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

(1A) (1) Where in order to mitigate the effects of very serious safety concerns the Secretary of State considers that an item or family of pressure equipment are to be subject to different categories of modules, the Secretary of State may by regulations make such provision. (2) Regulations made under paragraph (1)— (a) are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament; and (b) include power— (i) to make different provision for different cases; and (ii) to make such supplemental, consequential and transitional provision as the Secretary of State considers appropriate. (2) The safety accessories defined in paragraph 5, are classified in category IV. However, by way of exception, safety accessories manufactured for specific equipment may be classified in the same category as the equipment they protect. (3) (1) The pressure accessories defined in paragraph 6, are classified on the basis of: (a) their maximum allowable pressure PS; (b) their volume V or their nominal size DN, as appropriate; (c) the group of fluids for which they are intended. (2) The appropriate table for vessels or piping is to be used to determine the conformity assessment category. (3) Where both the volume and the nominal size are considered appropriate in subparagraph (1)(b), the pressure accessory shall be classified in the highest category. (4) (1) The demarcation lines in the following conformity assessment tables indicate the upper limit for each category. (a) (i) Table 1: Vessels for gases, liquefied gases, gases dissolved under pressure, vapours and also those liquids whose vapour pressure is greater than 0.5 bar above normal atmospheric pressure (1013 mbar) and, for fluids in Group 1 with a volume greater than 1L and a product PS and V greater than 25 bar.L, or with a pressure PS greater than 200 bar (ii) Exceptionally, vessels intended to contain an unstable gas and falling within categories I or II on the basis of table 1 shall be classified in category III. (b) (i) Table 2: Vessels for gases, liquefied gases, gases dissolved under pressure, vapours and also those liquids whose vapour pressure is greater than 0.5 bar above normal atmospheric pressure (1013 mbar) and, for fluids in Group 2, with a volume greater than 1L and a product of PS and V is greater than 50 bar.L, or a pressure PS greater than 1000bar (ii) Exceptionally, portable extinguishers and bottles for breathing equipment shall be classified at least in category III. (c) Table 3: Vessels for liquids having a vapour pressure at the maximum allowable temperature of not more than 0.5 bar above normal atmospheric pressure (1013 mbar) and, for fluids in Group 1 with a volume greater than 1 L and a product of PS and V greater than 200 bar.L, or with a pressure PS greater than 500 bar (d) (i) Table 4: Vessels for liquids having a vapour pressure at the maximum allowable temperature of not more than 0.5 bar above normal atmospheric pressure (1013 mbar) and, for fluids in Group 2 with a pressure PS greater than 10 bar and a product of PS and V greater than 10000 bar.L, or with a pressure PS greater than 1000 bar (ii) Exceptionally, assemblies intended for generating warm water at temperatures not greater than 110°C which are manually fed with solid fuels and have a PS.V, shall be subject either to a Type examination (Module B — design type) with respect to their conformity with the essential requirements referred to in paragraphs 14, 15, 16, 17 and 30 and subparagraphs 33(2)(a) and (d) of Schedule 2 to these Regulations, or to full quality assurance (Module H). (e) (i) Table 5: Vessels fired or otherwise heated pressure equipment with the risk of overheating intended for generation of steam or superheated water at temperatures higher than 110°C having a volume greater than 2 L (ii) Exceptionally, the design of pressure-cookers shall be subject to a conformity assessment procedure equivalent to at least one of the category III modules. (f) (i) Table 6: Piping intended for gases, liquefied gases, gases dissolved under pressure, vapours and those liquids whose vapour pressure at the maximum allowable temperature is greater than 0.5 bar above normal atmospheric pressure (1013 mbar) and, for fluids in Group 1 with a DN greater than 25 (ii) Exceptionally, piping intended for unstable gases and falling within categories I or II on the basis of Table 6 shall be classified in category III. (g) (i) Table 7: Piping intended for gases, liquefied gases, gases dissolved under pressure, vapours and those liquids whose vapour pressure at the maximum allowable temperature is greater than 0.5 bar above normal atmospheric pressure (1013 mbar), and for fluids in Group 2 with a DN greater than 32 and a product of PS and DN greater than 1000 bar (ii) Exceptionally, all piping containing fluids at a temperature greater than 350 °C and falling within category II on the basis of Table 7 shall be classified in category III. (h) Table 8: Piping intended for liquids having a vapour pressure at the maximum allowable temperature of not more than 0.5 bar above normal atmospheric pressure (1013 mbar) and, for fluids in Group 1 with a DN greater than 25 and a product of PS and DN greater than 2000 bar (i) Table 9: Piping intended for liquids having a vapour pressure at the maximum allowable temperature of not more than 0.5 bar above normal atmospheric pressure (1013 mbar) and, for fluids in Group 2 with a PS greater than 10 bar, a DN greater than 200 and a product of PS and DN greater than 5000 bar (5) In this Schedule “safety accessories” are defined as follows— (a) devices designed to protect pressure equipment against the allowable limits being exceeded, including devices for direct pressure limitation, such as safety valves, bursting disc safety devices, buckling rods, controlled safety pressure relief systems (CSPRS), and limiting devices, which either activate the means for correction or provide for shutdown or a shutdown and lockout, such as pressure switched or temperature switches or fluid level switches and safety related measurement control and regulation (SRMCR) devices; and (b) devices intended for equipment covered in the tables in paragraph 6 including where such equipment is incorporated into an assembly. (6) In this Schedule “pressure accessories” are defined as follows— (a) devices with an operational function and having pressure-bearing housings; and (b) devices intended for equipment covered in the tables in paragraph 6 including where such equipment is incorporated into an assembly.

