Chwilio Deddfwriaeth

Commission Implementing Regulation (EU) 2017/2469Dangos y teitl llawn

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)

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ANNEX IU.K. 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)

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 categories, conditions of use and labelling requirementsU.K.

Food categorySpecific conditions of useAdditional 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)

(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.

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