Division GENERAL ASPECTS

This Annex sets out the requirements for establishing the list and the characteristics of studies and information on substances, micro-organisms and preparations to be submitted with dossiers under Article 7 of Regulation (EC) No 1831/2003 for:

• an authorisation as a new feed additive,

• an authorisation of a new use of a feed additive, F1or

• a modification of an existing authorisation of a feed additiveF2...

• F3...

The dossiers must enable an assessment to be made of additives based on the current state of knowledge and permit verification of the compliance of these additives with the fundamental principles for authorisation, which are laid down in Article 5 of Regulation (EC) No 1831/2003.

The studies to be submitted and the extent of them will depend on the additive nature, the category and functional group, the type of authorisation (non-holder specific vs. holder specific), the substance itself, the target animals and the conditions of use. The applicant shall refer to this Annex and to Annex III in order to evaluate which studies and information shall be submitted with the application.

The applicant shall clearly provide the reasons for the omission or deviation from the dossier of any data prescribed in this Annex, Annex III and Annex IV.

The dossier shall include detailed reports of all the studies performed, presented in accordance with the numbering system proposed in this Annex. The dossier shall include references and copies of all published scientific data mentioned and the copies of any other relevant opinions which have already been produced by any recognised scientific body. Where these studies have already been evaluated by a F4... scientific body F5under F6assimilated law, a reference to the result of the evaluation shall be sufficient. Data from studies that have been conducted and published previously or coming from peer review shall clearly refer to the same additive as the one subject to the application for authorisation.

Studies, including those that have been conducted and published previously or coming from peer review, shall be performed and documented according to appropriate quality standards (e.g. Good Laboratory Practice (GLP)) in accordance with F7Annex I to Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances^f1 or International Organisation for Standardisation (ISO).

Where in vivo or in vitro studies are carried out outside F8Great Britain, the applicant shall demonstrate that the facilities concerned comply with the Organisation for Economic Cooperation and Development (OECD) principles of Good Laboratory Practice or ISO standards.

The determination of physico-chemical, toxicological and eco-toxicological properties must be performed in accordance with the methods established by F9Regulation (EC) No 1272/2008, or with updated methods recognised by international scientific bodies. The use of methods other than these must be justified.

The use of in vitro methods or of methods refining or replacing the usual tests using laboratory animals or reducing the number of animals used in these test shall be encouraged. Such methods shall be of the same quality and provide the same level of assurance as the method they aim to replace.

The description of the methods of analysis in feed or water shall be in conformity with the rules of GLP as laid down in F10Annex I to Directive 2004/10/EC and/or EN ISO/IEC 17025. These methods shall comply with the requirements laid down in F11Articles 34 and 35 of Regulation (EU) 2017/625.

Each dossier shall contain a public summary and a scientific detailed summary in order to enable the additive concerned to be identified and characterised.

Each dossier shall contain a post-market monitoring proposal where required by Article 7(3)(g) of Regulation (EC) No 1831/2003 and a labelling proposal as referred to in Article 7(3)(e) of Regulation (EC) No 1831/2003.