Amended proposal for a Regulation of the European Parliament and of the Council on food additives (presented by the Commission pursuant to Article 250 (2) of the EC Treaty)
Date: 2007-10-24
Institutions: European Commission
Subjects: approximation of laws, consumer protection, food additive, food safety, foodstuff, foodstuffs legislation, labelling

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 24.10.2007 
COM(2007) 673 final 

2006/0145 (COD) 

Amended proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on food additives 

(presented by the Commission pursuant to Article 250 (2) of the EC Treaty) 

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EXPLANATORY MEMORANDUM 

I. 

PROCEDURE 

1.  On  28th  July  2006,  the  Commission  adopted  the  proposal  for  a  European 
Parliament  and  Council  Regulation  on  food  additives  [Document  (COM 
(2006)0428 final)] as part of a package of four proposals on food improvement 
agents.  The  proposal  was  submitted  to  the  Council  and  the  European 
Parliament on 28th July 2006. 

2. 

3. 

4. 

5. 

The Economic and Social Committee adopted its opinion on 25th April 2007. 

The  Council  has  agreed  a  ‘general  approach’  on  the  proposal  at  the  EPSCO 
meeting on 31st May 2007. 

The European Parliament has given in first reading a favourable opinion on the 
proposal on 10th July 2007 

The  present  proposal  amends  the  original  proposal  [COM  (2006)0428  – 
2006/0145(COD)] so as to take into account the amendments of the European 
Parliament that were accepted by the Commission. 

6.  With  regard  to  the  original  proposal,  the  European  Parliament  adopted  59 
amendments.  Commissioner  Kyprianou  had  indicated  to  the  plenary  meeting 
on  9  July  2007  that  the  Commission  could  accept  many  of  the  amendments, 
wholly  or  in  part,  and  subject  to  rewording.  The  amendments  that  cannot  be 
accepted by the Commission are: 10, 11, 12, 20, 24, 25, 29, 30, 34, 38, 40, 45, 
47, 52, 54, 5, 6, 69rev, 73 and78.  

7. 

The  amendments  in  the  revised  proposal  are  in  bold  and  underlined.  A 
number of amendments have been reformulated so as to ensure consistency of 
the  terminology  used  throughout  the  proposal  and  the  other  proposals  of  the 
package,  or  to  bring  the  text  in  line  with  the  approach  of  the  Council  where 
similar amendments have been proposed.  

8. 

The numbering of the Articles has been adapted to take into account a number 
of amendments.  

II. 

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; 

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– 

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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. 

III. 

OVERVIEW OF THE AMENDMENTS OF THE EUROPEAN PARLIAMENT 

9. 

Technical/editorial amendments 

A  number  of  the  proposed  amendments  aim  to  improve  the  proposal  from  a 
technical  and  editorial  point  of  view.  These  amendments  have  largely  been 
taken  over  by  the  Commission  although  some  have  been  subject  to  editorial 
amendment (Amendments concerned: 3, 8, 13, 14, 15, 16, 18, 19, 21, 22, 33 (in 
part), 36, 37, 39, 42, 43, 44, 46, 48,67rev, 79, 68rev, 80, 51, 55, 56, 57, 58, 59 , 
60 and 64rev.) 

10.  Scope (Article 2) 

Amendment 10 cannot be accepted as plant protection products used for post 
harvest  treatment  are  already  subject  to  separate  Community  legislation. 
However if the substance(s) used for post harvest treatment does not fall under 
the plant protection product definition it would be considered as a food additive 
if exerting a preservative effect.  

In the amended proposal, the Commission has not taken on board amendment 
11  which  would  exclude  microbial  cultures  from  the  scope  of  the  legislation. 
Some  cultures  are  added  to  foods  near  the  end  of  their  manufacture  for  an 
intended  preservation  effect  and  therefore  could  be  considered  to  be  food 
additives. It is therefore not appropriate to exclude such substances from food 
additives legislation.  

