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)Text with EEA relevance

• Published date: 30 December 2017
• Subject Matter: tutela dei consumatori,alimentari,Mercato interno - Principi,protección del consumidor,productos alimenticios,Mercado interior - Principios,protection des consommateurs,denrées alimentaires,Marché intérieur - Principes
• Official Gazette Publication: Gazzetta ufficiale dell'Unione europea, L 351, 30 dicembre 2017,Diario Oficial de la Unión Europea, L 351, 30 de diciembre de 2017,Journal officiel de l'Union européenne, L 351, 30 décembre 2017

02017R2468 — EN — 27.03.2021 — 001.001

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►B 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) (OJ L 351 30.12.2017, p. 55)

Amended by:

		Official Journal
		No	page	date
►M1	COMMISSION IMPLEMENTING REGULATION (EU) 2020/1824 of 2 December 2020	L 406	51	3.12.2020

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▼B

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)

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

▼M1

1.

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.

▼B

2.

The cover letter referred to in paragraph 1(a) shall be drafted in accordance with the template provided in Annex I.

3.

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.

4.

Where the applicant submits a notification to modify the conditions of use, the specifications, specific labelling requirements or post-market monitoring requirements of an authorised traditional food from a third country, it may not be necessary for the applicant to provide all the data required under Article 6 where the applicant provides verifiable justification explaining that the proposed changes do not affect the results of the existing safety assessment.

▼M1

5.

The summary of the dossier referred to in paragraph 1(c) shall provide evidence that the use of a traditional food from a third country complies with the conditions laid down in Article 7 of Regulation (EU) 2015/2283. The summary of the dossier shall not contain any information subject to a request for confidential treatment pursuant to Article 23 of Regulation (EU) 2015/2283 and Article 39a of Regulation (EC) No 178/2002.

▼B

Article 4

Structure, content and presentation of an application

▼M1

1.

An application shall consist of the following:

(a)

a cover letter;

(b)

a technical dossier;

(c)

a summary of the 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.

▼B

2.

The cover letter referred to in paragraph 1(a) shall be drafted in accordance with the template provided in Annex II.

3.

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.

4.

Where the applicant submits an application to modify the conditions of use, the specifications, specific labelling requirements or post-market monitoring requirements of an authorised traditional food from a third country, it may not be necessary for the applicant to provide all the data required under Article 6 where the applicant provides verifiable justification explaining that the proposed changes not affect the results of the existing safety assessment.

▼M1

5.

The summary of the dossier referred to in paragraph 1(c) shall provide evidence that the use of a traditional food from a third country complies with the conditions laid down in Article 7 of Regulation (EU) 2015/2283. The summary of the dossier shall not contain any information subject to a request for confidential treatment pursuant to Article 23 of Regulation (EU) 2015/2283 and Article 39a of Regulation (EC) No 178/2002.

▼B

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;

(c)

a table of contents of the dossier;

(d)

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

▼M1

(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;

▼M1

(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.

▼B

Article 6

Scientific data to be provided in a notification or an application

1.

The dossier submitted in support of a notification or an application for the authorisation of a traditional food from a third country shall enable a history of safe use of the traditional food from a third country to be assessed.

2.

The applicant shall provide a copy of the documentation on the procedure followed when gathering the data.

3.

The applicant shall provide a description of the safety evaluation strategy and shall justify the inclusion and exclusion of specific studies or information.

4.

The applicant shall propose an overall conclusion on the safety of the...