EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, 18.12.2013  
COM(2013) 894 final 
2013/0435 (COD) 
  
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on novel foods 
(Text with EEA relevance) 
 EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL 
• Grounds for and objectives of the proposal 
This proposal aims to ensure food safet y, to protect public health and secure 
the functioning of the internal market  for food, while supporting innovation for 
the food sector.  
It aims to streamline the authorisation procedure, to improve its efficiency and 
transparency. It clarifies the de finition of a novel food, including new 
technologies which have an impact on food.  
It introduces a faster and more proportio nate safety assessment for traditional 
foods from third countries havi ng a history of safe food use. 
The general criteria for the Novel Food definition remain unchanged: novel 
foods are foods and food ingredients whic h were not consumed in the EU to a 
significant degree before the entry into  force (15 May 1997) of the current 
Novel Food Regulation. 
• General context 
On 14 January 2008, the Commission adopt ed a proposal for a Regulation of 
the European Parliament and of the Council on Novel Food1.  
The legislative discussions under the Or dinary legislative procedure mainly 
focused on the provisions applicable to  nanomaterials, the cloning of animals 
for food production, traditional foods from third countrie s, the criteria to be 
examined for the risk assessment and risk management and to the procedure for the authorisation of novel foods in  accordance with the Treaty on the 
Functioning of the European Union (Lisbon Treaty). 
The discussions reached a stalemate on a limited number of issues (in 
particular those linked to cloning of animals). The Conciliation Committee did 
not reach a final agreement at its last meeting on 28 March 2011 and the proposal was not adopted by the Union legislator. 
The Commission considers that issues related to cloning of farm animals 
should be addressed in a separate pro posal, based on an impact assessment. 
This proposal is therefore limited to the safety of novel food and is based on 
the overall agreement achieved in Conciliation.  
                                                
 
1 COM(2007) 872 final. EN 3   EN • Current legislation 
Authorisation and use of novel foods  and food ingredients have been 
harmonised in the European Union since 1997 when Regulation (EC) No 258/97 on Novel Food and novel food ingredients
2 was adopted. The current 
legislation consists of the Nove l Food Regulation and one Commission 
Regulation: 
– Regulation (EC) No 258/97 of the European Parliament and of the 
Council concerning novel foods and novel food ingredients lays down 
the general principles for authorisation of novel foods and food ingredients in the European Union. 
– Commission Regulation (EC) No 1852/ 2001 lays down detailed rules for 
making certain information available to  the public and for the protection 
of information submitted pursuant to European Parliament and Council 
Regulation (EC) No 258/97
3. 
Currently, an application for a pre-market  authorisation is first assessed by a 
Member State food assessment body. The in itial assessment repor t is circulated 
for comments and objections  to all Member States by the Commission. If no 
reasoned safety objections are presente d, the novel food may be placed on the 
market. If reasoned safety objections are presented, an author isation decision is 
required by the Commission. This in most cases includes an additional assessment which is carried out by th e European Food Safety Authority 
(EFSA). 
The authorisation under current rules is  granted to the ap plicant (individual 
authorisation). In additi on, another applicant may not ify to the Commission the 
placing on the market of a f ood that is substantially equi valent to the authorised 
food. This notification has to be substant iated by scientific  evidence showing 
the substantial equivalence of the notif ied food to the authorised food. These 
rules have allowed for placing on the market various foods such as Baobab 
dried fruit pulp, Chia seeds, fish ( Sardinops sagax ) peptide product or synthetic 
vitamin K2. 
• Consistency with the other policies and objectives of the Union 
The proposal brings toge ther and updates the prov isions of the above 
mentioned texts which will be repealed at the time of entry into application of 
the new legislation. 
The proposal pursues the objectives  of the Communication on Smart 
Regulation in the European Union
4 and of the Europe 2020 Strategy5. The 
                                                 
2 Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 
concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1). 
3 OJ L 253, 21.9.2001, p. 17. 
4 COM(2010) 543 final. 
5 COM(2010) 2020 final. EN 4   EN emphasis is on simplifying and streamlin ing the regulatory process, thus 
reducing the administrative  burden and improving the competitiveness of the 
European food industry, while ensuring th e safety of food, maintaining a high 
level of public health protection and ta king global aspects into consideration. 
2. RESULTS  OF CONSULTATIONS  WITH  THE  INTERESTED  PARTIES  AND  
IMPACT  ASSESSMENT 
• Consultation of interested parties 
Stakeholders from food industry, c onsumers, third countries and national 
authorities and internationa l organisations have been consulted both before and 
after the adoption of Commission pr oposal of January 2008. Commission 
representatives also participated at seve ral meetings or seminars organised by 
stakeholders and dedicated to specific is sues (e.g. traditi onal food from third 
countries, assessment and authorisa tion procedure, nanotechnologies) and 
bilateral meetings with interested parties. 
During the first and second reading and the Conciliation procedure on the 2008 
legislative proposal, stakeholders also expressed their positions. 
• Impact assessment 
The Commission carried out an Impact Assessment in 2007. For each of the 
measures of the 2008 proposal, several opti ons were examined with regard to 
their economic, social and environmenta l impact on the various stakeholders 
and Member States. It is available at  http://ec.europa.eu/food/food/biot echnology/novelfood/ini tiatives_en.htm. 
Regarding the current proposal, the 2008 impa ct assessment is still valid, as the 
rationale for an in-depth revision of the current legislation (the length and cost 
of the current authorisation procedur e, the need for a centralised risk 
assessment and risk management and for an adjusted procedure for the placing 
on the EU market of traditional foods  from third countries) is unchanged. 
The main changes compared to th e 2008 proposal are primarily those 
introduced during the Ordinary legisl ative procedure whose impact is 
unchanged as they only clarify th e purpose of the measures.  
As regards a possible exclusion of micr o-enterprises from the scope, it appears 
that such an exemption would not be co mpatible with the overall objective of 
ensuring the safety of the novel foods  which are put on the EU market.  EN 5   EN 3. LEGAL  ELEMENTS  OF THE  PROPOSAL 
• Legal basis 
Legal basis of this propos al is Article 114 of the Tr eaty on the Functioning of 
the European Union. 
• Subsidiarity principle 
The proposal has to comply with the subsid iarity principle sinc e it does not fall 
under the exclusive competence of the Union. 
The objectives of the proposal cannot be  sufficiently achieved by the Member 
States for the following reasons: 
– Individual action by Member  States could lead to different levels of food 
safety and protection of human health  and confuse consumers. Repealing 
the Novel Food Regulation would do away with harmonised food safety 
rules and would endanger the free movement of food in the EU.  
– Effective functioning of the internal  market in relation to novel foods 
while protecting the health and the in terest of the European consumers 
can best be met by action at EU level.  
The proposal therefore complies with  the subsidiarity principle. 
• Proportionality principle 
The proposal complies with the proporti onality principle for the following 
reasons: 
– The proposal harmonises the regu latory framework for novel food 
authorisation and thus contributes to  the functioning of the food market 
in the EU.  
– The proposed measures are sufficient in terms of reaching the objectives 
of ensuring food safety and securing the functioning of the internal market for food while reduci ng the administrative burden. 
4. BUDGETARY
 IMPLICATION   
The financial and budgetary impact of the pr oposal is indicated in the legislative 
financial statement attached to this proposal. EN 6   EN 5. CHOICE OF INSTRUMENTS   
The proposed instrument is Regulation. 
Other means would not be adequate for the following reasons: – The area of novel foods is fully harmoni sed in the EU. Non-legislative action 
based, for example, on a code of good pr actice or guidelines could not give 
sufficient protection and w ould lack legal certainty. 
– The safe use of novel foods depends on pr e-market safety evaluations and often 
on permitted conditions of use of these substances, therefore recommendations or self-regulations would not guarantee the protection of consumer's health. 
6. OTHER
 ISSUES 
• Simplification 
The proposal provides for the simplificati on of legislation a nd administrative 
procedures for public authorities and private parties as compared to the 
legislation in place: 
– There is only one centralised procedure for the assessment and 
authorisation of novel foods. The word ing of the proposal has been up-
dated and clarified. 
– National administrative procedures a nd duplication of work are removed. 
– The authorisation procedure is streamlined, increasing its efficiency and 
reducing the administrative burden in particular for private parties. 
– A simplified procedure for the placing on the market of the traditional 
foods from third countries is introduced. 
• Cost for business, in particular SMEs 
The proposed measures will reduce administrative burden and the length and 
cost of the authorisation procedure for the food industry (18 months instead of 
3 years in average currently). Gene ric authorisation will avoid the re-
submission of new applications by other companies for the same novel food and are expected to benefit in particular SMEs. However, in order to maintain 
an incentive for developing really in novative food products, a "data protection" 
regime with the granting of  an applicant linked author isation for a maximum of 
5 years is introduced. The measures will also facilitate EU market access for 
traditional foods from third countries  by setting up a simplified and more 
proportionate procedure. EN 7   EN • European Economic Area 
The proposed act concerns an Eur opean Economic Area (EEA) matter and 
therefore extends to the EEA. 
• Detailed explanation of the proposal 
Chapter I  – Subject matter, scope and definitions 
Novel foods shall be subject to safety evaluation and authorisation via a fully 
harmonised procedure. The definitions are clarified and updated. It may be determined with the examination procedur e if a food falls within the scope of 
the Regulation.  
Nanomaterials which are intended for food uses and covered by the definition 
of "engineered nanomaterials", as laid down in Regulation (EU) n°1169/2011 
on Food Information to Consumers, shall be assessed and authorised under this 
Regulation before being placed on the EU market.  
Chapter II  – Requirements for placing novel foods on the market within the 
Union 
All novel foods and their use in food ha ve to comply with the following 
criteria: they should not present a dange r to human health and their use should 
not mislead the consumer.  
For every authorised novel food, spec ifications, labelling requirements, 
conditions of use and, where appropriate, a requirement of post-market monitoring may be laid down. 
The current system of individual authorisations is replaced by generic 
authorisations. The so called current  "simplified procedure" based on 
substantial equivalence, which aims to extend an individual  authorisation to 
another company for the same novel f ood, is removed since authorisations 
become directly generic. 
Already authorised novel foods shall co ntinue to be marketed and will be 
included in the Union list of novel foods. 
Chapter III  – Authorisation procedure for a novel food 
In line with the decision to switch to  a centralised EU-lev el procedure and to 
separate risk management and risk assessment, all applications for the 
authorisation of novel foods shall be submitted to the Commission. The Commission may then request a scientific  opinion on risk assessment from the 
European Food Safety Authority (EFSA). 
The inclusion of a novel food in the Union list of novel foods will be 
considered by the Commission on the ba sis of the opinion from EFSA. The 
Commission will be assisted by the Standing Committee on the Food Chain 
and Animal Health (SCOFCAH). EN 8   EN For traditional foods from third countri es, a safety assessment and a risk 
management, based on a history of safe f ood use, is introduced. If a history of 
safe food use in a third country for at least 25 years has been demonstrated by 
the applicant, and if the Member States  or EFSA do not present reasoned safety 
objections based on scientif ic evidence, the food may be included in the Union 
list. 
However, in case reasoned safety objections are presented, an EFSA 
assessment followed by an EU authorisation procedure, similar to the standard authorisation procedure but with shorter deadli nes, is required.  
This procedure provides for a more proportionate risk as sessment and risk 
management of traditional foods from third countries and allows for a quicker placing on the EU market for a range of products from primary production 
without compromising food safety.  
Chapter IV  – Additional procedural ru les and other requirements 
The information provided by the applican t should be kept confidential where 
the disclosure of such information mi ght significantly harm their competitive 
position. 
Chapter V – Data protection 
By way of derogation from the generi c authorisation in order to support 
innovation in the EU food industry and onl y in duly justified cases, individual 
authorisations with data  protection may be granted for a maximum period of 
five years. 
Chapter VI  – Penalties and committee procedure 
The Member States shall lay down rules on penalties applicable to 
infringements of the provisi ons of the proposed Regulation. 
Implementation of the measures proposed in this Regulation will mainly be 
adopted by the Commission in accordance with the examination procedure laid 
down in Article 5 of Regulation (EU)  n°182/2011. This consists of including 
the conditions of use and labelling of  a novel food as well as laying down 
specifications and, where appropriate pos t-market monitoring requirements.  
Chapter VII  – Transitional and final provisions 
Transitional measures are necessary to  ensure a smooth transition with on-
going applications and notifications, pendi ng the entry into application of this 
legislation. Furthermore, due to clarification of the de finition of the novel food 
laid down in this Regulation and to e nhance legal certaint y, a food that was 
legally placed on the market prior to th e application of this  Regulation, should 
be allowed to be continued to be marketed until the risk assessment and authorisation procedures have been concluded.  EN 9   EN 2013/0435 (COD) 
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on novel foods 
(Text with EEA relevance) 
THE EUROPEAN PARLIAMENT AND THE CO UNCIL OF THE EUROPEAN UNION, 
Having regard to the Treaty on the Functioning of the European Union, and in particular 
Article 114 thereof, 
Having regard to the proposal from the European Commission, 
After transmission of the draft legislative act to the national Parliaments, Having regard to the opinion of the Eu ropean Economic and Social Committee
6,  
Acting in accordance with the or dinary legislative procedure7, 
Whereas: (1) The free movement of safe and wholes ome food is an essential aspect of the 
internal market and contributes significantly to the health and well-being of citizens, as well as benefitting their social and economic interests. Differences between national laws concerning the safety assessment and authorisation of novel foods may hinder the 
free movement of such food, thereby crea ting unfair conditions of competition.  
(2) A high level of protection of human hea lth and of consumers’ interests and the 
effective functioning of the internal market should be assured in the pursuit of Union 
food policies, whilst ensuring transparency.
  
