New Feed Additive Guidance Documents Released by FEFANA

It is with pleasure that FEFANA is able to announce the release of a set of regulatory tools: the FEFANA Guidance documents. These provide an operational interpretation of the new Feed Additive Guidelines and help applicants building regulatory dossiers for existing and new additives.

Regulation (EC) No 1831/2003 has created a novel and modern framework for the authorisation of feed additives.

FEFANA is pleased to see that the Regulation is now reaching maturity: the classification of feed additives into categories and functional groups is understood and accepted by the market, the authorisation procedure is fully in place, and proportionate rules for the building and evaluation of dossiers (the so-called "Guidelines") are ready for publication¹.

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

About FEFANA

FEFANA is the EU Feed Additives and Premixtures Association. It was established on October 13th, 2004 and is the new juridical form of the feed additives producers association that was founded in 1963. With almost 90 members from 28 countries, the association is the interface between the feed additives industry and the European Union authorities, including Member States authorities, in order to promote, safeguard and defend common and general interests of the industry (in several topics like guidelines, register, labelling and definitions, analysis, feed hygiene and food chain safety or non-feed use of additives). FEFANA’s chairperson is Dr. Hadden Graham of AB Vista.