I 
(Legislativ e acts) 
REGUL ATIONS 
REGUL ATION (EU) 2015/2283 OF THE EUR OPEAN 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 
(Text with EEA relevance) 
THE EUR OPEAN PARLIAMENT AND THE COUNCIL OF THE EUR OPEAN UNION, 
Having regar d to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, 
Having regar d to the proposal from the European Commission, 
After transmission of the draf t legislative act to the national parliaments, 
Having regar d to the opinion of the European Economic and Social Committ ee (1), 
Acting in accordance with the ordinar y legislative procedure (2), 
Whereas: 
(1) The free movement of safe and wholesome food is an essential aspect of the internal mark et and contr ibut es sig­
nificantly to the health and well-being of citizens, and to their social and economic interests. Differen ces between 
national laws concer ning the safety assessment and author isation of novel foods may hinder the free movement 
of such food, thereby creating legal uncer tainty and unfai r conditions of competiti on. 
(2)  A high level of prote ction of human health and of consumers' interests and the effective functioning of the 
internal mark et needs to be assured in the pursuit of Union food policies, whilst ensur ing transparency . A high 
level of protection and improvement of the quality of the environment are among the objectives of the Union as 
established in the Treaty on European Union (TEU). It is important that all relevant Union legislation, including 
this Regulation, take those objectives into account. 
(3)  Union legislation applicable to food is also applicable to novel foods placed on the market within the Union, 
including novel foods imported from third countr ies. 
(4)  The Union's rules on novel foods were established by Regulation (EC) No 258/97 of the European Parliament and 
of the Council (3) and by Commission Regulation (EC) No 1852/2001 (4). Those rules need to be updat ed 11.12.2015 L 327/1 Official Jour nal of the European Union EN     
(1)OJ C 311, 12.9.2014, p. 73. 
(2)Position of the European Parliament of 28 October 2015 (not yet published in the Offi cial Jour nal) and decision of the Council of 
16 November 2015. 
(3)Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 Januar y 1997 concer ning novel foods and novel food 
ingredients (OJ L 43, 14.2.1997, p. 1). 
(4)Commission Regulation (EC) No 1852/2001 of 20 September 2001 laying down detailed rules for making certain information avai lable 
to the public and for the protection of information submitted pursuant to European Parliament and Council Regulation (EC) No 258/97 
(OJ L 253, 21.9.2001, p. 17). to simp lify the current author isation procedures and to take account of recent developments in Union law and 
technological progress. Regulations (EC) No 258/97 and (EC) No 1852/2001 should be repealed and replaced by 
this Regulation. 
(5)  Food intended to be used for technological purposes and genetically modified food whic h is already covered by 
other Union acts should not fall within the scope of this Regulation. Theref ore, genetically modifi ed food falling 
within the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council (1), food 
enzymes falling within the scope of Regulation (EC) No 1332/2008 of the European Parliament and of the 
Council (2), food used solely as additives falling within the scope of Regulation (EC) No 1333/2008 of the 
European Parliament and of the Council (3), food flavouri ngs falling within the scope of Regulation (EC) 
No 1334/2008 of the European Parliament and of the Council (4) and extraction solvents falling within the scope 
of Directive 2009/32/EC of the European Parliament and of the Council (5) should be excl uded from the scope of 
this Regulation. 
(6)  The existing definition of novel food in Regulation (EC) No 258/97 should be clarified and updat ed with a 
reference to the general definition of food provided for in Regulation (EC) No 178/2002 of the European 
Parliament and of the Council (6). 
(7)  In order to ensure continuity with the rules laid down in Regulation (EC) No 258/97, one of the criteria for food 
to be considered a novel food should continue to be the absence of use for human consum ption to a signif icant 
degree within the Union before the date of entr y into force of that Regulation, namely 15 May 1997. Use within 
the Union should also refer to a use in the Member States irrespective of the dates of their accession. 
(8)  The scope of this Regulation should, in principle, remain the same as the scope of Regulation (EC) No 258/97. 
However , on the basis of scientifi c and technological developments that have occur red since 1997, it is 
appropr iate to review , clarify and update the catego ries of food which constitute novel foods. Those cate gories 
should cover whole insects and their parts. There should be, inter alia, cate gories for food with a new or 
intenti onally modifi ed molecular structure, as well as for food from cell culture or tissue culture derived from 
animals, plants, microorg anisms, fungi or algae, for food from microorg anisms, fungi or algae and for food from 
mate rial of mineral origin. There should also be a categor y covering food from plants obtained by non-traditional 
propagati ng practices where those practices give rise to signif icant change s in the compo sition or structure of the 
food affecting its nutr itional value, metabolism or level of undesirable substances. The definition of novel food 
may also cover food consisting of certain micelles or liposomes. 
(9)  Emerging technologies in food production processes may have an impact on food and thereby on food safety . 
Theref ore, this Regulation should further specify that a food should be considered a novel food where it results 
from a production process not used for food production within the Union before 15 May 1997, whic h gives rise 
to signif icant chang es in the compo sition or structure of a food affecting its nutr itional value, metabolism or level 
of undesirable substances. 
(10)  To ensure a high level of prot ection of human health and consumers' interests, food consisting of engineered 
nanomat erials should also be considered a novel food under this Regulation. The term ‘engineered nanomater ial’ 11.12.2015 L 327/2 Official Jour nal of the European Union EN     
(1)Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 Sept ember 2003 on genetically modified food and 
feed (OJ L 268, 18.10.2003, p. 1). 
(2)Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes and amending 
Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and 
Regulation (EC) No 258/97 (OJ L 354, 31.12.2008, p. 7). 
(3)Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 
31.12.2008, p. 16). 
(4)Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food 
ingredients with flavouring proper ties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) 
No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (OJ L 354, 31.12.2008, p. 34). 
(5)Directive 2009/32/EC of the European Parliament and of the Council of 23 Apr il 2009 on the appro ximation of the laws of the Member 
States on extraction solvents used in the production of foodstuffs and food ingredients (OJ L 141, 6.6.2009, p. 3). 
(6)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 Safety Autho rity and laying down procedures in matters of food safety 
(OJ L 31, 1.2.2002, p. 1). is currently defined in Regulation (EU) No 1169/2011 of the European Parliament and of the Council (1). For 
consiste ncy and coherence purposes, it is impor tant to ensure a sing le definit ion of engineered nanomater ial in 
the area of food law. The appropr iate legislative framew ork for including such a definition is this Regulation. 
According ly, the definit ion of engineered nanomat erial, along with the related conferr al of deleg ated powers to 
the Commission, should be delet ed from Regulation (EU) No 1169/2011 and replaced by a reference to the 
definition set out in this Regulation. Further more, this Regulation should provide that the Commission should, 
by means of delegat ed acts, adjust and adapt the definition of engineered nanomat erial set out in this Regulation 
to technical and scientifi c progress or to definit ions agreed at international level. 
(11)  Vitamins, minerals and other substances intended to be used in food supplements in accordance with Directive 
2002/46/EC of the European Parliament and of the Council (2) and Regulation (EC) No 1925/2006 of the 
European Parliament and of the Council (3) or in infant formula and follow-on formulae, processed cereal-based 
food and baby food for infants and young children, food for special medical purposes, and total diet replacement 
for weight control in accordance with Regulation (EU) No 609/2013 of the European Parliament and of the 
Council (4), should also be assessed in accordance with the rules laid down in this Regulation when they fall 
within the definition of novel food set out therein. 
