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Safety evaluation of alkaline cellulase
R J Greenough1, D J Everett, M Stavnsbjerg
1Inveresk Research International Limited, Tranent, Scotland.
Summary
Alkaline cellulase, an enzyme used in food processing, was found safe for consumers and the environment. Studies showed low toxicity, no reproductive or mutagenic effects, and no significant pathogenicity from its production microorganism.
Area of Science:
- Food Science and Technology
- Enzymology
- Toxicology
Background:
- Alkaline cellulase is an enzyme utilized as a processing aid within the food industry.
- Ensuring the safety of food processing aids is crucial for consumer protection and regulatory compliance.
Purpose of the Study:
- To comprehensively evaluate the safety profile of alkaline cellulase.
- To assess potential risks associated with its use in food applications and its production process.
Main Methods:
- Conducted laboratory animal studies for general, inhalation, and reproductive toxicity, as well as skin and eye irritation/sensitization.
- Performed microbial and in vivo animal studies to determine mutagenic potential.
- Assessed the pathogenicity of Humicola insolens, the enzyme's production microorganism.
- Evaluated ecotoxicity across various test species.
Main Results:
- Demonstrated low general toxicity via multiple exposure routes.
- Observed mild skin irritation and slight eye conjunctival reddening, with no evidence of skin sensitization.
- Found no indications of reproductive toxicity, mutagenic potential, significant ecotoxicity, or notable pathogenicity.
- The production microorganism, Humicola insolens, exhibited no significant pathogenicity.
Conclusions:
- Alkaline cellulase is deemed safe for consumers in its intended food industry applications.
- No special occupational health precautions are necessary during its manufacture.
- The enzyme and its production process pose a low risk to the environment.