EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 14.1.2008 
COM(2007) 872 final 
2008/0002 (COD)   
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on novel foods and amending Regulation  (EC) No XXX/XXXX [common procedure] 
(presented by the Commission) 
   
[SEC(2008) 12] [SEC(2008) 13]  
EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT OF THE PROPOSAL  
• Grounds for and objectives of the proposal 
 As part of the framework to improve  and bring coherence to Community 
legislation from "farm to table" the Commission announced in the White Paper 
on Food Safety its intentions to exam ine the application of the novel food 
legislation and to make the necessary adaptations to the existing legislation in the light of the conclusions of the report on the implementation of the 
Regulation (EC) No 258/97 on novel foods  and novel ingredients (Actions 14 
and 51) and in accordance with the re gulatory framework of Directive 
90/220/EEC on GMO's. This was partly done by adopting the Regulation (EC) 
on 1829/2003 on GM food and feed. The novel food Regulation needs now to be clarified after removal of GM food from the scope. 
 Stakeholder consultations in 2002 on a Commission discussion paper and 
subsequent evaluation underlined the need to develop and update the Regulation. 
 In accordance with these commitments, this proposal aims to ensure food 
safety, protect human health and secure the functioning of th e internal market 
for food. In order to do this, it aims to streamline the author isation procedure, 
develop a more adjusted safety assessment system for traditional food from third countries, which is considered as  novel food under the current Regulation, 
and clarify the definition of novel food, including new technologies with an 
impact on food, and the scope of the novel food Regulation. Further, there is a 
need to improve the efficiency, transparency and application of the authorisation system, which also contributes to better implementation of the Regulation and to empower consumer s by informing them about food. In 
addition, legal clarity should be achi eved by making necessary changes and 
updating the legislation. 
• General context 
 Authorisation and use of novel foods a nd food ingredients is harmonised in the 
European Union since 1997 when Regulation (EC) No 258/97 on novel foods and novel food ingredients was adopted. The current legislation consists of the 
novel food Regulation and one  Commission Regulation. 
• Existing provisions in the area of the proposal 
 Regulation (EC) No 258/97 of the Eu ropean 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.  
EN 3   EN  This Regulation is complemented with the Commission Regulation (EC) 
No 1852/2001 laying down detailed rule s 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. 
 The proposal brings together, deve lops and updates the above mentioned 
provisions  
• Consistency with the other policies and objectives of the Union  
 The proposal is in line with the Commission's Better Regulation Policy, the 
Lisbon Strategy and the EU's Sustainable Development strategy. The emphasis is on simplifying the regulatory process,  thus reducing the administrative 
burden and improving the competitiven ess of the European food industry, 
while ensuring the safety of food, main taining high level of public health 
protection and taking global as pects into consideration. 
2. C
ONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT  
• Consultation of interested parties 
 Consultation methods, main secto rs targeted and general profile of 
respondents  
 The opinion of Member States and stakeholders has been sought through 
consultations, meetings or during bilateral contacts  since 2002. The 
Commission consulted on a discussion pa per for the implementation of the 
Novel Food Regulation (EC) No 258/97 in July 2002. Some 40 stakeholders 
sent in their comments, which were  discussed in a meeting in 2003.  
 Moreover, from 2 June to 1 August 2006 the Commission carried out, with the 
general public, an Interactive Policy Making online consultation, including a 
questionnaire, in order to collect information and data on the possible impacts of the main issues under considerati on for the revision of the Regulation. 65 
responses to the questionnaire were r eceived. In addition,  the Commission 
organised a stakeholder meeting on the draft impact assessment report in 
December 2006 inviting all relevant stak eholder groups. 12 organisations took 
part in this meeting. Finally, the Comm ission presented the outcome of this 
meeting in the SANCO Advisory Group of the Food Chain, Animal and Plant 
Health.  
 The stakeholders that have been cons ulted are food industry, consumers, third 
countries, national and EU authorities and international organisations. The 
Member State authorities were consulte d in the course of several novel food 
working group meetings in 2005-2007. Further consultation took place through 
Commission participation at  meetings or seminars organised by stakeholders 
and dedicated to specific issues (e.g. trad itional food from third countries, 
assessment and authorisation procedure) a nd bilateral meetings with interested 
parties.   
EN 4   EN  Summary of responses and how th ey have been taken into account  
 Stakeholder consultations in 2002- 2003 on a Commission discussion paper and 
the consultation on the impact assessme nt of the novel food Revision in 2006 
have underlined the importance of and the need to develop and update the existing Regulation. The objectives and many of the possible measurers have 
been broadly supported by the stak eholders consulted since 2002. 
 Concerning the Commission discussion paper in 2002 on the implementation 
of the Novel Food Regulation (EC) No  258/97, all comments, the evaluation 
report including the summary report as well as the executive summary are available at:  
 http://ec.europa.eu/food/food/bi otechnology/novelfood/initiaves_en.htm. 
