EFSA renews approval for DSM 11798, reinforcing trust in mycotoxin mitigation

EUROPE – The European Food Safety Authority (EFSA) has officially renewed the authorisation of DSM 11798, a bacterial strain at the heart of BIOMIN’s Mycofix® product, reaffirming its safety and effectiveness in animal feed applications across the European Union.

The decision, adopted on March 20, 2025, follows a comprehensive scientific review requested by the European Commission. 

It confirms that DSM 11798,  now reclassified as part of the Eggerthellaceae family (probiotics), remains safe for use in feed for pigs and all avian species under previously approved conditions.

DSM 11798, also known as BBSH® 797, is unique as the only additive authorised in the EU to biologically transform harmful trichothecenes, such as deoxynivalenol (DON), into harmless metabolites. 

Mycotoxins like DON, which are commonly found in contaminated grains, pose a significant threat to animal health and performance.

“DSM 11798 (BBSH® 797) is the only EU-approved ingredient that can turn harmful trichothecenes, like DON, into safe substances,” dsm-firmenich Animal Nutrition & Health stated in a LinkedIn post. 

“Safe for animals, the environment, and people. No changes in how it’s used – reliable protection continues. Proven safety and effectiveness = renewed trust from our customers. It’s a testament to our commitment to science, innovation, and trust.”

The EFSA assessment concluded that the additive is non-irritant to the eyes and skin but must be regarded as a skin and respiratory sensitiser, meaning exposure via inhalation or skin contact could pose risks. 

However, the agency confirmed no evidence of virulence or antimicrobial resistance associated with the strain. 

Additionally, a new in vitro micronucleus test confirmed that DSM 11798 does not induce chromosomal damage, further reinforcing its safety profile.

EFSA’s renewal is based on an evaluation of a detailed technical dossier submitted by BIOMIN GmbH, which was acquired by DSM in 2023, along with a review of scientific literature and manufacturing data. 

Importantly, no changes have been made to the composition or manufacturing process of the additive since its initial authorization. 

The agency also verified that the additive complies with all safety and efficacy parameters outlined in Regulation (EC) No 1831/2003.

The additive remains approved for inclusion in pig and poultry feeds at a minimum level of 1.7 × 10⁸ CFU/kg, maintaining its role as a cornerstone in mycotoxin risk management. It is also compatible with various authorised coccidiostats used in poultry nutrition.

EFSA’s decision is seen as a strong endorsement of DSM’s longstanding investment in microbial technologies that enhance animal health. 

DSM also extended its appreciation to its scientific team, on LinkedIn stating: “Congratulations to the team and especially to Eva Maria Binder, Hannes Binder, Gerd Schatzmayr, and Dian Schatzmayr for their groundbreaking work.”

As mycotoxin contamination continues to challenge global feed safety, the reauthorization of DSM 11798 ensures that European livestock producers can continue to rely on Mycofix® as a scientifically backed, regulatory-approved tool to protect animal health and safeguard feed quality.

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