Amended proposal for a Regulation of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1576/89, Council Regulation (EEC) No 1601/91, Regulation (EC) No 2232/96 and Directive 2000/13/EC (presented by the Commission pursuant to Article 250 (2) of the EC Treaty)
Date: 2007-10-24
Institutions: European Commission
Subjects: consumer protection, flavouring, food safety, foodstuff, foodstuffs legislation, labelling, public health

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 24.10.2007 
COM(2007) 671 final 

2006/0147 (COD) 

Amended proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on flavourings and certain food ingredients with flavouring properties for use in and on 
foods and amending Council Regulation (EEC) No 1576/89, Council Regulation (EEC) 
No 1601/91, Regulation (EC) No 2232/96 and Directive 2000/13/EC 

(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 flavourings and certain food ingredients 
with  flavouring  properties  for  use  in  and  on  foods  and  amending  Council 
Regulation  (EEC)  No  1576/89,  Council  Regulation  (EEC)  No  1601/91, 
Regulation  (EC)  No  2232/96  and  Directive  2000/13/EC  [Document  (COM 
(2006)0427 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 general approach agreed in the Council at the EPSCO meeting on 31st May 
2007 on the other text of the package does not apply to the text on flavourings.  

The European Parliament has given in first reading a favourable opinion on the 
proposal on 9 July 2007. 

The  present  proposal  amends  the  original  proposal  [COM  (2006)0427  – 
2006/0147(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  43 
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. From the adopted amendments the 
following cannot be accepted by the Commission 2, 11, 13, 16, 17, 19, 20, 21, 
23, 26, 31 (second part), 32, 37, 40, 43, 44, 46, 49, 52. 

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 

9. 

The  proposed  Regulation  aims  at  replacing  current  Council  Directive 
88/388/EEC  in  order  to  take  into  account  technological  and  scientific 
developments  in  the  area  of  flavourings  and  the  developments  of  the  food 
legislation in the European Community. 

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The main objectives are: 

• 

• 

• 

• 

• 

to clarify the scope of legislation on flavourings; 

to  modernise  and  adapt  the  existing  legislation  on  flavourings  to 
technological and scientific developments;  

to establish clear evaluation and authorisation procedures; 

to better inform the consumer about the use of natural flavourings; 

to adapt to the requirements of Regulation (EC) N° 882/2004 on official 
controls  performed  to  ensure  the  verification  with  feed  and  food  law, 
animal health and animal welfare rules.  

III. 

OVERVIEW OF THE AMENDMENTS OF THE EUROPEAN PARLIAMENT 

10.  Technical/editorial amendments 

Amendments 4, 5, 6, 7, 8, 9, 12, 15, 27, 28, 29, 30, 31 (first part), 35, 36, 39, 
41, 42, 45 aim to improve the proposal from a technical and editorial point of 
view  and  have  been  taken  over  by  the  Commission,  in  some  cases  subject  to 
some editorial changes. 

11.  Legal basis 

Article 37 is deleted as legal basis for the Regulation. The same reasoning as 
for enzymes applies for which the Parliament voted in favour of this deletion, 
because  the  agricultural  aspects  of  the  proposal  (amendments  to  vertical 
agricultural texts) are only secondary objectives of the proposed Regulation. 

12.  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.  

The  amendments  11,  23  and  32  concern  the  introduction  of  the  regulatory 
procedure  with  scrutiny.  The  decisions  referred  to  in  these  amendments  will 
not add new elements to the Regulation, scrutiny is therefore not required.  

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Amendment  16  removes  the  possibility  to  decide  (with  the  assistance  of  the 
Standing Committee) to which category a flavouring belongs and is therefore 
not acceptable, as the Commission is of the opinion that such a decision may 
be needed.  

Amendments  24,  33  and  34  are  partially  accepted,  the  urgency  procedure 
should  however  be  allowed  in  case  there  is  a  risk  for  the  safety  of  the 
consumer. 

13.  Definitions (Article 3) 

Amendment  14  defines  that  food  ingredients  with  flavouring  properties 
contribute significantly to the presence of the substances in Annex III part B. In 
practice, this may be the case, however, such a concept does not belong to the 
legal text and is already mentioned in recital 5.  

Amendment  13  changes  de  term  "other  flavouring"  to  "flavourings  not 
elsewhere specified". Even though both terms have the same meaning the first 
is preferred.  

Amendment  49  restricts  the  production  of  "flavouring  substances"  to 
appropriate  ‘natural’  processes  or  chemical  synthesis.  There  may  however  be 
other  ways  to  produce  flavouring  substances  e.g.  extraction  from  smoke 
condensates or from thermal process flavourings. The amendment is therefore 
not acceptable.  

14.  Prohibition of non-compliant flavourings 

This  amendment  is  introduced  in  order  to  bring  the  text  in  line  with  the 
amended  proposals  on  food  additives  and  food  enzymes.  The  proposed  text 
clarifies that a flavouring or a food in which a flavouring is used should not be 
placed  on  the  market,  if  the  flavouring  or  its  use  does  not  comply  with  the 
proposed Regulation. This clarification is introduced in the amended proposal 
with the inclusion of Article 5.  

15.  General conditions of use  

The Commission proposal sets general conditions of use of flavourings or food 
ingredients  with  flavouring  properties.  They  must  be  safe  and  their  use  must 
not  mislead  the  consumer.  In  recital  6  a clarification  is  introduced  explaining 
what is meant by misleading the consumer (amendment 1).  

Amendment 19 requires that the use of flavourings must have advantages and 
benefits  for  the  consumer  and  amendment  20  requires  that  there  should  be  a 
technological  need.  These  amendments  are  not  needed  as  technological  need 
and benefit for the consumer are implicit in the definition of flavourings 

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Amendment  2  and  17  require  the  authorisation  of  flavourings  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 
flavourings. 

16.  Presence of certain substances 

Amendment  46  concerns  the  maximum  limits  for  substances  of  toxicological 
concern  in  Annex  III  Part  B.  These  maximum  limits  would  not  apply  to 
compound  foods  to  which  no  flavourings  have  been  added  and  the  only  food 
ingredients  with  flavouring  properties  added  are  spices  and  herbs.  This  is 
unacceptable as a safety concern is not excluded.  

Amendments  21  and  40  introduce  a  blank  Annex  III  Part  B,  and  only  when 
there  is  a  justified  scientific  concern,  maximum  levels  could  be  included  by 
comitology.  This  amendment  is  not  in  line  with  recent  scientific  opinions 
which confirm the need for maximum limits as proposed in Annex III Part B. 

17.  Relation with Regulation 1829/2003 on GM food and feed (Article 12) 

Flavourings or source materials 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,  where 
appropriate,  be  dealt  with  under  the  flavourings  Regulation.  The  two 
evaluations and authorisations can run in parallel. 

Amendments 41 and 42 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 compatible with Regulation 1829/2003. 