(3) The Union's rules on novel foods were established by Regulati on (EC) No 258/97 of 
the European Parliament and of the Council8 and by Commission Regulation (EC) No 
1852/20019. Those rules need to be updated to  simplify the current authorisation 
                                                 
6 OJ C […], […], p. […]. 
7 OJ C […], […], p. […]. 
8 Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 
concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1). 
9 Commission Regulation (EC) No 1852/2001 of 20 September 2001 laying down detailed rules for 
making certain information available 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). EN 10   EN procedures and to take account of recent deve lopments in Union law. For the sake of 
clarity of Union legislation, Regulati ons (EC) No 258/97 and (EC) No 1852/2001 
should be repealed and Regulation (EC)  No 258/97 should be replaced by this 
Regulation.  
(4) Foods which are intended to be used for technological purposes and genetically 
modified food should not fall within the scop e of this Regulation as they are already 
covered by other Union rules. Therefore, ge netically modified f ood falling within the 
scope of Regulation (EC) No 1829/2003 of the European Parliament and of the 
Council10, enzymes falling within the scope of Regulation (EC) No 1332/2008 of the 
European Parliament and of the Council11, food used solely as additives falling within 
the scope of Regulation (EC) No 1333/2008 of  the European Parliament and of the 
Council12, flavourings falling within the sc ope of Regulation (EC) No 1334/2008 of 
the European Parliament and of the Council13 and extraction solvents falling within the 
scope of Directive 2009/32/EC of the Eu ropean Parliament and of the Council14 
should be excluded from the scope of this Regulation. 
(5) The existing categories of novel food laid down in Article 1 of Regulation (EC) No 
258/97 should be clarified and updated by re placing the existing categories with a 
reference to the general defi nition of food provided for in Article 2 of Regulation (EC) 
No 178/2002 of the European Pa rliament and of the Council15. 
(6) In order to ensure continuity with the rules laid down in Regulation (EC) No 258/97, 
the absence of a use for human consumption to a significant degr ee within the Union 
before the date of entry into force of that Regulation, namely 15 May 1997, should be 
maintained as a criterion for a food to be considered as a novel food. A use within the 
Union should also refer to a use in the Member States irrespective of the date of accession of the various Member States to the Union. 
(7) Emerging technologies in food production processes may have an impact on food and 
thereby on food safety. Therefore, it should also be clarified that a food should be 
considered as a novel food where a production process which was not previously used 
for food production in the Union is applied to that food or when foods contain or 
                                                
 
10 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 
on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1). 
11 Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on 
food enzymes (OJ L 354, 31.12.2008, p. 7). 
12 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). 
13 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 properties for use in and on foods (OJ L 
354, 31.12.2008, p. 34). 
14 Directive 2009/32/EC of the European Parliament and of the Council of 23 April 2009 on the 
approximation of the laws of the Member States on extraction solvents used in the production of 
foodstuffs and food ingredients (r ecast) (OJ L 141, 6.6.2009, p. 3). 
15 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down the general principles and requirements of food law, establishing the European Food Safety 
Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).  EN 11   EN consist of engineered nanomaterials, as defi ned in Article 2(2)(t) of Regulation (EU) 
No 1169/2011 of the European Parliament and of the Council16. 
(8) Vitamins, minerals and other substances in tended to be used in food supplements or to 
be added to food including infant formul a 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 we ight control are subject to the rules 
provided for in Directive 2002/46/EC of the European  Parliament and of the 
Council
17, in Regulation (EC) No 1925/2006 of the European Parliament and of the 
Council18 and in Regulation (EU) No 609/2013 of the European Parlia ment and of the 
Council19. Those substances should also be assess ed in accordance w ith the ru les laid 
down in this Regulation when they fall with in the definition of novel food laid down 
in this Regulation.  
(9) When there is a significant change in th e production process of a substance that has 
been used in accordance with Direc tive 2002/46/EC, Regulation (EC) No 1925/2006 
or Regulation (EU) No 609/2013, or a change in  particle size of such a substance, for 
example through nanotechnology, it may have an impact on food and thereby on food 
safety. Therefore, that substance shoul d be considered a novel food under this 
Regulation and should be re-evaluated firs t in accordance with this Regulation and 
subsequently in accordance with the relevant specific legislation. 
(10) If, prior to 15 May 1997, a food was used exclusively as, or in, a food supplement, as 
defined in point (a) of Article 2 of Dir ective 2002/46/EC, it shoul d be allowed to be 
placed on the market within the Union after that date for the same use without being 
considered a novel food for the purposes of th is 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 consumption to a significant degree within the Union 
before 15 May 1997. Therefore, uses of the f ood concerned other than  in, or as, a food 
supplement should be subj ect to this Regulation. 
(11) The placing on the market within the Uni on of traditional foods from third countries 
should be facilitated, where the history of safe food use in a third country has been 
                                                 