11.  Comitology  

Since  the  package  was  adopted  around  the  time  that  Decision  2006/512/EC 
amending Decision 1999/468/EC laying down the procedures for the exercise 
of  implementing  powers  conferred  on  the  Commission  was  adopted,  the 
Commission  proposal  referred  to  the  normal  regulatory  procedure.  Therefore 
the alignment of the amended proposal with Decision 2006/512/EC is generally 
endorsed by the Commission.  

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However amendment 12 introduces the regulatory procedure with scrutiny for 
deciding  whether  or  not  a  given  substance  falls  within  the  scope  of  the 
Regulation. The application of this provision is an implementation of the rules 
contained in the basic act ('food additive' definition) and therefore does not fall 
within  the  new  regulatory  procedure  with  scrutiny.  The  normal  regulatory 
procedure should therefore apply. Similarly amendments 40 and 47 cannot be 
accepted  as  they  also  relate  to  provisions  the  application  of  which  are  an 
implementation of the rules contained in the basic act and therefore do not fall 
within the new regulatory procedure with scrutiny. 

12.  Prohibition of non-compliant food additives (Article 5) 

Amendments 9 and 22 aim to clarify that a food additive or a food in which a 
food additive is used should not be placed on the market, if the food additive or 
its  use  does  not  comply  with  the  proposed  Regulation.  This  clarification  is 
endorsed in the amended proposal with the inclusion of Article 5.  

13.  Criteria for authorisation (Article 6)  

The Commission proposal sets criteria for the authorisation of food additives. 
Food additives must be safe; there must be a technological need for their use; 
and their use must not mislead the consumer. The Commission introduced into 
the  amended  proposal  in  recital  7  the  clarification  of  what  is  meant  by 
misleading the consumer (amendments 3 and 26). The principle of amendment 
28  has  also  been  included  in  recital  8  of  the  amended  proposal  which  will 
reiterate that the authorisations of food additives will refer to the consideration 
of the criteria in the Regulation. 

However,  amendment  78  requires  the  authorisation  of  food  additives  to  be 
based  on  the  precautionary  principle.  The  precautionary  principle  and  the 
conditions  for  its  application  are  already  laid  down  in  the  General  Food  Law 
(Regulation (EC) No 178/2002) and it should not be repeated in the proposed 
Regulation on food additives. 

Amendment 24 proposes to link the technological need of a food additive with 
the benefit to the consumer. The technological function of a food additive can, 
in  many  cases,  be  beneficial  for  manufacturers  without  having  a  detrimental 
effect nor a direct benefit for the consumer. An example of this could be when 
the use of a food additive reduces wastage in a production process.  

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The environmental impact is not among the general conditions for authorising 
food  additives  but  it  is  of  course  a  legitimate  factor  to  be  considered.  For 
instance when adverse environmental effects are identified, these can be taken 
into account during the authorisation or revision of the conditions of use for a 
food  additive.  Therefore,  although  amendment  25  cannot  be  accepted,  other 
changes  can  be  made  to  the  text  to  reinforce  the  environmental  aspects. 
Similarly  amendment  7  can  be  accepted  subject  to  modification  to  reflect  the 
other principles contained within the General Food Law, i.e. that the rules on 
food additives used in foods will ensure the effective functioning of the internal 
market  and  a  high  level  of  protection  of  human  health  and  protection  of 
consumers'  interests,  including  fair  practices  in  food  trade,  taking  account  of 
the environment.  

In relation to amendment 1, the allergenicity of food (including food additives) 
is covered by labelling under Directive 2000/13/EC. Although the Commission 
cannot accept an outright restriction on the use of food additives which may be 
allergenic, the allergenicity can of course be considered as a legitimate factor 
during  the  authorisation  of  a  food  additive.  This  principle  has  therefore  been 
emphasised in recital 7.  