(12)  Where vitamins, minerals or other substances used in accordance with Directive 2002/46/EC, Regulation (EC) 
No 1925/2006 or Regulation (EU) No 609/2013 result from a production process not used for food production 
within the Union before 15 May 1997, which gives rise to signif icant changes in the compo sition or structure of 
a food, affecting its nutr itional value, metabolism or level of undesirable substances, or where those vitamins, 
minerals or other substances contain or consist of engineered nanomat erials, they should also be considered 
novel foods under this Regulation and should be re-assessed first in accordance with this Regulation and 
subsequently in accordance with the relevant specif ic legislation. 
(13)  A food used before 15 May 1997 excl usively as, or in, a food supplement, as defined in Directive 2002/46/EC, 
should be permitted to be placed on the mark et within the Union after that date for the same use, as it should 
not be considered to be a novel food for the purposes of this Regulation. However , that use as, or in, a food 
supplement should not be taken into account for the assessment of whether the food was used for human 
consum ption to a signif icant degree within the Union before 15 May 1997. Theref ore, uses of the food 
concer ned other than as, or in, a food supplement should be subject to this Regulation. 
(14)  Food from animal clones has been regulate d under Regulation (EC) No 258/97. It is crucial that no legal 
ambiguity should emerg e as regards the placing on the mark et of food from animal clones during the transitional 
period after the end of the application of Regulation (EC) No 258/97. Theref ore, until specifi c legislation on food 
from animal clones enters into force, food from animal clones should fall under the scope of this Regulation as 
food from animals obtained by non-traditional breeding practices and should be appropr iately labelled for the 
final consumer in accordance with the Union legislation in force. 
(15)  The placing on the market within the Union of traditional foods from third countr ies should be facilitated where 
the histo ry of safe food use in a third countr y has been demonstrated. Those foods should have been consumed 
in at least one third countr y for at least 25 years as a part of the customary diet of a signif icant number of 
people. The histor y of safe food use should not include non-f ood uses or uses not relat ed to normal diets. 11.12.2015 L 327/3 Official Jour nal of the European Union EN     
(1)Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food 
information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the 
Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, 
Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and 
Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18). 
(2)Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the appro ximation of the laws of the Member 
States relating to food supplements (OJ L 183, 12.7.2002, p. 51). 
(3)Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and 
minerals and of certain other substances to foods (OJ L 404, 30.12.2006, p. 26). 
(4)Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young 
children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, 
Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and 
of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35). (16)  Foods from third countr ies whic h are rega rded as novel foods in the Union should only be considered as 
traditional foods from third countr ies when they are derived from primar y production as defined in Regulation 
(EC) No 178/2002, regardless of whether or not they are processed or unprocessed foods. 
(17)  Food produced excl usively from food ingredients that do not fall within the scope of this Regulation, in 
particular by changing the ingredients of the food or their amount, should not be considered to be a novel food. 
However , modifi cations to a food ingredient that has not yet been used for human consum ption to a significant 
degree within the Union, should fall within the scope of this Regulation. 
(18)  Directive 2001/83/EC of the European Parliament and of the Council (1) applies in cases where a product, taking 
into account all its character istics, may fall both within the definition of ‘medicinal product’ as laid down in that 
Directive and within the definition of a product covered by this Regulation. In that respect, where a Member 
State establishes in accordance with Directive 2001/83/EC that a product is a medicinal product, it may restr ict 
the placing on the market of that product in accordance with Union law. Moreo ver, medicinal products are 
excl uded from the definition of food as laid down in Regulation (EC) No 178/2002 and should theref ore not fall 
within the scope of this Regulation. 
(19)  The determi nation of whether a food was used for human consum ption to a signif icant degree within the Union 
before 15 May 1997 should be based on information submitted by food business operat ors and, where 
appropr iate, suppor ted by other information available in Member State s. Food business operat ors should consult 
Member State s if they are unsure of the status of the food whic h they intend to place on the market. Where there 
is no information on human consum ption before 15 May 1997 or the information available is insuffi cient, a 
simple and transparent procedure, involving the Commission, the Member States and food business operat ors, 
should be established for collecting such information. 
(20)  Novel foods should be author ised and used only if they fulfil the criteria laid down in this Regulation. Novel 
foods should be safe and if their safet y cannot be assessed and scientifi c uncer tainty persists, the precautionar y 
principle may be applied. Their use should not mislead the consumer . Theref ore, where a novel food is intended 
to replace another food, it should not differ from that food in a way that would be nutr itionally less 
advantag eous for the consumer . 
(21)  Novel foods should not be placed on the mark et or used in food for human consump tion unless they are 
included in a Union list of novel foods author ised to be placed on the market within the Union (‘the Union list’). 
Theref ore, it is appropr iate to establish, by means of an implementing act, the Union list by including in that list 
the novel foods already author ised or notified in accordance with Regulation (EC) No 258/97, including any 
existing author isation conditions. That list should be transparent and easily accessible. 
(22)  It is appropr iate to author ise a novel food by updating the Union list subject to the criteria and procedures laid 
down in this Regulation. A procedure that is efficient, time-limited and transparent should be put in place. As 
regar ds traditional foods from third countr ies having a histor y of safe food use, the applicants should be able to 
opt for a faster and simplified procedure to updat e the Union list if no duly reasoned safety objections are 
expressed. 
(23)  Criteria for the assessment of the safet y risks arising from novel foods should also be clearly defined and laid 
down. In order to ensure the harmonised scientific assessment of novel foods, such assessments should be carried 
out by the European Food Safet y Authority (‘the Author ity’). Under the procedure for author ising a novel food 
and updating the Union list, the Author ity should be request ed to give its opinion if the update is liable to have 
an effect on human health. In its opinion, the Authority should assess, inter alia, all the charact eristics of the 
novel food that may pose a safety risk to human health and consider possible effects on vulnerable groups of the 
population. In particular , the Author ity should verify that, where a novel food consists of engineered nanoma ­
terials, the most up-to -date test methods are used to assess their safety . 11.12.2015 L 327/4 Official Jour nal of the European Union EN     
(1)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). (24)  The Commission and the Author ity should be subject to deadlines to guarant ee a smooth processing of 
applications. However , in certain cases, the Commission and the Author ity should have the right to extend those 
deadlines. 
(25)  The applicant may be request ed by the Author ity or by the Commission to provide additional information for the 
purposes of risk assessment or risk manag ement respectively . In case the applicant fails to provide the additional 
information, as required, within the period set by the Author ity or by the Commission after consulting the 
applicant, lack of such information may have consequences for the opinion of the Author ity or for a possible 
author isation and update of the Union list. 
(26)  As regards the possible use of nanomater ials for food use, the Auth ority considered in its opinion of 6 Apr il 
2011 on Guidance on the risk assessment of the application of nanoscience and nanotec hnologies in the food 
and feed chain that limited information is available in relation to aspects of nanoto xicokinetics and toxicology of 
engineered nanomat erials and that existing toxicity testin g methods may need methodological modifications. The 
Org anisation for Economic Cooperation and Development Council Recommendation of 19 Sept ember 2013 on 
the Safety Testing and Assessment of Manufactured Nanomat erials concluded that the approach es for the testing 
and assessment of traditional chemicals are, in general, appropr iate for assessing the safety of nanomat erials, but 
may have to be adapt ed to the specificities of nanomat erials. In order to better assess the safety of nanomate rials 
for food use and in order to address the current gaps in toxicological kno wledge and measurement 
methodologies, test methods, including non-animal tests, which take into account specifi c charact eristics of 
engineered nanomat erials may be needed. 