16 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 Regulation (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 Directive 2002/67/EC and 2008/5/EC and 
Commission Regulation (EC No 608/2004 (OJ L 304, 22.11.2011, p. 18). 
17 Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the 
approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, 
p. 51). 
18 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). 
19 Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food 
intended for infants and young childre n, food for special medical pur poses, 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). EN 12   EN demonstrated. Those foods should have been consumed in a third country for at least 
25 years as a part of the customary diet w ithin a large part of the population of the 
country. The history of safe  food use should not include  non-food uses or uses not 
related to normal diets. 
(12) It should be clar ified that foods from th ird countries which are regarded as novel foods 
in the Union should only be considered as traditional foods from third countries when 
they are derived from primary production as defined in Article 3 of Regulation (EC) 
No 178/2002, regardless of whether or not they are processed or unprocessed foods. 
Therefore, where a new production process has been applied to this food or where the 
food contains or consists of "engineered nanom aterials" as defined in  Article 2(2)(t) of 
Regulation (EU) No 1169/2011, th e food should not be considered to be traditional. 
(13) Food products produced from food ingredients that do not fa ll within the scope of this 
Regulation, in particular by changing the ingredients of the f ood, their composition or 
amount, should not be considered as novel foods. However, modifications of a food 
ingredient, such as selective extracts or the use of other parts of a plant, that have so 
far not been used for human consumption to a significant degree within the Union, 
should fall within the sc ope of this Regulation. 
(14) Directive 2001/83/EC of the Eur opean Parliament and of the Council20 applies where a 
product, taking into account all its characteri stics, may fall both w ithin the definition 
of "medicinal product" as laid down in Arti cle 1(2) of that Dire ctive and within the 
definition of a product covered by this Regul ation. In that respect, where a Member 
State establishes in accordance with Directive 2001/83/EC th at a product is a 
medicinal product, it may restrict the pl acing on the market of that product in 
accordance with Union law. Moreover, medicinal products are excluded from the definition of food as laid down in Arti cle 2 of Regulation (EC) No 178/2002 and 
should therefore not fall within the scope of this Regulation. 
(15) Implementing powers should be conferre d to the Commission to decide whether a 
particular food falls within th e definition of a novel food and is thereby subject to rules 
on novel food laid down in this Regulation. 
(16) The determination of whether a food was used for human consumption to a significant 
degree within the Union before 15 May 1997 should be based on information submitted by food business operators and, where appropriate, supported by other information available in the Member Stat es. Food business operators should consult 
Member States if they are unsure of the status of the food they intend to place on the market. When there is no information or insufficient information available on human consumption before 15 May 1997, a simple a nd transparent procedure, involving the 
Commission, the Member States and food bus iness operators, should be established 
for collecting such information. Implem enting powers should be conferred on the 
Commission to specify the procedural steps of such cons ultation process. 
(17) Novel foods should be authorised and used  only if they fulfil th e criteria laid down in 
this Regulation. Novel foods should be sa fe and their use should not mislead the 
                                                
 
20 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the 
Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). EN 13   EN consumer. Therefore, where a novel food is intended to replace another food, it should 
not differ from that food in a way that woul d be nutritionally less advantageous for the 
consumer. 
(18) Novel foods should not be placed on the market or used in food for human 
consumption unless they are included in a Union list of novel foods  authorised to be 
placed on the market within the Union (‘the Unio n list’). Therefore, it is appropriate to 
establish, by means of an implementing act , a Union list of novel foods by entering 
novel foods already authorised or notified in accordance with Ar ticle 4, 5 or 7 of 
Regulation (EC) No 258/97 in the Union list, including any ex isting authorisation 
conditions. As those novel foods have alrea dy been evaluated for their safety, have 
been legally produced and marketed in the Union and have not given rise to health 
concerns in the past, the advisory pr ocedure should be used for the initial 
establishment of the Union list.  
(19) It is appropriate to authorise a novel food by updating the Uni on list subject to the 
criteria and the procedures laid down in this  Regulation. A procedure that is efficient, 
time-limited and transparent should be put in  place. As regards traditional foods from 
third countries having a history of safe use it is appropr iate to provide for a faster and 
simplified procedure to update the Union lis t if no reasoned safety objections are 
expressed. As the updating of the Union list implies the applicati on of criteria laid 
down in this Regulation, implementi ng powers should be conferred on the 
Commission in that respect. 
(20) Criteria for the evaluation of the safety risks arising from novel foods should also be 
laid down. In order to ensu re the harmonised scientific  assessment of novel foods, 
such assessments should be carried out by the European Food Safety Authority ("EFSA"). 
(21) As regards the possible use of nanomate rials for food use, EFSA considered in its 
opinion of 6 April 2011
21 on Guidance on the risk assessment of the application of 
nanoscience and nanotechnologies in the food and feed chain that limited information 
is available in relation to aspects of nanot oxicokinetics and toxi cology of engineered 
nanomaterials and that existing toxicity  testing methods may need methodological 
modifications. In order to be tter assess the safety of na nomaterials for food use, the 
Commission is developing test methods which take into account specific 
characteristics of engineered nanomaterials. 
(22) When a novel food is authorised and included in the Union list, the Commission 
should have the power to in troduce post-market monitoring  requirements to monitor 
the use of the authorised novel food to ensure  that the use is wi thin safe limits as 
established in the safety assessment by EFSA.  
(23) Under specific circumstances, in order to  stimulate research and development within 
the agri-food industry, and thus innovation, it is appropriate to protect the investment 
made by innovators in gathering the inform ation and data provided in support of an 
application for a novel food made in  accordance with this Regulation.  The newly 
developed scientific evidence and proprie tary data provided in support of an 
                                                 
21 EFSA Journal 2011;9(5):2140. EN 14   EN application for inclusion of a novel food in  the Union list should be protected. Those 
data and information should, for a limited period of time, not be used to the benefit of a subsequent applicant, without the agreemen t of the prior applican t. The protection of 
scientific data provided by one applicant s hould not prevent othe r applicants from 
seeking the inclusion in the Union list on the basis of their own scie ntific data or by 
referring to the protected data with the agreement of the prior applicant. However, the overall five year period of  data protection which has been granted to the prior 
applicant should not be extende d due to the granting of data  protection to subsequent 
applicants. 
(24) Novel foods are subject to  the general labelling require ments laid down in Regulation 
(EU) No 1169/2011 of the European Parliament  and of the Council on the provision of 
food information to consumers and other re levant labelling requirements in Union 
food law. In certain cases it may be necessary to provide for additional labelling information, in particular regarding the description of the food, its source or its 
conditions of use to ensure that consumers are sufficiently informed  of the nature of 
the novel food.  
(25) For those applications which have b een submitted under Regulation (EC) No 258/97 
before the date of application of this Regulation risk assessm ent and authorisation 
procedures should be concluded in accordan ce with this Regulation. Furthermore, due 
to clarification of the defi nition of novel food laid down in this Regulation and to 
enhance legal certainty, a food that was le gally placed on the market at the date of 
application of this Regulation, should in principle be allowed to be placed on the 
market until the risk assessment and author isation procedures have been concluded. 
Therefore, transitional rules should be laid  down to ensure a smooth transition to the 
rules of this Regulation. 
(26) The Member States should lay down rules on penalties applicable to infringements of 
the provisions of this Regulation and should ta ke all measures necessary to ensure that 
they are implemented. Those penaltie s should be effective, proportionate 
and dissuasive. 
(27) In order to ensure unif orm conditions for the implementation of this Regulation with 
regard to updating the Union list concerni ng the adding of a traditional food from a 
third country where no reasone d safety objections have be en expressed, implementing 
powers should be conferred on the Commission. 
(28) The implementing powers relating to the definition of ‘novel food’, the consultation 
process for determination of novel food stat us, other updates of the Union list, the 
drafting and presentation of applications or notifications for the inclusion of foods in 
the Union list, the arrangements for checking the validity of applications or notifications, confiden tiality treatment and transitional provisions, should be exercised 
in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council
22.  
                                                 
