COMMI SSION IMPLEMENTING REGUL ATION (EU) 2018/456 
of 19 March 2018 
on the procedural steps of the consulta tion process for deter mination 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 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 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 Regulation (EU) 2015/2283 lays down basic principles on the procedure for the determination of 
novel food status. Paragraph 1 of that Article requires food business operators to verify whether or not the food 
whic h they intend to place on the Union mark et falls within the scope of that Regulation. 
(3)  In order to determi ne the novel food status of a particular food, a consultation request should be submitte d. The 
Member States should verify the validity of such requests. Theref ore, it is necessar y to establish rules for the 
verification process. 
(4)  Rules should be established in order to ensure that the consultation request for deter mination of novel food 
status provid es all the information necessar y for the evaluation by the Member States. 
(5)  In order to ensure that food business operat ors 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 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 4 of Regulation (EU) 2015/2283 as regar ds the 
procedural steps of the consultation process to determine whether or not a food falls within the scope of that 
Regulation. 
Article 2 
Def initions 
In addition to the definitions laid down in Regulation (EC) No 178/2002 of the European Parliament and of the 
Council (2) and Regulation (EU) 2015/2283, the followi ng definitions shall apply: 
(a)  ‘consultation request’ means a request from a food business operator to a recipient Member State to deter mine the 
novel food status of a particular food; 
(b)  ‘recipient Member State’ means a Member State where the food business operat or intends to place on the mark et 
a particular food for the first time. 20.3.2018 L 77/6 Official Jour nal of the European Union EN     
(1)OJ L 327, 11.12.2015, p. 1. 
(2)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 3 
Submission of a consulta tion request 
1. The food business operat or shall consult the recipient Member State as provided for in Article 4(2) of Regulation 
(EU) 2015/2283 by submitting a consultation request to that Member State. 
2. Where the food business operat or intends to place the food on the mark et simultaneously in several Member 
States, the food business operat or shall submit the consultation request only to one of those Member States. 
Article 4 
Content and presentation of a consultation request 
1. The consultation request shall be submitted electronically to the recipient Member State and shall consist of the 
follo wing: 
(a)  a cover letter; 
(b)  a technical dossier; 
(c)  suppor ting documentation; 
(d)  an explanato ry note clarifying the purpose and relevance of the submitted documentation. 
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 refer red to in paragraph 1(b) shall contain the information necessar y to enable the recipient 
Member State to conclude on the novel food status and shall be draf ted in accordance with the template provided in 
Annex II. 
4. By way of derogation from paragraph 3, an applicant is not required to provid e all the elements refer red to in 
Annex II, provid ed that the applicant has submitt ed verifiable justif ication for the absence of each missing element. 
Article 5 
Procedures for verifying the validity of a consulta tion reques t 
1. The recipient Member State shall without dela y verify whether the consultation request compl ies with the 
requirements of Article 4. 
2. Where the food business operator submits insuff icient information in the consultation request, the recipient 
Member State shall request the food business operat or to provide additional information or make the relevant updat es to 
the consultation request within the time period specif ied by the recipient Member State . 
3. The consultation request shall be considered not valid where: 
(a)  the food business operat or does not provid e requeste d additional information or updated consultation request within 
the period specifi ed by the recipient Member State; 
(b)  the submitted additional information is insuffic ient to conclude that the consultation request is valid. 
4. The recipient Member State shall decide on the validity of the consultation request and without dela y inform the 
food business operat or, the other Member States and the Commission of the decision. Where the consultation request is 
considered not valid, the recipient Member State shall provide the reasons for that conclusion. 
Article 6 
Procedures for evaluating a valid consulta tion request 
1. The recipient Member State shall conclude on the novel food status of a food within 4 months from the date on 
whic h it decided on the validity of the consultation request. 
2. Where the recipient Member State identif ies that it does not have sufficient evidence to decide on the novel food 
status of a food, it may request the food business operator to provid e additional information. The period of that request 
shall be determined together with the food business operat or. 
The recipient Member State may consult the other Member States and the Commission. 20.3.2018 L 77/7 Official Jour nal of the European Union EN     3. Without prejudice to paragraph 4, a request for additional information refer red to in paragraph 2 shall not extend 
the time period refer red to in paragraph 1. 
4. In duly justified cases, the recipient Member State may extend the time period refer red to in paragraph 1 by 
a maximum of 4 months. The recipient Member State shall inform the food business operator , the other Member States 
and the Commission of their decision and shall provide justif ication. 
