COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/1772 
of 26 November 2020 
amending Implementing Regulation (EU) 2017/2469 laying down administ rativ e and scientif ic 
requirements for applications refer red to in Article 10 of 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 13 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 Imple menting Regulation (EU) 2017/2469 (2) lays down administrative and scientific requirements for 
applications referred to in Article 10(1) of Regulation (EU) 2015/2283. 
(3) Regulation (EU) 2019/1381 of the European Parliament and the Council (3) amended Regulation (EC) 
No 178/2002 (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 
Authority (‘the Author ity’) delivers a scientific risk assessment, including in the area of novel foods. 
(4) As regar ds the placing on the market of novel foods, the amendments to Regulation (EC) No 178/2002 introduced 
new provis ions concer ning amongst other issues: general pre-submission advice by the staff of the Author ity at the 
request of a pote ntial applicant and the oblig ation to notify studies commissioned or carried out by business 
operat ors to suppor t an application and the consequences of non-com pliance with that oblig ation. It also 
introduced provis ions on the public disclosure by the Author ity of all scientifi c data, studies and other information 
suppor ting applications, with the excep tion of confidential information, early on in the risk assessment process, 
follo wed up by a consultation of third parties. The amendments also set out specif ic procedural requirements for 
the submission of conf identiality 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 Auth ority. 
(5) Regulation (EU) 2019/1381 also amended Regulation (EU) 2015/2283 to include provisions ensur ing consistency 
with the adap tations of Regulation (EC) No 178/2002 and taking into account sectoral specificities with respect to 
conf idential information. 
(6) Given the scope and application of all those amendments, Implementing Regulation (EU) 2017/2469 should be 
adjusted to accommodat e the changes as rega rds the content, draf ting and presentation of applications referred to in 
Article 10 of Regulation (EU) 2015/2283, the arrange ments for verifying the validity of applications, and the 
information to be included in the opinion of the Auth ority. In particular , Implementing Regulation (EU) 2017/2469 
should mak e reference to the standard data formats and require that applications provid e information demonstrating 
compl iance with the notifi cation requirement laid down in Article 32b of Regulation (EC) No 178/2002. It should 
also clarify that the assessment of compl iance with the notifi cation requirement forms part of the verification of the 
validity of an application. 
(1)OJ L 327, 11.12.2015, p. 1. 
(2)Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scientific requirements 
for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods 
(OJ L 351, 30.12.2017, p. 64). 
(3)Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and the 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 27.11.2020                                                                                                                                       L 398/13   (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 also be made possible for the Commission 
to consult the Author ity as part of the verification of the validity of applications to ascer taining that the 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 Authority is subject. 
(9) This Regulation should apply from 27 Marc h 2021 and to applications submitted as of that date, whic h 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) 2017/2469 
Implementing Regulation (EU) 2017/2469 is amended as follows: 
(1) Article 3 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 . 
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 syste m provided by the Commission, in an 
electronic format allowing for the down loading, printing and searc hing of documents. After the adoptio n of 
standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, the application shall be submitte d 
through the electronic submission system provided by the Commission in accordance with those standard data 
formats.’; 
(b) paragraph 5 is replaced by the follo wing: 
‘5. In addition to the information refer red to in points (a), (b) and (e) of Article 10(2) of Regulation (EU) 2015/ 
2283, the summar y of the dossier refer red to in paragraph 1(c) of this Article shall set out the reasons why the use 
of the novel food 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 replaced by the followi ng: 
‘Article 4 
Adminis trativ e data requirements 
In addition to the information set out in Article 10(2) of Regulation (EU) 2015/2283, the application shall include the 
following administrative data: 
(a) the name(s) of the manufacturer(s) of the novel food, if diffe rent than the applicant ’s, address and contact details; 
(b) the name, address and contact details of the person responsible for the dossier author ised to communicate on 
behalf of the applicant with the Commission and the Author ity; EN Offi cial Jour nal of the European Union L 398/14                                                                                                                                       27.11.2020   (c) the date of submission of the dossier; 
(d) a table of cont ents of the dossier; 
(e) a detailed list of documents annexed to the dossier , including references to titles, volume s and pages; 
(f) where the applicant submits, in accordance with Article 23 of Regulation (EU) 2015/2283, a request to treat as 
conf idential certain parts of the information of the dossier , including supplementar y information, a list of the 
parts to be treated as confidential accompan ied by verifiable justif ication demonstrating how the disclosure of 
such information would pote ntially harm the interests of the applicant to a significant degree; 
(g) where the production process contains conf idential data, a non-confide ntial summar y of the production process; 
(h) separately included information and explanations substantiating the existen ce of the applicant’s right of reference 
to the propr ietar y scientifi c evidence or scientific data in accordance with Article 26 of Regulation (EU) 2015/ 
2283; 
(i) a list of the studies submitte d to suppor t the application, including information demonstrating compliance with 
Article 32b of Regulation (EC) No 178/2002.’; 
(3) Article 6 is replaced by the followi ng: 
‘Article 6 
Verification of the validity of an application 
1. On receip t of an application, the Commission shall, without dela y verify whether the application falls within the 
scope of Regulation (EU) 2015/2283 and whether the application fulfils the requirements set out in Article 10(2) of 
that Regulation, Articles 3 to 5 of this Regulation and in Article 32b of Regulation (EC) No 178/2002. 
