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. )

Current text a fecha 2021-03-27

Article 1

Scope and subject matter

This Regulation lays down rules for the implementation of Article 20 of Regulation (EU) 2015/2283 as regards the administrative and scientific requirements concerning traditional foods from third countries and transitional measures referred to in Article 35(3) of that Regulation.

It applies to notifications and applications as referred to in Articles 14 and 16 of Regulation (EU) 2015/2283.

Article 2

Definitions

In addition to the definitions laid down in Articles 2 and 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (¹) and Regulation (EU) 2015/2283, the following definitions shall apply:

(a) ‘notification’ means a stand-alone dossier containing the information and the scientific data submitted in accordance with Article 14 of Regulation (EU) 2015/2283.

(b) ‘application’ means a stand-alone dossier containing the information and the scientific data submitted in accordance with Article 16 of Regulation (EU) 2015/2283.

Article 3

Structure, content and presentation of a notification

A notification shall consist of the following:

(a) a cover letter;

(b) a technical dossier;

(c) a summary of the dossier. Prior to the adoption of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, the notification shall be submitted through the electronic submission system provided by the Commission, in an electronic format allowing for the downloading, printing and searching of documents. After the adoption of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, the notification shall be submitted through the electronic submission system provided by the Commission in accordance with those standard data formats.

The technical dossier referred to in paragraph 1(b) shall contain:

(a) the administrative data as provided for in Article 5;

(b) the scientific data as provided for in Article 6.

Article 4

Structure, content and presentation of an application

An application shall consist of the following:

(a) a cover letter;

(b) a technical dossier;

(d) duly reasoned safety objections referred to in Article 15(2) of Regulation (EU) 2015/2283;

(e) the applicant’s response to duly reasoned safety objections. Prior to the adoption of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, the application shall be submitted through the electronic submission system provided by the Commission, in an electronic format allowing for the downloading, printing and searching of documents. After the adoption of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, the application shall be submitted through the electronic submission system provided by the Commission in accordance with those standard data formats.

The technical dossier referred to in paragraph 1(b) shall contain:

(a) the administrative data as provided for in Article 5;

(b) the scientific data as provided for in Article 6.

Article 5

Administrative data to be provided in a notification or an application

In addition to the information set out in Article 14 of Regulation (EU) 2015/2283, the notifications and the applications shall include the following administrative data:

(a) the name, address and contact details of the person responsible for the dossier authorised to communicate on behalf of the applicant with the Commission;

(b) the date of submission of the dossier;

(d) a detailed list of documents annexed to the dossier, including references to titles, volumes and pages;

(e) where the applicant submits, in accordance with Article 23 of Regulation (EU) 2015/2283, a request to treat as confidential certain parts of the information of the dossier, including supplementary information, a list of the parts 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;

(f) a list of the studies submitted to support the notification or application, including information demonstrating compliance with Article 32b of Regulation (EC) No 178/2002.

Article 6

Scientific data to be provided in a notification or an application

Article 7

Verification of the validity of a notification

Article 8

Verification of the validity of an application

Article 9

Duly reasoned safety objections

The duly reasoned safety objections submitted by a Member State or the Authority to the Commission in accordance with Article 15(2) of Regulation (EU) 2015/2283 shall include the following information:

(a) the name and description of the traditional food from a third country;

(b) a scientific statement indicating why the traditional food from a third country may pose a safety risk to human health.

Article 10

Information to be included in the opinion of the Authority

The opinion of the Authority shall include the following information:

(a) the identity and characterisation of the traditional food from a third country;

(b) the assessment of the history of safe use in a third country;

(c) an overall risk assessment establishing if possible the safety of the traditional food from a third country and highlighting uncertainties and limitations where relevant;

(d) conclusions;

(e) the results of consultations performed during the risk assessment process in accordance with Article 32c(2) of Regulation (EC) No 178/2002.

Article 11

Transitional measures

The notifications as referred to in Article 35(2) of Regulation (EU) 2015/2283 shall be submitted to the Commission not later than 1 January 2019.

Article 12

Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX I

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

ANNEX II

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.