Proposal for a Regulation of the European Parliament and of the Council on novel foods and amending Regulation (EC) No XXX/XXXX [common procedure]  [SEC(2008) 12] [SEC(2008) 13]
Date: 2008-01-14
Institutions: European Commission
Subjects: consumer protection, food inspection, food safety, food standard, foodstuff, human nutrition

COMMISSION OF THE EUROPEAN 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] 

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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  examine  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  regulatory  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 the internal market 
for food. In order to do this, it aims to streamline the authorisation 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 
the 
authorisation  system,  which  also  contributes  to  better  implementation  of  the 
Regulation  and  to  empower  consumers  by  informing  them  about  food.  In 
addition,  legal  clarity  should  be  achieved  by  making  necessary  changes  and 
updating the legislation. 

transparency  and  application  of 

the  efficiency, 

improve 

to 

• 

General context 

Authorisation and use of novel foods and 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  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. 

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This  Regulation  is  complemented  with  the  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 European Parliament and Council Regulation (EC) No 258/97. 

The  proposal  brings  together,  develops  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  competitiveness  of  the  European  food  industry, 
while  ensuring  the  safety  of  food,  maintaining  high  level  of  public  health 
protection and taking global aspects into consideration. 

2. 

CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

• 

Consultation of interested parties 

Consultation  methods,  main  sectors 
respondents 

targeted  and  general  profile  of 

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  paper  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  consideration  for  the  revision  of  the  Regulation.  65 
responses  to  the  questionnaire  were  received.  In  addition,  the  Commission 
organised  a  stakeholder  meeting  on  the  draft  impact  assessment  report  in 
December 2006 inviting all relevant stakeholder groups. 12 organisations took 
part  in  this  meeting.  Finally,  the  Commission  presented  the  outcome  of  this 
meeting in the SANCO Advisory Group of the Food Chain, Animal and Plant 
Health.  

The stakeholders that have been consulted are food industry, consumers, third 
countries,  national  and  EU  authorities  and  international  organisations.  The 
Member  State  authorities  were  consulted  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.  traditional  food  from  third  countries, 
assessment and authorisation procedure) and bilateral meetings with interested 
parties.  

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Summary of responses and how they have been taken into account 

Stakeholder consultations in 2002-2003 on a Commission discussion paper and 
the consultation on the impact assessment 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 stakeholders 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/biotechnology/novelfood/initiaves_en.htm. 

A more detailed summary of the consultation process and its outcome can be 
found  in  the  Impact  Assessment  report,  which  is  presented  together  with  this 
draft  Regulation.  All  contributions  have  been  considered  when  preparing  the 
draft Impact Assessment Report and the draft Regulation.  

The results are available at: 
http://ec.europa.eu/food/food/biotechnology/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 the 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-changes scenario was 
considered  as  a  reference  against  which  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/biotechnology/novelfood/initiaves_en.htm. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

• 

Summary of the proposed action 

Adoption  of  a  Regulation  of  the  European  Parliament  and  of  the  Council  on 
novel  foods,  that  regulates  the  placing  on  the  market  of  novel  foods.  It  lays 
down rules for authorisation, supervision, labelling and use of novel foods. 

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Repeal  Regulation  (EC)  No  258/97  of  the  European  Parliament  and  of  the 
Council  concerning  novel  foods  and  novel  food  ingredients  laying  down  the 
general principles for authorisation 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 insofar 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 differing 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 (novel) food in the EU.  

Community  action  will  better  achieve  the  objectives  of  the  proposal  for  the 
following reasons. 

Effective  functioning  of  the  internal  market  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, harmonised food safety rules would apply.  

The proposal therefore complies with the subsidiarity principle. 

• 

Proportionality principle 

The  proposal  complies  with  the  proportionality  principle  for  the  following 
reasons. 

The  proposal  harmonises  the  regulatory  framework  for  novel  food  approval 
and  thus  contributes  to  the  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  functioning  of  the  internal  market  for 
food. At the same time they do not impose an excessive or unjustified burden. 

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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 already, 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 harmonised in the EU. Non-legislative action 
based,  for  example,  on  a  code  of  good  practice  or  guidelines  could  not  give 
sufficient protection and would lack legal certainty. The safe use of novel food 
depends on pre-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. 

4. 

BUDGETARY IMPLICATION 

The proposal has no implication for the Community budget.  

5. 

ADDITIONAL INFORMATION 

• 

Simplification 

The  proposal  provides  for  simplification  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  Commission's  rolling  programme  for  up-date 
and simplification of the  acquis communautaire 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. 

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• 

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  clarified  and  updated  following 
legal 
developments. A procedure to collect information on the novelty of a food may 
be  laid  down.  It  may  be  determined  with  the  comitology  procedure  if  a  food 
falls within the scope of the Regulation. 

Chapter II – Requirements and inclusion 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 nutritional disadvantages for the consumer. 

In line with the decision to switch to a centralised EU-level procedure and to 
separate risk management and risk assessment, all applications for the approval 
of  novel  food  shall  be  submitted  to  the  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 Community 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  procedure  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  proprietary  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. 

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For traditional food from third countries, a safety assessment and management 
based on history of safe food use in the country of origin shall be introduced. If 
the history of safe food use in the country of origin has been demonstrated, and 
the Member States and EFSA do not present reasoned safety objections, based 
on  scientific  evidence,  the  food  could  be  placed  on  the  market  on  basis  of  a 
notification  of  the  food  business  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  specification,  labelling,  conditions  of  use 
and, where appropriate, a requirement of post-market monitoring may be laid 
down. 

To  ensure  that  novel  foods  once  authorised  are  kept  under  continuous 
observation  and  re-evaluated  wherever  necessary,  producers  of  novel  foods 
will be obliged to inform the Commission of any new information which may 
affect the safety assessment of the novel food. 

Chapter III - General provisions 

The  Member  States  shall  lay  down  rules  on  penalties  applicable  to 
infringements of the provisions of the proposed Regulation 

Implementation of the measures proposed in the Regulation will be adopted by 
the  Commission  in  accordance  with  the  regulatory  procedure  laid  down  in 
Council  Decision  1999/468/EC.  This  consists  of  including  the  conditions  of 
use  and  labelling  of  a  novel  food  as  well  as  laying  down  specifications  and, 
where  appropriate  post-market  monitoring  requirements.  As  these  are  matters 
of  high  technicality  that  are  adopted  on  the  basis  of  commonly  agreed 
principles, they should be trusted to the Commission for the sake of efficiency 
and simplification.  

Chapter IV Transitional and final provisions 

Already  authorised  novel  foods  shall  continue  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 sectoral food laws. 

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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 COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article 95 thereof, 

Having regard to the proposal from the Commission1, 

Having regard to the opinion of the European Economic and Social Committee2, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty3, 

Whereas:  

(1) 

(2) 

(3) 

The free movement of safe and wholesome food is an essential aspect of the internal 
market and contributes significantly to the health 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. 

A  high  level  of  human  health  protection  should  be  assured  in  the  pursuit  of 
Community policies. 

Community rules on novel foods were established by Regulation (EC) No 258/97 of 
the  European  Parliament  and  of  the  Council  of  27  January  1997  concerning  novel 
foods and novel food ingredients4 and by 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 258/975. 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 
2 
3 
4 

5 

OJ C […],[…], p. […]. 
OJ C […],[…], p. […]. 
OJ C […],[…], p. […]. 
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). 
OJ L 253, 21.9.2001, p. 17. 

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(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

In order to ensure continuity with Regulation (EC) No 258/97, the absence of a use for 
human consumption to a significant degree within 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. 

The existing definition of novel food should be clarified and updated by replacing the 
existing  categories  with  a  reference  to  the  general  definition  of  food  in  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 
safety6.  

It should also be clarified that a food should be considered as novel when it is applied 
a  production  technology  which  was  not  previously  used.  In  particular,  emerging 
technologies  in  breeding  and  food  production  processes,  which  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 breeding techniques, and foods modified by new 
production processes, such as nanotechnology and nanoscience, which might have an 
impact on food. Food derived from new plant varieties, or animal breeds produced by 
traditional breeding techniques, should not be considered as novel foods.  