14.  Criteria for authorisation (sweeteners) (Article 7)  

Amendments 20 and 29 cannot be accepted. The current criteria of the use of 
sweeteners  restrict  their  use  to  foods  which  are  energy  reduced  or  which 
contain  no  added  sugar.  This  ensures  that  consumers  have  a  benefit  from  the 
use  of  such  sweeteners  in  that  there  is  either  an  appreciable energy reduction 
(of 30%) or the product contains no added sugars. The new criterion proposed 
here has the potential to increase the range of foods to which sweeteners can be 
used and therefore may have an impact on the consumption of such additives. 
In  addition  in  some  instances  there  may  only  be  a  marginal  benefit  to  the 
consumer from the replacement of 30% sugar.  

Sweeteners are not used for the purpose of increasing the shelf life of foods by 
preservation. However, a consequence of the use of sweeteners can be that the 
shelf  life  is  increased  because  of  the  lack  of  fermentable  sugar  which  the 
sweetener  has  replaced;  therefore  the  Commission  is  unable  to  accept 
amendment 73.  

15.  Criteria for authorisation (colours) (Article 8)  

The general criteria for the use of additives in Article 6 already stipulate that 
the  use  of  additives  should  not  mislead  the  consumer.  General  labelling 
information also exists to ensure that consumers are aware of the composition 
of foods in particular with regard to the ingredients present. With regard to the 
use of colours, these are traditionally used in some foods to identify particular 
flavours for instance in soft drinks or confectionery. In these instances there is 
no  evidence  that  consumers  are  mislead  as  to  the  content  of  the  foods. 
Therefore  bearing  in  mind  the  principle  already  contained  in  Article  6, 
amendment 30 has not been taken on board in this amended proposal.  

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16.  Community lists of food additives (Articles 4 and 10, Annexes II and III)  

Amendment 34 is proposed to include in the Community list a reference to the 
other  food  additives  which  may  not  be  used  in  combination  with  the  food 
additive. The Commission has not accepted this amendment as it is considered 
that such a reference would already be covered under point 'c' which requires 
the conditions of use to be specified. In such cases, where concerns relating to 
the  use  of  additives  in  combination  are  highlighted  in  the  EFSA  evaluation, 
suitable conditions of use would be stipulated when the additive is authorised.  

17.  Relation with Regulation 1829/2003 on GM food and feed (Article 13) 

The  Commission  proposal  aims  to  cover  all  food  additives  including  those 
produced  from  genetically  modified  organisms  (GMOs)  or  by  (fermentation 
using)  genetically  modified  micro-organisms  (GMMs).  Food  additives 
produced  using  GMMs  do  not  fall  under  Regulation  1829/2003  on  GM  food 
and  feed  and  they  will  be  entirely  covered  for  their  assessment  and 
authorisation  by  the  Regulation  on  food  additives.  Food  additives  which  fall 
within  the  scope  of  Regulation  (EC)  No  1829/2003  will  be  subject  to  that 
Regulation  with  regard  to  the  safety  assessment  of  the  genetic  modification, 
while the other aspects of safety, the consideration of the other criteria and the 
final authorisation will be dealt with under the food additives Regulation. The 
two evaluations and authorisations can run in parallel. 

Amendments 4 and 63 clarify that the two procedures may run simultaneously 
in accordance with good administrative practice. The proposed clarification is 
endorsed by the Commission subject to some drafting changes in order to make 
the  provision  more  compatible  with  Regulation  1829/2003.  Amendment  38 
however proposes to introduce additional labelling requirements. The labelling 
of GMOs is subject to horizontal rules under Regulation 1829/2003, therefore 
it  is  not  appropriate  to  introduce  specific  measures  under  this  vertical 
legislation on food additives.  

18.  Labelling (Articles 21 to 24) 

Amendment 45 would introduce a requirement for allergen warning where azo 
dyes  are  present.  The  labelling  of  allergens  is  addressed  horizontally  under 
Directive  2000/13/EC  and  therefore  the  issue  of  allergen  labelling  should 
continue to be addressed under that legislation based on scientific evaluations 
by EFSA.  

Labelling  of  food  additives  sold  from  business  to  business  or  to  the  final 
consumer 

Amendments  42,  43  and  44  are  acceptable  as  they  introduce  some  useful 
aspects  to  the  business  to  business  labelling  provisions.  In  particular 
amendment 44 provides a practical derogation so that certain information can 
be included on the accompanying documentation rather than the packaging in 
the case of bulk delivery of additives (e.g. in tankers).  

