- Latest available (Revised)
- Original (As adopted by EU)
Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (Text with EEA relevance)
When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.
Legislation.gov.uk publishes the UK version. EUR-Lex publishes the EU version. The EU Exit Web Archive holds a snapshot of EUR-Lex’s version from IP completion day (31 December 2020 11.00 p.m.).
This is the original version as it was originally adopted in the EU.
This legislation may since have been updated - see the latest available (revised) version
EUROPEAN COMMISSION
Directorate General
Directorate
Unit
Date: …
Subject: Application for authorisation of a novel food in accordance with Regulation (EU) 2015/2283.
(Please indicate clearly by ticking one of the boxes)
Application for an authorisation of a new novel food.
Application for adding, removing or changing the conditions of use of an already authorised novel food. Please provide a reference to that authorisation.
Application for adding, removing or changing the specifications of an already authorised novel food. Please provide a reference to that authorisation.
Application for adding, removing or changing additional specific labelling requirements of an already authorised novel food. Please provide a reference to that authorisation.
Application for adding, removing or changing post market monitoring requirements of an already authorised novel food. Please provide a reference to that authorisation.
The Applicant(s) or their Representative(s) in the Union
(name(s), address(es)…)
…
…
…
submit(s) this application in order to update the Union list on novel foods.
Identity of the novel food (information on the identity of the novel food should be provided, depending on the category(ies) under which the novel food falls):
…
…
Confidentiality(1). Where appropriate, state whether the application includes confidential data in accordance with Article 23 of Regulation (EU) 2015/2283
Yes
No
Data Protection(2). Where appropriate, state whether the application includes a request for the protection of proprietary data according to Article 26 of Regulation (EU) 2015/2283:
Yes
No
Food category | Specific conditions of use | Additional specific labelling requirement |
---|---|---|
Yours sincerely,
Signature …
Enclosures:
Complete dossier
Summary of the dossier
List of the parts of the dossier requested to be treated as confidential and verifiable justification for such claims
Information supporting the protection of proprietary data relating to the novel food application
Copy of administrative data of applicant(s)
This Annex shall be updated during the 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 II to indicate which information they wish to have treated as confidential and should provide all necessary details to substantiate the request for confidentiality.
Applicant should specify the part(s) of the application which include(s) proprietary data for which protection is requested, clearly stating section(s) and page number(s). Applicant should provide verifiable justification /declaration for the proprietary claim.
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As adopted by EU): The original version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
Click 'View More' or select 'More Resources' tab for additional information including: