) In making an approved body designation the Secretary of State may have regard (in addition to the approved body criteria) to any other matter which appears to the Secretary of State to be relevant. (6) Where an approved body was a UK notified body immediately before IP completion, an “approved body designation” means a notified body designation within the meaning of regulation 16(2) and (4) of these Regulations, as they had effect immediately before IP completion. (16C) (1) The Secretary of State must, from time to time, carry out an inspection of each approved body with a view to verifying that it— (a) meets the approved body criteria; (b) complies with any condition to which its designation is subject— (i) in accordance with regulation 16B(4)(e); (ii) in the case of an approved body which was a UK notified body immediately before IP completion, in accordance with regulation 16(8)(e) as it applied before IP completion; and (c) complies with these Regulations. (2) An approved body must comply with any request of the Secretary of State to provide information relevant to determining its compliance with the approved body criteria, these Regulations, or any condition to which its designation is subject.

Amendment to regulation 17

17

Regulation 17 (duration, variation and termination of designations) is amended as follows—

• (a) in each place in which it occurs—

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

• (ii) for “a UK notified” substitute “ an approved ”;

• (iii) for “the UK notified” substitute “ the approved ”;

• (iv) for “another notified” substitute “ another approved ”;

• (v) for “another UK notified” substitute “ another approved ”.

• (b) after paragraph (6) insert—

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

Amendment to regulation 18

18

In regulation 18 (functions of UK notified bodies) in the heading and in each place in which it occurs—

• (a) for “notified” substitute “ approved ”;

• (b) for “UK notified” substitute “ approved ”

• (c) for “a UK notified” substitute “ an approved ”;

• (d) for “the UK notified” substitute “ the approved ”.

Amendment to regulation 19

19

In regulation 19 (fees) in each place in which it occurs for “a UK notified” substitute “ an approved ”.

Insertion of Regulation 19A

20

After regulation 19 insert—

(19A) (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 restriction on those activities. (2) The register referred to in paragraph (1) must be made publicly available.

Amendment to regulation 21

21

In regulation 21 (non-compliance with CE marking requirements)—

• (a) in the heading and in each place in which it occurs for “CE” substitute “ UK ”;

• (aa) in paragraph (1) after “affixed to it” insert “ (or, where regulation 7(2A) applies, to a label affixed to it or a document accompanying it) ” (four times);

• (b) in paragraph (1)(a) in both places in which it occurs for “the Directive” substitute “ these Regulations ”;

• (c) in paragraph (1)(b)(ii) omit “EC”.

Insertion of regulations 30 and 31

22

After regulation 29 insert—

(30) (1) In this regulation— - “pre-exit period” means the period beginning with 29 December 2009 and ending immediately before IP completion day; - “product” means machinery to which these Regulations apply. (2) Where a product was made available on the market during the pre-exit period, despite the amendments made by Schedule 12 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 , any obligation to which a person was subject under these Regulations as they had effect immediately before IP completion day, continues to have effect as it did immediately before IP completion day, in relation to that product. (3) Where during the pre-exit period— (a) a product has not been placed on the market; and (b) a manufacturer has taken any action to comply with regulations 10 to 12 as they had effect immediately before IP completion day in relation to that product that action has effect as if it had been done under regulations 10 to 12 as they have effect on and after IP completion day. (31) (1) In this regulation— “information requirements” means the requirements set out in— 1. section 1.7.3 of Schedule 2, Part 1 that all machinery must be marked visibly, legibly and indelibly with the business name and full address of the manufacturer and where applicable the manufacturer's authorised representative; and 2. section 4.3.1 of Schedule 2, Part 1 that each length of lifting chain, rope or webbing not forming part of an assembly must bear a mark or, where this is not possible, a plate or irremovable ring bearing the name and address of the responsible person and the identifying reference of the relevant certificate. (2) The information requirements do not apply to a person who— (a) falls within paragraph (b) of the definition of manufacturer in regulation 2(2); (b) has imported machinery from an EEA state and places it on the market within a period of 24 months beginning with IP completion day; and (c) before placing the machinery on the market, sets out the information referred to in sections 1.7.3 and 4.3.1 of Schedule 2, Part 1 in a document accompanying the machinery.

Amendment to Schedule 2 Part 1 Annex 1

23

• (1) Schedule 2 Part 1 Annex 1 (essential health and safety requirements relating to the design and construction of machinery) is amended as follows.

• (2) In point 1 (general Principles) in the fourth indent omit “in accordance with the objective of the Directive”.

• (3) In section 1.5.1 (electricity Supply)—

• (a) for “Directive 2006/95/EC” substitute “ Electrical Equipment (Safety) Regulations 2016 ” ;

• (b) for “the Directive” substitute “ these Regulations ”.

• (4) In section 1.5.7 (explosion) “EU directives” substitute “enactments”.

• (5) In section 1.7.1 (information and warnings on machinery) for the paragraph under the heading substitute—

Information and warnings on the machinery should preferably be provided in the form of readily understandable symbols or pictograms. Any written or verbal information and warnings must be expressed in English and may be accompanied on request by versions in any other language or languages understood by the operators.

• (6) In section 1.7.1.2 (warning devices) for “EU Directives” substitute “ enactments ”.