The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019

[^key-f69c73463b3f8aac1994b61b89c804d1]: Sch. 3 para. 40 inserted (31.12.2020 immediately before S.I. 2020/1577, Pt. 2 comes into force) by The REACH etc. (Amendment etc.) (EU Exit) (No. 3) Regulations 2019 (S.I. 2019/1144), regs. 1, 5(5) (as amended by S.I. 2020/1577, regs. 1(1)(a), 13(2)(4)(d))

[^key-f76590dc5f8d37158c7eb917d6b65046]: Sch. 1 para. 4 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(1)

[^key-f803b356feaa27ccefe8166a9ee1a29a]: Sch. 3 para. 13 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(1)

[^key-f80613b8345b4112f7c203f3f15df200]: Sch. 1 para. 75 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(1)

[^key-f8e2a1d8a29cde49d8eb6191efee4925]: Sch. 1 para. 26 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(1)

[^key-f95d927cc866da07f0f2db197bac9f24]: Sch. 3 para. 4 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(1)

[^key-f9984393cbd4271fff20e7d2eef67925]: Words in Sch. 10 para. 1(5) omitted (31.12.2020 immediately before IP completion day) by virtue of The REACH etc. (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1577), regs. 1(1)(b), 10(4)(b)

[^key-f9c0adb60e72055457f76caa1ea7237b]: Words in Sch. 1 para. 8(3) substituted (31.12.2020 immediately before IP completion day) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1577), regs. 1(1)(b), 4(15)(a)

[^key-fa172e02f9bda6f58f90b082b37555a1]: Sch. 1 para. 92 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(1)

[^key-fb7d9c5e44a232211a68462ed5e7a07c]: Sch. 1 para. 66 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(1)

[^key-fc3feb4eed710f13266218270b73421c]: Sch. 10 para. 1(6) inserted (31.12.2020 immediately before IP completion day) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1577), regs. 1(1)(b), 10(5)

[^key-fcec62b59740cb405d2c7f7068646629]: Sch. 4 para. 3 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(1)

[^key-fd72ac474b01cb2282d2c5efc85cafeb]: Sch. 5 para. 3 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(1)

[^key-fe1c5423afd2eca1c7f09a2a254ab657]: Sch. 1 para. 8 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(1)

[^key-fe78a50bf71d8a7699c9ac50b444806e]: Sch. 1 para. 10 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(1)

[^M_I_0cd9dc96-7380-4efa-e99d-ee070169a929]: Sch. 2A para. 1 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(1)

[^M_I_19613dfb-6b4f-4916-d7d7-de7fcfea8e95]: Sch. 3 para. 28A in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(1)

[^M_I_4ba4ade3-5597-4a2e-aa4f-6cddabd9f1e2]: Reg. 4A in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(1)

[^M_I_68c1de08-60ef-4f6f-dad7-fd48de509e89]: Sch. 3 para. 40 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(1)

[^M_I_767927a7-83a7-4da1-811a-417e8b076b8e]: Sch. 10 para. 1A in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(1)

[^M_I_9234c0ec-3a9b-468d-8f54-55fcc28f4f20]: Sch. 3 para. 37A in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(1)

[^M_I_adda515e-73ec-4e19-d8c5-c402dd0de1f9]: Sch. 11 para. 2A in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(1)

Citation, commencement , interpretation and extent

Imports from Northern Ireland

4A

The provision in Schedule 2A in respect of imports from Northern Ireland has effect.

