13.6.  80 Official  Journal  of the  European  Communities NoC  144/9 
Proposal  for a Council  Directive  on the approximation  of the laws  of the Member  States 
relating  to flavourings  for use in foodstuffs  and  to source  materials  for their  production 
(Submitted  by the Commission  to the Council  on 28 May  1980) 
THE  COUNCIL  OF THE  EUROPEAN 
COMMUNITIES, 
Having  regard  to  the  Treaty  establishing  the 
European  Economic  Community  and  in particular 
Article  100  thereof, 
Having  regard  to the proposal  from  the Commission, 
Having  regard  to the  opinion  of the  European 
Parliament, 
Having  regard  to the  opinion  of the  Economic  and 
Social  Committee, 
Whereas  differences  between  national  laws  relating  to 
flavourings  hinder  the  free  movement  of foodstuffs 
and may  create  conditions  of unequal  competition, 
thereby  affecting  the establishment  or functioning  of 
the common  market; 
Whereas  the approximation  of those  laws  is necessary 
if the free  movement  of foodstuffs  is to be achieved; 
Whereas  laws  relating  to flavourings  for  use  in 
foodstuffs  should  take  account  primarily  of human 
health  requirements  but also,  within  the limit  required 
for the  protection  of health,  of economic  and 
technical  needs; 
Whereas  the  first  step  should  be to lay  down  in a 
framework  Directive  provisions  on  general  purity 
criteria,  definitions,  labelling,  and  the  principles  on 
the basis  of which  legal  differences  may  subsequently 
be eliminated. Whereas  on the  most  recent  scientific  and  technical 
advice  certain  components  of natural  flavouring 
materials  and  natural  flavouring  preparations  ought 
to be limited  in foodstuffs; 
Whereas  specific  purity  criteria  for  flavourings  and 
substances  and  materials  used  in their  production,  and 
methods  of analysis  and  sampling  of flavourings  in 
and on foodstuffs  should  be established; 
Whereas,  in order  to encourage  technical  progress, 
Member  States  should  be allowed  to permit  provi-
sionally  in their  territory,  under  official  control,  the 
use of flavourings  not  provided  for  in one  of the 
specific  Directives,  pending  a final  decision  at 
Community  level; 
Whereas,  should  the  use  in a flavouring  of  a 
substance  or material  provided  for  in one  of the 
specific  Directives  or the presence  of one  of the sub-
stances  listed  in Annex  II appear  to constitute  a 
health  risk,  Member  States  should  be authorized  to 
suspend  or limit  such  use,  or to reduce  the  limits 
provided,  pending  a decision  at Community  level; 
Whereas  the  updating  of the  list of flavourings  and 
substances  and  materials  authorized  in their  manu-
facture  and  the  establishment  of sampling  procedures 
and of the methods  of analysis  required  for checking 
not only  the substances  listed,  their  purity  standards 
and conditions  of use  but  also  the limits  which  have 
been  laid  down  in Annex  II constitute  technical 
implementing  measures;  whereas  in order  to simplify 
and expedite  the  procedure,  the  adoption  of such 
measures  should  be entrusted  to the Commission; 
Whereas  at a later  stage  specific  Directives  relating  to 
individual  categories  of  flavourings  and  source 
materials  from  which  they  are  derived  should  be 
adopted,  listing  the flavourings  which  are to be auth-
orized  by the  Member  States  for  the  treatment  of 
foodstuffs  and  indicating  any  special  conditions  of 
manufacture  or limitations  on use  that  might  be 
necessary; Whereas,  it is desirable  that  for  all cases  where  the 
Council  empowers  the  Commission  to implement 
rules  relating  to flavourings  for  use  in foodstuffs, 
provision  should  be made  for a procedure  establishing 
close  cooperation  between  the Member  States  and  the 
Commission  within  the  Standing  Committee  for 
No C 144/10 Official  Journal  of the  European  Communities 13.6.  80 
Foodstuffs  set  up  by  Council  Decision  69/414/ 
EEC  ('); 
Whereas,  without  prejudice  to the  application  of 
national  provisions  which  in the  absence  of specific 
Directives  on flavourings  shall  apply  to certain  groups 
of flavourings,  the  requirements  laid  down  in the 
following  provisions  should  be applied  in such  a way 
as to authorize,  two  years  after  notification  of this 
Directive,  trade  in and  use  of flavourings  complying 
with  the  provisions  of this  Directive  and  to prohibit, 
three  years  after  the notification  thereof,  trade  in and 
use of flavourings  which  do not comply  therewith, 
HAS  ADOPTED  THIS  DIRECTIVE: 
Article  1 
1. This  Directive  shall  apply  to flavouring  agents, 
hereinafter  called  'flavourings'  used  or intended  for 
use in or on foodstuffs  to impart  odour  or taste,  and 
to natural  flavouring  materials  and  other  source 
materials  used  for the production  of flavourings. 
