COMMI SSION IMPLEMENTING REGUL ATION (EU) 2017/2469 
of 20 December 2017 
laying down administrativ 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, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having 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 market and use of novel foods in the Union. 
(2)  Pursuant to Article 13 of Regulation (EU) 2015/2283, the Commission has to adopt implementing acts laying 
down administrative and scientifi c data requirements for applications refer red to in Article 10(1) of that 
Regulation. 
(3)  Without prejudice to Articles 5 and 10 of Regulation (EU) 2015/2283, the Commission should verify whether 
the application falls within the scope of that Regulation and its validity . 
(4)  Applications refer red to in Article 10(1) of Regulation (EU) 2015/2283 should contain suffi cient information and 
scientific documentation to allow the Commission to verify their validity and enable the European Food Safety 
Author ity (the Auth ority) to conduct compreh ensive risk assessments of the novel foods. 
(5)  The applications should include detailed descr iptions of the safety evaluation strategy , the raw data, information 
on the relevance of the test mater ial used in the toxicological studies, and detec tion and characteri sation test 
methods for the engineered nanomat erials. 
(6)  Exper ience has shown that in certain cases a novel food intended for a particular group of the population may 
also reasonably be expected to be consumed by other groups of the population and that risk manage ment 
measures may be necessar y to mitig ate poten tial health risks to those other population groups. Theref ore, 
sufficient information should be provi ded in the application to enable the risks to those population groups to be 
assessed. 
(7)  Where the applicant submits an application to add, remo ve or change the conditions of use, the specifi cations, 
additional specifi c labelling requirements or post-market monitori ng requirements of an author ised novel food, it 
may not be necessar y for the applicant to provi de all the data required for the risk assessment, where the 
applicant provides verifiable justification. 
(8)  In order to ensure that toxicological tests are performed to a certain standard, they should be carried out in 
accordance with the rules set out in Directive 2004/10/EC of the European Parliament and of the Council (2). 
Where those tests are carried out outside the territory of the Union, they should follow the OECD Principles of 
Good Laboratory Practice (3). 
(9)  The opinion of the Author ity should provide suffic ient information to ascer tain whether the proposed use of the 
novel food is safe for consumers. 30.12.2017 L 351/64 Official Jour nal of the European Union EN     
(1)OJ L 327, 11.12.2015, p. 1. 
(2)Directive 2004/10/EC of the European Parliament and of the Council of 11 Febr uary 2004 on the harmonisation of laws, regulations 
and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their 
applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44). 
(3)OECD Series on Principles of Good Laborato ry Practice and Compliance Monitoring. Number 1. OECD Principles on Good Laboratory 
Practice (as revised in 1997) ENV/MC/C HEM(98)17. (10)  In order to benefit from data protection, as laid down in Article 26 of Regulation (EU) 2015/2283, requests for 
prot ection of propr ietar y data should be justif ied and all data concer ned should be kept in a separate part of the 
application. 
(11)  Pursuant to Article 35 of Regulation (EU) 2015/2283, it is necessar y to lay down transitional measures for the 
entr y into force of that Regulation. 
(12)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
Scope and subject matter 
This Regulation lays down rules for the implementation of Article 13 of Regulation (EU) 2015/2283 as regards the 
administrative and scientific requirements for applications refer red to in Article 10(1) and the transitional measures 
referred to in Article 35(3) of that Regulation. 
Article 2 
Def initions 
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 definition shall apply: 
‘application’ means a stand-alone dossier containing the information and the scientific data submitted for the author i­
sation of a novel food pursuant to Article 10(1) of Regulation (EU) 2015/2283. 
Article 3 
Structure, content and present ation of an application 
1. An application shall be submitted electronically to the Commission and shall consist of the following: 
(a)  a cover letter; 
(b)  a technical dossier; 
(c)  a summar y of the dossier . 
2. The cover letter referred to in paragraph 1(a) shall be draf ted in accordance with the template provi ded in Annex I. 
3. The technical dossier referred to in paragraph 1(b) shall contain: 
(a)  the administrative data as provid ed for in Article 4; 
(b)  the scientifi c data as provid ed for in Article 5. 
4. Where the applicant submits an application to modify the conditions of use, the specific ations, additional specifi c 
labelling requirements or post-marke t monitori ng requirements of an author ised novel food, it may not be necessar y for 
the applicant to provi de all the data required under Article 5 of this Regulation where the applicant provides verifiable 
justification explaining that the proposed chang es do not affect the results of the existing risk assessment. 
