Dubbed the ‘Redbook’, this offers advice on the toxicology for the safety assessments of substances regulated by the FDA’s Center for Food Safety and Applied Nutrition (CFSAN). This includes food contact substances, additives, ingredients covered by the generally regarded as safe (Gras) programme, new plant varieties, and dietary supplements and ingredients.
The FDA is particularly interested in feedback on which areas of the document, which was last published in 2007 it, should prioritise in the current revision.
It also seeks information on what could be done to make the Redbook’s sections on safety assessment criteria clearer: what other guidance document should be referenced in it; and whether there are any new assays, test methods or end points that deserve inclusion.
The FDA notes that: ‘Specific examples, precise wording, or other clear and direct suggestions that address these issues are particularly welcome.’
This public consultation phase will close to comments on 11 May 2015.
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