(27)  When test methods are applied to nanomater ials, an explanation should be provided by the applicant of their 
scientific appropr iatene ss for nanomat erials and, where applicable, of the technical adapt ations and adjustments 
that have been made in order to respond to the specific character istics of those mat erials. 
(28)  When a novel food is author ised and included in the Union list, the Commission should have the power to 
introduce post-market monitoring requirements to monitor the use of the author ised novel food to ensure that 
the use is within safe limits as established in the risk assessment by the Author ity. Post-mark et monitori ng 
requirements may theref ore be justif ied by the necessity to gather information on the actual mark eting of the 
food. In any event, food business operat ors should inform the Commission of any new relevant information 
regar ding the safety of the food they have placed on the mark et. 
(29) New technologies and inno vations in food production should be encourag ed as they could reduce the environ ­
mental impact of food production, enhance food secur ity and bring benefi ts to consumers as long as the high 
level of consumer prot ection is ensured. 
(30)  Under specific circumstances, in order to stimulate research and development within the agri-food industr y, and 
thus inno vation, it is appropr iate to prot ect the investment made by the applicants in gather ing the information 
and data provided in suppor t of an application for a novel food made in accordance with this Regulation. The 
newly developed scientifi c evidence and propr ietar y data provided in suppor t of an application for inclusion of a 
novel food in the Union list should be protect ed. Those data and information should, for a limited period of 
time, not be used to the benefit of a subsequent applicant, without the agreement of the initial applicant. The 
prot ection of scientific data provided by an applicant should not prevent other applicants from seeking the 
inclusion of a novel food in the Union list on the basis of their own scientific data or by referring to the 
prot ected data with the agreement of the initial applicant. However , the overall five-ye ar period of data protection 
whic h has been grant ed to the initial applicant should not be extended due to the granting of data protection to 
subsequent applicants. 
(31)  In cases where an applicant requests the prot ection of scientific data relating to the same food in accordance with 
this Regulation and with Regulation (EC) No 1924/2006 of the European Parliament and of the Council (1), it 
should be possible for the respective data prot ection periods to run concur rently . Theref ore, provision should be 
made for staying, on request by the applicant, the author isation procedure for a novel food. 11.12.2015 L 327/5 Official Jour nal of the European Union EN     
(1)Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutr ition and health claims 
made on foods (OJ L 404, 30.12.2006, p. 9). (32)  In accordance with Directive 2010/63/EU of the European Parliament and of the Council (1), tests on animals 
should be replaced, reduced or refined. Theref ore, within the scope of this Regulation, duplication of animal 
testing should be avoided, where possible. Pursuing this goal could reduce possible animal welf are and ethical 
concer ns with regard to novel food applications. 
(33)  Novel foods are subject to the general labelling requirements laid down in Regulation (EU) No 1169/2011 and 
other relevant labelling requirements in Union food law. In certain cases it may be necessar y to provide for 
additional labelling information, in particular regarding the descr iption of the food, its source, its compo sition or 
its conditions of intended use to ensure that consumers are suffi ciently informed of the nature and safet y of the 
novel food, particularly with regar d to vulnerable groups of the population. 
(34)  Mate rials and articles intended to come into contact with novel foods are subject to Regulation (EC) 
No 1935/2004 of the European Parliament and of the Council (2) and the specific measures adopt ed thereunder . 
(35)  In line with the Commission's better regulation policy , the Commission should carry out an ex-post evaluation of 
the implemen tation of this Regulation, addressing in particular the new procedures on traditional foods from 
third countr ies. 
(36)  For those applications which have been submitted under Regulation (EC) No 258/97 and for which a final 
decision has not been take n before the date of application of this Regulation risk assessment and author isation 
procedures should be concluded in accordance with this Regulation. Further more, a food not falling within the 
scope of Regulation (EC) No 258/97, which was lawfully placed on the market before the date of application of 
this Regulation and which falls under the scope of this Regulation, should in principle be allowed to continue to 
be placed on the mark et until the risk assessment and author isation procedures under this Regulation have been 
concluded. Theref ore, transitional provisions should be laid down to ensure a smooth transition to the rules of 
this Regulation. 
(37)  This Regulation respects the fundamental rights and obser ves the principles recognised, in particular , by the 
Char ter of Fundamental Rights of the European Union. 
(38)  The Member State s should lay down rules on penalties applicable to infringements of this Regulation and should 
take all measures necessar y to ensure that they are implemented . Those penalties should be effective, propor ­
tionate and dissuasive. 
(39)  In order to achi eve the objectives of this Regulation, the power to adopt delegat ed acts in accordance with 
Article 290 of the Treaty on the Functioning of the European Union should be delega ted to the Commission in 
respect of the adjustment and adaptation of the definition of engineered nanomate rial to technical and scientific 
progress or to definitions agreed at intern ational level. It is of particular importance that the Commission carry 
out appropr iate consultations during its preparat ory work, including at exper t level. The Commission, when 
prepar ing and drawing up delegat ed acts, should ensure simultaneous, timely and appropr iate transmission of 
relevant documents to the European Parliament and to the Council. 
(40)  In order to ensure unif orm conditions for the implementation of this Regulation with regar d to updating the 
Union list concer ning the adding of a traditional food from a third countr y where no reasoned safety objections 
have been expressed, implementing powers should be conferr ed on the Commission. 
(41)  The advisor y procedure should be used for the adoption of the implementing act establishing the initial Union 
list given that it will concer n only novel foods that have already been assessed for their safety , have been legally 
produced and mark eted in the Union and have not given rise to health concer ns in the past. The examination 
procedure should be used for the adoption of implementing acts in all other cases. 11.12.2015 L 327/6 Official Jour nal of the European Union EN     
(1)Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for 
scientific purposes (OJ L 276, 20.10.2010, p. 33). 
(2)Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on material s and articles intended to 
come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4). (42)  Since the objectives of this Regulation, in particular the laying down of rules for the placing of novel foods on 
the market within the Union, cannot be suffi ciently achieve d by the Member State s but can rather be bette r 
achi eved at Union level, the Union may adop t measures, in accordance with the principle of subsidiar ity as set 
out in Article 5 TEU. In accordance with the principle of propor tionality , as set out in that Article, this 
Regulation does not go beyond what is necessar y in order to achieve those objectives, 
HAVE ADOPTED THIS REGUL ATION: 
CHAPTER I 
SUBJECT MA TTER, SCOPE AND DEFINITIONS 
Article 1 
Subject matter and pur pose 
1. This Regulation lays down rules for the placing of novel foods on the mark et within the Union. 
2. The purpose of this Regulation is to ensure the effective functioning of the internal market while providing a high 
level of prote ction of human health and consumers' interests. 