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In  its  original  proposal  the  Commission  aligned  the  labelling  provisions  of 
additives with those of enzymes. The European Parliament made a number of 
amendments  to  the  enzymes  proposal  to  ensure  a  new  presentation  and 
simplification  of  the  labelling  provisions  for  enzymes  sold  from  business  to 
business  or  to  the  final  consumer.  The  Commission  has  therefore  taken  on 
board  the  spirit  of  these  amendments  also  in  this  amended  proposal  on  food 
additives. 

In  addition,  since  food  additives  intended  for  sale  to  the  final  consumer  are 
considered  food  and  must  comply  with  the  relevant  labelling  provisions  of 
Directive 2000/13/EC relating to the labelling, presentation and advertising of 
foodstuffs, the text has been further simplified so as not to repeat the provisions 
of Directive 2000/13/EC.  

19.  Changes  in  production  process  or  starting  materials  of  a  food  additive 

(Article 11) 

Amendment  35  would  introduce  separate  limit  values  for  nanoscale  food 
additives; the Commission does not feel that such an amendment is necessary 
as specific restrictions could already be allocated under the conditions of use if 
these are deemed necessary.  

However as this is an important issue it is useful to amend the text to reiterate 
and  clarify  that  nanoscale  additives  would  need  to  be  evaluated  by  EFSA 
before  they  could  be  used  as  they  may  behave  in  a  different  manner  which 
could affect their safety.  

The  amended  Commission  proposal  includes  a  new  Article  11  introducing 
requirements for food additives already included in the Community list which 
are prepared by production methods or starting materials significantly different 
from  those  included  in  the  risk  assessment  of  the  Authority.  This  Article 
reflects the principle in recital 14 of the Commission proposal.  

20.  Reviews and re-evaluation (Articles 29 and 30) 

The Commission has proposed that the current authorisations for food additives 
will be transferred into the new annexes after a review of the criteria other than 
safety.  This  review  will  take  approximately  2  years.  At  the  same  time  the 
EFSA  has  been  tasked  with  a  re-evaluation  of  the  safety  of  all  currently 
permitted  food  additives,  which  will  take  a  number  of  years.  If  during  the 
EFSA re-evaluation particular concerns are raised, any necessary amendments 
can  be  made  at  any  time.  Because  of  the  differences  in  timing,  it  is  not 
appropriate to bind these two separate reviews together. Additionally for clarity 
it  is  appropriate  that  the  annexes  are  completed  at  the  earliest  possible 
opportunity.  Amendments  52,  6  and  69rev  would  link  these  2  aspects  and 
therefore,  for  the  reasons  highlighted  above,  cannot  be  accepted  by  the 
Commission.  The  principle  of  amendment  55  can  however  be  accepted  and 
article 29 has been amended to make clear that when the annex II is populated, 
food additive uses which are no longer necessary will not be included.  

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In  amendment  57  it  has  been  proposed  to  amend  the  definition  of  carriers  to 
include  also  substances  which  are  used  to  dissolve,  dilute,  disperse  or 
otherwise  physically  modify  nutrients  and/or  other  substances  added  for 
nutritional  or  physiological  purposes.  Amendment  60  provides  provision  for 
such substances to be included in Annex III. The Commission can accept these 
amendments  which  widen  the  scope  and  further  harmonise  the  area  of  food 
additives.  The  amended  proposal  has  therefore  been  drafted  to  reflect  these 
amendments  and  also  some  other  consequential  changes  necessary  to 
incorporate  these  provisions.  As  this  change  in  scope  will  be  new  to  the 
legislation  on  food  additives  the  entry  into  force  will  be  delayed  as  with  the 
other new provisions on food additives in food additives and food enzymes.  

