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

11. RE-EVALUATION OF CERTAIN ADDITIVES ALREADY AUTHORISED UNDER DIRECTIVE 70/524/EEC

The additives concerned by this point 11 are additives which were authorised under Directive 70/524/EEC and are to be re-evaluated in accordance with Article 10(2) of Regulation (EC) No 1831/2003 and which belong to the following groups:

• antioxidant substances,

• flavouring and appetising substances,

• emulsifying and stabilising substances, thickeners and gelling agents,

• colourants, including pigments,

• preservatives,

• vitamins, provitamins and chemically well-defined substances having similar effect,

• trace elements,

• binder, anti-caking agents and coagulants,

• acidity regulators, and

• radionuclide binders.

The level and quality of risk evaluation for these additives shall be similar to other additives. However, due to their long history of safe use, data from studies already published may be used, under provisions provided by this Regulation, to show that the additive remains safe under the approved conditions for the target species, consumers, users and the environment.

11.1. Section I: summary of the dossier

The whole of Section I of Annex II applies.

11.2. 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 not subject to a specific holder of the authorisation 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;

• for other additives subject to a specific holder of the authorisation, the whole of Section II applies.

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

Where an additive has been assessed for safety for target species, consumers, users/workers and the environment, a summary of the safety studies submitted for the previous authorisation, plus any new information arising since the previous authorisation shall be provided. Where a formal safety assessment has not been undertaken for the use of the substance as a feed additive, studies and data from the scientific literature can be used provided it is equivalent to that which would be required in a new application. Otherwise, a complete set of safety studies shall be provided.

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

Where appropriate, the compliance with the requirement of efficacy provided for in Article 5(3) of Regulation (EC) No 1831/2003 may be demonstrated by submission of material other than studies, in particular relating to the long history of use.

11.5. 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.