Amendment of Annexes and Appendices

Amendment of the Test Methods Regulation

Amendment of the Data Regulation

Amendment of the Fees and Charges Regulation

Amendment of an authorisation under Article 60(4) of the REACH Regulation

Revocation of direct retained EU legislation

Amendment of the EEA agreement

Amendment of the REACH Enforcement Regulations 2008

Amendment and revocation of subordinate legislation

SCHEDULE 2A — Provision in respect of imports from Northern Ireland

1

After Article 139, insert—

(1) This Article applies in a case where there is a protected NI import of a substance. (2) There is a protected NI import of a substance if— (a) a substance— (i) has a relevant connection to Northern Ireland, and (ii) is imported on its own, in a mixture or in an article, (b) the substance, mixture or article is a qualifying Northern Ireland good, and (c) the person who supplies the substance, mixture or article for the import is a registrant or a downstream user under EU REACH as respects the substance as it is imported. (3) A substance has a relevant connection to Northern Ireland if— (a) it is— (i) manufactured in Northern Ireland, (ii) in a mixture that is manufactured or formulated in Northern Ireland, or (iii) in an article that is manufactured or produced in Northern Ireland, and (b) it is imported from a supplier established in Northern Ireland. (4) The importer of the substance (the “GB importer”) is to be treated for the purposes of this Regulation as a downstream user as respects any protected NI imports of the substance by them. (5) The provisions of this Regulation that apply to importers do not apply to the GB importer in relation to the protected NI import of the substance by the GB importer. (6) If the GB importer imports the substance in quantities of 1 to 10 tonnes per year they must, before they make a protected NI import— (a) notify the Agency of their intention to make the protected NI import, (b) supply the Agency with the information referred to in point (a)(i) of Article 10, (c) supply the Agency with the information referred to in points (a)(ii) and (iv) of Article 10 to the extent that information is available to the GB importer, (d) supply the Agency with the information referred to in points (a) to (d) of Article 32(1) and otherwise comply with Article 32, (e) supply the Agency with the relevant registration number for the substance under EU REACH to the extent that information is available to the GB importer, (f) supply the Agency with such other evidence as the Agency may require demonstrating that the information supplied in accordance with subparagraph (d) complies with the requirements of Articles 10, 12 and 14 (as they apply to the tonnage of the substance which the GB importer imports into Great Britain by protected NI imports). (7) If the GB importer imports the substance in quantities of 10 tonnes or more per year they must, before they make a protected NI import— (a) notify the Agency of their intention to make the protected NI import, (b) supply the Agency with the information referred to in point (a)(i) of Article 10, (c) supply the Agency with the information referred to in points (a)(ii) and (iv) of Article 10 to the extent that information is available to the GB importer, (d) supply the Agency with the information referred to in— (i) Article 14(6) to the extent that information is available to the GB importer, (ii) Article 31, and (iii) Article 32(1)(a) to (d), (e) otherwise comply with Articles 14(6), 31 and 32, (f) supply the Agency with the relevant registration number for the substance under EU REACH to the extent that information is available to the GB importer, (g) supply the Agency with such other evidence as the Agency may require demonstrating that the information supplied in accordance with subparagraph (d) complies with the requirements of Articles 10, 12 and 14 (as they apply to the tonnage of the substance which the GB importer imports into Great Britain by protected NI imports). (8) The GB importer must update the information provided to the Agency under paragraph 6 or 7 with any relevant new information and submit it to the Agency. (1) 9. Paragraphs 6, 7 and 8 are subject to paragraph 6 of Article 139B. (1) This Article applies in relation to a protected NI import of a substance. (2) A person established in Northern Ireland who manufactures a substance on its own, in mixtures or in articles, formulates a mixture or produces an article that is imported into Great Britain may fulfil the obligations on the GB importer under Article 139A (the “NI notifier”). (3) Article 36 applies to the NI notifier. (4) The NI notifier must, without prejudice to Article 36, keep available and up-to-date information on quantities imported and customers sold to, as well as information on the supply of the latest update of the safety data sheet referred to in Article 31. (5) A person who intends to act in accordance with paragraph 2 must inform the GB importer that they intend to do so. (6) If the GB importer is informed of the intention in accordance with paragraph 5, then paragraphs 6 to 8 of Article 139A apply to the NI notifier instead of the GB importer as respects any protected NI import from the NI notifier. Subject to Articles 139D and 139E, Title 7 applies to and in respect of substances imported from Northern Ireland as it applies to and in respect of other substances. (1) This Article applies to a person (“P”) that is established in Northern Ireland that is a manufacturer, importer or downstream user of a substance under EU REACH. (2) P may apply for an authorisation in respect of that substance under Article 62 if the substance is a qualifying Northern Ireland good (“QNIG”). (3) A substance is a QNIG if it is a QNIG on its own, or contained in a mixture or article that is a QNIG. (4) This Regulation applies to P in respect of the application, and to the authorisation if it is granted, as if P was an only representative of P appointed in accordance with Article 8. (1) This Article applies to a person established in Northern Ireland that made an existing application for an EU authorisation within the meaning of Article 127G(6) (the “existing NI applicant”) that satisfies the condition in paragraph 2. (2) The condition is that the substance in respect of which the application was made is a qualifying Northern Ireland good (“QNIG”). (3) The condition in paragraph (2) is satisfied if the application was in respect of a substance that is a QNIG on its own, or a substance contained in a mixture or article that is a QNIG. (4) Paragraphs 1 to 4 and 6 of Article 127G apply to the existing NI applicant as if the references to “Great Britain” were to “the United Kingdom”. (5) If the authorisation is granted— (a) it has no effect in Northern Ireland, (b) this Regulation applies to the existing NI applicant in respect of the authorisation as if the existing NI applicant was an only representative of the existing NI applicant appointed in accordance with Article 8.

