PART 3Amendment of retained direct EU legislation

I183

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 ”;

F1ii

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 ”;

F2iii

in point 2.1.4.1, for “European Community food additive authorisations” substitute “food additive authorisations in Great Britain”;

F3iv

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”;

F4v

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 ”;

F5iii

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”;

F6iv

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—

F7i

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 ”;