The Pressure Equipment (Safety) Regulations 2016

All economic operators U.K.

Cases in which obligations of manufacturers apply to importers and distributors U.K.

36.  An importer or distributor (“A”) is to be considered a manufacturer for the purposes of these Regulations, and is subject to the obligations of the manufacturer under this Part, where A—

(a) places pressure equipment or an assembly on the market under A's own name or trademark; or

(b) modifies pressure equipment or an assembly already placed on the market in such a way that it may affect whether the pressure equipment or assembly is in conformity with Part 2.

Translation of F1 ... declaration of conformity E+W+S

37.—(1) Before making pressure equipment or an assembly available on the market, an economic operator must ensure that the F2 ... declaration of conformity is [F3 in English].

F4 (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E1 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F1 Word in reg. 37 heading omitted (E.W.S.) (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 24 para. 23(a) (with Sch. 24 para. 41) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F2 Word in reg. 37(1) omitted (E.W.S.) (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 24 para. 23(a) (with Sch. 24 para. 41) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in reg. 37(1) substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 24 para. 23(b) (with Sch. 24 para. 41) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F4 Reg. 37(2) omitted (E.W.S.) (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 24 para. 23(c) (with Sch. 24 para. 41) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Translation of EU declaration of conformity N.I.

37.—(1) Before making pressure equipment or an assembly available on the market, an economic operator must ensure that the EU declaration of conformity is prepared in, or translated into, the language required by the [F9 relevant state] in which it is to be made available on the market.

(2) Where the pressure equipment or assembly is to be made available on the market in [F10 Northern Ireland], the language required is English.

Extent Information

E3 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F9 Words in reg. 37(1) substituted (N.I.) (31.12.2020) by The Pressure Vessels (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/678), reg. 1(b), Sch. 2 para. 3(1)

F10 Words in reg. 37(2) substituted (N.I.) (31.12.2020) by The Pressure Vessels (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/678), reg. 1(b), Sch. 2 para. 3(2)

Identification of economic operators U.K.

38.—(1) An economic operator (“E”) who receives a request in relation to pressure equipment or an assembly from the market surveillance authority before the end of the relevant period must, within such period as that authority may specify, identify to the authority—

(a) any other economic operator who has supplied E with the pressure equipment or assembly; and

(b) any other economic operator to whom E has supplied the pressure equipment or assembly.

(2) The relevant period is—

(a) for information under paragraph (1)(a), 10 years beginning on the day on which E was supplied with the pressure equipment or assembly; and

(b) for information under paragraph (1)(b), 10 years beginning on the day on which E supplied the pressure equipment or assembly.

Prohibition on improper use of [F5 UK] marking E+W+S

39.—(1) An economic operator must not affix the [F6 UK] marking to pressure equipment or an assembly unless—

(a) that economic operator is the manufacturer of the pressure equipment or assembly; and

(b) the conformity of the pressure equipment or assembly with the essential safety requirements has been demonstrated by a relevant conformity assessment procedure.

(2) An economic operator must not affix the [F6 UK] marking to pressure equipment or an assembly where—

(a) the conformity assessment procedure followed in accordance with regulation 41 is either module A2, C2, F or G; and

(b) the conformity assessment procedure has been carried out by a user inspectorate.

(3) An economic operator must not affix to pressure equipment or an assembly a marking which—

(a) is not the [F6 UK] marking; but

(b) purports to attest that the pressure equipment or assembly is in conformity with the essential safety requirements.

(4) An economic operator must not affix to pressure equipment or an assembly a marking, sign or inscription which is likely to mislead any other person as to the meaning or form of the [F6 UK] marking.

(5) An economic operator must not affix to pressure equipment or an assembly any other marking if the visibility, legibility and meaning of the [F6 UK] marking would be impaired as a result.

Extent Information

E2 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F5 Word in reg. 39 heading substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 24 para. 24 (with Sch. 24 para. 41) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F6 Word in reg. 39 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 24 para. 24 (with Sch. 24 para. 41) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Prohibition on improper use of CE marking N.I.

39.—(1) An economic operator must not affix the CE marking to pressure equipment or an assembly unless—

(a) that economic operator is the manufacturer of the pressure equipment or assembly; and

(b) the conformity of the pressure equipment or assembly with the essential safety requirements has been demonstrated by a relevant conformity assessment procedure.

(2) An economic operator must not affix the CE marking to pressure equipment or an assembly where—

(a) the conformity assessment procedure followed in accordance with regulation 41 is either module A2, C2, F or G; and

(b) the conformity assessment procedure has been carried out by a user inspectorate.

