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Opinion of the Scientific Committee on "A Harmonised Approach for Risk Assessment of Compounds which are both Genotoxic and Carcinogenic". Comments from the Norwegian Scientific Committee for Food Safety

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Vitenskapskomiteen for Mattrygghet

Norwegian ScientificCommittee for Food Safety

05/901-4 final

Opinion of the Scientific Committee on "A Harmonised Approach for Risk Assessment of Compounds which are both Genotoxic and Carcinogenic"

Comments from the Norwegian Scientific Committee for Food Safety Oslo, 27 May 2005

General comments

The Norwegian Scientific Committee for Food Safety welcomes the EFSA initiative to develop a harmonised approach to risk assessment of exposures to chernicals that are both genotoxic and carcinogenic. The proposed method applying a margin of exposure (MOE) approach, based on the ratio between a benchmark dose (lower 95% confidence limit of a BMDIO) in animal experiments and the human exposure, is one way ofmoving forward in this important area. However, it should be recognised that other approaches are in use, even within the EU. This is not mentioned in the opinion, thus it is difficult to see the proposed method at present as the harmonised approach. It is somewhat surprising that the quantitative approaches used by the European Chemicals Bureau and US Enviromnental Protection Agency are not mentioned. In !hese approaches a maximal point estimate of the risk may be calculated by linear extrapolation from a point of comparison, such as the LED I O (US EPA

1996) or the T25 (Dybing et al., 1997).

By using a MOE approach, the opinion avoids giving a point estimate of the risk. However, indirectly the application of a MOE of 10,000 from an incidence of 10% can easily be converted into a risk leve! of 10·5 (or using a MOE of 25,000 from an incidence of 25%).

Thus, the present proposal could give the impression of developing the necessary uncertainty factors in arriving at such a risk leve! post hoc, without coming clearly out and saying so. The foundation of the application of the 10 factor each for the uncertainties relating to the carcinogenic process and in particular that the BMDL relates to a small but measurable response, is not very well supported by the arguments and references given in the opinion.

N'orvl'egian Scientific Comtnittee for .:Food Safety

VKM Report 2005: 34

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