Probiotics in animal nutrition: let’s talk about it!

FEFANA (EU Feed Additives and Premixtures Association) in partnership with its French platform SYNPA (Syndicat national des producteurs d'additifs et d'ingrédients de la chaîne alimentaire) recently held a press conference about probiotics as feed additives at the Maison de la Meunerie in Paris. This meeting was an opportunity to focus on the evolution of the European regulations concerning feed additives and more particularly probiotics. Probiotics, essentially live bacteria or living yeasts, are authorized in Europe as zootechnical additives. Since 1993, they have therefore followed a very strict regulation which makes provision for scientific assessment by a committee of experts during which manufacturers shall produce evidence of the identity, safety and efficacy of their product. When this assessment is positive, the relevant product receives an authorization fixing very specific usage and labelling conditions, particularly as far as product claims are concerned, under Regulation (EC) No 1831/2003 on additives for use in animal nutrition. This process provides a guarantee of the safety, traceability and efficacy for probiotics entering the food and feed chain. The press conference is one of the actions initiated by the FEFANA working group in charge of communicating about probiotics and gathering the main producers of probiotic bacteria and yeasts in Europe. Its role is not only to promote benefits of probiotics in feed but also to address technical issues linked with their usage as well as to share this information with other professionals.

The classification of additives according to Regulation (EC) No 1831/2003 is based on their functionality and not on their composition. As mentioned by Didier Jans, Secretary General of FEFANA, five categories have been defined as follows: technological additives, sensory additives, nutritional additives, zootechnical additives and coccidiostats/histomonostats. Some specific authorization criteria concerning identity/quality, safety and efficacy apply to each category. These categories are also divided into functional groups which correspond to very precise claims: digestibility enhancers, gut flora stabilizers or substances which favourably affect the environment are, for instance, taken into account as far as zootechnical additives are concerned.

Professor Michel Larbier, Honorary Research Director at INRA, presented the main steps of the feed additive registration in Europe. The dossier, compiled by the manufacturer, shall be composed of three main sections (see attached text frame). Dossier construction can take several years, to which more years for basic product development must be added (selection, characterization of one specific microorganism strain among thousands of natural strains and also production parameters).

The European Commission passes the dossier to EFSA (European Food Safety Authority) which relies on a specialized experts panel (FEEDAP) for the scientific assessment. For each section of the dossier, methodology and validity of results are assessed. Proposed claims are verified against the presented results on efficacy. If questions are raised during the assessment, the manufacturer is required to answer them. EFSA has a fixed period of maximum six months for assessment if no question is raised, while each question can "stop" the clock. EFSA, which has a strictly consultative role, gives advice to the Commission, after which the dossier is submitted for the vote by the 27 Member States.

Mrs. Catherine Evrevin of the DGCCRF indicated that additives follow the principle of the positive list, and only those for which evidence of identity, quality, safety and efficacy are provided are registered and authorized under specific usage conditions (dosage, target animal species, physiological stage, ...). On the other hand, feed raw materials follow a principle of free circulation provided that they do not represent any risk (existence of a negative list). Unlike raw materials which cannot make functional claims, authorized additives can have clear demonstrated and approved claims on the performance, welfare or environment of the animal.

In order to help manufacturers and users to clearly identify different categories of products, a new regulation was voted by the European Parliament at first reading on February 9th, 2009. The text will be soon adopted by the Council. This new regulation aims at clarifying the definition of raw materials, with the possibility of allocating some nutritional claims to them. It will lead to the creation of a Community catalogue of raw materials and a Community code of good practices for labelling of composed feed which will regulate the demonstration and the usage of any claims. Catherine Evrevin also said that this regulation, which "is an additional step towards harmonization for products which are in a 'grey' zone", has been set for more transparency and traceability for users, "from farm to table". The new regulation also makes provisions for the set up of a helpful decision tool regarding additives, raw materials and medicines. Thereon, Didier Jans explained that FEFANA took a lead as the association already offers "ID-feed", an online tool which allows the identification of the regulatory status of any individual product or mixture in animal nutrition.

FEFANA is the EU Feed Additives and Premixtures Association created in 1963. It represents 101 operators (producers and retailers) from the 27 European Union countries.

SYNPA (Syndicat national des producteurs d'additifs et d'ingrédients de la chaîne alimentaire) has been FEFANA network's French platform since 2005. It represents FEFANA on the French scene and shares its positions with the local authorities.