CHAPTER I

SCOPE AND DEFINITIONS

Scope
Article 1
1
The purpose of this Regulation is to establish a ... procedure for authorising the placing on the market and use of feed additives and to lay down rules for the supervision and labelling of feed additives and premixtures in order to provide the basis for the assurance of a high level of protection of human health, animal health and welfare, environment and users' and consumers' interests in relation to feed additives, whilst ensuring the effective functioning of the ... market.
2
This Regulation shall not apply to:
a
processing aids;
b
veterinary medicinal products ..., with the exception of coccidiostats and histomonostats used as feed additives.
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.

Definitions
Article 2
1
For the purpose of this Regulation, the definitions of ‘feed’, ‘feedingstuff’, ‘feed business’, ‘feed business operator’, ‘placing on the market’ and ‘traceability’ laid down in Regulation (EC) No 178/2002 shall apply.
2
The following definitions shall also apply:
a
‘feed additives’ means substances, micro-organisms or preparations, other than feed material and premixtures, which are intentionally added to feed or water in order to perform, in particular, one or more of the functions mentioned in Article 5(3);
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;
e
‘premixtures’ means mixtures of feed additives or mixtures of one or more feed additives with feed materials or water used as carriers, not intended for direct feeding to animals;
f
‘daily ration’ means the average total quantity of feedingstuffs, calculated on a moisture content of 12 %, required daily by an animal of a given species, age category and yield, to satisfy all its needs;
g
‘complete feed’ means compound feed which, by reason of its composition, is sufficient for a daily ration;
h
‘processing aids’ means any substance not consumed as a feedingstuff by itself, intentionally used in the processing of feedingstuffs or feed materials to fulfil a technological purpose during treatment or processing which may result in the unintentional but technologically unavoidable presence of residues of the substance or its derivatives in the final product, provided that these residues do not have an adverse effect on animal health, human health or the environment and do not have any technological effects on the finished feed;
i
‘antimicrobials’ means substances produced either synthetically or naturally, used to kill or inhibit the growth of micro-organisms, including bacteria, viruses or fungi, or of parasites, in particular protozoa;
j
‘antibiotic’ means antimicrobials produced by, or derived from, a micro-organism, which destroys or inhibits the growth of other micro-organisms;
k
‘coccidiostats’ and ‘histomonostats’ means substances intended to kill or inhibit protozoa;
l
‘maximum residue limit’ means the maximum concentration of residue resulting from the use of an additive in animal nutrition which may be accepted by the appropriate authority as being legally permitted or recognised as acceptable in or on a food;
m
‘micro-organism’ means: colony-forming micro-organisms.
n
‘first placing on the market’ means the initial placing on the market of an additive after its manufacture, the import of an additive, or, where an additive has been incorporated into feed without being placed on the market, the first placing on the market of that feed.
o
“
third country
” means any country or territory other than the British Islands;
p
“
prescribe
” means prescribe by regulations;
q
“
appropriate authority
” means—
i
in relation to England, the Secretary of State;
ii
in relation to Wales, the Welsh Ministers;
iii
in relation to Scotland, the Scottish Ministers;
r
“
Food Safety Authority
” means—
i
as regards England and Wales, the Food Standards Agency;
ii
as regards Scotland, Food Standards Scotland;
s
“
reference laboratory
” means a laboratory designated by the appropriate authority under Article 100 of Regulation 2017/625;
t
‘Register’ means the Register of Feed Additives referred to in Article 17.
3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Word in Art. 1 omitted (31.12.2020) by virtue of The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 9(a); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 1 omitted (31.12.2020) by virtue of The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 9(b); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 2(2)(l) substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 10(a)(i); 2020 c. 1, Sch. 5 para. 1(1)
Art. 2(2)(o)-(s) inserted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 10(a)(ii) (as substituted by S.I. 2020/1504, regs. 1(2), 12(3)); 2020 c. 1, Sch. 5 para. 1(1)
Art. 2(3) omitted (31.12.2020) by virtue of The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 10(b); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 1(2)(b) omitted (31.12.2022) by virtue of The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 8(2)(a)
Art. 1(3) inserted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 8(2)(b)
Art. 2(2)(b)-(d) substituted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 8(3)(a)
Art. 2(2)(g) substituted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 8(3)(b)
Art. 2(2)(t) inserted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 3(2) (with reg. 23)