EU probiotics regulation

Probiotics, essentially live bacteria or yeast, 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 labeling conditions, particularly as far as product claims are concerned, under Regulation (EC) No 1831/2003 on feed additives. This process provides a guarantee of the safety, traceability and efficacy of the probiotics entering the feed and food chain.

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. These categories are also divided into functional groups which correspond to very precise claims:

1. Technological additives:

2. Sensory additives:

3.: Nutritional additives:

5. Coccidiostats/histomonostats.

Some specific authorization criteria concerning identity/quality, safety and efficacy apply to each category.

Professor Michel Larbier, Honorary Research Director at INRA, the French Agronomic Research Institute, presented the main steps of feed additive registration in Europe.

The dossier, compiled by the manufacturer, shall be composed of three main sections (see 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, development of the production process, as far as microorganisms for probiotics or silage additives are concerned).

The European Commission passes the dossier to EFSA (European Food Safety Authority) which relies on a specialized experts panel (FEEDAP) for its 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, which has a strictly consultative role, releases a scientific opinion, after which the dossier is submitted for the vote by the 27 Member States.

Upon receiving the dossier from the Commission, EFSA has three months to verify its content, then the assessment period is limited to a maximum of six months if no question is raised, while each question can "stop" the clock.

Mrs. Catherine Evrevin of the DGCCRF (the French General Directorate for Competition Policy, Consumer affairs and Fraud Control) 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.

Confusion may arise between raw materials and additives, as illustrated by Professor Jouany, also from INRA, in his presentation about the effects and modes of action of probiotics in animal nutrition. He explained the difference between inactivated yeast, used as raw material, and probiotic yeast. While the former are used as a source of nutriments, the latter exert zootechnical effects linked to their biological activity in the animal digestive tract.

In order to help manufacturers and users 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 labeling 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 fork". 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.

 

At Lallemand Animal Nutrition, we put

a lot of efforts towards the registration

of our probiotics and silage additives.

Here is a summary of the regulatory  status of our ruminant and monogastric ranges.   

Levucell^® SC20 and Levucell SC^® 10ME (S . cerivisiae CNCM I-1077) are authorized in bovine destined to the production of milk and meat, dairy small ruminants (sheep and goat) as well as fattening lamb (authorization N° E1711/4b1711). An equine authorization is being assessed by the Commission.

Bactocell^® (Pediococcus acidilactici MA 18/5M) is authorized for fattening pig under authorization number E1712.

Levucell^® SB (Saccharomyces cerevisiae boulardii I-1079) is authorized for piglet and sow (authorization N° E1703).

Bactocell^® (Pediococcus acidilactici MA 18/5M) is authorized for broiler chicken (authorization N° E1712).

Bactocell^® (Pediococcus acidilactici MA 18/5M)  is being assessed by the Commission for use in shrimp and fish.

The specific microbial strains that constitute the active ingredients of the Lalsil^® range of forage-specific silage inoculants (Lalsil^® CL, Lalsil^® PS, Lalsil^® Dry, Lalsil^® MS01 and Lalsil^® Fresh) have been notified to the Community register of feed additives in 2005. Under European regulation 1831/2003, products listed on the Register are authorised until November 2010, when a new authorisation will have to be filed for a ten years period.