xmlns:atom="http://www.w3.org/2005/Atom" xmlns:atom="http://www.w3.org/2005/Atom"
83. In Annex 2—
(a)in the part of the Annex headed “General Aspects”,
(i)in the fifth paragraph (which begins with the words “The dossier”)—
(aa)omit “European”;
(bb)for “following the legislation in force in the Community”, substitute “ under retained EU law ”;
[F1(ii)in the seventh paragraph (which begins with the words “Where in vivo”), for “the Community” substitute “Great Britain”;]
(b)in Section 1, in point 1.1.2(f), for “Community Legislation”, substitute “ retained EU law ”;
(c)in Section 2—
(i)in point 2.1.3, in the sixth paragraph (which begins with the words “Without prejudice”), for “Authority”, substitute “ Food Safety Authority ”;
(ii)in point 2.1.4, in the third paragraph (which begins with the words “Specific requirements”), for “existing Community legislation”, substitute “ retained EU law ”;
[F2(iii)in point 2.1.4.1, for “European Community food additive authorisations” substitute “food additive authorisations in Great Britain”;]
[F3(iv)in point 2.1.4.2, in the second paragraph (which begins with the words “For feed additives”), for “the European Community” substitute “Great Britain”;]
[F4(v)in point 2.2.1.2, in the second paragraph (which begins with the words “For micro-organisms), for “the European Union” substitute “Great Britain”;]
(vi)in point 2.6—
(aa)in each place in which it occurs, for “CRL”, substitute “ reference laboratory ”;
(bb)in the fourth paragraph (which begins with the words “Analytical methods”), for “Commission”, substitute “ appropriate authority ”;
(cc)in both places in which it occurs, for “Authority”, substitute “ Food Safety Authority ”;
(vii)in point 2.6.1.1., in the first indent, for “Community rules (e.g. Community methods of analysis)” substitute “ retained EU law ”;
(viii)in point 2.6.1.3, omit the words from “For reasons of independence” to “evaluation of the application”;
(ix)in point 2.6.1.4—
(aa)for “CRL”, substitute “ reference laboratory ”;
(bb)for “Authority”, substitute “ Food Safety Authority ”;
(x)in point 2.6.1.5, for “CRL”, substitute “ reference laboratory ”;
(xi)in point 2.6.2.3—
(aa)omit the words from “For reasons of independence” to “evaluation of the application”;
(bb)in each place in which it occurs, for “CRL”, substitute “ reference laboratory ”;
(xii)in point 2.6.3—
(aa)for “Authority”, substitute “ Food Safety Authority ”;
(bb)for “Commission”, substitute “ appropriate authority ”;
(xiii)in point 2.6.2.4—
(aa)for “CRL”, substitute “ reference laboratory ”;
(bb)for “Authority”, substitute “ Food Safety Authority ”;
(xiv)in point 2.6.2.5, for “CRL”, substitute “ reference laboratory ”;
(d)in Section 3—
(i)in point 3.2.1, in the second paragraph (which begins with the words “Studies must be carried out”)—
(aa)for “European legislation in force”, substitute “ retained EU law ”;
(bb)for “European Community legislation”, substitute “ retained EU law ”;
(ii)in point 3.2.2, in the final subparagraph, in both places in which it occurs, for “European legislation”, substitute “ retained EU law ”;
[F5(iii)in point 3.2.3.3, in the final paragraph (which begins with the words “In certain situations”) for “Community data” substitute “data in Great Britain”;]
[F6(iv)in point 3.2.3.4—
(aa)in the first paragraph, for “the Community” substitute “ Great Britain ”;
(bb)in the fourth paragraph (which begins with the words “Studies concerning”), omit the bracketed wording;]
(e)in Section 4—
[F7(i)in the first paragraph (which begins with the words “Studies shall demonstrate”) for “the EU” substitute “Great Britain”;]
(ii)in point 4.4, in the second paragraph (which begins with the words “Efficacy trials”), for “European Union”, substitute “[F8Great Britain]”;
(iii)in point 5, in the second paragraph (which begins with the words “The design”), for “Commission and the Authority”, substitute “ appropriate authority and the Food Safety Authority ”;
Textual Amendments
F1Reg. 83(a)(ii) substituted (31.12.2020 immediately before IP completion day) by The Food and Feed Hygiene and Safety (Miscellaneous Amendments etc.) (EU Exit) Regulations 2020 (S.I. 2020/1504), regs. 1(2), 12(15)(a)
F2Reg. 83(c)(iii) substituted (31.12.2020 immediately before IP completion day) by The Food and Feed Hygiene and Safety (Miscellaneous Amendments etc.) (EU Exit) Regulations 2020 (S.I. 2020/1504), regs. 1(2), 12(15)(b)(i)
F3Reg. 83(c)(iv) substituted (31.12.2020 immediately before IP completion day) by The Food and Feed Hygiene and Safety (Miscellaneous Amendments etc.) (EU Exit) Regulations 2020 (S.I. 2020/1504), regs. 1(2), 12(15)(b)(ii)
F4Reg. 83(c)(v) substituted (31.12.2020 immediately before IP completion day) by The Food and Feed Hygiene and Safety (Miscellaneous Amendments etc.) (EU Exit) Regulations 2020 (S.I. 2020/1504), regs. 1(2), 12(15)(b)(iii)
F5Reg. 83(d)(iii) substituted (31.12.2020 immediately before IP completion day) by The Food and Feed Hygiene and Safety (Miscellaneous Amendments etc.) (EU Exit) Regulations 2020 (S.I. 2020/1504), regs. 1(2), 12(15)(c)(i)
F6Reg. 83(d)(iv) substituted (31.12.2020 immediately before IP completion day) by The Food and Feed Hygiene and Safety (Miscellaneous Amendments etc.) (EU Exit) Regulations 2020 (S.I. 2020/1504), regs. 1(2), 12(15)(c)(ii)
F7Reg. 83(e)(i) substituted (31.12.2020 immediately before IP completion day) by The Food and Feed Hygiene and Safety (Miscellaneous Amendments etc.) (EU Exit) Regulations 2020 (S.I. 2020/1504), regs. 1(2), 12(15)(d)(i)
F8Words in reg. 83(e)(ii) substituted (31.12.2020 immediately before IP completion day) by The Food and Feed Hygiene and Safety (Miscellaneous Amendments etc.) (EU Exit) Regulations 2020 (S.I. 2020/1504), regs. 1(2), 12(15)(d)(ii)
Commencement Information
I1Reg. 83 in force at 31.12.2020 on IP completion day (in accordance with 2020 c.1, Sch. 5 para. 1(1)), see reg. 1