COMMI SSION IMPLEMENTING REGUL ATION (EU) 2017/2468 
of 20 December 2017 
laying down administrativ 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, 
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 20 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 20 of Regulation (EU) 2015/2283 the Commission has to adopt implementing acts laying 
down administrative and scientific requirements concer ning traditional foods from third countr ies. 
(3)  Without prejudice to Articles 5, 15 and 16 of Regulation (EU) 2015/2283, the Commission should verify 
whether the notificati on falls within the scope of that Regulation and the validity of the notific ation or the 
application. 
(4)  Notifications refer red to in Article 14 of Regulation (EU) 2015/2283 should contain suffi cient information and 
scientific documentation to allow the Commission to verify the validity and enable Member States and the 
Author ity to evaluate the histor y of safe use of the traditional food from a third countr y. 
(5)  Applications refer red to in Article 16 of Regulation (EU) 2015/2283 should contain sufficient information and 
scientific documentation to allow the Commission to verify the validity and enable the Author ity to conduct 
compre hensive risk assessments. 
(6)  Where the applicant submits a notifi cation or an application to add, remo ve or change the conditions of use, the 
specifications, additional specifi c labelling requirements or post-market monitori ng requirements of an author ised 
traditional food from a third countr y, it may not be necessar y for the applicant to provide all the data required 
for the safety assessment where the applicant provid es adequate verifiable justification. 
(7)  The exchang e of information between the Commission, the Member States and the Auth ority should allow that 
duly reasoned safety objections are submitt ed to the Commission where necessar y. 
(8)  The opinion of the Author ity should provide suffic ient information to ascer tain whether the proposed use of the 
traditional food from a third countr y is safe for consumers. 
(9)  Pursuant to Article 35(3) of Regulation (EU) 2015/2283 the Commission has to adopt implementing acts laying 
down the requirements refer red to in Article 20 of that Regulation. 
(10)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 30.12.2017 L 351/55 Official Jour nal of the European Union EN     
(1)OJ L 327, 11.12.2015, p. 1. HAS ADOPTED THIS REGUL ATION: 
Article 1 
Scope and subject matter 
This Regulation lays down rules for the implementation of Article 20 of Regulation (EU) 2015/2283 as regards the 
administrative and scientifi c requirements concer ning traditional foods from third countr ies and transitional measures 
referred to in Article 35(3) of that Regulation. 
It applies to notifications and applications as referred to in Articles 14 and 16 of Regulation (EU) 2015/2283. 
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 definitions shall apply: 
(a)  ‘notificat ion’ means a stand-alone dossier containing the information and the scientifi c data submitt ed in accordance 
with Article 14 of Regulation (EU) 2015/2283. 
(b)  ‘application’ means a stand-alone dossier containing the information and the scientific data submitte d in accordance 
with Article 16 of Regulation (EU) 2015/2283. 
Article 3 
Structure, content and presentation of a notif ication 
1. A notificati on shall be submitte d electronically to the Commission and shall consist of the followi ng: 
(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 5; 
(b)  the scientifi c data as provid ed for in Article 6. 
4. Where the applicant submits a notificati on to modify the conditions of use, the specifi cations, specifi c labelling 
requirements or post-market monitori ng requirements of an author ised traditional food from a third countr y, it may not 
be necessar y for the applicant to provide all the data required under Article 6 where the applicant provides verifiable 
justification explaining that the proposed chang es do not affect the results of the existing safety assessment. 
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 complies with the conditions laid down in Article 7 of Regulation (EU) 2015/2283. 
Article 4 
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; 
(d)  duly reasoned safety objections referred to in Article 15(2) of Regulation (EU) 2015/2283; 
(e)  the applicant's response to duly reasoned safet y objections. 30.12.2017 L 351/56 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 Author ity and laying down procedures in matters of food safet y  
(OJ L 31, 1.2.2002, p. 1). 2. The cover lette r refer red to in paragraph 1(a) shall be draf ted in accordance with the template provided in 
Annex II. 
3. The technical dossier referred to in paragraph 1(b) shall contain: 
(a)  the administrative data as provid ed for in Article 5; 
(b)  the scientifi c data as provid ed for in Article 6. 
4. Where the applicant submits an application to modify the conditions of use, the specifi cations, specif ic labelling 
requirements or post-market monitori ng requirements of an author ised traditional food from a third countr y, it may not 
be necessar y for the applicant to provide all the data required under Article 6 where the applicant provides verifiable 
justification explaining that the proposed chang es not affect the results of the existing safety assessment. 
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 complies with the conditions laid down in Article 7 of Regulation (EU) 2015/2283. 
Article 5 
Administ rativ e data to be provided in a notif ication or an application 
In addition to the information set out in Article 14 of Regulation (EU) 2015/2283, the notifi cations and the applications 
shall include the follo wing administrative data: 
(a)  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; 
(b)  the date of submission of the dossier; 
(c)  a table of contents of the dossier; 
(d)  a detailed list of documents annexed to the dossier , including referen ces to titles, volumes and pages; 
(e)  a list of the parts of the dossier to be treated as confidential in accordance with Article 23 of Regulation (EU) 
2015/2283 and the rules set out in Annex III to this Regulation. 
Article 6 
Scientif ic data to be provided in a notif ication or an application 
1. The dossier submitted in suppor t of a notifi cation or an application for the author isation of a traditional food 
from a third countr y shall enable a histo ry of safe use of the traditional food from a third countr y to be assessed. 
