COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/1824 
of 2 December 2020 
amending Implementing Regulation (EU) 2017/2468 laying down administ rativ e and scientif ic 
requirements concer ning traditional foods from third countr ies in accordance with Regulation (EU) 
2015/2283 of the European Parliament and of the Council on novel foods 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Havi ng regar d to the Treaty on the Functioning of the European Union, 
Havi ng regar d to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on 
novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing 
Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) 
No 1852/2001 (1), and in particular Article 20 and Article 35(3) thereof, 
Whereas: 
(1) Regulation (EU) 2015/2283 lays down rules for the placing on the mark et and use of novel foods in the Union. 
(2) Commission Implementing Regulation (EU) 2017/2468 (2) lays down administrative and scientific requirements 
concer ning traditional foods from third countr ies. 
(3) Regulation (EU) 2019/1381 of the European Parliament and the Council (3) amended Regulation (EC) No 178/2002 
of the European Parliament and of the Council (4) and Regulation (EU) 2015/2283. Those amendments are aimed at 
strengthening the transparency and the sustainability of the EU risk assessment in all areas of the food chain where 
the European Food Safet y Auth ority (‘the Author ity’) delivers a scientific risk assessment, including in the area of 
traditional foods from third countr ies. 
(4) As regards the placing on the mark et of traditional foods from third countr ies, the amendments to Regulation (EC) 
No 178/2002 introduced new provisions concer ning, amongst other issues: general pre-submission advice by the 
staff of the Author ity at the request of a poten tial applicant or notifi er and the oblig ation to notify studies 
commissioned or carried out by business operat ors to suppor t an application or notificati on and the consequences 
of non-com pliance with that oblig ation. It also introduced provi sions on the public disclosure by the Auth ority of 
all scientifi c data, studies and other information suppor ting applications, with the excep tion of conf idential 
information, early on in the risk assessment process, followed up by a consultation of third parties. The 
amendments also set out specifi c procedural requirements for the submission of confidentiality requests and the 
assessment thereof by the Auth ority in relation to the information submitted by an applicant, where the 
Commission requests the opinion of the Author ity. 
(5) Regulation (EU) 2019/1381 also amended Regulation (EU) 2015/2283 to provide for the public disclosure by the 
Authority of notifi cations where it submits duly reasoned safety objections as well as to include provisions ensur ing 
consistency with the adaptations of Regulation (EC) No 178/2002 and taking into account sector al specificities with 
respect to conf idential information. 
(1)OJ L 327, 11.12.2015, p. 1. 
(2)Commission Implementing Regulation (EU) 2017/2468 of 20 December 2017 laying down administrative and scientific requirements 
concer ning traditional foods from third countr ies in accordance with Regulation (EU) 2015/2283 of the European Parliament and of 
the Council on novel foods (OJ L 351, 30.12.2017, p. 55). 
(3)Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of 
the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, 
(EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC 
(OJ L 231, 6.9.2019, p. 1). 
(4)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down the general principles 
and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety 
(OJ L 31, 1.2.2002, p. 1). EN Offi cial Jour nal of the European Union 3.12.2020                                                                                                                                         L 406/51   (6) Given the scope and application of all those amendments, Implementing Regulation (EU) 2017/2468 should be 
adjusted to accommodat e the changes as regar ds the content, draf ting and presentation of notificati ons and 
applications referred to in Articles 14 and 16 of Regulation (EU) 2015/2283, the arrange ments for verifying the 
validity of notifi cations and applications and the information to be included in the opinion of the Author ity. In 
particular , Implementing Regulation (EU) 2017/2468 should mak e reference to the standard data formats and 
require that applications provide information demonstrating compliance with the notific ation requirement laid 
down in Article 32b of Regulation (EC) No 178/2002. It should also clarify that the assessment of compl iance with 
the notificati on requirement forms part of the verification of the validity of an application. 
(7) Further more, taking into account the fact that the Authority is responsible for managing the database of studies in 
accordance with Article 32b of Regulation (EC) No 178/2002, it should be made possible for the Commission to 
consult the Auth ority as part of the verification of the validity of notifi cations and applications, in particular with a 
view to ascer taining that the notification or application fulfils the relevant requirements that are laid down in that 
Article. 