Amendment to Schedule 2

45

Schedule 2 (essential safety requirements) is amended as follows—

• (a) in paragraph 21(4), 31(4)(b)(i) and 35 (1) for “harmonised” substitute “ designated ”;

• (b) in paragraph 29 (1) for “CE” substitute “ UK ”; ...

• (c) omit paragraph 31(4)(b)(ii) ....

• (d) in paragraph 31(8) for “within the Union” substitute “ in the United Kingdom ”

Amendment to Schedule 3

46

Schedule 3 (classification of pressure equipment) is amended as follows—

• (a) beneath the heading to “Schedule 3” insert the Part heading “ Part 1 ”;

• (b) for the heading “classification of pressure equipment” substitute “ classification of pressure equipment before IP completion day”;

• (c) after paragraph 4 insert—

(5) Pressure equipment referred to in regulation 6 (pressure equipment and assemblies subject to essential safety requirements) must be classified by category in accordance with Schedule 1B (conformity assessment tables) to these Regulations according to an ascending level of hazard. (6) (1) In order to determine the appropriate category for classification of pressure equipment coming within regulations 6(a) to (c), the manufacturer must refer to the following tables within Schedule 1B to these Regulations— (a) for pressure equipment coming within— (i) regulation 6(a)(i)(aa), table 1; (ii) regulation 6(a)(i) (bb), table 2; (iii) regulation 6(a)(ii)(aa), table 3; (iv) regulation 6(a)(ii)(bb), table 4; (v) regulation 6(b), table 5; (vi) regulation 6(c)(i)(aa), table 6; (vii) regulation 6(c)(i)(bb), table 7; (viii) regulation 6(c)(ii)(aa), table 8; (ix) regulation 6(c)(ii)(bb), table 9; (b) for pressure equipment coming within regulation 6(d), the category must be determined in accordance with paragraphs 2 and 3 of Schedule 1B to these Regulations. (2) Where a vessel is composed of a number of chambers, it must be classified in the highest category applicable to the individual chambers and, where a chamber contains several fluids, classification must be on the basis of the fluid which requires the highest category. (7) For the purposes of the classification referred to in paragraph (5), fluids shall be divided up into the following groups— (a) group 1 consisting of substances and mixtures, as defined in points 7 and 8 of Article 2 of Regulation (EC) 1272/2008 of the European Parliament and of the Council of 16th December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EEC, and amending Regulation (EC) No 1907/2006, that are classified as hazardous in accordance with the following physical or health hazard classes laid down in Parts 2 and 3 of Annex 1 to that Regulation— (i) unstable explosives or explosives of Divisions 1.1. 1.2. 1.3, 1.4 and 1.5; (ii) flammable gases, category 1 and 2; (iii) oxidising gases, category 1; (iv) flammable liquids, categories 1 and 2; (v) flammable liquids, category 3 where the maximum allowable temperature is above the flashpoint; (vi) flammable solids, category 1 and 2; (vii) self-reactive substances and mixtures, type A to F; (viii) pyrophoric liquids, category 1; (ix) pyrophoric solids, category 1; (x) oxidising liquids, category 1, 2 and 3; (xi) substances and mixtures which in contact with water emit flammable gases, category 1, 2 and 3; (xii) oxidising liquids, category 1, 2 and 3; (xiii) oxidising solids, category 1, 2 and 3; (xiv) organic peroxides types A to F; (xv) acute oral toxicity, category 1 and 2; (xvi) acute dermal toxicity, category 1, 2 and 3; (xvii) acute inhalation toxicity, category 1, 2 and 3; (xviii) specific target organ toxicity – single exposure, category 1; Group 1 also comprises substances and mixtures contained in pressure equipment with a maximum allowable temperature TS which exceeds the flashpoint of the fluid; (b) group 2 consisting of substances and mixtures not referred to in point (a). (8) Where a vessel is composed of a number of chambers, it shall be classified in the highest category applicable to the individual changes. Where a chamber contains several fluids, classification shall be on the basis of the fluid which requires the highest category.

Amendment to Schedule 4

47

Schedule 4 (notified body requirements) is amended as follows—

• (a) in the heading and in every place in which it occurs, for “notified”, substitute “ approved ”;

• (b) for “a notified body” substitute “ an approved body ” in every place in which it occurs;

• (c) in paragraph 12(c) for “harmonised standards and of the Directive and” substitute “ designated standards ”;

• (d) in paragraph 18 omit “established under the Directive”.

Amendment to Schedule 5

48

Schedule 5 (user inspectorate requirements) is amended as follows—

• (a) in paragraph 10(c)—

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

• (ii) omit “of the Directive and”;

• (b) in paragraph 16—

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

• (ii) omit “established under the Directive”.