Amendments 52 introduces a definition of the term  "produced by GMO's". If 
such  a  definition  is  needed  it  should  be  covered  by  Regulation  (EC)  No 
1829/2003. 

18.  Labelling  

Amendment  29  concerns  the  labelling  of  natural  flavourings,  were  the  90  % 
rules  is  replaced  by  95  %  when  referring  to  a  natural  source.  The  proposed 
change is acceptable as it corresponds better to consumer expectations and will 
have limited impact on current practices. 

Amendment  26  requires  that  for  trade  between  food  business  operators,  an 
address in the EU should be provided. This is not accepted as it could lead to 
barriers to trade with third countries. 

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A  description  of  smoke  flavourings  such  as  "smoked  salmon  flavour" 
(amendment 37) is not acceptable as this could be misleading for the consumer; 
in practice the flavouring could be a mixture of smoke flavouring with salmon 
flavouring. 

Labelling  of  flavourings  obtained  from  GMO's  should  be  covered  by 
Regulation 1829/2003 and not by this Regulation (amendment 38). 

Finally the Commission can not accept amendment 43 as it is a basic principle 
of the proposal to name the source of the natural flavouring to ensure correct 
consumer information. 

In  its  original  proposal  the  Commission  aligned  furthermore  the  labelling 
provisions  of  flavourings  with  those  additives  and  enzymes.  The  European 
Parliament  made  a  number  of  amendments  to  the  latter  proposals  to  ensure  a 
new  presentation  and  simplification  of  the  labelling  provisions  for  additives 
and  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 flavourings. 

19.  Reporting by food business operators 

Amendment  31  is  partly  accepted,  as  a  producer  or  user  of  a  flavouring 
substance should inform the Commission immediately of any new scientific or 
technical  information  which  might  affect  the  assessment  of  the  safety  of  the 
flavouring substance. An addition that it concerns information which is known 
and accessible to him is not acceptable as this restricts the responsibility of the 
producer 

The  second  part  of  Amendment  31,  which  lays  down  what  information 
should  be  requested  is  not  acceptable  as  it  restricts  the  Commission  proposal 
and pre-empts the contents of the implementation measure.  

20.  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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2006/0147 (COD) 

Amended proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on flavourings and certain food ingredients with flavouring properties for use in and on 
foods and amending Council Regulation (EEC) No 1576/89, Council Regulation (EEC) 
No 1601/91, Regulation (EC) No 2232/96 and Directive 2000/13/EC 

(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 
Articles 37 and 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) 

1 
2 
3 

4 
5 

Council  Directive  88/388/EEC of  22 June 1988 on  the approximation  of  the laws of 
the Member States relating to flavourings for use in foodstuffs and to source materials 
for  their  production3  needs  to  be  updated  in  the  light  of  technical  and  scientific 
developments.  In  the interests of clarity and efficiency Directive 88/388/EEC should 
be replaced by the present Regulation.  

Council  Decision  88/389/EEC  of  22  June  1988  on  the  establishment,  by  the 
Commission,  of  an  inventory  of  the  source  materials  and  substances  used  in  the 
preparation  of  flavourings4  provides  for  the  establishment  of  that  inventory  within 
24 months of its adoption. That Decision is now obsolete and should be repealed. 

Commission  Directive  91/71/EEC  of  16  January  1991  completing  Council  Directive 
88/388/EEC  on  the  approximation  of  the  laws  of  the  Member  States  relating  to 
flavourings  for  use  in  foodstuffs  and  to  source  materials  for  their  production5  lays 
down  rules  on  the  labelling  of  flavourings.  These  rules  are  being  replaced  by  the 
present Regulation and the Directive should now be repealed. 

OJ C […], […], p. […]. 
OJ C 168, 20.7.2007, p 34. 
OJ  L  184,  15.7.1988,  p.  61.  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). 
OJ L 184, 15.7.1988, p. 67. 
OJ L 42, 15.2.1991, p. 25. 

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(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

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. 

In order to protect human health the scope of this Regulation should cover flavourings, 
source materials for flavourings and foods containing flavourings. It should also cover 
certain  food  ingredients  with  flavouring  properties  which  are  added  to  food  for  the 
main purpose of adding flavour and which contribute significantly to the presence in 
food  of  certain  naturally  occurring  undesirable  substances  (‘food  ingredients  with 
flavouring properties’), their source material and foods containing them.  

Flavourings and food ingredients with flavouring properties may only be used if they 
fulfil  the  criteria  laid  down  in  this  Regulation.  They  must  be  safe  when  used,  and 
certain  flavourings  should,  therefore,  undergo  a  risk  assessment  before  they  can  be 
permitted in food. They should not mislead the consumer and their presence in food 
should,  therefore,  always  be  indicated  by  appropriate  labelling.  Misleading  the 
consumer  includes,  but  is  not  limited  to,  issues  related  to  the  nature,  freshness, 
quality  of  ingredients  used,  the  naturalness  of  a  product  or  of  the  production 
process, or the nutritional quality of the product. 

Since  1999,  the  Scientific  Committee  on  Food  and  subsequently  the  European  Food 
Safety  Authority  has  expressed  opinions  on  a  number  of  substances  occurring 
naturally  in  source  materials  for  flavourings  and  food  ingredients  with  flavouring 
properties6 which, according to the Committee of Experts on Flavouring Substances of 
the  Council  of  Europe,  raise  toxicological  concern.  Substances  for  which  the 
toxicological concern was confirmed by the Scientific Committee on Food should be 
regarded as undesirable substances which should not be added as such to food. 

Due to their natural occurrence in plants, undesirable substances might be present in 
flavouring preparations and food ingredients with flavouring properties. The plants are 
used traditionally as food or food ingredients. Appropriate maximum levels should be 
established for the presence of these undesirable substances in foods which contribute 
most  to  the  human  intake  of  these  substances,  taking  into  account  both  the  need  to 
protect human health and their unavoidable presence in traditional foods. 

Provisions should be established at Community level in order to prohibit or restrict the 
use  of  certain  plant  or  animal  materials  which raise  concern for human health  in the 
production  of  flavourings  and  food  ingredients  with  flavouring  properties  and  their 
applications in food production. 

(10)  Risk  assessments  should  be  carried  out  by  the  European  Food  Safety  Authority, 
to  as  “the  Authority”,  established  by  Regulation  (EC) 
hereinafter  referred 
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 safety7. 

6 
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http://europa.eu.int/comm/food/food/chemicalsafety/flavouring/scientificadvice_en.htm 
OJ  L  31,  1.2.2002,  p.  1.  Regulation  as  last  amended  by  Regulation  (EC)  No  1642/2003  (OJ  L  245, 
29.9.2003, p. 4). 

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(11) 

In order to ensure harmonisation, the risk assessment and approval of flavourings and 
source  materials  that  need  to  undergo  an  evaluation  should  be  carried  out  in 
accordance  with  the  procedure  laid  down  in  Regulation  (EC)  No  […]establishing  a 
common approval procedure for food additives, food enzymes and food flavourings8. 