If necessary, implementing measures should be adopted to provide for criteria in order 
to facilitate the assessment of whether a food has been used for human consumption to 
a  significant  degree  within  the  Community  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 after that date for the same use without being 
considered as a novel food. However, that use 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  within  the  Community  before  15  May  1997. 
Therefore,  other  uses  of  the  food  concerned,  e.g.  other  than  food  supplement  uses, 
have to be authorised in accordance with this Regulation. 

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. 

Novel  foods  authorised  under  the  Regulation  (EC)  No  258/97  should  maintain  their 
novel food status but authorisation 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). 

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(10)  Foods  which  are  intended  for  technological  uses  or  which  are  genetically  modified 
should  not  fall  within  scope  of  this  Regulation.  Therefore,  food  used  solely  as 
additives  falling  within  the  scope  of  Regulation  (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  laws  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  European  Parliament  and  of  the  Council  of 
22 September 2003 on genetically modified food and feed11 should be excluded from 
the scope of this Regulation.  

(11)  The  use  of  vitamins  and  minerals  is  governed  by  specific  sectoral  food  laws.  The 
vitamins  and  minerals  falling  within  the  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  particular  nutritional  uses12,  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  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 and of certain other substances to foods14 should 
therefore be excluded from the scope of this Regulation. 

(12)  Novel foods, other than vitamins and minerals, intended for particular nutritional uses, 
for  food  fortification  or  as  food  supplements,  should  be  assessed  in  conformity  with 
the  safety  criteria  and  requirements  applicable  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 available in the Member States. Where 
the  Commission  does  not  have  information  on  human  consumption  before  15  May 
1997,  a  simple  and  transparent  procedure  for  collecting  that  information  should  be 
established involving the Member States and any interested parties.  

7 
8 
9 
10 
11 

12 
13 

14 

OJ C […],[…], p. […]. 
OJ C […], […], p. […]. 
OJ L 157, 24.6.1988, p. 28. Directive as last amended by Regulation (EC) No 1882/2003. 
OJ C […],[…], p. […]. 
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). 
OJ L 186, 30.6.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003. 
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). 
OJ L 404, 30.12.2006, p. 26. 

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(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 procedures 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 novel foods should also 
be  laid  down.  In  order  to  ensure  a  harmonised  scientific  assessment  of  novel  foods, 
such assessments should be carried out by the European Food Safety Authority ("the 
Authority"). 

(17) 

In  order  to  simplify  procedures,  applicants  should  be  allowed  to  present  a  single 
application for foods regulated under different sectoral food laws. Regulation EC No 
[common procedure] should therefore be amended accordingly. 

(18)  Where appropriate and based on the conclusions of the safety assessment, post-market 
monitoring requirements for the use of novel foods for human consumption should be 
introduced.  

(19)  The inclusion of a novel food in the Community 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  to,  or  used  for  the  manufacture  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  developed  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 another applicant during a 
limited period of time, without the agreement of the first applicant. The protection of 
scientific  data  provided  by  one  applicant  should  not  prevent  other  applicants  from 
seeking the inclusion in the Community list of novel foods on the basis of their own 
scientific data.  

15 

OJ L […],[…], p. […]. 

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(21)  Novel  foods  are  subject  to  the  general  labelling  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 States 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.  Therefore,  the  inclusion  of  a  novel  food  in  the 
Community list may impose specific conditions of use or labelling obligations.  

(22)  Regulation  (EC)  No  1924/2006  of  the  European  Parliament  and  of  the  Council  of 
20 December  2006  on  nutrition  and  health  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  management  of  traditional  food  from  third 
countries, their history of safe use in the third 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  scientific  evidence,  for  example  information  on 
adverse  health  effects,  it  should  be  permissible  to  place  the  food  on  the  Community 
market after notification of the intention to do so.  

