Meeting on Feed additives applications under the Regulation (EC) No 429/2008
Regulation (EC) No 1831/2003 establishes the rules governing the Community authorisation of additives for use in animal nutrition in order to provide the basis for the assurance of a high level of protection of human health, animal health and welfare, the environment, and users' and consumers' interests, whilst ensuring the effective functioning of the internal market.
In May 2008, Commission Regulation (EC) No 429/2008 was issued on detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives. These rules are intended to replace the provisions laid down in the Annex to Council Directive 87/153/EEC fixing guidelines for the assessment of additives in animal nutrition. They provide for the legislative requirements to be satisfied by the dossier accompanying the application. Furthermore, they set out the scientific data to be submitted for the identification and the characterisation of the additive concerned as well as the studies to be submitted to demonstrate its efficacy and its safety for humans, animals and the environment in view of the verification and assessment of the applications for evaluation by the European Food Safety Authority (EFSA).
In the short term, and according to the provisions of Regulation (EC) No 1831/2003, a deadline for the submission of applications for re-evaluation is approaching. EFSA is aware of the situation applicants are facing. For this reason, EFSA, and especially the FEEDAP Panel, have been working on drafting detailed guidance to assist applicants in the preparation and presentation of their applications. The resulting guidance documents are meant to ease the comprehension of the requirements provided in the European Commission’s guidelines, increasing thereof the consistency and quality of the dossiers submitted.
The guidance documents prepared by EFSA contain three sub-sets of documents:
- Five guidance documents for the specific categories of feed additives: Technological, Sensory, Nutritional, Zootechnical, Coccidiostats and Histomonostats.
- Seven guidance documents dealing with horizontal issues, including guidance on tolerance and efficacy studies in target animals, microbial additives, consumer safety, user safety, environmental risk assessment, additives already authorised for use in food and extrapolation from major species to minor species.
- One specific document dealing with the re-evaluation of certain additives already authorised under Directive 70/524/EEC.
With those user-friendly guidance documents, EFSA presents in a transparent way the approach taken by the FEEDAP Panel when evaluating the applications submitted.
Objectives of the meeting
The objectives of the meeting are:
- (i) to provide advice to applicants regarding the administrative requirements when preparing and submitting a dossier,
- (ii) to explain the interaction between the different guidance documents prepared by EFSA according to the legislative requirements established under Regulation (EC) No 429/2008, and
- (iii) to present the EFSA Guidance documents in support of the submission of comprehensive feed additives dossiers.
Structure of the meeting
The meeting will consist of common and parallel sessions. In the common sessions, EFSA will present issues that are relevant for all types of feed additives applications/dossiers while the parallel sessions will address issues specifically related to three selected categories of feed additives (zootechnical, nutritional, technological). In this way, EFSA is organising a tailor-made event aiming at providing information to applicants according to their particular needs.
Who should attend?
The meeting will be relevant for industry representatives/applicants, consultants, or other people involved in the preparation of applications for feed additives.
For logistical reasons participation will be limited to 150 participants. Interested participants are requested to register by 3 October 2008 using the online registration form.
Each participant is invited to indicate in the registration form his /her preference for the parallel sessions, ranking them from 1 to 3, where 1 indicates higher preference. In this way, EFSA will allocate each one of the participants in one of the parallel sessions according to their preferences. Since one session can accommodate maximum 50-60 participants, participants may be relocated to their second ranked session.
Acceptance will be made on a ‘first come, first served’ basis. Given that one of the aims of the meeting is to cover a wide number of applicants, EFSA will accept only a maximum of two participants from the same organisation.
Travel and accommodation
Participation to the meeting is free of charge. Participants are asked to make their own travel arrangements. List of hotels in Parma.
Dates and venue
The meeting will be held on 23 October 2008 in Parma, Italy. The meeting will start at 9.30 and end at 17.30 on the same day. The event venue is Star Hotel Du Parc, Viale Piacenza, 12/C, 43100 Parma, Italy.
English will be the official language. No simultaneous translations will be provided.