Regulation (EC) No 1831/2003 of the European Parliament and of the CouncilShow full title

CHAPTER I SCOPE AND DEFINITIONS

Article 1 Scope

1. The purpose of this Regulation is to establish a Community 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 internal market.

2. This Regulation shall not apply to:

(a) processing aids;

(b) veterinary medicinal products as defined in Directive 2001/82/EC(1), with the exception of coccidiostats and histomonostats used as feed additives.

Article 2 Definitions

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 as defined in Article 2(a) of Council Directive 96/25/EC of 29 April 1996 on the circulation of feed materials(2);

(c) ‘compound feedingstuffs’ means products as defined in Article 2(b) of Directive 79/373/EEC;

(d) ‘complementary feedingstuffs’ means products as defined in Article 2(e) of Directive 79/373/EEC;

(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 feedingstuffs’ means products as defined in Article 2(c) of Council Directive 1999/29/EC of 22 April 1999 on the undesirable substances and products in animal nutrition(3);

(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 Community 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.

3. Where necessary, it may be determined, in accordance with the procedure referred to in Article 22(2), whether a substance, micro-organism or preparation is a feed additive within the scope of this Regulation.

(1)

OJ L 311, 28.11.2001, p. 1.

(2)

OJ L 125, 23.5.1996, p. 35. Directive as last amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

(3)

OJ L 115, 4.5.1999, p. 32. Directive as last amended by Regulation (EC) No 806/2003.