Risk assessment of food additives

Abstract

Food additives are substances used for technological purposes, such as preservation, sweetening, or coloring, during the production of food. The requirements for the risk assessment of food additives are described in a recent guidance document of the European Food Safety Authority (EFSA). According to this guidance, a tiered approach which balances toxicity data requirements against the risk is applicable for the risk assessment of food additives. The approach was established to evaluate the following core areas: toxicokinetics, genotoxicity, toxicity (encompassing subchronic toxicity, chronic toxicity, and carcinogenicity), and reproductive and developmental toxicity. Additional studies on other toxicological endpoints may be required on a case-by-case basis. The approach consists of three tiers. It provides guidance to applicants in designing their toxicity testing strategy in which the decision on the requirement for further testing can be based on the results of certain initial studies. While maintaining the high level of consumer safety, the application of this tiered approach could result in a smaller number of animal tests or more refined animal studies, compared to the requirements applied before, and thus benefit animal welfare. This chapter provides the legal background and delineates the principles and requirements for the risk assessment of food additives based on the EFSA guidance for submission for food additive evaluations.