(24)  The  European  Group  on  Ethics  in  Science  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 included in the Community list of novel foods 
established  by  this  Regulation.  In  addition,  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 Regulation, should be considered as applications under this 
Regulation. 

(26)  Since the objectives of the action to be taken cannot be achieved 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  order  to  achieve  those 
objectives.  

16 

17 
18 

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). 
OJ L 404, 30.12.2006, p. 9. Corrected version (OJ L 12, 18.1.2007, p. 3). 
SEC(97) 2404. 

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(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 provided 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 implementing powers conferred on the Commission19.  

(29) 

In  particular,  power  should  be  conferred  on  the  Commission  to  establish  the  criteria 
under which foods may be considered as having been used for human consumption to 
a significant degree within the Community before 15 May 1997. Since those measures 
are of general scope and are designed to supplement this Regulation by the addition of 
new  non-essential  elements,  they  must  be  adopted  in  accordance  with  the  regulatory 
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  controls  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  high  level  of  human  health  and  consumers’ 
protection, whilst ensuring the effective functioning of the internal market. 

Article 2 
Scope 

This  Regulation  shall  apply  to  the  placing  of  novel  foods  on  the  market  in  the 
Community. 

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). 
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). 

1. 

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20 

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2. 

This Regulation shall not apply to:  

(a) 

foods when and insofar as they are used as: 

(i) 

food  additives falling within the  scope  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 production of foodstuffs and falling within 

the scope of Council Directive 88/344/EEC; 

(iv)  food  enzymes  falling  within  scope  of  Regulation  (EC)  No  [on  food 

enzymes]; 

(v)  vitamins and minerals falling within 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 type of food falls within the scope of this Regulation. 

Article 3 
Definitions 

1. 

2. 

For the purposes of this Regulation, the definitions laid down in Regulation (EC) No 
178/2002 shall apply.  

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 been used for human consumption to a 
significant degree within the Community 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 for human consumption to a significant 
degree within the Community before 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 referred to in Article 14(3). 

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(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  process  gives  rise  to  significant 
changes  in  the  composition  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  country,  meaning  that  the  food  in  question  has  been  and 
continues to be part of the normal diet for at least one generation 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 the use of a food for human consumption 

1. 

2. 

The Commission may collect information from 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.  

Implementing  measures  for  the  application  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  regulatory  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 list 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 list only if it meets the following conditions:  

(a) 

it does not, on the basis of the scientific evidence available, pose a safety concern to 
the health of the consumer under normal consumption conditions; 

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(b) 

(c) 

1. 

2. 

3. 

4. 

it does not mislead the consumer, by the way it is presented or by its intended use; 

in the case where it is intended to replace another food, it does not differ from that 
food  to  such  an  extent  that  its  normal  consumption  would  be  nutritionally 
disadvantageous for the consumer.  

Article 7 
Content of the Community list 

The Community list shall be updated in accordance with the procedure laid down in 
Regulation (EC) No [common procedure].  

The entry of a novel food in the Community list shall include a specification of the 
food,  and,  where  appropriate,  specify  the  conditions  of  use,  additional  specific 
labelling requirements to inform the final consumer and/or a post-market monitoring 
requirement. 

By way of derogation from the third paragraph of Article 7 of Regulation (EC) No 
[common  procedure],  the  updating  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  where  newly  developed 
scientific evidence and proprietary data are protected in accordance with Article 12.  

In  the  cases  referred  to  in  the  first  subparagraph  the  entry  of  a  novel  food  in  the 
Community  list  shall  indicate,  in  addition  to  the  information  referred  to  in 
paragraph 2: 

(a) 

the date of entry of the novel food in the Community list; 

(b) 

the fact that the entry is based on newly developed scientific evidence and/or 
proprietary data protected in accordance with Article 12;  

(c) 

the name and address of the applicant.  

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  accordance  with  the 
regulatory  procedure  with  scrutiny  referred  to  in  Article  14(3)  laid  down  in 
Regulation (EC) No [common procedure] 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  subparagraph  of  this  Article,  are  no  longer 
included.  

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1. 

2. 

3. 

4. 

5. 

6. 

