Guidance documents released by FEFANA

Regulation (EC) No 1831/2003 has created a novel and modern framework for the authorization of feed additives. The Regulation is now reaching maturity: the classification of feed additives into categories and functional groups is understood and accepted by the market, the authorization procedure is fully in place and proportionate rules for the building and evaluation of the Guidelines are ready for publication¹.

What is now on the immediate time horizon is the re-evaluation of existing feed additives according to Article 10 of this feed additive Regulation. This will lead to full market clarity: the Register will list all additives in a coherent, harmonized way, together with their specifications.

The re-evaluation process promises however to be difficult to manage, and time-consuming both for the authorities and the industry.

FEFANA strongly feels that the best way to streamline this is to develop a global, coherent industry interpretation of the new guidelines. Based on the final draft of the Guidelines, which are to be published imminently, FEFANA has developed a comprehensive set of tools which will help applicants through the dossier-building process:

- deciding whether a dossier is necessary for a particular product;

- finding the appropriate additive category and functional group;

- determining which of the Guidelines sections apply to the product;

- interpreting the Guidelines demands into operational requirements.

This set of tools is supplemented by a glossary and numerous references to FEFANA and external sources of information.

The FEFANA Guidance tools are available to FEFANA members and to the FEFANA Consortia members.

FEFANA has entered into an exchange of views with the EFSA FEEDAP Panel, to promote the industry's interpretation of the Guidelines and to identify possible areas where this interpretation might be challenged by the Panel. This should lead to a situation where both the applicant and the risk assessor will save time and resources, as a high-quality dossier will be more easily and quickly evaluated by the Panel.

¹ Commission Regulation 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.