(8) Where public consultations are performe d during the risk assessment in accordance with Article 32c(2) of 
Regulation (EC) No 178/2002, the opinion of the Auth ority should also include the results of those consultations in 
line with the transparency requirements to which the Author ity is subject. 
(9) This Regulation should apply from 27 March 2021 and to notifications and applications submitt ed as of that date, 
which is the date of application of Regulation (EU) 2019/1381. 
(10) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
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 follo wing: 
‘1. A notifi cation shall consist of the following: 
(a) a cover letter; 
(b) a technical dossier; 
(c) a summar y of the dossier . 
Prior to the adopt ion of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, the 
notifi cation shall be submitted through the electronic submission system provid ed by the Commission, in an 
electronic format allowing for the downloading, printing and searching of documents. After the adop tion of 
standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, the notifi cation shall be submitte d 
through the electronic submission system provid ed by the Commission in accordance with those standard data 
formats.’; 
(b) paragraph 5 is replaced by the follo wing: 
‘5. The summar y of the dossier refer red to in paragraph 1(c) shall provide evidence that the use of a traditional 
food from a third countr y compl ies with the conditions laid down in Article 7 of Regulation (EU) 
2015/2283. The summar y of the dossier shall not contain any information subject to a request for 
conf idential 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 follo wing: 
‘1. An application shall consist of the followi ng: 
(a) a cover letter; 
(b) a technical dossier; 
(c) a summar y of the dossier . EN Offi cial Jour nal of the European Union L 406/52                                                                                                                                         3.12.2020   (d) duly reasoned safety objections refer red to in Article 15(2) of Regulation (EU) 2015/2283; 
(e) the applicant ’s response to duly reasoned safet y objections. 
Prior to the adopt ion of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, the 
application shall be submitted through the electronic submission system provid ed by the Commission, in an 
electronic format allowing for the downloading, printing and searching of documents. After the adop tion of 
standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, the application shall be submitted 
through the electronic submission system provid ed by the Commission in accordance with those standard data 
formats.’; 
(b) paragraph 5 is replaced by the follo wing: 
‘5. The summar y of the dossier refer red to in paragraph 1(c) shall provide evidence that the use of a traditional 
food from a third countr y compl ies with the conditions laid down in Article 7 of Regulation (EU) 
2015/2283. The summar y of the dossier shall not contain any information subject to a request for 
conf idential 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 supplementar y information, a list of the 
parts to be treated as conf idential accompan ied by verifiable justification demonstrating how the disclosure of 
such information would potentially harm the interests of the applicant to a signif icant degree;’; 
(b) point (f) is added: 
‘(f) a list of the studies submitted to suppor t the notific ation or application, including information demonstrating 
compl iance with Article 32b of Regulation (EC) No 178/2002.’; 
(4) Article 7 is replaced by the followi ng: 
‘Article 7 
Verification of the validity of a notif ication 
1. On receipt of a notificati on of a traditional food from a third countr y, the Commission shall, without dela y, verify 
whether the food concer ned falls within the scope of Regulation (EU) 2015/2283 and whether the notifi cation 
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 Author ity on whether the notification fulfils the 
requirements referred to in paragraph 1. The Member State s 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 regar ds 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 notifi cation may be considered 
valid even if it does not contain all the elements required under Articles 3, 5 and 6 of this Regulation, provid ed 
that the applicant has submitted appropr iate justif ication for each missing element. 
5. The Commission shall inform the applicant, the Member States and the Author ity 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 followi ng: 
‘Article 8 
Verification of the validity of an application 
1. On receip t of an application for the author isation of a traditional food from a third countr y the Commission 
shall, without dela y, 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. EN Offi cial Jour nal of the European Union 3.12.2020                                                                                                                                         L 406/53   2. The Commission may consult the Author ity on whether the application fulfils the requirements refer red to in 
paragraph 1. The Author ity 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 matte rs regar ding the validity of the 
application and inform the applicant of the period within whic h that information has to be provid ed. 
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, provi ded that 
the applicant has submitted appropr iate justif ication for each missing element. 
5. The Commission shall inform the applicant, the Member States and the Auth ority 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 follo ws: 
point (e) is added: 
‘(e) the results of consultations perf ormed during the risk assessment process in accordance with Article 32c(2) of 
Regulation (EC) No 178/2002.’; 
(7) Annex es I and II are replaced in accordance with the Annex to this Regulation; 
(8) Annex III is deleted. 
