The Treatment of Conformity Assessment Bodies (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Regulations 2024

Statutory Instruments

2024 No. 504

BUILDING AND BUILDINGS

CIVIL AVIATION

CONSTRUCTION

CONSUMER PROTECTION

ELECTROMAGNETIC COMPATIBILITY

ENERGY CONSERVATION

HEALTH AND SAFETY

MERCHANT SHIPPING

TELECOMMUNICATIONS

TRADE

TRANSPORT

WEIGHTS AND MEASURES

The Treatment of Conformity Assessment Bodies (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Regulations 2024

Made

7th April 2024

Laid before Parliament

15th April 2024

Coming into force in accordance with regulation 1(2)

The Secretary of State makes these Regulations in exercise of the powers conferred by section 2(1) and (2) of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024(1).

Part 1 Preliminary

Citation, commencement and extent

1.—(1) These Regulations may be cited as the Treatment of Conformity Assessment Bodies (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Regulations 2024.

(2) These Regulations come into force immediately after the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024 comes into force in accordance with section 7(1) of that Act, ignoring the different provision in section 7(2).

(3) These Regulations extend to England and Wales and Scotland only.

Part 2 Amendment to subordinate legislation

Amendment to the Ammonium Nitrate Materials (High Nitrogen Content) Safety Regulations 2003

2.—(1) The Ammonium Nitrate Materials (High Nitrogen Content) Safety Regulations 2003(2) are amended as follows.

(2) In regulation 2(2) (interpretation)—

(a) for the definition of “competent laboratory” substitute—

““competent laboratory” means a laboratory which—

(a)

is accredited by the United Kingdom Accreditation Service under standard ISO 17025 (general requirements for the competence of testing and calibration laboratories) of the International Organisation for Standardisation;

(b)

is based in the United Kingdom or in the territory of a party to the CPTPP; and

(c)

has sufficient equipment, facilities and expertise to conduct a detonation resistance test and is independent from any person having an interest in the outcome of such test;”;

(b) after the definition of “competent laboratory” insert—

““the CPTPP” has the meaning set out in section 1 of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024;”;

(c) omit “and” at the end of the definition of “unique numbered copy”; and

(d) after the definition of “unique numbered copy” insert—

““United Kingdom Accreditation Service” means a company limited by guarantee incorporated in England and Wales under number 03076190; and”.

(3) In regulation 13(2) (transitional provision) after “were a reference to the United Kingdom or the European Union” insert “, and as if words “from the United Kingdom Accreditation Service” were omitted for laboratories based in the European Union”.

Amendment to the Ecodesign for Energy-Related Products Regulations 2010

3.  In paragraph 10 (UK national accreditation body) of Schedule 1B (conformity assessment bodies) to the Ecodesign for Energy-Related Products Regulations 2010(3)—

(a) for sub-paragraph (1) substitute—

“(1) A conformity assessment body must have legal personality and must be established in—

(a) Great Britain; or

(b) the territory of a party to the CPTPP.”; and

(b) after sub-paragraph (1) insert—

“(1A) In sub-paragraph (1) “the CPTPP” has the meaning set out in section 1 of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024.”.

Amendment to the Toys (Safety) Regulations 2011

4.  For paragraph 1 of Schedule 7 (approved body requirements) to the Toys (Safety) Regulations 2011(4) substitute—

“1.— (1) A conformity assessment body must have legal personality and must be established in—

(a) the United Kingdom; or

(b) the territory of a party to the CPTPP.

(2) In sub-paragraph (1) “the CPTPP” has the meaning set out in section 1 of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024.”.

Amendment to the Explosives Regulations 2014

5.  For paragraph 1 of Schedule 15 (approved body requirements) to the Explosives Regulations 2014(5) substitute—

“1.— (1) A conformity assessment body must have legal personality and must be established in—

(a) the United Kingdom; or

(b) the territory of a party to the CPTPP.

(2) In sub-paragraph (1) “the CPTPP” has the meaning set out in section 1 of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024.”.

Amendment to the Merchant Shipping (Marine Equipment) Regulations 2016

6.  For paragraph 2 of Schedule 3 (requirements to be met by conformity assessment bodies in order to become approved bodies) to the Merchant Shipping (Marine Equipment) Regulations 2016(6) substitute—

“2.— (1) A conformity assessment body must have legal personality and must be established in—

(a) the United Kingdom; or

(b) the territory of a party to the CPTPP.

