Title :

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

Author(s) :

Agostoni, C. [Auteur]
European Food Safety Authority [EFSA]
Canani, R. B. [Auteur]
Fairweather-Tait, S. [Auteur]
Heinonen, M. [Auteur]
Korhonen, H. [Auteur]
La Vieille, S. [Auteur]
Marchelli, R. [Auteur]
Martin, A. [Auteur]
Naska, A. [Auteur]
Neuhauser-Berthold, M. [Auteur]
Nowicka, G. [Auteur]
Sanz, Y. [Auteur]
Siani, A. [Auteur]
Sjodin, A. [Auteur]
Stern, M. [Auteur]
Strain, S. J. J. [Auteur]
Tetens, I. [Auteur]
Tome, D. [Auteur]
Turck, Dominique [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Verhagen, H. [Auteur]

Journal title :

EFSA Journal

Abbreviated title :

EFSA J.

Volume number :

19

Pages :

-

Publication date :

2022-03-31

ISSN :

1831-4732

English keyword(s) :

food allergens
allergenicity
foodstuff
exemption
labelling
application
guidance document

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

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 ...
Show more >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 labellingof 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 1169/2011or 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 mustbe addressedin the application in order to assess the likelihood of a food allergen-derived preparation/foodstuff(s)triggeringadverse reactions in sensitive individuals under the proposed conditions of use. Thisguidance document was adopted by the NDA Panel in2013and updated in2017 to reflect the application of Regulation (EU) No 1169/2011.Upon request from the European Commissionin 2020, it has been revised to inform applicants of new provisionsin 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.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Université de Lille
Inserm
CHU Lille

Collections :

• Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286

Submission date :

2024-01-12T07:04:35Z
2024-03-08T13:44:41Z