Guidance for submission for food additive evaluations


Panel on Food Additives and Nutrient Sources Added to Food
EFSA Journal
EFSA Journal 2012;10(7):2760
Panel members at the time of adoption
Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, Pierre Galtier, John Gilbert, David Gott, Ursula Gundert-Remy, Jürgen König, Claude Lambré, Jean-Charles Leblanc, Alicja Mortensen, Pasquale Mosesso, Dominique Parent-Massin, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright

The Panel wishes to thank the members of the Working Group on Guidance on Food Additives: Riccardo Crebelli, Birgit Dusemund, Pierre Galtier, David Gott, Ursula Gundert-Remy, Rainer Gürtler, Jürgen König, Claude Lambré, Jean-Charles Leblanc, Alicja Mortensen, Dominique Parent-Massin, Iona Pratt, Ivan Stankovic, Paul Tobback, Tatjana Verguieva, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright, as well as its former Chair Ivonne Magdalena Catherina Maria Rietjens and also the members of the ANS Panel with mandate 2008-2011: Sandra Grilli, Rainer Gürtler, John Christian Larsen, Iona Pratt, and Tatjana Verguieva for the preparatory work on this scientific opinion, and EFSA staff: Anastasia Kesisoglou, Georges Kass and Hugues Kenigswald for the support provided to this scientific opinion.

Guidance of the Scientific Committee/Scientific Panel
On request from
Question Number
7 June 2012
Published in the EFSA Journal
18 July 2012
Last Updated
16 August 2012. This version replaces the previous one/s.
European Food Safety Authority (EFSA), Parma, Italy

This guidance document refers to the applications for authorisation of a new food additive or to a modification of an already authorised food additive, combining in a single document the description of the data requirements and their context, and also a description of the risk assessment paradigm applied. The document is arranged in four main sections: chemistry and specifications, existing authorisations and evaluations, proposed uses and exposure assessment, and toxicological studies. Assessment of the exposure to food additives is based on information on known or anticipated human exposure to the proposed additive or toxicologically relevant components of the additive from food, and any other potential dietary sources. For the toxicological studies, this guidance describes a tiered approach which balances data requirements against the risk, taking into consideration animal welfare by adopting animal testing strategies in line with the 3-Rs (replacement, refinement, reduction). This tiered approach for toxicological studies consists of 3 tiers, for which the testing requirements, key issues and triggers are described. According to this tiered approach, a minimal dataset applicable to all compounds has been developed under Tier 1, while Tier 2 testing, generating more extensive data, will be required for compounds which are absorbed and/or demonstrate (geno)toxicity in Tier 1 tests. Tier 3 should be performed on a case-by-case basis taking into consideration all the available data, to elucidate specific endpoints needing further investigation of findings in Tier 2 tests. This guidance document replaces the previous guidance document by the Scientific Committee for Food published in 2001.

EFSA guidance, Food additives, Application, Tiered approach, Risk assessment, Toxicological studies