EFSA Updates Guidance on Data Requirements for Food Additive Risk Assessments
The European Food Safety Authority (EFSA) has updated its guidance document on the data requirements for the risk assessment of food additive applications.
The document defines the scientific data required to evaluate if a food additive is safe under the proposed conditions of use as part of applications for a new authorization or a modification of an existing authorization of a food additive. Data requirements relate to an additive’s characterization; proposed uses and use levels and the assessment of dietary exposure; and human and environmental safety.
Specifically, new or updated information provided in the guidance includes:
- Developments in the techniques/approaches applied in the manufacturing of food additives and improvements in the performances of the analytical methods, which allow an in-depth characterization of the final product and its source materials, as well as more accurately defining specifications for the food additive
- References to guidance on considering the potential exposure of consumers to small particles, including nanoparticles, if present in the food additive
- The most recent versions of the Food Additives Intake Model (FAIM) tool and the Dietary Exposure (DietEx) tool
- Consideration of guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age
- Consideration of all cross-cutting guidance documents relevant for genotoxicity and toxicological assessment of food additives published after 2012
- Reference to the latest versions of the relevant Organization for Economic and Co-operation and Development Test Guidelines (OECD TG)
- Consideration of environmental protection, as occurrence in the environment may be a relevant issue for some food additives.
The full guidance document can be read here.
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