Article 2 
Scope 
1. This Regulation applies to the placing of novel foods on the mark et within the Union. 
2. This Regulation does not apply to: 
(a)  genetically modifi ed foods falling within the scope of Regulation (EC) No 1829/2003; 
(b)  foods when and in so far as they are used as: 
(i)  food enzymes falling within the scope of Regulation (EC) No 1332/2008; 
(ii)  food additives falling within the scope of Regulation (EC) No 1333/2008; 
(iii)  food flavouri ngs falling within the scope of Regulation (EC) No 1334/2008; 
(iv)  extraction solvents used or intended to be used in the production of foodstuffs or food ingredients and falling 
within the scope of Directive 2009/32/EC. 
Article 3 
Def initions 
1. For the purposes of this Regulation, the definitions laid down in Articles 2 and 3 of Regulation (EC) No 178/2002 
apply . 
2. The following definitions also apply: 
(a)  ‘novel food’ means any food that was not used for human consum ption to a signif icant degree within the Union 
before 15 May 1997, irrespective of the dates of accession of Member States to the Union, and that falls under at 
least one of the following categor ies: 
(i)  food with a new or intenti onally modifi ed molecular structure, where that structure was not used as, or in, a 
food within the Union before 15 May 1997; 
(ii)  food consisting of, isolate d from or produced from microorganisms, fungi or algae; 11.12.2015 L 327/7 Official Jour nal of the European Union EN     (iii)  food consisting of, isolate d from or produced from mater ial of mineral origin; 
(iv)  food consisting of, isolated from or produced from plants or their parts, excep t when the food has a histo ry of 
safe food use within the Union and is consisting of, isolate d from or produced from a plant or a variety of the 
same species obtained by: 
—  traditional propagating practices whic h have been used for food production within the Union before 
15 May 1997; or 
—  non-traditional propagati ng practices whic h have not been used for food production within the Union 
before 15 May 1997, where those practices do not give rise to significant chang es in the compo sition or 
structure of the food affecting its nutr itional value, metabolism or level of undesirable substances; 
(v)  food consisting of, isolat ed from or produced from animals or their parts, excep t for animals obtained by 
traditional breeding practices whic h have been used for food production within the Union before 15 May 1997 
and the food from those animals has a histo ry of safe food use within the Union; 
(vi)  food consisting of, isolate d from or produced from cell culture or tissue culture derived from animals, plants, 
micro-organis ms, fungi or algae; 
(vii)  food resulting from a production process not used for food production within the Union before 15 May 1997, 
which gives rise to significant chang es in the compo sition or structure of a food, affecting its nutr itional value, 
metabolism or level of undesirable substances; 
(viii)  food consisting of engineered nanomater ials as defined in point (f) of this paragraph; 
(ix)  vitamins, minerals and other substances used in accordance with Directive 2002/46/EC, Regulation (EC) 
No 1925/2006 or Regulation (EU) No 609/2013, where: 
—  a production process not used for food production within the Union before 15 May 1997 has been applied 
as refer red to in point (a) (vii) of this paragraph; or 
—  they contain or consist of engineered nanomater ials as defined in point (f) of this paragraph; 
(x)  food used excl usively in food supplements within the Union before 15 May 1997, where it is intended to be 
used in foods other than food supplements as defined in point (a) of Article 2 of Directive 2002/46/EC; 
(b)  ‘history of safe food use in a third countr y’ means that the safety of the food in question has been conf irmed with 
compo sitional data and from exper ience of continued use for at least 25 years in the customary diet of a signif icant 
number of people in at least one third countr y, prior to a notifi cation refer red to in Article 14; 
(c)  ‘traditional food from a third countr y’ means novel food as defined in point (a) of this paragraph, other than novel 
food as refer red to in points (a) (i), (iii), (vii), (viii), (ix) and (x) thereof whic h is derived from primar y production as 
defined in point 17 of Article 3 of Regulation (EC) No 178/2002 with a histo ry of safe food use in a third countr y; 
(d)  ‘the applicant ’ means the Member State, the third countr y or the interest ed party, whic h may represent several 
inter ested parties and has submitt ed to the Commission an application in accordance with Article 10 or 16 or a 
notificati on in accordance with Article 14; 
(e)  ‘valid’ in respect to an application or a notifi cation means an application or a notification whic h falls within the 
scope of this Regulation and contains the information required for risk assessment and author isation procedure; 11.12.2015 L 327/8 Official Jour nal of the European Union EN     (f)  ‘engineered nanomat erial’ means any intentionally produced mater ial that has one or more dimensions of the order 
of 100 nm or less or that is compo sed of discrete functional parts, either internally or at the surface, man y of which 
have one or more dimensions of the order of 100 nm or less, including structures, agglomerat es or aggreg ates, 
which may have a size above the order of 100 nm but retain proper ties that are charact eristic of the nanoscale. 
Proper ties that are charact eristic of the nanoscale include: 
(i)  those related to the large specifi c surface area of the mater ials considered; and/or 
(ii)  specifi c physico-chem ical proper ties that are diffe rent from those of the non-nanof orm of the same mat erial. 
Article 4 
Procedure for deter mination of novel food status 
1. Food business operat ors shall verify whether or not the food which they intend to place on the market within the 
Union falls within the scope of this Regulation. 
2. Where they are unsure whether or not a food which they intend to place on the market within the Union falls 
within the scope of this Regulation, food business operators shall consult the Member State where they first intend to 
place the novel food. Food business operat ors shall provide the necessar y information to the Member State to enable it 
to determine whether or not a food falls within the scope of this Regulation. 
3. In order to determi ne whether or not a food falls within the scope of this Regulation, Member States may consult 
the other Member States and the Commission. 
4. The Commission shall, by means of imple menting acts, specify the procedural steps of the consultation process 
provided for in paragraphs 2 and 3 of this Article, including deadlines and the means to make the status publicly 
available. Those implementing acts shall be adopt ed in accordance with the examination procedure refer red to in 
Article 30(3). 
Article 5 
Implementing power concer ning the definition of novel food 
The Commission may decide, on its own initiative or upon a request by a Member State , by means of implementing 
acts, whether or not a particular food falls within the definition of novel food, as laid down in point (a) of Article 3(2). 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 30(3). 
CHA PTER II 
REQUIREMENTS FOR PLACING NOVEL FOODS ON THE MARKET WITHIN THE UNION 
Article 6 
Union list of author ised novel foods 
1. The Commission shall establish and update a Union list of novel foods author ised to be placed on the mark et 
within the Union in accordance with Articles 7, 8 and 9 (‘the Union list’). 
2. Only novel foods author ised and included in the Union list may be placed on the mark et within the Union as 
such, or used in or on foods, in accordance with the conditions of use and the labelling requirements specified therein. 11.12.2015 L 327/9 Official Jour nal of the European Union EN     Article 7 
General conditions for inclusion of novel foods in the Union list 
The Commission shall only author ise and include a novel food in the Union list if it compl ies with the following 
conditions: 
(a)  the food does not, on the basis of the scientifi c evidence available, pose a safety risk to human health; 
(b)  the food's intended use does not mislead the consumer , especially when the food is intended to replace another food 
and there is a signif icant chang e in the nutr itional value; 
(c)  where the food is intended to replace another food, it does not differ from that food in such a way that its normal 
consump tion would be nutr itionally disadvantage ous for the consumer . 
