This opinion, which is an initiative of EFSA’s Scientific Committee, is part of the Authority’s ongoing efforts to ensure that its risk assessment always reflects the state-of-the-art in science. It will help inform the risk assessment of substances used in the food and feed chain and contribute to further harmonisation of genotoxicity testing across EFSA’s Scientific Panels[3].

In the opinion, EFSA’s experts reviewed the latest scientific knowledge on genotoxicity testing at European and international level. A wide range of aspects was taken into consideration, including: current experience on combining tests which have different levels of sensitivity and predictivity; internationally accepted guidelines or protocols for tests; and guidance for the consideration of use of in vivo testing taking into account the need to avoid unnecessary animal testing.

The opinion says that in order to provide an adequate evaluation of the genotoxic potential of a substance, it is necessary to assess gene mutations, structural and numerical chromosomal alterations, as all these aspects are known to be implicated in carcinogenesis and the development of heritable diseases. It recommends that adequate coverage of all these aspects can be obtained through the use of two in vitro tests in the first instance with follow-up in vivo if necessary. Details on the tests recommended by EFSA’s Scientific Committee are provided in the draft document.

In finalising its opinion, the Scientific Committee will take into all account all comments received during the public consultation. A summary report will be published on the EFSA website along with the final opinion expected to be completed in the autumn.

Notes to editors

Genotoxicity testing is a key component in the risk assessment of chemicals in general, including those used in food and feed. In developing its approach the Scientific Committee has considered other national and international initiatives in this area (such as that of WHO and the guidance document developed for REACH - the European Community Regulation on chemicals and their safe use.)

EFSA’s Scientific Committee supports the work of EFSA’s scientific Panels on scientific matters of a horizontal nature and is responsible for general co-ordination to ensure consistency in the scientific opinions prepared by the Scientific Panels. The Scientific Committee focuses on developing harmonised risk assessment methodologies in fields where EU-wide approaches are not already defined.

• Public consultation on draft opinion on “Genotoxicity testing strategies applicable to food and feed safety assessment"

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