Existing guidance

10.            EFSA’s Scientific Committee and panels have produced a large number of guidance documents. These include cross-cutting areas of guidance as well as sector specific guidance. These are listed in Annex B. The cross-cutting areas of guidance address a wide range of topics of relevance to the COT, including benchmark dose modelling, risk assessment of mixtures, weight of evidence, biological relevance and risk-benefit assessment, amongst others. The COT responded to public consultations by EFSA on the draft versions of many of the cross-cutting areas of guidance. Consideration of sector-specific guidance by EFSA, e.g. on food additives and consumer risk assessment of feed additives, may be of value in developing the overarching approach. In general, the guidance documents for food additives, feed additives and food contact materials take tiered approaches to the data requirements, but there are differences between them.

11.            Also listed in Annex B are relevant guidance documents published by the United States (US) Food and Drug Administration (FDA) and Environmental Protection Agency (EPA).

12.            EHC 240, the International Programme on Chemical Safety’s “Principles and methods for the risk assessment of chemicals in food” was developed and published in 2009, and chapters and sections on genotoxicity, dose-response assessment and derivation of health-based guidance values, dietary exposure assessment and enzymes were updated in 2020. This is available with the updated chapters at Principles and methods for the risk assessment of chemicals in food.

13.            Other guidance which the COT may wish to consider includes the REACH guidance on chemical safety assessment  (Guidance on Information Requirements and Chemical Safety Assessment - ECHA) and VICH guidelines for veterinary medicines (Guidelines).