Proposal for a Regulation of the European Parliament and of the Council on food additives {SEC(2006) 1040} {SEC(2006) 1041}
Date: 2006-07-28
Institutions: European Commission
Subjects: approximation of laws, consumer protection, food additive, foodstuff, foodstuffs legislation, labelling, public health, single market

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 28.7.2006 
COM(2006) 428 final 

2006/0145 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on food additives  

(presented by the Commission) 

{SEC(2006) 1040} 
{SEC(2006) 1041} 

EN 

   EN 

 
 
 
  
 
EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

• 

Grounds for and objectives of the proposal 

The Commission announced in the White Paper on Food Safety (COM (1999) 
719  final)  that  it  would  up-date  and  simplify  existing  Community  legislation 
with regard to food additives (Action 11 in the White Paper).The objectives of 
this proposal are: 

– 

– 

– 

– 

– 

To simplify food additive legislation by creating a single instrument for 
principles, procedures and approvals; 

To  confer  the  implementing  powers  on  the  Commission  to  update  the 
Community list of authorised food additives; 

To  consult  the  European  Food  Safety  Authority  (EFSA)  for  the  safety 
evaluation of food additives; 

To set up a re-evaluation programme for existing food additives; 

To  require  the  authorisation  of  additives  that  consist  of,  contain  or  are 
produced  from  genetically  modified  organism  under  Regulation  (EC) 
No 1829/2003  of  the  European  Parliament  and  of  the  Council  of 
22 September 2003 on genetically modified food and feed. 

• 

General context 

Authorisation and use  of  food additives in foodstuffs has been harmonised in 
the European Union since 1995 when the last of the specific directives on food 
additives  (95/2/EC)  was  adopted.  The  current  legislation  consists  of  4  co-
decision  directives  (framework  and  3  specific  directives)  and  3  Commission 
Directives (specifications).  

Food additives legislation is the only technical area where the approval for use 
of  a  substance  requires  a  co-decision  procedure,  which  makes  managing  the 
approvals cumbersome and slow. 

Two related proposals are proposed simultaneously:  

1. 

Proposal  on  Regulation  (EC)  No  […]  establishing  a  common 
authorisation  procedure  for  food  additives,  food  enzymes  and  food 
flavourings 

2. 

Proposal on Regulation for food enzymes. 

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• 

Existing provisions in the area of the proposal 

Council  Directive  89/107/EEC  on  the  approximation  of  the  laws  of  the 
Member  States  concerning  food  additives  authorised  for  use  in  foodstuffs 
intended  for  human  consumption  lays  down  the  general  principles  for 
authorisation of food additives in the European Union. 

This Directive is complemented with the European Parliament and the Council 
Directives 94/35/EC on sweeteners for use in foodstuffs, 94/36/EC on colours 
for  use  in  foodstuffs  and  95/2/EC  on  food  additives  other  than  colours  and 
sweeteners.  These  3  directives  lay  down  the  list  of  authorised  food  additives 
and their conditions of use to the exclusion of all others.  

In addition, the European Parliament and the Council have adopted a Decision 
No  292/97/EC  on  the  maintenance  of  national  laws  prohibiting  the  use  of 
certain additives in the production of certain specific foodstuffs. 

The proposal brings together all the above mentioned provisions. 

• 

Consistency with the other policies and objectives of the Union 

Not applicable. 

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  at  several  working  groups  and  during  bilateral  contacts  with 
stakeholders since 2000. Among the stakeholders consulted were: 

BEUC (The European Consumers' Organisation) 

CIAA (Confederation of the food and drink industries of the EU) 

ISA (International Sweeteners Association) 

CEFIC (European Chemical Industry Council) 

AMFEP (Association of Manufacturers and Formulations of Enzyme products) 

ELC (Federation of European Food Additives and Food Enzymes Industries) 

FEDIMA  (Federation  of  the  Intermediate  products  Industries  for  the  Bakery 
and Confectionery trades in the EEA) 

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CAOBISCO  (Association  of  the  Chocolate,  Biscuit  and  Confectionery 
Industries of the EU) 

Moreover, a questionnaire on the impacts of the proposal was circulated to the 
different  stakeholders  on  22.2.2005  to  which  70  replies  were  received  by  the 
end of the consultation 

Summary of responses and how they have been taken into account 

After each consultation, the comments have been considered and the texts have 
been  adapted.  The  following  points  were  specifically  raised  and  comments 
considered as follows: 

1.  Harmonisation and scope of legislation: 

During  the  development  of  this  proposal  it  was  considered  whether  the 
definition  of  processing  aid  could  be  revised  to  reduce  interpretation 
difficulties.  However  the  food  industry  considered  that  such  a  change 
would  cause  a  considerable  impact,  it  was  therefore  decided  not  to 
progress  such  a  change  at  this  stage  but  to  consider  other  approaches 
such  as  development  of  agreed  interpretive  guidelines  based  upon  the 
current definition.  

2. 

Time limited authorisation: 

There  was  a  strong  indication  from  industry  that  a  time  limited 
authorisation  could  be  a  barrier  to  innovation  and  would  introduce 
uncertainty  in  the  food  additives  market.  On  the  other  hand  Member 
States  and  Consumer  organisations  considered  that  additive  approvals 
should be kept under some form of review to ensure that the Regulation 
remains  current.  A  compromise  solution  has  therefore  been  proposed 
where producers or users of additives should provide to the Commission 
on its request information on their actual uses. 

3. 

Transitional periods: 

As  part  of  the  harmonisation  and  development  of  the  scope  of  this 
Regulation it is proposed to additionally regulate the use of additives in 
additives  and  enzymes  as  is  already  the  situation  for  additives  used  in 
flavourings.  Although  this  will  have  some  impact  on  the  food  industry 
this  move  has  been  generally  welcomed  by  all  stakeholders.  The  food 
industry did however suggest that an appropriate time period be included 
to  allow  for  this  change.  This  proposal  therefore  foresees  a  transitional 
period of 5 years to reduce the impact of this measure. 

• 

Collection and use of expertise 

There was no need for external expertise. 

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• 

Impact assessment 

Environmental impact 

There  would  be  no  environmental  impacts  from  any  of  the  policy  options 
considered,  since  the  industry  concerned  is  involved  in  secondary  or  tertiary 
processing of food products. Additives are already widely available and widely 
used. 

No action 

Economic impact 

The process of amending additive authorisations would still require the lengthy 
co-decision  procedure  including  the  time  spent  by  the  Member  States  on 
implementing  the  authorisation.  This  would  continue  to  act  as  a  barrier  to 
innovation  by  industry,  and  as  a  consequence  technological  developments 
would not be encouraged. 

Social impact 

EFSA  would  not  be  required  to  carry  out  a  review  reassessing  all  currently 
approved  additives  and  consumers  would  not  benefit  from  the  additional 
controls on the use of additives used in food additives and enzymes. 

Non legislative action 

Economic impact 

The process of amending additive authorisations would still require the lengthy 
codecision  procedure  including  the  time  spent  by  the  Member  States  on 
implementing  the  authorisation.  This  would  continue  to  act  as  a  barrier  to 
innovation  by  industry,  whereby  technological  developments  would  not  be 
encouraged.  Member  States  and  stakeholders  would  have  to  elaborate  and 
agree a code of practice on the use of additives in additives and in enzymes.  

Social impact 

Consumers would not benefit from increased assurance on the safety of food.  

Legislative option 

Additive  legislation  is  already  harmonised  across  the  European  Community, 
and  therefore  many  aspects  of  the  proposed  legislative  action  will  have  a 
limited impact. This action will however affect all food additive manufacturers 
and will have some consequential impacts on the food industry.  

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Economic impact 

The  introduction  of  comitology  for  additive  approvals  will  have  a  positive 
impact  on  industry  as  the  procedures  for  permitting  new  additives  will  be 
faster.  This  has  the  potential  to  stimulate  investment  in  developing  new 
additives  by  removing  many  of  the  delays  currently  associated  with  realising 
the  benefits  of  new  developments.  There  will  be  an  economic  impact  of  the 
extension  of  the  scope  to  cover  additives  in  additives  and  enzymes,  where 
some new substances may require authorisation, however the number of such 
substances is thought to be low. There will also be a small impact as a result of 
updating  technical  data  sheets  and  also  from  minor  changes  in  labelling  as  a 
result of enzymes being removed from the scope. However, these will be one 
off  costs  and  the  effect  should  be  dissipated  by  the  use  of  suitable  transition 
periods  included  to  allow  time  to  adapt  to  these  changes.  Such  changes  are 
unlikely to affect the cost of goods sold to consumers. 

Social impact 

Consumers  will  benefit  from  increased  assurances  on  the  composition  and 
safety  of  the  food  which  they  purchase.  Consumer  organisations,  however, 
have voiced some concern that the introduction of comitology may reduce the 
overall  transparency  of  the  process,  where  authorisations  will  no  longer  be 
scrutinised  and  debated  to  the  same  extent  by  the  European  Parliament.  The 
use of comitology is however appropriate as food additive legislation is one of 
the  few  areas  in  food  law  where  co-decision  is  still  required  for  largely 
technical  amendments.  Consumer  need  and  technological  benefit  will  remain 
as  important  parameters  to  be  considered  by  Member  States  representatives 
when authorisations are debated under the comitology procedure. In addition to 
formal  comitology  procedures  and  the  routine  publishing  of  agendas  for 
standing  committee  meetings  on  the  internet,  other  methods  of  consultation 
will  continue.  These  will  include  discussing  amendments  to  legislation  in 
expert  working  groups  or  other  fora  to  which  consumer  groups  and  other 
stakeholders are routinely invited. 

