Proposal for a EUROPEAN PARLIAMENT AND COUNCIL REGULATION (EC) laying down a Community procedure for flavouring substances used in foodstuffs
Date: 1993-12-01
Institutions: European Commission
Subjects: approximation of laws, flavouring, food additive, foodstuff, marketing, public health

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COMMISSION  OF THE  EUROPEAN  COMMUNITIES 

COM(93) 609 final  - COD 478 

Brussels,  1 December  1993 

Proposal  for a 

EUROPEAN  PARLIAMENT  AND COUNCIL REGULATION (EC) 

laying down  a Community  procedure for flavouring  substances 

used in  foodstuffs 

(presented by the Commission) 

-  2 -

EXPLANATORY  MEMORANDUM 

1.  Article 5(1) of Directive 88/388/EEC^1>  states that: 

"The  Council,  acting  in  accordance  with  the  procedure  laid  down  in 
Article  100a of  the Treaty, shall  adopt 

1. Appropriate provisions concerning: 

-  flavouring  sources composed  of  foodstuffs, and of  herbs  and  spices 

normally considered  as foods, 

-  flavouring  sources  composed  of  vegetable  or  animal  raw  materials 

not normally considered  as foods, 

-  flavouring substances obtained  by appropriate physical  processes or 
by  enzymatic  or  microbiological  processes  from  vegetable  or  animal 
raw mater ials, 

-  chemically synthesized  or chemically  isolated  flavouring  substances 
chemically  identical  to  flavouring  substances  naturally  present  in 
foodstuffs or  in herbs and spices normally  considered  as foods, 

-  chemically synthesized or  chemically  isolated  flavouring  substances 
chemically  identical  to  flavouring  substances  naturally  present  in 
vegetable or animal  raw materials not normally  considered  as foods, 

-  chemically synthesized or  chemically  isolated  flavouring  substances 

other  than those referred  to  in the fourth  and  fifth  indents, 

-  source  materials  used  for  the  production  of  smoke  flavourings  or 
process  flavourings,  and  the  reaction  conditions  under  which  they 
are prepared." 

This  Regulation  deals  with  flavouring  substances.  Where  necessary,  other 
provisions will  be proposed  for  the other  categories of  flavourings. 

2. 

The  Scientific  Committee  for  Food  was  consulted  in  December  1991 
concerning  the  principles  of  the  safety  evaluation  of  flavouring 
substances.  Its opinion  was  published  (29th  series).  It  recommended 
that  flavouring  substances  should  be  subject  to an  appropriate  safety 
evaluation.  The Committee  agreed  to take  into account  the findings of 
Council  of  Europe's  committee of  experts on  flavourings, the  Food  and 
Drug  Administration  (FDA) and  the  Flavours  and  Extracts  Manufacturers 
Association  (FEMA).  The  Committee  has  also  defined  criteria  for  the 
safety  evaluation of  flavouring  substances.  The  flavouring  substances 
will  be  evaluated  in groups  of  substances  having  a  similar  chemical 
structure. 

(1)  0J  No L 184, 15.7.1988, p. 61 

3 -

This  Regulation  defines  general  criteria  (Annex  I)  for  the  use  of 
flavouring  substances  in  foodstuffs.  On  the  basis  of  these  general 
criteria  and  the  opinion  of  the  Scientific  Committee  for  Food,  a 
Community  positive  list of  flavouring  substances will  be drawn  up  by 
a  committee  procedure.  The  substances  deemed  acceptable  by  the 
Scientific Committee  for Food will  be  included  in the  list; given that 
technical  measures  are  involved,  the  committee  procedure  Is  the  most 
appropriate. This  list will  be drawn up  in stages. 

After  31  December  1993,  the  food  industry  will  have  to  use  the 
flavouring  substances  which  have  been  subject  to  the  procedure  laid 
down  in this Regulation.  Some members of  the  industry  will  therefore 
have to adapt  their manufacturing processes. 

This  draft  Regulation  is  unlikely  to  have  any  negative  effect  on 
employment. 

Justification  of  the  proposal  with  regard  to  the  principle  of 
subsidiar i ty 

What  are  the  objectives  of  the  proposed  measure  in  terms  of  the 
obligations of  the Community? 