Other  amendments  have  also  been  proposed  with  a  the  consequence  that  the 
food additives permitted in flavourings will be listed in Annex III rather than 
Annex II as originally foreseen (amendments 58 and 59). The Commission can 
accept this amendment which will treat food additives used in food additives, 
food enzymes and flavourings in the same way and has amended the proposal 
to reflect this change; some consequential amendments to other aspects of the 
proposal have also been made. The listing of tables in the annex however has 
been  adapted  to  take  into  account  the  different  requirements  and  also  in 
particular the differences in their date of entry into force or completion.  

21.  Re-evaluation programme 

Amendments  5  and  54  would  introduce  a  requirement  for  a  rolling  re-
evaluation  programme.  Food  additives  are  subject  of  continuous  observation 
once they have been  authorised  and are re-evaluated whenever new scientific 
data  becomes  available  which  may  affect  the  outcome  of  the  previous 
evaluation.  A  regular  review  is  therefore  not  necessary  and  it  would  increase 
the administrative burden for the Commission and EFSA.  

22.  Transitional provisions (Article 32) 

As  some  amendments,  in  particular  to  labelling,  introduce  changes  from  the 
current  legislation  it  is  appropriate  to  introduce  a  transitional  provision  as 
proposed in amendment 56. A suitable provision has therefore been included in 
Article  32  which  will  permit  food  additives  which  were  legally  labelled  to 
continue to be marketed until their date of minimum durability.  

23.  Pursuant  to  Article  250(2)  of  the  EC-Treaty,  the  Commission  amends  it 

proposals in accordance with the lines set out above. 

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2006/0145 (COD) 

Amended 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. 

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OJ C […], […], p. […].  
OJ C 168, 20.7.2007, p. 34.  
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). 

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(5) 

(6) 

(7) 

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.  Misleading  the  consumer  includes,  but  is  not 
limited to, issues related to the quality of the ingredients used, the naturalness of 
a  product  or  of  the  production  process,  its  nutritional  quality  and  its  fruit  and 
vegetable  content.  The  approval  of  food  additives  should  also  take  into  account 
other  factors  relevant  to  the  matter  under  consideration  including  societal, 
economic,  traditional,  ethical  and  environmental  factors  and  the  feasibility  of 
controls. The use and maximum levels of a food additive should take into account 
the  intake  of  the  food  additive  from  other  sources  and  the  exposure  to  the  food 
additive by special groups of consumers (e.g. allergic consumers). 

(8) 

The  inclusion  of  a  food  additive  in  the  annexes  shall  refer  to  the  consideration 
given to the criteria laid down in this Regulation. 

4 

OJ L […], dd/mm/yyyy, p. […]. 

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(9) 

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. 

(10)  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.  

(11) 

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.  

(12)  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. 

(13)  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  subject  to  the  authorisation  procedure  under 
that Regulation with regard to the safety assessment of the genetic modification 
while  the  final  authorisation  of  the  food  additives  should  be  granted  authorised 
under that Regulation prior to its approval under this Regulation. 

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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). 
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.  

EN 

11 

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(14)  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. 

(15)  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. 

(16)  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.  

(17)  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. 

(18)  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.  

(19) 

In  particular  power  should  be  conferred  on  the  Commission  to  amend  the 
Annexes of this Regulation and to adopt appropriate transitional measures. Since 
those  measures  are  of  general  scope  and  are  designed  to  amend  non-essential 
elements  of  this  Regulation,  and/or  to  supplement  it  by  addition  of  new  non 
essential  elements,  they  should  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. 

11 

12 
13 

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. 
OJ L 184, 17.7.1999, p. 23. 

EN 

12 

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(20) 

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. 

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

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

(22)  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. 

(23)  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 food enzymes as 
well  as  carriers  for  nutrients  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 and food additives in flavourings, should not apply until [1.1.2011]. 

(24)  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.  

14 

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

EN 

13 

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(25)  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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14 

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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  protection  of  human  health  and 
protection  andof  consumers'  interest,  including  fair  practices  in  food  trade,  taking 
account of the environment protection. 

