EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10801/2017 Rev. 1 CIS 
(POOL/E2/2017/10801/10801R1 -EN 
CIS.doc)  
[…](2017) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
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)   EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
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)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the F unctioning of the European Union , 
Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council 
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 1852/20011, 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 concerning 
traditional foods from third countries.   
(3) Without prejudice to Articles 5 , 15 and 1 6 of Regulation (EU) 2015/2283 , the 
Commission should verify whether the notification falls within the scope of that 
Regulation and the validity of the notification or the application.  
(4) Notifications  referred to in Article s 14 of Regula tion (EU) 2015/2283 should contain 
sufficient information and scientific documentation to allow the Commission to verify 
the validity and enable Member States and the Authority to evaluate the history of safe 
use of the traditional food from a third countr y.  
(5) Applications referred 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 Authority to conduct compre hensive risk assessments.  
(6) Where the applicant submits  a notification or an application to modif y the conditions 
of use , the specifications or additional specific labelling requirements of an authorised 
traditional food from a third country, it may not be necessary for the applicant to 
provide all the data required for the safety assessment  where the applicant provides 
adequate verifiable justif ication.   
                                                 
1 OJ L 327, 11.12.2015, p. 1 . EN 3   EN (7) The exchange of information between the Member States and the Authority is 
necessary in order to ensure that duly reasoned safety ob jections  are developed and 
submitted to the Commission.   
(8) The opinion of the Authority should  provide  sufficient information to ascertain 
whether the authorisation of the proposed use of the traditional food from a third 
country is safe for consumers.  
(9) Pursu ant to Article 35(3) of Regulation (EU) 2015/2283 the Commission has to adopt 
implementing acts laying down the requirements referred to in Article 20  of that 
Regulation .  
(10) The measures provided for in this Regulation are in accordance with the opinion of t he 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
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 sc ientific requirements concerning traditional 
foods from third countries  and transitional measures referred to in Article 35 (3) of that 
Regulation.  
It applies to notifications and applications as referred to in Article s 14 and 16 of Regulation 
(EU) 2015/228 3. 
Article 2  
Definitions  
In addition to  the definitions laid down in  Articles 2 and 3 of Regulation (EC) No 178/20022 
and Regulation (EU) 2015/2283 , the following definitions shall apply:  
(a) "notification" means a stand -alone dossier containing the information and the 
scientific data submitted in accordance with Article 14 of Regulation (EU) 
2015/2283 .  
(b) "application" means a stand -alone dossier containing the information and the 
scientific data submitted in accordance with Article 16 of Regulatio n (EU) 
2015/2283.  
Article 3  
Structure , content  and presentation  of a notification  
1. A notification  shall be submitted electronically  to the Commission  and shall consist 
of the following:   
(a) a cover letter;  
(b) a technical dossier;  
                                                 
