Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Exposure to enzymes will be limited because of the DMEL (derived minimum exposure levels) settings for workers, professionals and consumers to prevent respiratory allergy (supported by exposure scenarios and DMEL values).


Justification for selection of genetic toxicity endpoint
Genotoxicity testing is in general performed to confirm that the production strain does not produce any genotoxic or carcinogenic metabolites. Basically all enzyme substances have therefore been tested in the Ames test and in the chromosome aberration test in vitro and a few enzyme substances also in the mouse lymphoma test. In none of these test systems did enzyme proteins show evidence of genotoxicity.
Genetic toxicity is not expected for enzyme preparations in general in the light of the following:
• Availability of extensive negative mutagenicity data on enzyme preparations
• Documented and recognized lack of genotoxic effects with enzyme preparations in both bacterial and mammalian systems.
• Substantial amounts of genotoxicity data are available from regulatory agencies in support of enzymes used in food and feed.

Short description of key information:
Technical enzymes are produced by fermentation and contain not only the principal enzyme protein but also residual growth medium from the fermentation and metabolites from the production strain. As with other proteins, the enzymes are not genotoxic.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

In conclusion, the large amount of data on genotoxicity available together with structural knowledge, toxicokinetic and human data provide no evidence for genotoxic or carcinogenic potential of enzymes.