 A more detailed summary of the consu ltation process and its outcome can be 
found in the Impact Assessment report, wh ich is presented t ogether with this 
draft Regulation. All contri butions have been  considered when preparing the 
draft Impact Assessment Repor t and the draft Regulation.  
 The results are available at: 
http://ec.europa.eu/food/food/biot echnology/novelfood/initiaves_en.htm. 
• Collection and use of expertise  
 There was no need for external expertise. 
• Impact assessment 
 For each of the measures proposed in th e draft Regulation, as appropriate, one 
to three options and ranging from repealing to mandatory measures, have been examined with regard to their economic, social and environmental impact on the various stakeholders and authorities.  In addition, a no-c hanges scenario was 
considered as a reference against whic h to assess the possible impacts of the 
different options. 
 The Commission carried out an Impact  Assessment the report of which is 
presented in parallel to this proposal as a Commission Staff Working Paper. It 
is also available at  http://ec.europa.eu/food/food/biot echnology/novelfood/initiaves_en.htm. 
3. L
EGAL ELEMENTS OF THE PROPOSAL  
• Summary of the proposed action  
 Adoption of a Regulation of the Europ ean Parliament and of the Council on 
novel foods, that regulates the placing on the market of novel foods. It lays 
down rules for authorisation, supervis ion, labelling and use of novel foods.  
EN 5   EN  Repeal Regulation (EC) No 258/97 of the European Parliament and of the 
Council concerning novel foods and nove l food ingredients laying down the 
general principles for aut horisation of novel foods and food ingredients in the 
European Union. 
 Repeal Commission Regulation (EC) No 1852/2001 laying down detailed rules 
for making certain information available to  the public and for the protection of 
information submitted pursuant to Regulation (EC) No 258/97. 
• Legal basis 
 Article 95 of the EC Treaty. 
• Subsidiarity principle 
 The subsidiarity principle applies inso far as the proposal does not fall under the 
exclusive competence of the Community. 
 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 differi ng levels of food safety 
and protection of human health and c onfuse consumers. Repealing the Novel 
Food Regulation would do away with ha rmonised food safety rules and would 
endanger the free movement of  (novel) food in the EU.  
 Community action will better achieve th e objectives of the proposal for the 
following reasons. 
 Effective functioning of the internal ma rket in relation to novel foods while 
protecting the health and the interest of  the European consumers can best be 
met via a centralised EU level procedure for authorisation.  
 A centralised authorisation procedure will  improve the efficiency of novel food 
authorisations. In addition, harmonise d food safety rules would apply.  
 The proposal therefore complies wi th the subsidiarity principle. 
• Proportionality principle 
 The proposal complies with the proporti onality principle for the following 
reasons. 
 The proposal harmonises the regulat ory framework for novel food approval 
and thus contributes to th e functioning of the (novel)  food market in the EU. 
The proposed measures are sufficient in  terms of reaching the objectives of 
ensuring food safety and securing the f unctioning of the internal market for 
food. At the same time they do not impos e an excessive or unjustified burden.  
EN 6   EN  The absence of harmonisation could result in the appearance of individual 
national approval systems, resulting in  multiple authorisation work and 
increased administrative burden in the EU. Financial burden is minimised as 
the current provisions exist alre ady, they are only simplified. 
• Choice of instruments 
 Proposed instruments: Regulation. 
 Other means would not be adequate for the following reasons.  The area of novel foods is fully harm onised in the EU. N on-legislative action 
based, for example, on a code of good pr actice or guidelines could not give 
sufficient protection and would lack lega l certainty. The safe use of novel food 
depends on pre-market safety evaluations and often on permitted conditions of use of these substances, therefore re commendations or self-regulations would 
not guarantee the protection of consumer's health. 
4. B
UDGETARY IMPLICATION  
The proposal has no implication for the Community budget.  
5. ADDITIONAL INFORMATION  
• Simplification 
 The proposal provides for simplificati on of legislation and administrative 
procedures for public authorities (EU or national) and private parties. 
 There will be only one centralised procedure for the assessment and 
authorisation of novel foods. The wording of the legislation will be up-dated 
and clarified. 
 National administrative procedures  and double work will be abolished. 
 Streamlining and increasing the efficiency  of authorisation procedure decreases 
administrative burden also for private parties. 
 The proposal is included in the Commi ssion's rolling programme for up-date 
and simplification of the acquis communa utaire and its Work and Legislative 
Programme under the reference 2007/SANCO/006.  
• Repeal of existing legislation 
 The adoption of the proposal will lead to the repeal of existing legislation. 
• Review/revision/sunset clause 
 The proposal includes a review clause.  
EN 7   EN • European Economic Area 
 The proposed act concerns an EEA matter and should therefore extend to the 
European Economic Area. 
• Detailed explanation of the proposal 
 Chapter I - Introductory provisions 
 Novel foods shall be subject to safety  evaluation and approval via community 
procedure. The definitions are cl arified and updated following legal 
developments. A procedure to collect in formation on the novelty of a food may 
be laid down. It may be determined w ith the comitology procedure if a food 
falls within the scope of the Regulation. 