Deregulation of additive legislation 

Economic impact 

Deregulation  could  result  in  different  risk  assessments  being  undertaken  for 
additives between Member States. Member States could also stipulate different 
procedures for authorisation. Such a move would therefore have an impact on 
the  administrative  burden  for  the  competent  authorities  of  Member  States  in 
undertaking this additional work. As a consequence this would also present a 
considerable administrative burden on food additive manufacturers whereby it 
would  be  necessary  to  apply  for  authorisation  individually  in  all  the  Member 
States in which they wish to use the additive. This would also have an effect on 
the food industry and international trade.  

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Social impact 

Although the general principles of food law apply, the deregulation of additives 
legislation could still lead to a deterioration of consumer protection relating to 
food  additives.  This  could  arise  due  to  different  degrees  of  risk  assessment 
being  carried  out  in  Member  States  combined  with  potential  differences  in 
interpretation  of  such  assessments.  The  resulting  divergence  in  additive 
authorisations would also complicate procedures for estimating and comparing 
the intake of authorised food additives across the European Union and within 
individual Member States where imported foods would be subject to different 
additive authorisations. 

The  Commission  carried  out  an  impact  assessment  listed  in  the  Work 
Programme, 
on 
accessible 
http://ec.europa.eu/food/food/chemicalsafety/additives/index_en.htm. 

whose 

report 

is 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

• 

Summary of the proposed action 

Creation  of  a  Regulation  of  the  European  Parliament  and  of  the  Council  on 
food additives that lays down the principles for the use of food additives and 
lays down the positive list of substances that may be used as food additives. 

Repeal of Council Directive 89/107/EEC on the approximation of the laws of 
the  Member States concerning  food additives authorised for use in foodstuffs 
intended for human consumption, European Parliament and Council Directives 
94/35/EC on sweeteners for use in foodstuffs, 94/36/EC on colours for use in 
foodstuffs  and  95/2/EC  on  food  additives  other  than  colours  and  sweeteners 
and the European Parliament and the Council Decision No. 292/97/EC on the 
maintenance  of  national  laws  prohibiting  the  use  of  certain  additives  in  the 
production of certain specific foodstuffs. 

• 

Legal basis 

Article 95 

• 

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 reason(s). 

Action  by  Member  States  only  could  lead  to  a  confusing  situation  for  the 
consumers,  with  different  levels  of  protection,  and  a  loss  of  confidence  in 
certain Member States and in the internal market. 

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Community  action  will  better  achieve  the  objectives  of  the  proposal  for  the 
following reason(s). 

A  positive  list  with  about  300  food  additives  needs  to  be  managed.  This 
requires a harmonised and centralised approach. 

Efficiency  of  the  authorisation  procedure  and  effective  functioning  of  the 
internal market will indicate that the objectives are best met by the European 
Union. 

Effective functioning of the internal market in relation to food additives used in 
and  on  food  while  protecting  the  health  and  the  interest  of  the  European 
consumers can best be met via a centralised procedure for authorisation. 

The proposal therefore complies with the subsidiarity principle. 

• 

Proportionality principle 

The  proposal  complies  with  the  proportionality  principle  for  the  following 
reason(s). 

The  proposed  measure  simplifies  current  provisions  by  combining  four  co-
decision Directives and one Decision and confers the implementing powers to 
the Commission to create and update the Community list of food additives. The 
proposed measure is a Regulation to accelerate the entry into force of approvals 
and to avoid misinterpretation of provisions. 

Administrative  burden  will  be  minimised  as  the  Regulation  will  be  directly 
applicable.  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 reason(s). 

The area of food additives is fully harmonised in the EU. The safe use of food 
additives depends on the safety evaluations and permitted conditions of use of 
these  substances,  therefore  recommendations  or  self-regulations  would  not 
guarantee the protection of consumer's health. This proposal combines current 
framework Directive and specific Directives to a single instrument to facilitate 
the use of food additives in the EU. 

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4. 

BUDGETARY IMPLICATION 

The Community may finance the establishment of a harmonised policy and system in 
the field of food additives including: 

– 

– 

– 

development  of  an  appropriate  database  for  gathering  and  storing  all 
information relating to Community legislation on food additives, 

undertaking  studies  necessary  for  the  preparation  and  development  of 
legislation on food additives,  

undertaking  studies  necessary  to  harmonise  procedures,  decision-making 
criteria  and  data  requirements,  to  facilitate  work  sharing  between  Member 
States and to develop guidance in these areas.  

5. 

ADDITIONAL INFORMATION 

• 

Simulation, pilot phase and transitory period 

There was or there will be a transitory period for the proposal. 

• 

Simplification 

The proposal provides for simplification of legislation. 

There will be only one co-decision Regulation to manage instead of the current 
four. The positive list can be created and updated by comitology procedure. In 
addition  as  the  measure  is  a  Regulation  this  will  accelerate  considerably  the 
approval procedure for food additives. 

The  proposal  is  included  in  the  Commission's  Work  and  Legislative 
Programme under the reference 2005/SANCO/034. 

• 

Repeal of existing legislation 

The adoption of the proposal will lead to the repeal of existing legislation. 

• 

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 - Subject matter, scope and definitions 

Food additives used in foods, in food additives and  in food enzymes shall be 
subject to safety evaluation and approval via community positive lists.  

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Chapter II - Community lists of approved food additives 

All  food  additives  and  their  use  in  food  will  be  evaluated  for  the  following 
criteria:  safety,  technological  need,  benefit  to  the  consumer  and  that  the 
consumer is not being misled by the use. 

In line with the decision to separate risk management and risk assessment, all 
applications  for  the  approval  of  new  food  additives  will  be  directed  to  EFSA 
which will carry out the safety evaluations. The inclusion of a food additive in 
the Community positive list will be considered by the Commission on the basis 
of the opinion from EFSA. In addition to the safety of the substance, the other 
general  criteria  (technological  need,  consumer  aspects)  have  to  be  examined 
before  a  food  additive  may  be  included  in  the  Community  positive  list.  This 
will be done by the Standing Committee on the Food Chain and Animal Health 
(SCFCAH). 

The  final  inclusion  in  the  positive  list  will  be  done  by  the  Commission  by 
entering the food additive and its conditions of use in Annexes II and III of this 
Regulation. 

A  food  additive  which  consists,  contains  or  is  produced  from  a  genetically 
modified organism, should be authorised in respect of the genetic modification 
according to Regulation (EC) No 1829/2003 on genetically modified food and 
feed, prior to its inclusion in the positive list under this Regulation. 

For every authorised food additive included in the positive list a specification 
must be laid down. This contains the criteria on purity and defines the origin of 
a food additive.  

Chapter III - Use of food additives in foods 

General rules on placing on the market of foods containing food additives are 
laid down. 

Chapter IV - Labelling 

Labelling of food additives sold to the manufacturer or directly to the consumer 
is regulated by Directive 89/107/EC. This proposal up-dates these rules. 

Chapter V - Procedural provisions and implementation 

To  ensure  that  food  additives  once  permitted  are  kept  under  continuous 
observation  and  re-evaluated  wherever  necessary  producers  or  users  of  food 
additives  will  be  obliged  to  inform  the  Commission  of  any  new  information 
which  may  affect  the  safety  assessment  of  the  food  additive.  They  shall  also 
provide  data  on  the  usage  of  food  additives  to  enable  assessments  of  dietary 
intake to be undertaken. 

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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  use  of  a  food 
additive  and  laying  down  the  conditions  of  use  in  the  positive  list  as  well  as 
laying down specifications, including criteria on origin and purity criteria and 
the verification of such criteria. 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 VI - Transitional and final provisions 

Food  additives  currently  included  in  Directives  94/35/EC,  94/36/EC  and 
95/2/EC shall be entered in Annex II of this proposal after a review carried out 
by  the  SCFCAH.  The  Standing  Committee  will  evaluate  the  compliance  of 
existing  authorisations  for  food  additives  and  their  conditions  of  use  with  the 
general  criteria  laid  down  in  the  Regulation  taking  into  account  the  latest 
scientific opinion on the safety of the food additive. Until the Committee has 
completed 
the  above-mentioned 
Directives shall remain applicable.  

the  review  of  existing  authorisations, 

The Authority shall carry out a risk assessment on all currently approved food 
additives. In consultation with the Authority, the Commission should set up an 
evaluation programme in order to define the need and the order of priorities for 
the risk assessment. Time limits for the evaluation should be laid down in the 
programme.  

Provisions  on  additives  in  food  additives  (other  than  carriers)  and  in  food 
enzymes  will  apply  after  an  appropriate  interval  to  provide  time  for  safety 
assessments to be undertaken. 

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2006/0145 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on food additives  

(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 Treaty, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

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,  and  to 
their social and economic interests. 

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

This Regulation replaces previous Directives and Decisions concerning food additives 
permitted  for  use  in  foods  with  a  view  to  ensuring  the  effective  functioning  of  the 
internal  market  and  a  high  level  of  protection  of  human  health  and  the  interests  of 
consumers via comprehensive and streamlined procedures. 

This Regulation harmonises the use of food additives in foods in the Community. This 
includes the use of food additives in foods covered by 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 uses3 and the use of certain food colours 
for  the  health  marking  of  meat  and  the  decoration  and  stamping  of  eggs.  It  also 
harmonises the use of food additives in food additives and food enzymes thus ensuring 
their safety and quality and facilitating their storage and use. The last category has not 
previously been regulated at Community level. 

1 
2 
3 

OJ C […], […], p. […].  
OJ C […], […], p. […].  
OJ  L  186,  30.6.1989.  Directive  as  last  amended  by  Regulation  (EC)  No  1882/2003  of  the  European 
Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). 

EN 

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(5) 

(6) 

(7) 

(8) 

Food  additives  are  substances  that  are  not  normally  consumed  as  food  itself  but  are 
added  to  food  intentionally  for  a  technological  purpose,  such  as  the  preservation  of 
food. However, substances should not be considered as food additives when they are 
used  for  the  purpose  of  imparting  flavour  and/or  taste.  Moreover,  substances 
considered as foods which may be used for a technological function, such as sodium 
chloride  or  saffron  for  colouring  and  food  enzymes  should  also  not  fall  within  the 
scope  of  this  Regulation.  Finally,  as  regard  food  enzymes,  they  are  covered  by 
Regulation  (No)  …[on  food  enzymes]4,  which  excludes  the  application  of  this 
Regulation. 

