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Safety evaluation of esperase
R K Hjortkjaer1, M Stavnsbjerg, P B Pedersen
1Danish Toxicology Centre, Hørsholm.
Summary
Esperase, a food processing enzyme, demonstrated low toxicity and no mutagenic potential in safety studies. These findings confirm its safety for consumers in processed foods.
Area of Science:
- Food Science
- Toxicology
- Enzymology
Background:
- Enzyme preparations are utilized as processing aids in the food industry.
- Safety assessments are crucial for food additives and processing aids.
Purpose of the Study:
- To evaluate the safety of Esperase, a proteolytic enzyme preparation, for consumer use in food processing.
- To establish the toxicological profile of Esperase through various safety studies.
Main Methods:
- Conducted a 13-week oral toxicity study in rats.
- Performed teratogenicity studies in rats.
- Carried out gene mutation assays in Salmonella typhimurium and mammalian cells.
- Conducted chromosome aberration assays in vitro.
Main Results:
- General toxicity was found to be low.
- Observed effects were attributed to proteolytic activity and sodium chloride content, deemed irrelevant to consumers.
- No evidence of adverse effects on pregnancy outcomes was detected.
- No mutagenic potential was identified in the conducted assays.
Conclusions:
- Esperase exhibits low toxicity and no mutagenic potential.
- The enzyme preparation is safe for its intended application as a food processing aid.
- Safety is supported by toxicological data and knowledge of the production organism.