PART 3 Amendment of retained direct EU law

CHAPTER 3 Animal by-products

12 Regulation (EC) No 1069/2009
1 Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption is amended as follows.
2 In the Regulation, for “Community legislation”, in each place where it occurs (other than in Articles 5(1) and 34(2)), substitute “retained EU law”.
3 In Article 2—
(a) in paragraph 2—
(i) in point (g)(i), for “internationally” substitute “outside the British Islands”;
(ii) in point (h), omit “without prejudice to Community environmental legislation,”;
(b) omit paragraph 3.
4 In Article 3—
(a) in each of paragraphs 14 and 16, for “the Community” substitute “Great Britain”;
(b) in paragraph 21, for “Directive 1999/31/EC” substitute “the Environmental Permitting (England and Wales) Regulations 2016 or the Pollution Prevention and Control (Scotland) Regulations 2012”;
S.I. 2016/1154, amended by S.I. 2017/1012, 1075, 2018/110, 428, 575, 721 (W. 140), 1216 (W. 249), 1227, 2020/904. It is prospectively amended by S.I. 2019/39, 620. S.I. 2019/39 is prospectively amended by S.I. 2019/1078.
S.S.I. 2012/360, amended by S.S.I. 2014/267, 2015/100, 101, 438, 2016/39, 2017/446 and 2018/391, S.I. 2014/469, 2015/483, 1973, 2020/818. It is prospectively amended by S.S.I. 2019/26. S.S.I. 2019/26 is prospectively amended by S.I. 2019/175.
(c) after paragraph 27 insert—

“28 ‘constituent nation’ means England, Wales or Scotland;
29 ‘third country’ means a country or territory other than the British Islands;
30 ‘the Implementing Regulation’ means Commission Regulation (EU) No 142/2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive;
31 ‘the Official Controls Regulation’ means Regulation (EU) 2017/625 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products;
32 ‘the England Trade Regulations’ means the Trade in Animals and Related Products Regulations 2011;
S.I. 2011/1197, amended by S.I. 2012/2897, 2013/2996, 2014/3158, 2018/575, 1037, 2019/526, 782, 1488, 2020/109. It is prospectively amended by S.I.2019/796, 1225.
33 ‘the Wales Trade Regulations’ means the Trade in Animals and Related Products (Wales) Regulations;
S.I. 2011/2379 (W. 252), amended by S.I. 2018/1152 (W. 234), 1216 (W. 249), 2019/463 (W. 111), 2019/737 (W. 140), 2020/44 (W. 5), 177 (W. 38). It is prospectively amended by S.I. 2019/597 (W.126), 1334 (W.232).
34 ‘the Scotland Trade Regulations’ means the Trade in Animals and Related Products (Scotland) Regulations..
S.S.I. 2012/177, amended by S.S.I. 2012/198, 199, 2015/100, 401, 2018/391, 2019/5, 412 and S.I. 2014/3158. It is prospectively amended by S.S.I. 2019/71, 288.”

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5 After Article 3 insert—

“Article 3a Definition: appropriate authority
1 In this Regulation “the appropriate authority” means—
(a) in relation to England, the Secretary of State;
(b) in relation to Wales, the Welsh Ministers;
(c) in relation to Scotland, the Scottish Ministers.
2 But the appropriate authority is the Secretary of State if consent is given by—
(a) in relation to Wales, the Welsh Ministers;
(b) in relation to Scotland, the Scottish Ministers.”

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6 In Article 4—
(a) in each of paragraphs 3 and 4, for “Member States” substitute “The appropriate authority”;
(b) in paragraph 5—
(i) for “Member States”, in the first place where it occurs, substitute “The appropriate authority”;
(ii) for “Member States”, in the second place where it occurs, substitute “appropriate authorities”.
7 In Article 5—
(a) in paragraph 1, in the first subparagraph—
(i) omit “Community”;
(ii) for “that Article” substitute “Article 34(1)”;
(b) omit paragraph 4.
8 In Article 6(1)(a), for “Community veterinary legislation” substitute “veterinary legislation forming part of retained EU law”.
9 In Article 8—
(a) in point (c)—
(i) omit “or Article 2(b) of Directive 96/23/EC”;
(ii) at the end insert “reading that Article as if for references to “Community legislation” there were substituted references to “retained EU law””;
(b) in point (d), after “thereof, by” insert “other”;
(c) in point (f), for “internationally” substitute “outside the British Islands”.
10 In Article 9—
(a) in point (c), for “as referred to in Article 15(3) of Directive 96/23/EC” substitute “set by retained EU law or, in the absence thereof, by other national legislation”;
(b) in point (e)—
(i) in point (i)—
(aa) for “Community veterinary legislation” substitute “veterinary legislation forming part of retained EU law”;
(bb) for “the Community”, substitute “Great Britain”;
(cc) at the end of the sentence, omit “or”;
(ii) omit point (ii).
11 Omit Article 15(2).
12 In Article 19—
(a) in paragraph 2, for “the Member State concerned” substitute “Great Britain”;
(b) in paragraph 3—
(i) for “Member States” substitute “The appropriate authorities”;
(ii) for “the Commission” substitute “each other, and the Department of Agriculture, Environment and Rural Affairs,”.
13 In Article 21—
(a) in paragraph 2, for “the same Member State” substitute “Great Britain”;
(b) in paragraph 3, for “Member State”, in both places where it occurs, substitute “constituent nation”;
(c) for paragraph 4 substitute—

