Guidance on the preparation and submission of the notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283 (Revision 1)

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dc.citation.issue3
dc.citation.volume19
dc.contributor.authorEFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)
dc.contributor.authorTurck D
dc.contributor.authorBresson J-L
dc.contributor.authorBurlingame B
dc.contributor.authorDean T
dc.contributor.authorFairweather-Tait S
dc.contributor.authorHeinonen M
dc.contributor.authorHirsch-Ernst KI
dc.contributor.authorMangelsdorf I
dc.contributor.authorMcArdle HJ
dc.contributor.authorNaska A
dc.contributor.authorNeuhäuser-Berthold M
dc.contributor.authorNowicka G
dc.contributor.authorPentieva K
dc.contributor.authorSanz Y
dc.contributor.authorSiani A
dc.contributor.authorSjödin A
dc.contributor.authorStern M
dc.contributor.authorTomé D
dc.contributor.authorVinceti M
dc.contributor.authorWillatts P
dc.contributor.authorEngel K-H
dc.contributor.authorMarchelli R
dc.contributor.authorPöting A
dc.contributor.authorPoulsen M
dc.contributor.authorSchlatter J
dc.contributor.authorGelbmann W
dc.contributor.authorde Sesmaisons-Lecarré A
dc.contributor.authorVerhagen H
dc.contributor.authorvan Loveren H
dc.coverage.spatialUnited States
dc.date.accessioned2023-07-12T03:23:09Z
dc.date.accessioned2023-09-04T01:40:30Z
dc.date.available2023-07-12T03:23:09Z
dc.date.available2023-09-04T01:40:30Z
dc.date.issued2021-03-26
dc.description.abstractFollowing the adoption of Regulation (EU) 2015/2283 on Novel Foods, the European Commission requested EFSA to develop a scientific and technical guidance for the preparation and submission of notifications for traditional foods from third countries. This guidance presents a common format for the organisation of the information to be presented by applicant for the preparation of a well-structured dossier. The safety of a traditional food should be substantiated by reliable data on its composition, its experience of continued use and its proposed conditions of use. Its normal consumption should not be nutritionally disadvantageous. This guidance is also intended to support applicants in providing the type and quality of information EU Member States and EFSA need for the assessments of traditional foods from third countries. The applicant should integrate the information on the composition and the experience of continued use and provide a concise overall consideration on how this substantiates the history of safe use of the traditional food and how this relates to the proposed conditions of use for the EU. Where potential health hazards have been identified on the basis of the composition and/or data from the experience of continued use, they should be discussed. On the basis of the information provided, EFSA will assess the safety related to the consumption of the traditional food under the proposed conditions of use. This guidance was originally adopted by the NDA Panel in 2016. It has been revised in 2020 to inform applicants 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.It is applicable to allnotifications and applications submitted as of 27 March 2021. The 2016 version remains applicable to notifications and applications submitted before 27 March 2021.
dc.description.publication-statusPublished online
dc.format.extente06557 - ?
dc.identifierhttps://www.ncbi.nlm.nih.gov/pubmed/33791041
dc.identifierEFS26557
dc.identifier.citationEFSA J, 2021, 19 (3), pp. e06557 - ?
dc.identifier.doi10.2903/j.efsa.2021.6557
dc.identifier.eissn1831-4732
dc.identifier.elements-id444540
dc.identifier.harvestedMassey_Dark
dc.identifier.urihttp://hdl.handle.net/10179/19840
dc.languageeng
dc.publisherJohn Wiley and Sons Ltd on behalf of the European Food Safety Authority
dc.relation.isPartOfEFSA J
dc.rightsCC BY-ND 4.0
dc.rights.urihttps://creativecommons.org/licenses/by-nd/4.0/
dc.subjectguidance
dc.subjectnovel foods
dc.subjectprimary production
dc.subjectsafety
dc.subjectthird country
dc.subjecttraditional foods
dc.titleGuidance on the preparation and submission of the notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283 (Revision 1)
dc.typeJournal article
pubs.notesNot known
pubs.organisational-group/Massey University
pubs.organisational-group/Massey University/College of Health
pubs.organisational-group/Massey University/College of Health/School of Health Science
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