22 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 
laying down the rules and general principles concerni ng mechanisms for contro l by Member States of 
the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). EN 15   EN (29) Since the objective of th is Regulation, namely laying down rules for the placing of 
novel foods on the market within the Uni on, cannot be sufficiently achieved by the 
Member States but can rather be better ach ieved at Union level, the Union may adopt 
measures, in accordance with the principle of subsidiarity as set out in Article 5 of the 
Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not  go beyond what is necessary in order to 
achieve that objective, 
HAVE ADOPTED THIS REGULATION: 
Chapter I  
Subject matter, scope and definitions 
Article 1 
Subject matter and scope 
1. This Regulation lays down rules for the placing of novel foods on the market within 
the Union in order to ensure the effective functioning of the internal market while providing a high level of pr otection of human health and consumer interests. 
2. This Regulation shall not apply to: 
(a) genetically modified foods falling w ithin 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 sc ope of Regulation (EC) No 1332/2008; 
(ii) food additives falling within the scope of Regulation (EC) No 
1333/2008; 
(iii) food flavourings falling within  the scope of Regulation (EC) No 
1334/2008; 
(iv) extraction solvents used or inte nded to be used in the production of 
foodstuffs or food ingredients and fall ing within the scope of Directive 
2009/32/EC; 
(c) food falling within the scope of Council Directive XXX/XX/EU on [on the 
placing on the market of food from animal clones]. 
Article 2 
Definitions  
1. For the purposes of this Regulation, the de finitions laid down in Articles 2 and 3 of 
Regulation (EC) No 178/2002 shall apply.  EN 16   EN 2. The following definitions shall also apply: 
(a) "novel food" means all food that was not used for human consumption to a 
significant degree within the Union before 15 May 1997 irrespective of the 
date of accession of the various Member States to the Union and includes in 
particular: 
(i) food to which a new production pr ocess not used for food production 
within the Union before 15 May 1997 is applied, where that production 
process gives rise to significant ch anges in the composition or structure 
of the food which affect its nutritional value, the way it is metabolised or 
the level of undesirable substances; 
(ii) food containing or consisting of "eng ineered nanomaterials" as defined in 
Article 2(2)(t) of Regulation (EU) No 1169/2011; 
(iii) 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 new production process has been app lied as referred to in point (i) 
of this paragraph; or  
– such substances contain or consist of "engineered nanomaterials" as 
defined in Article 2(2)t of  Regulation (EU) No 1169/2011;  
(iv) food used exclusively in food s upplements 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) "traditional food from a third coun try" means novel food, other than the 
novel food as referred to in point (a)(i) to  (iii), which is derived from primary 
production, with a history of safe  food use in a third country;  
(c) "history of safe food use in a third c ountry" means that the safety of the food 
in question has been conf irmed with compositional data and from experience 
of continued use for at least 25 years in th e customary diet of a large part of the 
population of a third country, prior to a notification referred to in Article 13; 
(d) "the applicant" means the Member Stat e, the third country or the interested 
party, who may represent several interested parties, who has submitted an application in accordance with Article 9 or 15 or a notification in accordance 
with Article 13 to the Commission; 
(e) "valid application" and “valid no tification” mean an application or a 
notification which falls in the scope of this Regulation and contains the information required for risk assessm ent and authorisation procedure. EN 17   EN Article 3 
Implementing power concerni ng the definition of novel food in Article 2(2)(a) 
In order to ensure the uniform implementa tion of this Regulation, the Commission may 
decide, by means of implementing acts, whether or not a particular food falls within the 
definition of novel food, as laid down in Article 2(2)(a). 
Those implementing acts shall be adopted in accordance with the examination procedure 
referred to in Article 27(3). 
Article 4 
Procedure for determination of novel food status 
1. Food business operators shall verify whethe r or not the food which they intend to 
place on the market within the Union falls  within the scope of this Regulation. 
2. Food business operators shall consult a Me mber State where they are unsure whether 
or not a food which they intend to place on the market within th e Union falls within 
the scope of this Regulation. In that case,  food business operators shall provide the 
necessary information to the Member State on request to enable it to determine in particular the extent to which the food in  question was used for human consumption 
within the Union before 15 May 1997.  
3. The Commission may, by means of implemen ting acts, specify the procedural steps 
of the consultation process provided for in paragraph 2.  
Those implementing acts shall be adopted  in accordance with the examination 
procedure referred to in Article 27(3). 
Chapter II 
Requirements for placing novel foods 
on the market within the Union 
Article 5 
Union list of novel foods 
1. The Commission shall establish and update a Union list of novel foods authorised to 
be placed on the market w ithin the Union in accordance wi th Articles 6, 7 and 8 ("the 
Union list"). 
2. Only novel foods authorised and include d in the Union list may be placed on the 
market within the Union as such and used in or on foods under the conditions of use specified therein. EN 18   EN Article 6 
General conditions for inclusion of 
novel foods in the Union list 
The Commission shall only authorise and includ e a novel food in the Union list if it complies 
with the following conditions: 
(a) it does not, on the basis of the scientific  evidence available, pose a safety risk to 
human health; 
(b) its use does not mislead the consumer; (c) where it is intended to re place another food, it does not differ from that food in such 
a way that its normal consumption would be  nutritionally disadvantageous for the 
consumer. 
Article 7 
Initial establishment of the Union list 
No later than …
23 the Commission shall, by means of an implementing act, establish the 
Union list by entering novel f oods authorised or notified under Articles 4, 5 or 7 of 
Regulation (EC) N° 258/97 in the Union list, including any existing authorisation conditions. 
That implementing act shall be adopted in accord ance with the advisory procedure referred to 
in Article 27(2). 
Article 8 
Contents of the Union list 
1. The Commission shall authorise a novel food and update the Union list in accordance 
with the rules laid down in: 
(a) Articles 9, 10 and 11 and, where appli cable, in accordance with Article 25 or 
(b) Articles 13 to 18. 
2. The authorisation of a novel food and updati ng 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) removing a novel food from the Union list; (c) adding, removing or changing the condi tions, specifications or restrictions 
associated with the inclusion of a novel food on the Union list. 
                                                
 
23 Publications Office: please insert date: 24 months  after the entry into force of this Regulation. EN 19   EN 3. The entry for a novel food in the Union list provided for in paragraph 2 shall include 
where relevant: 
(a) a specification of the novel food; (b) the conditions under which the novel food may be used, in order to avoid, in 
particular, possible adverse effects on particular groups of the population, the 
exceeding of maximum intake levels and risks in case of excessive 
consumption; 
(c) additional specific label ling requirements to inform the final consumer of any 
specific characteristic or food propert y, such as the composition, nutritional 
value or nutritional effects and intended  use of the food, which renders a novel 
food no longer equivalent to an existing food or of implications for the health 
of specific groups of the population; 
(d) a post-market monitoring requirement in accordance with Article 23. 
Chapter III 
Authorisation procedure for a novel food 
SECTION I 
GENERAL RULES  
Article 9 
The procedure for authorising the placing on the market within the Union of a novel food and 
updating the Union list 
1. The procedure for authorising the placing on the market within  the Union of a novel 
food and updating of the Union list provided for in Article 8 shall start either on the 
Commission's initiative or following an application to the Commission by an 
applicant.  
The application shall include: 
(a) the name and description of the novel food; 
(b) the composition of the novel food;  (c) scientific evidence dem onstrating that the novel food does not pose a safety 
risk to human health; 
(d) where applicable, a proposal for th e conditions of use and a proposal for 
specific labelling requirements whic h do not mislead the consumer. 
2. The Commission may request EFSA to rende r its opinion if the update is liable to 
have an effect on human health.  EN 20   EN 3. The procedure for authorising the placing on the market within  the Union of a novel 
food and updating the Union list as provided for in Article 8 shall end with the 
adoption of an implementing act in accordance with Article 11.  
4. By way of derogation from paragraph 3, the Commission may end the authorisation 
procedure and decide not to proceed with an  update, at any stage of the procedure, 
where it considers that such an update is not justified. 
Where applicable, it shall ta ke account of the views of Member States, the EFSA's 
opinion and any other legitimate factors re levant to the update under consideration. 
In such cases, the Commission shall inform the applicant and all Member States 
directly, indicating the reasons for not considering the update justified. 
5. The applicant may withdraw its applicati on referred to in para graph 1 at any time 
before the adoption of EFSA's opinion referre d to in paragraph 2, thereby terminating 
the procedure for authorising a nove l food and updating the Union list.  
Article 10 
Opinion of EFSA  
1. Where the Commission requests an opinion from EFSA, it shall forward the valid 
application to EFSA. EFSA shall adopt its opinion within nine months from the date 
of receipt of a valid application. 
In assessing the safety of novel foods, EFSA  shall, where appropr iate, consider the 
following: 
(a) whether the novel food concerned is as safe as food from a comparable food 
category already existing on the market within the Union; 
(b) whether the composition of the novel f ood and the conditions of its use do not 
pose a safety risk to human health in the Union. 
2. EFSA shall forward its opinion to the Commission, the Member  States and, where 
applicable, to the applicant. 
3. In duly justified cases, where EFSA requests additional information from the 
applicant, the period of nine months pr ovided for in paragraph 1 may be extended. 
After consulting the applicant, EFSA shall specify a period within which that 
additional information may be provided an d shall inform the Commission of the 
additional period required. 
Where the Commission does not object within eight working days of being informed 
by EFSA, the period of nine months pr ovided for in paragraph 1 shall be 
automatically extended by that additional period. The Commission shall inform the 
Member States of that extension. EN 21   EN 4. Where the additional information referred to  in paragraph 3 is not sent to EFSA 
within the additional period refe rred to in that paragraph, it  shall finalise its opinion 
on the basis of the information already provided to it. 
5. Where applicants submit additional inform ation on their own initiative, they shall 
send it to the Commission and to EFSA. 
In such cases, EFSA shall give its opinion within the period of nine months provided 
for in paragraph 1. 
6. EFSA shall make the additional information referred to in paragraph 3 available to 
the Commission and to the Member States. 
Article 11 
Authorisation of a novel f ood and updating the Union list  
1. Within nine months from the date of publication of EFSA's opinion, the Commission 
shall submit to the committee referred to in Article 27(1) a draft implementing act updating the Union list taking account of: 
(a) the conditions provided for in  Article 6 where applicable; 
(b) any relevant provisi ons of Union law;  
(c) the EFSA's opinion; (d) any other legitimate fact ors relevant to the app lication under consideration. 
That implementing act shall be adopted  in accordance with the examination 
procedure referred to in Article 27(3). 
2. Where the Commission has not requested an  opinion from EFSA in accordance with 
Article 9(2), the nine-month period provided for in paragr aph 1 shall start from the 
date on which the Commission received a va lid application in accordance with 
Article 9(1). 
Article 12 
Implementing power concerning administrative a nd scientific requireme nts for applications 
By …
24 at the latest, the Commission sha ll adopt implementing acts concerning: 
(a) the contents, drafting and presentation of the application referred to in Article 9(1);  
(b) the arrangements for checking th e validity of those applications; 
(c) the type of information required to be in cluded in the opinion of EFSA referred to in 
Article 10.   
                                                 
