6. In Article 5—
(a)for “, 21 and 23” substitute “and 21”;
(b)for “Community” substitute “United Kingdom”.
7.—(1) Article 7 is amended as follows.
(2) In paragraph 7, for “From 1 June 2011 paragraphs” substitute “Paragraphs”.
(3) For paragraph 8 substitute—
“8. Any measures for the implementation of paragraphs 1 to 7 shall be adopted by regulations made by the Secretary of State. Regulations under this paragraph are to be made by statutory instrument; and a statutory instrument containing regulations under this paragraph is subject to annulment in pursuance of a resolution of either House of Parliament.
The function of making regulations under this paragraph is subject to the consent requirement in Article 4A.”.
8.—(1) Article 8 is amended as follows.
(2) In the heading, for “non-Community” substitute “non-United Kingdom”.
(3) In paragraph 1, for “Community”, in each place it occurs, substitute “United Kingdom”.
(4) In paragraph 3, for “non-Community” substitute “non-United Kingdom”.
9.—(1) Article 9 is amended as follows.
(2) In paragraph 1—
(a)for “a period of five years” substitute “a five-year exemption period”;
(b)for “Community” substitute “United Kingdom”.
(3) After paragraph 1, insert—
“1A. In paragraph 1 “five-year exemption period” means a period of five years beginning when Articles 5, 6, 7, 17, 18 and 21 would otherwise apply to the substance (if it were not manufactured or imported as mentioned in paragraph 1).”.
(4) In paragraph 3, in the final sentence, for “competent authority of the Member State(s) concerned” substitute “appropriate authorities that request it”.
(5) In paragraph 8—
(a)in the first subparagraph, for the words from “competent” to the end substitute “appropriate authorities that request them”;
(b)in the second subparagraph, for “such competent authorities” substitute “the appropriate authorities”.
(6) In paragraph 9, for “competent authorities of the Member States concerned” substitute “appropriate authorities”.
10. In Article 10(a), in the final subparagraph, for “, Article 27(6) or Article 30(3)” substitute “or Article 27(6)”.
11. In Article 11(1), for “Community” substitute “United Kingdom”.
12.—(1) Article 13 is amended as follows.
(2) In paragraph 2—
(a)in the second sentence—
(i)for “The Commission,” substitute “The Secretary of State,”;
(ii)for “Commission Regulation on test methods adopted in accordance with the procedure referred to in Article 133(4)” substitute “Test Methods Regulation”;
(b)for the third sentence substitute—
“Amendments to the Test Methods Regulation may be made by regulations made by the Secretary of State. Amendments to the Annexes of this Regulation may be made by regulations made by the Secretary of State. Regulations under this paragraph are to be made by statutory instrument; and a statutory instrument containing regulations under this paragraph is subject to annulment in pursuance of a resolution of either House of Parliament. The functions of making regulations under this paragraph are subject to the consent requirement in Article 4A.”.
(3) In paragraph 3, in the first subparagraph—
(a)in the first sentence—
(i)for “a Commission Regulation” substitute “the Test Methods Regulation”;
(ii)omit “the Commission or”;
(b)omit the second sentence.
(4) In paragraph 4—
(a)for “Directive 2004/10/EC” substitute “the Good Laboratory Practice Regulations 1999(1)”;
(b)omit “the Commission or”;
(c)for “Directive 86/609/EC” substitute “the Animals (Scientific Procedures) Act 1986(2)”.
(5) At the end insert—
“6. In this Article “Test Methods Regulation” means Commission Regulation (EU) No 440/2008.”.
13.—(1) Article 14 is amended as follows.
(2) In paragraph 1, for “without prejudice to Article 4 of Directive 98/24/EC, a” substitute “A”.
(3) In paragraph 5(b), for “Directive 76/768/EEC” substitute “Regulation (EC) No 1223/2009 on cosmetic products”.
14.—(1) Article 16 is amended as follows.
(2) In the heading, omit “the Commission, the Agency and”.
(3) Omit paragraph 1.
(4) In paragraph 2, for “28” substitute “27”.
15. In Articles 17(2) and 18(2), in the second subparagraph, for “, Article 27(6) or Article 30(3)” substitute “or Article 27(6)”.
16. In Article 19(1), for “Community” substitute “United Kingdom”.
17.—(1) Article 20 is amended as follows.
(2) In paragraph 2—
(a)in the second subparagraph, omit the words from “, or within” to the end;
(b)in the third subparagraph, in the first sentence, omit “or three-month”.
(3) In paragraph 4—
(a)in the first subparagraph, for “competent authority of the relevant Member State” substitute “appropriate authorities that request the notification”;
(b)omit the second and third subparagraphs;
(c)in the fourth subparagraph, for “competent authority of the relevant Member State(s)” substitute “appropriate authorities that request the notification”.
18. In Article 21(1), omit the second subparagraph.
19.—(1) Article 22 is amended as follows.
(2) In the following provisions, for “competent authority of the relevant Member State” substitute “appropriate authorities that request it”—
(a)paragraph 1, the final subparagraph;
(b)paragraph 2, the final sentence.
20. Omit Article 23.
21. In Article 24, omit paragraph 1.
S.I. 1999/3106. The definition of “principles of good laboratory practice” was substituted by, and Schedules 1 and 2 were amended by, S.I. 2004/994.
1986 c. 14, amended by paragraph 66 of Schedule 10 to the Courts and Legal Services Act 1990 (c. 41), the Schedule to the Protection of Badgers Act 1992 (c. 51), paragraph 59 of Schedule 4 to the Criminal Procedure (Consequential Provisions) (Scotland) Act 1995 (c. 40), Part 9 of Schedule 37 to the Criminal Justice Act 2003 (c. 44), paragraph 5 of Schedule 11 to the Constitutional Reform Act 2005 (c. 4), paragraph 12 of Schedule 3 and Schedule 4 to the Animal Welfare Act 2006 (c. 45), paragraph 18 of Schedule 10 to the Tribunal, Courts and Enforcement Act 2007 (c. 15), and paragraph 3 of Schedule 4 and Schedule 5 to the Welfare of Animals Act (Northern Ireland) 2011 (c. 16); S.I. 1993/2013, 1996/3278, 1998/1674, 1974, 2006/2407, 2012/3039, 2014/2124, 2015/1782, 2018/486; S.S.I 2006/536; and S.R. 1993/407, 1997/226, 1998/331.