What are the important considerations in the early food safety evaluation of a new protein?
You should consider whether the new protein is an allergen or a toxin. While the 1992 policy addresses the full food safety evaluation of foods derived from new plant varieties, general considerations for conducting a food safety evaluation of a new protein, as well as flow charts diagramming specific questions relevant to such an evaluation, may also be found in the 1992 policy (see footnote 7). We also encourage you to refer to the approach that is discussed in the Codex Alimentarius “Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants” (Codex Plant Guideline, see footnote 5) (CAC/GL 45-2003) Paragraphs 34-43 under Expressed Substances (non-nucleic acid substances) and the Codex Allergenicity Annex (see footnote 5).
