for the preparatory work on this scientific opinion and EFSA staff: Silvia Valtueña Martínez for the support provided to this scientific opinion. Guidance for applications for labelling exemption EFSA Journal 2013;11(10):3417 2 SUMMARY 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

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... 6 Paragraph 11 of Directive 2000/13/EC, as amended by Directive 2003/89/EC. 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, hereafter referred to as food allergens. Food allergen-derived preparation refers to a product derived from a food allergen, and for which an exemption from labelling is requested. In this guidance, foods or beverages manufactured using (i.e. intentionally adding) food allergen-derived preparations, and for which an exemption from labelling is requested, are referred to as food allergen-derived foodstuffs. The purpose of this guidance is to update the Commission guidelines in view of assisting applicants in the preparation and presentation of well-structured applications for exemption from labelling pursuant to Article 6 Paragraph 11 of Directive 2000/13/EC, as amended by Directive 2003/89/EC. 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 should 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 format will also help the NDA Panel to deliver its scientific advice in an effective and consistent way. To allow a scientific evaluation by the NDA Panel of the likelihood that the food allergen-derived preparation/foodstuff(s) for which an exemption is requested triggers adverse reactions in sensitive individuals under the proposed conditions of use, the application must contain: a) information on the characteristics of the food allergen-derived preparation for which the labelling exemption is requested. If the food allergen-derived preparation is intended for use in the manufacturing of foodstuff(s), information on the characteristics of the foodstuff(s) as consumed must be provided in the application. Where applicable, this information should contain aspects considered pertinent to the allergenic potential of the food allergen-derived preparation/foodstuff(s) for which an exemption is requested, such as the composition, physical and chemical characteristics, detailed description of the manufacturing process, stability, intended use, and an assessment of the residual allergenic proteins contained in the food allergen-derived preparation/foodstuff(s). b) all pertinent scientific data which form the basis for the scientific evaluation of the allergenicity of the food allergen-derived preparation/foodstuff(s) for which an exemption from labelling is requested. Pertinent data means all human and non-human studies, published or unpublished, in favour and not in favour of the non-allergenicity of the food allergen-derived preparation/foodstuff(s) for the proposed use. In cases where any of the required data are not relevant for a particular application, reasons/justification must be given for the absence of such data in the application. Pertinent published human data should be identified through a comprehensive review which addresses the allergenicity of the food allergen-derived preparation/foodstuff(s) for the proposed conditions of use in a transparent manner. Data from food challenge studies in humans addressing the presence/absence of adverse reactions in susceptible (food allergic) individuals while consuming the food-allergen derived preparation/foodstuff(s) may provide important information regarding its allergenicity. Double-blind placebo controlled food challenges (DBPCFC) are less subject to bias Guidance for applications for labelling exemption EFSA Journal 2013;11(10):3417 3 than single-blind challenges or open challenges. Sufficient characterisation of the study population regarding the diagnosis of food allergy is important. The selected sample size should be adequately