Regulation 83 I1

United Kingdom

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 ”;

Annotations

Textual amendments

F1: Reg. 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)
F2: Reg. 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)
F3: Reg. 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)
F4: Reg. 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)
F5: Reg. 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)
F6: Reg. 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)
F7: Reg. 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)
F8: Words 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

I1: Reg. 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