(12)  Flavouring  substances  are  chemically  defined  substances  with  flavouring  properties. 
An  evaluation  programme  of  flavouring  substances  is  ongoing  in  accordance  with 
Regulation  (EC)  No  2232/96  of  the  European  Parliament  and  of  the  Council  of  28 
October 1996 laying down a Community procedure for flavouring substances used or 
intended  for  use  in  or  on  foodstuffs9.  Under  that  Regulation  a  list  of  flavouring 
substances is to be adopted within five years of adoption of that programme. A  new 
deadline  should  be  set  for  the  adoption  of  that  list.  That  list  will  be  proposed  for 
inclusion in the list referred to in Article 2(1) of Regulation (EC) No […].  

(13)  Flavouring  preparations  are  flavourings  other  than  chemically  defined  substances 
obtained  from  materials  of  vegetable,  animal  or  mineral  origin,  by  appropriate 
physical,  enzymatic  or  microbiological  processes,  either  in  the  raw  state  of  the 
material or after processing for human consumption. Flavouring preparations produced 
from food do not need to undergo an evaluation or an approval procedure for use in 
and on foods unless there is doubt about their safety. However, the safety of flavouring 
preparations produced from non-food material should be evaluated prior to approval. 

(14)  Regulation  (EC)  No  178/2002  defines  food  as  any  substance  or  product,  whether 
processed, partially processed or unprocessed, intended to be, or reasonably expected 
to be ingested by humans. Materials of vegetable, animal or microbiological origin, for 
which  hitherto  there  is  significant  evidence  of  use  for  the  production  of  flavourings, 
are  considered  as  food  materials  for  this  purpose,  even  though  some  of  these  source 
materials,  such  as  rose  wood,  oak  wood  chips  and  strawberry  leaves,  may  not  have 
been used for food as such. They do not need to be evaluated. 

(15)  Likewise,  thermal  process  flavourings  produced  from  food  under  authorised 
conditions need not undergo an evaluation or an approval procedure for use in and on 
foods unless there is doubt about their safety. However, the safety of thermal process 
flavourings  produced  from  non-food  material  or  produced  under  non-authorised 
conditions should be evaluated prior to approval. 

(16)  Regulation (EC) No 2065/2003/EC of the European Parliament and of the Council of 
10  November  2003  on  smoke  flavourings  used  or  intended  for  use  in  or  on  foods10, 
lays  down  a  procedure  for  the  safety  assessment  and  approval  of  smoke  flavourings 
and aims to establish a list of primary smoke condensates and primary tar fractions the 
use of which is authorised to the exclusion of all others. 

8 
9 

10 

OJ L […], […], p […]. 
OJ L 299, 23.11.1996, p. 1. Regulation as last amended by Regulation (EC) No 1882/2003 (OJ L 284, 
31.10.2003, p. 1). 
OJ L 309, 26.11.2003, p. 1. 

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(17)  Flavour precursors impart flavour to food by chemical reactions occurring during food 
processing.  Flavour  precursors  produced  from  food  do  not  need  to  undergo  an 
evaluation or an approval procedure for use in and on foods unless there is doubt about 
their  safety.  However,  the  safety  of  flavour  precursors  produced  from  non-food 
material should be evaluated prior to approval. 

(18)  Other flavourings which do not fall under the definitions of the previously mentioned 
flavourings may be used in and on foods after they have undergone an evaluation and 
approval procedure. 

(19)  Material of vegetable, animal, microbiological or mineral origin other than food may 
only be authorised for the production of flavourings after its safety has been evaluated 
scientifically.  It  might  be  necessary  to  authorise  the  use  of  only  certain  parts  of  the 
material or to set conditions of use. 

(20)  A  flavouring  or  a  source  material  which  falls  under  the  scope  of  Regulation  (EC) 
No 1829/2003 of the European Parliament and of the Council of 22 September 2003 
on  genetically  modified  food  and  feed11  should  be  subject  to  the  authorization 
procedure  under  that  Regulation  with  regard  to  the  safety  assessment  of  the 
genetic  modification,  while  the  final  authorization  should  be  granted  under  this 
Regulation.  authorised  according  to  that  Regulation,  prior  to  its  approval  under  this 
Regulation. 

(21)  Flavouring substances or flavouring preparations should only be labelled as ‘natural’ if 
they comply with certain criteria which ensure that consumers are not misled. 

(22)  Specific  information  requirements  should  ensure  that  consumers  are  not  misled 
concerning  the  source  material  used  for  the  production  of  natural  flavourings.  The 
source of vanillin obtained from wood will, for example, have to be mentioned.  

(23)  Flavourings  should  remain  subject  to  the  general  labelling  obligations  as 
provided for in Directive 2000/13/EC and, where appropriate, in Regulation (EC) 
No 1829/2003. In addition, specific provisions on labelling of flavourings sold as 
such  to  the  manufacturer  or  to  the  final  consumer  should  be  included  in  this 
Regulation. 

(24)  Consumers  should  be  informed  if  the  smoky  taste  of  a  particular  food  is  due  to  the 
addition of smoke flavourings. In accordance with Article 5 of Directive 2000/13/EC 
of  the  European  Parliament  and  of  the  Council  of  20  March  2000  on  the 
approximation of the laws of the Member States relating to the labelling, presentation 
and advertising of foodstuffs12, the name under which the product is sold should not 
confuse the consumer as to whether the product is smoked conventionally with fresh 
smoke  or  treated  with  smoke  flavourings.  This  Directive  needs  to  be  adapted  to  the 
definitions of flavourings, smoke flavourings and the term ‘natural’ for the description 
of flavourings laid down in the present Regulation.  

11 
12 

OJ L 268, 18.10.2003, p. 1.  
OJ L 109, 6.5.2000, p. 29. Directive as last amended by Directive 2003/89/EC (OJ L 308, 25.11.2003, 
p. 15). 

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(25)  For the evaluation of the safety of flavouring substances for human health, information 
on  the  consumption  and  use  of  flavouring  substances  is  crucial.  The  amounts  of 
flavouring substances added to food should therefore be checked on a regular basis. 

(26)  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.  

(27) 

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

(28)  Annexes  II  to  V  to  this  Regulation  should  be  adapted  to  scientific  and  technical 

progress. 

(29) 

In  order  to  develop  and  update  Community  legislation  on  flavourings  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  a  view  to  facilitating  the  decision-
making process. It is appropriate that the Community 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. 

(30)  Pending  the  establishment  of  the  Community  list,  provision  should  be  made  for  the 
evaluation  and  approval  of  flavouring  substances  which  are  not  covered  by  the 
evaluation  programme  provided  for  in  Regulation  (EC)  No  2232/96.  A  transitional 
regime should therefore be laid down. Under that regime such flavouring substances 
should  be  evaluated  and  approved  in  accordance  with  the  procedure  laid  down  in 
Regulation (EC) No [procedural Regulation]. However the time periods provided for 
in  that  Regulation  for  the  Authority  to  adopt  its  opinion  and  for  the  Commission  to 
submit a draft Regulation updating the Community list to the Standing Committee on 
the Food Chain and Animal Health should not apply, because priority should be given 
to the ongoing evaluation programme. 

