processing aids;

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

‘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);

‘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 );

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

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

‘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;

‘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;

‘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 );

‘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;

‘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;

‘antibiotic’ means antimicrobials produced by, or derived from, a micro-organism, which destroys or inhibits the growth of other micro-organisms;

‘coccidiostats’ and ‘histomonostats’ means substances intended to kill or inhibit protozoa;

‘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;

‘micro-organism’ means: colony-forming micro-organisms.

‘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.

it is covered by an authorisation granted in accordance with this Regulation;

the conditions for use set out in this Regulation, including the general conditions set out in Annex IV, unless otherwise provided for in the authorisation, and in the authorisation of the substance are met; and

the conditions on labelling set out in this Regulation are met.

have an adverse effect on animal health, human health or the environment,

be presented in a manner which may mislead the user,

harm the consumer by impairing the distinctive features of animal products or mislead the consumer with regard to the distinctive features of animal products.

favourably affect the characteristics of feed,

favourably affect the characteristics of animal products,

favourably affect the colour of ornamental fish and birds,

satisfy the nutritional needs of animals,

favourably affect the environmental consequences of animal production,

favourably affect animal production, performance or welfare, particularly by affecting the gastro-intestinal flora or digestibility of feedingstuffs, or

have a coccidiostatic or histomonostatic effect.

technological additives: any substance added to feed for a technological purpose;

sensory additives: any substance, the addition of which to feed improves or changes the organoleptic properties of the feed, or the visual characteristics of the food derived from animals;

nutritional additives;

zootechnical additives: any additive used to affect favourably the performance of animals in good health or used to affect favourably the environment;

coccidiostats and histomonostats.

acknowledge receipt of the application, including the particulars and documents referred to in paragraph 3, in writing, to the applicant within 15 days of its receipt, stating the date of receipt;

make any information supplied by the applicant available to the Member States and the Commission;

make public the application and any information supplied by the applicant, in accordance with Article 18.

his name and address;

the identification of the feed additive, a proposal for its classification by category and functional group under Article 6, and its specifications, including, where applicable, purity criteria;

a description of the method of production, manufacturing and intended uses of the feed additive, of the method of analysis of the additive in feed according to its intended use and, where appropriate, of the method of analysis for the determination of the level of residues of the feed additive, or its metabolites, in food;

a copy of the studies which have been carried out and any other material which is available to demonstrate that the feed additive satisfies the criteria laid down in Article 5(2) and (3);

proposed conditions for placing the feed additive on the market, including labelling requirements and, where appropriate, specific conditions for use and handling (including known incompatibilities), use levels in complementary feedingstuffs and animal species and categories for which the feed additive is intended;

a written statement that three samples of the feed additive have been sent by the applicant directly to the Community reference laboratory referred to in Article 21, in accordance with the requirements set out in Annex II;

for additives which, according to the proposal under point (b), do not belong to either category (a) or category (b) referred to in Article 6(1), and for additives falling within the scope of Community legislation relating to the marketing of products consisting of, containing or produced from GMOs, a proposal for post-market monitoring;

a summary containing the information provided under points (a) to (g);

for additives falling within the scope of Community legislation relating to the marketing of products consisting of, containing or produced from GMOs, details of any authorisation granted in accordance with the applicable legislation.

shall verify that the particulars and documents submitted by the applicant are in accordance with Article 7 and undertake an assessment in order to determine whether the feed additive complies with the conditions laid down in Article 5;

shall verify the report of the Community Reference Laboratory.

the name and address of the applicant;

the designation of the feed additive including its categorisation and allocation within functional groups provided for in Article 6, its specification, including, where applicable, purity criteria and method of analysis;

depending on the outcome of the assessment, specific conditions or restrictions in relation to handling, post-market monitoring requirements and use, including animal species and categories of animal species for which the additive is to be used;

specific additional requirements for the labelling of the feed additive necessary as a result of conditions and restrictions imposed under (c);

a proposal for the establishment of Maximum Residues Limits (MRLs) in the relevant foodstuffs of animal origin, unless the opinion of the Authority concludes that the establishment of MRLs is not necessary for the protection of consumers or MRLs have already been established in Annex I or III to Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin ( 6 ).

within one year of the entry into force of this Regulation, persons first placing the feed additive on the market or any other interested parties shall notify this fact to the Commission. At the same time, the particulars mentioned in Article 7(3)(a), (b) and (c) shall be directly sent to the Authority;

within one year of the notification mentioned under (a), the Authority shall, after verification that all the information required has been submitted, notify the Commission that it has received the information required under this Article. The products concerned shall be entered in the Register. Each entry in the Register shall mention the date on which the product concerned was first entered in the Register and, where applicable, the expiry date of the existing authorisation.

a copy of the authorisation for placing the feed additive on the market;

a report on the results of the post-market monitoring, if such monitoring requirements are included in the authorisation;

any other new information which has become available with regard to the evaluation of the safety in use of the feed additive and the risks of the feed additive to animals, humans or the environment;

where appropriate, a proposal for amending or supplementing the conditions of the original authorisation, inter alia, the conditions concerning future monitoring.

the specific name given to the additives upon authorisation, preceded by the name of the functional group as mentioned in the authorisation;

the name or business name and the address or registered place of business of the person responsible for the particulars referred to in this Article;

the net weight or, in the case of liquid additives and premixtures, either the net volume or the net weight;

where appropriate, the approval number of the establishment manufacturing or placing on the market the feed additive or the premixture pursuant to Article 10 of Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene ( 9 ) or, as applicable, to Article 5 of Directive 95/69/EC;

directions for use, and any safety recommendations regarding the use and, where applicable, the specific requirements mentioned in the authorisation, including animal species and categories for which the additive or premixture of additives is intended;

the identification number;

the batch reference number and date of manufacture.

the study plan for studies demonstrating the efficacy of a feed additive in terms of the aims of its intended use as defined in Article 6(1) of, and Annex I to, this Regulation; and

specifications of the impurities of the active substance and the relevant methods of analysis developed internally by the applicant, except for impurities that may have adverse effects on animal health, human health, or the environment.