EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10802/2017 Rev. 1 CIS 
(POOL/E2/2017/10802/10802R1 -EN 
CIS.doc)  
[…](2017) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
on the procedural steps of the consultation process for determination of novel food 
status 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  
on the procedural steps of the consultation  process for determination of novel food 
status 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 Functioning of t he 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 4 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) Article 4  of Reg ulation (EU) 2015/2283  lays down basic principles on the procedure 
for the determination of novel food status. Paragraph 1 of that Article obliges f ood 
business operators to verify whether or not the food which they intend to place on the 
Union market fall s within the scope of that Regulation.  
(3) In order to determine novel food status of a particular food, a consultation request 
should be submitted. The Member States should verify the validity of such request s. 
Therefore, it is necessary to establish rules for the verification process.  
(4) Rules should be established in order to ensure that the consultation request for 
determination of novel food status provides all the information necessary for the 
evaluation  by the Member States.  
(5) In order to ensure that food b usiness operators and the public are informed of the 
novel food status, the information on the novel food status should be made publicly 
available.  
(6) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee o n Plants, Animals, Food and Feed,  
                                                 
1 OJ L 327, 11.12.2015, p. 1 . EN 3   EN HAS ADOPTED THIS REGULATION:  
Article 1  
Scope and subject matter  
This Regulation lays down rules for the implementation of Article 4 of Regulation (EU) 
2015/2283 as regards  the procedural steps of the consultation process to determine  whether or 
not a food falls within the scope of that Regulation .  
Article 2  
Definitions   
In addition  to the definitions laid down in Regulation (EC) No 178/2002  of the European 
Parliament and of the Council2 and Regulation (EU) 2015/2283 , the following definitions 
shall apply : 
(a) "consultation request" means a request from a food business operator to a recipient 
Member State to determine novel food status of a particular food ; 
(b) "recipient Member State" means a Member State where the food bu siness operator  
intend s to place on the market a particular food for the first time.  
Article 3  
Submission of a consultation request   
1. The food business operator shall consult the recipient Member State as provided for 
in Article 4(2) of Regulation (EU) 2 015/2283  by submitting  a consultation request to 
that Member State.  
2. Where  the food business operator intends to place the food on the market 
simultaneously in several Member States, the food business operator shall submit the 
consultation request only to one of th ose Member States .  
Article 4  
Content and presentation of a consultation request  
1. The consultation request shall be submitted electronic ally to the recipient Member 
State and shall consist of the following:  
(a) a cover letter;  
(b) a technical  dossier;  
(c) supporting document ation ; 
(d) an explanatory note clarifying the purpose and relevance of the submitted 
document ation . 
2. The cover letter referred to in paragraph 1(a) shall be drafted in accordance with the 
template provided in Annex I. 
                                                 
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 3. The technical dossier referred to in paragraph 1(b) shall contain the information 
necessary to enable the recipient Member State to conclude on the novel food status 
and shall be drafted in accordance with the template provided in Annex  II.  
4. By way of d erogation from paragraph 3, an applicant is not required to provide all 
the elements referred to in Annex II, provided that  the applicant  has submitted  
verifiable justification for the absence of each missing element.  
Article 5  
Procedures for verifying the  validity of a consultation request  
1. The recipient Member State shall without delay verify whether the consultation 
request complies with the requirements of Article 4 .  
2. Where the food business operator submits insufficient information in the consultation 
request , the recipient Member State shall request the food business operator to 
provide additional information or make the relevant updates to the consultation 
request within the time period specified by the recipient Member State.  
3. The cons ultation request shall be considered not valid where:   
(a) the food business operator does not provide requested additional information  or 
updated consultation request within the period specified by the recipient 
Member State ; 
(b) the submitted additional information is insufficient to conclude that the 
consultation request is valid.  
4. The recipient Member State shall decide on the validity of the consultation request  
and without delay inform the food business operator, the other Member States and 
the Com mission  of the decision . Where the consultation request is considered not 
valid , the recipient Member State shall provide  the reasons for th at conclusion . 
Article 6  
Procedures for evaluating a valid consultation request  
1. The recipient Member State shall conclude on the status of a novel food status within 
four mo nths from the date on which it  decided on the validity of the consultation 
request . 
2. Where the recipient Member State does not have sufficient evidence to decide on the 
status of a  novel food, it may request the food business operator to provide additional 
information.  That request  shall not extend the deadline of 4 months provided  in 
paragraph 1.  
In that regard the recipient Member State may consult the other Memb er States and 
the Commission.  
3. In duly justified cases, the recipient Member State may extend the time period 
referred to in paragraph 1 by a maximum of four months . The recipient Member 
State shall inform the food business operator, the other Member Sta tes and the 
Commission of their decision and shall provide justif ication . EN 5   EN Article 7  
Information on the novel food status and publication  
1. The recipient Member State shall notify to the food business operator, the other 
Member States and the Commission th e status of the novel food . 
2. The notification sent by the recipient Member State  shall include the following:  
(a) the name and description of the food concerned;  
(b) a statement indicating whether the food concerned is novel, not novel or not 
novel only in food supplements;  
(c) reasons justif ying the statement  referred to in point (b) ; 
(d) where the food is novel  food, the food category under which it falls in 
accordance with  Article 3(2) of Regulation (EU) 2015/2283.  
3. The Commission shall without delay make the information on the novel food status 
publicly available  on the Commission's website . 
Article 8  
Competent authorities of the Member States  
Member States shall provide the Commission with the contact details of the national  
competent a uthorit ies and the contact details of the respective contact points designated for 
the purposes of this Regulation  by 1 March 2018 . 
The Commission shall publish th ose contact details  on the Commission's website  by 1 May 
2018 . 
Article 9  
Entry into force and  application  
This Regulation 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 Commission  
 The President  
 Jean -Claude JUNCKER  
  EN 6   EN ANNEX  
ANNEX I  
TEMPLATE COVER LETTER ACCOMPANYING A CONSULTATION REQUEST 
FOR DETERMINATION OF THE  NOVEL FOOD STATUS  
Competent authority of the Member State  
Date: ________  
Subject: Consultation request for determination of the novel food status of the______ _______  
______________________________________________________________________ _____ 
The Food business operator(s)/consulting party:  
Company:  __________________________________________________________________  
Address:  
____________________________________________________________________  
Telephone: _____________________________________________________ _____________  
Email:  _____________________________________________________________________  
Contact person:  ______________________________________________________________  
submit(s) the present consultation request in order to determine the novel food status  of the 
________ ___________________________________________________________________  
Yours sincerely,  
Signature ____________________________________  
Enclosures:  
 Technical dossier  
 Documents in support of the consultation request  with the full information  in 
electronic format  
 Explanatory note  
 EN 7   EN ANNEX II  
TECHNICAL DOSSIER  
Where app licable , the technical dossier shall contain a proposal on the category under which 
the novel food falls as defined in Article 3(2) of Regulation (EU) 2015/2283.   
The connection between the different pieces of information shall be explained in an 
explanatory note. In particular, as regards the evidence presented to support a human 
consumption to a significant degree within the Union before 15 May 1997, where documents 
from a range of sources must be considered to be able to reach a conclusion.  
Where only parts of the documents are relevant for the assessment, those parts shall be 
highlighted.  
For foods, other than extracts and other than foods resulting from a production process not 
used for food production within the Union before 15 May 1997, Section 1 must be completed.  
For extracts Section 1 and Section 2 must be completed.  
For foods resulting from a production process not used for food production within the Union 
before 15 May 1997 Section 1 (points 1 to 3 and point 7) and Section 3 must be completed.  
Section 1: All foods other than extracts and foods resulting from a produ ction process 
not used for food production within the Union before 15 May 1997  
1. Description of the food  
1.1 Name of the food   
1.2 Detailed description of the food   
1.3 Proposed category of the novel food in 
accordance with Article 3 (2) (a) of 
Regulation (EU) 2015/2283   
 
