EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10799/2017 Rev. 2 CIS 
(POOL/E2/2017/10799/10799R2 -EN 
CIS.doc)  
[…](2017) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
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  
(Text with EEA relevance)   EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
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  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the Europ ean 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 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 scientific data requirements for 
applications referred to in Article 10(1) of th at 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 referred to in Article 10(1) of Regulation (EU) 2015/2283 should contain 
sufficient informat ion and scientific documentation to allow the Commission to verify 
their validity and enable the European Food Safety Authority (the Authority ) to 
conduct comprehensive risk assessments of the novel foods.  
(5) The applications should include detailed descript ions of the safety evaluation strategy, 
the raw data, information on the relevance of the test material used in the toxicological 
studies,  and detection and characterisation test methods for the engineered 
nanomaterials .  
(6) Experience has shown that in certa in cases a novel food intended for a particular group 
of the population may also be consumed by other groups of the population and that the 
labelling may not be effective in mitigating the potential health risks for th ose other 
groups of population. Theref ore, sufficient information for the safety assessment of 
those population groups should be provided  in the application . 
                                                 
1 OJ L 327, 11.12.2015, p. 1 .  EN 3   EN (7) Where  the applicant submits an application to modif y the conditions of use , the 
specifications or additional specific labelling requirements  of an authorised novel 
food, it may not be necessary for the applicant to provide 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 Council2. Where those  tests are carried out outside 
the territory of the Union, they should follow The OECD  Principles of Good 
Laboratory Practice3. 
(9) The opinion of the Authority should  provide  sufficient  information  to ascertain 
whether the authorisation of the proposed use of the novel food is safe for consumers.  
(10) In order to benefit from data protection, as la id down in Article 26 of Regulation (EU) 
2015/2283, requests for protection of proprietary data should be justified and all data 
concerned should be kept in a separate part of the application . 
(11) Pursuant to Article 35 of Regulation (EU) 2015/2283, i t is nece ssary to lay down 
transitional measures for the entry into force of that Regulation.  
(12) The measures provided for in this Regulation are in accordance with the opinion of the 
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 13 of Regulation (EU) 
2015/2283 as regards the administrative and scientific requirements for applications referred 
to in Article 10(1)  and the transition al measures referred to in Article 35 (3) of that Regulation.  
Article 2  
Definitions  
In addition to  the definitions laid down in Articles 2 and 3 of  Regulation (EC) No 178/20024 
and Regulation (EU) 2015/2283 , the following definition shall apply : 
                                                 