 Chapter II – Requirements and inclus ion in Community list of novel foods 
 All novel foods and their use in food shall be evaluated for the following 
criteria: they should not present a danger to or mislead the consumer and in the 
case of replacement be of nutritiona l disadvantages for the consumer. 
 In line with the decision to switch to  a centralised EU-lev el procedure and to 
separate risk management and risk asse ssment, all applications for the approval 
of novel food shall be submitted to th e Commission and then directed to 
European Food Safety Authority (EFSA ) which will carry out the safety 
evaluations. The inclusion of a novel food in the Comm unity list of novel foods 
will be considered by the Commission on the basis of the opinion from EFSA. The Commission will be assisted by  the Standing Committee on the Food 
Chain and Animal Health (SCFCAH). 
 The final decision to include a novel food in the Community  list of novel foods 
shall be made by the Commission via the comitology procedure. The applicant-linked authorisation shall be replaced and the simplified pr ocedure abolished 
by authorisation decisions addressed to  the Community as a general rule. 
Protection of data could be granted in justified cases concerning newly 
developed scientific evidence and pr oprietary data in order to support 
innovation in the agri-food industry. 
 Without prejudice to Directive 2000/13 on labelling, the decision shall include, 
where appropriate, specific additional  labelling for novel foods sold to the 
consumer.  
EN 8   EN  For traditional food from third countri es, a safety assessment and management 
based on history of safe food use in the c ountry of origin shall be introduced. If 
the history of safe food use in the countr y of origin has been demonstrated, and 
the Member States and EFSA do not pr esent reasoned safety objections, based 
on scientific evidence, the food could be  placed on the market on basis of a 
notification of the food busin ess operator intending to  market the food. This 
will allow a more proportional safety assessment and management for food with a history of safe food use. In  case reasoned safety objections are 
presented, the normal comitology procedure will apply.  
 For every authorised novel food a speci fication, labelling,  conditions of use 
and, where appropriate, a requirement of  post-market monitoring may be laid 
down. 
 To ensure that novel foods once au thorised are kept under continuous 
observation and re-evaluated wherev er necessary, producers of novel foods 
will be obliged to inform the Commi ssion of any new information which may 
affect the safety asse ssment of the novel food. 
 Chapter III - General provisions  The Member States shall lay down rules on penalties applicable to 
infringements of the provisi ons of the proposed Regulation 
 Implementation of the measures propos ed in the Regulation will be adopted by 
the Commission in accordance with the regulatory procedure laid down in 
Council Decision 1999/468/EC. Th is consists of includi ng the conditions of 
use and labelling of a novel food as we ll as laying down specifications and, 
where appropriate post-market monitori ng requirements. As these are matters 
of high technicality that  are adopted on the ba sis of commonly agreed 
principles, they should be trusted to th e Commission for the sake of efficiency 
and simplification.  
 Chapter IV Transitional and final provisions  Already authorised novel foods shall c ontinue be marketed  and included the 
Community list of novel foods.  
 The Regulation (EC) No [common procedure] is amended to include novel 
foods in the scope of the Regulation and to enable the applicant to present one 
single application for foods regulated  under different se ctoral food laws.  
EN 9   EN 2008/0002 (COD) 
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on novel foods and amending Regulation  (EC) No XXX/XXXX [common procedure] 
(Text with EEA relevance) 
THE EUROPEAN PARLIAMENT AND THE CO UNCIL OF THE EUROPEAN UNION, 
Having regard to the Treaty establishing th e European Community, and in particular 
Article 95 thereof , 
Having regard to the proposal from the Commission1, 
Having regard to the opinion of the Eu ropean Economic and Social Committee2, 
Acting in accordance with the procedure laid down in Article 251 of the Treaty3, 
Whereas:  (1) The free movement of safe and wholesome food  is an essential aspect of the internal 
market and contributes significantly to the heal th and well-being of citizens, as well as 
to their social and economic interests. Differences between national laws, regulations and administrative provisions concerning the safety assessment and authorisation of 
novel foods may hinder their free movement, thereby creating unfair competition conditions. 
(2) A high level of human health protection should be assured in the pursuit of 
Community policies. 
(3) Community rules on novel foods were es tablished by Regulation (EC) No 258/97 of 
the European Parliament and of the C ouncil of 27 January 1997 concerning novel 
foods and novel food ingredients
4 and by Commission Regul ation (EC) No 1852/2001 
of 20 September 2001 laying down detailed rules for making certain information 
available to the public and for the protec tion of information submitted pursuant to 
European Parliament and Council Regulation (EC) No 258/975. For the sake of clarity, 
Regulation (EC) no 258/97 should be repealed  and replaced by this Regulation. The 
present Regulation should include measures  currently governed by Regulation (EC) 
No 1852/2001. 
                                                 
1 OJ C […],[…], p. […]. 
2 OJ C […],[…], p. […]. 
3 OJ C […],[…], p. […]. 
4 OJ L 43, 14.2.1997, p. 1. Regulation as last amended by Regulation (EC) No 1882/2003 (OJ L 284, 
31.10.2003, p. 1). 