24 Publications Office: please insert date: 24 months af ter the date of entry into force of this Regulation. EN 22   EN Those implementing acts shall be adopted in  accordance with the examination procedure 
referred to in Article 27(3). 
SECTION II  
SPECIFIC RULES FOR TRADITIONAL FOODS FROM THIRD COUNTRIES  
Article 13 
Notification of traditional foods from third countries 
An applicant, who intends to place on the market  within the Union a traditional food from a 
third country, shall notify that  intention to the Commission. 
The notification shall include the following information: 
(a) the name and a description of the traditional food; 
(b) its composition; (c) its country of origin; (d) documented data demonstrating the histor y of safe food use in a third country; 
(e) where applicable, the conditions of use and specific labelling requirements, which do 
not mislead the consumer. 
Article 14 
Procedure for traditional foods from third countries 
1. The Commission shall forward the valid notification provided for in Article 13 
without delay to the Memb er States and to EFSA. 
2. Within four months from the date on wh ich the valid notification is forwarded by the 
Commission in accordance with paragraph 1, a Member State or EFSA may submit 
to the Commission reasoned safety objections , based on scientific evidence, to the 
placing on the market within the Uni on of the traditional food concerned. 
3. The Commission shall inform the Member States, EFSA and the applicant of the 
outcome of the procedure referred to in paragraph 2. 
4. Where no reasoned safety objections are made  in accordance with paragraph 2 within 
the time-limit laid down in that paragr aph, the Commission shall authorise the 
placing on the market within the Union of  the traditional food concerned and update 
without delay the Union list. 
5. Where reasoned safety objections, based on scientific evidence, are submitted to the 
Commission in accordance with paragraph 2, the Commission shal l not authorise the 
placing on the market of the traditional f ood concerned nor update the Union list. 
In that case, the applicant may subm it an application to the Commission in 
accordance with Article 15. EN 23   EN Article 15 
Application for a traditional  food from a third country 
The application provided for in Article 14(5) shall include in addition to the information 
already provided in accordance with Article 13, documented data relating to the reasoned safety objections submitted in accordance with Article 14(5). 
The Commission shall forward the valid applic ation without undue dela y to EFSA and make 
it available to the Member States. 
Article 16 
Opinion of EFSA on a traditiona l food from a third country 
1. EFSA shall adopt its opinion within six months from the date of receipt of a valid 
application. 
2. In assessing the safety of a traditional f ood from a third country, EFSA shall consider 
the following matters: 
(a) whether the history of safe food use in a third country is substantiated by 
reliable data submitted by the applicant in accordance with Articles 13 and 15; 
(b) whether the composition of the food and the conditions of its use, do not pose a 
safety risk to human health in the Union. 
3. EFSA shall forward its opinion to the Commission, the Member States and the 
applicant. 
4. In duly justified cases, where EFSA requests additional information from the 
applicant, the period of six months provi ded for in paragraph 1 may be extended. 
After consulting the applicant, EFSA shall specify a period within which that 
additional information may be provided an d shall inform the Commission of the 
additional period needed. 
Where the Commission does not object within eight working days of being informed 
by EFSA, the period of six months provided fo r in paragraph 1 shall be automatically 
extended by that additional period. The Commission shall in form the Member States 
of that extension. 
5. Where the additional information referred to  in paragraph 4 is not sent to EFSA 
within the additional period refe rred to in that paragraph, it  shall finalise its opinion 
on the basis of the information already provided to it.  
6. Where applicants submit additional inform ation on their own initiative, they shall 
send it to the Commission and to EFSA. 
In such cases, EFSA shall give its opinion within the period of  six months provided 
for in paragraph 1.  
7. EFSA shall make the additional informati on available to the Commission and to the 
Member States. EN 24   EN Article 17 
Authorisation of a traditional  food from a third country and update of the Union list 
1. Within three months of the date of p ublication of EFSA's opinion, the Commission 
shall submit to the Committee referred to in  Article 27(1) a draft implementing act to 
authorise the placing on the market within the Union of the traditional food from a 
third country and to update the Union list, taking in to account the following: 
(a) the conditions provided for in  Article 6 where applicable; 
(b) any relevant provisi ons of Union law;  
(c) the EFSA's opinion; (d) any other legitimate fact ors relevant to the app lication under consideration. 
That implementing act shall be adopted  in accordance with the examination 
procedure referred to in Article 27(3). 
2. By way of derogation from paragraph 1, the Commission may end the authorisation 
procedure and decide not to proceed with an  update, at any stage of the procedure, 
where it considers that such an update is not justified. 
Where applicable, it shall ta ke account of the views of Member States, the EFSA's 
opinion and any other legitimate factors re levant to the update under consideration. 
In such cases, the Commission shall inform the applicant and all Member States 
directly, indicating the reasons for not considering the update justified. 
3. The applicant may withdraw its applicati on referred to in Artic le 15 at any time 
before the adoption of EFSA's opinion referr ed to in Article 16, thereby terminating 
the procedure for authorising a traditiona l food from a third country and updating the 
Union list.  
Article 18 
Updates to the Union list as regards authoris ed traditional foods from third countries 
For removing a traditional food from a third country from the Union list or for adding, 
removing or changing conditions, specifications or restrictions associated with the inclusion 
of a traditional food from a third country on the Union list, Articles 9 to 12 apply. 
Article 19 
Implementing power concerning administrative and scientific requirements concerning 
traditional foods from third countries 
By ...
25 the Commission shall adopt implementing acts concerning: 
                                                 
25 Publications Office: please insert date: 24 months af ter the date of entry into force of this Regulation. EN 25   EN (a) the contents, drafting and presentation of the notificati on provided for in Article 13 
and of the application provi ded for in Article 14(5);  
(b) the arrangements for checking the validity of those notifications  and applications; 
(c) the procedural steps for the exchange of information with the Member States and 
with EFSA for submitting reasoned safety obj ections as referred to in Article 14(2), 
(4) and (5); 
(d) the type of information required to be in cluded in the opinion of EFSA referred to in 
Article 16. 
Those implementing acts shall be adopted in accordance with the examination procedure 
referred to in Article 27(3). 
Chapter IV 
Additional procedural rule s and other requirements 
Article 20 
Additional information con cerning risk management  
1. Where the Commission requests additional information from an applicant on matters 
concerning risk management, it shall determ ine, together with the applicant, the 
period within which that information must be provided. 
In such cases, the time period provided for in  Article 11(1) or (2) or in Article 17(1) 
may be extended accordingly. The Commission shall inform the Member States of 
that extension and shall make the additi onal information availa ble to the Member 
States once it has been received.  
2. Where the additional information referred to in paragraph 1 is not received within the 
extended period referred to in that paragraph, the Comm ission shall act on the basis 
of the information already provided.  
Article 21 
Extension of time periods 
In exceptional circumstances, the Commission may extend the time periods provided for in 
Articles 10(1), 11(1) or (2), 16( 1) and 17(1) on its own initia tive or, where applicable, at 
EFSA's request, where the nature of th e matter in question so justifies.  
In such cases the Commission shall inform th e Member States and the applicant of the 
extension and the reasons for it. EN 26   EN Article 22 
Confidentiality of the applicati on for updating of the Union list  
1. Applicants may request c onfidential treatment of certain information submitted under 
this Regulation where disclosure of such  information may significantly harm their 
competitive position.  
2. For the purposes of paragraph 1, applican ts shall indicate which of the information 
provided they wish to be treated as c onfidential and provide all the necessary 
information to substantiate their request fo r confidentiality. Verifiable justification 
shall be given in such cases. 
3. After being informed of the Commissi on’s position on the request, applicants may 
withdraw their application within three week s so as to preserve the confidentiality of 
the information provided.  
Confidentiality shall be preser ved until that period expires. 
4. After expiry of the time period referre d to in paragraph 3, the Commission may 
decide after consulting with the applicants which information may remain 
confidential and, in the case a decision ha s been taken, shall notify the Member 
States and the applicants accordingly. 
However, confidentiality shall not apply to the following information: (a) the name and address of the applicant; (b) the name and description of the novel food; 
(c) the proposed use of the novel food; 
(d) a summary of the studies submitted by the applicant; (e) where applicable, the analysis method(s). 
5. The Commission, the Member St ates and EFSA shall take the necessary measures to 
ensure appropriate confidentiality of th e information received by them under this 
Regulation in accordance with paragraph 4, except for information which is required 
to be made public in order to protect human health. 
6. Where an applicant withdraws, or has withdrawn, its appli cation, the Commission, 
the Member States and EFSA shall not di sclose confidential information, including 
information the confidentiality of which is the subject of disagreement between the 
Commission and the applicant. 
7. The application of paragraphs 1 to 6 sha ll not affect the circulation of information 
concerning the application between the Co mmission, the Member States and EFSA. 
8. The Commission may, by means of implem enting acts, adopt detailed rules on the 
implementation of paragraphs 1 to 6. 
Those implementing acts shall be adopted  in accordance with the examination 
procedure referred to in Article 27(3). EN 27   EN Article 23 
Post-market monitoring  
1. The Commission may, for food safety reas ons and taking into account the opinion of 
EFSA, impose a requirement for post-marke t monitoring of a novel food to ensure 
that the use of the authorised novel food is within safe limits. 
2. The food business operators shall fo rthwith inform the Commission of: 
(a) any new scientific or technical information which might influence the 
evaluation of the safety in use of the novel food; 
(b) any prohibition or restriction imposed  by any third country in which the novel 
food is placed on the market. 
Chapter V 
Data protection 
Article 24  
Authorisation procedure in case of data protection 
1. On request by the applicant, supported by appropriate and verifiable information 
included in the application provided for in Article 9(1), newly developed scientific 
evidence or scientific data supporting the a pplication may not be used for the benefit 
of a subsequent application during a peri od of five years from the date of the 
authorisation and the inclusion of the novel food in the Union list without the 
agreement of the prior applicant.  
2. That data protection shall be grante d where the following conditions are met:  
(a) the newly developed scientific eviden ce or scientific data  was designated as 
proprietary by the prior applicant at the time the first application was made;  
(b) the prior applicant had ex clusive right of reference to the proprietary scientific 
evidence or scientific data at the time the first application was made and 
(c) the novel food could not have been au thorised without the submission of the 
proprietary scientific evidence or scientific data by the prior applicant. 
However, the prior applicant may agree with a subsequent applicant that such 
scientific evidence and scie ntific data may be used. 
3. Paragraphs 1 and 2 shall not apply to no tifications and applic ations concerning the 
placing on the market within the Union of traditional foods from third countries. EN 28   EN Article 25  
Authorisation of a novel food and inclusion in the Union list based on protected proprietary 
scientific evidence or scientific data 
1. Where a novel food is authorised and include d in the Union list based on proprietary 
scientific evidence or scientific data that  are granted data prot ection as provided for 
in Article 24(1), the entry of a novel food in  the Union list shall indicate, in addition 
to the information referred to in Article 8(3): 
(a) the date of entry of the novel food in the Union list; (b) the fact that that entry is based on propr ietary scientific evidence and scientific 
data protected in accordance with Article 24; 
(c) the name and address of the applicant; (d) the fact that the novel f ood is authorised for placi ng on the market within the 
Union only by the applicant specified in point (c) during the period of data protection, unless a subseque nt applicant obtains au thorisation for the novel 
food without reference to the proprietary sc ientific evidence or scientific data 
designated as such by the prior applican t or with the agreement of the prior 
applicant; 
(e) the end date of the data prot ection provided for in Article 24. 
2. Scientific evidence or scientific data pr otected in accordance with Article 24 or for 
which the protection period under that Arti cle has expired shall not be protected 
again. 
Chapter VI 
Penalties and committee procedure 
Article 26  
Penalties 
Member States shall lay down th e rules on penalties applicable to infringements of the 
provisions of this Regulation and shall take all measures necessa ry to ensure that they are 
implemented. The penalties provided for must be effective, proportionate and dissuasive. 
Member States shall notify those provisions to the Commission by …26 at the latest and shall 
notify it without delay of any subsequent amendment affecting them. 
                                                 