Substances  not  consumed  as  food  itself  but  used  intentionally  in  the  processing  of 
foods, which only remain as residues in the final food and do not have a technological 
effect in the final product (processing aids), should not be covered by this Regulation. 

Food additives should be approved and used only if they fulfil the criteria laid down in 
this Regulation. Food additives must be safe when used, there must be a technological 
necessity  for  their  use,  their  use  must  not  mislead  the  consumer  and  their  use  must 
bring a benefit to the consumer.  

Food  additives  must  at  all  times  comply  with  the  approved  specifications.  The 
specification  should  include  information  to  adequately  identify  the  food  additive, 
including  origin  and  to  describe  the  acceptable  criteria  of  purity.  The  specifications 
previously developed for food additives included in Commission Directive 95/31/EC 
of 5 July 1995 laying down specific criteria of purity concerning sweeteners for use in 
foodstuffs5,  Commission  Directive  95/45/EC  of  26  July  1995  laying  specific  purity 
criteria concerning colours for use in foodstuffs6 and Commission Directive 96/77/EC 
of 2 December 1996 laying down specific purity criteria on food additives other than 
colours  and  sweeteners7  should  be  maintained  until  the  corresponding  additives  are 
entered  in  the  Annexes  to  this  Regulation.  At  that  time,  the  specifications  related  to 
such  additives  should  be  set  out  in  a  Regulation.  Those  specifications  should relate 
directly  to  the  additives  included  in  the  Community  lists  in  the  Annexes  to  this 
Regulation.  However, considering  the  complex  character  and  substance  of  such 
specifications for the sake of clarity, they should not be integrated as such in the those 
Community lists but should be set out in one or more separate Regulations. 

(9) 

Some food additives are permitted for specific uses for certain authorised oenological 
practices  and  processes.  The  use  of  such  food  additives  should  comply  with  this 
Regulation  and  with  the  specific  provisions  laid  down  in  the  relevant  Community 
legislation.  

4 
5 

6 

7 

OJ L […], dd/mm/yyyy, p. […]. 
OJ L 178, 28.7.1995, p. 1. Directive as last amended by Directive 2004/46/EC (OJ L 114, 21.4.2004, 
p. 15). 
OJ L 226, 22.9.1995, p. 1. Directive as last amended by Directive 2004/47/EC (OJ L 113, 20.4.2004, 
p. 24). 
OJ L 339, 30.12.1996, p. 1. Directive as last amended by Directive 2004/45/EC (OJ L 113, 20.4.2004, 
p. 19). 

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(10) 

In  order  to  ensure  uniformity,  the  risk  assessment  and  approval  of  food  additives 
should be carried out in accordance with the procedure laid down in Regulation (EC) 
No  […]  establishing  a  common  authorisation  procedure  for  food  additives,  food 
enzymes and food flavourings8.  

(11)  Under 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 safety9 the European Food Safety Authority (’the Authority’), is to be 
consulted on matters likely to affect public health. 

(12)  A food additive which falls 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  feed10  should  be  authorised  under  that  Regulation  prior  to  its 
approval under this Regulation. 

(13)  A  food  additive  already  approved  under  this  Regulation  which  is  prepared  by 
production methods or starting materials significantly different from those included in 
the  risk  assessment  of  the  Authority,  or  different  than  those  covered  by  the 
specifications  laid  down,  should  be  submitted  for  evaluation  by  the  Authority  for  an 
evaluation  with  emphasis  on  the  specifications.  Significantly  different  production 
methods  or  starting  materials  could  mean  a  change  of  the  production  method  from 
extraction  from  a  plant  to  production  by  fermentation  using  a  micro-organism  or  a 
genetic modification of the original micro-organism. 

(14)  Food additives should be kept under continuous observation and must be re-evaluated 
whenever  necessary  in  the  light  of  changing  conditions  of  use  and  new  scientific 
information. 

(15)  Member States which have maintained prohibitions on the use of certain additives in 
certain  specific  foods  which  are  considered  traditional  and  are  produced  on  their 
territory  should  be  permitted  to  continue  to  apply  those  prohibitions.  Moreover,  as 
regard  products  such  as  ‘Feta’  or  ‘Salame  cacciatore’,  the  present  Regulation  is 
without prejudice to more restrictive rules linked to the use of certain denominations 
under  Council  Regulation  (EEC)  No  2081/92  of  14  July  1992  on  the  protection  of 
geographical  indications  and  designations  of  origin  for  agricultural  products  and 
foodstuffs11 and Council Regulation (EEC) No 2082/92 of 14 July 1992 on certificates 
for specific character for agricultural products and foodstuffs12.  

8 
9 

10 
11 

12 

OJ L […], […], p. […]. 
OJ L 31, 1.2.2002, p. 1. Regulation as amended by Regulation (EC) 1642/2003 (OJ L 245, 29.9.2003, 
p. 4). 
OJ L 268, 18.10.2003, p. 1.  
OJ  L  208,  24.7.1992,  p.  1.  Regulation  as  last  amended  by  Regulation  (EC)  No  806/2003  (OJ  L  122, 
16.5.2003, p. 1). 
OJ L 208, 24.7.1992, p. 9. Regulation as last amended by Regulation (EC) No 806/2003. 

EN 

14 

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(16)  Food  additives  remain  subject  to  the  general  labelling  obligations  as  provided  for  in 
Directive  2000/13/EC  and,  as  the  case  may  be,  in  Regulations  (EC)  Nos  1829/2003 
and 1830/2003. In addition, specific provisions on labelling of food additives sold as 
such  to  the  manufacturer  or  to  the  final  consumer  should  be  contained  in  this 
Regulation. 

(17)  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 Commission13.  

(18) 

In  order  to  develop  and  update  Community  legislation  on  food  additives  in  a 
proportionate and effective way, it is necessary to collect data, share information and 
coordinate  work  between  Member  States.  For  that  purpose,  it  may  be  useful  to 
undertake studies to address specific issues with the view to facilitating the decision-
making process. It is appropriate that the Community may finance such studies as part 
of its budgetary procedure. The financing of such measures is covered by 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 rules14 and consequently the legal basis for the 
financing of the above measures will be Regulation (EC) No 882/2004. 

(19)  Member States are to carry out official controls in order to enforce compliance with 

this Regulation in accordance with Regulation (EC) No 882/2004.  

(20)  Since the objective of the action to be taken, namely to lay down Community rules on 
food  additives  cannot  be  sufficiently  achieved  by  the  Member  States  and  can 
therefore, by reason of market unity and high level of consumer  protection 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. 

(21)  Following  the  adoption  of  this  Regulation  the  Commission  assisted  by  the  Standing 
Committee  on  Food  Chain  and  Animal  Health  should  review  all  the  existing 
authorisations for criteria, other than safety, such as intake, technological need and the 
potential  to  mislead  the  consumer.  All  food  additives  that  are  to  continue  to  be 
authorised  in  the  Community  should  be  transferred  to  the  Community  lists  in 
Annexes II  and  III  to  this  Regulation.  Annex  III  to  this  Regulation  should  be 
completed with the other food additives used in food additives and enzymes and their 
conditions of use in accordance with Regulation (EC) No […] establishing a common 
authorisation  procedure  for  food  additives,  food  enzymes  and  food  flavourings.  To 
allow  a  suitable  transition  period,  the  provisions  in  Annex  III,  other  than  the 
provisions concerning carriers for food additives, should not apply until [1.1.2011]. 

13 
14 

OJ L 184, 17.7.1999, p. 23. 
OJ L 165, 30.4.2004, p. 1. Corrected version (OJ L 191, 28.5.2004, p. 1). 

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15 

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(22)  Without  prejudice  to  the  outcome  of  that  review,  within  one  year  following  the 
adoption of this Regulation, the Commission should set up an evaluation programme 
for  the  Authority  to  re-evaluate  the  safety  of  the  food  additives  that  were  already 
approved in the Community. That programme should define the needs and the order of 
priorities according to which the approved food additives are to be examined.  

(23)  This  Regulation  repeals  and  replaces  the  following  acts:  Council  Directive 
62/2645/EEC on the approximation of the rules of the Member States concerning the 
colouring matters authorised for use in foodstuffs intended for human consumption15, 
Council Directive 65/66/EEC of 26 January 1965 laying specific criteria on purity for 
preservatives  authorised  for  use  in  foodstuffs  intended  for  human  consumption16, 
Council Directive 78/663/EEC of 25 July 1978 laying down specific criteria of purity 
for  emulsifiers,  stabilizers,  thickeners  and  gelling  agents  for  use  in  foodstuffs17, 
Council Directive 78/664/EEC of 25 July 1978 laying down specific criteria of purity 
for antioxidants which may be used in foodstuffs intended for human consumption18, 
First  Commission  Directive  81/712/EEC  of  28  July  1981  laying  down  Community 
methods  of  analysis  for  verifying  that  certain  additives  used  in  foodstuffs  satisfy 
criteria  of  purity19,  Council  Directive  89/107/EEC  of  21  December  1988  on  the 
approximation of the laws of the Member States concerning food additives authorised 
for  use  in  foodstuffs  intended  for  human  consumption20,  Directive  94/35/EC  of  the 
European  Parliament  and  of  the  Council  of  30  June  1994  on  sweeteners  for  use  in 
foodstuffs21, Directive 94/36/EC of the European Parliament and of the Council of 30 
June  1994  on  colours  for  use  in  foodstuffs22,  Directive  95/2/EC  of  the  European 
Parliament  and  of  the  Council  of  20  February  1995  on  food  additives  other  than 
colours and sweeteners23 and Decisions 292/97/EC of the European Parliament and of 
the Council of 19 December 1996 on the maintenance of national laws prohibiting the 
use  of  certain  additives  in  the  production  of  certain  specific  foodstuffs24  and 
Commission Decision 2002/247/EC of 27 March 2002 suspending the placing on the 
market and import of jelly confectionary containing the food additive E 425 konjac25. 
However, it is appropriate that certain provisions of those acts remain in force during a 
transitional  period  to  allow  time  for  the  preparation  of  the  Community  lists  in  the 
Annexes to the present Regulation,  