5 OJ L 253, 21.9.2001, p. 17.  
EN 10   EN (4) In order to ensure co ntinuity with Regulation (EC) No  258/97, the absence of a use for 
human consumption to a significant degree w ithin the Community before the date of 
application of Regulation (EC) No 258/97, namely 15 May 1997, should be kept as 
criteria for a food to be considered as novel. 
(5) The existing definition of novel food should be clarified and updated by replacing the 
existing categories with a reference to th e general definition of  food in Regulation 
(EC) No 178/2002 of the European Parlia ment and of the Council of 28 January 2002 
laying down the general principles and requ irements of food law, establishing the 
European Food Safety Authority and layi ng down procedures in matters of food 
safety6.  
(6) It should also be clarified that a food shoul d be considered as novel when it is applied 
a production technology which was not prev iously used. In particular, emerging 
technologies in breeding a nd food production processes, wh ich have an impact on 
food and thus might have an impact on food safety, should be covered by this 
Regulation. Novel food should therefore include foods derived from plants and 
animals, produced by non-traditional breedi ng techniques, and foods modified by new 
production processes, such as nanotechnol ogy and nanoscience, which might have an 
impact on food. Food derived from new plant va rieties, or animal breeds produced by 
traditional breeding techniques, should not be considered as novel foods.  
(7) If necessary, implementing measures should be adopted to provide fo r criteria in order 
to facilitate the assessment of whether a food has been used for human consumption to 
a significant degree within the Commun ity before 15 May 1997. If a food has been 
used exclusively as or in a food supplement , as defined in Directive 2002/46/EC, prior 
that date, it can be placed on the market af ter that date for the same use without being 
considered as a novel food. However, that us e as or in a food supplement should not 
be taken into account for the assessment whether it has been used for human 
consumption to a significant degree with in the Community before 15 May 1997. 
Therefore, other uses of the food concer ned, e.g. other than food supplement uses, 
have to be authorised in accordance with this Regulation. 
(8) The reformulation of food products produced  from existing food ingredients available 
on the Community market, in particular by changing the composition or amounts of 
those food ingredients, should not  be considered as novel food. 
(9) Novel foods authorised under the Regulati on (EC) No 258/97 should maintain their 
novel food status but authorisa tion should be required for any new uses of such foods. 
                                                 
6 OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 575/2006 
(OJ L 100, 8.4.2006, p. 3).  
EN 11   EN (10) Foods which are intended for technological uses or which are genetically modified 
should not fall within scope of this Regul ation. Therefore, food used solely as 
additives falling within the scope of Re gulation (EC) No XX/XXX of the European 
Parliament and of the Council of [..]7, flavourings falling within the scope of 
Regulation (EC) No XX/XXX of the European  Parliament and of the Council of [..]8, 
extraction solvents falling within the scope of Council Directive 88/344/EEC of 
13 June 1988 on the approximation of the la ws of the Member States on extraction 
solvents used in the production of foodstuffs and food ingredients9, enzymes falling 
within the scope of Regulation (EC) No XX/ XXX of the European Parliament and of 
the Council of [..]10 and genetically modified food falling within the scope of 
Regulation (EC) No 1829/2003 of the Europe an Parliament and of the Council of 
22 September 2003 on genetical ly modified food and feed11 should be excluded from 
the scope of this Regulation.  
(11) The use of vitamins and minerals is gove rned by specific sectoral food laws. The 
vitamins and minerals falling within th e scope of Council Directive 89/398/EEC of 
3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for pa rticular nutritional uses
12, Directive 2002/46/EC of the 
European Parliament and of the Council of 10 June 2002 on the a pproximation of the 
laws of the Member States relating to food supplements13 and Regulation (EC) 
No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on 
the addition of vitamins and minerals a nd of certain other substances to foods14 should 
therefore be excluded from th e scope of this Regulation. 
(12) Novel foods, other than vitamins and minera ls, intended for particular nutritional uses, 
for food fortification or as food supplements, should be as sessed in conformity with 
the safety criteria and requirements applicab le to all novel foods. At the same time 
they should remain subject to the rules provided for in Directive 89/398/EEC and in 
the specific Directives referred to in Article 4(1) thereof and in Annex I thereof, in Directive 2002/46/EC and in Regulation (EC) No 1925/2006. 
(13) Whether a food was used for human consumption to a significant degree before 
15 May 1997, should be based on information av ailable in the Member States. Where 
the Commission does not have information on human consumption before 15 May 1997, a simple and transparent procedure fo r collecting that information should be 
established involving the Member Stat es and any interested parties.  
                                                
 
7 OJ C […],[…], p. […]. 
8 OJ C […], […], p. […]. 
9 OJ L 157, 24.6.1988, p. 28. Directive as last amended by Regulation (EC) No 1882/2003. 
10 OJ C […],[…], p. […]. 
11 OJ L 268, 18.10.2003, p. 1. Regulation as amended by Commission Regulation (EC) No 1981/2006 
(OJ L 368, 23.12.2006, p. 99). 