Article 8 
Traditional food from a third country 

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 documented data demonstrating the history 
of safe food use in the third country. 

The  Commission  shall  forward  the  notification  including  the  demonstration  of 
history  of  safe  food  use  referred  to  in  paragraph  1  without  delay  to  the  Member 
States and the Authority.  

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 reasoned 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  placed  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  business  operator  concerned  accordingly 
within five months from the date of the notification in accordance with paragraph 1. 

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.  

The Commission shall publish a list of traditional foods from third countries that may 
be  placed  on  the  market  in  the  Community  in  accordance  with  paragraph  4  on  a 
dedicated page of the Commission's website. 

Detailed  rules  for  the  implementation  of  this  Article,  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  referred  to  in 
Article 14(3). 

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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 and submitting applications under this Regulation. 

Article 10 
Opinion of the Authority 

In assessing the safety of novel foods, the Authority shall:  

(a) 

(b) 

1. 

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; 

take  into  account  for  traditional  food  from  a  third  country,  the  history  of  safe  food 
use. 

Article 11 
Obligations on the food business operators  

The  Commission may impose  for  food safety 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 requirements 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) 

(b) 

any  new  scientific  or  technical  information  which  might  influence  the 
evaluation of the safety in use of the novel food; 

any prohibition or restriction imposed by the competent authority of any third 
country in which the novel food is placed on the market. 

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Chapter III 
General provisions 

Article 12 
Data protection 

On request by the applicant, supported by appropriate and verifiable information included in 
the  application  dossier,  newly  developed  scientific  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 agreement of the applicant. 

Article 13 
Penalties 

The Member  States  shall  lay  down  the  rules on penalties  applicable to  infringements  of the 
provision  of  this  Regulation  and  shall  take  all  measures  necessary  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. 

2. 

3. 

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". 

Where  reference  is  made  to  this  paragraph,  Articles  5  and  7  of  Decision 
1999/468/EC shall apply having regard to the provisions of Article 8 thereof.  

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three 
months. 

Where  reference  is  made  to  this  paragraph,  Article  5a  (1)  to  (4)  and  Article  7  of 
Decision  1999/468/EC  shall  apply,  having  regard  to  the  provisions  of  Article  8 
thereof. 

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Article 15 
Review 

No later than  [1 January  2015] and in the light of experience gained,  the  Commission shall 
forward to the European Parliament and to the Council a report on the implementation of this 
Regulation and in particular of Article 8, accompanied, where 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 the date of application of this 
Regulation. 

Article 17 
Establishment of the Community list 

By  six  months  from  the  date  of  entry  into  force  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  existing  authorisation 
conditions, as appropriate.  

Article 18 
Transitional measures 

1. 

2. 

Any  request  for  placing  a  novel  food  on  the  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. 

Any appropriate transitional measures for the application of paragraph 1, which are 
designed  to  amend  non-essential  elements  of  this  Regulation,  inter  alia  by 
supplementing it, shall be adopted in accordance with the regulatory procedure with 
scrutiny referred to in Article 14(3).  

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Article 19 
Amendments to Regulation (EC) No [common procedure] 

Regulation (EC) No [common procedure] is amended as follows: 

(1) 

The title is replaced by the following: 

"Regulation (EC) No XXX/XXXX of the European Parliament and of the Council of 
[date]  establishing  a  common  authorisation  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  "common  procedure")  for  food  additives,  food 
enzymes, food flavourings and sources of food flavourings used or intended for 
use  in  or  on  foodstuffs  and  novel  foods  (hereinafter  referred  to  as  the 
"substances  or  products"),  which  contributes  to  the  free  movement  of  foods 
within  the  Community  and  to  a  high  level  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  marketing  of  which  is  authorised  in  the 
Community pursuant to Regulation (EC) 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  paragraphs  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 relating 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 the beginning of Article 6, paragraph 1:  

"In  the  case  of  scientific  grounds  for  safety  concerns,  additional  information 
concerning risk assessment, shall be identified and requested from the applicant." 

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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 date of publication of this 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 
The President 

For the Council 
The President 

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