Amendment to Schedule 6

49

Schedule 6 (operational obligations of notified bodies, recognised third party organisations and user inspectorates) is amended as follows—

• (a) in the heading and in every place in which it occurs, for “notified”, substitute “ approved ”;

• (b) in every place in which it occurs, for “a notified body”, substitute “ an approved body ”;

• (c) in paragraph 5, for “harmonised”, substitute “ designated ”;

• (d) in paragraph 12, for “bodies notified under the Directive”, substitute “ other approved bodies ”; and

• (e) in paragraph 13, for “established under the Directive”, substitute “ established by the Secretary of State ”.

Amendment to Schedule 11

50

Schedule 11 (EU Declaration of Conformity) is amended as follows—

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

• (b) in paragraph 5, for “Union harmonisation legislation”, substitute “ statutory requirements ”;

• (c) in paragraph 6, for “harmonised”, substitute “ designated ”; and

• (d) in paragraph 7, for “notified”, substitute “ approved ”.

SCHEDULE 25 — Amendment of the Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016

Introduction

1

The Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016 are amended in accordance with paragraphs 2 to 41.

Amendment to regulation 2

2

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

• (2) In paragraph (1)—

• (a) in the definition of the “1994 Directive” at the end insert “ (as it has effect immediately before IP completion day ) ”;

• (b) after the definition of the “1996 Regulations” insert—

“approved body” has the meaning given to it in regulation 42;

• (c) omit the definition of “accreditation certificate”;

• (d) in the definition of “attestation of conformity”—

• (i) omit “EU”; and

• (ii) for “CE” substitute “ UK ”;

• (e) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (f) omit the definition of “CE Marking”;

• (g) omit the definition of “competent national authority”;

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

“conformity assessment activities” means any activities connected with conformity assessment including calibration, testing, certification and inspection;

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

“conformity assessment procedure” means a procedure referred to in regulation 39 (conformity assessment procedures); “declaration of conformity” means a declaration of conformity required to be drawn up in accordance with regulation 7(1)(a) (declaration of conformity and UK marking); “designated standard” has the meaning given to it in regulation 2A;

• (j) for the definition of “equipment category” substitute—

“equipment category” means the classification of equipment, within each equipment group, specified in Schedule 1A to these Regulations;

• (k) in the definition of “equipment-group I” for “as set out in Annex I of the ATEX Directive (as amended from time to time)” substitute “ as set out in Schedule 1A to these Regulations ”;

• (l) in the definition of “equipment-group II” for “as set out in Annex I of the ATEX Directive (as amended from time to time)” substitute “ as set out in Schedule 1A to these Regulations ”;

• (m) omit the definition of “EU declaration of conformity”;

• (n) omit the definition of “European Commission”;

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

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

“importer” means a person who— (a) is established in the United Kingdom and places a product from a country outside of the United Kingdom on the market; or (b) is established in Northern Ireland and places a product on the market that has been supplied to them for distribution, consumption or use in the course of a commercial activity, whether in return for payment or free of charge, from an EEA state;

• (q) in the definition of “make available on the market” for “EU market” substitute “market of Great Britain”;

• (r) omit the definition of “national accreditation body”;

• (s) omit the definition of “notified body requirements”;

• (t) omit the definition of “Official Journal”;

• (u) in the definition of “place on the market” for “EU market” substitute “market of Great Britain”;

• (v) in the definition of “putting into service” omit “within the EU market”;

• (w) after the definition of “technical specification” insert—

“UK marking” means the marking in the form set out in Annex 2 of RAMS; “UK national accreditation body” means the body appointed by the Secretary of State in accordance with Article 4 of RAMS.

• (3) After paragraph (1) insert—

(1A) Schedule 1A reproduces the provisions of Annex I to the ATEX Directive with amendments to correct deficiencies in retained EU law. (1B) A reference to a provision of Schedule 1A is a reference to the equivalent provisions of Annex I to the ATEX Directive as set out in Schedule 1A. (1C) Schedule 3A reproduces the provisions of Annexes III to IX to the ATEX Directive with amendments to correct deficiencies in retained EU law. (1D) A reference to any provision of Schedule 3A is a reference to the equivalent provisions of Annex III to IX of the ATEX Directive.

• (4) Omit paragraph (3).

• (5) Omit paragraph (6).

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, service or system, including— (i) levels of quality, performance, interoperability, environmental protection, health, safety or dimensions, and (ii) the requirements applicable to the product, service or system 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, service or system. (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) The Secretary of State may by regulations amend paragraph (3) to reflect any changes in the name or structure of the recognised standardisation bodies. (9) Regulations made under paragraph (8) are to be made by statutory instrument. (10) A statutory instrument containing regulations made under paragraph (8) is subject to annulment in pursuance of a resolution of either House of Parliament.

Amendment to regulation 3

4

In regulation 3 for paragraph (g) substitute—

(g) products connected with the production of trade in arms, munitions and war material;

Amendment to regulation 6

5

In regulation 6 (technical documentation and conformity assessment) for paragraph (b) substitute—

(b) draw up the technical documentation referred to— (i) for a product in respect of which the conformity assessment procedure in regulation 39(1)(a) is being carried out, in paragraph 3(c) of Part 1 of Schedule 3A to these Regulations; (ii) for a product in respect of which the conformity assessment procedure in regulation 39(1)(b) is being carried out, in paragraph 3(c) of Part 1 of Schedule 3A to these Regulations; (iii) for a product in respect of which the conformity assessment procedure in regulation 39(1)(c) is being carried out, in paragraph 2 of Part 6 of Schedule 3A to these Regulations; (iv) for a product in respect of which the conformity assessment procedure in regulation 39(1)(d) is being carried out, in paragraph 2 of Part 7 of Schedule 3A to these Regulations.

