PART 3Amendment of retained direct EU legislation
Amendment of Regulation (EC) No 1831/2003 on additives for use in animal nutrition8
1
Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition12 is amended as follows.
2
In Article 1—
a
in paragraph 2(b), omit “as defined in Directive 2001/82/EC”;
b
after paragraph 2 insert—
3
In this Article ‘veterinary medicinal product’ means:
a
any substance or combination of substances presented as having properties for treating or preventing disease in animals; or
b
any substance or combination of substances which may be used in, or administered to, animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
For the purposes of the definition of ‘veterinary medicinal product’, ‘substance’ means any matter, irrespective of origin, which may be:
a
human, including human blood and human blood products;
b
animal, including micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts and blood products;
c
vegetable, including micro-organisms, plants, parts of plants, vegetable secretions and extracts; or
d
chemical, including elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis.
3
In Article 2(2)—
a
for points (b) to (d) substitute—
b
‘feed materials’ means products of vegetable or animal origin, whose principal purpose is to meet animals’ nutritional needs, in their natural state, fresh or preserved, and products derived from their industrial processing, and organic or inorganic substances, whether or not containing feed additives, which are intended for use in oral animal-feeding either directly as such, or after processing, or in the preparation of compound feed, or as a carrier of premixtures;
c
‘compound feed’ means a mixture of at least two feed materials, whether or not containing feed additives, for oral animal-feeding in the form of complete feed or complementary feed;
d
‘complementary feed’ means compound feed which has a high content of certain substances but which, by reason of its composition, is sufficient for a daily ration only if used in combination with other feed;
b
for point (g) substitute—
g
‘complete feed’ means compound feed which, by reason of its composition, is sufficient for a daily ration;
4
In Article 3—
a
in paragraph 2, for “Directive 87/153/EEC, Directive 83/228/EEC” substitute “Regulation (EC) No 767/200913”
;
b
in paragraph 4, for “Directive 95/69/EC” substitute “Regulation (EC) No 183/200514”
.
5
In Article 4(2), for “Articles 53 and 54” substitute “Article 53”
.
6
In Article 7—
a
in paragraph 3—
i
in point (e), for “feedingstuffs” substitute “feed”
;
ii
in point (f), for “have been sent by the applicant directly” substitute “will be made available, upon request,”
;
b
in paragraph 4, omit the final sentence.
7
In Article 8(4)(e), for the words from “Annex I” to the end substitute “Regulation (EC) No 470/200915”
.
8
Omit Article 13(6).
9
In Article 16(1)—
a
in the words before point (a), for “Great Britain” substitute “the British Islands”
;
10
In Annex 2—
a
before point 2 insert—
1A
The reference laboratory may be assisted by scientific experts or official laboratories with the performance of the duties and tasks set out in this Annex.
b
in point 4, for “Articles 11 and 32 of Regulation (EC) No 882/2004 of the European Parliament and of the Council” substitute “Regulation (EU) 2017/62516”
;
c
after point 5 insert—
6
The reference laboratory shall:
a
be responsible for the overall coordination of scientific experts or official laboratories; and
b
ensure that the relevant data concerning the applications are made available to the scientific experts or official laboratories.
d
in point 7, for “Article 32 of Regulation (EC) No 882/2004” substitute “Regulation (EU) 2017/625”
.
11
In Annex 4, in point 3, for “complete feedingstuffs” substitute “complete feed”
.