2. Further characterisation of the food and/or source of the food (where relevant)  
A. Organisms (microorganisms, fungi, algae, plants, animals)  
2.1 Taxonomic name (full Latin name with 
author name)   
2.2 Synonyms, other names, where 
applicable   
2.3 Specification of which part of the 
organism the use for human consumption 
before 15 May 1997 within the Union 
refers to   
B. Chemical substances  
2.4 CAS number(s) (if this has been 
attributed)   EN 8   EN 2.5 Chemical name(s) according  to IUPAC 
nomenclature rules   
2.6 Synonyms, trade name, common name, 
where applicable   
2.7 Molecular and structural formulae   
2.8 Specification about purity/concentration   
 
3. Conditions of use  
3.1 How is the food intended to be used   
3.2 Type of product(s) in which the food is 
intended to be used   
3.3 Level/concentration (or range of levels) 
in the product(s) in which the food is 
intended to be used   
 
4. Production process  
4.1 Detailed description of the production 
process. Include a flow process chart to 
describe the production process.   
 
5. History of human consumption of the food within the Union before 15 May 1997  
5.1 To what extent was the food consumed 
to a significant degree throughout the 
Union. Details shall be provided.   
5.2 To what extent was the food consumed 
to a significant degree in one Member 
State. Details shall be provided.   
5.3 Food consumed only regionally/on a 
small local scale in the Union.   
5.4 Was the food available before 15 May 
1997 in the Union as an ingredi ent 
designed for specific target population 
(e.g. food for a special medical purpose)?   
 EN 9   EN 6. Consultations on availability in the Union  
Where food business operators are unsure whether the information in their possession is 
sufficient to prove that the food concerned has been used for human consumption to a 
significant degree within the Union before 15 May 1997, they shall consult other fo od 
business operators or food business operator federations in order to gather sufficient 
information.  
6.1 Have other food business operators or 
food business operator federations been 
consulted? Details shall be provided.   
6.2 Is the food currently ava ilable on the 
market within the Union? Details shall 
be provided.   
 
7. Additional information  
7.1 Is there any information that the 
product concerned is used within the 
Union as medicinal product in 
accordance with Directive 
2001/83/EC3?  
7.2 Is there any other information which 
would assist in determining the novel 
food status? Any information which is 
relevant even if not specifically 
requested shall be submitted.   
Section 2: Extracts  
8. Extracts  
8.1 Any further details of the source 
material for the extract, if not provided 
in Section 1.   
8.2 Specification of the extract   
8.3 If extracted from a food source, will the 
intake of any extract components in the 
new food be higher than the intake of 
these components from the original 
food source?   
                                                 
3 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the 
Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).  EN 10   EN Section 3: Foods resulting from a production process not used for food production 
within the Union before 15 May 1997  
9. Production process  
9.1 Detailed description of the production 
process. Include a flow process chart to 
describe the production process.   
9.2 Is the structure or composition of the 
food affecting its nutritional value, 
metabolism or level of undesirable 
substances because of the process by 
which the food has been prepared?  
Details shall be provided.   
9.3 Is the food produced from a source that 
in itself is not normal ly consumed as 
part of the diet?  Details shall be 
provided.