Amendment to regulation 7

6

Regulation 7 (EU declaration of conformity and CE marking) is amended as follows—

• (a) in the heading to that regulation—

• (i) for “EU declaration” substitute “ Declaration ”; and

• (ii) for “CE” substitute “ UK ”;

• (b) in paragraph (1)(a) omit “EU”;

• (c) in paragraph (1)(b) for “CE” substitute “ UK ” in each place in which it occurs;

• (d) in paragraphs (2), (4) and (5) omit “EU”;

• (e) for paragraph (6) substitute—

(6) Where a product is subject to more than one enactment requiring the drawing up of a declaration of conformity, the manufacturer must draw up a single declaration of conformity which identifies each enactment by its title.

Amendment to regulation 8

7

In regulation 8 (retention of technical documentation and EU declaration of conformity) and in the heading of that regulation omit “EU”.

Amendment to regulation 9

8

In regulation 9 (compliance procedures for series production), in paragraph (2)(b)—

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

• (b) omit “EU”.

Amendment to regulation 13

9

In regulation 13 (information identifying manufacturer), for paragraph 3 substitute—

(3) The information specified in paragraph (1) must be in a language which can be easily understood by end users and the market surveillance authority.

Amendment to regulation 14

10

For regulation 14 (instructions and safety information) substitute—

(14) When placing a product on the market, a manufacturer must ensure that a product is accompanied by instructions and safety information that are clear, legible and in easily understandable English.

Amendment to regulation 15

11

In regulation 15 (duty to take action in respect of a product placed on the market which is considered not to be in conformity), in paragraph (2) omit “, and the competent national authorities of any other Member State in which the manufacturer made the product available on the market,”.

Amendment to regulation 17

12

In regulation 17 (authorised representatives)—

• (a) in paragraph (1) for “EU” substitute “ United Kingdom ”;

• (b) in paragraph (4)(a) omit “EU”.

Amendment to regulation 19

13

In regulation 19 (requirements which must be satisfied before an importer places a product on the market)—

• (a) in paragraph (1)(c)(i) for “CE” substitute “ UK ”;

• (b) in paragraph (1)(c)(ii) omit “EU”;

• (c) in paragraph (2)(c) for “14(1) (instructions and safety information)” substitute “ 14 (provision of instructions and safety information) ”.

Amendment to regulation 21

14

Regulation 21 (information identifying importer) is amended as follows—

• (a) in paragraph (2) for “by the competent national authority in the Member State in which it is to be made available to end-users” substitute “ the market surveillance authority ”;

• (b) for paragraph (3) substitute—

(3) Paragraph (1) does not apply where— (a) either— (i) it is not possible to set out the information referred to in paragraph (1) on the product, or (ii) the importer has imported the product from an EEA state or Switzerland and places it on the market within the period of 24 months beginning with IP completion day, and (b) before placing the product on the market, the importer sets out the information referred to in paragraph (1)— (i) on the packaging; or (ii) in a document accompanying the product.

Amendment to regulation 22

15

For regulation 22 (instructions and safety information) substitute—

(22) When placing a product on the market, an importer must ensure that the product is accompanied by instructions and safety information that are clear, legible and in easily understandable English.

Amendment to regulation 25

16

In regulation 25 (duty to take action in respect of a product placed on the market which is considered not to be in conformity), in paragraph (2) omit “, and the competent national authorities of any other Member State in which the importer made the product available on the market,”.

Amendment to regulation 27

17

In regulation 27 (retention of technical documentation and EU declaration of conformity) and in the heading to that regulation omit “EU”.

Amendment to regulation 29

18

In regulation 29 (requirements which must be satisfied before a distributor makes a product available on the market)—

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

• (b) in paragraph (1)(a)(ii) omit “EU”;

• (c) for paragraph (1)(a)(iv) substitute—

(iv) is accompanied by instructions and safety information that are clear, legible and in easily understandable English;

Amendment to regulation 32

19

In regulation 32 (duty to take action in respect of products made available on the market which are not in conformity), in paragraph (2) omit “, and the competent national authorities of the other Member States in which the distributor has made the product available on the market,”.

Amendment to regulation 36

20

In regulation 36 (prohibition on improper use of CE marking) in each place in which it occurs, and in the heading, for “CE” substitute “ UK ”.