2. The applicant shall provide a copy of the documentation on the procedure follo wed when gatheri ng the data. 
3. The applicant shall provid e a descr iption of the safety evaluation strateg y and shall justify the inclusion and 
excl usion of specifi c studies or information. 
4. The applicant shall propose an overall conclusion on the safety of the proposed uses of the traditional food from 
a third countr y. The overall evaluation of potential risk to human health shall be made in the conte xt of kno wn or likely 
human exposure. 
Article 7 
Verification of the validity of a notif ication 
1. On receipt of a notific ation 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. 
2. 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 whic h that information shall be provid ed. 
3. By way of derog ation from paragraph 1 of this Article and without prejudice to Article 14 of Regulation (EU) 
2015/2283, 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, provided that the applicant has submitted verifiable justification for each missing element. 30.12.2017 L 351/57 Official Jour nal of the European Union EN     4. The Commission shall inform the applicant, the Member States and the Author ity of the reasons why the 
notificati on is considered not valid. 
Article 8 
Verification of the validity of an application 
1. On receipt 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. 
2. The Commission may request additional information from the applicant on matters regar ding the validity of the 
application and inform the applicant of the period within whic h that information shall be provid ed. 
3. By way of derog ation from paragraph 1 of this Article and without prejudice to Article 16 of Regulation (EU) 
2015/2283, 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 verifiable justification for each missing 
element. 
4. 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 9 
Duly reasoned safety objections 
1. On receipt of a valid notifi cation, consultation between the Commission, the Member States and the Author ity 
may be carried out in the first three months of the period established in Article 15(2) of Regulation (EU) 2015/2283. 
2. The duly reasoned safet y objections submitted by a Member State or the Authority to the Commission in 
accordance with Article 15(2) of Regulation (EU) 2015/2283 shall include the followi ng information: 
(a)  the name and descr iption of the traditional food from a third countr y; 
(b)  a scientific state ment indicating why the traditional food from a third countr y may pose a safety risk to human 
health. 
Article 10 
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 and charact erisation of the traditional food from a third countr y; 
(b)  the assessment of the histo ry of safe use in a third countr y; 
(c)  an overall risk assessment establishing if possible the safety of the traditional food from a third countr y and 
highlighting uncer tainties and limitations where relevant ; 
(d)  conclusions. 
2. The Commission may ask for additional information in its request for an opinion of the Auth ority. 
Article 11 
Transitional measures 
The notifi cations as referred to in Article 35(2) of Regulation (EU) 2015/2283 shall be submitted to the Commission 
not later than 1 Januar y 2019. 30.12.2017 L 351/58 Official Jour nal of the European Union EN     Article 12 
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. 
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 351/59 Official Jour nal of the European Union EN     ANNEX I 
Template cover letter accompanying a notif ication for traditional food from a third countr y 
follo wing the requirements of Article 14 of Regulation (EU) 2015/2283 
EUR OPEAN COMMISSION 
Direct orate General 
Direct orate 
Unit 
Date: ........................................ 
Subject: Notif ication for author isation 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, removi ng or changing the conditions of use of an already author ised traditional food. 
Please provide a reference to that notifi cation. 
Notif ication for adding, remo ving or changing the specifications of an already author ised traditional food. Please 
provide a referen ce to that notificati on. 
Notif ication for adding, removing or changing additional specific labelling requirements of an already author ised 
traditional food. Please provid e a reference to that notifi cation. 
Notif ication for adding, remo ving or changing the post-market monit oring requirements of an already author ised 
traditional food. Please provid e a reference to that notifi cation. 
The Applicant(s) or their Representative(s) in the Union 
(name(s), address(es)…) 
.................................................................................................................................................................................. 
.................................................................................................................................................................................. 
.................................................................................................................................................................................. 
submit(s) this notifi cation in order to updat e the Union list on novel foods. 
Identity of the traditional food: 
.................................................................................................................................................................................. 
.................................................................................................................................................................................. 
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 
Food categor ies, conditions of use and labelling requirements 
Food categ ory Specific conditions of use Additional specific labelling requirement 
—       
Yours sincerely , 
Signature .................................. 30.12.2017 L 351/60 Official Jour nal of the European Union EN     
(1)Applicants should use the format established in Annex III 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 . Enclosures: 
Complet e technical 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 
Cop y of administrative data of applicant(s)  30.12.2017 L 351/61 Official Jour nal of the European Union EN     ANNEX II 
Template cover letter accompan ying an application for traditional food from a third countr y 
follo wing the requirements of Article 16 of Regulation (EU) 2015/2283 
EUR OPEAN COMMISSION 
Direct orate General 
Direct orate 
Unit 
Date: ........................................ 
Subject: Application for author isation of a traditional food from a third countr y following the requirements of 
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 updat e the Union list on novel foods. 
Identity of the traditional food: 
.................................................................................................................................................................................. 
.................................................................................................................................................................................. 
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 
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 application 
Summar y of the application 
List of the parts of the application request ed to be treated as confidential and verifiable justif ication for such claims 
Documented data relating to the duly reasoned safety objections 
Cop y of administrative data of applicant(s)  30.12.2017 L 351/62 Official Jour nal of the European Union EN     
(1)Applicants should use the format established in Annex III to indicate the information they wish to have treated as confidential and should 
provi de all necessar y details to substantiat e the request for confidentiality . ANNEX III 
Just ification for conf idential information 
This Annex shall be updat ed during the notificati on or 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 351/63 Official Jour nal of the European Union EN