(2) In sub-paragraph (1) “the CPTPP” has the meaning set out in section 1 of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024.”.

Amendment to the Electromagnetic Compatibility Regulations 2016

7.  For paragraph 1 of Schedule 5 (requirements for approved bodies) to the Electromagnetic Compatibility Regulations 2016(7) substitute—

“1.— (1) A conformity assessment body must have legal personality and must be established in—

(a) the United Kingdom; or

(b) the territory of a party to the CPTPP.

(2) In sub-paragraph (1) “the CPTPP” has the meaning set out in section 1 of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024.”.

Amendment to the Simple Pressure Vessels (Safety) Regulations 2016

8.  For paragraph 1 of Schedule 4 (approved bodies) to the Simple Pressure Vessels (Safety) Regulations 2016(8) substitute—

“1.— (1) A conformity assessment body must have legal personality and must be established in—

(a) the United Kingdom; or

(b) the territory of a party to the CPTPP.

(2) In sub-paragraph (1) “the CPTPP” has the meaning set out in section 1 of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024.”.

Amendment to the Lifts Regulations 2016

9.  For paragraph 1 of Schedule 4 (approved body requirements) to the Lifts Regulations 2016(9) substitute—

“1.— (1) A conformity assessment body must have legal personality and must be established in—

(a) the United Kingdom; or

(b) the territory of a party to the CPTPP.

(2) In sub-paragraph (1) “the CPTPP” has the meaning set out in section 1 of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024.”.

Amendment to the Pressure Equipment (Safety) Regulations 2016

10.—(1) The Pressure Equipment (Safety) Regulations 2016(10) are amended as follows.

(2) In regulation 2(1) (interpretation), after the definition of “conformity assessment procedure” insert—

““the CPTPP” has the meaning set out in section 1 of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024;”.

(3) In paragraph 31 (materials) of Schedule 2 (essential safety requirements), for sub-paragraph (8) substitute—

“(8) Certificates issued by a material manufacturer are presumed to certify conformity with the relevant requirements of this paragraph where the manufacturer has an appropriate quality-assurance system that—

(a) is certified by a competent body established in—

(i) the United Kingdom;

(ii) the territory of an EEA state; or

(iii) the territory of a party to the CPTPP; and

(b) has undergone a specific assessment for materials.”.

(4) For paragraph 2 of Schedule 4 (approved body requirements) substitute—

“2.   A conformity assessment body must have legal personality and must be established in—

(a) the United Kingdom; or

(b) the territory of a party to the CPTPP.”.

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

11.  For paragraph 1 of Schedule 2 (approved body requirements) to the Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016(11) substitute—

“1.— (1) A conformity assessment body must have legal personality and must be established in—

(a) the United Kingdom; or

(b) the territory of a party to the CPTPP.

(2) In sub-paragraph (1) “the CPTPP” has the meaning set out in section 1 of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024.”.

Amendment to the Non-automatic Weighing Instruments Regulations 2016

12.  For paragraph 1 of Schedule 3 (approved body requirements) to the Non-automatic Weighing Instruments Regulations 2016(12) substitute—

“1.— (1) A conformity assessment body must have legal personality and must be established in—

(a) the United Kingdom; or

(b) the territory of a party to the CPTPP.

(2) In sub-paragraph (1) “the CPTPP” has the meaning set out in section 1 of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024.”.

Amendment to the Measuring Instruments Regulations 2016

13.  For paragraph 1 of Schedule 5 (requirements related to approved bodies) to the Measuring Instruments Regulations 2016(13) substitute—

“1.— (1) A conformity assessment body must have legal personality and must be established in—

(a) the United Kingdom; or

(b) the territory of a party to the CPTPP.

(2) In sub-paragraph (1) “the CPTPP” has the meaning set out in section 1 of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024.”.

Amendment to the Recreational Craft Regulations 2017

14.  For paragraph 1 of Schedule 11 (requirements of approved bodies) to the Recreational Craft Regulations 2017(14) substitute—

“1.— (1) A conformity assessment body must have legal personality and must be established in—

(a) the United Kingdom; or

(b) the territory of a party to the CPTPP.

(2) In sub-paragraph (1) “the CPTPP” has the meaning set out in section 1 of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024.”.