13 

14 

OJ L 184, 17.7.1999, p. 23. Decision as amended by Decisions 2006/512/EC (OJ L 200, 22.7.2006, 
p.11). 
OJ L 165, 30.4.2004, p. 1. Corrected version (OJ L 191, 28.5.2004, p. 1). 

EN 

11 

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(31)  Since the objective of the action to be taken, namely to lay down Community rules on 
the use of flavourings and certain food ingredients with flavouring properties in and on 
foods,  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. 

(32)  Council Regulation (EEC) No 1576/89 of 29 May 1989 laying down general rules on 
the  definition,  description  and  presentation  of  spirit  drinks15  and  Council  Regulation 
(EEC)  No  1601/91  of  10  June  1991  laying  down  general  rules  on  the  definition, 
description  and  presentation  of  aromatised  wines,  aromatised  wine-based  drinks  and 
aromatised wine-product cocktails16 need to be adapted to certain new definitions laid 
down in the present Regulation. 

(33)  Regulations  (EEC)  No  1576/89,  (EEC)  No  1601/91  and  (EC)  No  2232/96  and 

Directive 2000/13/EC should be amended accordingly, 

HAVE ADOPTED THIS REGULATION: 

CHAPTER I 

SUBJECT MATTER, SCOPE AND DEFINITIONS 

Article 1 
Subject matter 

This  Regulation  lays  down  rules  on  flavourings  and  food  ingredients  with  flavouring 
properties  for  use  in  and  on  foods  to  ensure a high level of human  health protection and 
consumer protection and 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) 

a  Community  list  of  flavourings  and  source  materials  approved  for  use  in  and  on 
foods, set out in Annex I (‘the Community list’); 

conditions  of  use  of  flavourings  and  food  ingredients  with  flavouring  properties  in 
and on foods; 

(c) 

rules on labelling of flavourings. 

15 
16 

OJ L 160, 12.6.1989, p. 1. Regulation as last amended by the 2003 Act of Accession. 
OJ L 149, 14.6.1991, p. 1. Regulation as last amended by Regulation (EC) No 1882/2003. 

EN 

12 

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1. 

This Regulation shall apply to: 

Article 2 
Scope 

(a) 

flavourings  which  are  used  or  intended  to  be  used  in  or  on  foods,  without 
prejudice  to  more  specific  provisions  laid  down  in  the  exception  of  smoke 
flavourings falling within the scope of Regulation (EC) No 2065/2003; 

(b) 

food ingredients with flavouring properties; 

(c) 

food containing flavourings and/or food ingredients with flavouring properties; 

(d) 

source  materials  for  flavourings  and  food  ingredients  with  flavouring 
properties. 

2. 

This Regulation shall not apply to: 

(a) 

substances which have exclusively a sweet, sour or salty taste;  

(b) 

raw foods; 

3. 

1. 

2. 

(c)  non-compound foods and mixtures of spices and/or herbs, mixtures of tea 
and  mixtures  for  infusion  as  such,  as  long  as  they  have  not  been  used  as 
food ingredients. 

(b) 

raw or non-compound foods. 

Where necessary, it may be decided in accordance with the procedure referred to in 
Article 1820(2) whether or not a given substance or mixture of substances, material 
or type of food 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) 

'flavourings' shall mean products: 

(i) 

not intended to be consumed as such, which are added to food in order to 
impart odour and/or taste; 

(ii)  made  or  consisting  of  the  following  categories:  flavouring  substances, 
flavouring preparations, thermal process flavourings, smoke flavourings, 
flavour precursors or other flavourings or mixtures thereof; 

EN 

13 

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(b) 

(c) 

(iii)  which  may  contain  food  including  additives  as  permitted  by 
Regulation (EC) No XXX/200717 of the European Parliament and of 
the Council of … on food additives; 

'flavouring  substance'  shall  mean  a  chemically  defined  substance  with 
flavouring properties; 

'natural  flavouring  substance'  shall  mean  a  flavouring  substance  obtained  by 
appropriate physical, enzymatic or microbiological processes from material of 
vegetable,  animal  or  microbiological  origin  either  in  the  raw  state  or  after 
processing  for  human  consumption  by  one  or  more  of  the  traditional  food 
preparation processes listed in Annex II;  

(d) 

'flavouring  preparation’  shall  mean  a  product,  other  than  a  flavouring 
substance, obtained from: 

(i) 

food  by  appropriate  physical,  enzymatic  or  microbiological  processes 
either  in  the  raw  state  of  the  material  or  after  processing  for  human 
consumption by one or more of the traditional food preparation processes 
listed in Annex II and/or appropriate physical processes; 

and/or 

(ii)  material of vegetable, animal or microbiological origin, other than food, 
obtained  by  one  or  more  of  the  traditional  food  preparation  processes 
listed 
II  and/or  appropriate  physical,  enzymatic  or 
in  Annex 
microbiological processes; 

(e) 

‘thermal process flavouring’ shall mean a product obtained after heat treatment 
from  a  mixture  of  ingredients  not  necessarily  having  flavouring  properties 
themselves,  of  which  at  least  one  contains  nitrogen  (amino)  and  another  is  a 
reducing  sugar;  the  ingredients  for  the  production  of  thermal  process 
flavourings may be: 

(i) 

food; 

and/or 

(ii) 

source material other than food; 

(f) 

(g) 

‘smoke  flavouring’  shall  mean  a  product  obtained  by  fractionation  and 
purification  of  a  condensed  smoke  yielding  primary  smoke  condensates, 
primary tar fractions and/or derived smoke flavourings as defined in points (1), 
(2) and (4) of Article 3 of Regulation (EC) No 2065/2003;  

‘flavour  precursor’  shall  mean  a  product,  not  necessarily  having  flavouring 
properties itself, intentionally added to food for the sole purpose of producing 
flavour  by  breaking  down  or  reacting  with  other  components  during  food 
processing; it may be obtained from: 

17 

OJ C […], […], p. […]. 

EN 

14 

   EN 

 
 
 
                                                 
(i) 

food; 

and/or 

(ii) 

source material other than food; 

(h) 

(i) 

(j) 

‘other  flavouring’  shall  mean  a  flavouring  added  or  intended  to  be  added  to 
food  in  order  to  impart  odour  and/or  taste  and  which  does  not  fall  under  the 
definitions (b) to (g); 

‘food ingredient with flavouring properties’ shall mean a food ingredient other 
than flavourings which may be added to food for the main purpose of adding 
flavour to it or modifying its flavour; 

‘source material’ shall mean material of vegetable, animal, microbiological or 
mineral  origin  from  which  flavourings  or  food  ingredients  with  flavouring 
properties are produced; it may be: 

(i) 

food; 

or 

(ii) 

source material other than food; 

(k) 

‘appropriate  physical  process’  shall  mean  a  physical  process  which  does  not 
intentionally modify the chemical nature of the components of the flavouring, 
without prejudice to the listing of traditional food preparation processes in 
Annex  II,  and  does  not  involve  the  use  of  singlet  oxygen,  ozone,  inorganic 
catalysts, metal catalysts, organometallic reagents and/or UV radiation. 

For  the  purpose  of  the  definitions  listed  in  paragraph  2  (d),  (e),  (g)  and  (j),  source 
materials for which hitherto there is significant evidence of use for the production of 
flavourings, are considered as food. 

Where necessary, it may be decided in accordance with the procedure referred to in 
Article  1820(2)  whether  or  not  a  given  substance  falls  within  a  specific  category 
listed in paragraph 2(b) to (j).  

3. 

4. 

CHAPTER II 

CONDITIONS FOR USE OF FLAVOURINGS, FOOD INGREDIENTS WITH 
FLAVOURING PROPERTIES AND SOURCE MATERIALS 

Article 4  
General conditions for use of flavourings or food ingredients with flavouring properties 

Only  flavourings  or  food  ingredients  with  flavouring  properties  which  meet  the  following 
conditions may be used in or on foods: 

EN 

15 

   EN 

 
 
 
(a) 

they do not, on the basis of the scientific evidence available, pose a safety concern to 
the health of the consumer; 

(b) 

their use does not mislead the consumer. 

Article 5 
Prohibition of non-compliant flavourings and/or non-compliant foodstuffs  

No flavouring and/or any food in which such a flavouring has been used may be placed 
on the market, if the flavouring or its use does not comply with this Regulation and its 
implementing measures. 

Article 56 
Presence of certain substances 

1. 

2. 

3. 

1. 

2. 

Substances listed in Part A of Annex III shall not be added as such to food.  

Maximum  levels  of  certain  substances,  naturally  present  in  flavourings  and  food 
ingredients  with  flavouring  properties,  in  the  compound  foods  listed  in  Part  B  of 
Annex  III  shall  not  be  exceeded  as  a  result  of  the  use  of  flavourings  and  food 
ingredients with flavouring properties in and on those foods.  

The  maximum  levels  shall  apply  to  the  compound  foods  as  offered  ready  for 
consumption or as prepared according to the instructions of the manufacturer. 

Detailed rules for the implementation of paragraph 2 may be adopted in accordance 
with the procedure referred to in Article 1820(2). 

Article 67 
Use of certain source materials 

Source materials listed in Part A of Annex IV shall not be used for the production of 
flavourings and food ingredients with flavouring properties. 

Flavourings  and  food  ingredients  with  flavouring  properties  produced  from  source 
materials  listed  in  Part  B  of  Annex  IV  may  only  be  used  under  the  conditions 
indicated in that Annex. 

Flavourings for which an evaluation and approval is not required 

Article 78  

1. 

The following flavourings may be used in or on foods without an approval under this 
Regulation, provided that they comply with Article 4: 

(a) 

flavouring preparations referred to in Article 3(2)(d)(i); 

EN 

16 

   EN 

 
(b) 

thermal process flavourings referred to in Article 3(2)(e)(i) and which comply 
with  the  conditions  for  the  production  of  thermal  process  flavourings  and 
maximum levels for certain substances in thermal process flavourings set out in 
Annex V; 

(c) 

flavour precursors referred to in Article 3(2)(g)(i);  

(d) 

food ingredients with flavouring properties.  

2. 

Notwithstanding  paragraph  1,  if  the  Commission,  a  Member  State  or  the  European 
Food Safety Authority (‘the Authority’) expresses doubts concerning the safety of a 
flavouring or food ingredient with flavouring properties referred to in paragraph 1, a 
risk assessment of such flavouring or food ingredient with flavouring properties shall 
be  carried  out  by  the  Authority.  Articles  4  to  6  of  Regulation  (EC)  No  [procedural 
Regulation] shall then apply mutatis mutandis.  

If  necessary,  the  Commission  shall  adopt  measures  following  the  opinion  of  the 
Authority,  which  are  designed  to  amend  non-essential  elements  of  this 
Regulation,  inter  alia  by  supplementing  it,  in  accordance  with  the  regulatory 
procedure  with  scrutiny  referred  to  in  Article  20(3).  in  accordance  with  the 
procedure referred to in Article 18(2). Such measures shall be laid down in Annexes 
III,  IV  and/or  V  as  appropriate.  On  imperative  grounds  of  urgency,  the 
Commission may use the urgency procedure referred to in Article 20(4).  

CHAPTER III 

COMMUNITY LIST OF FLAVOURINGS AND SOURCE MATERIALS APPROVED 
FOR USE IN OR ON FOODS 

Article 89 
Flavourings and sources materials for which an evaluation and approval is required  

The present Chapter applies to: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

flavouring substances; 

flavouring preparations referred to in Article 3(2)(d)(ii); 

thermal  process  flavourings  obtained  by  heating  ingredients  which  fall  partially  or 
totally  under  Article  3(2)(e)(ii)  or  for  which  the  conditions  for  the  production  of 
thermal  process  flavourings  and  the  maximum  levels  for  certain  undesirable 
substances set out in Annex V are not met; 

flavour precursors referred to in Article 3(2)(g)(ii);  

other flavourings referred to in Article 3(2)(h); 

source materials other than food referred to in Article 3(2)(j)(ii). 

EN 

17 

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Article 910 
Community list of flavourings and source materials 

Of the flavourings and source materials referred to in Article 89, only those included in the 
Community list may be placed on the market as such and used in or on foods. 

Article 1011 
Inclusion of flavourings and source materials in the Community list 

1. 

A  flavouring  or  source  material  may  be  included  in  the  Community  list,  in 
accordance  with  the  procedure  laid  down  by  Regulation  (EC)  No  [common 
procedure], only if it complies with the conditions set out in Article 4. 

2. 

The entry for a flavouring or source material in the Community list shall specify: 

(a) 

the identification of the flavouring or the source material approved; 

(b)  where necessary, the conditions under which the flavouring may be used. 

3. 

The Community list 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 1112 
Flavourings or source materials falling within the scope of Regulation (EC) No 1829/2003  

A  flavouring  or  source  material  falling  within  the  scope  of  Regulation  (EC)  No  1829/2003 
may  be  included  in  the  Community  list  in  Annex  I  in  accordance  with  the  present 
Regulation  only  when  it  is  covered  by  an  authorisation  in  accordance  with  Regulation 
(EC)  No  1829/2003.  only  after  it  has  been  authorised  in  accordance  with  the  procedure 
referred to in Article 7 of Regulation (EC) No 1829/2003.  