12 OJ L 186, 30.6.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003. 
13 OJ L 183, 12.7.2002, p. 51. Directive as amended by Commission Directive 2006/37/EC (OJ L 94, 
1.4.2006, p. 32). 
14 OJ L 404, 30.12.2006, p. 26.  
EN 12   EN (14) Novel foods should be placed on the Community  market only if they are safe and do 
not mislead the consumer. In addition, they  should not differ from the food that they 
are to replace in any way that would be  nutritionally disadvantageous for the 
consumer.  
(15) It is necessary to apply a harmonised centralised procedure for safety assessment and 
authorisation that is efficient, time-limited and transparent. With a view to further 
harmonising different authorisation procedur es of food, the safety assessment of novel 
foods and their inclusion in the Community  list should be carried out in accordance 
with the procedure laid down in Regulation (EC) No [..] of the European Parliament 
and of the Council of [date] establishing a common authorisation procedure for the 
food additives, food enzymes and flavourings15. 
(16) Criteria for the evaluation of the potential risks arising from nove l foods should also 
be laid down. In order to ensure a harmoni sed scientific assessm ent of novel foods, 
such assessments should be carried out by the European Food Safety Authority ("the 
Authority"). 
(17) In order to simplify procedur es, applicants should be allowed to present a single 
application for foods regulated under differe nt sectoral food laws. Regulation EC No 
[common procedure] should therefore be amended accordingly. 
(18) Where appropriate and based on the conclusi ons of the safety assessment, post-market 
monitoring requirements for the use of nove l foods for human consumption should be 
introduced.  
(19) The inclusion of a novel food in the Commun ity list of novel foods should be without 
prejudice to the possibility of evaluating the effects of the overall consumption of a 
substance which is added t o, or used for the manufactur e of that food, or of a 
comparable product in accordance with Article 8 of Regulation (EC) No 1925/2006.  
(20) Under specific circumstances in order to stimulate research and development within 
the agri-food industry, and thus innovation, the newly deve loped scientific evidence 
and proprietary data provided in support of an application for inclusion of a novel food 
in the Community list should not be used to the benefit of anothe r applicant during a 
limited period of time, without the agreement of the first ap plicant. The protection of 
scientific data provided by one applicant s hould not prevent othe r applicants from 
seeking the inclusion in the Community list  of novel foods on th e basis of their own 
scientific data.  
                                                 
15 OJ L […],[…], p. […].  
EN 13   EN (21) Novel foods are subject to the general labe lling requirements laid  down in Directive 
2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the 
approximation of the laws of the Member St ates relating to labelling, presentation and 
advertising of foodstuffs16. In certain cases it might be necessary to provide for 
additional labelling information, in particular  regarding the description of the food, its 
source, or its conditions of use. Theref ore, the inclusion of a novel food in the 
Community list may impose specific conditi ons of use or labelling obligations.  
(22) Regulation (EC) No 1924/2006 of the Europe an Parliament and of the Council of 
20 December 2006 on nutrition and h ealth claims made on foods17 harmonises the 
provisions in the Member States which relate  to nutrition and health  claims. Therefore, 
claims regarding novel foods should only be made in accordance with that Regulation. 
(23) As regards the safety assessment and ma nagement of traditional food from third 
countries, their history of safe use in the th ird country of origin should be taken into 
account. The history of safe food use should not include non-food uses or uses not 
related to normal diets. If Member States  and the Authority have not presented any 
reasoned safety objections, based on scien tific evidence, for example information on 
adverse health effects, it should be pe rmissible to place the food on the Community 
market after notification of the intention to do so.   
(24) The European Group on Ethics in Scien ce and New Technologies established by 
Commission Decision of 16 December 199718 may be consulted, where appropriate, 
with a view to obtaining advice on ethical issues regarding the placing on the market 
of novel foods.  
(25) Novel foods placed on the Community market under Regulation (EC) No 258/97 
should continue to be placed on the market. Novel foods authorised in accordance with Regulation (EC) No 258/97 should be include d in the Community list of novel foods 
established by this Regulation. In additi on, applications submitted under Regulation 
(EC) No 258/97, and for which a final decision  has not been take before the date of 
application of the present Re gulation, should be considered as applications under this 
Regulation. 
(26) Since the objectives of the act ion to be taken cannot be ac hieved by the Member States 
and can therefore be better achieved at Community level, the Community may adopt 
measures, in accordance with the principle of subsidiarity as set out in Article 5 of the 
Treaty. In accordance with the principle of proportionality, as set out in that Article, 
this Regulation does not go beyond what is  necessary in orde r to achieve those 
objectives.  
                                                
 
16 OJ L 109, 6.5.2000, p. 29. Directive as last amended by Commission Directive 2006/142/EC (OJ L 368, 
23.12.2006, p. 110). 
