Guidance on the scientific data requirements for an application for authorisation of a food additive submitted under Regulation (EC) No 1331/2008

Abstract

This guidance document applies to applications for a new authorisation as well as for a modification of an existing authorisation of a food additive, submitted under Regulation (EC) No 1333/2008. It defines the scientific data required to evaluate if the food additive is safe under the proposed conditions of use, in accordance with Articles 1 and 6 of Regulation (EC) No 1333/2008. The data requirements pertain to the characterisation of the proposed food additive, including the description of its identity, manufacturing process, specifications, stability, reaction and fate in foods and methods of analysis in food; the proposed uses and use levels and the dietary exposure; the safety data, including information on the genotoxic potential of the food additive, toxicological data other than genotoxicity and information on the safety for the environment. For the toxicological studies, a tiered approach is applied, for which the testing requirements, key issues and triggers are described. Applicants should provide data in accordance with this guidance document to support the safety assessment of the proposed food additive. Based on the submitted data, EFSA will assess the safety of the food additive in line with the risk assessment principles described in this document and conclude whether or not it presents risks to human health and to the environment, if applicable, under the proposed conditions of use.

Keywords: EFSA guidance; authorisation; food additives; risk assessment; tiered approach.

FIGURE 1

Flow chart describing the dietary exposure scenarios of an already authorised food additive for which an extension/modification of use is requested.

FIGURE 2

Tiered approach for toxicokinetic and toxicity testing of food additives. Supportive data as described in Section 5.4.5 of the guidance (Tier I) are not included in the flow chart. For food additives intended for use in infants below 16 weeks of age this flow chart is not entirely applicable, considering that toxicity data should be provided in line with the recommended by the (EFSA Scientific Committee, 2017a) (for more details see paragraph 5.9). GIT: gastrointestinal tract; GM: gene mutation; MN: micronucleus; TK: toxicokinetic. The following colour code is used to indicate different types of data: grey = non‐testing methods; green = genotoxicity studies; yellow = toxicokinetic studies; blue = general toxicity studies, including reproductive/developmental, chronic toxicity and carcinogenicity. (*) If the proposed food additive is concluded to be genotoxic in vivo via a relevant route of administration, the safety of the food additive cannot be established, and the applicant should not perform any further toxicological testing. If the genotoxicity is restricted to aneugenicity, the EFSA Guidance on aneugenicity (EFSA Scientific Committee, 2021c) should be consulted. If there is no evidence of absorption in Tier I, the integration of in vivo genotoxicity assays into the in vivo toxicity study in Tier II (A) should be envisaged where possible, in line with the 3Rs principle.