Guidance on the preparation and presentation of applications pursuant to Article 6 Paragraph 11 of Directive 2000/13/EC, as amended

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 This draft guidance document was endorsed by the NDA Panel on 11 July 2013, and was released for public consultation from 26 July 2013 to 13 September 2013.