17 OJ L 404, 30.12.2006, p. 9. Corrected version (OJ L 12, 18.1.2007, p. 3). 
18 SEC(97) 2404.  
EN 14   EN (27) The Member States should lay down the rules on penalties applicable to infringements 
of the provisions of this Regulation and should take all measures necessary to ensure that they are implemented. The penalties pr ovided for must be effective, proportionate 
and dissuasive. 
(28) The measures necessary for the implementation of this Regulation should be adopted 
in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of impl ementing powers conferred on the Commission
19.  
(29) In particular, power should be conferred on the Commission to es tablish the criteria 
under which foods may be considered as ha ving been used for human consumption to 
a significant degree within  the Community before 15 Ma y 1997. Since those measures 
are of general scope and are designed to s upplement this Regulation by the addition of 
new non-essential elements, they must be a dopted in accordance w ith the re gulatory 
procedure with scrutiny provided for in  Article 5a of Decision 1999/468/EC.  
(30) Regulation (EC) No 882/2004 of the European  Parliament and of the Council of 
29 April 2004 on official controls performed to ensure the verification of compliance 
with feed and food law, animal health and animal welfare rules20 lays down general 
rules for the performance of official cont rols to verify compliance with food law. 
Therefore, the Member States are to carry out official controls in accordance with 
Regulation (EC) No 882/2004, in order to enforce compliance with the present 
Regulation. 
HAVE ADOPTED THIS REGULATION: 
Chapter I 
Introductory provisions 
Article 1 
Subject matter 
This Regulation lays down harmonised rules for the placing of novel foods on the market in 
the Community with a view to ensuring a hi gh level of human health and consumers’ 
protection, whilst ensuring the effective functioning of the internal market. 
Article 2 
Scope 
1. This Regulation shall apply to the plac ing of novel foods on the market in the 
Community. 
                                                 
19 OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, 
p. 11). Consolidated version (OJ C 255, 21.10.2006, p. 4). 
20 OJ L 165, 30.4.2004, p. 1. Corrected version (OJ L 191, 28.5.2004, p. 1). Regulation as last amended by 
Council Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1).  
EN 15   EN 2. This Regulation shall not apply to:  
(a) foods when and insofar as they are used as: 
(i) food additives falling within the sc ope of Regulation (EC) No [on food 
additives]; 
(ii) food flavourings falling within the scope of Regulation (EC) No [on food 
flavourings]; 
(iii) extraction solvents used in the pr oduction of foodstuffs and falling within 
the scope of Council Directive 88/344/EEC; 
(iv) food enzymes falling within scop e of Regulation (EC) No [on food 
enzymes]; 
(v) vitamins and minerals falling w ithin the scope of Directive 89/398/EEC, 
Directive 2002/46/EC or Regulation (EC) No 1925/2006. 
(b) foods falling within the scope of Regulation (EC) 1829/2003. 
3. Where necessary, it may be determined in accordance with the procedure referred to 
in Article 14(2) whether a t ype of food falls within th e scope of this Regulation. 
Article 3 
Definitions 
1. For the purposes of this Regulation, the de finitions laid down in Regulation (EC) No 
178/2002 shall apply.  
2. The following definitions shall also apply: 
(a) "novel food" means: 
(i) food that has not been used for human consumption to a significant 
degree within the Community before 15 May 1997;  
 The use of a food exclusively as or  in a food supplement shall not be 
sufficient to show whether it has be en used for human consumption to a 
significant degree within the Commu nity before 15 May 1997. However, 
if a food has been used exclusively as or in a food supplement prior that 
date, it can be placed on the Community market after that date for the same use without being considered as novel food. Further criteria for 
assessing if a food has been used fo r human consumption to a significant 
degree within the Community befo re 15 May 1997, which are designed 
to amend non-essential elements of  this Regulation, inter alia by 
supplementing it, may be adopted in accordance with the regulatory procedure with scrutiny refe rred to in Article 14(3).  
EN 16   EN (ii) food of plant or animal origin when  to the plant and animal is applied a 
non-traditional breeding technique not used before 15 May 1997; and 
(iii) food to which is applied a new production process, not used before 
15 May 1997, where that production pr ocess gives rise to significant 
changes in the compositi on or structure of the food which affect its 
nutritional value, metabolism or level of undesirable substances. 
(b) "traditional food from a third country"  means novel food with a history of food 
use in a third coun try, meaning that the food in question has been and 
continues to be part of the normal diet fo r at least one genera tion in a large part 
of the population of the country; 
(c) "history of safe food use" means that  the safety of the food in question is 
confirmed with compositional data and from experience of use and continued use in the normal diet of a large part of the population of a country.  
Article 4 
Collection of information regarding th e use of a food for human consumption 
1. The Commission may collect information fr om the Member States and/or from food 
business operators to determine to what extent a food has been used for human 
consumption within the Community before 15 May 1997.  
2. Implementing measures for the applicati on of paragraph 1, which are designed to 
amend non-essential elements of this Regulation, inter alia by supplementing it, may be adopted in accordance with the regulat ory procedure with scrutiny referred to 
Article 14(3).  