2. For  the purposes  of this  Directive: 
(a) 'flavouring'  means  flavouring  substance,  flavour-
ing preparation  or their  mixtures; 
(b) 'flavouring  substance'  means  a defined  chemical 
substance  with  flavouring  properties  and  is: 
— 'natural'  when  isolated  from  natural  flavour-
ing materials,  natural  flavouring  preparations 
or foodstuffs  by  appropriate  physical 
processes,  (including  distillation,  solvent 
extraction), 
— 'nature-identical'  when  obtained  by chemical 
synthesis,  or isolated  by chemical  processes 
and chemically  identical  to  a substance 
occuring  naturally  in  natural  flavouring 
materials,  natural  flavouring  preparations  or 
foodstuffs, 
— 'artificial'  when  not  chemically  identical  to a 
substance  occuring  naturally  in  natural 
flavouring  materials,  natural  flavouring 
preparations  or foodstuffs; 
(c) 'flavouring  preparation'  means  a product  or 
mixture,  concentrated  or not  with  flavouring 
properties  and  is: 
(') OJ No L 291,  19. 11. 1969,  p. 9. — 'natural'  when  isolated  by appropriate  physical 
processes  (including  distillation,  solvent 
extraction)  or  trditional  food  preparation 
processes  (including  drying,  torrefaction  and 
fermentation)  from  natural  flavouring 
materials  or  foodstuffs  and  when  the 
composition  of the  flavouring  component  of 
the preparation  is substantially  the same  as in 
the natural  flavouring  material  or foodstuff, 
— 'artificial'  when  obtained  by other  than  appro-
priate  physical  processes  or  other  than 
traditional  food  preparation  processes  from 
natural  flavouring  materials  or foodstuffs,  or 
when  not  exclusively  derived  from  natural 
flavouring  materials  or foodstuffs; 
(d) 'natural  flavouring  material'  means  material  of 
vegetable  or animal  origin,  inherently  having 
flavouring  properties  and  used  for  its flavouring 
properties  either  as such  or processed  for  human 
consumption  by  traditional  food  preparation 
processes  (including  drying,  torrefaction  and 
fermentation). 
Article  2 
This  Directive  shall  not apply  to 
— substances  and  products  intended  to be consumed 
as such,  with  or without  reconstitution, 
— natural  flavouring  materials,  except  as is provided 
for in Articles  4 and  5, 
— substances  and  products  which  have  exclusively  a 
sweet,  sour  or salt  taste, 
— protein  hydrolysates  obtained  by the autolysis  or 
hydrolysis  of protein  rich  foods,  or food  proteins, 
without  the addition  of other  substances. 
Article  3 
Member  States  shall  take  all measures  necessary  to 
ensure  that  flavourings  and,  insofar  as this  Directive 
applies,  natural  flavouring  materials  may  be marketed 
or used  only  if they  comply  with  the rules  laid  down 
in this  Directive. 
