Event Detail

Background and objectives

In 2005, the EFSA/WHO international conference with support of ILSI Europe on "Risk Assessment of Compounds that are both Genotoxic and Carcinogenic: New Approaches" concluded that it would be helpful to calculate Margin of Exposures (MOEs) for more examples in order to better define the level of health concern associated with a certain MOE (or range of MOE). Therefore, the task force on Risk Assessment of Genotoxic Carcinogens in Food decided to set up a new expert group that works in collaboration with WHO/IPCS and EFSA in order to address this question.

The task of the expert group was:

• To choose 10-12 examples to calculate the MOE (e.g. by taking the substances evaluated by JECFA and EFSA/SCF in the last 10-15 years)
  • with a range of low and high carcinogenic potency,
  • with limited and with large amounts of relevant data
• To evaluate carcinogenicity data including dose response, as available at the time of the assessments (data quality, uncertainties and limitations), also considering the duration of exposure in relation to the carcinogenicity
• To select the appropriate cancer data for mathematical modelling
  • BMD and BMDL to be calculated on the 1%, 5% and 10% level; T25 only to be
    calculated if needed
  • to evaluate human exposure data as available at the time of the assessments (data quality, uncertainties and limitations):
  • characterise exposure by different scenarios, e.g. general population, subgroups
  • select the appropriate exposure value(s)
  • include some examples for exposure with the same subset of data
• To provide a narrative on the assumptions and uncertainties in a consistent way for each of the examples.

The manuscript developed by the expert group will provide the basis for the discussions at the workshop. The overall objectives of the workshop are:

• To critically appraise the MOE approach in the light of these assessments
• To provide guidance on the application of the MOE approach
• To further characterise the interpretation of the numerical value of the MOE (e.g. banding).

The revised manuscript will then be submitted to Food and Chemical Toxicology. In addition, the abstracts will provide the basis for a workshop summary report to be published in the ILSI Europe Report Series.

To download the short report of the workshop, click here.

For more information, please contact: info@ilsieurope.be