Application of new approach methods (NAMs) in food safety with considerations for new proteins.

As new sources of food emerge and technologies advance, the concepts of safe food and risk assessment have evolved. New Approach Methods (NAMs) are appearing at a pivotal point in toxicology and provide an opportunity to adopt improved science (from a sensitivity and specificity perspective), which is more human relevant, is quicker and is ethically sounder (does not employ animals). The safety standard for any substance added to food in the United States is that there is a reasonable certainty of no harm under the intended conditions of use and applies to food additives and substances that are Generally Recognized as Safe (GRAS). This means that the use of NAMs must have a wide acceptability amongst the scientific community, including the regulatory authorities. The demand for new sources of protein ingredients is increasing, and is one category of food to which NAMs can be applied to determine safety. Safety considerations for proteins are described and for this purpose have been grouped into i) biosynthetic proteins produced by precision fermentation, ii) protein concentrates from traditional foods, and iii) total protein extracts. NAMs can be used to support the safety determination of proteins by: i) addressing mechanistic questions; ii) demonstrating equivalence to foods already in the food supply; iii) comparing intake to the amount traditionally consumed; iv) potential allergenicity. Confidence now needs to be built amongst stakeholders in food safety, with more food case studies in which NAMs are used in GRAS determinations and food additive petitions.