Scientific Opinion on Genotoxicity Testing Strategies

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At the request of the European Food Safety Authority, the Scientific Committee has reviewed the current state-of-the-science on genotoxicity testing strategies and provided a commentary and recommendations on testing strategies, bearing in mind the needs of EFSA’s various Scientific Panels to have appropriate data for risk assessment. It is anticipated that this opinion will contribute to greater harmonisation between EFSA Panels on approaches to such testing.

The purpose of genotoxicity testing for risk assessment of substances in food and feed is: to identify substances which could cause heritable damage in humans, to predict potential genotoxic carcinogens in cases where carcinogenicity data are not available, and to contribute to understanding of the mechanism of action of chemical carcinogens.

For an adequate evaluation of the genotoxic potential of a chemical substance, different end-points, i.e. induction of gene mutations, structural and numerical chromosomal alterations, need to be assessed, as each of these events has been implicated in carcinogenesis and heritable diseases.

An adequate coverage of all the above mentioned end-points can only be obtained by the use of more than one test system, as no individual test can simultaneously provide information on all these end-points.

In reaching its recommendations for a basic test battery, the Scientific Committee has considered. past experience with various tests when combined in a basic battery, the availability of guidelines or internationally accepted protocols, the performance of in vitro and in vivo tests in prediction of rodent carcinogenesis, correlations between in vitro and in vivo positive results for genotoxicity, the minimum number of tests necessary to achieve adequate coverage of the three required endpoints, and the need to avoid unnecessary animal tests.

More information and the scientific opinion may be found on the EFSA Web site.