EN 

18 

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CHAPTER IV 

LABELLING 

SECTION 1 

LABELLING OF FLAVOURINGS NOT INTENDED FOR SALE TO THE FINAL 
CONSUMER 

Article 1213  
Labelling of flavourings not intended for sale to the final consumer 

1. 

2. 

Flavourings not intended for sale to the final consumer may be marketed only if they 
comply  with  the  labelling  if  their  packaging,  containers  or  accompanying 
documents bear the information provided for in Articles 134 and 145, which must be 
easily  visible,  clearly  legible  and  indelible.  The  information  provided  for  in 
Article 14 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 1314 
General information requirements for labelling of flavourings not intended for sale to the 
final consumer 

1. 

Where flavourings not intended for sale to the final consumer are sold singly or 
mixed with each other and/or with other food ingredients and/or to which other 
substances  are  added  in  accordance  with  Article  3(2)(a)(iii),  their  packaging  or 
containers  of  flavourings  not  intended  for  sale  to  the  final  consumer  shall  bear  the 
following information: 

(a) 

the sales description: either the word ‘flavouring’ or a more  specific name or 
description of the flavouring; 

(cb)  the statement either ‘for use in food’ or the statement ‘restricted use in food’ or 

a more specific reference to its intended food use;  

(fc) 

if necessary, the special conditions for storage and use; 

(hd)  a mark identifying the batch or lot; 

EN 

19 

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(de)  a list in descending order of weight of: 

(i) 

the categories of flavourings present; and 

(ii) 

the  names  of  each  of  the  other  substances  or  materials  contained  in  the 
product  or,  where  appropriate,  their  E-number  and  an  indication  a 
accordance with Regulation (EC) No 1829/2003; 

(bf) 

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

(eg)  an  indication  of  the  maximum  quantity  of  each  component  or  group  of 
components  subject  to  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, 
including Regulation (EC) No 1829/2003; 

(ih) 

the net quantity. 

(gi)  a date of minimum durability; 

(j)  where relevant, information on a flavouring or other substances referred 
to  in  this  Article  and  listed  in  Annex  IIIa  to  Directive  2000/13/EC  as 
regards the indication of the ingredients present in foodstuffs. 

By way of derogation from paragraph 1, the information required in points (ce) to (g) 
and  (j)  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.  

By  way  of  derogation  from  paragraph  1  of  this  article,  where  flavourings  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 1415  
Specific information requirements for the sales description of flavourings  

The term ‘natural’ may only be used to describe a flavouring in the sales description 
referred to in Article 1314(1)(a) as provided for in paragraphs 2 to 6. 

The  term  ‘natural’  for  the  description  of  a  flavouring  may  only  be  used  if  the 
flavouring  component  comprises  only  flavouring  preparations  and/or  natural 
flavouring substances.  

2. 

3. 

1. 

2. 

EN 

20 

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3. 

4. 

5. 

6. 

1. 

The  term  “natural  flavouring  substance(s)”  may  only  be  used  for  flavourings  in 
which the flavouring component contains exclusively natural flavouring substances. 

The term ‘natural’ may only be used in combination with a reference to a food, food 
category or a vegetable or animal flavouring source, if at  least  9095% [by w/w] of 
the flavouring component has been obtained from the source material referred to. 

The  flavouring  component  may  contain  flavouring  preparations  and/or  natural 
flavouring substances.  

The  description  shall  read  “natural  <<food(s)  or  food  category  or  source(s)>> 
flavouring”. 

“Natural  <<food(s)  or  food  category  or  source(s)>>  flavouring  with  other  natural 
flavourings” may only be used if the flavouring component is partially derived from 
the source material referred to and can easily be recognised. 

The  flavouring  component  may  contain  flavouring  preparations  and/or  natural 
flavouring substances. 

The  term  “natural  flavouring”  may  only  be  used  if  the  flavouring  component  is 
derived from different source materials and where a reference to the source materials 
would not reflect their flavour or taste.  

The  flavouring  component  may  contain  flavouring  preparations  and/or  natural 
flavouring substances. 

SECTION 2 

LABELLING OF FLAVOURINGS INTENDED FOR SALE TO THE FINAL 
CONSUMER 

Article 1516 
Labelling of flavourings intended for sale to the final consumer 

Without  prejudice  to  Directive  2000/13/EC,  Directive  89/396/EEC  and  where 
appropriate,  Regulation  (EC)  No  1829/2003,  flavourings  sold  singly  or  mixed 
with each other and/or to which other substances have been added intended for 
sale  to  the  final  consumer  may  be  marketed  only  if  their  packaging  contains  the 
statement either ‘for use in food’ or the statement ‘restricted use in food’ or a more 
specific  reference  to  its  intended  food  use,  which  must  be  easily  visible,  clearly 
legible and indelible. 

2. 

The  term  ‘natural’  shall  be  used  to  describe  a  flavouring  in  the  sales  description 
referred to in Article 134(1)(a) only as provided for in Article 145.  

EN 

21 

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Article 17  
Other labelling requirements 

Articles 13 to 16 shall apply 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. 

CHAPTER V 

PROCEDURAL PROVISIONS AND IMPLEMENTATION 

Article 1618 
Reporting by the food business operators 

1. 

12. 

23. 

1. 

2. 

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

The food business operators or their representatives shall report to the Commission 
the annual amounts of flavouring substances added to foods in the Community and 
the use levels for each food category in the Community. 

Detailed rules for the implementation of paragraph 12 shall be adopted in accordance 
with the procedure referred to in Article 1820(2). 

Article 1719 
Monitoring and reporting by the Member States 

Member  States  shall  establish  systems  to  monitor  the  consumption  and  use  of 
flavourings  set  out  in  the  Community  list  and  the  consumption  of  the  substances 
listed in Annex III and report their findings each year to the Commission and to the 
Authority.  

After the Authority has been consulted, a common methodology for the gathering of 
information by the Member States on the consumption and use of flavourings set out 
in the  Community list  and of  the substances listed in Annex III  may  be  adopted in 
accordance with the procedure referred to in Article 1820(2). 

Article 1820 
Committee 

1. 

The Commission shall be assisted by the Standing Committee on the Food Chain and 
Animal Health (hereinafter referred to as ‘the Committee’). 

EN 

22 

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2. 

3. 

4. 

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. 

Where  reference  is  made  to  this  paragraph,  Article  5a(1),  (2),  (4)  and  (6),  and 
Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of 
Article 8 thereof. 

5. 

The Committee shall adopt its Rules of Procedure. 

Article 1921 
Amendments to Annexes II to V 

Amendments to Annexes II to V to this Regulation to reflect scientific and technical progress, 
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 
20(3).,shall be adopted in accordance with the procedure referred to in Article 18(2). 

On  imperative  grounds  of  urgency,  the  Commission  may  use  the  urgency  procedure 
referred to in Article 20(4). 

Article 2022 
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 

Article 2123 
Repeals 

1. 

Directive 88/388/EEC, Decision 88/389/EEC and Directive 91/71/EEC are repealed.  