28A

• (1) In entry 51 of the table (Bis(2-ethylhexyl) phthalate (DEHP) etc.), the second column is amended as follows.

• (2) In paragraph 4(c), for “Directive 2007/46/EC” substitute “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”.

• (3) In paragraph 4(g), for “Directives 90/385/EEC, 93/42/EEC or 98/79/EC” substitute “The Medical Devices Regulations 2002 ”.

• (4) In paragraph 4(h), for “Directive 2011/65/EU” substitute “ the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 ”.

• (5) In paragraph 4(i), for the words from “Regulation (EC) No 726/2004” to the end substitute “ the Veterinary Medicines Regulations 2013 or the Human Medicines Regulations 2012 ”.

• (6) In paragraph 6(a), for “Regulation (EC) No 216/2008” substitute “ Regulation (EU) 2018/1139 ”.

37A

• (1) In entry 72 of the table (the substances listed in column 1 of the table in Appendix 12), the second column is amended as follows.

• (2) In paragraph 4, for “Regulation (EU) 2017/745” to the end substitute “The Medical Devices Regulations 2002”.

• (3) In paragraph 6, omit “Union”.

• (4) In paragraph 7—

• (a) for “Commission” substitute “ Secretary of State ”;

• (b) omit “and, if appropriate, modify that point accordingly”.

40

• (1) Appendix 12 (entry 72 – restricted substances and maximum concentration limits by weight in homogenous materials) is amended as follows.

• (2) For “Part 3 of Annex VI to Regulation (EC) No 1272/2008” wherever it occurs, substitute “ the GB mandatory classification and labelling list ”.

1A

After regulation 1 insert—

(1A) These Regulations apply to— (a) England and Wales and Scotland; and (b) offshore installations in relevant waters, other than such waters within the seaward limits of the territorial sea adjacent to Northern Ireland.

The REACH (Appointment of Competent Authorities) Regulations 2007: Northern Ireland

2A

• (1) The REACH (Appointment of Competent Authorities) Regulations 2007 are amended in accordance with this regulation.

• (2) In regulation 2 omit—

• (a) the definition of “devolved administration”;

• (b) the definition of “Welsh Ministers”.

• (3) In regulation 3(1)—

• (a) omit sub-paragraphs (a) and (b);

• (b) in paragraph (c)—

• (i) for “Department of Enterprise, Trade and Investment” substitute “Department for the Economy”;

• (ii) for “Department of the Environment” substitute “Department of Agriculture, Environment and Rural Affairs”.

• (4) In regulation 3(2), for “a devolved administration” substitute “the Northern Ireland Assembly”.

• (5) Omit paragraph 4.

The Tribunal Procedure (First-tier Tribunal) (General Regulatory Chamber) Rules 2009