2. The Commission may consult the Author ity on whether the application fulfils the relevant requirements refer red 
to in paragraph 1. The Author ity shall provid e the Commission with its views within a period of 30 working days. 
3. The Commission may request additional information from the applicant as regards 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 10(2) 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 3 to 5 of this Regulation, provided 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.’; 
(4) in Article 7(1), the following point (n) is added: 
‘(n) the results of consultations performe d during the risk assessment process in accordance with Article 32c(2) of 
Regulation (EC) No 178/2002.’; 
(5) Annex I is replaced in accordance with the Annex to this Regulation; 
(6) Annex II is delet ed. 
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 applications submitt ed to the Commission from that date. EN Offi cial Jour nal of the European Union 27.11.2020                                                                                                                                       L 398/15   This Regulation shall be binding in its entirety and directly applicable in all Member States. 
Done at Brussels, 26 November 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union L 398/16                                                                                                                                       27.11.2020   ANNEX 
‘ANNEX 
Template cover letter accompan ying an application for novel food 
EUR OPEAN COMMISSION 
Direct orate-General 
Direct orate 
Unit 
Date: .......................................................................................................................... 
Subject: Application for author isation of a novel food in accordance with Regulation (EU) 2015/2283 
(Please indicate clearly by ticking one of the boxes) 
Application for an author isation of a new novel food. 
Application for adding, removing or changing the conditions of use of an already author ised novel food. Please provid e 
a reference to that author isation. 
Application for adding, remo ving or changing the specifi cations of an already author ised novel food. Please provid e a 
referen ce to that author isation. 
Application for adding, removing or changing additional specifi c labelling requirements of an already author ised novel 
food. Please provid e a reference to that author isation. 
Application for adding, remo ving or changing post market monit oring requirements of an already author ised novel 
food. Please provid e a reference to that author isation. 
The Applicant(s) or their Representative(s) in the Union 
(name(s), address(es)…) 
................................................................................................................................ 
................................................................................................................................ 
................................................................................................................................ 
submit(s) this application in order to update the Union list on novel foods. 
Identity of the novel food (Please provide information on the identity of the novel food depending on the cate gory(ies) 
under which the novel food falls): 
................................................................................................................................ 
................................................................................................................................ 
Confidenti ality . Where appropr iate, state whether the application includes confidential data in accordance with Article 23 
of Regulation (EU) 2015/2283: 
Yes 
No 
Data Prote ction (*). Where appropr iate, state whether the application includes a request for the protection of propr ietar y 
data according to Article 26 of Regulation (EU) 2015/2283: 
Yes 
No EN Offi cial Jour nal of the European Union 27.11.2020                                                                                                                                       L 398/17   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 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 
Information suppor ting the prot ection of propr ietar y data relating to the novel food application 
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’ 
_____________ 
(*)  Applicant should specify the part(s) of the application which include(s) propr ietar y data for which prot ection is requested, clearly 
stating section(s) and page number(s). Applicant should provide verifiable justificat ion/declaration for the propr ietar y claim.   EN Offi cial Jour nal of the European Union L 398/18                                                                                                                                       27.11.2020   