For those purposes, this Regulation provides for:  

(a) 

(b) 

Community lists of approved food additives; 

conditions  of  use  of  food  additives  in  foods,  including  food  additives,  and  infood 
enzymes  as  referred  to  in  Regulation  (EC)  No  …/…[on  food  enzymes]  and 
flavourings as referred to in Regulation (EC) No …/… [on food ingredients with 
flavouring properties]; 

(c) 

rules on labelling of food additives sold as such.  

1. 

2. 

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. 

26 

OJ L 330, 5.12.1998, p. 32. 

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15 

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3. 

4. 

5. 

1. 

2. 

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; 

(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 2827(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, 
and foods containing them, 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 or other technological 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'); 

EN 

16 

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(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,  blood  proteins,  edible  gelatin,  protein  hydrolysates  and 

their salts, milk protein and gluten;  

(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, or disaccharidesor oligosaccharides; or 

(ii) 

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

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17 

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(f) 

(g) 

(h) 

‘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 sugars. 

'quantum  satis'  shall  mean  that  no  maximum  level  is  specified  and  that 
substances  have  to  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. 

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  and  in  food  flavourings  under  the  conditions  of 
use specified therein.  

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, food flavourings and nutrients or categories thereof to 
which they may be added. 

Food  additives  shall  at  all  times  comply  with  the  specifications  as  referred  to  in 
Article 1214.  

Article 5 
Prohibition of non-compliant food additives and/or non-compliant foodstuffs  

No  food  additive  and/or  food  containing  such  a  food  additive  may  be  placed  on  the 
market  if  the  food  additives  or  its  use  does  not  comply  with  the  requirements  of  this 
Regulation.  

EN 

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Article 56 
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 and where relevant other legitimate factors: 

(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) 

(d) 

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; 

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. 

EN 

19 

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Article 67 
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 56(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 78 
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 56(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.  

Article 89 
Functional classes of food additives 

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.  

EN 

20 

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2. 

1. 

Where necessary, as a result of scientific progress or technological development, the 
measures, designed to amend non-essential elements of this Regulation, relating 
to  additional  functional  classes  may  be  added  to  Annex  I  shall  be  adopted  in 
accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in  Article 
2827(23).  

Article 910 
The content of the Community lists of food additives 

A food additive which complies with the conditions set out in Articles 56, 67 and 78 
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  and/or  food  additives  and/or  food  enzymes  and/or  food 
flavourings 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 11  
Changes in production process or starting materials of a food additive already included in a 
Community list 

When,  as  regard  a  food  additive  already  included  in  a  Community  list,  there  is  a 
significant change in the production methods or the starting materials, the food additive 
prepared by these new methods or materials shall be considered as a different additive 
and a new entry in the Community lists or change in the specifications shall be required 
before it can be placed on the market. 

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Article 1012  
Levels of use of food additives 

1. 

When establishing the conditions of use referred to in Article 910(2)(c):  

(a) 

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

(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 the principle 
of quantum satis 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. For dried and/or concentrated foods which need to be reconstituted, the 
maximum  levels  apply  to  the  food  as  reconstituted  taking  into  account  the 
minimum dilution factor.  

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 1113 
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 in accordance with the to the present Regulation 
only when it is covered by an authorisation after it has been authorised in accordance with 
Article 7 of Regulation (EC) No 1829/2003.  

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Article 1214 
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 1315 
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. 

Article 1416  
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 1517  
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. 

27 
28 

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

EN 

23 

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Article 1618 
Carry-over principle 

1. 

The presence of a food additive shall be permitted: 

(a) 

(b) 

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;  

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

(i) 

is  permitted  in  the  food  additive,  food  enzyme  or  flavouring  in 
compliance with this Regulation;  

(ii)  has been carried over to the food via the food additive, food enzyme or 

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. 

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. 

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.  

2. 

3. 

4. 

Article 1719 
Interpretation decisions 

Where  necessary,  a  it  may  be  decided  in  accordance  with  the  procedure  referred  to  in 
Article 2827(2) as to whether or not: 

(a) 

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

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(b) 

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 1012(2). 

Article 1820 
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 

1. 

2. 

1. 