26 Publications Office: please insert date: 24 months af ter the date of entry into force of this Regulation. EN 29   EN Article 27  
Committee procedure 
1. The Commission shall be assisted by the Standing Committee on the Food Chain and 
Animal Health established by Article 58( 1) of Regulation (E C) No 178/2002. That 
committee shall be the committee within the meaning of Regulation (EU) No 182/2011. 
2. Where reference is made to this para graph, Article 4 of Regulation (EU) No 
182/2011 shall apply. 
Where the opinion of the committee is to be  obtained by writte n procedure, that 
procedure shall be terminated without re sult when, within the time-limit for delivery 
of the opinion, the chair of the committee so decides or a simple majority of 
committee members so request. 
3. Where reference is made to this para graph, Article 5 of Regulation (EU) No 
182/2011 shall apply. 
Where the opinion of the committee is to be  obtained by writte n procedure, that 
procedure shall be terminated without re sult when, within the time-limit for delivery 
of the opinion, the chair of the committee so decides or a simple majority of 
committee members so request. 
Chapter VII 
Transitional and final provisions 
Article 28  
Repeal 
Regulation (EC) No 258/97 and Regulation (EC) No 1852/2001 are hereby repealed.  
Article 29  
Transitional measures  
1. Any request for placing a novel food on the market within the Union submitted to a 
Member State in accordance with Article 4 of Regulation (EC)  No 258/97 and for 
which the final decision has not been taken before …27 shall be considered as an 
application under this Regulation. 
2. Foods which are lawfully placed on the market  at the date of entry into force of this 
Regulation and which fall within the defini tion of novel foods laid down in this 
Regulation may continue to be placed on the market subject to the following 
conditions: 
                                                 
27 Publications Office: please insert date: 24 months af ter the date of entry into force of this Regulation. EN 30   EN (a) An application for authorisation of a novel food in accordance with Article 9(1) 
or a notification or applic ation for authorisation of a traditional food from a 
third country in accordance with Articl es 13 and 15 shall be submitted by [date 
of application of implementing rules acco rding to Article 12(a) or 19(a) + 24 
months] at the latest. That  application or notificati on shall be forwarded by the 
Commission to the Member States and EFSA. 
(b) If no reasoned safety objections are ma de by a Member State or EFSA within 
four months from the date of receipt of  the application or of the notification 
referred to in point (a), the food may c ontinue to be placed on the market until 
a final decision on the application or notification has been taken in accordance with Article 11, 14 or 17. 
(c) If reasoned safety objections are made by a Member State or EFSA, the 
Commission shall take an interim decisi on on the placing on the market of the 
food within the Union within four mont hs of the date of receipt of such 
objections. 
3. The Commission may, by means of implementing acts, adopt transitional measures 
for the application of paragraphs 1 and 2. Those implementing acts shall be adopted 
in accordance with the examination pr ocedure referred to in Article 27(3). 
Article 30 
Entry into force 
This Regulation shall enter into  force on the twentieth day follo wing that of its publication in 
the Official Journal of  the European Union. 
It shall apply from …
28. 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
For the European Parliament For the Council 
The President The President 
                                                 
28 Publications Office: please insert date: 24 months af ter the date of entry into force of this Regulation. EN 31   EN LEGISLATIVE FINANCIAL STATEMENT  
1. FRAMEWORK  OF THE  PROPOSAL/INITIATIVE   
 1.1. Title of the proposal/initiative 
 1.2. Policy area(s) concerned in the ABM/ABB structure  1.3. Nature of the proposal/initiative  
 1.4. Objective(s)  1.5. Grounds for the proposal/initiative  1.6. Duration and financial impact  1.7. Management method(s) envisaged 
2. MANAGEMENT
 MEASURES   
 2.1. Monitoring and reporting rules  
 2.2. Management and control system   2.3. Measures to prevent fraud and irregularities  
3. ESTIMATED
 FINANCIAL  IMPACT  OF THE  PROPOSAL/INITIATIVE   
 3.1. Heading(s) of the multiannual fina ncial framework and expenditure budget 
line(s) affected  
 3.2. Estimated impact on expenditure   
 3.2.1. Summary of estimated impact on expenditure  
 3.2.2. Estimated impact on ope rational appropriations  
 3.2.3. Estimated impact on appropriati ons of an administrative nature 
 3.2.4. Compatibility with the current  multiannual financial framework 
 3.2.5. Third-party participation in financing  
 3.3. Estimated impact on revenueEN 32   EN LEGISLATIVE FINANCIAL STATEMENT  
1. FRAMEWORK  OF THE  PROPOSAL/INITIATIVE   
1.1. Title of the proposal/initiative  
Proposal for a Regulation of the European  Parliament and of the Council on novel 
foods 
1.2. Policy area(s) concerned in the ABM/ABB structure29  
Novel Food and Food Safety 
1.3. Nature of the proposal/initiative  
 The proposal/initiative relates to  a new action   
 The proposal/initiative relates to a new action following a pilot project/preparatory 
action30  
 The proposal/initiative relates to the extension of an existing action   
X The proposal/initiative relates to an action redirected towards a new action31  
1.4. Objectives 
1.4.1. The Commission’s multiannual strategi c objective(s) targeted by the 
proposal/initiative  
In the field of novel foods, the proposals aim  
(1) to ensure a high level of public health  and the good functioning of the internal 
market , 
(2) to facilitate market access for traditiona l foods from third countries which have a 
long history of safe food use, 
(3) to promote innovation  for the food sector. 
1.4.2. Specific objective(s) and ABM /ABB activity(ies) concerned  
Specific objective 1: Simplification of legislation a nd of administrative procedures 
for public authorities and food business ope rators through streamlined and fully 
centralised authorisation procedure. 
                                                 
29 ABM: Activity-Based Management – ABB: Activity-Based Budgeting. 
30 As referred to in Article 49(6)(a) or (b) of the Financial Regulation. 
31 The applications currently sent to the Member States will be sent to the Commission and the risk 
assessment currently managed by the Member States  will be performed by EFSA (fully centralised 
procedure). EN 33   EN ABM/ABB activity(ies) concerned  
Health within the heading 3 Security and Citizenship. 
1.4.3. Expected result(s) and impact 
Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted. 
On food business operators : the authorisation procedur e is streamlined and fully 
centralised with deadlines for each step of  the procedure. The administrative burden 
is reduced (removal of current double risk assessment). Time and related costs for 
getting a Novel Food authorisation are reduced.  
Individual authorisations are becoming ge neric which facilitates market access in 
particular for SMEs. The introduction of th e "data protection" regime stimulates 
innovation in the food sector. 
On operators from third countries : Better EU market acce ss for traditional foods 
from third countries through simp lified procedure (notification). 
On EU consumers : a high level of public health is ensured by a systematic 
centralised risk assessment by EFSA follo wed by an EU authorisation decision.  
On Member State authorities : The workload for ensuring the national assessment is 
removed. 
1.4.4. Indicators of results and impact  
Specify the indicators for m onitoring implementation of  the proposal/initiative. 
- The average length for applicants to get an author isation decision. 
- Number of notifications agreed per year  for traditional foods from third countries. 
- Number and ratio of authorisations w ith data protection regime granted to 
innovative foods per year. 
1.5. Grounds for the proposal/initiative  
1.5.1. Requirement(s) to be met in the short or long term  
The existing regulatory framework is be ing criticised for being particularly 
burdensome, lengthy and costly to get a Novel Food authorisation. As a consequence 
most EU food businesses do not want to deve lop and put on the market new foods or 
food ingredients which would fall under the Novel Food scope, in particular SMEs. 
At international level, the EU is much criticized at WTO level by third countries 
which consider that the Nove l Food authorisation is a barr ier to trade and prevents 
EU market access to foods which have a l ong history of safe food use in their 
country of origin. EN 34   EN The present revision aims to address these weaknesses of current EU legislation and 
to put in place a streamlined and adapted regulatory framework, thus ensuring a high 
level of public health. 
1.5.2. Added value of EU involvement  
The proposed revision of the existing Re gulation concerning novel foods can only be 
achieved at Union level. The proposal is based on Article 114 of the Treaty on the 
Functioning of the European Union (TFEU).  
1.5.3. Lessons learned from sim ilar experiences in the past 
The removal of the national assessment ha s already been achieved for other food 
ingredients (additives, fl avourings and enzymes) under Regulation (EC) N° 
1331/2008 establishing a common authoris ation procedure. The Novel Food 
authorisation proce dure is similar.  
1.5.4. Coherence and possible synergy wi th other relevant instruments 
The Novel Food Regulation addresses mainly the authorisation procedure to ensure 
that novel foods are safe. The requirements of the food law also apply to novel foods. EN 35   EN 1.6. Duration and financial impact  
 Proposal/initiative of limited duration  
– Proposal/initiative in effect fr om [DD/MM]YYYY to [DD/MM]YYYY  
– Financial impact from YYYY to YYYY  
X Proposal/initiative of unlimited duration  
– Implementation with a start-up period from end 2014 to end 2016, followed by 
full-scale operation. 
1.7. Management mode(s) envisaged32  
X Centralised direct management  by the Commission. 
X Centralised indirect management  with the delegation of implementation tasks 
to: 
–  executive agencies  
– X bodies set up by the Communities33  
–  national public-sector bodies/bodies with public-service mission  
–  persons entrusted with the implem entation of specifi c actions pursuant 
to Title V of the Treaty on European Un ion and identified in the relevant basic 
act within the meaning of Article  49 of the Financial Regulation  
 Shared management with the Member States  
 Decentralised management with third countries   
 Joint management with international organisations (to be specified) 
If more than one management mode is indicated, pl ease provide details in the "Comments" section. 
Comments  
The Commission intends to ensure the services concerned via centralised direct management 
with the EFSA in charge of the scientific risk assessment. 
                                                 
