FEFANA responds to EFSA guidance on Bacillus safety

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 harmonise the safety assessment criteria, based on scientific sound methods. However FEFANA and AMFEP 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. 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 recognised in vitro assay developed for measurement of lipopeptides, EFSA suggests using assays developed for other purposes. We 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 authorised additives with a known effect and already tested in animals, as well as limiting the development of new products based on Bacillus strains.

Independent scientists shared our concerns on the scientific robustness of the draft EFSA approaches to Bacillus safety.

AMFEP & FEFANA appreciated the chance to comment on the EFSA guidance and look forward to a well-based scientifically-justified final version of the text.