Article  4 
1. Member  States  shall  take  all measures  necessary 
to ensure  that 
(a) flavourings  satisfy  the general  purity  criteria  listed 
in Annex  I, 
13.6.  80 Official  Journal  of the  European  Communities No C 144/11 
(b) the  use  of natural  flavouring  materials  and/or 
natural  flavouring  preparations  may  not  result  in 
the presence  in food  as  consumed  of  any 
substance  listed  in Annex  II in a quantity  greater 
than  therein  specified.  These  substances  must  not 
be added  as such,  being  present  exclusively  from 
the use  of such  natural  flavouring  materials  or 
natural  flavouring  preparations. 
2. Annex  II shall  be completed  as soon  as possible 
on the basis  of the list drawn  up under  the provisions 
of Article  5 (1) (c). 
Article  5 
1. The  Council  shall,  under  the  procedure 
provided  for  in Article  100  of the  Treaty  adopt  by 
means  of  specific  Directives  special  provisions 
applicable  to groups  of flavourings  (e.g.  special 
conditions  governing  their  use  which  may  be 
necessary  and  methods  used  in their  production). 
These  specific  Directives  shall  include  lists  bf subs-
tances  or materials  the use  of which  is authorized  to 
the exclusion  of all others  of: 
(a) artificial  flavouring  substances; 
(b) nature-identical  flavouring  substances; 
(c) source  materials  for  the  production  of natural 
flavouring  preparations  and  natural  flavouring 
substances; 
(d) source  materials  for  the  production  of artificial 
flavouring  preparations; 
2. The  Council,  under  the procedure  provided  for 
in Article  100  of the Treaty,  shall: 
(a) adopt  lists  of substances  or materials  the  use  of 
which  is authorized  to the exclusion  of all others 
of; 
— additives  necessary  for  the  production  and 
storage  of flavourings, 
— products  used  for  dissolving  and  diluting 
flavourings, 
— processing  aids  (e.g.  extraction  solvents) 
necessary  for the production  of flavourings; 
(b) specifiy  the  conditions  for  the  use  of the  sub-
stances  and  materials  referred  to in paragraph 
2(a). 
Article  6 
The procedure  laid  down  in Article  11 shall  be used 
to determine: — the  methods  of  analysis  needed  to  verify 
compliance  with  the  general  and  specific  purity 
criteria  referred  to in Article  4 (1) (a) and  this 
Article; 
— the  methods  of  analysis  needed  to  verify 
compliance  with  the  limits  referred  to in Article 
4(l)(b); 
— the  procedure  for taking  samples  and  the methods 
for qualitative  and  quantitative  analysis  of 
flavourings  in or on foodstuffs; 
— the  specific  criteria  of purity  for  the  substances 
and materials  referred  to in Article  5 (1) (a) and 
(b), and  where  necessary  Article  5 (1) (c) and  (d) 
and 2 (a). 
Article  7 
1. Notwithstanding  Article  5, a Member  State  may, 
where  a list of substances  or materials  has been  drawn 
up in accordance  with  paragraph  1 (a) to (d) of that 
Article,  authorize  the  use  within  its territory  of a 
substance  or material  not included  in such  list,  subject 
to the following  conditions: 
(a) the  authorization  must  be limited  to a maximum 
period  of three  years; 
(b) flavourings  manufactured  using  the substance  or 
material  must  bear  a distinctive  indication  which 
will be defined  on the authorization. 
2. The  Member  State  shall  forward  to tile  other 
Member  States  and  to the Commission  the text  of any 
authorization  drawn  up  pursuant  to paragraph  1 
within  two  months  of the date  of its entry  into  force. 
3. Before  the  expiry  of the  three  year  period 
provided  for  in paragraph  1, the Member  State  may 
submit  to the Commission  a request  to authorize  the 
inclusion  of the  substance  or material  referred  to in 
paragraph  1 in a list as referred  to in Article  5 (1) (a) 
to (d).  At the  same  tiipe,  it shall  supply  supporting 
documents  setting  out the grounds  on which  it deems 
such  authorization  justified  and  shall  indicate  the uses 
for which  such  substance  or material  is intended. 
