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,
a modification of an existing authorisation of a feed additive, or
a renewal of the authorisation of a feed additive.
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 European scientific body following the legislation in force in the Community, 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 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(1) or International Organisation for Standardisation (ISO).
Where in vivo or in vitro studies are carried out outside the Community, 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 Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(2), as last amended by Commission Directive 2004/73/EC(3), 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 Directive 2004/10/EC and/or EN ISO/IEC 17025. These methods shall comply with the requirements laid down in Article 11 of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules(4).
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.
Safety assessment
This is based on studies intended to demonstrate the safety of the use of the additive in relation to:
the target species at the highest proposed levels of incorporation in the feed or water and at a multiple of that level to establish a margin of safety;
consumers who ingest food products obtained from animals that have received the additive, its residues or its metabolites. In this case, safety will be ensured by the setting of maximum residue limits (MRLs) and withdrawal periods based on an Acceptable Daily Intake (ADI) or an Tolerable Upper Intake Level (UL);
persons likely to be exposed to the additive by respiratory, mucosal, eye or cutaneous contact while handling the additive or incorporating it into premixtures or complete feed or water or using feed or water containing the additive concerned;
animals and humans with respect to the selection and spread of antimicrobial resistance genes; and
the environment, as a result of the additive itself or products derived from the additive, either directly and/or as excreted by animals.
Where an additive has multiple components, each one may be separately assessed for consumer safety and then consideration given to the cumulative effect (where it can be shown that there are no interactions between the components). Alternatively, the complete mixture shall be assessed.
Efficacy assessment
This is based on studies that are intended to demonstrate the efficacy of an additive in terms of the aims of its intended use as defined in Article 6 (1) and Annex I of Regulation (EC) No 1831/2003.
OJ L 196, 16.8.1967, p. 1. Directive as last amended by Directive 2006/121 of the European Parliament and of the Council (OJ L 396, 30.12.2006, p. 852; corrected by OJ L 136 29.5.2007, p. 281).
OJ L 152, 30.4.2004, p. 1; corrected by OJ L 216, 16.6.2004, p. 3.
OJ L 165, 30.4.2004; corrected by OJ L 191, 28.5.2004, p. 1.