Article 2 
Entr y into force and application 
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union. 
It shall apply from 27 March 2021 and to notificati ons and applications submitte d to the Commission from that date. 
This Regulation shall be binding in its entirety and directly applicable in all Member States. 
Done at Brussels, 2 December 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union L 406/54                                                                                                                                         3.12.2020   ANNEX 
Annex es I and II to Regulation (EU) 2017/2468 are replaced as follows: 
(1) Annex I is replaced by the follo wing: 
‘ANNEX I 
TEMPL ATE COVER LETTER ACCO MPANYING A NOTIFIC ATION OF A TRADITIONAL FOOD 
FROM A THIRD COUNTR Y IN ACCORD ANCE WITH ARTIC LE 14 OF REGUL ATION (EU) 
2015/2283 
EUR OPEAN COMMISSION 
Direct orate-General 
Direct orate 
Unit 
Date: … 
Subject: Notification of a traditional food from a third countr y in accordance with Regulation (EU) 2015/2283 
(Please indicate clearly by ticking one of the boxes) 
Notif ication for an author isation of a new traditional food. 
Notif ication for adding, removing or changing the conditions of use of an already author ised traditional food. Please 
provid e a reference to that notificati on. 
Notif ication for adding, removing or changing the specifi cations of an already author ised traditional food. Please 
provid e a reference to that notificati on. 
Notif ication for adding, removi ng or changing additional labelling requirements of an already author ised traditional 
food. Please provid e a reference to that notification. 
Notif ication for adding, remo ving or changing the post-market monitor ing requirements of an already author ised 
traditional food. Please provid e a reference to that notification. 
The Applicant(s) or their Representative(s) in the Union 
(name(s), address(es)….) 
… 
… 
… 
submit(s) this notifi cation in order to update the Union list on novel foods. 
Identity of the traditional food: 
… 
… 
Confidenti ality . Where appropr iate, state whether the application includes confidential data in accordance with Article 23 
of Regulation (EU) 2015/2283 
Yes 
No EN Offi cial Jour nal of the European Union 3.12.2020                                                                                                                                         L 406/55   Food categor ies, conditions of use and labelling requirements                                                              
Food categor y Specific conditions of use Additional specific labelling requirement 
-        
Yours sincerely , 
Signature … 
Enclosures: 
Com plete technical dossier 
Summar y of the dossier (non-confi dential) 
List of the parts of the dossier requeste d to be treated as conf idential, accompanied by verifiable justification 
demonstrating how the disclosure of such information would poten tially harm the interests of the applicant to a 
signif icant degree 
Cop y of administrative data of applicant(s) 
List of studies and all information concer ning the notification of the studies in accordance with Article 32b of 
Regulation (EC) No 178/2002’ 
(2) Annex II is replaced by the followi ng: 
‘ANNEX II 
TEMPL ATE COVER LETTER ACCO MPANYING AN APPLIC ATION FOR THE AUTHORISA TION OF 
A TRADITIONAL FOOD FROM A THIRD COUNTR Y IN ACCO RDANCE WITH ARTIC LE 16 OF 
REGUL ATION (EU) 2015/2283 
EUR OPEAN COMMISSION 
Direct orate-General 
Direct orate 
Unit 
Date: … 
Subject: Application for the author isation of a traditional food from a third countr y 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: 
… 
… EN Offi cial Jour nal of the European Union L 406/56                                                                                                                                         3.12.2020   Confidenti ality . Where appropr iate, state whether the application includes confidential data in accordance with Article 23 
of Regulation (EU) 2015/2283 
Yes 
No 
Food categor ies, conditions of use and labelling requirements                                                              
Food categor y Specific conditions of use Additional specific labelling requirement         
Yours sincerely , 
Signature … 
Enclosures: 
Com plete application 
Summar y of the application (non-confi dential) 
List of the parts of the application request ed to be treate d as conf idential, accompanied by verifiable justif ication 
demonstrating how the disclosure of such information would poten tially harm the interests of the applicant to a 
signif icant degree 
Documente d data relating to the duly reasoned safety objections 
Cop y of administrative data of applicant(s) 
List of studies and all information concer ning the notification of the studies in accordance with Article 32b of 
Regulation (EC) No 178/2002’   EN Offi cial Jour nal of the European Union 3.12.2020                                                                                                                                         L 406/57