After studying data for the food enzymes β-amylase, made by fermenting the genetically modified Bacillus licheniformis strain, and pullulanase which is made using a genetically modified strain of Bacillus subtilis, EFSA scientists said there were no safety concerns.
The Danish company developed both enzymes for starch processing in glucose syrup production.
“Toxicological tests made with the food enzyme under application indicated that there was no concern with respect to genotoxicity, mutagenicity or systemic toxicity,” they concluded.
As processing aids, the enzymes are used in small amounts during production and then removed from the final products through filtration, carbon treatment and ion exchange, meaning the EFSA panel did not need to calculate dietary exposure.
This also means they do not need to feature on ingredient lists.
The pullulanase enzyme can be used to produce glucose syrups containing maltose, at an intended use level of up to 78.1 mg total organic solids (TOS) per kilogram of starch. It is added after liquefaction during the saccharification step in order to convert liquefied starch into maltose-rich glucose syrups.
The β-amylase enzyme, sold under the brand name Secura, is intended to be used at levels of up to 98.7 mg TOS/kg starch.
The concentrated food enzymes are sold in liquid and solid form with preservatives to ensure they are stable solutions.
Global marketing manager at Novozymes Hans Christian Lindstrøm Wegge said both enzymes secure a more a more robust and stable production of syrups for manufacturers.
Both enzymes are already approved for the market and legally sold in the EU, according to local member state. This EFSA safety assessment is one step of the EU's Food Improvement Agents Package (FIAP), which aims to create a harmonised regulatory system for food enzymes across the bloc.
FIAP will result in a first-ever European list of approved food enzymes, expected to be published at some point after 2022.
The EFSA panel also tested for allergens by searching for similarity of amino acid sequences to those of known allergens but found no matches, and so there is no evidence for potential allergenicity.
The full EFSA opinion for pullulanase can be read here and here for β-amylase.