Guidance on the preparation and submission of an application for authorisation of a novel food in the context of Regulation (EU) 2015/22831 (Revision 1)2
| Autor: | Hans Verhagen, Monika Neuhäuser-Berthold, Allergies Nda, Morten Poulsen, Annette Pöting, Anders Sjödin, Susan J. Fairweather-Tait, Dominique Turck, Rosangela Marchelli, Josef Rudolf Schlatter, Allergies (Nda) Products, Androniki Naska, Karl-Heinz Engel, Karen Ildico Hirsch-Ernst, Harry J McArdle, Peter Willatts, Jean-Louis Bresson, Yolanda Sanz, Hendrik van Loveren, Marco Vinceti, Inge Mangelsdorf, Marina Heinonen, Nutrition Efsa Panel on Dietetic Products, Barbara Burlingame, Davide Arcella, Alfonso Siani, Tara Dean, Kristina Pentieva, Martin Stern, Seppo Salminen, Agnès de Sesmaisons-Lecarré, Wolfgang Gelbmann, Grażyna Nowicka, Daniel Tomé |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
safety
authorisation Authorisation Relation (database) Traditional foods 040301 veterinary sciences Computer science Novel foods Veterinary (miscellaneous) Novel food Context (language use) Plant Science TP1-1185 novel foods 010501 environmental sciences 01 natural sciences Microbiology 0403 veterinary science guidance toxicity traditional foods TX341-641 0105 earth and related environmental sciences Toxicity Nutrition. Foods and food supply Chemical technology Authorization 04 agricultural and veterinary sciences Risk analysis (engineering) Transparency (graphic) Sustainability Table (database) Guidance Animal Science and Zoology Parasitology Safety Risk assessment Food Science |
| Zdroj: | EFSA Journal 19 (2021). doi:10.2903/j.efsa.2021.6555 info:cnr-pdr/source/autori:Nutrition; Allergies A.; Turck D.; Bresson J.-L.; Burlingame B.; Dean T.; Fairweather-Tait S.; Heinonen M.; Hirsch-Ernst K.I.; Mangelsdorf I.; McArdle H.J.; Naska A.; Neuhauser-Berthold M.; Nowicka G.; Pentieva K.; Sanz Y.; Siani A.; Sjodin A.; Stern M.; Tome D.; Vinceti M.; Willatts P.; Engel K.-H.; Marchelli R.; Poting A.; Poulsen M.; Salminen S.; Schlatter J.; Arcella D.; Gelbmann W.; de Sesmaisons-Lecarre A.; Verhagen H.; van Loveren H./titolo:Guidance on the preparation and submission of an application for authorisation of a novel food in the context of Regulation (EU) 2015%2F22831 (Revision 1)2/doi:10.2903%2Fj.efsa.2021.6555/rivista:EFSA Journal/anno:2021/pagina_da:/pagina_a:/intervallo_pagine:/volume:19 Sjödin, A & EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Products 2021, ' Guidance on the preparation and submission of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283 1 (Revision 1) 2 ', E F S A Journal, vol. 19, no. 3, 6555 . https://doi.org/10.2903/j.efsa.2021.6555 EFSA Journal EFSA Journal, Vol 19, Iss 3, Pp n/a-n/a (2021) |
| Popis: | Endorsement date 21 January 2021 Implementation date 27 March 2021 Following the adoption of Regulation (EU) 2015/2283 on novel foods, the European Commission requested EFSA develop scientific and technical guidance for the preparation and submission of applications for authorisation of novel foods. This guidance presents a common format for the organisation of the information to be presented by the applicant when preparing a well‐structured application to demonstrate the safety of the novel food. It outlines the data needed for the safety assessments of novel foods. Requirements relate to the description of the novel food, production process, compositional data, specification, proposed uses and use levels, and anticipated intake of the novel food. Further sections on the history of use of the novel food and/or its source, absorption, distribution, metabolism, excretion, nutritional information, toxicological information and allergenicity should be considered by the applicant by default. If not covered in the application, this should be justified. The applicant should integrate the data presented in the different sections to provide their overall considerations on how the information supports the safety of the novel food under the proposed conditions of use. Where potential health hazards have been identified, they should be discussed in relation to the anticipated intakes of the novel food and the proposed target populations. On the basis of the information provided, EFSA will assess the safety of the novel food under the proposed conditions of use. This guidance was originally adopted in 2016.It has beenrevised to informapplicants of the new provisions introduced by 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.This revised guidance applies to all dossiers submitted as of 27 March 2021. The 2016 version of this guidance remains applicable to applications submitted before 27 March 2021. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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