Guidance Statements
The Committee on Mutagenicity of Chemicals in Food, Consumer Products and the Environment (COM) is an expert advisory committee whose members are appointed by the Chief Medical Officer for England and the Chair of the Food Standards Agency folowing an appointments exercise involving public advertisement. Members serve in their own capacity as independent experts and observe a published code of practice including principles relating the declaration of possible conflicting interests.
The remit of the committee is to advise all UK Government departments and Agencies with an interest in the safety of chemicals across various sectors, on all aspects of the mutagenicity and genotoxicity of chemicals. The Secretariat is provided by the Health Protection Agency (who lead) and the Food Standards Agency (FSA). Other government departments with an interest provide assessors to the Committee; these are specifically from the Department of Health, the Department of the Environment, Food and Rural Affairs (Defra), the Chemicals Regulation Directorate (CRD) of the Health and Safety Executive (HSE) (responsible for legislation regulating chemicals, pesticides, biocides and detergents), the Veterinary Medicines Directorate (VMD: a Defra agency responsible for the licensing of veterinary drugs) and the Medicines and Healthcare Regulatory Agency (MRHA; a DH agency responsible for the licencing of human medicines). In addition there are assessors from the Scottish Government, the Welsh Assembly Government and the Northern Ireland Assembly).
The role of the COM is advisory. It has no regulatory status, although its advice may be provided to an agency that does have such a role (e.g. HSE CRD for occupational aspects and for pesticides etc). Its remit is to advise on all aspects of mutagenicity and genotoxcicity of chemicals, and this may involve advice on a specific chemical and also on testing strategies and research. The COM also has a general remit to advise on important general principles or new scientific discoveries in connection with mutagenic and genotoxic hazards (the inherent property of the substance) or risk (the likelihood of mutagenic or genotoxic effects occurring after a given exposure) and to present recommendations for genotoxicity testing. In practice the bulk of the work of the Committee relates to assessing genotoxcicity tests and providing advice on mutagenic hazard of chemicals.
These guidance documents present COM conclusions on these topics and are considered accurate at time of publication. As the science which underpins each of these statements advances, the COM may consider it necessary to review a statement and issue a revised version.
Assessment Strategies
A Strategy for Testing of Chemicals for Genotoxicity. The strategy recommended by COM for testing chemicals with no existing genotoxicity data. |
2011 | G strategy | V 3 |
| Stage 0: Prescreening considerations prior to testing.
Link to the Committee's advice on examining the physico-chemical properties, structural alerts for genotoxicity and screening high throughput assays. |
2011 | G0 | V1 |
Stage 1: A strategy for in vitro assessment of the genotoxicity of chemicals. Link to the Committee's recommended approach to in vitro testing. |
2011 | G1 | V1 |
Stage 2; A strategy for in vivo testing of the genotoxicity of chemicals including germ cell genotoxicity.Link to the Committee's recommended strategy for in vivo genotoxicity testing. |
2011 | G2 | V1 |
Stage 3: Guidance on a strategy for chemicals with inadequate genotoxicity data. Details of the Committee's recommended approach to genotoxicity testing and hazard assessment of chemicals with inadequate genotoxicity data. |
2011 | G3 | V1 |
Impurities: An interim statement on an approach to assessment of impurities. |
2011 | G4 | V1 |
| Assessment of Threshold for in vivo Mutagens
A statement providing definitions relating to thresholds for in vivo mutagens, examples of substances where a threshold mode of genotoxicity has been agreed and approaches to the determination of threshold doses for in vivo genotoxins. |
2010 | G5 | V1 |
Genotoxicity Tests
The COM terms of reference includes generic statements on particular genotoxicity tests. The list of tests to be considered is given below. At the time of writing, December 2011, none of the reviews of specific genotoxicity tests had been initiated. This introduction will be updated when work on these guidance statements commences.
In Vitro HPRT assays for Gene Mutation