(3) An economic operator must not affix to pressure equipment or an assembly a marking which—

(a) is not the CE marking; but

(b) purports to attest that the pressure equipment or assembly is in conformity with the essential safety requirements.

(4) An economic operator must not affix to pressure equipment or an assembly a marking, sign or inscription which is likely to mislead any other person as to the meaning or form of the CE marking.

(5) An economic operator must not affix to pressure equipment or an assembly any other marking if the visibility, legibility and meaning of the CE marking would be impaired as a result.

Extent Information

E4 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F7 Obligations which are met by complying with the obligations in the Directive E+W+S

39A.— (1) In this regulation—

(a) any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive;

(b) “CE marking” has the meaning given to it in Article 2(31); and

(c) “pressure equipment and assemblies” means the pressure equipment and assemblies referred to in Article 4(1) and (2).

(2) Paragraph (3) applies where, before placing pressure equipment or an assembly on the market, the manufacturer—

(a) ensures that the pressure equipment or assembly has been manufactured in accordance with the essential safety requirements set out in Annex I;

(b) ensures that the relevant conformity assessment procedures referred to in Article 14 have been carried out;

(c) draws up the technical documentation referred to in Annex III;

(d) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in or translated into English;

(e) affixes a CE marking and the identification number of the notified body (where that body is involved in the product control phase) in accordance with Articles 18 and 19(1) to (4);

(f) draws up an EU declaration of conformity, in accordance with Article 17; and

(g) ensures that the EU declaration of conformity is prepared in or translated into English.

(3) Where this paragraph applies—

(a) the requirements of regulations 9(1), 10 and 11(1) are to be treated as being satisfied;

(b) regulations 2(2)(a), 11(3), 12, 15(2), 19(2) and 39 apply subject to the modifications in paragraph (8); and

(c) Part 3 does not apply;

(d) regulation 74 does not apply.

(4) Paragraph (5) applies where, before placing pressure equipment or an assembly on the market, the importer ensures that—

(a) the relevant conformity assessment procedure referred to in Article 14 has been carried out;

(b) the manufacturer has drawn up the technical documentation referred to in Annex III; and

(c) the pressure equipment or assembly bears the CE marking and any notified body identification number.

(5) Where this paragraph applies—

(a) the requirements of regulation 21(1)(a) to (c) are to be treated as being satisfied; and

(b) regulations 2(2)(a), 22(1), 25 and 28 apply subject to the modifications in paragraph (8).

(6) Paragraph (7) applies where, before making pressure equipment or an assembly available on the market, a distributor ensures that the pressure equipment or assembly bears the CE marking.

(7) Where this paragraph applies—

(a) regulation 31(1)(a)(i) is to be treated as being satisfied; and

(b) regulations 2(2)(a) and 33(1) apply subject to the modifications in paragraph (8).

(8) The modifications referred to in sub-paragraphs (3)(b), (5)(b) and (7)(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;

(c) any reference to “essential safety requirements” is to be read as a reference to the essential safety requirements referred to in Annex I;

(d) any reference to “designated standard” is to be read as a reference to a harmonised standard within the meaning of Article 2(24); and

(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 14.

Textual Amendments

F7 Regs. 39A-39D inserted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 24 para. 25 (with Sch. 24 para. 41) (as amended by S.I. 2020/676, regs. 1(1), 2 and S.I. 2020/1460, reg. 1(4), Sch. 3 para. 16(3)(b)); 2020 c. 1, Sch. 5 para. 1(1)

Conformity assessment procedure obligation which is met by complying with the Directive. E+W+S

39B .— (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, prior to the manufacture of pressure equipment or an assembly, the manufacturer ensures that the conformity assessment procedure that applies to that pressure equipment or assembly in accordance with Article 14(2), referred to as Module B and set out in Annex III, has been carried out.

(3) Where this paragraph applies—

(a) the requirement in regulation 42 to follow the conformity assessment procedure referred to in that regulation as Module B is to be treated as being satisfied;

(b) any reference to “relevant conformity assessment procedure” in regulations 10(1)(c), 11(1), 21(1)(a), 39(1)(b) and 48(b) is to be read as including the conformity assessment procedure referred to in Article 14(2), referred to as Module B and set out in Annex III; and

(c) any reference to “technical documentation” in regulations 10(1)(d), 21(1)(b) and 28(b) is to be read as including the technical documentation relating to the design of the pressure equipment or assembly referred to as Module B as set out in Annex III.