Regulation  (EC)  No  2232/96  is  repealed  from  the  date  of  application  of  the  list 
referred to in Article 2(2) of that Regulation. 

EN 

23 

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2. 

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

Article 2224  
Establishment of the Community list of flavourings and source materials and transitional 
regime 

1. 

2. 

3. 

The Community list shall be established by placing the list of flavouring substances 
referred  to  in  Article  2(2)  of  Regulation  (EC)  No  2232/96  in  Annex  I  to  this 
Regulation at the time of its adoption. 

Until  the  establishment  of  the  Community  list,  Regulation  (EC)  No  […]  [the 
common  procedure]  shall  apply  for  the  evaluation  and  approval  of  flavouring 
substances  which  are  not  covered  by  the  evaluation  programme  provided  for  in 
Article 4 of Regulation (EC) No 2232/96.  

By way of derogation from that procedure, the time periods of sixnine months and 
nine months referred to in Article 5(1) and Article 7 of Regulation (EC) No […] [the 
common procedure] shall not apply to such evaluation and approval. 

Any appropriate transitional measures which are designed to amend non-essential 
elements  of  this  Regulation,  inter  alia  by  supplementing  it  shall  be  adopted  in 
accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in  Article 
20(3).may be adopted in accordance with the procedure referred to in Article 18(2). 

Article 2325 
Amendment to Regulation (EEC) No 1576/89 

Regulation (EEC) No 1576/89 is hereby amended as follows: 

1. 

Article 1(4)(m) is amended as follows: 

(a) 

In point (1)(a), the second subparagraph shall be replaced by the following: 

“Other flavouring substances as defined in Article 3(2)(b) of Regulation (EC) 
No  […],  and/or  aromatic  plants  or  parts  of  aromatic  plants  may  be  used  in 
addition,  but  the  organoleptic  characteristics  of  juniper  must  be  discernible, 
even if they are sometimes attenuated.” 

(b)  Point 2(a) shall be replaced by the following: 

“The drink may be called ‘gin’ if it is produced by flavouring organoleptically 
suitable  ethyl  alcohol  of  agricultural  origin  with  flavouring  substances  as 
defined  in  Article  3(2)(b)  of  Regulation  (EC)  No  […]  and/or  flavouring 
preparations as defined in Article 3(2)(d) of that Regulation so that the taste is 
predominantly that of juniper.” 

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(c) 

In point 2(b), the first subparagraph shall be replaced by the following:  

“The drink may be called ‘distilled gin’ if it is produced solely by redistilling 
organoleptically  suitable  ethyl  alcohol  of agricultural  origin of  an  appropriate 
quality  with  an  initial  alcoholic  strength  of  at  least  96  %  vol  in  stills 
traditionally used for gin, in the presence of juniper berries and of other natural 
botanicals  provided  that  the  juniper  taste  is  predominant.  The  term  ‘distilled 
gin’ may also apply to a mixture of the product of such  distillation and  ethyl 
alcohol of agricultural origin with the same composition, purity and alcoholic 
strength.  Flavouring  substances  as  defined  in  Article  3(2)(b)  of  Regulation 
(EC)  No  […]  and/or  flavouring  preparations  as  specified  at  (a)  may  also  be 
used to flavour distilled gin. London gin is a type of distilled gin.” 

2. 

In Article 1(4)(n)(1), the second subparagraph shall be replaced by the following: 

“Other  flavouring  substances  as  defined  in  Article  3(2)(b)  of  Regulation  (EC) 
No […]  and/or  flavouring  preparations  as  defined  in  Article  3(2)(d)  of  that 
Regulation  may  additionally  be  used  but  there  must  be  a  predominant  taste  of 
caraway.” 

3. 

In Article 1(4)(p), the first subparagraph shall be replaced by the following: 

“Spirit drinks with a predominantly bitter taste produced by flavouring ethyl alcohol 
of  agricultural  origin  with  flavouring  substances  as  defined  in  Article  3(2)(b)  of 
Regulation (EC) No […] and/or flavouring preparations as defined in Article 3(2)(d) 
of that Regulation.” 

4. 

In Article 1(4)(u), the first subparagraph shall be replaced by the following: 

“A  spirit  drink  produced  by  flavouring  ethyl  alcohol  of  agricultural  origin  with 
flavouring  of  cloves  and/or  cinnamon  using  one  of  the  following  processes: 
maceration and/ or distillation, redistillation of the alcohol in the presence of parts of 
the  plants  specified  above,  addition  of  flavouring  substances  as  defined  in 
Article 3(2)(b) of Regulation (EC) No […] of cloves or cinnamon or a combination 
of these methods.” 

5. 

In Article 4(5), the first and second paragraphs, excluding the lists in points (a) and 
(b), shall be replaced by the following: 

“Only  natural  flavouring  substances  and  flavouring  preparations  as  defined  in 
Article 3(2)(bc) and (d) of Regulation (EC) No […] may be used in the preparation 
of  the  spirit  drinks  defined  in  Article  1(4),  except  in  the  case  of  those  defined  in 
Article 1 (4) (m), (n) and (p).  

However,  flavouring  substances  as  defined  in  Article  3(2)(b)  of  Regulation  (EC) 
No […] and flavouring preparations as defined in Article 3(2)(d) of that Regulation 
shall be authorized in liqueurs except those mentioned below:” 

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Article 2426 
Amendment to Regulation (EEC) No 1601/91 

Article 2(1) is hereby amended as follows: 

1. 

In point (a), the first sub-indent of the third indent shall be replaced by the following:  

“− 

flavouring  substances  and/or 
Article 3(2)(b) and (d) of Regulation (EC) No […], and/or”  

flavouring  preparations  as  defined 

in 

In  point  (b),  the  first  sub-indent  of  the  second  indent  shall  be  replaced  by  the 
following: 

“− 

flavouring  substances  and/or 
Article 3(2)(b) and (d) of Regulation (EC) No […], and/or”  

flavouring  preparations  as  defined 

in 

In  point  (c),  the  first  sub-indent  of  the  second  indent  shall  be  replaced  by  the 
following: 

2. 

3. 

“− 

flavouring  substances  and/or 
Article 3(2)(b) and (d) of Regulation (EC) No […], and/or”  

flavouring  preparations  as  defined 

in 

Article 2527 
Amendment to Regulation (EC) No 2232/96 

In Article 5 of Regulation (EC) No 2232/96, paragraph 1 shall be replaced by the following: 

“1. 

The  list  of  flavouring  substances  referred  to  in  Article  2(2)  shall  be  adopted  in 
accordance with the procedure referred to in Article 7 by 31 December 2008 at the 
latest.” 

Article 2628 
Amendment to Directive 2000/13/EC 

In Directive 2000/13/EC, Annex III shall be replaced by the following: 

“Annex III 

DESIGNATION OF FLAVOURINGS IN THE LIST OF INGREDIENTS 

1. 

