Following the adoption of Regulation (EU) 2015/2283 of the European Parliament and of the Councilon Novel Foods, the European Commission requested EFSA to develop a scientiﬁc and technicalguidance for the preparation and presentation of notiﬁcations for traditional foods from third countries.This guidance presents a common format for the organisation of the information to be presented inorder to assist the applicant in the preparation of a well-structured dossier. The safety of a traditionalfood should be substantiated by reliable data on its composition, its experience of continued use andits proposed conditions of use. Besides, its normal consumption should not be nutritionallydisadvantageous. To that end, information is requested on the description, production process,composition, stability data, speciﬁcations, data from experience of continued use in a third country andon the proposed conditions of use of the traditional food for the EU market. The structure of thenotiﬁcation dossier should follow the sections presented in this guidance. This guidance is alsointended to support applicants in provi ding the type and quality of information EU Member States andEFSA need for the assessments of traditional foods from third countries. The applic ation should becomprehensive and complete. The applicant should integrate the information on the compo sition andthe experience of continued use and provide a concise overall conside ration on how this substantiatesthe history of safe use of the traditional food and how this relates to the proposed conditions of usefor the EU. Where potential health hazards have been identiﬁed on the basis of the composition and/ordata from the experience of continu ed use, they should be discussed. On the basis of the informationprovided, EFSA will assess the safety related to the consumption of the traditional food under theproposed conditions of use.
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|Data di pubblicazione:||2016|
|Titolo:||Guidance on the preparation and presentation of thenotiﬁcation and application for authorisation of traditionalfoods from third countries in the context of Regulation(EU) 2015/2283|
|Autori:||Dominique, Turck; Jean-Louis, Bresson; Barbara, Burlingame; Tara, Dean; Susan, Fairweather-Tait; Marina, Heinonen; Karen, Ildico Hirsch-Ernst; Inge, Mangelsdorf; Harry, Mcardle; Androniki, Naska; Monika, Neuhäuser-Berthold; Grażyna, Nowicka; Kristina, Pentieva; Yolanda, Sanz; Alfonso, Siani; Anders, Sjödin; Martin, Stern; Daniel, Tomé; Marco, Vinceti; Peter, Willatts; Karl-Heinz, Engel; Rosangela, Marchelli; Annette, Pöting; Morten, Poulsen; Josef, Schlatter; Wolfgang, Gelbmann; Agnès, de Sesmaisons-Lecarré; Hans, Verhagen and Hendrik van Loveren|
|Digital Object Identifier (DOI):||10.2903/j.efsa.2016.4590|
|Appare nelle tipologie:||Articolo su rivista|
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