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Safety evaluation of esperase

R K Hjortkjaer1, M Stavnsbjerg, P B Pedersen

  • 1Danish Toxicology Centre, Hørsholm.

Food and Chemical Toxicology : an International Journal Published for the British Industrial Biological Research Association
|December 1, 1993
PubMed
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.

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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.

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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.