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Commission Implementing Regulation (EU) 2017/2468 of 20 December 2017 laying down administrative and scientific requirements concerning traditional foods from third countries in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (Text with EEA relevance)
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EUROPEAN COMMISSION
Directorate General
Directorate
Unit
Date: …
Subject: Notification for authorisation of a traditional food from a third country in accordance with Regulation (EU) 2015/2283.
(Please indicate clearly by ticking one of the boxes)
Notification for an authorisation of a new traditional food.
Notification for adding, removing or changing the conditions of use of an already authorised traditional food. Please provide a reference to that notification.
Notification for adding, removing or changing the specifications of an already authorised traditional food. Please provide a reference to that notification.
Notification for adding, removing or changing additional specific labelling requirements of an already authorised traditional food. Please provide a reference to that notification.
Notification for adding, removing or changing the post-market monitoring requirements of an already authorised traditional food. Please provide a reference to that notification.
The Applicant(s) or their Representative(s) in the Union
(name(s), address(es)…)
…
…
…
submit(s) this notification in order to update the Union list on novel foods.
Identity of the traditional food:
…
…
Confidentiality(1). Where appropriate, state whether the application includes confidential data in accordance with Article 23 of Regulation (EU) 2015/2283
Yes
No
Food category | Specific conditions of use | Additional specific labelling requirement |
---|---|---|
— | ||
Yours sincerely,
Signature …
Enclosures:
Complete technical dossier
Summary of the dossier
List of the parts of the dossier requested to be treated as confidential and verifiable justification for such claims
Copy of administrative data of applicant(s)
EUROPEAN COMMISSION
Directorate General
Directorate
Unit
Date: …
Subject: Application for authorisation of a traditional food from a third country following the requirements of Article 16 of Regulation (EU) 2015/2283
The Applicant(s) or their Representative(s) within the European Union
(name(s), address(es)…)
…
…
…
submit(s) this application in order to update the Union list on novel foods.
Identity of the traditional food:
…
…
Confidentiality(2). Where appropriate, state whether the application includes confidential data in accordance with Article 23 of Regulation (EU) 2015/2283
Yes
No
Food category | Specific conditions of use | Additional specific labelling requirement |
---|---|---|
Yours sincerely,
Signature …
Enclosures:
Complete application
Summary of the application
List of the parts of the application requested to be treated as confidential and verifiable justification for such claims
Documented data relating to the duly reasoned safety objections
Copy of administrative data of applicant(s)
This Annex shall be updated during the notification or application procedure each time an applicant submits a request for information to be treated as confidential.
Where the production process contains confidential data, a non-confidential summary of the production process shall be provided.
Information requested to be considered as confidential | Justification |
---|---|
Section x.y (submitted on YYYY/MM/DD) | |
Annex X (submitted on YYYY/MM/DD) | |
Section x.y. (submitted on YYYY/MM/DD) | |
Annex X (submitted on YYYY/MM/DD) |
Applicants should use the format established in Annex III to indicate which information they wish to have treated as confidential and should provide all necessary details to substantiate the request for confidentiality.
Applicants should use the format established in Annex III to indicate the information they wish to have treated as confidential and should provide all necessary details to substantiate the request for confidentiality.
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