Article 8 
Initial establishment of the Union list 
By 1 Januar y 2018 the Commission shall, by means of an implementing act, establish the Union list by including in it 
the novel foods author ised or notifi ed under Article 4, 5 or 7 of Regulation (EC) No 258/97, including any existing auth ­
orisation conditions. 
That implementing act shall be adop ted in accordance with the advisor y procedure refer red to in Article 30(2). 
Article 9 
Content and updating of the Union list 
1. The Commission shall author ise a novel food and update the Union list in accordance with the rules laid down in: 
(a)  Articles 10, 11 and 12 and, where applicable, Article 27; or 
(b)  Articles 14 to 19. 
2. The author isation of a novel food and updating of the Union list provided for in paragraph 1 shall consist of one 
of the following: 
(a)  adding a novel food to the Union list; 
(b)  remo ving a novel food from the Union list; 
(c)  adding, remo ving or changing the specific ations, conditions of use, additional specifi c labelling requirements or post- 
mark et monitoring requirements associated with the inclusion of a novel food in the Union list. 
3. The entr y for a novel food in the Union list provided for in paragraph 2 shall include the specifi cation of the novel 
food and, where appropr iate: 
(a)  the conditions under which the novel food may be used, including in particular any requirements necessar y to avoid 
possible adverse effects on particular groups of the population, the exceed ing of maximum intak e levels and risks in 
case of exces sive consum ption; 
(b)  additional specific labelling requirements to inform the final consumer of any specifi c charact eristic or food 
proper ty, such as the composition, nutr itional value or nutr itional effects and intended use of the food, whic h 
renders a novel food no long er equivalent to an existing food or of implications for the health of specific groups of 
the population; 
(c)  post-market monit oring requirements in accordance with Article 24. 11.12.2015 L 327/10 Official Jour nal of the European Union EN     CHAPTER III 
AUTHORISA TION PROCEDURES FOR A NOVEL FOOD 
SECTION I 
Gener al rules 
Article 10 
Procedure for author ising the placing on the market within the Union of a novel food and updating the 
Union list 
1. The procedure for author ising the placing on the mark et within the Union of a novel food and updating of the 
Union list provided for in Article 9 shall start either on the Commission's initiative or following an application to the 
Commission by an applicant. The Commission shall mak e the application available to the Member States without dela y. 
The Commission shall make the summar y of the application, based on the information referred to in points (a), (b) 
and (e) of paragraph 2 of this Article, publicly available. 
2. The application for an author isation shall include: 
(a)  the name and address of the applicant ; 
(b)  the name and descr iption of the novel food; 
(c)  the descr iption of the production process(es); 
(d)  the detailed compo sition of the novel food; 
(e)  scientific evidence demonstrating that the novel food does not pose a safety risk to human health; 
(f)  where appropr iate, the analysis method(s); 
(g)  a proposal for the conditions of intended use and for specifi c labelling requirements whic h do not mislead the 
consumer or a verifiable justification why those elements are not necessar y. 
3. Upon request by the Commission, the European Food Safety Auth ority (‘the Author ity’) shall give its opinion as to 
whether the updat e is liable to have an effect on human health. 
4. When test methods are applied to engineered nanomate rials as referred to in points (a) (viii) and (ix) of 
Article 3(2), an explanation shall be provided by the applicants of their scientifi c appropr iateness for nanomat erials and, 
where applicable, of the technical adaptations or adjustments that have been made in order to respond to the specifi c 
characteri stics of those mater ials. 
5. The procedure for author ising the placing on the market within the Union of a novel food and updating the Union 
list as provided for in Article 9 shall end with the adoptio n of an imple menting act in accordance with Article 12. 
6. By way of derogation from paragraph 5, the Commission may terminate the procedure at any stage, and decide 
not to proceed with an updat e, where it considers that such an updat e is not justified. 
In such cases, where applicable, the Commission shall take account of the views of Member States, the Auth ority's 
opinion and any other legitimate factors relevant to the update under consideration. 
The Commission shall inform the applicant and all Member State s directly of the reasons for not consider ing the updat e 
to be justif ied. The Commission shall make the list of such applications publicly available. 
7. The applicant may withdraw its application at any time, thereby terminating the procedure. 11.12.2015 L 327/11 Official Jour nal of the European Union EN     Article 11 
Opinion of the Author ity 
1. Where the Commission requests an opinion from the Author ity, it shall forward the valid application to the 
Author ity without dela y, and not later than one month after having verified its validity . The Auth ority shall adopt its 
opinion within nine months from the date of receipt of a valid application. 
2. In assessing the safet y of novel foods, the Auth ority shall, where appropr iate, consider whether : 
(a)  the novel food concer ned is as safe as food from a comparable food catego ry already placed on the mark et within 
the Union; 
(b)  the compo sition of the novel food and the conditions of its use do not pose a safet y risk to human health in the 
Union; 
(c)  a novel food, which is intended to replace another food, does not differ from that food in such a way that its normal 
consump tion would be nutr itionally disadvantage ous for the consumer . 
3. The Author ity shall forward its opinion to the Commission, to the Member States and, where applicable, to the 
applicant. 
4. In duly justified cases, where the Author ity requests additional information from the applicant, the nine-month 
period provided for in paragraph 1 may be extended. 
After consulting the applicant, the Author ity shall specify a period within which that additional information is to be 
provided and shall inform the Commission thereof. 
Where the Commission does not object to the extensi on within eight working days of being informed by the Author ity, 
the nine-month period provided for in paragraph 1 shall be automatically extende d by that additional period. The 
Commission shall inform the Member States of that extension. 
5. Where the additional information referred to in paragraph 4 is not provided to the Author ity within the additional 
period referred to in that paragraph, the Author ity shall draw up its opinion on the basis of the available information. 
6. Where an applicant submits additional information on its own initiative, it shall send that information to the 
Author ity. 
In such cases, the Auth ority shall give its opinion within the nine-month period provided for in paragraph 1. 
7. The Auth ority shall make the additional information provided in accordance with paragraphs 4 and 6 available to 
the Commission and to the Member States. 
Article 12 
Author isation of a novel food and updates of the Union list 
1. Within seven months from the date of publication of the Auth ority's opinion, the Commission shall submit to the 
committee referred to in Article 30(1) a draf t implementing act author ising the placing on the market within the Union 
of a novel food and updating the Union list, taking into account the following: 
(a)  the conditions provided for in points (a) and (b) of Article 7 and, where applicable, in point (c) of that Article; 
(b)  any relevant provision of Union law, including the precautionar y principle as referred to in Article 7 of Regulation 
(EC) No 178/2002; 
(c)  the Auth ority's opinion; 
(d)  any other legitimate factors relevant to the application under consideration. 11.12.2015 L 327/12 Official Jour nal of the European Union EN     That implementing act shall be adop ted in accordance with the examination procedure refer red to in Article 30(3). 
2. Where the Commission has not request ed an opinion from the Author ity in accordance with Article 10(3), the 
seven-month period provided for in paragraph 1 of this Article shall start from the date on whic h a valid application is 
received by the Commission in accordance with Article 10(1). 
Article 13 
Implementing acts laying down administ rativ e and scientif ic requirements for applications 
By 1 Januar y 2018, the Commission shall adopt implementing acts concer ning: 
(a)  the content, draf ting and presentation of the application referred to in Article 10(1); 
(b)  the arrangements for verifying the validity , without dela y, of those applications; 
(c)  the type of information to be included in the opinion of the Author ity referred to in Article 11. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 30(3). 
