Regulation 83 Amendment of Regulation 429/2008

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”;

(ii)

in the seventh paragraph (which begins with the words “Where in vivo”), for “Community”, substitute “United Kingdom”;

(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”;

(iii)

in point 2.1.4.1, for “European Community”, substitute “United Kingdom”;

(iv)

in point 2.1.4.2, in the second paragraph (which begins with the words “For feed additives”), for “European Community”, substitute “United Kingdom”;

(v)

in point 2.2.1.2, in the second paragraph (which begins with the words “For micro-organisms”), for “European Union”, substitute “United Kingdom”;

(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”;

(iii)

in point 3.2.3.3, in the final paragraph (which begins with the words “In certain situations”), for “Community”, substitute “United Kingdom”;

(iv)

in point 3.2.3.4, in the first paragraph, for “Community”, substitute “United Kingdom”;

(e)

in Section 4—

(i)

in the first paragraph (which begins with the words “Studies shall demonstrate”), for “EU”, substitute “United Kingdom”;

(ii)

in point 4.4, in the second paragraph (which begins with the words “Efficacy trials”), for “European Union”, substitute “the United Kingdom”;

(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”;