Amendment to the Radio Equipment Regulations 2017

15.  For paragraph 1 of Schedule 8 (approved body requirements) to the Radio Equipment Regulations 2017(15) substitute—

“1.— (1) A conformity assessment body must have legal personality and must be established in—

(a) the United Kingdom; or

(b) the territory of a party to the CPTPP.

(2) In sub-paragraph (1) “the CPTPP” has the meaning set out in section 1 of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024.”.

Part 3 Amendment to assimilated direct legislation

Amendment to Regulation (EU) No 305/2011

16.—(1) Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC(16) is amended as follows.

(2) In Article 2 (definitions), after paragraph (28) insert—

“(29) “the CPTPP” has the meaning set out in section 1 of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024.”.

(3) In Article 19 (UK assessment document), after paragraph (1) insert—

“(1A) The duty in paragraph (1) applies only to TABs that are established in the United Kingdom.”.

(4) In Article 21 (obligations of the TAB receiving a request for a UK technical assessment), after paragraph (1A) insert—

“(1B) Paragraph (1)(a) and (1)(c) apply only to TABs that are established in the United Kingdom.”.

(5) In Article 29 (designation, monitoring and evaluation of TABs), for paragraph (3) substitute—

“(3) The Secretary of State may designate a body as a TAB for one or several of the product areas listed in Table 1 of Annex 4 providing the body is established in—

(a) the United Kingdom; or

(b) the territory of a party to the CPTPP.”.

(6) In Article 30 (requirements for TABs), after paragraph (2) insert—

“(2A) Paragraph (2)(a) applies only to TABs that are established in the United Kingdom.”.

(7) In Article 43 (requirements for approved bodies), for paragraph (2) substitute—

“(2) An approved body must have legal personality and must be established in—

(a) the United Kingdom; or

(b) the territory of a party to the CPTPP.”.

Amendment to Regulation (EU) 2016/425

17.  In Article 24 (approved body requirements) of Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC(17)—

(a) for paragraph (2) substitute—

“(2) A conformity assessment body must have legal personality and must be established in—

(a) the United Kingdom; or

(b) the territory of a party to the CPTPP.”; and

(b) after paragraph (2) insert—

“(2A) In paragraph (2) “the CPTPP” has the meaning set out in section 1 of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024.”.

Amendment to Regulation (EU) 2016/426

18.  In Article 23 (approved body requirements) of Regulation (EU) 2016/426 of the European Parliament and of the Council on appliances burning gaseous fuels and repealing Directive 2009/142/EC(18)—

(a) for paragraph (2) substitute—

“(2) A conformity assessment body must have legal personality and must be established in—

(a) the United Kingdom; or

(b) the territory of a party to the CPTPP.”; and

(b) after paragraph (2) insert—

“(2A) In paragraph (2) “the CPTPP” has the meaning set out in section 1 of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024.”.

Amendment to Regulation (EU) 2018/858

19.  In Article 68 (designation of technical services) of Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC(19)—

(a) for paragraph (3) substitute—

“(3) Subject to paragraph (3B), a technical service must have legal personality and must be established in—

(a) the United Kingdom;

(b) a member State; or

(c) the territory of a party to the CPTPP.”; and

(b) after paragraph (3) insert—

“(3A) In paragraph (3) “the CPTPP” has the meaning set out in section 1 of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024.

(3B) Paragraph (3) does not apply to a technical service belonging to an approval authority or an accredited in-house technical service of the manufacturer, as referred to in Article 72.”.

Amendment to Commission Delegated Regulation (EU) 2019/945

20.  In Article 22 (requirements relating to approved bodies) of Commission Delegated Regulation (EU) 2019/945 of 12 March 2019 on unmanned aircraft systems and on third-country operators of unmanned aircraft systems(20)—

(a) for paragraph (2) substitute—

“(2) A conformity assessment body shall have legal personality and shall be established in—

(a) the United Kingdom; or

(b) the territory of a party to the CPTPP.”; and

(b) after paragraph (2) insert—

“(2A) In paragraph (2) “the CPTPP” has the meaning set out in section 1 of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024.”.

