Food Law News - EU - 2009

EFSA News Story, 3 August 2009

ADDITIVES - EFSA publishes data requirements for assessing food additives

The European Food Safety Authority (EFSA) has published a statement adopted by its Panel on additives and nutrient sources added to food  (ANS Panel) on 9 July 2009 specifying the type of data that industry should provide for the safety assessment of food additives.

This follows on from new EU legislation, adopted in December 2008, which sets out a common procedure for the authorisation of additives, flavourings and enzymes based on scientific risk assessments by EFSA.

The data requirements indicated by the ANS Panel will be considered by the Commission when finalising legislative measures concerning applications submitted for the evaluation and authorisation of food additives. The Commission is due to complete these measures by the end of 2010 following a public consultation.

In addition to this statement defining general data requirements, the ANS Panel is also due to review the separate guidance document on specific scientific methods to be used – e.g. the type of tests which should be carried out by applicants to demonstrate safety – when preparing applications for the approval of food additives.

The revision of this guidance, which will take account of advances in risk assessment, will begin this autumn and should be completed by mid-2011. It will also be the subject of a public consultation by EFSA.

EFSA’s Panel on food contact materials, enzymes, flavourings and processing aids (CEF Panel) is due to publish the details of its data requirements for the safety assessment of flavourings and enzymes in the coming weeks.

The following is a summary of the published document

Data requirements for the evaluation of food additive applications

Question number: EFSA-Q-2007-188

Adopted: 9 July 2009


The present statement defines the general data requirements, while specific scientific approaches are suggested in the guidance for food additives applicable at the time of the application. During its second plenary meeting in September 2008, the Panel endorsed provisionally the guidance document for food additive evaluations adopted by the Scientific Committee on Food (SCF) in 2001. In order to reflect current thinking in risk assessment, the Panel will commence a detailed reappraisal of the guidance in September 2009. It is anticipated that, following a period of public consultation, this new guidance will be finalised in July 2011. Applicants should also take into consideration the opinions adopted in 2009 by the Scientific Committee of EFSA on Nanoscience and Nanotechnologies, on the use of the benchmark dose approach in risk assessment and on the replacement and reduction of animal testing, as well as the guidance on transparency in the scientific aspects of risk assessments adopted in 2009 and the guidance on the safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements adopted in 2008.

Published: 4 August 2009

For citation purposes: Scientific Statement of the Panel on Food Additives and Nutrient Sources added to Food on data requirements for the evaluation of food additives applications following a request from the European Commission. The EFSA Journal (2009) 1188, 1-7.

A copy of the full Statement can be found on the EFSA web site at:

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