Proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE amending European Parliament and Council Directive 94/35/EC on sweeteners for use in foodstuffs
Date: 1995-10-18
Institutions: European Commission
Subjects: consumer protection, foodstuff, foodstuffs legislation, human nutrition, marketing, sweetener

COMMISSION  OF THE EUROPEAN  COMMUNITIES 

Brussels,  18.10.1995 
COM(95) 482 final 

95/0251  (COD) 

Proposal  for a 

EUROPEAN PARLIAMENT  AND COUNCIL  DIRECTIVE 

amending European Parliament and Council Directive 94/35/EC 

on sweeteners for use in  foodstuffs 

(presented  by the Commission) 

EXPLANATORY  MEMORANDUM 

1.  SUBSIDIARITY IMPACT STATEMENT 

1.  What are the objectives  of the proposed  measure with  regard to the  Community's 

obligations? 

Directive  89/107/EEC provides  for  the adoption  of specific  directives to harmonize  the use 
of different  categories  of additives  in foodstuffs.  The Directive  on sweeteners was adopted 
on 21 June  1994.  It now needs to be adapted  in the  light of recent  technical  and  scientific 
developments. 

2.  Does  competence  for the proposed  measure lie solely with  the Community  or is it 

shared with the Member States? 

Competence for the proposed measure lies solely with the Community. 

3.  To what extent is this a problem on a Community scale? 

Harmonization  of the use of additives  at Community  level was a priority  for  completion  of 
the internal  market.  It was also a tricky subject.  The framework  Directive  89/107/EEC on 
additives was adopted on 21 December  1988 and the three specific  Directives in 1994.  Since 
then,  the  instruments  relating  to  the  use  of  additives  have  been  the  same  in  the  fifteen 
Member  States.  This  structure  guarantees  the  free  movement  of  foodstuffs,  ensures  a high 
level  of  consumer  protection  and  offers  the  consumer  greater  freedom  of  choice  between 
different  foodstuffs. 

Like  the  two  other  specific  Directives,  Directive  94/35/EC  on  sweeteners  for  use  in 
foodstuffs  is based on the principle of the positive list.  A list of authorized  sweeteners is set: 
out in the Annex to the Directive with a list of the foodstuffs  in which they may be used and 
the conditions of use.  All sweeteners not included in the list are prohibited. 

Since  the  legal  basis  of  the  Directive  is  Article  100A  of  the  EC  Treaty,  the  proposal  for 
amendment has to follow the same procedure, implying the participation of Parliament in the 
decision-making process. 

4.  What  is the  most  effective  solution  taking  into  account  the  means  available  to the 

Community and the Member States? 

Once the  period  for  transposing  the aforementioned  Directives  has expired,  Member  States 
will  not  be  able  to  use  new  additives  or  amend  the  rules  governing  use  on  their  own 
initiative.  Action must therefore be taken at Community level. 

5.  What  practical  additional  benefit  will  the  proposed  measure  provide  and  what 

would be the cost of failure to take action? 

The Commission proposals will establish effective  legislation at Community level, attuned to 
new  developments  in  industry  and  consumer  needs.  If  the  amendment  is  not  adopted  the 
legislation  will  become  ineffective,  if  not  obsolete,  and  this  could  disrupt  the  proper 
functioning  of the internal market in  foodstuffs. 

6.  What forms of action are open to the Community? 

A  new  Directive  adopted  by  Parliament  and  the  Council  on  the  basis  of  Article  100a  is 
needed to amend Directive 94/35/EC. 

7.  Is it absolutely  necessary  to adopt uniform  rules or would  a Directive  establishing 
general principles and leaving implementation to the Member States be sufficient? 

The  Commission  proposal  is  based  on  the  principle  of  complete  harmonization  at 
Community  level.  Uniform  rules  are needed  since  additives  concern  public  health.  There 
needs to be a large degree of transparency between the Member States in order to establish a 
reasonable level of safety in trade in foodstuffs  within the Community. 

2.  SPECIFIC REMARKS 

This  amendment  to  Directive  94/35/EC  merely  allows  already  authorized  sweeteners  to  be 
used in certain new categories of food in which they cannot currently be used. 

No changes can be made to the conditions of use laid down in the Directive until the results 
of the consumer surveys required by Article 8 of the Directive are available. 

New  sweeteners  will  not  be accepted  as they  have  yet  to  be  dealt  with  in  a report  by  the 
Scientific  Committee for Food and have not been proved harmless. 

The proposal also adds technical  Articles (definition  of "quantum  satis", introduction  of the 
carryover clause) to bring Directive 94/35/EC into line with the other additives Directives. 

Lastly, the proposed amendment reformulates  a category  of foodstuffs  authorized to contain 
sweeteners  which  had  caused  controversy  on  account  of  its  relatively  imprecise  wording; 
"Vitamins  and  dietary  preparations"  thus  becomes  "Food  supplements/diet  integrators  (e.g. 
vitamins, trace elements), syrup-type or chewable." 