Insertion of regulations 36A and 36B

21

After regulation 36 insert—

(36A) (1) In this regulation— (a) any reference to an Article or an Annex is a reference to an Article or an Annex of the ATEX Directive; (b) “CE marking” has the meaning given to it in Article 2(26); and (c) “harmonised standard” has the meaning given to in in Article 2(18). (2) Subject to paragraphs (6) and (7) paragraph (3) applies where, before placing the product on the market, the manufacturer— (a) ensures that the product has been designed and manufactured in accordance with the essential safety requirements set out in Annex II; (b) ensures that the relevant conformity assessment procedures that apply to that product in accordance with Article 13(1) and (2) have been carried out; (c) draws up the technical documentation referred to in Annexes III to IX; (d) ensures that the records and correspondence relating to the conformity assessment procedures are prepared in or translated into English; (e) affixes a CE marking and the inscriptions in accordance with Articles 15 and 16(1) to (4); (f) draws up an EU declaration of conformity, in accordance with Article 14; and (g) ensures that the declaration of conformity is prepared in or translated into English. (3) Where this paragraph applies— (a) the requirements of regulations 5, 6, 7(1), (3) and 7(6) are to be treated as being satisfied; (b) regulations 2(a), 7(6), 8, 9(2), 17(4), 36 and 59 apply subject to the modifications in paragraph (10); (c) Part 3 does not apply; and (d) regulation 57 does not apply. (4) Subject to paragraphs (6) and (7) paragraph (5) applies where, before placing a product on the market, the importer ensures that— (a) the relevant conformity assessment procedure referred to in Article 13 has been carried out; (b) the manufacturer has drawn up the technical documents relevant to the conformity assessment procedure followed; and (c) the product bears the CE marking and inscriptions referred to in point 1.0.5 of Annex II. (5) Where this paragraph applies— (a) the requirements of regulation 19(1)(a) to (c) are to be treated as being satisfied; and (b) regulations 2(a),18, 23 and 27 apply subject to the modifications in paragraph (10). (6) This paragraph applies 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 12. (7) Where paragraph (6) applies, paragraphs (2)(b) and (4)(a) are to be treated as requiring the manufacturer to carry out— (a) the conformity assessment procedure set out in Article 13(1)(b); and (b) the relevant conformity assessment procedure that applies to that product in accordance with Article 13(2). (8) Paragraph (9) applies where, before making a product available on the market, a distributor ensures that the product bears the CE marking and inscriptions referred to in point 1.0.5 of Annex II. (9) Where this paragraph applies— (a) regulation 29(1)(a)(i) is to be treated as being satisfied; and (b) regulations 2(a), 30 and 31(1) apply subject to the modifications in paragraph (10). (10) The modifications referred to in subparagraphs (3)(b), (5)(b) and (9)(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 reference to the CE marking; (c) any reference to “essential safety requirements” is to be read as a reference to the essential safety requirements referred to in Annex II; (d) any reference to “designated standard” is to be read as a reference to a harmonised standard; (e) any reference to “relevant conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedures referred to in Article 13; (f) any reference to “technical documentation” is a reference to the technical documentation referred to in Annexes III to IX. (36B) (1) In this regulation any reference to an Article or Annex is a reference to an Article or an Annex of the ATEX Directive; (2) Paragraph (3) applies where, prior to the manufacture of a product, the manufacturer ensures that the conformity assessment procedure that applies to that product in accordance with Annex III as referred to in Article 13(1)(a) and (b) has been carried out. (3) Where this paragraph applies— (a) any requirement to follow the Type-examination set out in Part 1 of Schedule 3A in regulation 39 is to be treated as being satisfied; (b) any reference to “relevant conformity assessment procedure” in regulations 6(a), 7(1), 19(a), 36(1)(b), 40(c) and 41(3) is to be read as including the conformity assessment procedure set out in Annex III as referred to in Article 13(1)(a) and (b); and (c) any reference to “technical documentation” in regulations 6(b), 8, 19(b) and 27(b) is to be read as including the technical documentation relating to the design of the product referred to in Annex III. (36C) (1) Subject to paragraph (2), regulation 36A ceases to have effect at the end of the period of 12 months beginning with IP completion day. (2) Notwithstanding the expiry of regulation 36A— (a) any product which was placed on the market pursuant to regulation 36A may continue to be made available on the market on or after the expiry of regulation 36A; (b) any obligation to which a person was subject under regulation 36A in respect of any product placed on the market pursuant to regulation 36A continues to have effect after the expiry of regulation 36A, in respect of that product. (3) Subject to paragraph (4), regulation 36B ceases to have effect at the end of the period of 12 months beginning with IP completion day. (4) Where a conformity assessment procedure has been completed pursuant to regulation 36B in relation to a product prior to the expiry of regulation 36B, regulation 36B continues to apply in respect of that pressure equipment or assembly where— (a) the manufacturer arranges for the EU-Type examination certificate and any annexes to be transferred to an approved body; (b) the approved body referred to in sub-paragraph (a) accepts responsibility for the EU-Type examination certificate; and (c) the approved body issues a Type-examination certificate relying, or relying in part, on any examinations or tests undertaken prior to the issue of the EU-Type examination certificate. (5) In paragraph (4) “EU-Type examination certificate” means a certificate issued after the conformity assessment referred to in regulation 36B(2) has been carried out. (36D) (1) In this regulation— - “the 2017 Regulations” means the Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations (Northern Ireland) 2017; - “CE marking” has the meaning given to it in regulation 2(1) of the 2017 Regulations; - “qualifying Northern Ireland goods” has the meaning given to it in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018; - “relevant conformity assessment procedure” has the meaning given to it in regulation 2(1) of the 2017 Regulations; - “technical documentation” has the meaning given to it in regulation 2(1) of the 2017 Regulations. (2) Where paragraph (3) applies, a product is to be treated as being in conformity with Part 2. (3) This paragraph applies where— (a) a product— (i) is in conformity with Part 2, within the meaning of regulation 2(2) of the 2017 Regulations; and (ii) is qualifying Northern Ireland goods; and (b) an importer has complied with the obligations set out in paragraph (4). (4) The obligations referred to in paragraph (3)(b) are that, before placing the product on the market, the importer— (a) complies with regulation 21; (b) ensures that— (i) the relevant conformity assessment procedure has been carried out in relation to the product; (ii) the manufacturer has drawn up the technical documentation; and (iii) the product bears the CE marking.

