Safety evaluation of the food enzyme glucan 1,4-α-maltohydrolase from the genetically modified Escherichia coli strain MLAVSC

Area of Science:

• Food Science and Technology
• Biotechnology
• Enzymology

Background:

• A novel food enzyme, glucan 1,4-α-maltohydrolase (EC 3.2.1.133), is produced using a genetically modified <i>Escherichia coli</i> strain.
• The production process ensures the final enzyme product is free from viable cells and DNA of the production organism.

Purpose of the Study:

• To assess the safety of glucan 1,4-α-maltohydrolase for use in three specific food manufacturing processes.
• To evaluate potential risks associated with dietary exposure to the food enzyme and its total organic solids (TOS).

Main Methods:

• Dietary exposure was estimated for European populations based on intended use, excluding processes with residual TOS removal.
• Safety was evaluated through genotoxicity testing and a 90-day repeated dose oral toxicity study in rats.
• Amino acid sequence homology to known allergens was analyzed to assess allergenic potential.

Main Results:

• Estimated dietary exposure was up to 0.172 mg TOS/kg body weight per day.
• No genotoxicity concerns were identified. The no observed adverse effect level (NOAEL) from the toxicity study was 1000 mg TOS/kg bw per day.
• A low likelihood of allergic reactions was considered, despite matches with some known allergens.

Conclusions:

• The food enzyme glucan 1,4-α-maltohydrolase does not pose safety concerns under the specified conditions of use.
• The margin of exposure was substantial (at least 5814), indicating a low risk from systemic toxicity.
• While a low risk of allergy is possible, the overall safety profile supports its intended application in food manufacturing.