Within  18 months  of the submission  of this  request,  a 
decision  shall  be taken  on the  basis  of information 
relating  to public  health,  and  in accordance  with  the 
procedure  laid  down  in Article  11 as to whether  the 
substance  or material  in question  may  be included  in 
the list  as referred  to in Article  5 (1) (a) to (d)  or 
whether  the authorization  should  be revoked.  If any 
special  provisions  prove  necessary  pursuant  to the 
provisions  of Article  5 (1), these  too  shall  be adopted 
under  the  same  procedure.  Notwithstanding 
paragraph  1 (a), the  national  authorization  shall 
remain  in force  until  a decision  is taken  on  the 
request. 
No C 144/12 Official  Journal  of the  European  Communities 13. 6. 80 
Should  the authorization  be revoked  by the Member 
State,  this  decision  to revoke  shall  apply  to any  other 
temporary  authorization  granted  in respect  of the 
substance  or material  in question.  Such  decision  may 
stipulate  that  the ban  on the use of the substance  or 
material  in question  shall  extend  to uses  other  than 
those  referred  to in the first  sub-paragraph. 
Article  8 
Without  prejudice  to Article  7 (3), amendments  to the 
technical  Annexes  of the  specific  Directives  referred 
to in Article  5 (1), to the lists  referred  to in Article 
5 (2), and  to the Annexes  to this  Directive,  necessary 
to take  account  of progress  in scientific  and technical 
knowledge  shall  be adopted  in accordance  with  the 
procedure  provided  for in Article  11. 
Article  9 
1. Where  a Member  State,  as a result  of new  infor-
mation  or of a reassessment  of existing  information 
made  since  this  Directive  or one  of the  specific 
Directives  laid  down  in Article  5 was  adopted  has 
detailed  grounds  for establishing 
— that  the presence  of one  of the substances  listed  in 
the Annexes  to this  Directive  or the  maximum 
level  which  may  be present,  although  it complies 
with the provisions  of this  Directive, 
— that  the use  of a flavouring  although  it complies 
with the relevant  specific  Directive, 
endangers  human  health,  that  Member  State  may 
temporarily  suspend  or restrict  application  of the 
provisions  in question  in its  territory.  It shall 
immediately  inform  the other  Member  States  and  the 
Commission  thereof  and  give  reasons  for its decision. 
2. The  Commission  shall  examine  as soon  as 
possible  the  grounds  given  by the  Member  State 
within  the  Standing  Committee  for  Foodstuffs,  and 
shall  then  deliver  its opinion  forthwith  and  take  the 
appropriate  measures. 
3. If  the  Commission  considers  that  amendments 
to this  Directive  or a specific  Directive  are necessary 
in order  to resolve  the  difficulties  mentioned  in 
paragraph  1 and  to ensure  the protection  of human 
health,  it shall  initiate  the  procedure  laid  down 
in Article  11,  with  a view  to adopting  these 
amendments;  the Member  State  which  has  adopted 
safeguard  measures  may  in that  event  retain  them 
until  the amendments  enter  into  force. Article  10 
1. Without  prejudice  to any  exception  provided  for 
in the  specific  Directives,  flavourings  may  be 
marketed  only  if their  packagings  or containers  bear 
the following  information: 
(a) the  name  or business  name  and  address  of the 
manufacturer  or  packager,  or  of  a seller 
established  within  the Community; 
(b) either  the  word  'flavouring'  or a more  specific 
name  or description  of the flavouring; 
(c) either  the  statement  'for  foodstuffs'  or a more 
specific  reference  to its intended  food  use; 
(d) in the case  of mixtures  of flavourings  a list of the 
categories  of flavourings  present  in accordance 
with the definitions  given  in Article  1 (2) in order 
of proportion  by weight  which  each  category 
bears  to the total; 
(e) in the case  of flavourings  containing  other  sub-
stances  or materials  in accordance  with  the  first 
and second  indents  of Article  5 (2) 
— the  name  of any  such  substances  or material 
or where  appropriate  its 'E' number, 
— the  percentage  of such  substance  or material, 
where  this  requirement  is laid  down  in 
provisions  relating  to other  categories  of 
additives; 
(f) an indication  of the maximum  amount  present  of 
any substance  listed  in Annex  II, and  instructions 
for use  where  the  absence  of such  instructions 
would  make  it impossible  for the user  to comply 
with the  special  conditions  of use  stipulated  in 
Article  4 (1) (b); 
(g) in the case/  of pre-packaged  flavourings,  the net 
quantity;  Article  8 of  Council  Directive 
79/112/EEC  of 19  December  1978  on  the 
approximation  of the laws  of the Member  States 
relating  to  the  labelling,  presentation  and 
advertising  of foodstuffs  for sale  to the ultimate 
consumer  (') shall  apply  by analogy. 
