Commission Implementing Regulation (EU) 2017/2469Show full title

ANNEX I Template cover letter accompanying an application for novel food

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)

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Application for an authorisation of a new novel food.

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Application for adding, removing or changing the conditions of use of an already authorised novel food. Please provide a reference to that authorisation.

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Application for adding, removing or changing the specifications of an already authorised novel food. Please provide a reference to that authorisation.

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Application for adding, removing or changing additional specific labelling requirements of an already authorised novel food. Please provide a reference to that authorisation.

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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

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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:

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Yes

☐

No

Food categories, conditions of use and labelling requirements

Food category	Specific conditions of use	Additional specific labelling requirement

Yours sincerely,

Signature …

Enclosures:

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Complete dossier

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Summary of the dossier

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List of the parts of the dossier requested to be treated as confidential and verifiable justification for such claims

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Information supporting the protection of proprietary data relating to the novel food application

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Copy of administrative data of applicant(s)

ANNEX II Justification for confidential information

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)

(1)

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.

(2)

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.