15 

16 

17 

18 
19 
20 

21 
22 
23 
24 
25 

OJ  L  115,  11.11.1962,  p.  2645/62.  Directive  as  last  amended  by  Directive  95/45/EC  (OJ  L  226, 
22.9.1995, p. 1). 
OJ  22,  9.2.1965,  p.  373.  Directive  as  last  amended  by  Commission  Directive  96/77/EC  (OJ  L  339, 
30.12.1996, p. 1). 
OJ  L  223,  14.8.1978,  p.  7.  Directive  as  amended  by  Commission  Directive  92/4/EC  (OJ  L  55, 
29.2.1992, p. 96). 
OJ L 223, 14.8.1978, p. 30. Directive as last amended by Commission Directive 96/77/EC. 
OJ L 257, 10.9.1981. p. 1. 
OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003 of the European 
Parliament and of the Council. 
OJ L 237, 10.9.1994, p. 3. Directive as last amended by Regulation (EC) 1882/2003. 
OJ L 237, 10.9.1994, p. 13. Directive as amended by Regulation (EC) 1882/2003. 
OJ L 61, 18.3.1995, p. 3. Directive as last amended by Regulation (EC) 1882/2003. 
OJ L 48, 19.2.1997, p. 13.  
OJ L 84, 28.3.2002, p. 69. 

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HAVE ADOPTED THIS REGULATION: 

CHAPTER I 
SUBJECT-MATTER, SCOPE AND DEFINITIONS 

Article 1 
Subject matter 

This  Regulation  lays  down  rules  on  food  additives  used  in  foods  to  ensure  the  effective 
functioning of the internal market and a high level of human health protection and consumer 
protection. 

For those purposes, this Regulation provides for:  

(a) 

(b) 

(c) 

1. 

2. 

3. 

4. 

Community lists of approved food additives; 

conditions of use of food additives in foods, in food additives and in food enzymes; 

rules on labelling of food additives sold as such.  

Article 2 
Scope 

This Regulation shall apply to food additives.  

This Regulation shall not apply to the following substances unless they are used as 
food additives: 

(a) 

processing aids;  

(b) 

substances  used  for  the  protection  of  plants  and  plant  products  in  conformity 
with Community rules relating to plant health;  

(c) 

substances added to foods as nutrients;  

(d) 

substances  used  for  the  treatment  of  water  for  human  consumption  falling 
within the scope of Council Directive 98/83/EC26. 

This  Regulation  shall  not  apply  to  food  enzymes  falling  within  the  scope  of 
Regulation (EC) No […/..] [on food enzymes].  

This  Regulation  shall  apply  without  prejudice  to  any  specific  Community  rules 
concerning the use of food additives: 

(a) 

in specific foods; 

26 

OJ L 330, 5.12.1998, p. 32. 

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17 

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5. 

1. 

2. 

(b) 

for purposes other than those covered by this Regulation.  

Where necessary, it may be decided in accordance with the procedure referred to in 
Article  28(2)  as  to  whether  or  not  a  given  substance  falls  within  the  scope  of  this 
Regulation.  

Article 3 
Definitions 

For  the  purposes  of  this  Regulation,  the  definitions  laid  down  in  Regulations  (EC) 
Nos 178/2002 and 1829/2003 shall apply. 

The following definitions shall also apply: 

(a) 

‘food additive’ shall mean any substance not normally consumed as a food in 
itself and not normally used as a characteristic ingredient of food, whether or 
not  it  has  nutritive  value,  the  intentional  addition  of  which  to  food  for  a 
technological  purpose  in  the  manufacture,  processing,  preparation,  treatment, 
packaging,  transport  or  storage  of  such  food  results,  or  may  be  reasonably 
expected  to  result,  in  it  or  its  by-products  becoming  directly  or  indirectly  a 
component of such foods;  

however, the following are not considered to be food additives:  

(i) 

(ii) 

foods  containing  monosaccharides,  disaccharides  or  oligosaccharides 
used for their sweetening properties; 

foods,  whether  dried  or  in  concentrated  form,  including  flavourings 
incorporated  during  the  manufacturing  of  compound  foods,  because  of 
their  aromatic,  sapid  or  nutritive  properties  together  with  a  secondary 
colouring effect; 

(iii)  substances used in covering or coating materials, which do not form part 

of foods and are not intended to be consumed together with those foods; 

(iv)  products containing pectin and derived from dried apple pomace or peel 
of  citrus  fruits,  or  from  a  mixture  of  both,  by  the  action  of  dilute  acid 
followed by partial neutralisation with sodium or potassium salts ('liquid 
pectin'); 

(v) 

chewing gum bases;  

(vi)  white or yellow dextrin, roasted or dextrinated starch, starch modified by 
acid or alkali treatment, bleached starch, physically modified starch and 
starch treated by amylolitic enzymes; 

(vii)  ammonium chloride;  

(viii)  blood  plasma,  edible  gelatin,  protein  hydrolysates  and  their  salts,  milk 

protein and gluten;  

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18 

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(ix)  amino acids and their salts other than glutamic acid, glycine, cysteine and 

cystine and their salts having no technological function;  

(x) 

caseinates and casein; 

(xi) 

inulin; 

(b) 

‘processing aid’ shall mean any substance which:  

(i) 

is not consumed as a food by itself;  

(ii) 

is  intentionally  used  in  the  processing  of  raw  materials,  foods  or  their 
ingredients, to fulfil a certain technological purpose during treatment or 
processing; and 

(iii)  may  result  in  the  unintentional  but  technically  unavoidable  presence  in 
the final product of residues of the substance or its derivatives provided 
they  do  not  present  any  health  risk  and  do  not  have  any  technological 
effect on the final product;  

(c) 

(d) 

‘functional class’ shall mean one of the categories set out in Annex I based on 
the technological function a food additive exerts in the foodstuff;  

‘unprocessed food’ shall mean a food which has not undergone any treatment 
resulting  in  a  substantial  change  in  the  original  state  of  the  food,  for  which 
purpose the following in particular are not regarded as resulting in substantial 
change: dividing, parting, severing, boning, mincing, skinning, paring, peeling, 
grinding, cutting, cleaning, trimming, deep-freezing, freezing, chilling, milling, 
husking, packing or unpacking; 

(e) 

‘food with no added sugars’ shall mean a food without the following:  

(i) 

any added monosaccharides, disaccharides or oligosaccharides; or 

(ii) 

food  containing  monosaccharides,  disaccharides  or  oligosaccharides 
which is used for its sweetening properties;  

‘energy-reduced  food’  shall  mean  a  food  with  an  energy  value  reduced  by  at 
least 30% compared with the original food or a similar product; 

‘table-top sweeteners’ shall mean preparations of permitted sweeteners, which 
may  contain  other  food  additives  and/or  food  ingredients  and  which  are 
intended for sale to the final consumer as a substitute for sugar. 

(f) 

(g) 

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CHAPTER II 
COMMUNITY LISTS OF APPROVED FOOD ADDITIVES 

Article 4 
Community lists of food additives 

1. 

2. 

3. 

4. 

5. 

Only food additives included in the Community list in Annex II may be placed on the 
market as such and used in foods, including foodstuffs for particular nutritional uses 
falling within the scope of Directive 89/398/EEC.  

Only food additives included in the Community list in Annex III may be used in food 
additives and in food enzymes.  

The listing of food additives in Annex II shall be made on the basis of the categories 
of food to which they may be added. 

The  listing  of  food  additives  in  Annex  III  shall  be  made  on  the  basis  of  the  food 
additives or food enzymes or categories thereof to which they may be added. 

Food  additives  shall  at  all  times  comply  with  the  specifications  as  referred  to  in 
Article 12.  

Article 5 
General conditions for inclusion and use of food additives in Community lists  

1. 

A food additive may be included in the Community lists in Annexes II and III only if 
it meets the following conditions: 

(a) 

(b) 

it  does  not,  on  the  basis  of  the  scientific  evidence  available,  pose  a  safety 
concern to the health of the consumer at the level of use proposed; 

there  is  a  reasonable  technological  need  that  cannot  be  achieved  by  other 
economically and technologically practicable means; 

(c) 

its use does not mislead the consumer. 

2. 

To  be  included  in  the  Community  lists  in  Annexes  II  and  III  a  food  additive  must 
have  advantages  and  benefits  for  the  consumer  and  therefore  serve  one  or  more  of 
the following purposes: 

(a) 

preserving the nutritional quality of the food;  

(b)  providing  necessary  ingredients  or  constituents  for  foods  manufactured  for 

groups of consumers with special dietary needs; 

(c) 

enhancing  the  keeping  quality  or  stability  of  a  food  or  improving  its 
organoleptic  properties,  provided  that  the  nature,  substance  or  quality  of  the 
food is not changed in such a way as to mislead the consumer; 

EN 

20 

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(d) 

aiding  in  the  manufacture,  processing,  preparation,  treatment,  packing, 
transport  or  storage  of  food,  provided  that  the  food  additive  is  not  used  to 
disguise  the  effects  of  the  use  of  faulty  raw  materials  or  of  any  undesirable 
practices  or  techniques,  including  unhygienic  practices  or  techniques,  during 
the course of any such activities. 

3. 

By way of derogation from point (a) of paragraph 2, a food additive which reduces 
the nutritional quality of a food may be included in the Community list in Annex II 
provided that: 

(a) 

the food does not constitute a significant component of a normal diet; or  

(b) 

the  food  additive  is  necessary  for  the  production  of  foods  for  groups  of 
consumers with special dietary needs. 

