Safety evaluation of an extension of use of the food enzyme bacillolysin from the non-genetically modified Bacillus amyloliquefaciens strain AE-NP

|July 5, 2024

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View abstract on PubMed

Summary

The food enzyme bacillolysin, produced by Bacillus amyloliquefaciens, is safe for use in fifteen food manufacturing processes. EFSA

Area of Science:

Background:

Bacillolysin (EC 3.4.24.28) is a food enzyme produced by Bacillus amyloliquefaciens.
Previous evaluation by EFSA concluded no safety concerns for 13 food manufacturing processes.

Purpose of the Study:

To update the safety evaluation of bacillolysin for an extended use in 15 food manufacturing processes.
To assess the safety of bacillolysin for two additional food manufacturing processes.

Main Methods:

Dietary exposure estimation for bacillolysin-total organic solids (TOS).
Safety evaluation based on previous data and revised dietary exposure.
Assessment of bacillolysin produced by non-genetically modified Bacillus amyloliquefaciens strain AE-NP.

Keywords:

Main Results:

Dietary exposure to bacillolysin-TOS estimated up to 35.251 mg TOS/kg body weight/day in European populations.
The food enzyme is removed in two of the fifteen processes, with exposure estimated for the remaining thirteen.
No safety concerns identified for the revised intended conditions of use.

Conclusions:

Bacillolysin does not pose safety concerns for consumers under the revised intended conditions of use.
The updated safety assessment supports the expanded application of bacillolysin in food manufacturing.
EFSA's evaluation confirms the safety of bacillolysin for an extended range of food products.