2.—(1) Article 2 is amended as follows.U.K.
(2) In paragraph 1(a), for “Council Directive 96/29/Euratom” to the end of the point substitute “ retained EU law that transposed Council Directive 2013/59/Euratom M1 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation M2; ”.
(3) In paragraph 2, for “Directive 2006/12/EC” substitute “ Article 3(1) of Directive 2008/98/EC M3 ”.
(4) After paragraph 2, insert—
[F1“2A. For the purposes of this Regulation, “Directive 2008/98/EC” means that Directive as last amended by Directive (EU) 2018/851, and read in accordance with paragraphs 2B and 2C.
2B. Article 5 is to be read as if—
(a)in paragraph 1, “Member States shall take appropriate measures to ensure that” were omitted;
(b)after paragraph 1 there were inserted—
“1A. Any decision as to whether a substance or object is a by-product must be made—
(a)in accordance with any regulations setting out detailed criteria on the application of the conditions in paragraph 1 to specific substances or objects; and
(b)having regard to any guidance published by the appropriate authority or the appropriate agency for the purposes of this Article.”;
(c)paragraphs 2 and 3 were omitted.
2C. Article 6 is to be read as if—
(a)in paragraph 1, “Member States shall take appropriate measures to ensure that” were omitted;
(b)after paragraph 1 there were inserted—
“1A. Any decision as to whether a substance or object has ceased to be waste must be made—
(a)in accordance with any regulations or retained direct EU legislation setting out detailed criteria on the application of the conditions in paragraph 1 to specific types of waste; and
(b)having regard to any guidance published by the appropriate authority or the appropriate agency for the purposes of this Article.”;
(c)in paragraph 2—
(i)the first subparagraph were omitted;
(ii)in the second subparagraph, for “Those detailed criteria” there were substituted “Any detailed criteria set out in guidance as referred to in paragraph 1A”;
(iii)the third and fourth subparagraphs were omitted;
(d)paragraph 3 were omitted;
(e)in paragraph 4—
(i)in the first subparagraph—
(aa)in the first sentence, for the words from the beginning to “Member State”, there were substituted “Where criteria have not been set out as referred to in paragraph 1A(a), the appropriate agency”;
(bb)the second sentence were omitted;
(ii)in the second subparagraph—
(aa)for “Member States” there were substituted “The appropriate agency”;
(bb)“by competent authorities” were omitted.
2D. In paragraphs 2B and 2C, “appropriate agency” means—
(a)the Environment Agency, in relation to England;
(b)the Natural Resources Body for Wales, in relation to Wales;
(c)the Scottish Environment Protection Agency, in relation to Scotland.”].
(5) In paragraph 3, for “Member States” substitute “ The Secretary of State ”.
(6) Omit paragraph 4.
(7) In paragraph 5—
(a)for point (a) substitute—
“(a)in medicinal products for human or veterinary use within the scope of the Veterinary Medicines Regulations 2013 M4, or the Human Medicines Regulations 2012 M5;”;
(b)for point (b)(i) substitute—
“(i)as a food additive in foodstuffs as defined by Article 3(2)(a) of Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives;”;
(c)for point (b)(ii) substitute—
“(ii)as a flavouring in foodstuffs within the scope of Regulation (EC) No 1334/2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods or Commission Implementing Regulation (EU) No 872/2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council;”;
(d)for point (b)(iv) substitute—
“(iv)in animal nutrition within the scope of Article 2(1) of Regulation (EC) No 767/2009.”.
(8) In paragraph 6—
(a)for point (a) substitute—
“(a)medicinal products for human or veterinary use within the scope of the Veterinary Medicines Regulations 2013, or the Human Medicines Regulations 2012;”;
(b)for point (b) substitute—
“(b)cosmetic products as defined in Regulation (EC) No 1223/2009 on cosmetic products;”;
(c)for point (c) substitute—
“(c)medical devices which are invasive or used in direct physical contact with the human body in so far as legislation relating to the classification and labelling of dangerous substances and mixtures applies to them which ensures the same level of information provision and protection as Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures;”;
(d)for point (d)(i) and (ii) substitute—
“(i)as a food additive in foodstuffs as defined by Article 3(2)(a) of Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives;
(ii)as a flavouring in foodstuffs within the scope of Regulation (EC) No 1334/2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods or Commission Implementing Regulation (EU) No 872/2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council;”;
(e)for point (d)(iv) substitute—
“(iv)in animal nutrition within the scope of Article 2(1) of Regulation (EC) No 767/2009.”.
(9) In paragraph 7(c)—
(a)for “from the Community” substitute “ from [F2Great Britain] ”;
(b)for “into the Community” substitute “ into [F3Great Britain] ”.
(10) In paragraph 7(d), for “[F4the Community]” substitute “ [F5Great Britain] ”.
Textual Amendments
F1Words in Sch. 1 para. 2(4) 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(2)
F2Words in Sch. 1 para. 2(9)(a) 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(3)
F3Words in Sch. 1 para. 2(9)(b) 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(3)
F4Words in Sch. 1 para. 2(10) 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(4)(a)
F5Words in Sch. 1 para. 2(10) 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(4)(b)
Commencement Information
I1Sch. 1 para. 2 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)
Marginal Citations
M1Different aspects of Council Directive 2013/59/Euratom have been transposed by various pieces of legislation, including the Ionising Radiations Regulations 2017 (S.I. 2017/1075) in Great Britain and the Ionising Radiations Regulations (Northern Ireland) 2017 (S.R. 2017/229) in Northern Ireland.
M2OJ No. L 13, 17.1.2014, p. 1.
M3OJ No. L 312, 22.11.2008, p. 3, as last corrected by Corrigendum (OJ No. L 042, 18.2.2017, p. 43).
M4S.I. 2013/2033, amended by S.I. 2014/599, 2018/761.
M5S.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.