The main aims of  the proposed  Regulation are 

to achieve a high  level of protection  for  consumers 

-  to  improve  the free movement  of goods  in the  internal  market, and 

to  create  greater  legal  certainty  for  economic  operators  and,  in 
particular, for  the food  industry 

in relation  to the use of  flavouring  substances  in foodstuffs. 

These  objectives  satisfy  the  requirements  of  Article  100a  of  the 
Treaty  and  fit  in  with  Article  5  of  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  production. 

Does  the proposed  measure  involve any  sharing of  competence  with  the 
Member  States? 

Yes, competence  is shared. 

What  is the scale of  the problem? 

The  legislative  situation  differs  widely  from  one  Member  State  to 
another.  Some  States  have  compiled  positive  lists  of  flavouring 
substances,  others  are  content  with  the  general  principle  of  non-
toxicity  or  a  list  of  prohibited  substances.  These  differences 
constitute  barriers  to trade  in foodstuffs containing  flavourings. 

-  4 -

What  is the most effective solution,'given the respective resources of 
the Community  and of  the Member  States? 

In  line with  the recommendations of  the Scientific  Committee  for  Food 
(see 29th  report - 1993) flavouring substances are required  to undergo 
an  appropriate  toxicologicaI  evaluation.  In  view  of  the  number  of 
substances  involved  (between  2000 and  3000),  these  evaluations  should 
be  undertaken  at  Community  level  using  resources  that  exist  in  the 
Member  States under  the auspices of scientific cooperation. 

What  concrete  added  value  does  the  envisaged  Community  measure  have 
and what would be the cost of  failing to act? 

The  proposed  regulation  will  facilitate  the  free  movement  of 
foodstuffs  in  the  Community.  Failure  to  act  would  perpetuate  the 
compartmentalIzation of national markets. 

What means of action are available to the Community? 

The  completion  of  the  internal  market  necessitates  the  use  of  a 
binding  legal  instrument. 

Are  uniform  rules  necessary  or  would  a  directive  specifying  general 
objectives  and  leaving  it  to  the  Member  States  to  adopt  appropriate 
measures  to  implement  them suffice? 

Total  harmonization  is necessary  because the ultimate aim  is to have a 
Community  list of substances that are toxicologically acceptable. 

r 

Proposal  for a 

EUROPEAN PARLIAMENT AND COUNCIL REGULATION (EC) 

laying down a Community  procedure for flavouring  substances 

used in  foodstuffs 

r Cx -

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European 
and  in particular  Article  100a  thereof. 

Community 

Having  regard  to the proposal  from  the Commission,^1) 

Having  regard  to the opinion of  the Economic  and Social  Committee,^) 

Having consulted  the Scientific Committee  for  Food, 

Whereas  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  product ion,^3^  provides  for 
the  adoption  by  the  Council  of  the  appropriate  provisions  concerning 
flavouring substances, 

Whereas  differences  between  national  laws  relating  to  flavourings  hinder 
the  free  movement  of  foodstuffs  and  may  create  conditions  of  unequal 
competition, thereby directly  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,  according  to  the  scope  and  effects  of  the  proposed  action,  the 
Community  measures envisaged  by  this  Regulation are not only  necessary  but 
indispensable  for  the  attainment  of  the  stated  objectives,  and  whereas 
these objectives cannot be achieved  by Member  States  individually, 

(1)  0J L 184, 15.07.1988, p. 61 
(2) 
(3)  0J No L 184, 15.07.1988, p. 61 

- 6 -

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  it  is  necessary  to  establish  general  criteria  for  the  use  of 
flavouring substances, 

Whereas  on  the basis of  the most  recent  scientific  advice  it  Is necessary 
to  lay down a  list of  flavouring  substances  that may be used  in food. 

Whereas this  list must be open and capable of being amended  in the  light of 
scientfic and  technical  developments; 

Whereas  it may  be  necessary  for  health  reasons  to  adopt  conditions  of  use 
for certain  flavouring substances, 

HAVE ADOPTED THIS REGULATION; 

- 7 -

Article 1 

1.  This Regulation  lays down  the procedure  for  the establishment  of  rules 
in  respect  of  the  flavouring  substances  referred  to  In  the  third, 
fourth,  fifth  and  sixth  indents of  Article  5(1) of  Council  Directive 
88/388/EEC. 

2. 