2. The  word  'natural',  or any  word  having  sub-
stantially  the  same  meaning,  may  only  be used  for 
flavourings,  the  flavouring  component  of which 
contains  exclusively  natural  flavouring  preparations. 
(') OJ No L 33, 8. 12. 1979,  p. 1. 
13.6.  80 Official  Journal  of the  European  Communities No C 144/13 
3. Any  reference  to the  type  of flavour  shall  be 
accompanied  by the  word  'reproduced'  where  the 
flavouring  contains  nature-identical  flavouring  sub-
stances,  this  indication  being  replaced  by 'artificial'  if 
one or more  artificial  flavouring  substances  is present. 
4. The  details  referred  to in paragraph  1 (b) and 
(c) and  paragraph  3 shall  appear  on one  of the main 
surfaces  of the  packaging  or container  and  in the 
same  field  of vision. 
5. By  derogation  from  the  provisions  of this 
Article,  where  flavourings  are not  intended  for  retail 
sale,  the information  required  in paragraph  1 (a), (d), 
(e), (f) and  (g)  may  figure  on the  relevant  trade 
documents. 
6. Member  States  shall  refrain  from  laying  down 
requirements  more  detailed  than  those  already 
contained  in this  Article,  concerning  the  manner  in 
which  the particulars  provided  for are to be shown. 
The Member  States  shall,  however,  ensure  that  the 
sale of flavourings  within  their  own  territories  is 
prohibited  if the particulars  provided  in this  Article  do 
not appear  in a language  easily  undertstood  by 
purchaser,  unless  other  measures  have  been  taken  to 
ensure  that  the purchaser  is informed.  This  provision 
shall  not  prevent  such  particulars  from  being 
indicated  in various  languages. 
Article  11 
1. Where  the procedure  laid  down  in this  Article  is 
to be followed,  the  matter  shall  be referred  to the 
Standing  Committee  for  Foodstuffs  set  up  by 
Decision  69/414/EEC  (hereinafter  called  'the 
Committee')  by its Chairman,  either  on his  own 
initiative  or at the  request  of a representative  of a 
Member  State. 
2. The  representative  of the  Commission  shall 
submit  to the  Committee  a draft  of the  measures  to 
be taken.  The  Comittee  shall  give  its opinion  on that 
draft  within  a time  limit  set by the Chairman  having 
regard  to the urgency  of the matter.  Opinions  shall  be 
delivered  by a majority  of 41 votes,  the votes  of the 
Member  States  being  weighted  as provided  in Article 
148 (2) of the Treaty.  The  Chairman  shall  not vote. 
3. (a) Where  the  measures  envisaged  are  in 
accordance  with  the  Opinion  of  the 
Committee,  the Commission  shall  adopt  them. (b) Where  the  measures  envisaged  are  not  in 
accordance  with  the  Opinion  of  the 
Committee,  or if no Opinion  is delivered,  the 
Commission  shall  without  delay  submit  to the 
Council  a proposal  on the  measures  to be 
taken.  The  Council  shall  act  by a qualified 
majority. 
(c) If within  three  months  of the  proposal  being 
submitted  to it the Council  has  not  acted,  the 
proposed  measures  shall  be adopted  by the 
Commission. 
Article  12 
1. Without  prejudice  to Article  14, Member  States 
shall  adopt  all the measures  necessary  to ensure  that 
trade  in flavourings  referred  to in Article  1 which 
comply  with  the  definitions  and  rules  laid  down  in 
this Directive  or in the  Directives  referred  to in 
Article  5(1)  and  (2)  cannot  be impeded  by  the 
application  of non-harmonized  national  provisions 
governing  the  composition,  manufacturing  specifi-
cations,  packaging  or labelling  of those  products. 