Chapter II 
Requirements and inclusion in the Community list of novel foods  
Article 5 
Community list of novel foods 
Only novel foods included in the Community lis t of novel foods (hereinafter "the Community 
list") may be placed on the market  
Article 6 
Conditions for inclusion in the Community list 
A novel food may be included in the Community lis t only if it meets the following conditions:  
(a) it does not, on the basis of the scientific ev idence available, pose a safety concern to 
the health of the consumer unde r normal consumption conditions;  
EN 17   EN (b) it does not mislead the consumer, by the way it is presented or by its intended use;  
(c) in the case where it is intended to repl ace another food, it does not differ from that 
food to such an extent that its nor mal consumption would be nutritionally 
disadvantageous for the consumer.  
Article 7 
Content of the Community list 
1. The Community list shall be updated in acco rdance with the procedure laid down in 
Regulation (EC) No [c ommon procedure].  
2. The entry of a novel food in the Community  list shall include a specification of the 
food, and, where appropriate, specify the co nditions of use, additional specific 
labelling requirements to inform the final consumer and/or a post-market monitoring requirement. 
3. By way of derogation from the third para graph of Article 7 of Regulation (EC) No 
[common procedure], the upda ting of the Community list  with a novel food, other 
than traditional food from third countries , shall be decided in accordance with the 
regulatory procedure referred to in Article  14(2) in cases wh ere newly developed 
scientific evidence and proprie tary data are protected in accordance with Article 12.  
In the cases referred to in the first s ubparagraph the entry of a novel food in the 
Community list shall indicate, in additi on to the information referred to in 
paragraph 2: 
(a) the date of entry of the n ovel food in the Community list; 
(b) the fact that the entry is based on ne wly developed scientif ic evidence and/or 
proprietary data protected in  accordance with Article 12;  
(c) the name and address of the applicant.  
4. Before the expiry of the period referred to in Article 12, the Community list shall be 
updated to amend non-essential elements of this Regulation in a ccordance with the 
regulatory procedure with scrutiny referre d to in Article 14(3) laid down in 
Regulation (EC) No [common pr ocedure] so that, provided that the authorised food 
still meets the condition laid down in this Regulation, the specific indications referred to in paragraph 3, second subpa ragraph of this Article, are no longer 
included.   
EN 18   EN Article 8 
Traditional food from a third country 
1. A food business operator intending to place a traditional food from a third country on 
the market in the Community shall notify it to the Commission, indicating the name 
of the food, its composition and country of origin.  
The notification shall be accompanied by doc umented data demonstrating the history 
of safe food use in  the third country.  
2. The Commission shall forward the notific ation including the demonstration of 
history of safe food use referred to in paragraph 1 without delay to the Member 
States and the Authority.  
3. Within four months from the date on which the notification provided for in 
paragraph 2 is forwarded by the Commission, a Member State and the Authority may 
inform the Commission that they have reas oned safety objections , based on scientific 
evidence, to the placing on the market  of the traditional food concerned.  
In that case, the food shall not be pl aced on the market in the Community and 
Articles 5 to 7 shall apply. The notification as referred to in paragraph 1 shall be 
considered as an application referred to  in Article 3(1) of the Regulation XX/XXX 
[common procedure]. 
The Commission shall inform the food bus iness operator concerned accordingly 
within five months from the date of th e notification in accord ance with paragraph 1. 
4. If no reasoned safety objections, based on scientific evidence, have been raised and 
no information thereof has been communicated to the food business operator concerned in accordance with paragraph 3, the traditional food may be placed on the 
market in the Community after five months from the date of the notification in accordance with paragraph 1.  
5. The Commission shall publish a list of trad itional foods from thir d countries that may 
be placed on the market in the Commun ity in accordance with paragraph 4 on a 
dedicated page of the Commission's website. 
6. Detailed rules for the implementation of this Article, which are designed to amend 
non-essential elements of this Regulation, inter alia by suppl ementing it, may be 
adopted in accordance with the regulatory procedure with scru tiny referred to in 
Article 14(3).  
EN 19   EN Article 9 
Technical guidance 
The Commission shall, where appropriate, in close cooperation with  the Authority, make 
available technical guidance and tools to assist  food business operators and especially small 
and medium-sized enterprises in preparing a nd submitting applications under this Regulation. 
Article 10 
Opinion of the Authority 
In assessing the safety of novel foods, the Authority shall:  
(a) compare, where appropriate, if the food is  as safe as food from a comparable food 
category already existing on the market in  the Community or as the food that the 
novel food is intended to replace; 
(b) take into account for trad itional food from a third country, the history of safe food 
use. 
Article 11 
Obligations on the food business operators  
1. The Commission may impose for food safe ty reasons and following the opinion of 
the Authority, a requirement for post-market monitoring. The food business operators placing the food in the Community  market shall be responsible for the 
implementation of the post-marketing requireme nts specified in the entry of the food 
concerned in the Community list of novel foods. 