Article 6 
Specific conditions for sweeteners 

A food additive may be included in the Community list in Annex II for the functional class of 
sweetener only if, in addition to serving one or more of the purposes set out in Article 5(2), it 
also serves one or more of the following purposes: 

(a) 

(b) 

(c) 

replacing sugars for the production of energy-reduced food, non-cariogenic food or 
food with no added sugars; 

extending shelf life through the replacement of sugars;  

producing food intended for particular nutritional uses as defined in Article 1 (2)(a) 
of Directive 89/398/EEC.  

Article 7 
Specific conditions for colours 

A food additive may be included in the Community list in Annex II for the functional class of 
colour only if, in addition to serving one or more of the purposes set out in Article 5(2), it also 
serves one of the following purposes: 

(a) 

(b) 

(c) 

restoring  the  original  appearance  of  food  of  which  the  colour  has  been  affected  by 
processing,  storage,  packaging  and  distribution,  whereby  visual  acceptability  may 
have been impaired; 

making food more visually appealing; 

giving colour to food otherwise colourless.  

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Article 8 
Functional classes of food additives 

1. 

2. 

1. 

Food  additives  may  be  assigned  to  one  of  the  functional  classes  in  Annex  I  on  the 
basis of the principal technological function of the food additive.  

Allocating a food additive to a functional class shall not preclude it from being used 
for several functions.  

Where  necessary,  as  a  result  of  scientific  progress  or  technological  development, 
additional  functional  classes  may  be  added  to  Annex  I  in  accordance  with  the 
procedure referred to in Article 28(2).  

Article 9 
The content of the Community lists of food additives 

A  food  additive  which  complies  with  the  conditions  set  out  in  Articles  5,  6  and  7 
may, in accordance with the procedure laid down in Regulation (EC) No [common 
procedures], be included in: 

(a) 

the Community list in Annex II to the present Regulation; and/or  

(b) 

the Community list in Annex III to the present Regulation.  

2. 

The  entry  for  a  food  additive  in  the  Community  lists  in  Annexes  II  and  III  shall 
specify: 

(a) 

the name of the food additive and its E number if one has been assigned;  

(b) 

the foods to which the food additive may be added; 

(c) 

the conditions under which the food additive may be used; 

(d) 

if appropriate, whether there are any restrictions on the sale of the food additive 
directly to consumers. 

3. 

The Community lists in Annexes II and III shall be amended in accordance with the 
procedure  referred  to  in  Regulation  (EC)  No  […]  establishing  a  common 
authorisation procedure for food additives, food enzymes and food flavourings. 

Article 10  
Levels of use of food additives 

1. 

When establishing the conditions of use referred to in Article 9(2)(c):  

(a) 

the level of use shall be set at the lowest level necessary to achieve the desired 
effect; 

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22 

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(b) 

the level shall take into account: 

(i) 

any acceptable daily intake, or equivalent assessment, established for the 
food additive and the probable daily intake of it from all sources; 

(ii)  where the food additive is to be used in foods eaten by special groups of 
consumers, the possible daily intake of the food additive by consumers in 
those groups. 

2. 

3. 

4. 

Where  appropriate,  no  maximum  level  shall  be  fixed  for  a  food  additive  (quantum 
satis).  In  that  case,  the  food  additive  shall  be  used  in  accordance  with  good 
manufacturing practice, at a level not higher than is necessary to achieve the intended 
purpose and provided that the consumer is not misled. 

The maximum levels of use of food additives set out in Annex II apply to ready-to-
eat  foods  prepared  in  accordance  with  the  instructions  for  use  unless  otherwise 
stated.  

The  maximum  levels  for  colours  set  out  in  Annex  II  apply  to  the  quantities  of 
colouring principle contained in the colouring preparation unless otherwise stated. 

Article 11 
Food additives falling within the scope of Regulation (EC) No 1829/2003 

A food additive falling within the scope of Regulation (EC) No 1829/2003 may be included in 
the  Community  lists  in  Annexes  II  and  III  to  the  present  Regulation  only  after  it  has  been 
authorised in accordance with Article 7 of Regulation (EC) No 1829/2003.  

Article 12 
Specifications of food additives 

The  specifications  of  food  additives  relating,  in  particular,  to  origin,  purity  criteria  and  any 
other  necessary  information,  shall  be  adopted  when  the  food  additive  is  included  in  the 
Community  lists  in  Annexes  II  and  III  for  the  first  time,  in  accordance  with  the  procedure 
referred  to  in  Regulation  EC  […establishing  a  common  authorisation  procedure  for  food 
additives, food enzymes and food flavourings].  

CHAPTER III 
USE OF FOOD ADDITIVES IN FOODS  

Article 13 
Use of food additives in unprocessed foods 

Food additives shall not be used in unprocessed foods, except where such use is specifically 
provided for in Annex II. 

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Article 14  
Use of colours and sweeteners in foods for infants and young children 

Colours and sweeteners shall not be used in foods for infants and young children as referred 
to in Directive 89/398/EEC, including dietary foods for infants and young children for special 
medical  purposes,  except  where  specifically  provided  for  in  Annex  II  to  the  present 
Regulation. 

Article 15  
Use of colours for markings 

Only food colours listed in Annex II to the present Regulation may be used for the purpose of 
health  marking  as  provided  for  in  Council  Directive  91/497/EEC27  and  other  markings 
required on meat products, for the decorative colouring of eggshells and for the stamping of 
eggshells as provided for in Commission Regulation (EEC) No 1274/9128. 

Article 16 
Carry-over principle 

1. 

The presence of a food additive shall be permitted: 

(a) 

in  a  compound  food  other  than  as  referred  to  in  Annex  II,  where  the  food 
additive is permitted in one of the ingredients of the compound food;  

(b) 

in a food to which a flavouring has been added, where the food additive: 

(i) 

is permitted in the flavouring in compliance with this Regulation;  

(ii)  has been carried over to the food via the flavouring;  

(iii)  has no technological function in the final food;  

(c) 

in a food which is to be used solely in the preparation of a compound food and 
provided that the compound food complies with this Regulation. 

2. 

3. 

Paragraph  1  of  this  Article  shall  not  apply  to  infant  formulae,  follow-on  formulae, 
processed  cereal-based  foods  and  baby  foods  and  dietary  foods  for  special  medical 
purposes  intended  for  infants  and  young  children  as  referred  to  in  Directive 
89/398/EEC, except where specifically provided for.  

Where  a  food  additive  in  a  flavouring,  food  additive  or  food  enzyme  is  added  to  a 
food and has a technological function in that food, then it shall be considered a food 
additive of that food and not a food additive of the added flavouring, food additive or 
food enzyme. 

27 
28 

OJ L 268. 24.9.1991, p. 69. 
OJ L 121, 16.5.1991, p. 11. 

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4. 

Without  prejudice  to  paragraph  1,  the  presence  of  an  intense  sweetener  shall  be 
permitted in a compound food with no added sugar, in an energy-reduced compound 
food, in compound dietary foods intended for low-calorie diets, and in a compound 
food with a long shelf-life, provided that the intense sweetener is permitted in one of 
the ingredients of the compound food.  

Article 17 
Interpretation decisions 

Where  necessary,  a  it  may  be  decided  in  accordance  with  the  procedure  referred  to  in 
Article 28(2) as to whether or not: 

(a) 

(b) 

a particular food belongs to a category of food referred to in Annex II; or 

a food additive listed in Annexes II and III and permitted at “quantum satis” is used 
in accordance with the criteria referred to in Article 10(2). 

Article 18 
Traditional foods 

The Member States listed in Annex IV may continue to prohibit the use of certain categories 
of food additives in the traditional foods produced on their territory as listed in that Annex.  

CHAPTER IV 
LABELLING 

SECTION 1 
LABELLING OF FOOD ADDITIVES NOT INTENDED FOR SALE TO THE FINAL 
CONSUMER 

Article 19 
Labelling of food additives not intended for sale to the final consumer 

Food additives not intended for sale to the final consumer, whether sold singly or mixed with 
each other and/or with ingredients as defined in Article 6(4) of Directive 2000/13/EC may be 
marketed  only  if  their  packaging  or  containers  bear  the  information  provided  for  in 
Articles 20  to  23  of  this  Regulation,  which  must  be  easily  visible,  clearly  legible  and 
indelible. 

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25 

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Article 20 
Information requirements concerning the identification of food additives 

1. 

2. 

Where food additives not intended for sale to the final consumer, are sold singly or 
mixed  with  each  other,  their  packaging,  or  containers  shall  bear  the  following 
information in respect of each food additive: 

(a) 

the name and/or its E-number laid down in this Regulation; or  

(b) 

in  the  absence  of  a  name  and/or  E-number,  as  referred  to  in  point  (a),  a 
description of the food additive that is sufficiently precise to distinguish it from 
products with which it could be confused.  

Where food additives are sold mixed with each other, the information provided for in 
paragraph 1 shall be given in respect of each food additive, in descending order of its 
percentage by weight of the total. 

Article 21 
Information requirements where other substances, materials or food ingredients are 
incorporated in food additives 

Where substances, materials or food ingredients other than food additives are incorporated in 
food  additives  not  intended  for  sale  to  the  final  consumer  to  facilitate  their  storage,  sale, 
standardisation,  dilution  or  dissolution, 
the  packaging,  containers  or  accompanying 
documents of the food additives shall bear the information provided for in Article 20 and an 
indication of each component in descending order of its percentage by weight of the total.  

Article 22 
Information requirements where food additives are mixed with other food ingredients 

Where food additives not intended for sale to the final consumer are mixed with other food 
ingredients,  the  packaging  or  containers  of  the  food  additives  shall  bear  a  list  of  all 
components in descending order of their percentage by weight of the total. 

Article 23 
General information requirements for food additives 

1. 