2 Directive 2004/10/EC of the European Parliament and of the Council of 11 February 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 Seri es on Principles of Good Laboratory Practice and Compliance Monitoring. Number 1. 
OECD Principles on Good Laboratory Practice (as revised in 1997) ENV/MC/CHEM(98)17.  
4 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 "applicatio n" means a stand -alone dossier containing the information and the scientific data 
submitted for the authorisation of a novel food pursuant to Article 10(1) of Regulation (EU) 
2015/2283 .  
Article 3  
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.  
2. The cover l etter referred to in paragraph 1(a) shall be drafted in accordan ce 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 4; 
(b) the technical data as provided for in Article 5. 
4. Where the applicant submits an application to modif y the conditions of use , the 
specifications or  specific labelling requirements of an authorised novel food , it may 
not be necessary for the applicant to provide  all the data required under Article 5 of 
this Regulation  where t he applica nt provides  verifiable justification explaining that  
the proposed changes 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 summary of the dossier referred to in paragraph 1(c) 
of this Article  shall set out the reasons why  the use of the novel food complies with 
the conditions laid down in Article 7 of Regulation (EU) 2015/2283.  
Article 4 
Administrative 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 different than the applicant’s 
address and cont act details;  
(b) the name , address and contact details of the person responsible for the dossier  
authorised 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 references to titles,  
volumes and pages;  
(f) a list of the parts of the dossier to be treated as confidential  and verifiable 
justification in accordance with Article 23 of Regulation (EU) 201 5/2283  and the 
rules set out in Annex II  to this Regulation . Where the production process contains 
confidential data, a non -confidential summary of the production process shall be 
provided ;  EN 5   EN (g) information  and explanations  substantiating the existence of the applicant's right of 
reference to the proprietary scientific evidence or scientific data in accordance with 
Article 26 of Regulation (EU) 2015/2283. Th at information shall be included in a 
separate folder .  
Article 5 
Scientific data requirements  
1. The dossier submitted in support of an application for the authorisation of a novel 
food shall enable a comprehensive risk assessment of the novel food . 
2. Where the application for the authorisation of a novel food involving the use of 
engineered nanomateria ls as referred to  in points (a) (viii) and (ix) of Article 3(2) of 
Regulation (EU) 2015/2283, the applicant shall provide detection and 
characterisation test methods  in compliance with the requirements of Article  10(4) of 
that Regulation . 
3. The applicant shall provide a copy of the documentation on the procedure and 
strategy followed when gathering the data.   
4. The applicant shall provide a description of the safety evaluation strategy and the 
corresponding toxicological testing strategy and shall justif y the inclusion or 
exclusion of specific studies or information . 
5. 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.  
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  and where 
labelling may not mitigate  the potential health risks for those other groups of the 
population , the safety data provided  shall also cover those groups . 
7. For each biological or toxicological study, the applicant  shall clarif y whether the test 
material conforms to the proposed or existing specification. Where the test material 
differs from that specification, the applicant shall demonstrate the relevance of those 
data to the novel food under consideration.  
Toxicological studies shall be conducted in facilities which comply 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 Laboratory Practice. 
The applicant shall provide evidence of compliance with those requirements  and 
shall justify a ny deviation from the standard protocols .  
8. The applicant shall propose an overall con clusion on the safety of the proposed uses 
of the novel food. The overall evaluation of potential risk to human health shall be 
made in the context of known or likely human exposure.  EN 6   EN Article 6 
Verification of the validity of an application  
1. On receipt of  an application the Commission shall without delay verify whether the 
novel food 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 co nsult the Authority.  The Authority 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 regards 
the validity of the application and inform the applicant of the period within which 
that information shall 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, an application may be considered as 
valid even if it does not contain all the elements required under  Article s 3 to 5  of this 
Regulation , provided that the applicant has submitted verif iable justification for each 
missing element.  
5. The Commission shall inform the applicant, the Member States and the Authority of 
the reasons why the application is considered not valid.  
Article 7 
Information to be included in the opinion of the Authority  
1. The opinion of the Authority shall include the following information:  
(a) the identity of the novel food;  
(b) the assessment of the production process;  
(c) compositional data;  
(d) specifications;  
(e) the history of use of the novel food and/or its sour ce; 
(f) the proposed uses and use levels and anticipated intake;  
(g) absorption, distribution, metabolism and excretion (ADME);  
(h) nutritional information;  
(i) toxicological information;  
(j) allergenicity;  
(k) an overall risk assessment for the novel food  under the proposed uses and use 
levels and highlighting uncertainties and limitations where relevant;  
(l) when the dietary exposure exceeds the health -based guidance value identified 
in the overall risk assessment, the dietary exposure assessment of the n ovel 
food shall be detailed, providing the contribution to the total exposure of each 
food category or foodstuff for which the use is authorised or has been 
requested;  
(m) conclusions.  EN 7   EN 2. The Commission may ask for additional information in its request for  an opinion of 
the Authority.  
Article 8 
Transitional measures  
1. By 1 March 2018 t he Member States shall notify  to the Commission the lists of 
requests referred to in Article 35(1) of Regulation (EU) 2015/2283.   
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 referred to in paragraph 1  of this  Article shall be updated  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, paragraph 1 and 2 shall not apply to requests referred to in 
paragraph 1 of this Article  for which an initial assessment report has been forwarded 
to the Commission pursuant to Article 6(4) of Regulation (EC) No 258/97 by 1 
January 2018 , and for which no reasoned objections have been made to the 
marketing of the novel food concerned within the pe riod established in Article 6(4) 
of Regulation (EC) No 258/97.  
5. The deadline  for the submission of the applications  referred to in Article 35(2) of 
Regulation (EU) 2015/2283  shall  be 1 January 2019.  
Article 9 
Entry into force and application  
This Regula tion shall enter into force on the twentieth day following 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 States.  
Done at Brussels,  
 For the Comm ission  
 The President  
 Jean -Claude JUNCKER  
  EN 8   EN ANNEX  
ANNEX I  
TEMPLATE COVER LETTER  ACCOMPANYING AN APPL ICATION FOR NOVEL FO OD  
EUROPEAN COMMISSION  
Directorate General  
Directorate  
Unit 
Date: ________  
Subject: Application for authorisation of a novel food in accordance with Regulation (EU) 
2015/2283.  
(Please indicate clearly by ticking one of the boxes)  
 Application for an authorisation of  a new novel food.  
 Application for a modification of the conditions of use of an already authorised novel 
food. Please provide a reference to that notification . 
 Application for a modification of the specifications of an already authorised novel 
food. Please provide a reference to that notification . 
 Application for a modification of labelling requirements of an already authorised 
novel food. Please provide a reference to that notification . 
The Applicant(s) or their Representative(s) in the Union  
(name( s), address(es)….) 
__________________________________________________________________________  
__________________________________________________________________________  
__________________________________________________________________________  
submit(s) th is application in order to update the Union list on novel foods.  
Identity of the novel food (information on the identity of the novel food should be provided, 
depending on the category(ies) under which the novel food falls):  
______________________________ ____________________________________________  
__________________________________________________________________________  EN 9   EN Confidentiality5. Where appropriate, state whether the application includes confidential data 
in accordance with Article 23 of Regulatio n (EU) 2015/2283  
 Yes 
 No  
Data Protection6. Where appropriate, state whether the application includes a request for the 
protection of proprietary data according to Article 26 of Regulation (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 dossier  
 Summary of the dossier  
 List of the parts of the dossier requested to be treated as confidential and verifiable 
justification for such claims  
 Information supporting the protection of proprietary data relating to the novel food 
application  
 Copy of administrative data of applicant(s)  
 
                                                 
5 Applicants should use the format established in Annex II to indicate which information  they wish to 
have treated as confidential and should provide all necessary details to substantiate the request for 
confidentiality.  
6 Applicant should specify the part(s) of the application which include(s) proprietary data for which 
protection is request ed, clearly stating section(s) and page number(s). Applicant should provide 
verifiable justification /declaration for the proprietary claim.  EN 10   EN ANNEX II 
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 production 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)