5. On concluding on the novel food status of a food, the recipient Member State shall without dela y notify the food 
business operator , the other Member States and the Commission of the decision and shall provid e justification in 
accordance with Article 7 of this Regulation. 
Article 7 
Informa tion on the novel food status and publication 
1. The notifi cation refer red to in Article 6(5) of this Regulation shall include the follo wing: 
(a)  the name and descr iption of the food concer ned; 
(b)  a statement indicating whether the food concer ned is novel, not novel or not novel only in food supplements; 
(c)  reasons justifying the statement referred to in point (b); 
(d)  where the food is novel food, the most appropr iate food categor y under whic h it falls in accordance with 
Article 3(2) of Regulation (EU) 2015/2283. 
2. The Commission shall without dela y make the information on the novel food status publicly available on the 
Commission's website. 
Article 8 
Competent author ities of the Member States 
Member States shall provide the Commission with the contact details of the national compet ent author ities and the 
contact details of the respective contact points designat ed for the purposes of this Regulation by 1 March 2018. 
The Commission shall publish those contact details on the Commission's website by 1 May 2018. 
Article 9 
Conf identiality 
1. Food business operat ors may request the recipient Member State to agree that the disclosure of certain information 
submitted as part of the consultation request needs to benefi t from conf idential treatment where disclosure of such 
information may harm their competiti ve position. 
2. For the purpose of paragraph 1, food business operat ors shall indicate to the recipient Member State the parts of 
the information provi ded that they wish to be treated as conf idential and provide all the necessar y details to substantiate 
their request for conf identiality . 
3. The recipient Member State shall inform the food business operat or of its views on which parts of the information 
are to remain confidential. 
Howe ver, confidentiality shall not apply to the followi ng information: 
(a)  the name and address of the applicant ; 
(b)  the name and descr iption of the food; 
(c)  a summar y of the studies submitte d by the applicant ; 
(d)  where appropr iate, the analysis method(s). 
4. In case of the consultation of other Member States pursuant to Article 6(2), second subparagraph, the recipient 
Member State shall inform the Commission and the Member States about its views on confidentiality of the consultation 
request. 20.3.2018 L 77/8 Official Jour nal of the European Union EN     5. After being informed pursuant to paragraph 3, the food business operat or may withdra w its consultation request 
within 3 weeks during which the confidentiality of the information provid ed shall be obser ved. 
6. The Commission and the Member States shall take necessar y measures to ensure appropr iate conf identiality of the 
information refer red to in paragraphs 3 and received by them under this Regulation, excep t for information which is 
required to be made public in order to prote ct human health. 
7. Where a food business operator withdra ws or has withdrawn its consultation request in accordance with 
paragraph 5, neither the Commission nor the Member States shall disclose information for whic h conf identiality was 
request ed by the food business operat or pursuant to paragraph 1. 
8. The application of paragraphs 1 to 7 shall not affect the exchang e of information between the Commission and 
the Member States necessar y to consider the consultation requests submitted under this Regulation. 
Article 10 
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, 19 Marc h 2018. 
For the Commission 
The President 
Jean-Claude JUNCK ER  20.3.2018 L 77/9 Official Jour nal of the European Union EN     ANNEX I 
TEMPL ATE COVER LETTER ACCOMP ANYING A CONSUL TATION REQUEST FOR DETERMINA TION OF THE NOVEL 
FOOD STATUS 
Competent author ity of the Member State 
Date: .................................................. 
Subject: Consultation request for deter mination of the novel food status of .................................................................. 
.................................................................................................................................................................................. 
The Food business operat or(s)/consulting party: 
Com pany: ................................................................................................................................................................. 
Address: .................................................................................................................................................................... 
Telephone: ................................................................................................................................................................. 
Email: ....................................................................................................................................................................... 
Contact person: ......................................................................................................................................................... 
submit(s) the present consultation request in order to deter mine the novel food status of .............................................. 
Yours sincerely , 
Signature ............................................ 
Enclosures: 
Techn ical dossier 
Documents in suppor t of the consultation request 
Explanator y note  20.3.2018 L 77/10 Official Jour nal of the European Union EN     ANNEX II 
TEMPL ATE TECHNIC AL DOSSIER 
The connection between the differ ent pieces of information shall be explained in an explanato ry note . In particular , as 
regar ds the evidence present ed to suppor t a human consum ption to a signif icant 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 determination of the novel food status, those parts shall be 
highlight ed. 