The  packaging  or  containers  of  food  additives  not  intended  for  sale  to  the  final 
consumer shall bear the following information:  

(a) 

the statement either ‘for use in food' or the statement ‘restricted use in food' or 
a more specific reference to its intended food use;  

(b) 

if necessary, the special conditions of storage and use; 

(c) 

instructions for use, if the omission thereof would preclude appropriate use of 
the food additive; 

EN 

26 

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(d) 

a mark identifying the batch or lot; 

(e) 

the name or business name and address of the manufacturer, packager or seller; 

(f)  where  a  component  of  the  food  additive  is  subject  to  a  limit  on  quantity  in 
food,  an  indication  of  that  component’s  percentage  of  the  food  additive  or 
sufficient  information  on  the  composition  of  the  food  additive  to  enable  the 
purchaser  to  ensure  compliance  with  the  limit  on  quantity  in  food;  where  the 
same  limit  on  quantity  applies  to  a  group  of  components  used  singly  or  in 
combination,  the  combined  percentage  may  be  given  as  a  single  figure;  the 
limit on quantity shall be expressed either numerically or by the quantum satis 
principle;  

(g) 

the net quantity; 

(h)  where relevant, information on a food additive or other substances referred to 
in Articles 20, 21 and 22, of the present Regulation and listed in Annex IIIa to 
Directive  2000/13/EC  as  regards  the  indication  of  the  ingredients  present  in 
foodstuffs.  

2. 

By way of derogation from paragraph 1, the information required in points (c) to (f) 
and point (h) of that paragraph may appear merely on the documents relating to the 
consignment which are to be supplied with or prior to the delivery, provided that the 
indication “intended for the manufacture of food and not for retail sale” appears on 
an easily visible part of the packaging or container of the product in question. 

SECTION 2 
LABELLING OF FOOD ADDITIVES INTENDED FOR SALE TO THE FINAL CONSUMER 

Article 24 
Labelling of food additives intended for sale to the final consumer 

1. 

Without  prejudice  to  Directive  2000/13/EC,  food  additives  intended  for  sale  to  the 
final  consumer  may  be  marketed  only  if  their  packaging  contains  the  following 
information, which must be easily visible, clearly legible and indelible: 

(a) 

the name under which the food additive is sold; that name shall be constituted 
by  the  name  laid  down  by  any  Community  provisions  applying  to  the  food 
additive in question and its E-number;  

(b) 

the  information  required  in  accordance  with  Articles  20,  21  and  22  and 
points(a) to (e), (g) and (h) of Article 23(1). 

2. 

The  sales  description  of  a  table-top  sweetener  shall  include  the  term  ‘.  .  .  -based 
table-top sweetener’, using the name(s) of the sweetener(s) used in its composition. 

EN 

27 

   EN 

 
3. 

The  labelling  of  a  table-top  sweetener  containing  polyols  and/or  aspartame  and  or 
aspartame-acesulfame salt shall bear the following warnings: 

(a) 

polyols: 'excessive consumption may induce laxative effects’; 

(b) 

aspartame/aspartame-acesulfame salt: ‘contains a source of phenylalanine’. 

SECTION 3 
OTHER LABELLING REQUIREMENTS 

Article 25 
Other labelling requirements 

1. 

2. 

1. 

2. 

Articles 19 to 24 shall be without prejudice to more detailed or more extensive laws, 
regulations or administrative provisions regarding weights and measures or applying 
to  the  presentation,  classification,  packaging  and  labelling  of  dangerous  substances 
and preparations or applying to the transport of such substances. 

The  information  provided  for  in  Articles  19  to  24  shall  be  in  a  language  easily 
understandable to purchasers. 

Within its own territory, the Member State in which the product is marketed may, in 
accordance with the rules of the Treaty, stipulate that this information shall be given 
in one or more of the official languages of the Community, to be determined by that 
Member  State.  The  first  and  second  subparagraph  of  this  paragraph  shall  not 
preclude such information from being indicated in several languages. 

CHAPTER V 
PROCEDURAL PROVISIONS AND IMPLEMENTATION 

Article 26 
Information obligation 

A producer or user of a food additive shall inform the Commission immediately of 
any new scientific or technical information which might affect the assessment of the 
safety of the food additive.  

A producer or user of a food additive shall, at the request of the Commission, inform 
it of the actual use of the food additive. 

EN 

28 

   EN 

 
1. 

2. 

1. 

2. 

Article 27 
Monitoring of food additive intake 

Member States shall maintain systems to monitor the consumption and use of food 
additives  and  report  their  findings  each  year  to  the  Commission  and  the  European 
Food Safety Authority (hereinafter referred to as the ‘Authority’).  

After the Authority has been consulted, a common methodology for the gathering of 
information  by  the  Member  States  on  dietary  intake  of  food  additives  in  the 
Community  may  be  adopted  in  accordance  with  the  procedure  referred  to  in 
Article 28(2). 

Article 28 
Committee 

The Commission shall be assisted by the Standing Committee on the Food Chain and 
Animal Health (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. 

3. 

The Committee shall adopt its Rules of Procedure.  

Article 29 
Community financing of harmonised policies 

The legal basis for the financing of measures resulting from this Regulation is Article 66(1)(c) 
of Regulation (EC) No 882/2004. 

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CHAPTER VI 
TRANSITIONAL AND FINAL PROVISIONS 

1. 

2. 

3. 

4. 

1. 

2. 

Article 30 
Establishment of Community lists of food additives 

Food  additives  which  were  permitted  for  use  in  foods  under  Directives  94/35/EC, 
94/36/EC and 95/2/EC before the date of entry into force of this Regulation and their 
conditions of use shall be entered in Annex II to the present Regulation after a review 
of their compliance with Articles 5, 6 and 7 of the present Regulation in accordance 
with the procedure referred to in Article 28(2). This review shall not include a new 
risk assessment carried out by the Authority. The review shall be completed by […]  

Food additives authorised for use in food additives as permitted carriers in Annex V 
to Directive 95/2/EC and their conditions of use shall be entered in Annex III, Part 1 
to this Regulation after a review of their compliance with Article 5 of this Regulation 
in  accordance  with  the  procedure  laid  down  in  Article  28(2).  This  review  shall  not 
include  a  new  risk  assessment  carried  out  by  the  Authority.  The  review  shall  be 
completed by […..]. 

Specifications of the food additives covered under paragraphs 1 and 2 of this Article 
shall  be  adopted,  in  accordance  with  Regulation  EC  […establishing  a  common 
authorisation  procedure  for  food  additives,  food  enzymes  and  food  flavourings],  at 
the moment those food additives are entered in the Annexes in accordance with those 
paragraphs. 

Any  appropriate  transitional  measures  may  be  adopted  in  accordance  with  the 
procedure laid down in Article 28(2). 

Article 31 
Re-evaluation of approved food additives 

Food  additives  which  were  permitted  before  the  date  of  entry  into  force  of  this 
Regulation shall be subject to a new risk assessment carried out by the Authority. 

After  consultation  of  the  Authority,  an  evaluation  programme  for  those  additives 
shall be adopted within one year after the date of entry into force of this Regulation, 
in  accordance  with  the  procedure  laid  down  in  Article  28(2).  The  evaluation 
programme shall be published in the Official Journal of the European Union. 

EN 

30 

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1. 

The following acts are repealed: 

Article 32 
Repeals 

(a)  Directive 62/2645/EEC;  

(b)  Directive 65/66/EEC; 

(c)  Directive 78/663/EEC; 

(d)  Directive 78/664/EEC; 

(e)  Directive 81/712/EEC; 

(f)  Directive 89/107/EEC; 

(g)  Directive 94/35/EC; 

(h)  Directive 94/36/EC; 

(i)  Directive 95/2/EC; 

(j)  Decision 292/97/EC; 

(k)  Decision 2002/247/EC.  

2. 

References to the repealed acts shall be construed as references to this Regulation. 

Article 33 
Transitional provisions 

By way of derogation from Article 32, the following provisions shall continue to apply until 
[…]: 

(a) 

(b) 

Article 2 (1), (2) and (4) of Directive 94/35/EC and the Annex thereto; 

Article  2(1)  to  (6),  (8),  (9)  and  (10)  of  Directive  94/36/EC  and  Annexes  I  to  V 
thereto; 

(c) 

Articles 2 and 4 of Directive 95/2/EC and Annexes I to VI thereto.  

Notwithstanding point (c), the authorisations for E 1103 Invertase and E 1105 Lysozyme laid 
down  in  Directive  95/2/EC  are  repealed  with  effect  from  the  date  of  application  of  the 
Community  list  on  food  enzymes  in  accordance  with  Article  18  of  the  [Regulation  on  food 
enzymes]. 

EN 

31 

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Article 34 
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 [one year after the date of publication of this Regulation]. 

However, Article 4(2) shall apply to Parts 2 and 3 of Annex III from [1 January 2011]  

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 

EN 

32 

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Functional classes of food additives in foods and of food additives in food additives and food 
enzymes 

ANNEX I 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 

11. 

12. 

"sweeteners" are substances (bulk sweeteners and intense sweeteners) used to impart 
a sweet taste to foods or in table top sweeteners. 