Omission of regulation 37

22

Omit regulation 37 (translation of declaration of conformity).

Amendment to regulation 38

23

In regulation 38 (presumption of conformity), in paragraph (1)—

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

• (b) omit “the reference to which has been published in the Official Journal”.

Amendment to regulation 39

24

In regulation 39 (conformity assessment procedures)—

• (a) for paragraph (1)(a) substitute—

(a) for equipment-groups I and II, equipment-categories M1 and 1, the manufacturer must follow either— (i) the Type-examination set out in Part 1 of Schedule 3A, in conjunction with either the procedure set out in— (aa) Part 2 of Schedule 3A, or (bb) Part 3 of Schedule 3A; or (ii) the conformity based on unit verification referred to in Part 7 of Schedule 3A;

• (b) for paragraph (1)(b) substitute—

(b) for equipment-groups I and II, equipment-categories M2 and 2, the manufacturer must follow— (i) for internal combustion engines and electrical equipment in these groups and categories the Type examination set out in Part 1 of Schedule 3A, in conjunction with either the procedure set out in either Part 4 or Part 5 of Schedule 3A; (ii) for other equipment in these groups and categories the procedures set out in Part 6 of Schedule 3A;

• (c) for paragraph (1)(c) substitute—

(c) for equipment group II, equipment-category 3, the procedure relating to internal production control referred to in Part 6 of Schedule 3A;

• (d) for paragraph (1)(d) substitute—

(d) for equipment-groups I and II, instead of the procedures referred to in paragraphs (1)(a), (b) and (c), the manufacturer may follow conformity based on unit verification referred to in Part 7 of Schedule 3A.

• (e) in paragraph (3)(a)(i) for “CE” substitute “ UK ”;

• (f) in paragraph (3)(a)(ii) omit “EU”;

• (g) in paragraph (4) for “Annex VIII to the ATEX Directive (as amended from time to time)” substitute “ Part 6 of Schedule 3A ”;

• (h) in paragraph (5), omit “in the Member State concerned”;

• (i) in paragraph (6) for the words beginning with “the language” and ending with “market” substitute “ English ”.

Amendment to regulation 40

25

Regulation 40 (EU declaration of conformity) is amended as follows—

• (a) in the heading and in the body of the regulation, omit “EU”;

• (b) in paragraph (c) for “Annexes III to IX of the ATEX Directive (as amended from time to time)” substitute “ Schedule 3A to these Regulations ”.

Amendment to regulation 41

26

In regulation 41 (CE marking)—

• (a) for paragraph (1) substitute—

(1) The UK marking must be affixed visibly, legibly and indelibly— (a) to the product; (b) to its data plate; or (c) where paragraph (1A) applies, to— (i) a label affixed to the product; or (ii) a document accompanying the product.

• (aa) after paragraph (1) insert—

(1A) For a period of 24 months beginning with IP completion day, the UK marking may be affixed to— (a) a label affixed to the product; or (b) a document accompanying the product.

• (ab) in paragraph (2)—

• (i) after “Where” insert “ paragraph (1A) does not apply and ”;

• (ii) for “paragraph (1)” substitute “ paragraph (1)(a) or (b) ”;

• (ac) in the heading and in paragraphs (2) to (5) for “CE” substitute “ UK ” in each place in which it occurs;

• (b) for “notified body” substitute “ approved body ” in each place in which it occurs.

