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

7. PETS AND OTHER NON FOOD-PRODUCING ANIMALS

Pets and other non food-producing animals are defined in Article 1(1) of this Regulation.

7.1. Section I: summary of the dossier

The whole of Section I of Annex II applies.

7.2. Section II: identity, characterisation and conditions of use of the additive; methods of analysis

The Section II of Annex II applies as following:

• for additives subject to a specific holder of the authorisation, the while of Section II applies

• for other additives the paragraphs 2.1.2, 2.1.3, 2.1.4, 2.1.4.2, 2.2, 2.3.1, 2.3.2., 2.4.1, 2.4.2, 2.4.4, 2.5, 2.6 apply.

7.3. Section III: studies concerning the safety of the additive

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

The requirements for the different categories/functional groups of additives apply. Where a tolerance study is required, its duration shall be at least 28 days.

A tolerance study is not required if the additive has shown a comparable and wide margin of safety in three major species (including monogastric and ruminant mammals and poultry).

7.3.2. Studies concerning the safety of use of the additive for consumers

This subsection is not usually required. Consideration shall be given to the safety of the owner.

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

The whole of subsection 3.3 of Annex II applies.

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

Subsection 3.4 of Annex II is not required.

7.4. Section IV: studies concerning the efficacy of the additive

The requirements for the different categories/functional group of additives apply.

When the additive, for which animal studies are required, has been previously authorised for other physiological similar species, no further demonstration of efficacy is required provided the requested effect and mode of action are the same. If the additive has not been previously authorised, the requested effect, or the mode of action are different than former authorisation, efficacy shall be demonstrated following the general rules for Section IV in Annex II.

The duration of the long term efficacy trials shall be at least 28 days.

7.5. Section V: post-market monitoring plan

This section of Annex II shall apply under provision of Article 7(3) (g) of Regulation (EC) No 1831/2003.