Commission Implementing Regulation (EU) 2020/1824 of 2 December 2020 amending Implementing Regulation (EU) 2017/2468 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)

Amendments to Implementing Regulation (EU) 2017/2468

Article 1

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.

Entry into force and application

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union . It shall apply from 27 March 2021 and to notifications and applications submitted to the Commission from that date.

ANNEXSupplementary provisions

ANNEX Annexes I and II to Regulation (EU) 2017/2468 are replaced as follows: (1) Annex I is replaced by the following: ‘ANNEX I TEMPLATE COVER LETTER ACCOMPANYING A NOTIFICATION OF A TRADITIONAL FOOD FROM A THIRD COUNTRY IN ACCORDANCE WITH ARTICLE 14 OF REGULATION (EU) 2015/2283 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 ’ (2) Annex II is replaced by the following: ‘ANNEX II TEMPLATE COVER LETTER ACCOMPANYING AN APPLICATION FOR THE AUTHORISATION OF A TRADITIONAL FOOD FROM A THIRD COUNTRY IN ACCORDANCE WITH ARTICLE 16 OF REGULATION (EU) 2015/2283 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. 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 application ☐ Summary of the application (non-confidential) ☐ List of the parts of the application 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 ☐ Documented data relating to the duly reasoned safety objections ☐ 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 ’