Without prejudice to paragraph 2, flavourings shall be designated by the terms 

– 

“flavourings”  or  a  more  specific  name  or description  of  the  flavouring,  if  the 
flavouring  component  contains  flavourings  as  defined  in  Article  3(2)(b),  (c), 
(d), (e), (f), (g) and (h) of Regulation (EC) No […] of the European Parliament 
and of the Council* [Regulation on flavourings]; 

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– 

“smoke  flavouring(s)”  if  the  flavouring  component  contains  flavourings  as 
defined  in  Article  3  (2)  (f)  of  Regulation  EC  No  […]  [Regulation  on 
flavourings] and imparts a smoky flavour to the food. 

The  term  ‘natural’  for  the  description  of  flavourings  shall  be  used  as  laid  down  in 
Article 1415 of Regulation (EC) No […] [Regulation on flavourings].” 

OJ L […], […], […] 

2. 

* 

Article 2729  
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 [please insert date] [24 months after entry into force]. However, Articles 
910, 2325 and 2426 shall apply from the date of application of the Community list. 

Foods lawfully placed on the market or labelled prior to [24 months after the entry into 
force  of  this  Regulation]  which  do  not  comply  with  this  Regulation  may  be  marketed 
until their date of minimum durability. 

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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Community list of flavourings and source materials approved for use in and on foods 

ANNEX I 

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ANNEX II 

List of traditional food preparation processes by which natural flavouring substances 
and natural flavouring preparations are obtained 

Chopping 

Coating 

Cooking, baking, frying (up to 240°C) 

Cooling 

Cutting  

Drying 

Evaporation 

Fermentation 

Grinding 

Infusion 

Microbiological processes 

Peeling 

Pressing 

Distillation / rectification 

Emulsification 

Extraction, incl. solvent extraction 

Filtration 

Heating 

Maceration 

Mixing 

Percolation 

Refrigeration/Freezing 

Roasting / Grilling  

Squeezing  

Steeping  

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ANNEX III 

Presence of certain substances 

Part A: Substances which may not be added as such to food 

Agaric acid 

Capsaicin 

Hypericine 

Beta-asarone 

1-Allyl-4-methoxybenzene 

Hydrocyanic acid 

Menthofuran 

4-Allyl-1,2-dimethoxybenzene 

Pulegone 

Quassin 

1-Allyl-3,4-methylene dioxy benzene, safrole 

Teucrin A 

Thujone (alpha and beta) 

Part B: Maximum levels of certain substances, naturally present in flavourings and food 
ingredients  with  flavouring  properties,  in  certain  compound  food  to  which  flavourings 
and/or food ingredients with flavouring properties have been added 

Name of the 
substance 

Compound food in which the presence of 
the substance is restricted 

Maximum level 
[mg/kg] 

Beta-asarone 

Alcoholic beverages  

1-Allyl-4-
methoxybenzene 

Dairy products 

Processed fruits, vegetables (incl. 
mushrooms, fungi, roots, tubers, pulses and 
legumes), nuts and seeds 

Fish products 

Non-alcoholic beverages 

1.0 

50 

50 

50 

10 

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Hydrocyanic acid  Nougat,  marzipan  or 

its  substitutes  or 

similar products 

Canned stone fruits 

Alcoholic beverages 

Menthofuran 

Mint/peppermint  containing  confectionery, 
freshening 
except 
confectionery 

breath 

micro 

Micro breath freshening confectionery18 

Chewing gum 

Mint/peppermint 
beverages 

containing 

alcoholic 

4-Allyl-1,2-
dimethoxybenzene,  

Dairy products 

Meat  and  meat  products,  including  poultry 
and game 

Fish and fish products 

Soups and sauces 

Ready-to-eat savouries 

Non-alcoholic beverages 

Pulegone 

Mint/peppermint  containing  confectionery, 
except 
freshening 
confectionery 

breath 

micro 

Micro breath freshening confectionery18 

Chewing gum 

Mint/peppermint  containing  non-alcoholic 
beverages 

Mint/peppermint 
beverages 

containing 

alcoholic 

50 

5 

35 

500 

3000 

1000 

200 

20 

15 

10 

60 

20 

1 

250 

2000 

350 

20 

100 

18 

Candies with intensive taste; weight per candy not more than 1 g. 

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Quassin 

Non-alcoholic beverages 

1-Allyl-3,4-
methylene 
benzene, safrole 

dioxy 

Bakery wares 

Alcoholic beverages  

Meat  and  meat  products,  including  poultry 
and game 

Fish and fish products 

Soups and sauces 

Non-alcoholic beverages 

Teucrin A 

Alcoholic beverages 

Thujone (alpha and 
beta) 

Alcoholic beverages, except those produced 
from Artemisia species 

Alcoholic 
Artemisia species 

beverages 

produced 

from 

0,5 

1 

1.5 

15 

15 

25 

1 

2 

10 

35 

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ANNEX IV 

List of source materials to which restrictions apply for their use in the production of 
flavourings and food ingredients with flavouring properties 

Part A: Source materials which shall not be used for the production of flavourings and 
food ingredients with flavouring properties 

Source material 

Latin name 

Common name 

Tetraploid form of Acorus calamus 

Tetraploid form of Calamus 

Part  B:  Conditions  of  use  for  flavourings  and  food  ingredients  with  flavouring 
properties produced from certain source materials 

Source material 

Latin name 

Common name 

Conditions of use 

Quassia amara L. 
and 
Picrasma excelsa 
(Sw)  

Laricifomes 
officinales (Vill.: Fr) 
Kotl. et Pouz 
or 
Fomes officinalis 

Hypericum 
perforatum 

Teucrium 
chamaedrys 

Quassia 

White agaric mushroom 

Flavourings  and  food  ingredients  with 
flavouring  properties  produced  from  the 
source  material  may  only  be  used  for  the 
production of beverages and bakery wares. 

Flavourings  and  food  ingredients  with 
flavouring  properties  produced  from  the 
source  material  may  only  be  used  for  the 
production of alcoholic beverages 

St Johns wort 

Wall germander 

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Conditions for the production of thermal process flavourings and maximum levels for 
certain substances in thermal process flavourings 

ANNEX V 

Part A: Conditions for the production: 

(a) 

(b) 

The temperature of the products during processing shall not exceed 180°C. 

The  duration  of  the  thermal  processing  shall  not  exceed  15  minutes  at  180°C  with 
correspondingly  longer  times  at  lower  temperatures,  i.e.  a  doubling  of  the  heating 
time for each decrease of temperature by 10°C, up to a maximum of 12 hours. 

(c) 

The pH during processing should not exceed the value of 8,0. 

Part B: Maximum levels for certain substances 

Substance 

2-amino-3,4,8-trimethylimidazo [4,5-f] quinoxaline (4,8-DiMeIQx) 

2-amino-1-methyl-6-phenylimidazol [4,5-b]pyridine (PhIP) 

Maximum levels 
µg / kg 

50 

50 

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