Textual Amendments

F7 Regs. 39A-39D inserted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 24 para. 25 (with Sch. 24 para. 41) (as amended by S.I. 2020/676, regs. 1(1), 2 and S.I. 2020/1460, reg. 1(4), Sch. 3 para. 16(3)(b)); 2020 c. 1, Sch. 5 para. 1(1)

[F8 Further use of the UK marking E+W+S

39C.— (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) “pressure equipment or assembly” means the pressure equipment or assembly referred to in Article 4(1) and (2);

(c) “harmonised standard” has the meaning given in Article 2(24).

(2) Paragraph (3) applies where, before placing pressure equipment or assembly on the market, the manufacturer—

(a) ensures that the pressure equipment or assembly has been manufactured in accordance with the essential safety requirements set out in Annex I;

(b) ensures that the relevant conformity assessment procedures that apply to that pressure equipment or assembly referred to in Article 14 have been carried out;

(c) draws up the technical documentation referred to in Annex III; and

(d) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in or translated into English.

(3) Where this paragraph applies—

(a) regulations 9(1) and 10 are to be treated as being satisfied;

(b) except for regulations 48 and 49(1) to (5), Part 3 does not apply;

(c) regulations 2(2)(a), 12, 15, 21(1)(a) and (b), 22, 25, 31, 32, 33 and 39 apply subject to the modifications in paragraph (4);

(d) regulations 11, 14, 24, 48 and 49(2) and Schedule 11 are subject to the modifications in paragraphs (4) and (5).

(4) The modifications referred to in paragraph (3)(c) and (d) are that—

(a) any reference to “essential safety requirements” is to be read as a reference to the essential safety requirements set out in Annex I;

(b) any reference to “designated standard” is to be read as a reference to a harmonised standard;

(c) any reference to “conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedure referred to in Article 14;

(d) any reference to “technical documentation” is to be read as a reference to the technical documentation referred to in Annex III;

(e) any reference to “pressure equipment or an assembly referred to in regulation 6 or 7” is to be read as a reference to pressure equipment or assembly referred to in Article 4(1) or (2).

(5) The modifications referred to in paragraph (3)(d) are that—

(a) in regulation 11—

(i) paragraph (1) is to be read as if sub-paragraph (c) were omitted;

(ii) in paragraph (4) the reference to “enactment” is to be read as including the Directive;

(b) in regulations 14 and 24 any reference to paragraphs 29 and 30 of Schedule 2 is to be read as a reference to paragraphs 3.3 and 3.4 of Annex I;

(c) in regulation 48 the reference to “Schedule 1A to these Regulations” is to be read as a reference to Annex III;

(d) in regulation 49(2)—

(i) the reference to “regulation 42” is to be read as a reference to Article 14;

(ii) the reference to “user inspectorate” is to be read as a reference to any body designated in accordance with Article 16;

(e) in Schedule 11—

(i) in paragraph 5 the reference to “statutory requirements” is to be read as including a reference to the Directive;

(ii) paragraph 7 is to be read as requiring the manufacturer to include the details set out in paragraph 7 of Annex IV.]

Textual Amendments

F8 Reg. 39C substituted (1.10.2024) by The Product Safety and Metrology etc. (Amendment) Regulations 2024 (S.I. 2024/696), regs. 1(2), 15(3) (with reg. 23)

Qualifying Northern Ireland Goods E+W+S

39D.— (1) Where paragraph (2) applies any pressure equipment or assembly is to be treated as being in conformity with Part 2.

(2) This paragraph applies where—

(a) any pressure equipment or assembly—

(i) is in conformity with Part 2, as that Part applies in Northern Ireland; and

(ii) is qualifying Northern Ireland goods; and

(b) an importer has complied with the obligations set out in paragraph (3).

(3) The obligations referred to in paragraph (2)(b) are that, before placing the pressure equipment or assembly on the market, the importer—

(a) complies with regulation 23;

(b) ensures that—

(i) the relevant conformity assessment procedure has been carried out in accordance with Part 3, as that Part applies in Northern Ireland;

(ii) the manufacturer has drawn up the technical documentation; and

(iii) the pressure equipment or assembly bears the CE marking.

(4) In this regulation—

“CE marking” has the meaning given to it in regulation 2(1), as it applies in Northern Ireland;

“qualifying Northern Ireland goods” has the meaning given to it in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018;

“technical documentation” has the meaning given to it in regulation 2(1), as it applies in Northern Ireland.]

Textual Amendments

F7 Regs. 39A-39D inserted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 24 para. 25 (with Sch. 24 para. 41) (as amended by S.I. 2020/676, regs. 1(1), 2 and S.I. 2020/1460, reg. 1(4), Sch. 3 para. 16(3)(b)); 2020 c. 1, Sch. 5 para. 1(1)