"colours" are substances which add or restore colour in a food, and include natural 
constituents of foods and natural sources which are normally not consumed as foods 
as  such  and  not  normally  used  as  characteristic 
food. 
Preparations  obtained  from  foods  and  other  natural  source  materials  obtained  by 
physical and/or chemical extraction resulting in a selective extraction of the pigments 
relative  to  the  nutritive  or  aromatic  constituents  are  colours  within  the  meaning  of 
this Regulation. 

ingredients  of 

"preservatives"  are  substances  which  prolong  the  shelf-life  of  foods  by  protecting 
them against deterioration caused by micro-organisms; 

'antioxidants' are substances which prolong the shelf-life of foods by protecting them 
against deterioration caused by oxidation, such as fat rancidity and colour changes; 

'carriers',  are  substances  used  to  dissolve,  dilute,  disperse  or  otherwise  physically 
modify a food additive or a flavouring or food enzyme without altering its function 
(and  without  exerting  any  technological  effect  themselves)  in  order  to  facilitate  its 
handling, application or use; 

'acids' are substances which increase the acidity of a foodstuff and/or impart a sour 
taste to it;  

'acidity regulators' are substances which alter or control the acidity or alkalinity of a 
foodstuff; 

'anti-caking agents' are substances which reduce the tendency of individual particles 
of a foodstuff to adhere to one another;  

'anti-foaming agents' are substances which prevent or reduce foaming;  

'bulking agents' are substances which contribute to the volume of a foodstuff without 
contributing significantly to its available energy value; 

'emulsifiers'  are  substances  which  make  it  possible  to  form  or  maintain  a 
homogenous  mixture  of  two  or  more  immiscible  phases  such  as  oil  and  water  in  a 
foodstuff;  

'emulsifying  salts' are substances which convert proteins contained  in  cheese into a 
dispersed  form  and  thereby  bring  about  homogenous  distribution  of  fat  and  other 
components; 

EN 

33 

   EN 

 
13. 

14. 

15. 

16. 

17. 

18. 

19. 

20. 

21. 

22. 

23. 

24. 

25. 

26. 

'firming agents' are substances which make or keep tissues of fruit or vegetables firm 
or crisp, or interact with gelling agents to produce or strengthen a gel; 

'flavour enhancers' are substances which enhance the existing taste and/or odour of a 
foodstuff; 

'foaming  agents'  are  substances  which  make  it  possible  to  form  a  homogenous 
dispersion of a gaseous phase in a liquid or solid foodstuff;  

'gelling agents' are substances which give a foodstuff texture through formation of a 
gel;  

'glazing  agents'  (including  lubricants)  are  substances  which,  when  applied  to  the 
external  surface  of  a  foodstuff,  impart  a  shiny  appearance  or  provide  a  protective 
coating;  

'humectants'  are  substances  which  prevent  foods  from  drying  out  by  counteracting 
the  effect  of  an  atmosphere  having  a  low  degree  of  humidity,  or  promote  the 
dissolution of a powder in an aqueous medium;  

'modified  starches'  are  substances  obtained  by  one  or  more  chemical  treatments  of 
edible  starches,  which  may  have  undergone  a  physical  or  enzymatic  treatment,  and 
may be acid or alkali thinned or bleached;  

'packaging gases' are gases other than air, introduced into a container before, during 
or after the placing of a foodstuff in that container;  

'propellants' are gases other than air which expel a foodstuff from a container;  

'raising agents' are substances or combinations of substances which liberate gas and 
thereby increase the volume of a dough or a batter;  

'sequestrants' are substances which form chemical complexes with metallic ions;  

'stabilisers' are substances which make it possible to maintain the physico-chemical 
state of a foodstuff; stabilisers include substances which enable the maintenance of a 
homogenous  dispersion  of  two  or  more  immiscible  substances  in  a  foodstuff, 
substances  which  stabilise,  retain  or  intensify  an  existing  colour  of  a  foodstuff  and 
substances which increase the binding capacity of the food, including the formation 
of  cross-links  between  proteins  enabling  the  binding  of  food  pieces  into  re-
constituted food. 

‘thickeners’ are substances which increase the viscosity of a foodstuff; 

‘flour  treatment  agents’  are  substances,  other  than  emulsifiers,  which  are  added  to 
flour or dough to improve its baking quality. 

EN 

34 

   EN 

 
Community list of food additives approved for use in foods and conditions of use. 

ANNEX II 

EN 

35 

   EN 

 
Community list of food additives approved for use in food additives and food enzymes, and 
conditions of use. 

ANNEX III 

Part 1  Carriers in food additives 

Part 2  Additives other than carriers in food additives 

Part 3  Additives in food enzymes 

EN 

36 

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ANNEX IV 

Traditional foods for which certain Member States may continue to prohibit the use of 
certain categories of food additives 

Member State 

Foods 

Germany 

France 

France 

France 

France 

Austria 

Finland 

Sweden 
Finland 

Denmark 

Denmark 

Spain 

Italy 

Italy 

Categories of additives 
which may continue to be 
banned 

All except propellant gases 

Traditional German beer (“Bier nach 
deutschem Reinheitsgebot gebraut”) 

Traditional French bread 

All 

Traditional French preserved truffles 

All 

Traditional French preserved snails 

Traditional French goose and ducks 
preserves (“confit”) 

All 

All 

Traditional Austrian “Bergkäse” 

All except preservatives 

Traditional Finnish “Mämmi” 

All except preservatives 

Traditional Swedish and Finnish fruit 
syrups 

Colours 

Traditional Danish “Kødboller” 

Preservatives and colours 

Traditional Danish “Leverpostej” 

Preservatives (other than 
sorbic acid) and colours 

Traditional Spanish “Lomo 
embuchado” 

All except preservatives and 
antioxidants 

Traditional Italian “Mortadella” 

Traditional Italian “Cotechino e 
zampone” 

All except preservatives, 
antioxidants, pH-adjusting 
agents, flavour enhancers, 
stabilisers and packaging gas 

All except preservatives, 
antioxidants, pH-adjusting 
agents, flavour enhancers, 
stabilisers and packaging gas 

EN 

37 

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LEGISLATIVE FINANCIAL STATEMENT 

1. 

NAME OF THE PROPOSAL: 

Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  on  food 
additives. 

2. 

ABM / ABB FRAMEWORK 

Policy Area(s) concerned: Health and Consumer Protection 

Activity/Activities: Food Safety, Animal Health, Animal Welfare and Plant Health 

3. 

BUDGET LINES 

3.1.  Budget  lines  (operational  lines  and  related  technical  and  administrative 

assistance lines (ex- B..A lines)) including headings: 

17.01.04.05:  Feed  and  food  safety  and  related  activities  —  Expenditure  on 
administrative management. 

3.2.  Duration of the action and of the financial impact: 

Open ended 

3.3.  Budgetary characteristics (add rows if necessary):  

Budget 
line 

Type of expenditure 

New 

EFTA 
contribution 

Contributions 
from applicant 
countries 

Heading in 
financial 
perspective 

17.01.04.05 

Comp/ 

Diff29 

NO 

NO 

NO 

No 1a 

In  order  to  develop  and  update  Community  legislation  on  food  additives  in  a 
proportionate and effective way, it may be useful to undertake studies to collect 
data,  share  information  and  coordinate  work  between  Member  States.  This 
kind  of  support  expenditure,  indicated  under  points  4.1  and  8.1,  is  covered  by 
Regulation  (EC)  no  882/2004  on  official  feed  and  food  controls  within  the 
amounts foreseen for its implementation during 2007/2013. 

29 

Differentiated appropriations. 

EN 

38 

   EN 

 
 
 
                                                 
4. 

SUMMARY OF RESOURCES 

4.1.  Financial Resources 

4.1.1. Summary  of 

commitment  appropriations 

(CA)  and  payment 

appropriations (PA) 

EUR million (to 3 decimal places) 

Expenditure type 

Section 
no. 

Year 
n 

n + 1 

n + 2 

n + 3 

n + 4 

n + 5 
and 
later 

Total 

Operational 
expenditure30 

Commitment 
Appropriations 
(CA) 

Payment 
Appropriations 
(PA) 

Administrative 
amount31 

Technical & 
administrative 
assistance (NDA) 

8.1 

a 

0.1 

0.05 

0.05 

0.05 

0.05 

0.05 

0.35 

b 

0.1 

0.05 

0.05 

0.05 

0.05 

0.05 

0.35 

expenditure  within 

reference 

8.2.4. 

c 

0.0 

0.0 

0.0 

0.0 

0.0 

0.0 

0.0 

TOTAL REFERENCE AMOUNT 

Commitment 
Appropriations 

Payment 
Appropriations 

a+c 

0.1 

0.05 

0.05 

0.05 

0.05 

0.05 

0.35 

b+c 

0.1 

0.05 

0.05 

0.05 

0.05 

0.05 

0.35 

Administrative expenditure not included in reference amount32 

Human resources 
and associated 
expenditure 
(NDA) 

Administrative 
costs, other than 
human resources 
and associated 
costs, not included 
in reference 
amount (NDA) 

8.2.5. 

d 

8.2.6. 

e 

30 
31 
32 

Expenditure that does not fall under Chapter xx 01 of the Title xx concerned. 
Expenditure within article xx 01 04 of Title xx. 
Expenditure within chapter xx 01 other than articles xx 01 04 or xx 01 05. 

EN 

39 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Total indicative financial cost of intervention 

TOTAL CA 
including cost of 
Human 
Resources 

TOTAL PA 
including cost of 
Human 
Resources 

Co-financing details 

a+c
+d+
e 

b+c
+d+
e 

0.1 

0.05 

0.05 

0.05 

0.05 

0.05 

0.35 

0.1 

0.05 

0.05 

0.05 

0.05 

0.05 

0.35 

If  the  proposal  involves  co-financing  by  Member  States,  or  other  bodies  (please 
specify  which),  an  estimate  of  the  level  of  this  co-financing  should  be  indicated  in 
the table below (additional lines may be added if different bodies are foreseen for the 
provision of the co-financing): 

EUR million (to 3 decimal places) 

Year 
n 

n + 1 

n + 2 

n + 3 

n + 4 

n + 5 
and 
later 

Total 

Co-financing body 

…………………… 

TOTAL CA including co-
financing 

f 

a+c
+d+
e+f 

4.1.2. Compatibility with Financial Programming 

(cid:50) 

(cid:133) 

(cid:133) 

Proposal is compatible with existing financial programming. 

Proposal  will  entail  reprogramming  of  the  relevant  heading  in  the 
financial perspective. 

Proposal  may  require  application  of  the  provisions  of  the 
Interinstitutional Agreement33 (i.e. flexibility instrument or revision 
of the financial perspective). 