2. Paragraph  1 shall  not  be applicable  to non-
harmonized  provisions  justified  on grounds  of: 
— protection  of public  health; 
— prevention  of frauds  unless  such  provisions  are 
liable  to impede  the application  of the definitions 
and rules  laid  down  by this  Directive; 
— protection  of industrial  and  commercial  property, 
indications  of source,  registered  designation  and 
prevention  of unfair  competition. 
Article  13 
1. This  Directive  shall  apply  to  flavourings 
intended  for  use  in foodstuffs,  and  to foodstuffs, 
imported  into  the Community. 
2. This  Directive  shall  apply  neither  to flavourings, 
nor to foodstuffs,  intended  for  export  outside  the 
Community. 
Article  14 
Within  18 months  of the notification  of this  Directive, 
Member  States  shall  take  the  measures  necessary  to 
NoC  144/14 Official  Journal  of the  European  Communities 13. 6. 80 
comply  with  this  Directive  and  shall  forthwith  inform 
the Commission  thereof.  The  measures  taken  shall: 
— authorize,  two  years  after  notification  of this 
Directive,  trade  in and  use  of flavourings, 
complying  with  the  provisions  laid  down  in this 
Directive,  without  prejudice  to the application  of 
national  provisions,  which  in the absence  of the 
Directives  referred  to in Article  5(1)  and  (2) shall 
apply  to certain  groups  of flavourings; — prohibit,  three  years  after  notification  of this 
Directive,  trade  in and  use  of flavourings  which 
do not  comply  with  the  provisions  laid  down  in 
this Directive. 
Article  15 
This  Directive  is addressed  to the Member  States. 
ANNEX  I 
Flavourings  shall  not  contain  a toxicologically  dangerous  amount  of any  element. 
Subject  to any  exception  deriving  from  the criteria  of purity  referred  to in Article  6: 
— they  shall  not  contain  more  than  0-5  mg/kg  cadmium,  more  than  0-5  mg/kg  mercury,  more 
than  2 mg/kg  arsenic  or more  than  5 mg/kg  lead; 
— they  shall  not  contain  more  than  50 mg/kg  of copper  and  zinc  taken  together  of which  the zinc 
content  must  not exceed  25 mg/kg; 
13.6.  80 Official  Journal  of the European  Communities NoC  144/15 
ANNEX  II 
Maximum  limits  for certain  substances  having  biological  activity  present  in food  as consumed  as a 
result  of the use of natural  flavouring  materials  and/or  natural  flavouring  preparations 
Substance Food 
mg/kg Beverages 
mg/kg Exceptions 
Beta asarone 0-1 01 1 mg/kg  in alcoholic  beverages  and  sea-
sonings  used  in snack  foods 
Coumarin 2 2 10 mg/kg  in certain  types  of caramel  confec-
tionery 
50 mg/kg  in chewing  gum 
10 mg/kg  in alcoholic  beverages 
Hydrocyanic  acid 1 1 25 mg/kg  in confectionery 
50 mg/kg  in marzipan  or its substitutes 
1 mg/kg  per 1 % volume  alcohol  in alcoholic 
beverages 
5 mg/kg  in stone  fruit  juices 
Safrole  and 
iso-safrole 1 1 2 mg/kg  in alcoholic  beverages  less than  25 % 
volume  alcohol 
5 mg/kg  in alcoholic  beverages  above  25 % 
volume  alcohol 
15 mg/kg  in foods  containing  mace  and  nut-
meg 
Thujone  (alpha  and 
beta) 0-5 0-5 5 mg/kg  in alcoholic  beverages  less than  25 % 
volume  alcohol 
10 mg/kg  in alcoholic  beverages  above  25 % 
volume  alcohol 
50 mg/kg  in foods  containing  sage 
100 mg/kg  in sage  stuffings 
35 mg/kg  in bitters