PART 3Amendment of retained direct EU legislation
Amendment of Commission Regulation (EC) No 429/2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives14
1
Commission Regulation (EC) No 429/2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives22 is amended as follows.
2
In Annex 1—
a
after point 1.3 insert—
Note: where applicable, in accordance with Regulation (EC) No 378/2005, reference samples, documentation and payment will be requested after submission of the feed additive application by the reference laboratory.
b
omit point 1.4;
c
in point 1.5, omit the words from “three samples of” to “378/2005”.
3
In Annex 2—
a
in the sixth unnumbered subparagraph, before “Directive 2004/10/EC” insert “Annex I to”
;
b
in the eighth unnumbered subparagraph, for the words from “Council Directive 67/548/EEC” to “2004/73/EC” substitute “Regulation (EC) No 1272/200823”
;
c
in the tenth unnumbered subparagraph—
i
before “Directive 2004/10/EC” insert “Annex I to”
;
ii
for the words from “Article 11 of” to the end substitute “Articles 34 and 35 of Regulation (EU) 2017/625”
;
d
in point 2.3.1, in the second subparagraph, for “Council Directive 90/219/EC applies. A” substitute “a”
;
e
in point 2.5.2.1—
i
omit “material”;
ii
for the words from “Commission Directive” to “88/379/EEC” substitute “Regulation (EC) No 1907/200624”
;
f
in point 2.6—
i
in the third unnumbered subparagraph—
aa
for the words from “Council Regulation (EEC)” to “animal origin” substitute “Regulation (EC) No 470/2009”
;
bb
for the words from “to European Medicines Agency” to the end substitute “in accordance with Commission Implementing Regulation (EU) 2017/1225”
;
ii
in the fifth unnumbered subparagraph, for “prior to the evaluation of the technical dossier” substitute “, upon request”
;
g
in point 2.6.1.1, for “Article 11 of Regulation (EC) No 882/2004” substitute “Regulation (EU) 2017/625.”
;
h
in point 2.6.1.2, for “Regulation (EC) No 882/2004” substitute “Regulation (EU) 2017/625”
;
i
in point 2.6.1.4, for “Regulation (EC) No 882/2004” substitute “Regulation (EU) 2017/625”
;
j
in point 2.6.2.1, for “Article 11 of Regulation (EC) No 882/2004” substitute “Regulation (EU) 2017/625”
;
k
in point 2.6.2.2, for “Regulation (EC) No 882/2004” substitute “Regulation (EU) 2017/625”
;
l
in point 2.6.3—
i
in the third unnumbered subparagraph, before “Directive 2004/10/EC” insert “Annex I to”
;
ii
in the fourth unnumbered subparagraph, for “Article 11 of Regulation (EC) No 882/2004” substitute “Regulation (EU) 2017/625”
;
m
in point 3.4, in the second unnumbered subparagraph, for “Directive 67/548/EEC” substitute “Regulation (EC) No 1272/2008”
.
4
In Annex 3—
a
in point 2.2.3.1, in subparagraph 2, for the words from “of the Commission Regulation (EC) No 1565/2000” to “European Parliament and of the Council” substitute “Regulation (EU) No 872/201226”
;
b
in point 3.3.1.1, in subparagraph 1—
i
omit “authorised by Directive 82/471/EEC”;
ii
for “Directive 70/524/EEC” substitute “Article 10 of Regulation (EC) No 1831/2003”
.