This  Regulation  shall  apply  to  flavouring  substances  used  or  intended 
for  use  in or  on  foodstuffs  to  impart  odour  and/or  taste,  as  defined 
in Article  1(2)(b) of Directive  88/388/EEC. 

3.  This  Regulation  shall  apply  without  prejudice  to  specific  directives 
permitting  substances  covered  by  this  Regulation  to  be  used  for 
purposes other  than those mentioned  in Article 1(2). 

Art icle 2 

1.  Only  flavouring  substances  conforming  to  the general  criteria  set  out 

in Annex  I of  this Regulation may be used  in foodstuffs. 

2. 

A  list of  flavouring  substances  the use of which  is authorized  to the 
exclusion  of  all  others will  be  laid down.  This  list may  be drawn  up 
in stages. 
This  list  shall  be adopted  in accordance  with  the procedure  laid  down 
in  Article  4  and  may  include  conditions  under  which  flavouring 
substances may be added. 

3.  Flavouring  substances  will  be  included  in  the  list  mentioned  in 
paragraph  1 on  the basis of  the general  criteria described  in Annex  I. 

- 8 -

Art icle 3 

This  Regulation  shall  apply  without  prejudice  to  the  Community 
provisions  governing  the  use,  in  certain  foodstuffs,  of  certain 
categories  of  flavouring  substances  as  defined  in  Article  1  of 
Directive 88/388/EEC. 

However,  flavouring  substances  of  these  categories  must  conform  with 
Annex  I. 

Art icle 4 

The  Commission  shall  be  assisted  by  the  Standing  Committee  for  Foodstuffs 
set  up  by  Council  Decision  69/414/EEC^5^.  The  representative  of  the 
Commission  shall  submit  to  the  committee  a  draft  of  the  measures  to  be 
taken.  The committee shall  deliver  its opinion on  the draft, within a time 
limit  which  the  chairman  may  lay  down  according  to  the  urgency  of  the 
matter,  if necessary  by  taking a vote. 

The  opinion  shall  be  recorded  in  the  minutes 
in  addition,  each  Member 
State  shall  have  the  right  to  ask  to  have  its  position  recorded  in  the 
minutes. 

The  Commission  shall  take  the  utmost  account  of  the  opinion  delivered  by 
the  committee.  It  shall  inform  the  committee  of  the  manner  in which  its 
opinion has been  taken  into account. 

(5)  OJ No L 291, 19.11.1969, p. 9 

-  9  -

Art icle  5 

Member  States  may  not  prohibit,  restrict  or  obstruct  the  marketing,  or  the 
use  in  foodstuffs,  of  flavouring  substances  if  these  comply  with  the 
provisions  of  this  Regulation. 

Art icle  6 

Measures  to  bring  existing  Community  provisions  into  line  with  this 
Regulation  shall  be  adopted  according  to  the  procedure  laid  down  in 
Art icle  4. 

Art icle  7 

This  Regulation  shall  enter  into  force  on  31  December  1993. 

This  Regulation  shall  be  binding  in  its entirety  and  directly  applicable  in 
all  Member  States. 

'Done at 

For  the  CounciI 
The  President 

For  the  European  Parliament 
The  President 

-  10 

Annex I 

General  criteria for  the use of  flavouring substances: 

1.  Flavouring substances can be approved  provided  that-

-  they present  no risk to the health of  the consumer, 

so far as can be  judged on  the scientific evidence available 
-  and  their use does not mislead  the consumer, for  instance by 
disguising  the effects of  the use of  faulty  raw materials or 
of undesirable manufacturing practices. 

2. 

To  assess  the  possible  harmful  effects  of  a  flavouring  substance,  it 
must  be  subjected  to  appropriate  toxicological  evaluation.  When  a 
flavouring  substance  contains  or  consists  of  a  genetically  modified 
organism  within  the  meaning  of  Article  2(1)  and  (2)  of  Council 
Directive  90/220/EEC^65,  Articles  11  to  18  of  Directive  90/220/EEC 
will  not be applicable.  However, the evaluation of  the safety of  this 
flavouring  substance  must  take  into  account  environmental  safety  as 
provided  for  in Directive 90/220/EEC. 

3.  All  flavouring  substances must  be  kept  under  constant  supervision  and 

must be reevaluated whenever  necessary. 

(6)  OJ L 117, 8.5.1990, p. 15 

ISSN 0254-1475 

COM(93) 609 final 

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