5. In addition to the information referred 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. 30.12.2017 L 351/65 Official Jour nal of the European Union EN     
(1)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 Safet y Authority and laying down procedures in matt ers of food safet y  
(OJ L 31, 1.2.2002, p. 1). Article 4 
Administ rativ e data requirements 
In addition to the information set out in Article 10(2) of Regulation (EU) 2015/2283, the application shall include the 
follo wing administrative data: 
(a)  the name(s) of the manufa cturer(s) of the novel food, if different 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; 
(c)  the date of submission of the dossier; 
(d)  a table of contents of the dossier; 
(e)  a detailed list of documents annexed to the dossier , including referen ces to titles, volumes and pages; 
(f)  a list of the parts of the dossier to be treated as conf idential and verifiable justif ication in accordance with Article 23 
of Regulation (EU) 2015/2283 and the rules set out in Annex II to this Regulation. Where the production process 
contains conf idential data, a non-confi dential summar y of the production process shall be provi ded; 
(g)  information and explanations substantiating the existen ce of the applicant's right of referen ce to the propr ietar y 
scientific evidence or scientifi c data in accordance with Article 26 of Regulation (EU) 2015/2283. That information 
shall be included in a separate folder . 
Article 5 
Scientif ic data requirements 
1. The dossier submitted in suppor t of an application for the author isation of a novel food shall enable a compre ­
hensive risk assessment of the novel food. 
2. Where the application for the author isation of a novel food involves the use of engineered nanomate rials as 
referred to in points (a) (viii) and (ix) of Article 3(2) of Regulation (EU) 2015/2283, the applicant shall provi de detection 
and charact erisation test methods in compliance with the requirements of Article 10(4) of that Regulation. 
3. The applicant shall provid e a copy of the documentation on the procedure and strateg y follo wed when gatheri ng 
the data. 
4. The applicant shall provide a descr iption of the safet y evaluation strateg y and the corresponding toxicological 
testing strategy and shall justify the inclusion or excl usion of specific studies or information. 
5. The applicant shall provide on request the raw data for the individual studies, published and unpublished, 
under taken by the applicant, or on their behalf, to suppor t their application. This information includes data used to 
generate the conclusions of the individual studies and results of examinations. 
6. Where it cannot be excluded that a novel food intended for a particular group of the population would be also 
consumed by other groups of the population the safety data provided shall also cover those groups. 
7. For each biological or toxicological study , the applicant shall clarify whether the test mat erial conf orms to the 
proposed or existing specification. Where the test mate rial differ s from that specifi cation, the applicant shall 
demonstrate the relevance of those data to the novel food under consideration. 
Toxicological studies shall be conduct ed in facilities whic h compl y with the requirements of Directive 2004/10/EC or, if 
they are carried out outside the territory of the Union, they shall follow the OECD Principles of Good Laborat ory 
Practice. The applicant shall provid e evidence of compl iance with those requirements and shall justify any deviation 
from the standard protocols. 
8. The applicant shall propose an overall conclusion on the safet y of the proposed uses of the novel food. The overall 
evaluation of poten tial risk to human health shall be made in the context of known or likely human exposure. 30.12.2017 L 351/66 Official Jour nal of the European Union EN     Article 6 
Verification of the validity of an application 
1. On receipt 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. 
2. The Commission may consult the Author ity. The Author ity shall provide the Commission with its views on 
whether the application fulfils the relevant requirements set out in Article 10(2) of Regulation (EU) 2015/2283 within 
a period of 30 working days. 
3. The Commission may request additional information from the applicant as regar ds the validity of the application 
and agree with the applicant of the period within which that information shall be provided. 
4. By way of deroga tion from paragraph 1 of this Article, and without prejudice to Article 10(2) of Regulation (EU) 
2015/2283, an application may be considered as valid even if it does not contain all the elements required under 
Articles 3 to 5 of this Regulation, provid ed that the applicant has submitte d appropr iate justification for each missing 
element. 
5. The Commission shall inform the applicant, the Member State s and the Author ity whether the application is 
considered valid or not. If the application is not considered valid, the Commission shall indicate the reasons why it is 
not valid. 
