Commission Regulation (EC) No 429/2008 of 25 April 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 additives (Text with EEA relevance) (c. 429)

ANNEX II GENERAL REQUIREMENTS TO BE SATISFIED BY THE DOSSIER PROVIDED FOR IN ARTICLE 3

2. SECTION II: IDENTITY, CHARACTERISATION AND CONDITIONS OF USE OF THE ADDITIVE; METHODS OF ANALYSIS

2.5. Conditions of use of the additive

2.5.1. Proposed mode of use in animal nutrition

The animal species or categories, age group or production stage of animals shall be indicated in accordance with the categories listed in Annex IV of this Regulation. Possible contra-indications shall be mentioned. The proposed use, in feed or water shall be defined.

Details of the proposed method of administration and level of inclusion must be provided for premixtures, feedingstuffs or water for drinking. In addition, the proposed dose in the complete feed and the proposed duration of administration and proposed withdrawal period must be provided where appropriate. A justification is required where a particular use of an additive in complementary feedingstuffs is proposed.

2.5.2. Information related to users/workers safety

2.5.2.1. Chemical substances

A material safety data sheet formatted in accordance with the requirements of Commission Directive 91/155/EEC of 5 March 1991 defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 10 of Directive 88/379/EEC(1) must be provided. If necessary, measures for the prevention of occupational risks and means of protection during manufacture, handling, use and disposal shall be proposed.

2.5.2.2. Micro-organisms

A classification according to Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC)(2) shall be submitted. For micro-organisms not classified in group 1 in this Directive, information shall be provided to customers to allow them to take the relevant protection measures for their workers, as defined in Article 3 (2) of the said Directive.

2.5.2.3. Labelling requirements

Without prejudice to the labelling and packaging provisions laid down in Article 16 of Regulation (EC) No 1831/2003, any specific labelling requirements and, where appropriate, specific conditions for use and handling (including known incompatibilities and contraindications) and instructions for proper use shall be indicated.

(1)

OJ L 76, 22.3.1991, p. 35. Directive as last amended by Directive 2001/58/EC (OJ L 212, 7.8.2001, p. 24).

(2)

OJ L 262, 17.10.2000, p. 21.