Guidance for applications for labelling exemption


food allergens, allergenicity, foodstuff, exemption, labelling, application, guidance document
First published in the EFSA Journal
25 October 2013
10 October 2013
Last Updated
14 March 2017. This version replaces the previous one/s.
Scientific Opinion

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on Scientific and technical guidance for the preparation and presentation of applications pursuant to Article 6 Paragraph 11 of Directive 2000/13/EC, as amended. This guidance applies to food ingredients or substances with known allergenic potential listed in Annex IIIa of 2003/89/EC (as amended) or products thereof, and aims to assist applicants in the preparation and presentation of well-structured applications for exemption from labelling. It presents a common format for the organisation of the information to be provided and outlines the information and scientific data which must be included in the application, the hierarchy of different types of data and study designs, reflecting the relative strength of evidence which may be obtained from different study types, and the key issues which must be addressed in the application in order to assess the likelihood of a food allergen-derived preparation/foodstuff(s) triggering adverse reactions in sensitive individuals under the proposed conditions of use. This draft guidance document was endorsed by the NDA Panel on 11 July 2013, and was released for public consultation from 26 July 2013 to 13 September 2013.

Panel members at the time of adoption
Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen
Panel on Dietetic Products, Nutrition and Allergies
nda [at]
EFSA Journal 2013;11(10):3417 [17 pp.].
Question Number
On request from
European Commission
Print on demand
Number of Pages