SECTION II 
Specific rules for traditional foods from third countr ies 
Article 14 
Notif ication of a traditional food from a third countr y 
Inste ad of following the procedure refer red to in Article 10, an applicant, who intends to place on the mark et within the 
Union a traditional food from a third countr y, may opt to submit a notification of that intention to the Commission. 
The notifi cation shall include the following information: 
(a)  the name and address of the applicant ; 
(b)  the name and descr iption of the traditional food; 
(c)  the detailed compo sition of the traditional food; 
(d)  the countr y or countr ies of origin of the traditional food; 
(e)  documented data demonstrating the histo ry of safe food use in a third countr y; 
(f)  a proposal for the conditions of intended use and for specific labelling requirements, which do not mislead the 
consumer , or a verifiable justif ication why those elements are not necessar y. 
Article 15 
Procedure for notifying the placing on the market within the Union of a traditional food from a third countr y 
1. The Commission shall forward the valid notificati on provided for in Article 14 without dela y, and not later than 
one month after having verified its validity , to the Member States and to the Author ity. 
2. Within four months from the date on whic h a valid notificati on is forwarded by the Commission in accordance 
with paragraph 1, a Member State or the Author ity may submit to the Commission duly reasoned safety objections to 
the placing on the mark et within the Union of the traditional food concer ned. 11.12.2015 L 327/13 Official Jour nal of the European Union EN     3. The Commission shall inform the applicant of any duly reasoned safety objection as soon as it is submitted . The 
Member States, the Auth ority and the applicant shall be informed of the outcome of the procedure referred to in 
paragraph 2. 
4. Where no duly reasoned safety objections have been submitted in accordance with paragraph 2 within the time- 
limit laid down in that paragraph, the Commission shall author ise the placing on the market within the Union of the 
traditional food concer ned and update the Union list without dela y. 
The entr y in the Union list shall specify that it concer ns a traditional food from a third countr y. 
Where applicable, certain conditions for use, specific labelling requirements, or post-market monitori ng requirements 
shall be specified. 
5. Where duly reasoned safety objections have been submitte d to the Commission in accordance with paragraph 2, 
the Commission shall not author ise the placing on the mark et within the Union of the traditional food concer ned or 
updat e the Union list. 
In that case, the applicant may submit an application to the Commission in accordance with Article 16. 
Article 16 
Application for the author isation of a traditional food from a third countr y 
Where the Commission, acting in accordance with Article 15(5), does not author ise the placing on the mark et within 
the Union of a traditional food from a third countr y or update the Union list, the applicant may submit an application 
including, in addition to the information already provided in accordance with Article 14, document ed data relating to 
the duly reasoned safety objections submitte d in accordance with Article 15(2). 
The Commission shall, without dela y, forward the valid application to the Author ity and make it available to Member 
States. 
Article 17 
Opinion of the Author ity on a traditional food from a third countr y 
1. The Author ity shall adopt its opinion within six months from the date of receip t of a valid application. 
2. In assessing the safety of a traditional food from a third countr y, the Author ity shall consider the following 
matt ers: 
(a)  whether the histor y of safe food use in a third countr y is substantiate d by reliable data submitte d by the applicant in 
accordance with Articles 14 and 16; 
(b)  whether the compo sition of the food and the conditions of its use do not pose a safety risk to human health in the 
Union; 
(c)  where the traditional food from the third countr y is intended to replace another food, whether it does not differ 
from that food in such a way that its normal consump tion would be nutr itionally disadvantageous for the consumer . 
3. The Author ity shall forward its opinion to the Commission, the Member States and the applicant. 
4. In duly justif ied cases, where the Author ity requests additional information from the applicant, the six-month 
period provided for in paragraph 1 may be extended. 
After consulting the applicant, the Author ity shall specify a period within which that additional information is to be 
provided and shall inform the Commission thereof. 11.12.2015 L 327/14 Official Jour nal of the European Union EN     Where the Commission does not object to the extensi on within eight working days of being informed by the Author ity, 
the six-month period provided for in paragraph 1 shall be automatically exte nded by that additional period. The 
Commission shall inform the Member States of that extension. 
5. Where the additional information referred to in paragraph 4 is not provided to the Author ity within the additional 
period referred to in that paragraph, the Author ity shall draw up its opinion on the basis of the available information. 
6. Where an applicant submits additional information on its own initiative, it shall send that information to the 
Author ity. 
In such cases, the Auth ority shall give its opinion within the six-month period provided for in paragraph 1. 
7. The Auth ority shall make the additional information provided in accordance with paragraphs 4 and 6 available to 
the Commission and to Member State s. 
Article 18 
Author isation of a traditional food from a third countr y and updates of the Union list 
1. Within three months of the date of publication of the Author ity's opinion, the Commission shall submit to the 
committee referred to in Article 30(1) a draf t implementing act author ising the placing on the market within the Union 
of the traditional food from a third countr y and updating the Union list, taking into account the following: 
(a)  the conditions provided for in points (a) and (b) of Article 7 and, where applicable, point (c) of that Article; 
(b)  any relevant provision of Union law, including the precautionar y principle as referred to in Article 7 of Regulation 
(EC) No 178/2002; 
(c)  the Auth ority's opinion; 
(d)  any other legitimate factors relevant to the application under consideration. 
That implementing act shall be adop ted in accordance with the examination procedure refer red to in Article 30(3). 
2. By way of derog ation from paragraph 1, the Commission may term inate the procedure at any stage and decide not 
to proceed with an update where it considers that such an updat e is not justif ied. 
In such case, where applicable, the Commission shall take account of the views of Member States, the Author ity's 
opinion and any other legitimate factors relevant to the update under consideration. 
The Commission shall inform the applicant and all Member State s directly of the reasons for not consider ing the updat e 
to be justif ied. 
3. The applicant may withdra w its application referred to in Article 16 at any time, thereby term inating the 
procedure. 
Article 19 
Updates to the Union list as regards author ised traditional foods from third countr ies 
Articles 10 to 13 apply to remo ving a traditional food from a third countr y from the Union list or to adding, remo ving 
or changing specifi cations, conditions of use, additional specif ic labelling requirements or post-market monitor ing 
requirements associated with the inclusion of a traditional food from a third countr y on the Union list. 11.12.2015 L 327/15 Official Jour nal of the European Union EN     Article 20 
Implementing acts laying down administ rativ e and scientif ic requirements concer ning traditional foods from 
third countr ies 
By 1 Januar y 2018 the Commission shall adopt implementing acts concer ning: 
(a)  the content, draf ting and presentation of the notifications referred to in Article 14 and of applications refer red to in 
Article 16; 
(b)  the arrangements for verifying the validity , without dela y, of those notifi cations and applications; 
(c)  the arrang ements for the exchange of information with the Member State s and with the Auth ority for submitting 
duly reasoned safety objections as refer red to in Article 15(2); 
(d)  the type of information to be included in the opinion of the Author ity referred to in Article 17. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 30(3). 
CHAPTER IV 
ADDITIONAL PROCEDURAL RULES AND OTHER REQUIREMENTS 
Article 21 
Additional information concer ning risk management 
1. Where the Commission requests from an applicant additional information on matt ers concer ning risk 
manage ment, it shall deter mine, together with the applicant, the period within which that information is to be provided. 