Article 1921 
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  they  comply  with  the  labelling  their 
packaging or containers bear the information provided for in Articles 2022 to 23 of 
this  Regulation,  which  must  be  easily  visible,  clearly  legible  and  indelible.  The 
information  provided  for  in  Article  22  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  official  languages  of  the  Community,  to  be 
determined  by  that  Member  State.  This  shall  not  preclude  such  information 
from being indicated in several languages.  

Article 2022 
General labelling requirements for food additives not intended for sale to the final 
consumerInformation requirements concerning the identification of food additives 

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

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(a) 

(b) 

the name and/or its E-number laid down in this Regulation in respect of each 
food  additive  or  a  sales  description  which  includes  the  name  and/or  E-
number of each food additive; 

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.  

(b) 

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

(c) 

if necessary, the special conditions of storage and/or use; 

(d)  a mark identifying the batch or lot;  

(e) 

(f) 

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

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

(g)  where  applicable,  an  indication  of  the  maximum  quantity  of  each 
component or group of components subject to a quantitative limitation in 
food  and/or  appropriate  information  in  clear  and  easily  understandable 
terms  enabling  the  purchaser  to  comply  with  this  Regulation  or  other 
relevant Community legislation; 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; 

(h) 

the net quantity;  

(i) 

the date of minimum durability;  

(j)  where  relevant,  information  on  a  food  additive  or  other  substances  as 
referred to in this Article and listed in Annex IIIa to Directive 2000/13/EC 
to enable the purchaser to ensure complicane with that Directive.  

2. 

Where  food  additives  are  sold  mixed  with  each  other  and/or  with  other  food 
ingredients, the packaging or containers of the resulting product shall bear a list 
of  all  ingredients,  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. 

EN 

26 

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3. 

4. 

5. 

Where substances (including food additives or other food ingredients) are added 
to  food  additives  to  facilitate  their  storage,  sale,  standardisation,  dilution  or 
dissolution, their packaging or containers shall bear a list of all such substances 
in descending order of their percentage by weight of the total.  

By way of derogation from paragraphs 1, 2 and 3, the information required in 
paragraph 1 points (e) to (g), (j) and in paragraphs 2 and 3 may appear merely 
on the documents relating to the consignment which are to be supplied with or 
prior to delivery, provided that the indication "intended for the manufacture of 
food and not for retail sale" is easily visible on the packaging or container of the 
product in question.  

By  way  of  derogation  from  paragraph  1,  2  and  3,  where  food  additives  are 
supplied  in  tankers  all  of  the  information  may  appear  merely  on  the 
accompanying documents relating to the consignment which are to be supplied 
with the delivery. 

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; 

EN 

27 

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(c) 

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

(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 2423 
Labelling of food additives intended for sale to the final consumer 

1. 

Without  prejudice  to  Directive  2000/13/EC,  Directive  89/396/EEC  and  to 
Regulation (EC) 1829/2003, food additives sold singly or mixed with each other 
and/or  other  food  ingredients  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 and E-number under which the food additive is sold; that name shall 
be  constituted  by  the  name  laid  down  in  this  Regulation  in  respect  of  each 
food  additive  or  a  sales  description  which  includes  the  name  and  E-
number of each food additive by any Community provisions applying to the 
food additive in question and its E-number;  

EN 

28 

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(b) 

the statement either 'for food' or the statement 'restricted used in food' or 
a  more  specific  reference  to  its  intended  useinformation  required  in 
accordance  with  Articles  20,  21  and  22  and  points(a)  to  (e),  (g)  and  (h)  of 
Article 23(1). 

2. 

3. 

By  derogation  from  paragraph  1  (a),  Tthe  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. 

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’. 

4. 

For  the  information  provided  for  in  paragraphs  (1)  to  (3),  Article  13(2)  of 
Directive 2000/13/EC shall apply accordingly.  

SECTION 3 
OTHER LABELLING REQUIREMENTS 

Article 2524 
Other labelling requirements 

1. 

2. 

Articles 1921 to 2423 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. 

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CHAPTER V 
PROCEDURAL PROVISIONS AND IMPLEMENTATION 

1. 

