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 III SPECIFIC REQUIREMENTS TO BE SATISFIED BY THE DOSSIER PROVIDED FOR IN ARTICLE 3 WITH RESPECT TO CERTAIN CATEGORIES OF ADDITIVES OR CERTAIN PART ICULAR SITUATIONS, AS PROVIDED FOR IN ARTICLE 7(5) OF REGULATION (EC) No 1831/2003

5. COCCIDIOSTATS AND HISTOMONOSTATS

5.3. Section III: studies concerning the safety of the additives

5.3.1. Studies concerning the safety of use of the additive for target animals

The whole of the subsection 3.1 of Annex II applies

5.3.2. Studies concerning the safety of use of the additive for consumer

The whole of the subsection 3.2 of Annex II applies

5.3.3. Studies concerning the safety of use of the additive for users/workers

The whole of the subsection 3.3 of Annex II applies

5.3.4. Studies concerning the safety of use of the additive for environment

The whole of the subsection 3.4 of Annex II applies