32 Details of management modes and references to the Financial Regulation may be found on the 
BudgWeb site: http://www.cc.cec/b udg/man/budgmanag/budgmanag_en.html  
33 As referred to in Article 185 of the Financial Regulation. EN 36   EN 2. MANAGEMENT  MEASURES   
2.1. Monitoring and reporting rules  
Specify frequency and conditions.  
The Novel Food expert working group compos ed of Member State experts and the 
SCOFCAH committee (Member State Authorit ies) provide regular platforms to 
discuss issues related to the implemen tation of the new regulatory framework.  
Five years after entry into force, the Commission should report to the European 
Parliament and to the Council about th e implementation of the new Regulation 
including on indicato rs and results. The report should address the impact of the new 
rules in particular on th e simplified procedure for tr aditional foods from third 
countries. 
2.2. Management and control system  
2.2.1. Risk(s) identified  
It is the responsibility of food business operators to check  if their products need a 
Novel Food authorisation to be put on the EU market.  
The main risk for food safety is that f oods which are novel may be on the EU market 
without a Novel Food Authorisat ion and therefore illegal. 
2.2.2. Control method(s) envisaged 
Member States shall establis h annual official control pl ans for all types of foods 
which are submitted to Commission for authorisation. 
Regular meetings with stakeholders and Memb er States will be organised to ensure 
that the EU Regulation is respected. 
2.3. Measures to prevent fraud and irregularities 
Specify existing or envisaged prevention and protection measures.  
In addition to the applicati on of all regulatory control mechanisms, DG Health and 
Consumers will devise an anti-fraud strate gy in line with the Commission's new anti-
fraud strategy (CAFS) adopted on 24 June 2011 in order to ensure inter alia  that its 
internal anti-fraud related controls are fully  aligned with the CASF and that the fraud 
risk management approach is geared to  identify fraud risk areas and adequate 
responses. Where necessary, networking group s and adequate IT tools dedicated to 
analysing fraud cases related to the financing implementing activities of the Novel 
Food Regulation will be set up; In particular a series of measures will be put in place 
such as: 
- decisions, agreements and contracts re sulting from the financing implementing 
activities of the Novel Food regulation wi ll expressly entitle  the Commission, EN 37   EN including OLAF and the Court of Auditors to conduct aud its, on the spot checks and 
inspections; 
- during the evaluation phase of a call fo r proposals/tenders, the proposers and 
tenderers are checked against the published exclusion criteria base d on declarations 
and the Early Warning System (EWS); 
- the rules governing the eligibility of cost s will be simplified in accordance with the 
provisions of the financial Regulation; 
- regular training on issues related to fraud and irregularities is given to all staff 
involved in contract management as well as  to auditors and c ontrollers who verify 
the beneficiaries' declarations on the spot. EN 38   EN 3. ESTIMATED  FINANCIAL  IMPACT  OF THE  PROPOSAL/INITIATIVE   
3.1. Heading(s) of the multiannual financ ial framework and expenditure budget 
line(s) affected  
– Existing expenditure budget lines  
In order of multiannual financial fram ework headings and budget lines. 
No new resources will be needed. Operation al resources which are necessary for 
implementation of this initiative will be covered by redeployment within the 
contribution granted to EFSA during the annual budgetary procedure, in 
accordance with the financial programming  set by the Communication from the 
Commission to the European Parliament and the Council (reference COM (2013) 519 final). 
Budget line  Type of  
expenditureContribution  
Heading of 
multiannual 
financial 
framework Number  
[Description: EFSA]  Diff./non-
diff. 
(34) from 
EFTA35 
countries from 
candidate 
countries36 from third 
countries within the 
meaning of 
Article 18(1)(aa) 
of the Financial 
Regulation  
3 17.03.11. Diff/non -
diff. YES/NO  YES/ NO YES/ NO YES/ NO 
                                                 
34 Diff. = Differentiated appropriations / Non- diff. = Non-Differentiated Appropriations. 
35 EFTA: European Free Trade Association.  
36 Candidate countries and, where applicable, poten tial candidate countries from the Western Balkans.  
EN 39   EN 3.2. Estimated impact on expenditure  
3.2.1. Summary of estimated impact on expenditure (in current prices)  
EUR million (to 3 decimal places)  
Heading of multiannual financial 
framework:  Number 
3 Security and Citizenship 
 
DG SANCO   Year 
2014 Year 
2015 Year 
2016 Year 
2017 Year 
2018  2019 et sq years 
 TOTAL 
y Operational appropriations          
Commitments (1) 0 
 0 
 0 
 0 
0 0 
 0 
 0 
 0 
 Number of budget line: 17.03.11  
Payments (2) 0 
 0 
 0 
 0 
 0 
 0 
 0 
 0 
 
                     
Appropriations of an administrative nature financed  
 from the envelope for specific programmes37          
Number of budget line:   (3)         
Commitments =1+1a 
+3 0 
 0 
 0 
 0 
 0 
 0 
 0 
 0 
 TOTAL appropriations 
for DG SANCO Payments =2+2a 
+3 0 
 0 
 0 
 0 
 0 
 0 
 0 
 0 
 
                                                 
37 Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (f ormer "BA" lines), indirect research, 
direct research.  
EN 40   EN  
  
Commitments (4) 0 0 0  0 0 0 0 0  
y TOTAL operational appropriations  
Payments (5) 0 0 0  0 0 0 0 0  
y TOTAL appropriations of an administrative nature 
financed from the envelope for specific programmes  (6)         
Commitments =4+ 6 0 0 0  0 0 0 0 0  TOTAL appropriations  
under HEADING 3 
of the multiannual financial 
framework  Payments =5+ 6 0 0 0  0 0 0 0 0  
If more than one heading is affect ed by the proposal / initiative:  
Commitments (4)        0 
 y TOTAL operational appropriations  
Payments (5)        0 
 
y TOTAL appropriations of an administrative nature 
financed from the envelope for specific programmes  (6)         
Commitments =4+ 6 0 0 0  0 0 0 0 0 
 TOTAL appropriations  
under HEADINGS 1 to 4 
of the multiannual financial 
framework 
(Reference amount)  Payments =5+ 6 0 0 0  0 0 0 0 0 
 
  
EN 41   EN  
Heading of multiannual financial 
framework:  5 " Administrative expenditure " 
EUR million (to 3 decimal places) 
   Year 
2014 Year 
2015 Year 
2016 Year 
2017 Year 
2018  2019 et sq years  TOTAL 
DG SANCO 
y Human resources  0 0 0 0 0 0 0 0 
y Other administrative expenditure  0 0 0 0 0 0 0 0 
TOTAL DG SANCO Appropriations  0 0 0 0 0 0 00 
 
TOTAL appropriations 
under HEADING 5 
of the multiannual financial 
framework   (Total commitments 
= Total payments)         
  
EN 42   EN EUR million (to 3 decimal places) 
   Year 
2014 Year 
2015 Year 
2016 Year 
2017 Year 
2018  2019 et sq years  TOTAL 
Commitments  0 0 0 
 0 
 0 
 0 
 0 
 0 
 TOTAL appropriations  
under HEADINGS 1 to 5 
of the multiannual financial 
framework   Payments  0 0 0 
 0 0 0 0 0 
  
EN 43   EN 3.2.2. Estimated impact on opera tional appropriations  
–  The proposal/initiative does not requir e the use of operational appropriations  
– X The proposal/initiative requires the use of ope rational appropriations, as explained below: 
Commitment appropriations in EU R million (to 3 decimal places) 
  Year 
2014 Year 
2015 Year 
2016 Year 
2017 Year 
2018  2019 et sq years  TOTAL  
OUTPUTS  Indicate 
objectives 
and 
outputs  
 
Ø Type of 
output Avera
ge 
cost  
of the 
output 
Number 
of outputs Cost 
Number 
of outputs Cost 
Number 
of outputs Cost 
Number 
of outputs Cost 
Numbe r 
of out puts 
Cost 
Number 
of outputs Cost 
Number 
of outputs Cost Total 
num-
ber of 
out-
puts Total  
cost 
SPECIFIC OBJECTIVE No 1  Simplification of legislation and of  administrative procedures for pu blic authorities and food business 
operators through streamlined and fully centralised authorisation procedure.  
- Output Technical and 
scientific opinions and 
advice and 
scientific guidelines   0 0 0 0 0 0 0 0 
Sub-total for specific objective N°1  0 
 0 0 0 0 0 0 0 
 