“4 Operators must collect, transport and dispose of Category 3 catering waste so as to ensure that waste management is carried out without endangering human health, without harming the environment and, in particular:
(a) without risk to water, air, soil, plants or animals;
(b) without causing a nuisance through noise or odours; and
(c) without adversely affecting the countryside or places of special interest.”

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14 In Article 24(1), in each of points (b) and (c), for “Directive 2000/76/EC” substitute “the Environmental Permitting (England and Wales) Regulations 2016 or the Pollution Prevention and Control (Scotland) Regulations 2012”.
15 In Article 26(3), for “Community veterinary legislation” substitute “veterinary legislation forming part of retained EU law”.
16 In Article 32(1), in the third subparagraph, for “Member States may adopt or maintain national rules” substitute “Nothing in this Regulation prevents the appropriate authority from”.
17 In Article 33, in point (a), for “Article 1(1) of Directive 76/768/EEC” substitute “Article 2(1)(a) of Regulation 1223/2009/EC”.
18 In Article 34—
(a) in the first subparagraph of paragraph 1, for “the Community legislation referred to in that Article.” substitute “the following:”;
(b) after the first subparagraph of paragraph 1 insert—

“(a) Regulation 1223/2009/EC in the case of cosmetic products;
(b) the Medical Devices Regulations 2002 in the case of active implantable medical devices, medical devices and in vitro diagnostic medical devices;
S.I. 2002/618, amended by S.I. 2003/1697, 1400, 2005/2759, 2909, 2007/400, 803, 2008/2936, 2012/1426, 2013/525, 2327, 2017/207. It is prospectively amended by S.I. 2019/791, 1385.
(c) the Veterinary Medicines Regulations 2013 in the case of veterinary medicinal products;
S.I. 2013/2033, amended by S.I. 2014/599, 2018/761, 2019/676, 1488, 2020/44 (W. 5). It is prospectively amended by S.I. 2019/791, 1385.
(d) the Human Medicines Regulations 2012 in the case of medicinal products.
S.I. 2012/1916, amended by S.I. 2013/235, 1855, 2593, 2014/490, 1878, 2015/178, 323, 570, 895, 903, 1503, 1862, 1879, 2016/186, 696, 2017/1322, 2018/199, 378, 2019/62, 598, 703. It is prospectively amended by S.I. 2019/593, 775, 1094, 1385.”

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(c) in paragraph 2—
(i) omit “Community”;
(ii) for “Article 33” substitute “paragraph 1(a) to (d)”.
19 In Article 37(1), in point (c), for “the Community” substitute “Great Britain”.
20 In Article 41—
(a) in paragraph 1, in the first subparagraph—
(i) in the words before point (a), for “the Community” substitute “Great Britain”;
(ii) in point (a), for “the Community” substitute “Great Britain”.
(iii) in point (b), at the end omit “or”;
(iv) in point (c), for “Articles.” insert “Articles; or”;
(v) after point (c), insert—

“(d) the special transitional import arrangements set out in Schedule 5 to the England Trade Regulations or equivalent provisions in the Wales Trade Regulations or the Scotland Trade Regulations, and Annex 6 to the Official Controls Regulation.”

;
(b) in paragraph 2(c), after “take place” insert “pursuant to point (d) of paragraph 1 or”;
(c) in paragraph 4, in the last subparagraph, for “Commission and the Member States” substitute “appropriate authority”.
21 In Article 43(4), for “the Community” substitute “Great Britain”.
22 In Article 47(1)—
(a) in the first subparagraph—
(i) for “Each Member State” substitute “The appropriate authority”;
(ii) for “territory” substitute “constituent nation”;
(b) in the third subparagraph, for “Member States” substitute “The appropriate authority”;
(c) omit the fourth subparagraph.
(d) in the fifth subparagraph—
(i) for “Member States”, in the first place where it occurs, substitute “The appropriate authority”;
(ii) after “operators” insert “in their constituent nation”;
(iii) for “other Member States” substitute “the other appropriate authorities, the Department of Agriculture, Environment and Rural Affairs”;
23 Omit Articles 48, 51, 51a and 53.
24 In Article 56, omit the third paragraph.
25 After Article 56, omit the words from “This Regulation” to “Member States.”.