Regulation of anti-mycotoxin feed additives

Europe has begun authorizing feed additives that can reduce absorption of mycotoxins by animals, promote excretion or modify the mode of action of mycotoxins.

*Dr. Raj Murugesan is a poultry specialist, Dr. Gerald Schultheis, is head of regulatory affairs and Ines Rodrigues is technical manager, all with BIOMIN.

CONSIDERABLE research over the last three decades has been directed at finding methods to prevent mycotoxin toxicity to animals.

As a result, hundreds of feed additives are available on the global market that tout mycotoxin-counteracting claims.

In the U.S., anti-mycotoxin additives have been sold as anti-caking agents or feed supplements or their combinations. Although claims of mycotoxin adsorption are not made on the label, they are marketed with data showing improvements in animal health and immune parameters, suggesting the elimination of indirect effects of mycotoxins.

The critical reason for this situation is the absence of any regulation in place recognizing anti-mycotoxin additives — until lately.



The first step towards resolving this situation was taken in March 2009 by the Standing Committee on the Food Chain & Animal Health (SCFCAH) in the European Union. SCFCAH voted to establish a new functional group governing the EU authorization of feed additives that can suppress mycotoxin absorption and promote excretion by the animal or deactivate and modify the mode of action of mycotoxins.

This was a milestone in the feed additive industry as the manufacturers that choose to market anti-mycotoxin additives have to submit their product dossier for evaluation by the European Food Safety Authority (EFSA). The EFSA scrutiny has also come with certain guidelines that feed additive manufacturers must adhere to while submitting the anti-mycotoxin additive registration dossier. The major ones are:

* Mycotoxin specificity. Target mycotoxin(s) for the product must be declared. The product should not interfere with the analytical determination of mycotoxins in feed, which would ultimately encourage the use of feed ingredients and feed with contamination levels above those regulated by the EU.

* Species specificity. Data from a minimum of three in vivo studies performed in at least two different locations showing statistically significant effects must be provided to demonstrate efficacy at the lowest recommended dosage in a specific species. Extrapolation of data to other species cannot be done due to differences in mycotoxin degradation as well as absorption by the animal. Data from studies conducted in at least three major species — avian (e.g., poultry), monogastrics (e.g., swine) and ruminants (e.g., cattle) — should be presented for application to all livestock species.

* Efficacy. Demonstration of product efficacy must be provided in the form of scientifically recognized relevant biomarkers (e.g., aflatoxin M1 in milk or aflatoxin B1 in egg yolk for products against aflatoxins, deoxynivalenol/metabolites in serum for products against deoxynivalenol, etc.).

* Safety. Data ruling out the possibilities of interaction with other feed components such as vitamins should be presented for mycotoxin binders such as clays. For mycotoxin deactivators that modify the chemical structure of mycotoxins, the effects of the deactivating substance as well as the resulting metabolite(s) on the safety of target animals and the consumer must be presented.

The EFSA Panel on Additives & Products or Substances Used in Animal Feed carries out the evaluation, which is a lengthy and arduous procedure. Upon successful evaluation, EFSA provides a positive opinion on the product, resulting in the release of marketing authorization by the European Commission that may be adopted by EU member states.

In the U.S., the state of Texas published provisions for the use of aflatoxin-binding agents in February 2011 and criteria for aflatoxin-binding agents in May 2011. Part of the criteria requirements are to present an isothermal adsorption analysis that gives a Qmax value from an in vitro study and the efficacy of the product from in vivo studies.

These stringent EFSA and Texas guidelines have effectively discouraged many manufacturers from having their anti-mycotoxin additives legally registered. Therefore, these manufacturers are still marketing their products as generic feed additives such as anti-caking agents or under the "EU Catalogue of Feed Materials" or the "Feed Materials Register."

Products marketed these ways do not have to go through any scientific evaluation (i.e., EFSA review). For example, many yeast-based products are marketed in this fashion.


Case study

For a bentonite-based mycotoxin binder, BIOMIN received certification from Texas in January 2012 and was the first feed additive manufacturer to submit a registration dossier and to obtain a positive EFSA opinion for the same product.

In its opinion, EFSA recommended that a minimum in vitro binding capacity equivalent to 100 mg of aflatoxin B1 per gram should be required for a product since mycotoxin binders have a wide and unspecific binding range.

Hence, looking at the above events of approvals or opinions of anti-mycotoxin products, it is clear that not all mycotoxin binders are the same; as a matter of fact, no two clays are alike.

The mycotoxin binder against aflatoxins was the first product from BIOMIN to receive a positive EFSA opinion in 2011, followed by a positive opinion for a trichothecene deactivator (BBSH797) in 2013, while another dossier for a mycotoxin-inactivating enzyme has just been submitted.

Although this extensive, demanding process might be discouraging for anti-mycotoxin additive manufacturers, it will gradually eliminate ineffective products from the marketplace.

Livestock and poultry producers will be able to comprehensively compare all of the registered products and make informed decisions with the scientific assurance that they are purchasing quality products.

Volume:85 Issue:38

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