Annex
United Kingdom
Annexes I and II to Regulation (EU) 2017/2468 are replaced as follows:
- (1)
Annex I is replaced by the following:
‘ANNEX I
TEMPLATE COVER LETTER ACCOMPANYING A NOTIFICATION OF A TRADITIONAL FOOD FROM A THIRD COUNTRY IN ACCORDANCE WITH ARTICLE 14 OF REGULATION (EU) 2015/2283
EUROPEAN COMMISSION
Directorate-General
Directorate
Unit
Date: …
Subject: Notification 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 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. Where appropriate, state whether the application includes confidential data in accordance with Article 23 of Regulation (EU) 2015/2283
- ☐
Yes
- ☐
No
Food categories, conditions of use and labelling requirements
Food category Specific conditions of use Additional specific labelling requirement - Yours sincerely,
Signature …
Enclosures:
- ☐
Complete technical dossier
- ☐
Summary of the dossier (non-confidential)
- ☐
List of the parts of the dossier requested to be treated as confidential, accompanied by verifiable justification demonstrating how the disclosure of such information would potentially harm the interests of the applicant to a significant degree
- ☐
Copy of administrative data of applicant(s)
- ☐
List of studies and all information concerning the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002’
- ☐
- (2)
Annex II is replaced by the following:
‘ANNEX II
TEMPLATE COVER LETTER ACCOMPANYING AN APPLICATION FOR THE AUTHORISATION OF A TRADITIONAL FOOD FROM A THIRD COUNTRY IN ACCORDANCE WITH ARTICLE 16 OF REGULATION (EU) 2015/2283
EUROPEAN COMMISSION
Directorate-General
Directorate
Unit
Date: …
Subject: Application for the authorisation of a traditional food from a third country in accordance with 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. Where appropriate, state whether the application includes confidential data in accordance with Article 23 of Regulation (EU) 2015/2283
- ☐
Yes
- ☐
No
Food categories, conditions of use and labelling requirements
Food category Specific conditions of use Additional specific labelling requirement Yours sincerely,
Signature …
Enclosures:
- ☐
Complete application
- ☐
Summary of the application (non-confidential)
- ☐
List of the parts of the application requested to be treated as confidential, accompanied by verifiable justification demonstrating how the disclosure of such information would potentially harm the interests of the applicant to a significant degree
- ☐
Documented data relating to the duly reasoned safety objections
- ☐
Copy of administrative data of applicant(s)
- ☐
List of studies and all information concerning the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002’
- ☐