Food additives: EFSA’s new guidance for applicants

New guidance for the submission of food additive applications, reflecting advances in science and the latest risk assessment principles, has been developed on the initiative of scientific experts from the European Food Safety Authority (EFSA)’s Panel on Food Additives and Nutrient Sources Added to Food (ANS).

In the EU, the safety of food additives is assessed by EFSA prior to their consideration by the European Commission for market authorisation. EFSA considers all available scientific information in its risk assessments. Under EU legislation, applicants seeking such an authorisation are required to provide the necessary information and data supporting the safety of the food additive, according to EFSA’s requirements.

The guidance adopted by the ANS Panel in June 2012 replaces guidance originally established in 2001 by the European Commission’s former Scientific Committee on Food and endorsed by EFSA’s Panels for use in their risk assessments. New guidance was deemed necessary to reflect both advances in science and ten years experience in applying the existing guidance. It introduces a new tiered approach for the risk assessment of food additives that will guide applicants in designing their toxicological testing strategy with decisions based and justified on scientific evaluation of the results. By defining progressive requirements and reflecting current understanding, the guidance will help to generate the data necessary to demonstrate the high level of consumer safety required; its application can also result in the need for fewer or more refined animal tests and therefore benefit animal welfare. In relation to the toxicological studies to be conducted there are important changes to the requirements for genotoxicity, toxicity, carcinogenicity and reproductive toxicity testing. Also, an exposure assessment tool*, specifically developed by EFSA, will support the calculation by the applicant of estimates of exposure to the food additive and its by-products and harmonise the submission of the related data.

The finalisation of the guidance document follows a public consultation, which generated feedback from industry, NGOs, stakeholders and European national food safety agencies. In accordance with the Authority’s commitment to transparency, an overview of comments received is also published below.

*The tool will be available from September 2012 on EFSA’s website.

Notes to editors

EFSA’s scientific statement of 9 July 2009 specifies the data requirements that should be provided when an application for the use of a new food additive is submitted, as required under Regulation EU 234/2011 on the authorisation procedure for food additives, food enzymes and food flavourings. See: Data requirements for the evaluation of food additive applications

See: Guidance on submissions for food additive evaluations by the Scientific Committee on Food (SCF)

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