For all foods, Section 1 must be compl eted. 
For extracts, in addition to Section 1, Section 2 must be complet ed. 
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 compl eted. 
Section 1: All foods (for foods resulting from a production process not used for food production 
within the Union before 15 May 1997 only points 1 to 3 and point 7) 
1.  Descr iption of the food 
1.1  Name of the food  
1.2  Detailed descr iption of the food, including information whether the food consists of 
engineered nanomater ials as referred to in points (a)(viii) and (ix) of Article 3(2) of 
Regulation (EU) 2015/2283 (1)  
1.3  Proposed catego ry of the novel food in accordance with Article 3(2)(a) of Regulation 
(EU) 2015/2283, where applicable   
2.  Further character isation of the food and/or source of the food (where relevant) 
A.Org anisms (microorgani sms, fungi, algae, plants, animals) 
2.1  Taxonomic name (full Latin name with author name)  
2.2  Synon yms, other names, where applicable  
2.3  Specific ation of whic h part of the organism the use for human consum ption before 
15 May 1997 within the Union refers to, where applicable  
2.4  Specific ation about purity/concentration  
B.Chemical substances 
2.5  CAS number(s) (if this has been attribut ed)  
2.6  Chemical name(s) according to IUPAC nomenclature rules  
2.7  Synon yms, trade name, common name, where applicable  
2.8  Molecular and structural formulae  
2.9  Specific ation about purity/concentration   20.3.2018 L 77/11 Official Jour nal of the European Union EN     3.  Conditions of use 
3.1  How is the food intended to be used?  
3.2  Type of product(s) in whic h the food is intended to be used  
3.3  Level/concentration (or range of levels) in the product(s) in which the food is intende d 
to be used   
4.  Production process 
4.1  Detailed descr iption of the production process. Include a flow process char t to descr ibe 
the production process.   
5.  History of human consumption of the food within the Union before 15 May 1997 
5.1  To what exte nt was the food consumed to a signif icant degree throughout the Union 
before 15 May 1997? Details shall be provi ded.  
5.2  To what extent was the food consumed to a significant degree in one Member State 
before 15 May 1997? Details shall be provi ded.  
5.3  Was the food consumed only regionally/on a small local scale in the Union before 
15 May 1997? Details shall be provid ed.  
5.4  Was the food available before 15 May 1997 in the Union as an ingredient designed for 
specifi c targe t population (e.g. food for a special medical purpose)? Details shall be 
provid ed.   
6.  Consult ations on availability in the Union 
Where food business operators are unsure whether the information in their possession is suffi cient to prove that the 
food concer ned has been used for human consum ption to a signif icant degree within the Union before 15 May 1997, 
they may consult other food business operators or food business operat or federations in order to gather sufficient 
information. 
6.1  Have other food business operators or food business operator federations been 
consulte d? Details should be provided.  
6.2  Is the food currently available on the mark et within the Union? Details should be 
provid ed.   
7.  Additional infor mation 
7.1 Is there any information that the product concer ned is used within the Union as medi ­
cinal product in accordance with Directive 2001/83/EC (2)?  
7.2  Is there any other information which would assist in determining the novel food status? 
Any information which is relevant even if not specif ically requested shall be submitte d.   20.3.2018 L 77/12 Official Jour nal of the European Union EN     Section 2: Extracts 
8.  Extracts 
8.1  Any further details of the source mate rial for the extract, if not provided in Section 1. 
Details shall be provid ed.  
8.2  Specific ation of the extract. Details shall be provided.  
8.3  If extracted from a food source, will the intake of any extract compo nents in the food 
be higher than the intake of these components in the food source? Details shall be 
provid ed.   
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 descr iption of the production process. Include a flow process char t to descr ibe 
the production process.  
9.2  Is the structure or compo sition of the food affecting its nutr itional 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 normally consumed as part of 
the diet? Details shall be provided.   
(1)  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 (OJ L 327, 11.12.2015, p. 1). 
(2)  Directive 2001/83/EC of the European Parliament and of the Council of 6 Novem ber 2001 on the Community code relating to 
medicinal products for human use (OJ L 311, 28.11.2001, p. 67).                                                                                                                                                                   20.3.2018 L 77/13 Official Jour nal of the European Union EN