Guidance on the preparation and presentation of applications for exemption from mandatory labelling of food allergens and/or products thereof pursuant to Article 21 (2) of Regulation (EU) No 1169/2011.

[Table: see text] Following a request from the European Commission, the EFSA 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 for exemption from mandatory labelling of food allergens and/or products thereof. This guidance applies to food ingredients or substances with known allergenic potential listed in Annex II of Regulation (EU) No 1169/2011 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 guidance document was adopted by the NDA Panel in 2013 and updated in 2017 to reflect the application of Regulation (EU) No 1169/2011. Upon request from the European Commission in 2020, it has been revised to inform applicants of new provisions in the pre-submission phase and submission application procedure set out in Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain, that are applicable to all applications submitted as of 27 March 2021.