In such cases, the period provided for in Article 12(1) or (2) or in Article 18(1) may be extended according ly. The 
Commission shall inform the Member State s of that extensi on and shall make the additional information available to 
Member States once it has been received. 
2. Where the additional information refer red to in paragraph 1 is not received within the additional period refer red 
to in that paragraph, the Commission shall act on the basis of the available information. 
Article 22 
Ad hoc extension of time periods 
In excep tional circumstances, the Commission may extend the time periods provided for in Articles 11(1), 12(1) or (2), 
17(1) and 18(1) on its own initiative or, where applicable, at the Author ity's request, where the nature of the matter in 
question justifies an appropr iate extension. 
The Commission shall inform the applicant and the Member States of the extension and the reasons theref or. 
Article 23 
Conf identiality of applications for updates of the Union list 
1. Applicants may request conf idential treatment of certain information submitted under this Regulation where 
disclosure of such information may harm their competitive position. 
2. For the purposes of paragraph 1, applicants shall indicate which parts of the information provided they wish to be 
treated as conf idential and provide all the necessar y details to substantiate their request for confidentiality . Verifiable 
justification shall be given in such cases. 11.12.2015 L 327/16 Official Jour nal of the European Union EN     3. After being informed of the Commission's position on the request, applicants may withdra w their application 
within three weeks, during which the confidentiality of the information provided shall be obser ved. 
4. After expir y of the period refer red to in paragraph 3, if an applicant has not withdra wn the application and in case 
of disagreement the Commission shall decide which parts of the information are to remain confidential and, in case a 
decision has been taken, notify the Member States and the applicant according ly. 
However , confidentiality shall not apply to the following information: 
(a)  the name and address of the applicant ; 
(b)  the name and descr iption of the novel food; 
(c)  the proposed conditions of use of the novel food; 
(d)  a summar y of the studies submitte d by the applicant ; 
(e)  the results of the studies carried out to demonstrat e the safety of the food; 
(f)  where appropr iate, the analysis method(s); 
(g)  any prohibition or restr iction imposed in respect of the food by a third countr y. 
5. The Commission, the Member State s and the Author ity shall take necessar y measures to ensure appropr iate 
conf identiality of the information as refer red to in paragraph 4 and received by them under this Regulation, exce pt for 
information which is required to be made public in order to prot ect human health. 
6. Where an applicant withdra ws, or has withdrawn, its application, the Commission, the Member States and the 
Author ity shall not disclose confidential information, including the information whose confidentiality is the subject of 
disagreement between the Commission and the applicant. 
7. The application of paragraphs 1 to 6 shall not affect the exchange of information concer ning the application 
between the Commission, the Member States and the Author ity. 
8. The Commission may, by means of implementing acts, adopt detailed rules on the implementation of 
paragraphs 1 to 6. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 30(3). 
Article 24 
Post-market monit oring requirements 
The Commission may, for food safety reasons and taking into account the opinion of the Auth ority, impose post-market 
monitoring requirements. Such requirements may include, on a case-by-case basis, the identif ication of the relevant food 
business operat ors. 
Article 25 
Additional information requirements 
Any food business operat or which has placed a novel food on the mark et shall immediate ly inform the Commission of 
any information of which it has become awar e concer ning: 
(a)  any new scientific or technical information which might influence the evaluation of the safety of use of the novel 
food; 
(b)  any prohibition or restr iction imposed by a third countr y in which the novel food is placed on the mark et. 
The Commission shall make that information available to the Member States. 11.12.2015 L 327/17 Official Jour nal of the European Union EN     CHAPTER V 
DATA PROTECTION 
Article 26 
Author isation procedure in case of data protection 
1. On request by the applicant, and where suppor ted by appropr iate and verifiable information included in the 
application provided for in Article 10(1), newly developed scientific evidence or scientific data suppor ting the 
application shall not be used for the benefit of a subsequent application during a period of five years from the date of 
the author isation of the novel food without the agreement of the initial applicant. 
2. The data prot ection shall be grant ed by the Commission under Article 27(1) where the following conditions are 
met: 
(a)  the newly developed scientifi c evidence or scientific data was designat ed as propr ietar y by the initial applicant at the 
time the first application was made; 
(b)  the initial applicant had excl usive right of reference to the propr ietar y scientific evidence or scientific data at the 
time the first application was made; and 
(c)  the novel food could not have been assessed by the Auth ority and author ised without the submission of the 
propr ietar y scientific evidence or scientific data by the initial applicant. 
However , the initial applicant may agree with a subsequent applicant that such scientific evidence and scientific data 
may be used. 
3. Paragraphs 1 and 2 shall not apply to notifi cations and applications concer ning the placing on the market within 
the Union of traditional foods from third countr ies. 
Article 27 
Author isation of a novel food and inclusion in the Union list based on protected propr ietar y scientif ic 
evidence or scientif ic data 
1. Where a novel food is author ised and included in the Union list pursuant to Articles 10 to 12 based on 
propr ietar y scientific evidence or scientific data that are granted data protection as provided for in Article 26(1), the 
entr y of that novel food in the Union list shall indicate, in addition to the information referred to in Article 9(3): 
(a)  the date of inclusion of the novel food in the Union list; 
(b)  the fact that that inclusion is based on propr ietar y scientific evidence and scientific data protect ed in accordance 
with Article 26; 
(c)  the name and address of the applicant ; 
(d)  the fact that during the period of data prot ection the novel food is author ised for placing on the mark et within the 
Union only by the applicant specified in point (c) of this paragraph, unless a subsequent applicant obtains author is­
ation for the novel food without referen ce to the propr ietar y scientifi c evidence or scientific data protect ed in 
accordance with Article 26 or with the agreement of the initial applicant ; 
(e)  the end date of the data prot ection provided for in Article 26. 
2. Scientific evidence or scientifi c data prote cted in accordance with Article 26 or for which the prot ection period 
under that Article has expired shall not be granted renewed prot ection. 11.12.2015 L 327/18 Official Jour nal of the European Union EN     Article 28 
Author isation procedure in case of a parallel application for the author isation of a health claim 
1. The Commission shall, on request by the applicant, stay an author isation procedure for a novel food started 
following an application, where the applicant has submitted: 
(a)  a request for data protect ion in accordance with Article 26; and 
(b)  an application for the author isation of a health claim on the same novel food in accordance with Article 15 or 18 
of Regulation (EC) No 1924/2006, in conjunction with a request for data prot ection in accordance with Article 21 
of that Regulation. 
The stay of the author isation procedure shall be without prejudice to the assessment of the food by the Author ity in 
accordance with Article 11. 
2. The Commission shall inform the applicant about the date of effect of the stay. 
3. While the author isation procedure is stayed, time shall cease to run for the purposes of the time-limit laid down in 
Article 12(1). 
4. The author isation procedure shall resume when the Commission has received the opinion of the Author ity on the 
health claim pursuant to Regulation (EC) No 1924/2006. 
The Commission shall inform the applicant about the date of resum ption of the author isation procedure. From the date 
of resump tion, time shall begin to run afresh from the beginning for the purposes of the time-limit laid down in 
Article 12(1) of this Regulation. 
