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Biomin Receives Positive Votes for Mycofix in EU

25 September 2013

EU - Two products from the well-established Mycofix product line of BIOMIN, Mycofix Secure (bentonite/dioctahedral montmorillonite) and Biomin BBSH 797 (Gen. nov. sp. nov., formerly Eubacterium), are slated to become the first-ever products authorized by the EU as substances with proven mycotoxin counteracting properties.

Following the positive SCFCAH votes, the publication of the respective EU regulations would be the next and final stage towards confirming the scientific efficacy of Mycofix® Secure and Biomin® BBSH 797 as mycotoxin-deactivating products.

Biomin® BBSH 797 is the first-ever product to receive this positive vote, thereby affirming its capability in the biodegradation of trichothecenes. The patented active bacterium in Biomin® BBSH 797 modifies the structure of these mycotoxins, a biotransformation process that renders trichothecenes such as deoxynivalenol (DON) harmless. This makes Biomin® BBSH 797 a valuable feed additive for pigs, considered the species most susceptible to in-feed DON contamination.

Mycofix® Secure is a bentonite (dioctahedral montmorillonite) that fulfills the strict requirements on aflatoxin-binding capability according to the European Union Reference Laboratory (EURL). In cooperation with the EURL, BIOMIN developed an analytical method to characterize the AfB1-binding capacity of bentonites which has now become a crucial part of the authorization process for aflatoxin binders. These efforts spearheaded by BIOMIN have paved the way for legalizing "aflatoxin-binding" as an official claim.

The process towards the authorization of Mycofix® Secure and Biomin® BBSH 797 in the EU began when, on the initiative of BIOMIN, the EU Association of Specialty Feed Ingredients and their Mixtures, or FEFANA, established the Task Force "Mycotoxins" in 2005. In 2009, the Task Force succeeded in opening a new functional group for mycotoxin counteracting products, signifying a landmark development in the official approval of mycotoxin deactivating products within the EU. This led subsequently to the publication of stringent European Food Safety Authority (EFSA) guidance for anti-mycotoxin product registration—including proofs for mycotoxin and species specificity, efficacy and safety—which have generally deterred the industry from submitting dossiers for EU authorization of anti-mycotoxin feed additives.

In 2010, BIOMIN, however, became the first feed additive company to submit a dossier to legalize the claim of "aflatoxin-binding" properties (Mycofix® Secure). This was followed in 2012 with a dossier for the "biodegradation of trichothecenes" (Biomin® BBSH 797) for EU approval. After a thorough scientific evaluation process, BIOMIN became the first feed additive company to obtain positive opinions from EFSA on these technological feed additives capable of reducing the negative impacts of mycotoxins in animals.

These efforts, leading up to the legal recognition of scientific claims on mycotoxin deactivation, attest to the dedication and long-standing commitment of BIOMIN in the field of research and development in functional feed additives, specifically in products with proven mycotoxin deactivating properties.

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