Scientific opinion on genotoxicity testing strategies applicable to food and feed safety assessment

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Article
EFSA Journal
EFSA Journal 2011;9(9):2379 [69 pp.].
doi
10.2903/j.efsa.2011.2379
Panel members at the time of adoption
Boris Antunović, Susan Barlow, Andrew Chesson, Albert Flynn, Anthony Hardy, Michael-John Jeger, Ada Knaap, Harry Kuiper, John-Christian Larsen, David Lovell, Birgit Noerrung, Iona Pratt, Ivonne Rietjens, Josef Schlatter, Vittorio Silano, Frans Smulders and Philippe Vannier
Acknowledgements

The Scientific Committee wishes to thank the members of the Working Group on Genotoxicity testing Strategies: Gabriele Aquilina, Susan Barlow, Mona Lise Binderup, Claudia Bolognesi, Paul Brantom, Raffaella Corvi, Riccardo Crebelli, Eugenia Dogliotti, Metka Filipic, Corrado Galli (member until February 2011), Rainer Guertler, Andrea Hartwig, Peter Kasper, David Lovell, Daniel Marzin, Jan van Benthem for the preparatory work on this scientific opinion; David Kirkland as hearing expert. EFSA’s staff member Daniela Maurici for the support provided to this scientific opinion.

Type
Opinion of the Scientific Committee/Scientific Panel
On request from
EFSA
Question Number
EFSA-Q-2009-00782
Adopted
13 September 2011
Published in the EFSA Journal
30 September 2011
Last Updated
3 October 2012. This version replaces the previous one/s.
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

The Scientific Committee reviewed the current state-of-the-science on genotoxicity testing and provided a commentary and recommendations on genotoxicity testing strategies. A step-wise approach is recommended for the generation and evaluation of data on genotoxic potential, beginning with a basic battery of in vitro tests, comprising a bacterial reverse mutation assay and an in vitro micronucleus assay. Consideration should be given to whether specific features of the test substance might require substitution of one or more of the recommended in vitro tests by other in vitro or in vivo tests in the basic battery. In the event of negative in vitro results, it can be concluded that the substance has no genotoxic potential. In case of inconclusive, contradictory or equivocal results, it may be appropriate to conduct further testing in vitro. In case of positive in vitro results, review of the available relevant data on the test substance and, where necessary, an appropriate in vivo study to assess whether the genotoxic potential observed in vitro is expressed in vivo is recommended. Suitable in vivo tests are the mammalian erythrocyte micronucleus test, transgenic rodent assay, and Comet assay. The approach to in vivo testing should be step-wise. If the first in vivo test is positive, no further testing is necessary and the substance should be considered as an in vivo genotoxin. If the test is negative, it may be possible to conclude that the substance is not an in vivo genotoxin. However, in some cases, a second in vivo test may be necessary (e.g. if the first test is negative but more than one endpoint in the in vitro tests are positive, an in vivo test on a second endpoint may be necessary). The combination of assessing different endpoints in different tissues in the same animal in vivo should also be considered.

Keywords
Genotoxicity, testing strategies
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Number of Pages
69