4.1.3. Financial impact on Revenue 

(cid:50) 

Proposal has no financial implications on revenue 

(cid:133) 

Proposal has financial impact – the effect on revenue is as follows: 

NB:  All  details  and  observations  relating  to  the  method  of  calculating  the 

effect on revenue should be shown in a separate annex. 

33 

See points 19 and 24 of the Interinstitutional agreement. 

EN 

40 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Budget line 

Revenue 

EUR million (to one decimal place) 

Prior to
action 
[Year n-
1] 

[Year 
n] 

Situation following action 

[n+1] 

[n+2] 

[n+3] 

[n+4] 

[n+5]34

(a) Revenue in absolute terms  

(b) Change in revenue 

 ∆ 

(Please specify each revenue budget line involved, adding the appropriate number of 
rows to the table if there is an effect on more than one budget line.) 

4.2.  Human Resources FTE (including officials, temporary and external staff) 

– see detail under point 8.2.1. 

Annual requirements 

Year n 

n + 1 

n + 2 

n + 3 

n + 4 

n + 5 
and 
later 

Total  number  of  human 
resources 

0.4 

0.4 

0.4 

0.4 

0.4 

0.4 

5. 

CHARACTERISTICS AND OBJECTIVES 

Details of the context of the proposal are required in the Explanatory Memorandum. 
This  section  of  the  Legislative  Financial  Statement  should  include  the  following 
specific complementary information: 

5.1.  Need to be met in the short or long term 

Legislation on Food additives is harmonised within the EU. Presently there are 
around 330 food additives permitted under the legislation and requests to allow 
additional  additives  or  new  uses  of  additives  are  continually  being  presented. 
When assessing new additives and additional uses of additives data on usage is 
needed for risk management decisions. 

In  order  to  assure  proportionality  of  the  implementing  measures  that  will  be 
taken in the framework of the proposed regulation and to meet the objectives of 
Regulation  (EC)  882/2004  on  official  feed  and  food  control,  the  following 
instruments are therefore needed:  

• 

An appropriate database for gathering and storing all information relating 
to Community legislation on food additives, 

34 

Additional columns should be added if necessary i.e. if the duration of the action exceeds 6 years. 

EN 

41 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
• 

• 

undertaking of studies necessary for the preparation and development of 
legislation on food additives, 

undertaking  of  studies  necessary  to  harmonise  procedures,  decision-
making criteria and data requirements, to facilitate work sharing between 
Member States and to develop guidance in these areas 

5.2.  Value-added  of  Community  involvement  and  coherence  of  the  proposal 

with other financial instruments and possible synergy 

The data and information obtained will help in assuring the best protection of 
the health of the consumer while allowing industry to continue to develop and 
use food additives.  

In the harmonised market this can only be achieved via a coordinated approach 
allowing exchange of comparable information between Member States. 

5.3.  Objectives,  expected  results  and  related  indicators  of  the  proposal  in  the 

context of the ABM framework 

Objective 1:  Create and maintain a database and undertake related studies in 
collaboration with external organisations to be selected via the 
appropriate procedures. 

Objective 2:  Assure  that  the  use  of  food  additives  does  not  lead  to 
unacceptable risks for the consumer and at the same time does 
not impose unnecessary burden to the industry. 

Objective 3:  To  make  risk  management  decisions  based  on  appropriate 
estimations  of  intake  via  a  centralised  database  containing 
updated  information  about  composition  and  the  use  of  food 
additives. 

5.4.  Method of Implementation (indicative) 

Show below the method(s)35 chosen for the implementation of the action. 

X 

Centralised Management 

X 

directly by the Commission 

35 

If  more  than  one  method  is  indicated  please  provide  additional  details  in  the  "Relevant  comments" 
section of this point. 

EN 

42 

   EN 

 
 
 
 
 
 
 
 
 
 
 
                                                 
(cid:133) 

indirectly by delegation to: 

(cid:133) 

executive Agencies 

(cid:133) 

(cid:133) 

bodies set up by the Communities as referred to in art. 185 of 
the Financial Regulation 

national  public-sector  bodies/bodies  with  public-service 
mission 

(cid:133) 

Shared or decentralised management 

(cid:133)  with Member states 

(cid:133)  with Third countries 

(cid:133) 

Joint management with international organisations (please specify) 

Relevant comments: 

6. 

MONITORING AND EVALUATION 

6.1.  Monitoring system 

The content of the database and the conclusions of the results of the studies can 
be monitored via their usability for proposing good implementing measures. A 
basic  tool  will  be  the  Standing  Committee  for  the  Food  Chain  and  Animal 
Health. 

6.2.  Evaluation 

6.2.1. Ex-ante evaluation 

The anticipated expenditure is not significant and therefore data for an ex 
ante evaluation are not currently available. 

6.2.2. Measures  taken  following  an  intermediate/ex-post  evaluation  (lessons 

learned from similar experiences in the past) 

6.2.3. Terms and frequency of future evaluation 

Ongoing in relation to the need to propose implementing measures. 

7. 

ANTI-FRAUD MEASURES  

EN 

43 

   EN 

 
 
 
 
8. 

DETAILS OF RESOURCES 

8.1.  Objectives of the proposal in terms of their financial cost 

Type of output 

Av. 
cost 

Year n 

Year n+1 

Year n+2 

Year n+3 

Year n+4 

Year n+5 and 
later 

TOTAL 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

Commitment appropriations in EUR million (to 3 decimal places) 

1 

1 

0.137 

0.1 

1 

1 

0.0538 

0.05 

1 

1 

0.05 

0.05 

1 

1 

0.05 

0.05 

1 

1 

0.05 

0.05 

1 

1 

0.05 

0.05 

6 

6 

0.35 

0.35 

(Headings of 
Objectives, 
actions and 
outputs should be 
provided) 

OPERATIONAL 
OBJECTIVE 
36
No.1

TOTAL COST 

36 
37 
38 

As described under Section 5.3. 
Creation of the database. 
Updating and maintaining database, and organising related studies. 

EN 

44 

EN 

 
  
 
 
 
 
 
                                                 
8.2.  Administrative Expenditure 

8.2.1. Number and type of human resources 

Types of post 

Staff to be assigned to management of the action using existing and/or 
additional resources (number of posts/FTEs) 

Year n 

Year n+1  Year n+2  Year n+3  Year n+4  Year n+5 

Officials or 
temporary 
staff39  
(17 01 01) 

A*/AD 

0.2 

B*, 
C*/AST 

0.2 

0.2 

0.2 

0.2 

0.2 

0.2 

0.2 

0.2 

0.2 

0.2 

0.2 

Staff  financed40  by  art. 
XX 01 02 

Other  staff41  financed  by 
art. XX 01 04/05 

TOTAL 

0.4 

0.4 

0.4 

0.4 

0.4 

0.4 

8.2.2. Description of tasks deriving from the action 

Examination  of 
commitments and pass to payment 

technical  and  financial  reports,  preparations  of 

8.2.3. Sources of human resources (statutory) 

When more than one source is stated, please indicate the number of posts 
originating from each of the sources 

X 

(cid:133) 

(cid:133) 

(cid:133) 

(cid:133) 

Posts  currently  allocated  to  the  management  of  the  programme  to 
be replaced or extended 

Posts pre-allocated within the APS/PDB exercise for year n 

Posts to be requested in the next APS/PDB procedure 

Posts  to  be  redeployed  using  existing  resources  within  the 
managing service (internal redeployment) 

Posts  required  for  year  n  although  not  foreseen  in  the  APS/PDB 
exercise of the year in question 

39 
40 
41 

Cost of which is NOT covered by the reference amount. 
Cost of which is NOT covered by the reference amount. 
Cost of which is included within the reference amount. 

EN 

45 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
8.2.4. Other  Administrative  expenditure  included  in  reference  amount  (XX  01 

04/05 – Expenditure on administrative management) 

EUR million (to 3 decimal places) 

Budget line 
(number and heading) 

Year 
n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

Year 
n+5  
and 
later 

TOTAL 

1. 

Technical and 
administrative 
assistance (including 
related staff costs) 

Executive agencies42 

Other 
and 
technical 
administrative assistance 

– 

– 

intra muros  

extra muros 

Total Technical and 
administrative assistance 

8.2.5. Financial cost of human resources and associated costs not included in 

the reference amount 

Type of human resources 

Year n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

Year 
n+5 
and later 

EUR million (to 3 decimal places) 

Officials and temporary staff 
(XX 01 01) 

Staff financed by Art XX 01 
02 (auxiliary, END, contract 
staff, etc.) 

(specify budget line) 

Total cost of Human 
Resources and associated 
costs (NOT in reference 
amount) 

Calculation – Officials and Temporary agents 

42 

Reference should be made to the specific legislative financial statement for the Executive Agency(ies) 
concerned. 

EN 

46 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Reference should be made to Point 8.2.1, if applicable 

Calculation – Staff financed under art. XX 01 02 

Reference should be made to Point 8.2.1, if applicable 

8.2.6.  Other  administrative  expenditure  not  included  in  reference 

amount 

EUR million (to 3 decimal places)

Year 
n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

Year 
n+5 
and 
later 

TOTAL 

XX 01 02 11 01 – Missions 

XX 01 02 11 02 – Meetings & 
Conferences 

XX 
02 
01 
Committees43  

11 

03 

– 

XX  01  02  11  04  –  Studies  & 
consultations 

XX 01 02 11 05 - Information 
systems 

Total  Other  Management 
Expenditure 
(XX 01 02 11) 

Other  expenditure  of  an 
administrative 
nature 
(specify  including  reference  to 
budget line) 

2. 

3. 

Total  Administrative  expenditure, 
other  than  human  resources  and 
associated  costs  (NOT  included  in 
reference amount) 

Calculation – Other administrative expenditure not included in reference amount 

43 

Specify the type of committee and the group to which it belongs. 

EN 

47 

   EN