2 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 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 4   EN (c) a summary of the  dossier . 
2. The cover l etter referred to in paragraph 1 (a) shall be drafted in accordance with the 
template provided in Annex I. 
3. The technical dossier referred to in paragraph 1(b) shall contain:  
(a) the administrative data as provided for in Article 5; 
(b) the technical data as provided for in Article 6.  
4. Where the applicant submits a notification to modify the conditions of use , the 
specifications or specific labelling requirements of a n authorised traditional food 
from a third country , it may not be necessary for the applicant to provide all the data 
required under Article 6 where the applicant provides verifiable  justification 
explaining tha t the proposed changes do not affect the results of the existing safety 
assessment.  
5. The summary of the do ssier 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.  
Article 4  
Structure , content and presentation 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 summary of the dossier ; 
(d) duly reasoned safety objections referred to in Artic le 15(2) of R egulation (EU) 
2015/2283 ; 
(e) the applicant's response to duly reasoned safety objections.  
2. The cover letter referred to in paragraph 1(a) shall be drafted in accordance with the 
template provided in Annex I I. 
Article 5 
Administrative data requirements  to be provided in a notification or an application  
In addition to the information set out in Article 14 of Regulation (EU) 2015/2283 , the 
notifications  and the applications  shall include  the following  administrative data : 
(a) the name(s) of the producer(s) of the traditional food from a third country, if different 
to the applicant’s, address and contact details;  
(b) the name , address and contact details  of the person responsible for the dossier 
authorised to communicate on beha lf 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 references to titles,  
volumes and pages;  EN 5   EN (f) 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 
Scientific  data  requirements  to be provided in a notification or an application  
1. The dossier submitted in support of a notification or an application for the 
authorisation of a traditional food from a third country shall enable a history of safe 
use of the traditional food from a third country to be established and shall set out a 
risk assessment of the traditional food from a third country.  
2. The applicant shall provide a copy of the documentation on the procedure followed 
when gathering the data .  
3. The applicant shall provide a description of the safety evaluation strategy and shall 
justif y the inclusion and exclusion of specific studies or information.  
4. The applicant shall provide the raw data of the individual unpublished studies  and of 
the published studies as well as the individual results of examinations.  
5. The applicant sh all propose an overall conclusion on the safety of the proposed uses 
of the traditional food from a third country. The overall evaluation of potential risk to 
human health shall be made in the context of known or likely human exposure.  
Article 7 
Verificati on 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 to 6 of this Regulation . 
2. 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 shall be provided.  
3. By way of  derogation from paragraph 1  of this Article and without prejudice to 
Article 14 of Regulation (EU) 2015/2283, 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 , provid ed that the applicant has submitted verifiable justification for each 
missing element . 
4. The Commission shall inform the applicant, the Member States and the Authority of 
the reasons why the notification is considered not valid.  
Article 8 
Verification of the validity of an a pplica tion 
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 . EN 6   EN 2. 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 shall be provided.  
3. By way of derogation from paragraph 1 of this Article an d without prejudice to 
Article 16  of Regulation (EU) 2015/2283, a n application  may be considered valid 
even if it does not contain all the el ements required under Articles 4 , 5 and 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 States and the Authority of 
the reasons why the application  is considered not valid.  
Article 9 
Duly reasoned safety objections  
1. On receipt of a valid notifi cation , consultation between the Member State s and the 
Authority  may take place . That consultation shall 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 safety objection s 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 following information:  
(a) the name and description of the traditional food from a third country;  
(b) a scien tific statement indicating why the traditional food from a third country 
may pose a safety risk to human health.  
Article 1 0 
Information to be included in the opinion of the Authority  
1. The opinion of the Authority shall include the following information:  
(a) the identity and characterisation of the traditional food from a third country;  
(b) the assessment of the history of safe use in a third country;  
(c) an overall risk assessment establishing if possible the safety of the traditional 
food from a third c ountry and highlighting uncertainties and limitations where 
relevant;  
(d) conclusions.  
2. The Commission may ask for additional information in its request for an opinion of 
the Authority.  
Article 11 
Transitional measures  
The notifications or applications a s referred to in Article 35(2) of Regulation (EU) 2015/2283 
shall be submitted  to the Commission  not later than 1 January 2019 . EN 7   EN Article 1 2 
Entry into force and application  
This Regulation shall enter into force on the twentieth  day following that of its pu blication in 
the Official Journal of the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The Presiden t 
 Jean -Claude JUNCKER  
  EN 8   EN ANNEX  
ANNEX I  
TEMPLATE COVER LETTER  ACCOMPANYING A NOTIF ICATION FOR TRADITIO NAL FOOD 
FROM A THIRD COUNTRY FOLLOW ING THE REQUIREMENTS  OF ARTICLE 14 OF REGULATION 
(EU)  2015/2283  
EUROPEAN COMMISSION  
Directorate General  
Directorate  
Unit 
Date: ________  
Subject: Notification for authorisation 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 a modification of the conditions of use of an authorised traditional 
food. Please provide a reference to that notification.  
 Notification for a modification of the specifications of an authorised traditional food. 
Please provide a reference to that notification.  
 Notification for a modification of labelling requirements of an authoris ed 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:  
______________________ ____________________________________________________  
__________________________________________________________________________  EN 9   EN Confidentiality3. Where appropriate, state whether the application includes confidential data 
in accordance with Article 23 of R egulation (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  
 List of the parts of the dossier requested to be treated as confidential and verifiable 
justification for such claims  
 Copy of administrative data of applicant(s)  
                                                 
3 Applicants should use the format established in Annex III to indicate which information they wish to 
have treated as confidential and should provide all necessary details to substantiate the request for 
confidentiality.  EN 10   EN ANNEX II  
TEMPLATE COVER LETTER  ACCOMPANYING AN APPL ICATION FOR TRADITIO NAL FOOD 
FROM A THIRD COUNTRY  FOLLOWING THE REQUIR EMENTS OF ARTICLE 16 OF REGULATION 
(EU)  2015/2283  
EUROPEAN COMMISSION  
Directorate General  
Directorate  
Unit 
Date: ________  
Subject: Application for authorisation of a traditional food from a third country 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 update the Union list on novel foods.  
Identity of the traditional food:  
__________________________________________________________________________  
_____ _____________________________________________________________________  
Confidentiality4. Where appropriate, state whether the application includes confidential data 
in accordance with Article 23 of Regulation (EU) 2015/2283  
 Yes 
 No  
Food categories, cond itions of use and labelling requirements  
Food category  Specific conditions of use  Additional specific labelling 
requirement  
   
   
                                                 
4 Applicants should use the format established in Annex III to indicate the information they wish to have 
treated as confidential and should provide all necessary details to substantiate the request for 
confidentiality.  EN 11   EN Yours sincerely,  
Signature ____________________________________  
Enclosures:  
 Complete application  
 Summary of the application  
 List of the parts of the application requested to be treated as confidential and 
verifiable justification for such claims  
 Documented data relating to the duly reasoned safety objections  
 Copy of administrative data of applicant(s)  
 EN 12   EN ANNEX III  
Justification for confidential information  
This Annex shall be updated during the notification or application procedure each time an 
applicant submits a request for information to be treated as confidential.  
Where the productio n process contains confidential data, a non -confidential summary of the 
production process shall be provided . 
Information requested to be  
considered as confidential  Justification  
Section x.y (submitted on YYYY/MM/DD)   
  
Annex X (submitted on YYYY/MM/DD)   
  
Section x.y.z (submitted on YYYY/MM/DD)   
  
Annex X (submitted on YYYY/MM/DD)