Article 7 
Information to be included in the opinion of the Author ity 
1. The opinion of the Author ity shall include the follo wing information: 
(a)  the identity of the novel food; 
(b)  the assessment of the production process; 
(c)  compo sitional data; 
(d)  specifi cations; 
(e)  the histo ry of use of the novel food and/or its source; 
(f)  the proposed uses and use levels and anticipate d intake ; 
(g)  absor ption, distr ibution, metabolism and excre tion (ADME); 
(h)  nutr itional information; 
(i)  toxicological information; 
(j)  allergen icity ; 
(k)  an overall risk assessment for the novel food under the proposed uses and use levels and highlighting uncer tainties 
and limitations where relevant ; 
(l)  when the dietar y exposure excee ds the health-based guidance value identif ied in the overall risk assessment, the 
dietar y exposure assessment of the novel food shall be detailed, provid ing the contr ibution to the total exposure of 
each food catego ry or foodstuff for which the use is author ised or has been request ed; 
(m)  conclusions. 
2. The Commission may ask for additional information in its request for an opinion of the Auth ority. 
Article 8 
Transitional measures 
1. By 1 Januar y 2018 the Member State s shall notify to the Commission the lists of requests referred to in 
Article 35(1) of Regulation (EU) 2015/2283. 30.12.2017 L 351/67 Official Jour nal of the European Union EN     2. The Members States shall make available all the information they have received on each request referred to in 
paragraph 1 to the Commission. 
3. Any request refer red to in paragraph 1 of this Article shall be updat ed by the applicant in order to comply with 
the requirements set out in Article 10(2) of Regulation (EU) 2015/2283 and in this Regulation. 
4. By way of derogation, paragraphs 1 and 2 shall not apply to requests refer red to in paragraph 1 of this Article for 
whic h an initial assessment repor t has been forwarded to the Commission pursuant to Article 6(4) of Regulation (EC) 
No 258/97 of the European Parliament and of the Council (1) by 1 Januar y 2018, and for whic h no reasoned objections 
have been made to the mark eting of the novel food concer ned within the period established in Article 6(4) of that 
Regulation. 
5. The deadline for the submission of the applications refer red to in Article 35(2) of Regulation (EU) 2015/2283 
shall be 1 Januar y 2019. 
Article 9 
Entr y into force and application 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Jour nal of the 
European Union. 
This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 20 December 2017. 
For the Commission 
The President 
Jean-Claude JUNCK ER  30.12.2017 L 351/68 Official Jour nal of the European Union EN     
(1)Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 Januar y 1997 concer ning novel foods and novel food 
ingredients (OJ L 43, 14.2.1997, p. 1). ANNEX I 
Template cover letter accompanying 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, remo ving or changing the conditions of use of an already author ised novel food. Please 
provide a referen ce to that author isation. 
Application for adding, removing or changing the specific ations of an already author ised novel food. Please provi de 
a referen ce to that author isation. 
Application for adding, removi ng or changing additional specifi c labelling requirements of an already author ised 
novel food. Please provide a referen ce to that author isation. 
Application for adding, remo ving or changing post market monitoring requirements of an already author ised novel 
food. Please provi de 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 updat e the Union list on novel foods. 
Identity of the novel food (information on the identity of the novel food should be provid ed, depending on the 
catego ry(ies) under which the novel food falls): 
.................................................................................................................................................................................. 
.................................................................................................................................................................................. 
Confidentiality (1). Where appropr iate, state whether the application includes conf idential data in accordance with 
Article 23 of Regulation (EU) 2015/2283 
Yes 
No 
Data Prote ction (2). 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 30.12.2017 L 351/69 Official Jour nal of the European Union EN     
(1)Applicants should use the format established in Annex II to indicat e which information they wish to have treated as confidential and 
should provi de all necessar y details to substantiat e the request for confidentiality . 
(2)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 justification /declaration for the propr ietar y claim. Food categor ies, conditions of use and labelling requirements 
Food categ ory Specific conditions of use Additional specific labelling requirement        
Yours sincerely , 
Signature .................................. 
Enclosures: 
Complet e dossier 
Summar y of the dossier 
List of the parts of the dossier requested to be treated as conf idential and verifiable justification for such claims 
Information suppor ting the protection of propr ietar y data relating to the novel food application 
Cop y of administrative data of applicant(s)  30.12.2017 L 351/70 Official Jour nal of the European Union EN     ANNEX II 
Just ification for conf idential information 
This Annex shall be updated during the application procedure each time an applicant submits a request for information 
to be treated as conf idential. 
Where the production process contains conf idential data, a non-confide ntial summar y of the production process shall 
be provided. 
Information requested to be considered as conf idential Justif ication 
Section x.y (submitted on YYYY/MM/DD)    
Annex X (submitted on YYYY/MM/DD)    
Section x.y (submitted on YYYY/MM/DD)    
Annex X (submitted on YYYY/MM/DD)    30.12.2017 L 351/71 Official Jour nal of the European Union EN