Organizations have concerns regarding methods used to determine safety
FEFANA (the EU Association of Specialty Feed Ingredients and their Mixtures) and the Association of Manufacturers and Formulators of Enzyme Products (AMFEP) have responded to the European Food Safety Authority (EFSA)’s public consultation on the updated safety guidance on the assessment of the toxigenic potential of Bacillus species used in animal nutrition.
The Bacillus species have been widely used for decades as microbial feed additives (probiotics and silage inoculant) and as production organisms for enzymes and other fermentation products for feed and food use. The feed additive and enzyme industry welcome EFSA’s wish to secure safety and harmonize the safety assessment criteria, based on scientific sound methods. However, FEFANA and AMFEP said they have strong concerns about the approach used by EFSA in their new draft Bacillus guidance document.
EFSA questions the safety of Bacillus strains with an established, long history of safe use, based on their potential to produce lipopeptides, according to the organizations. Recent literature shows that the traditional Japanese food and health product natto contains strong lipopeptide-producing Bacillus spp.
Natto has been consumed without any adverse effects upon daily intake for centuries in Asia. It is also known from the scientific literature cited by EFSA that toxic effects seen in in vitro cell tests is not related to an in vivo toxicity. Therefore EFSA’s concern about lipopeptides is most likely unfounded.
As there is no international recognized in vitro assay developed for measurement of lipopeptides, EFSA suggests using assays developed for other purposes. The organizations said they believe that these assays may lead to wrong conclusions on the potential risk of Bacillus strains and the present test may leave some uncertainties on how they should be performed and interpreted.
This could have impact for already authorized additives with a known effect and already tested in animals, as well as limiting the development of new products based on Bacillus strains.