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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 “the Road Vehicles (Approval) Regulations 2009(1)”.
(3) In paragraph 4(g), for “Directives 90/385/EEC, 93/42/EEC or 98/79/EC” substitute “Parts II to IV of the Medical Devices Regulations 2002(2)”.
(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(3)”.
(5) In paragraph 4(i), for the words from “Regulation (EC) No 726/2004” to the end substitute “the Veterinary Medicines Regulations 2013(4) or the Human Medicines Regulations 2012(5)”.
(6) In paragraph 6(a), for “Regulation (EC) No 216/2008” substitute “Regulation (EU) 2018/1139”.”.
(3) In paragraph 37, for ““the Medical Devices” substitute ““Part II of the Medical Devices”.
(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 “Part VIII of the Medical Devices Regulations 2002(6)”.
(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 UK mandatory classification and labelling list”.”.
S.I. 2009/717, amended by S.I. 2011/1043, 1946, 2013/602, 2018/235, 236, 673, 984.
S.I. 2002/618, amended by S.I. 2003/1400, 1697, 2005/2759, 2909, 2007/400, 610, 803, 2008/530, 2936, 2009/383, 2010/557, 2012/1426, 2013/525, 2327, 2017/207, 2019/791.
S.I. 2012/3032, amended by S.I. 2014/1771, 2018/942.
S.I. 2013/2033, amended by S.I. 2014/599, 2018/761.
S.I. 2012/1916, amended by S.I. 2013/235, 1855, 2593, 2014/490, 1878, 2015/323, 570, 903, 1503, 1862, 1879, 2016/186, 190, 696, 2017/715, 1322, 2018/199, 378, 2019/62.
S.I. 2002/618, amended by S.I. 2019/791; there are other amending instruments but none is relevant.
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