2. 

1. 

2. 

1. 

2. 

3. 

Article 2625 
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. 

Article 2726 
Monitoring of food additive intake 

Member States shall maintain systems to monitor the consumption and use of food 
additives  on  a  risk  based  approach  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 2827(2). 

Article 2827 
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. 

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. 

3. 

The Committee shall adopt its Rules of Procedure.  

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Article 2928 
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. 

CHAPTER VI 
TRANSITIONAL AND FINAL PROVISIONS 

1. 

2. 

3. 

Article 3029 
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  56,  67  and  78  of  the  present  Regulation.  The 
measures relating to the entry of such additives in Annex II, which are designed 
to  amend  non-essential  elements  of  this  Regulation,  shall  be  adopted  in 
accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in  Article 
2827(23).  This  review  shall  not  include  a  new  risk  assessment  carried  out  by  the 
Authority.  The  review  shall  be  completed  by  […]2  years  after  the  date  of 
publication  of  this  Regulation.  Food  additives  and  uses  which  are  no  longer 
current shall not be entered in the Annex.  

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  56  of  this 
Regulation.  The  measures  relating  to  the  entry  of  such  additives  in  Annex  III, 
which are designed to amend non essential elements of this Regulation, shall be 
adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  laid  down 
referred to in Article 2827(23). This review shall not include a new risk assessment 
carried out by the Authority. The review shall be completed by […..] 2 years after 
the date of publication of this Regulation. Food additives and uses which are no 
longer current shall not be entered in the Annex. 

Food additives authorised for use in food flavourings in Directive 95/2/EC and 
their  conditions  of  use  shall  be  entered  in  Annex  III,  part  4  to  this  Regulation 
after  a  review  of  their  compliance  with  Article  6  of  this  Regulation.  The 
measure relating to the entry of such additives in Annex III, which are designed 
to  amend  non-essential  elements  of  this  regulation,  shall  be  adopted  in 
accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in  Article 
27(3).  This  review  shall  not  include  a  new  risk  assessment  carried  out  by  the 
Authority.  The  review  shall  be  completed  by  2  years  after  the  date  of 
publication  of  this  Regulation.  Food  additives  and  uses  which  are  no  longer 
current shall not be entered in the Annex. 

EN 

31 

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34. 

45. 

1. 

2. 

Specifications of the food additives covered under paragraphs 1, and 2 and 3 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. 

The  measures  relating  to  aAny  appropriate  transitional  measures,  which  are 
designed  to  amend  non-essential  elements  of  this  Regulation,  inter  alia  by 
supplementing it shall may be adopted in accordance with the regulatory procedure 
with scrutiny laid down referred to in Article 2827(23). 

Article 3130 
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  2827(2).  The  evaluation 
programme shall be published in the Official Journal of the European Union. 

1. 

The following acts are repealed: 

Article 3231 
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.  

EN 

32 

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2. 

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

Article 3332 
Transitional provisions 

By  way  of  derogation  from  Article  3231,  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 1817 of the [Regulation on food 
enzymes]. 

Food  additives  which  do  not  comply  with  the  provisions  of  the  Regulation  and  were 
legally placed on the market or labelled prior to [12 months after the publication of this 
Regulation] may continue to be marketed until their date of minimum durability.  

Article 3433 
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 45(2) shall apply to Parts 2, and 3 and 5 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 

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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,  nutrient  and/or  other 
substance added for nutritional or physiological purposes to a foodstuff (or food 
and/or  food  supplement)  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 

34 

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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 

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

ANNEX II 

EN 

36 

   EN 

 
ANNEX III 

Community list of food additives approved for use in food additives and, food enzymes, food 
flavourings and their conditions of use. Community list of carriers in nutrients and their 
conditions of use. 

Part 1  Carriers in food additives 

Part 2  Additives other than carriers in food additives 

Part 3  Additives including carriers in food enzymes 

Part 4  Additives including carriers in food flavourings 

Part 5  Carriers in nutrients 

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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 

38 

   EN