Exiting The European Union Citation and commencement 1 These Regulations may be cited as the REACH etc. (Amendment etc.) (EU Exit) (No. 3) Regulations 2019 and come into force immediately before Part 2 of the REACH etc. (Amendment etc.) (EU Exit) Regulations 2020 comes into force . Amendment of the REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 2 The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 are amended as follows. Amendment of Schedule 1 3 1 Schedule 1 (amendment of Titles 1 to 15) is amended in accordance with this regulation. 2 In sub-paragraph (3)(a)(ii) of paragraph 34— a for “by 31 May 2020” substitute “ within 12 months of exit day ” ; b for “each year after 2020” substitute “ in each subsequent year ” . 3 For sub-paragraph (4)(b) of paragraph 45 substitute— b in the second subparagraph, in the second sentence, for “by 1 June 2009” substitute “ within 12 months of exit day ” . . 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 In paragraph 95— a for sub-paragraph (3)(a) substitute— a in the first sentence, for “By 1 June 2019” substitute “ Within 18 months of exit day ” ; ; b for sub-paragraph (6)(a) substitute— a in the first sentence, for “By 1 June 2019” substitute “ Within 18 months of exit day ” ; ; c for sub-paragraph (7)(a) substitute— a for “by 1 June 2019” substitute “ within 18 months of exit day ” ; . Amendment of Schedule 2 4 1 Schedule 2 (transitional provision) is amended in accordance with this regulation. 2 In inserted Article 127A— a in paragraph 3(a), for “during the 2 year period” substitute “ in the period beginning with 29 March 2017 and ending immediately ” ; b in the second sub-paragraph of paragraph 6, for “during the 2 year period before exit” substitute “ in the period beginning with 29 March 2017 and ending immediately before exit day ” . 3 After inserted Article 127G insert— Article 127GA Substances of very high concern: sunset dates and latest application dates 1 Paragraphs 2 and 3 apply where— a immediately before exit day, a substance is included in Annex 14 to EU REACH; b the EU latest application date fell before or during the relevant pre-exit period; c the EU sunset date fell during the relevant pre-exit period; d before the EU latest application date, an application had been made for the grant of an authorisation in accordance with Articles 60 to 64 of EU REACH in relation to the substance (the “authorisation application”); and e immediately before exit day, the authorisation application was still under consideration (see paragraph 11). 2 Where, immediately before exit day, a person established in the United Kingdom may place the substance on the market or use it himself in reliance on Article 56(1)(d) of EU REACH by virtue of the authorisation application having been made, this Regulation has effect subject to the modifications set out in paragraph 3. 3 As respects that person placing the substance on the market or using it himself on and after exit day— a the UK latest application date, and b the UK sunset date, both fall on the transitional cut-off date (rather than on the dates specified in Annex 14 for that substance). 4 Paragraphs 5 and 6 apply where— a immediately before exit day, a substance is included in Annex 14 to EU REACH; b the EU latest application date fell during the relevant pre-exit period; c the EU sunset date falls after the end of that period; d before the EU latest application date, an application had been made for the grant of an authorisation in accordance with Articles 60 to 64 of EU REACH in relation to the substance (the “authorisation application”); and e immediately before exit day, the authorisation application was still under consideration (see paragraph 11). 5 Where, on and after the UK sunset date, a person established in the United Kingdom would be able to place the substance on the market or use it himself in reliance on Article 56(1)(d) of this Regulation had the authorisation application been made under this Regulation, this Regulation has effect subject to the modifications set out in paragraph 6. 6 As respects that person placing the substance on the market or using it himself on and after exit day— a the UK latest application date, and b the UK sunset date, both fall on the transitional cut-off date (rather than on the dates specified in Annex 14 for that substance). The effect of this paragraph is to be ignored in reading the reference to the UK sunset date in paragraph 5. 7 Paragraph 8 applies where— a immediately before exit day, a substance is included in Annex 14 to EU REACH; and b the UK latest application date falls during the 18 month post-exit period. 8 As respects a person established in the United Kingdom placing the substance on the market or using it himself on and after exit day, the UK latest application date falls on the transitional cut-off date (rather than on the date specified in Annex 14 for that substance). 9 Where paragraph 3, 6 or 8 modifies this Regulation, Article 56(1) has effect with the following provision substituted for point (d)— d the UK sunset date (within the meaning of Article 127GA) has been reached and he made an application before the UK latest application date (within the meaning of Article 127GA) but a decision on the application for authorisation has not yet been taken; or . 10 Where paragraph 3 or 6 modifies the date that is the UK sunset date, any reference in this Regulation to the date of the kind referred to in Article 58(1)(c)(i) has effect subject to the modification made by paragraph 3 or 6. 11 For the purposes of paragraph 1(e) or 4(e), the authorisation application is “still under consideration” unless— a the Commission has made a final decision granting or refusing the authorisation application, or b the authorisation application— i has the relevant connection with the United Kingdom (within the meaning of Article 127G), and ii is at the final decision stage (within the meaning of Article 127G). 12 In this Article— “ EU latest application date ”, in relation to a substance, means the date of the kind referred to in Article 58(1)(c)(ii) of EU REACH that is specified in Annex 14 to EU REACH in relation to the substance; “ EU sunset date ”, in relation to a substance, means the date of the kind referred to in Article 58(1)(c)(i) of EU REACH that is specified in Annex 14 to EU REACH in relation to the substance; “ relevant pre-exit period ” means the period that— a begins with 29 March 2017, and b ends immediately before exit day; “ transitional cut-off date ” means the last day of the 18 month post-exit period; “ UK latest application date ”, in relation to a substance, means the date of the kind referred to in Article 58(1)(c)(ii) of this Regulation that is specified in Annex 14 to this Regulation in relation to the substance; “ UK sunset date ”, in relation to a substance, means the date of the kind referred to in Article 58(1)(c)(i) of this Regulation that is specified in Annex 14 to this Regulation in relation to the substance; “ 18 month post-exit period ” means the period of 18 months beginning with the day after that on which exit day falls. . 4 In inserted Article 127N— a in paragraph 3(a), for “during the 2 year period” substitute “ in the period beginning with 29 March 2017 and ending immediately ” ; b in the second subparagraph of paragraph 5, for “during the 2 year period” substitute “ in the period beginning with 29 March 2017 and ending immediately ” . Amendment of Schedule 3 5 1 Schedule 3 (amendment of the Annexes and Appendices to the REACH Regulation) is amended in accordance with this regulation. 2 After paragraph 28, insert— 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 ” . . 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 After paragraph 37, insert— 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”. . 5 After paragraph 39, insert— 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 ” . . Thérèse Coffey Parliamentary Under Secretary of State Department for Environment, Food and Rural Affairs