Amendment to Part 4

27

For Part 4, substitute—

(42) (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 43 (approval of conformity assessment bodies); or (b) immediately before IP completion day was a notified body in respect of which the Secretary of State has taken no action under regulation 48(1) or (2) as it had effect immediately before IP completion day to restrict, suspend or withdraw the body's status as a notified body. (2) Paragraph (1) has effect subject to regulation 46 (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 States of the European Union, in accordance with Article 17 of the ATEX Directive; and 2. in respect of which no objections had been raised as referred to in regulation 42(1)(b) as it had effect immediately before IP completion day. - “approved body requirements” means the requirements set out in Schedule 2. (43) (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 category of products in respect of which the conformity assessment body claims to be competent; and (b) either— (i) an accreditation certificate, or (ii) the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the conformity assessment body's compliance with the approved body requirements. (4) The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the approved body requirements. (5) For the purposes of paragraph (4), the Secretary of State may accept an accreditation certificate, provided in accordance with paragraph (3)(b), as sufficient evidence that the conformity assessment body meets the approved body requirements. (6) When deciding whether to approve a conformity assessment body that applies 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. (44) (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 part of that standard). (2) The presumption in paragraph (1) is rebuttable. (45) 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 43(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 43(6)(b) as it applied immediately before IP completion day; and (c) carries out its functions in accordance with these Regulations. (46) the Secretary of State must restrict, suspend or withdraw the body's status as an approved body under regulation 42 (approved bodies). (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 45(b), (2) Where the Secretary of State determines that an approved body no longer meets a condition referred to in regulation 45(b), the Secretary of State may restrict, suspend or withdraw the body's status as an approved body under regulation 42. (3) In deciding what action is required under paragraph (1) or (2) the Secretary of State must have regard to the seriousness of the non-compliance. (4) Before taking action under paragraph (1) or (2) the Secretary of State must— (a) give notice in writing to the approved body of the proposed action and the reasons for it; (b) give the approved body an opportunity to make representations to the Secretary of State regarding the proposed action within a reasonable period from the date of the notice; and (c) consider any such representations made by the approved body. (5) Where the Secretary of State has taken action in respect of an approved body under paragraph (1) or (2), or where an approved body has ceased its activity, the approved body must, at the request of the Secretary of State— (a) transfer its files relating to the activities it has undertaken as an approved body to another approved body or to the Secretary of State, or (b) keep its files relating to the activities it has undertaken as an approved body available for the Secretary of State and market surveillance authorities for a period of 10 years from the date they were created. (6) The activities undertaken by an approved body referred to in paragraph (5) include any activities that the body has undertaken as a notified body. (47) (1) Subject to the terms of its appointment, an approved body must carry out the conformity assessment activities and procedures— (a) in respect of which the body's approval was given under regulation 43, or (b) in respect of which the body's notification as a notified body was made. (2) Where an approved body carries out a conformity assessment procedure, it must do so in accordance with Schedule 3. (3) An approved body must make provision for a manufacturer to be able to make an appeal against a refusal by the approved body— (a) to issue a Type examination certificate referred to in Part 1 of Schedule 3B; (b) to affix, or cause to be affixed, the body's identification number pursuant to regulation 41 (UK marking). (48) (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 meet the approved body requirements; (b) the body has informed the Secretary of State that it is satisfied that the subcontractor or subsidiary meet 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 documents 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 ; (49) (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 notification 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. (50) The Secretary of State may authorise the UK national accreditation body to carry out the following activities on behalf of the Secretary of State— (a) assessing whether a conformity assessment body meets the approved body requirements; (b) monitoring approved bodies in accordance with regulation 45; and (c) compiling and maintaining the register of approved bodies, in accordance with regulation 49.

Amendment to regulation 54

28

In regulation 54 (exercise of enforcement powers) omit paragraph (c).

Amendment to regulation 56

29

Regulation 56 (enforcement action in respect of products which are not in conformity and which present a risk) is amended as follows—

• (a) in paragraph (2) for “notified” substitute “ approved ”;

• (b) in paragraph (4) for “European Commission, Northern Ireland and the other Member states” substitute “ Health and Safety Executive for Northern Ireland ”;

• (c) in paragraph (7) for “European Commission, Northern Ireland and the other Member States” substitute “ Health and Safety Executive for Northern Ireland ”;

• (d) in subparagraph (8)(f)(ii) for “harmonised” substitute “ designated ”.

Amendment to regulation 57

30

Omit regulation 57 (EU safeguard procedure).

Amendment to regulation 58

31

In regulation 58 (enforcement action in respect of products which are in conformity, but present a risk in paragraph (3) for “the European Commission and the other Member States” substitute “ the Health and Safety Executive for Northern Ireland ”;

Amendment to regulation 59

32

Regulation 59 (enforcement action in respect of formal non-compliance) is amended as follows—

• (a) in paragraphs (1)(a) and (1)(c)(ii) for “CE” substitute “ UK ” in each place in which it occurs;

• (b) in paragraph (1)(b) for “a notified” substitute “ an approved ”; and

• (c) in paragraph (1)(c) omit “EU” in each place in which it occurs.

Amendment to regulation 72

33

In regulation 72 (transitional provisions) omit paragraph (2).

34

After regulation 72 insert—

(72A) (1) In this regulation— “pre-exit period” means the period beginning with the commencement date and ending immediately before IP completion day; (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 25 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) Paragraph (2) does not apply to— (a) any obligation of any enforcing authority to inform the European Commission or the member States of any matter; or (b) any obligation to take action outside of the market 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 38 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 38 as it had effect on and after IP completion day.

Amendment to regulation 73

35

Regulation 73 (revocations and savings) is amended as follows—

• (a) in paragraph (1) after “paragraph (3)” insert “ and (3A) ”;

• (b) for paragraph (3) substitute—

(3) Subject to the modifications made in paragraph (3A), the Regulations referred to in paragraph (1) continue to apply, as if they had not been revoked, to a product placed on the market before the commencement date.

• (c) After paragraph (3) (as substituted), insert—

(3A) The modifications in the 1996 Regulations referred to in paragraph (3) are as follows— (i) any reference to “the Community” shall be read as including the United Kingdom; (ii) any reference to “member State” shall be read as including the United Kingdom; (iii) any reference to “notified body” shall be read as “approved body” as defined in the Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016 .