5. In the cases refer red to in paragraph 1 of this Article, where data prot ection has been granted in accordance with 
Article 21 of Regulation (EC) No 1924/2006, the period of data protect ion granted in accordance with Article 26 of 
this Regulation shall not exceed the period of data prot ection granted in accordance with Article 21 of Regulation (EC) 
No 1924/2006. 
6. The applicant may withdra w at any time the request for staying the author isation procedure submitte d in 
accordance with paragraph 1. In that case, the author isation procedure shall resume and paragraph 5 shall not apply . 
CHAPTER VI 
PENAL TIES AND GENERAL PROVISIONS 
Article 29 
Penalties 
Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and 
shall take all measures necessar y to ensure that they are implement ed. The penalties provided for shall be effective, 
propor tionate and dissuasive. Member States shall notify those provisions to the Commission by 1 Januar y 2018 and 
shall notify it without dela y of any subsequent amendment affecting them. 
Article 30 
Committee procedure 
1. The Commission shall be assisted by the Standing Committ ee on Plants, Animals, Food and Feed established by 
Article 58(1) of Regulation (EC) No 178/2002. That committee shall be a committee within the meaning of Regulation 
(EU) No 182/2011 of the European Parliament and of the Council (1). 11.12.2015 L 327/19 Official Jour nal of the European Union EN     
(1)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 Febr uary 2011 laying down the rules and general 
principles concer ning mec hanisms for control by Member States of the Commission's exercise of implem enting powers (OJ L 55, 
28.2.2011, p. 13). 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply . 
Where the opinion of the committee is to be obtained by written procedure, that procedure shall be term inate d without 
result when, within the time-limit for deliver y of the opinion, the chair of the committe e so decides or a simple majority 
of committee members so request. 
3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply . 
Where the opinion of the committee is to be obtained by written procedure, that procedure shall be term inate d without 
result when, within the time-limit for deliver y of the opinion, the chair of the committe e so decides or a simple majority 
of committee members so request. 
Where the committee delivers no opinion, the Commission shall not adopt the draf t implementing act and the third 
subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply . 
Article 31 
Delegated acts 
For the purposes of achieving the objectives of this Regulation, the Commission shall, by means of delegat ed acts 
adopt ed in accordance with Article 32, adjust and adapt the definition of engineered nanomate rials referred to in 
point (f) of Article 3(2) to technical and scientific progress or to definitions agreed at internati onal level. 
Article 32 
Exercise of the delegation 
1. The power to adop t delegat ed acts is confe rred on the Commission subject to the conditions laid down in this 
Article. 
2. It is of particular importance that the Commission follow its usual practice and carry out consultations with 
exper ts, including Member States' exper ts, before adopting those delegat ed acts. 
3. The power to adop t delegat ed acts referred to in Article 31 shall be confe rred on the Commission for a period of 
five years from 31 December 2015. The Commission shall draw up a repor t in respect of the delegat ion of power not 
later than nine months before the end of the five-year period. The delegatio n of power shall be tacitly extended for 
periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 
three months before the end of each period. 
4. The delegatio n of power refer red to in Article 31 may be revok ed at any time by the European Parliament or by 
the Council. A decision to revok e shall put an end to the delegat ion of the power specif ied in that decision. It shall take 
effect the day following the publication of the decision in the Official Journal of the Europ ean Union or on a later date 
specified therein. It shall not affect the validity of any delegat ed acts already in force. 
5. As soon as it adop ts a delegat ed act, the Commission shall notify it simultaneously to the European Parliament and 
to the Council. 
6. A delegat ed act adop ted pursuant to Article 31 shall enter into force only if no objection has been expressed either 
by the European Parliament or the Council within a period of two months of notificati on of that act to the European 
Parliament and the Council or if, before the expir y of that period, the European Parliament and to the Council have both 
informed the Commission that they will not object. That period shall be exte nded by two months at the initiative of the 
European Parliament or of the Council. 11.12.2015 L 327/20 Official Jour nal of the European Union EN     CHA PTER VII 
TRANSITIONAL MEASURES AND FINAL PROVISIONS 
Article 33 
Amendments to Regulation (EU) No 1169/2011 
Regulation (EU) No 1169/2011 is amended as follows:  
(1) In Article 2(1) the following point is added: 
‘(h)  the definit ion of “engineered nanomater ials” as established by point (f) of Article 3(2) of Regulation (EU) 
2015/2283 of the European Parliament and of the Council (*).  
(*)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) Point (t) of Article 2(2) is delet ed. 
References to the delet ed point (t) of Article 2(2) of Regulation (EU) No 1169/2011 shall be constr ued as referen ces 
to point (f) of Article 3(2) of this Regulation.  
(3) In Article 18, paragraph 5 is deleted. 
Article 34 
Repeal 
Regulation (EC) No 258/97 and Regulation (EC) No 1852/2001 are hereby repealed from 1 Januar y 2018. References to 
Regulation (EC) No 258/97 shall be constr ued as referen ces to this Regulation. 
Article 35 
Transitional measures 
1. Any request for placing a novel food on the mark et within the Union submitte d to a Member State in accordance 
with Article 4 of Regulation (EC) No 258/97 and for whic h the final decision has not been taken before 1 Januar y 2018 
shall be treated as an application under this Regulation. 
The Commission shall not apply Article 11 of this Regulation, where a risk assessment has already been provided by a 
Member State on the basis of Regulation (EC) No 258/97 and no other Member State has raised any reasoned objection 
to that assessment. 
2. Foods not falling within the scope of Regulation (EC) No 258/97, whic h are lawfully placed on the mark et by 
1 Januar y 2018 and which fall within the scope of this Regulation may continue to be placed on the mark et until a 
decision is taken in accordance with Articles 10 to 12 or Articles 14 to 19 of this Regulation following an application 
for author isation of a novel food or a notificati on of a traditional food from a third countr y submitt ed by the date 
specified in the implementing rules adopt ed in accordance with Article 13 or 20 of this Regulation respectively , but no 
later than 2 Januar y 2020. 
3. The Commission may, by means of imple menting acts, adopt measures concer ning the requirements refer red to in 
Articles 13 and 20 necessar y for the application of paragraphs 1 and 2 of this Article. Those imple menting acts shall be 
adopt ed in accordance with the examination procedure refer red to in Article 30(3). 11.12.2015 L 327/21 Official Jour nal of the European Union EN     Article 36 
Entr y into force 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the 
European Union. 
It shall apply from 1 Januar y 2018, excep t for the following provisions: 
(a)  Article 4(4), Articles 8, 13 and 20, Article 23(8), Article 30 and Article 35(3) shall apply from 31 December 2015; 
(b)  Article 4(2) and (3) shall apply from the date of application of the implementing acts referred to in Article 4(4); 
(c)  Article 5 shall apply from 31 December 2015. However , implementing acts adop ted under Article 5 shall not apply 
before 1 Januar y 2018; 
(d)  Articles 31 and 32 shall apply from 31 December 2015. However , deleg ated acts adopt ed under those Articles shall 
not apply before 1 Januar y 2018. 
This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Strasbourg, 25 November 2015. 
For the European Parliament 
The President 
M. SCH ULZ  For the Council 
The President 
N. SCHMIT   11.12.2015 L 327/22 Official Jour nal of the European Union EN