2. The producer shall forthwith 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 the competent authority of any third 
country in which the novel food is placed on the market.  
EN 20   EN Chapter III 
General provisions 
Article 12 
Data protection 
On request by the applicant, supported by appropr iate and verifiable in formation included in 
the application dossier, newly developed scientif ic evidence and proprietary scientific data 
provided to support the applications, may not be used for the benefit of  another application 
during a period of five years from the date  of the inclusion of the novel food in the 
Community list without the ag reement of the applicant. 
Article 13 
Penalties 
The Member States shall lay down the rules on pe nalties applicable to infringements of the 
provision 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. The 
Member States shall notify those provisions to the Commission by [..] at  the latest and shall 
notify it without delay of any subsequent amendment affecting them. 
Article 14 
Committee  
1. The Commission shall be assisted by the Standing Committee on the Food Chain and 
Animal Health, set up by Article 58 of  Regulation (EC) No  178/2002, hereinafter 
referred to as "the Committee". 
2. Where reference is made to this pa ragraph, Articles 5 and 7 of Decision 
1999/468/EC shall apply having regard to th e provisions of Article 8 thereof.  
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three 
months. 
3. Where reference is made to this paragra ph, Article 5a (1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having re gard to the provisions of Article 8 
thereof.  
EN 21   EN Article 15 
Review 
No later than [1 January 2015] and in the li ght of experience gained, the Commission shall 
forward to the European Parliament and to th e Council a report on the implementation of this 
Regulation and in particular of Article 8, accompanied, wher e appropriate, by any proposals. 
The report and any proposal shall be made accessible to the public.  
Chapter IV 
Transitional and final provisions 
Article 16 
Repeal 
Regulation (EC) No 258/97 shall be  repealed with effect from th e date of application of this 
Regulation.  
Article 17 
Establishment of the Community list  
By six months from the date of entry into forc e of this Regulation [date] at the latest the 
Commission shall establish the Community list by entering novel foods authorised under Regulation (EC) No 258/97 in this Community  list, including any ex isting authorisation 
conditions, as appropriate.  
Article 18 
Transitional measures 
1. Any request for placing a novel food on th e market submitted to a Member State 
under Article 4 of Regulation (EC) No 258/ 97 and for which a final decision has not 
been taken before the date of application of  this Regulation shall be considered as an 
application under this Regulation. 
2. Any appropriate transitional measures for the application of paragraph 1, which are 
designed to amend non-esse ntial elements of this Regulation, inter alia by 
supplementing it, shall be adopted in accord ance with the regulatory procedure with 
scrutiny referred to in Article 14(3).   
EN 22   EN Article 19 
Amendments to Regulation (EC) No [common procedure] 
Regulation (EC) No [common proce dure] is amended as follows: 
(1) The title is replaced by the following: 
"Regulation (EC) No XXX/XX XX of the European Parliament and of the Council of 
[date] establishing a common authoris ation procedure for food additives, food 
enzymes, food flavourings and novel foods" 
(2) In Article 1, paragraph 1, first sub- paragraph is replaced by the following:  
"1. This Regulation lays down a common assessment and authorisation procedure 
(hereinafter referred to as the "comm on procedure") for food additives, food 
enzymes, food flavourings and sources of food flavourings used or intended for 
use in or on foodstuffs a nd novel foods (hereinaft er referred to as the 
"substances or products"), which contri butes to the free movement of foods 
within the Community and to a high leve l of protection of human health and 
protection of consumers' interests." 
(3) In Article 1, paragraph 2 is replaced by the following: 
"2. The common procedure shall set the procedural arrangements for updating the 
lists of substances and products the mark eting of which is authorised in the 
Community pursuant to Regulation (E C) No AAA/2007, Regulation (EC) No 
BBB/2007, Regulation (EC) No CCC/2007, Regulation (EC) No DDD/DDDD 
(hereinafter referred to as the "sectoral food laws")." 
(4) In Article 1 paragraph 3, Article 2 pa ragraphs 1 and 2, Article 9 paragraph 2, 
Article 12 paragraph 1 and Article 13 the word  'substance' or 'substances' is replaced 
by 'substance or product' or 'substances or products'.  
(5) The title of Article 2 is replaced by the following: 
"Community list of substances or products" 
(6) In Article 4 the following paragraph 3 is added: 
"3. A single application rela ting to a substance or product may be made to update 
the different Community lists regulated under the different sectoral food laws 
in so far as the application complies with the requirements of each of the 
sectoral food laws." 
(7) The following sentence is added at th e beginning of Article 6, paragraph 1:  
"In the case of scientific grounds for safety concerns, additional information 
concerning risk assessment, shall be iden tified and requested from the applicant."  
EN 23   EN Article 20 
Entry into force 
This Regulation shall enter into force on [the twentieth day] following that of its publication 
in the Official Journal of the European Union . 
It shall apply from six months after the da te of publication of th is Regulation [date]. 
However, Article 17 shall apply from the date of the entry into force of this Regulation.  
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