Amendment to Schedule 1

36

Schedule 1 (essential health and safety requirements) is amended as follows—

• (a) in paragraph 5(1)(b) for “CE marking (see Annex II RAMS)” substitute “ UK marking; ”;

• (b) at paragraph 13(2)—

• (i) for “other European Union legislation” substitute “ any other enactment ”;

• (ii) for “European Union legislation” substitute “ enactment ”.

Insertion of Schedule 1A

37

After Schedule 1 insert—

SCHEDULE 1A (1) Equipment group I (a) Equipment category M 1 comprises equipment designed and, where necessary, equipped with additional special means of protection to be capable of functioning in conformity with the operational parameters established by the manufacturer and ensuring a very high level of protection. Equipment in this category is intended for use in underground parts of mines as well as those parts of surface installations of such mines endangered by firedamp and/or combustible dust. Equipment in this category is required to remain functional, even in the event of rare incidents relating to equipment, with an explosive atmosphere present, and is characterised by means of protection such that: - — either, in the event of failure of one means of protection, at least an independent second means provides the requisite level of protection, - — or the requisite level of protection is assured in the event of two faults occurring independently of each other. - Equipment in this category must comply with the supplementary requirements referred to in paragraph 30 of Schedule 1. (b) Equipment category M 2 comprises equipment designed to be capable of functioning in conformity with the operational parameters established by the manufacturer and ensuring a high level of protection. Equipment in this category is intended for use in underground parts of mines as well as those parts of surface installations of such mines likely to be endangered by firedamp and/or combustible dust. This equipment is intended to be de-energised in the event of an explosive atmosphere. The means of protection relating to equipment in this category assure the requisite level of protection during normal operation and also in the case of more severe operating conditions, in particular those arising from rough handling and changing environmental conditions. Equipment in this category must comply with the supplementary requirements referred to in paragraph 31 of Schedule 1. (2) Equipment-group II (a) Equipment category 1 comprises equipment designed to be capable of functioning in conformity with the operational parameters established by the manufacturer and ensuring a very high level of protection. Equipment in this category is intended for use in areas in which explosive atmospheres caused by mixtures of air and gases, vapours or mists or by air/dust mixtures are present continuously, for long periods or frequently. Equipment in this category must ensure the requisite level of protection, even in the event of rare incidents relating to equipment, and is characterised by means of protection such that: - — either, in the event of failure of one means of protection, at least an independent second means provides the requisite level of protection, - — or the requisite level of protection is assured in the event of two faults occurring independently of each other. - Equipment in this category must comply with the supplementary requirements referred to in paragraphs 32 and 33 of Schedule 1. (b) Equipment category 2 comprises equipment designed to be capable of functioning in conformity with the operational parameters established by the manufacturer and of ensuring a high level of protection. Equipment in this category is intended for use in areas in which explosive atmospheres caused by gases, vapours, mists or air/dust mixtures are likely to occur occasionally. The means of protection relating to equipment in this category ensure the requisite level of protection, even in the event of frequently occurring disturbances or equipment faults which normally have to be taken into account. Equipment in this category must comply with the supplementary requirements referred to in paragraphs 34 and 35 of Schedule 1. (c) Equipment category 3 comprises equipment designed to be capable of functioning in conformity with the operating parameters established by the manufacturer and ensuring a normal level of protection. Equipment in this category is intended for use in areas in which explosive atmospheres caused by gases, vapours, mists, or air/dust mixtures are unlikely to occur or, if they do occur, are likely to do so only infrequently and for a short period only. Equipment in this category ensures the requisite level of protection during normal operation. Equipment in this category must comply with the supplementary requirements referred to in paragraphs 36 and 37 of Schedule 1.

Amendment to Schedule 2

38

Schedule 2 (notified body requirements) is amended as follows—

• (a) in the heading and in paragraphs 6, 9, 12(a) and 18 for “notified” substitute “ approved ”;

• (b) in paragraph 3 for “regulation 44 (notification)” substitute “ regulation 43 (approval of conformity assessment bodies) ”;

• (c) in paragraph 10(b) for “a notified” substitute “ an approved ”;

• (d) in paragraph 12(c) for “harmonised standards and of the ATEX Directive” substitute “ designated standards ”; and

• (e) in paragraph 18 for “under the ATEX Directive” substitute “ by the Secretary of State ”.

Amendment to Schedule 3

39

In Schedule 3 (operational obligations of notified bodies) is amended as follows—

• (a) in the shoulder reference for “Regulation 49” substitute “ Regulation 47 ”;

• (b) in the heading and in paragraphs 7 and 9 for “notified” substitute “ approved ”;

• (c) in all places in which it occurs (other than where stated in paragraph (b)) for “a notified” substitute “an approved";

• (d) in paragraph 10(b) for “regulation 44 (notification)” substitute “ regulation 43 (approval of conformity assessment bodies) ”;

• (e) in paragraph 10(d) for “notification under regulation 44” substitute “ approval under regulation 43 ”;

• (f) in paragraph 12 for “bodies notified under the ATEX Directive” substitute “ bodies approved under these Regulations ”;

• (g) in paragraph 13 for “notified body coordination group established under the ATEX Directive” substitute “ approved body coordination group established by the Secretary of State ”.

Insertion of Schedule 3A

40

After Schedule 3 insert—