The Association of Veterinarians in Industry (AVI) has expressed concern over the validity of in vitro tests, particularly a haemolytic test, used by EFSA to determine safety of Bacillus strains.

In vitro testing arose as part of last summer’s EFSA draft guidance and was welcomed by the AVI in favour of animal testing.

Bacillus strains are included as probiotics in food and feed supplements and as silage inoculants and have been used in the manufacture of fermented foods for centuries, particularly in Asia.

In a press release this week, the AVI - a division of the British Veterinary Association – noted that haemolysis does not exclusively mean the bacteria are disease causing.

This is because many non-pathogenic bacteria, including safe Bacillus and Lactobacillus strains, harbour haemolytic genes and exhibit a greater or lesser degree of haemolysis, noted the AVI.

Similarly, the AVI queried EFSA’s in vitro testing for lipopeptide toxins such as ‘natto’ – Bacillus subtilis natto.

In order to sure up the evaluation process, the AVI advised that Bacillus strains already used as food and feed additives should be considered among the historical context of global usage and that Bacillus strains entering the food industry should be evaluated via traditional in vitro safety studies.

A further recommendation was that EFSA broadens the consultation process to other specialist panels.

Human nutrition, pesticide, genetically modified micro-organisms and biological hazard specialists at EFSA could advise on specific bacterial strain safety.

This would ensure a robust final outcome on bacillus safety, the AVI concluded.