Greg Hands

Minister of State for Trade Policy

Department for Business and Trade

7th April 2024

Explanatory Note

(This note is not part of the Regulations)

These Regulations are made in exercise of the powers conferred by section 2(1) and (2) of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024 (“the Act”) in order to implement Article 8.6 of the Comprehensive and Progressive Agreement for Trans-Pacific Partnership, signed at Santiago on 8 March 2018, including the UK Accession Protocol, as it has effect in the United Kingdom from time to time (“the CPTPP”).

All the legislation being amended currently includes a restriction on where relevant conformity assessment bodies can be established. This restriction is typically to the United Kingdom but in some legislation it is to Great Britain and in some legislation it also includes member States. In order to implement the requirement of paragraph 1 of Article 8.6 that each party to the CPTPP shall accord to conformity assessment bodies located in the territory of another party treatment no less favourable than that it accords to conformity assessment bodies located in its own territory or in the territory of any other party, these Regulations amend the provisions containing these establishment requirements to also include conformity assessment bodies which are established in the territory of a party to the CPTPP.

These Regulations also make other minor changes to some of the legislation being amended in order to implement Article 8.6 and to make supplementary provision. This includes making additional amendments to the Ammonium Nitrate Materials (High Nitrogen Content) Safety Regulations 2003 in order to require that competent laboratories, unless based in the European Union, must receive their accreditation from the United Kingdom Accreditation Service, following other changes made by these Regulations to permit competent laboratories to additionally be based in the territory of a party to the CPTPP.

This also includes additional amendments to Regulation (EU) No 305/2011 (as assimilated into United Kingdom law), to require that certain requirements imposed on technical assessment bodies (“TABs”) are only imposed on TABs which are established in the United Kingdom. These requirements only include those requirements imposed on TABs which do not constitute conformity assessment activities and are therefore not within scope of Article 8.6 of the CPTPP.

A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, voluntary or public sector is foreseen.

(1)

2024 c. 6.

(2)

S.I. 2003/1082, amended by S.I. 2011/1885, 2019/306, 2019/601, 2022/29, 2022/1182; there are other amending instruments but none is relevant.

(3)

S.I. 2010/2617; Schedule 1B was inserted by S.I. 2019/539; there are other amending instruments but none is relevant; they were made under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018.

(4)

S.I. 2011/1881; Schedule 7 was inserted by S.I. 2019/696; there are other amending instruments but none is relevant; they were made under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018.

(5)

S.I. 2014/1638; Schedule 15 was inserted by S.I. 2016/315 and amended by 2019/696; there are other amending instruments but none is relevant; they were made under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018.

(6)

S.I. 2016/1025. Schedule 3 was inserted by S.I. 2019/470; there are other amending instruments but none is relevant; they were made under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018.

(7)

S.I. 2016/1091, amended by S.I. 2019/696; there are other amending instruments but none is relevant; they were made under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018.

(8)

S.I. 2016/1092, amended by S.I. 2019/696; there are other amending instruments but none is relevant; they were made under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018.

(9)

S.I. 2016/1093, amended by S.I. 2016/1186, 2019/696; there are other amending instruments but none is relevant; they were made under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018.

(10)

S.I. 2016/1105, amended by S.I. 2019/696, 2024/XXXX; there are other amending instruments but none is relevant; they were made under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018.

(11)

S.I. 2016/1107, amended by S.I. 2019/696; there are other amending instruments but none is relevant; they were made under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018.

(12)

S.I. 2016/1152, amended by S.I. 2019/696; there are other amending instruments but none is relevant; they were made under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018.

(13)

S.I. 2016/1153, amended by S.I. 2019/696; there are other amending instruments but none is relevant; they were made under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018.

(14)

S.I. 2017/737, amended by S.I. 2019/696; there are other amending instruments but none is relevant; they were made under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018.

(15)

S.I. 2017/1206, amended by S.I. 2019/696; there are other amending instruments but none is relevant; they were made under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018.

(16)

EUR 305/2011, as amended by S.I. 2019/465; there are other amending instruments but none is relevant.

(17)

EUR 2016/425, as amended by S.I. 2019/696; there are other amending instruments but none is relevant.

(18)

EUR 2016/426, as amended by S.I. 2019/696; there are other amending instruments but none is relevant.

(19)

EUR 2018/858, as amended by S.I. 2022/1273; there are other amending instruments but none is relevant.

(20)

EUR 2019/945, as amended by S.I. 2020/1593; there are other amending instruments but none is relevant.