Call for comment to permit the use of a genetically modified processing aid subtilisin

Food Standards Australia New Zealand (FSANZ) is calling for public comment on an application to permit the use of a protein engineered variant of the enzyme subtilisin as a processing aid to hydrolyse proteins in foods.  

FSANZ CEO Sandra Cuthbert said the application seeks approval to permit the use of a protein engineered variant of the enzyme subtilisin from a genetically modified strain of Bacillus subtilis. This strain contains the subtilisin gene from Bacillus clausii as a processing aid for hydrolysing proteins in food.

“A microbiological assessment concluded that the host organisms have a long history of safe use in food and is not pathogenic or toxigenic. A toxicological assessment combined with a dietary exposure assessment concluded the enzyme is safe according to the proposed use,” Dr Cuthbert said.

If approved, the amount of enzyme used would be consistent with good manufacturing practice.

Dr Cuthbert said FSANZ did not have any health concerns associated with this application after conducting safety and dietary exposure assessments.

To have your say, see our call for comment page. Submissions close 6pm (AEDT time) 14 March January 2024.

What happens to my feedback?

We will publish all submissions to our website as soon as possible at the end of the public comment period.

All feedback will be considered by FSANZ before making a decision on whether to approve the application.

Our decision will be notified to ministers responsible for food regulations who can ask for a review or agree to include the amendment in the Code.

More information:

Media contact:

  • 0401 714 265 (Australia)
  • +61 401 714 265 (from New Zealand)

media@foodstandards.gov.au