 
Total costs  0 
 0 
 0 
 0 
 0 
 0 0 0 
  
EN 44   EN 3.2.3. Estimated impact on appropriations  of an administrative nature 
3.2.3.1. Summary  
– X The proposal/initiative does not re quire the use of administrative 
appropriations  
–  The proposal/initiative requires the us e of administrative appropriations, as 
explained below: 
EUR million (to 3 decimal places) 
 Year 
2014 Year 
2015 Year 
2016 Year 
2017 Year 
2018  2019 et sq years  TOTAL 
 
HEADING 5 
of the multiannual 
financial framework         
Human resources          
Other administrative 
expenditure          
Subtotal HEADING 5 
of the multiannual 
financial framework          
 
Outside 
HEADING 538 
of the multiannual 
financial framework          
H u m a n  r e s o u r c e s           
Other expenditure  
of an administrative 
nature         
Subtotal  
outside HEADING 5 
of the multiannual 
financial framework          
 
TOTAL  0 0 0 0 0 0 0 0
Additional administrative cost s will be covered through re-a llocation within Commission 
services (DG SANCO).
                                                 
38 Technical and/or administrative assistance and expenditure in support of the implementation of EU 
programmes and/or actions (former "BA" li nes), indirect research, direct research.  
EN 45   EN 3.2.3.2. Estimated requirements of human resources  
– X The proposal/initiative does not require the use of human resources  
–  The proposal/initiative requires the use of  human resources, as explained below: 
Estimate to be expressed in full amounts (or at most to one decimal place) 
 Year 
2014  Year 
2015  Year 2016  Year 2017  Year 2018  Year 2019  Year > 2019  
y Establishment plan posts (officials and temporary agents)  
17 01 01 01 (Headquarters and Commission’s Representation Offices)  0 0 1 1 1 0 0 
XX 01 01 02 (Delegations)        
XX 01 05 01 (Indirect research)        
10 01 05 01 (Direct research)        
y External personnel (in Full Time Equivalent unit: FTE)39 
XX 01 02 01 (CA, INT, SNE from the "global envelope")         
XX 01 02 02 (CA, INT, JED, LA and SNE in the delegations)        
- at Headquarters41        
XX 01 04 yy 40 
- in delegations         
XX 01 05 02 (CA, INT, SNE - Indirect research)        
10 01 05 02 (CA, INT, SNE - Direct research)        
Other budget lines (specify)        
                                                 
39 CA= Contract Agent; INT= agency staff (" Intérimaire") ; JED= " Jeune Expert en Délégation" (Young Experts in Delegations); LA= Local Agent; SNE= Seconded 
National Expert. 
40 Under the ceiling for external personnel from op erational appropriations (former "BA" lines). 
41 Essentially for Structural Funds, European Agricultural Fund fo r Rural Development (EAFRD) and European Fisheries Fund (EFF).  
EN 46   EN TOTAL         
The human resources required will be met by staff from DG Health and Consumers who are already assi gned to the management of th e action and 
who will be redeployed within the DG, together if necessary with any additional allocation which may be granted to the managing  DG under the 
annual allocation procedure and in the light of budgetary constraints. 
Description of tasks to be carried out: 
Officials and temporary agents To transform existing individual authorisation decisions and notifications (around 100) 
into a consolidated Union list with harmonised specifications and conditions of use 
(2016-2017). 
To manage in parallel pending applications under current provisions and applications 
under new provisions (transitional period). 
External personnel  
3.2.4. Compatibility with the current multiannual financial framework  
– X Proposal/initiative is compatible with the new multiannual financial framework 2014-2020. 
–  Proposal/initiative will entail reprogramming of the relevant heading in the mu ltiannual financial framework. 
Explain what reprogramming is required, specifying the budget lines concerned and the corresponding amounts. 
–  Proposal/initiative requires application of the flexibility instrument or revi sion of the multiannual financial framework42. 
Explain what is required, specifying the headings and budget lines concerned and the corresponding amounts. 
                                                 
42 See points 19 and 24 of the Inter-institutional Agreement.  
EN 47   EN 3.2.5. Third-party contributions  
– X The proposal/initiative does not prov ide for co-financing by third parties  
– The proposal/initiative provides for the co-financing estimated below: 
 Appropriations in EUR m illion (to 3 decimal places) 
 
Year 
N Year 
N+1 Year 
N+2 Year 
N+3 … enter as many years as 
necessary to show the duration 
of the impact (see point 1.6)  Total 
Specify the c o-financing 
body          
TOTAL appropriations 
cofinanced          
 
  
EN 48   EN 3.3. Estimated impact on revenue  
– X Proposal/initiative has no financial impact on revenue. 
–  Proposal/initiative has the following financial impact: 
– 1. on own resources 
– 2. on miscellaneous revenue 
 EUR million (to 3 decimal places)  
Impact of the proposal/initiative43 
Budget revenue line: Appropriation
s available for 
the ongoing 
budget year 2014 2015 2016 2017 Subsequent years  
Article ………….  0 0 0 0 0 0 0 
For miscellaneous assigned revenue, specify  the budget expenditure line(s) affected. 
Specify the method for calcula ting the impact on revenue. 
                                                 
43 As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net amounts, i.e. gross amo unts after deduction of 25% for 
collection costs.  
EN 49   EN ANNEX to the NOVEL FOOD LEGIS LATIVE FINANCIAL STATEMENT 
(Information received from EFSA) 
1. Number and cost of human resources considered necessary  
 The proposal/initiative does not require the use of  human resources  
9 The proposal/initiative requires the use of  human resources , described as follows : 
EUR million (to 3 decimal places)  
Year 
2014 Year 
2015 Year  
2016 Year 
2017 Year 
2018 Year 
2019 Year 
2020 Total  
(Sum 2014-2020) EFSA 
FTE Appropriations FTE Appropriations FTE Appropriations FTE Appropriations FTE Appr opriations FTE Appropriations FTE Appropria tions FTE Appropriations 
AD 0 
 0 
 0 
 0 
 0 
 0 
 0 
 0 
 0 
 0 
 0 
 0 
 0 
 0 
 0 
 0 
 Staff 
AST                     
 
2. Cost of other expenditure of an administrative nature  
 The proposal/initiative does not require the use of any appropriation of an administrative nature 
9 The proposal/initiative requires the use of appropriatio ns of an administrative nature, described as follows : 
EUR million (to 3 decimal places) 
EFSA  Year  
2014 Year 
2015 Year  
2016  Year 
2017 Year 
2018 Year 
2019 Year 
2020 TOTAL 
(Sum 2014-
2020) 
Contractual agents  0,052 0,052 0,260 0,260 0,260 0,260 0,260 1,404 
Scientific Meetings     0.169 0.169 0.169 0.169 0.676 
Scientific Cooperation    0.150 0.150 0.150 0.150 0.600 
Staff Missions  0.010 0.010 0.010 0.010 0.010 0.010 0.010 0.070  
EN 50   EN Total44 0,062 0,062 0,270 0,589 0,589 0,589 0,589 2,750 
                                                 
44 The required financial resources will be met by the budget alr eady allocated to EFSA and will be redeployed within EFSA, toget her, if necessary, with any additional 
allocation which may be granted to EFSA under the annual allocation procedure and in the light of budgetary constraints.  
EN 51   EN 3. Methods of calculation used to estimate costs  
General considerations  
Regulation (EC) No 258/97 of January 1997 lays down deta iled rules for the 
authorisation of novel foods and novel food ingr edients. These rules include an initial 
safety assessment by a Member State. If concerns from other Member States with respect to this assessment are raised, EFSA  is asked to perform an additional risk 
assessment. At present around 2/3 of all novel food applications in Europe are 
subject to this further assessment by EFSA. 
The revised novel food legislation foresees amongst other that a ll novel food 
applications are to undergo a centr alised risk a ssessment by EFSA  and that a 
simplified notification procedure for traditio nal foods from third countries with the 
involvement of EFSA is established in or der to allow easier market access for these 
types of products. 
It is expected that EFSA will receive around 15 applications  for Novel Food per 
year. Also, the transfer from a partially decentralised to a fully centralised procedure alone will result in an increase in workload for EFSA. 
It is also expected that EFSA will receive per year around 10 notifications for 
traditional foods from third countries  with a high peak to be  expected immediately 
after the date of application of the Regulat ion. This is expected to be driven by 
botanicals used in traditional Chinese and Ayurvedic medicine which currently 
cannot enter the market because of their Novel Food status.  
EFSA will also be requested to revise the scientific guidelines  for the risk 
assessment of Novel Food as well as to develop  technical guidance and tools to 
assist food business operators  (EU and 3rd country operators) for submitting an 
application or a notification. 
Currently, the workload under the existing Novel Food Regulation (around 8 
applications per year) is covered by 2 FTE (1.5 scientists, 0.5 administrative support) 
and EFSA’s risk assessment can rely on preparatory work performed by Member 
States.  
The data provided under points 1 and 2 of this Annex pr ovides for the needs of 
EFSA on the basis of the increased work load compared to the current legal 
framework. 
EFSA will need to carry out administrative  tasks to support the increased workload, 
including organisation of meetings, docum ent management, and procurement as well 
as organisation of missions and additional financial transactions. EFSA will absorb 
those needs  by internal redeployment of resources and by further gains of efficiency 
in the provision of administrative and support services.