Anne Theobald - FoodDrinkEurope

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Exposure scenarios • Outline anticipated exposure scenarios as this will influence the extent of the hazard characterisation. – Direct or indirect addition to food/feed – Certain applications may give rise to a very limited exposure – Where ENM exposure is not detected by appropriate methods, conventional risk assessment should be considered for any non-nanoform fraction (degradation) 12
Toxicity Testing Outline 1. No persistence of ENM in preparations (as marketed) 2. No migration from food contact materials 3. Transformation in the food/feed matrix before digestion 4. Transformation during digestion – In vitro studies 5. Information on non-nanoform available (if present in food/GI) – Compare genotox, ADME and repeat dose 90-day study 6. No information on non-nanoform available (if present in food/GI) – Provide full data according to relevant EFSA guidance for intended use, with modifications to tests as proposed 13
Page 1 and 2: EFSA’s guidance in the field of n
Page 3 and 4: 1. Opinion - Terms of Reference •
Page 5 and 6: 1. Opinion - Conclusions • The cu
Page 7 and 8: 2. Opinion: Terms of Reference (1)
Page 9 and 10: http://www.efsa.europa.eu/en/efsajo
Page 11: Characterisation at several steps
Page 15 and 16: Exposure assessment • Determinati
Page 17 and 18: Guidance documents for RA Specific
Page 19 and 20: Data requirements in Guidance docum
Page 21 and 22: EFSA Re-evaluation of food additive

Anne Theobald - FoodDrinkEurope

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