Commission Implementing Regulation (EU) 2020/1824Show full title

Article 1 U.K. Amendments to Implementing Regulation (EU) 2017/2468

Implementing Regulation (EU) 2017/2468 is amended as follows:

(1)

Article 3 is amended as follows:

(a)

paragraph 1 is replaced by the following:

‘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)

paragraph 5 is replaced by the following:

‘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.’;

(2)

Article 4 is amended as follows:

(a)

paragraph 1 is replaced by the following:

‘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)

paragraph 5 is replaced by the following:

‘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.’;

(3)

Article 5 is amended as follows:

(a)

point (e) is replaced by the following:

‘(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;’;

(b)

point (f) is added:

‘(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.’;

(4)

Article 7 is replaced by the following:

‘Article 7 Verification of the validity of a notification

1. On receipt of a notification of a traditional food from a third country, the Commission shall, without delay, verify whether the food concerned falls within the scope of Regulation (EU) 2015/2283 and whether the notification fulfils the requirements set out in Articles 3, 5 and 6 of this Regulation and in Article 32b of Regulation (EC) No 178/2002.

2. The Commission may consult the Member States and the Authority on whether the notification fulfils the requirements referred to in paragraph 1. The Member States and the Authority shall provide the Commission with their views within a period of 30 working days.

3. The Commission may request additional information from the applicant as regards the validity of the notification and inform the applicant of the period within which that information has to be provided.

4. By way of derogation from paragraph 1 of this Article and without prejudice to Article 14 of Regulation (EU) 2015/2283 and to Article 32b(4) and (5) of Regulation (EC) No 178/2002, a notification may be considered valid even if it does not contain all the elements required under Articles 3, 5 and 6 of this Regulation, provided that the applicant has submitted appropriate justification for each missing element.

5. The Commission shall inform the applicant, the Member States and the Authority whether the notification is considered valid or not. Where the notification is not considered valid, the Commission shall indicate the reasons for that finding.’;

(5)

Article 8 is replaced by the following:

‘Article 8 Verification of the validity of an application

1. On receipt of an application for the authorisation of a traditional food from a third country the Commission shall, without delay, verify whether the application fulfils the requirements of Articles 4 to 6 of this Regulation and of Article 32b of Regulation (EC) No 178/2002.

2. The Commission may consult the Authority on whether the application fulfils the requirements referred to in paragraph 1. The Authority shall provide the Commission with its views within a period of 30 working days.

3. The Commission may request additional information from the applicant on matters regarding the validity of the application and inform the applicant of the period within which that information has to be provided.

4. By way of derogation from paragraph 1 of this Article and without prejudice to Article 16 of Regulation (EU) 2015/2283 and to Article 32b(4) and (5) of Regulation (EC) No 178/2002, an application may be considered valid even if it does not contain all the elements required under Articles 4 to 6 of this Regulation, provided that the applicant has submitted appropriate justification for each missing element.

5. The Commission shall inform the applicant, the Member States and the Authority whether the application is considered valid or not. Where the application is not considered valid, the Commission shall indicate the reasons for that finding.’;

(6)

Article 10 is amended as follows:

point (e) is added:

‘(e)

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

(7)

Annexes I and II are replaced in accordance with the Annex to this Regulation;

(8)

Annex III is deleted.