Abstract
| Endorsement date | 21 January 2021 |
| Implementation date | 27 March 2021 |
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.
Keywords: food allergens, allergenicity, foodstuff, exemption, labelling, application, guidance document
Suggested citation: 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. EFSA Journal 10.2903/j.efsa.2021.6543
Requestor: European Commission
Question number: EFSA‐Q‐2020‐00589
Panel members in 2013: 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.
Acknowledgements: The Panel wishes to thank the members of the Working Group on Food Allergy: Roberto Berni Canani, Sébastien La Vieille, Hendrik van Loveren, Martinus Løvik, Rosangela Marchelli, Martin Stern, Stephan Strobel and Dominique Turck for the preparatory work on this scientific opinion and EFSA staff: Silvia Valtueña Martínez for the support provided to this scientific opinion.
The guidance was originally adopted on 10 October 2013 and updated on 14 March 2017 to reflect the application of Regulation (EU) No 1169/2011, which repeals Directive 2000/13/EC of the European Parliament and of the Council, and the publication of the scientific opinion of the NDA Panel on the evaluation of allergenic foods and food ingredients for labelling purposes in 2014. The present revision only aims to inform applicants of the new requirements set out in the General Food Law (Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain), and to guide to EFSA's practical arrangements implementing these new requirements. For this purpose, the revision concerns only the administrative part. The scientific content remains unchanged. The present guidance was endorsed on 21 January 2021 by the Panel on Nutrition, Novel Foods and Food Allergens (NDA): Dominique Turck, Jacqueline Castenmiller, Stefaan de Henauw, Karen‐Ildico Hirsch‐Ernst, John Kearney, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Carmen Pelaez, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri and Marco Vinceti.
This Guidance is applicable for applications submitted as of 27 March 2021
This output supersedes the previous output: https://efsa.onlinelibrary.wiley.com/action/downloadSupplement?doi=10.2903%2Fj.efsa.2013.3417&file=efs23417-sup-0001-supinfo-Obsolete.pdf
References
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