3 

Proposal for a 
European Parliament and Council Directive 
amending European Parliament and Council Directive 94/35/EC 
on sweeteners for use in  foodstuffs 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN 
UNION, 

Having regard to the Treaty establishing the Euroj»can Community, and in particular Article 
100a thereof, 

Having regard to the proposal from the Commission, 

9 
Having regard to the opinion of the Economic and Social Committee, 

Acting in accordance with the procedure referred to in Article  189b of the Treaty, 

Having regard to Council Directive 89/107/EEC of 21 December  1988 on the approximation 
of the laws of the Member States concerning food  additives authorized  for  use in  foodstuffs 
intended  for  human  consumption,  as  last  amended  by  Directive  94/34/EC,  and  in 
particular Article 3(2) thereof, 

Whereas  since  the  adoption  of  Directive  94/35/EC  there  have  been  many  technical 
developments in the field of sweeteners; 

Whereas the Directive should be adapted to take account of these developments; 

Whereas the  Scientific  Committee  for  Food  set up by  Commission  Decision  74/234/EEC 
was consulted before the adoption of provisions liable to have an effect  on public health; 

HAVE ADOPTED THIS DIRECTIVE: 

OJ 
OJ 
OJ 
OJL40,  11.2.89, p.27. 
OJL237,  10.9.94, p. 1. 
OJL  136, 20.5.74, p. 1. 

S 

Directive 94/35/EC is hereby amended as follows: 

Article 1 

1.  The  following  paragraph  5  is  added  to  Article  2:"5.  In  the  Annex  to  this  Directive 
"quantum satis" means  that  no  maximum  level  is  specified.  Nonetheless,  sweeteners 
shall  be  used  in accordance  with  good  manufacturing  practice, the  dose  used  shall  not 
exceed the amount required to achieve the intended purpose and the consumer must not 
be misled." 

2.  The following Article 2a is added: 

Article 2a 

The presence of a sweetener in a foodstuff  is permissible: 

in  compound  foodstuffs  other  than  those  mentioned  in  Article  2(3),  provided  that 
the sweetener is permitted in one of the ingredients of the compound  foodstuff 

or 

if the foodstuff  is intended for use solely in the preparation of a compound  foodstuff 
which conforms to the provisions of this Directive." 

3.  The  category  "Vitamins  and  dietary  preparations"  in  the  Annex  is  renamed  "Food 
supplements/diet integrators (e.g. vitamins, trace elements), syrup-type or chewable". 

4.  The table  in the Annex is completed  in accordance  with the table in the  Annex to  this 

Directive. 

ArtieU2 

Member  States  shall,  where  necessary,  amend  their  laws,  regulations  and  administrative 
provisions in order to: 

authorize  trade  in products  conforming  to this  Directive,  by  31 December  1995  at 
the latest; 

prohibit  trade  in  products  not  conforming  to  this  Directive  from  30 June  1996. 
However, products placed  on the  market  or labelled  before  that  date which  do  not 
comply with the Directive may be marketed until stocks are exhausted. 

They shall forthwith inform the Commission thereof. 

S 

When Member States adopt these measures, they shall contain a reference to this Directive or 
shall  be  accompanied  by  such  reference  on  the  occasion  of their  official  publication.  The 
metkods of making such reference shall be laid down by the Member State*. 

Article 3 

This  Directive  shaii  enter  into  iwce  on  the  seventh  day  following  its  publication  in  the 
Official  Journal of the European Communities. 

Thk Directive is addressed to the Member Stales. 

AOkkA 

Done et Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

Annex 

Note 
1. For the substance E952, cyclamic acid and its Na and Ca salts, maximum  usable doses are expressed  in free 
acid. 
2.  or  the  substance  E954,  saccharine  and  its Na  and  Ca  salts,  maximum  usable  doses  are  expressed  in free 
imide. 

Maximum 
usable dose 

1200 mg/kg 

110 mg/l 
2500 mg/kg 

350 mg/l 
25 mg/l 

350 mg/l 

2000 mg/kg 

350 mg/kg 
2000 mg/kg 

1000 mg/kg 

110 mg/l 
6000 mg/kg 

600 mg/l 
25 mg/l 
600 mg/l 

350 mg/kg 

EC No 

Name 

Foodstuffs 

E950 

Acesulfame K. 

E951 

Aspartame 

-  high-fibre  breakfast cereals, 
energy-reduced or with no 
added sugar 
-  energy-reduced soups 
-  small  breath-freshening 
sweets, with no added sugar 
-  reduced-energy fruit wines 
-  carbohydrate-free  beer 
-  drinks consisting of a mixture 
of a non-alcoholic drink with 
beer, cider, perry, spirits or 
wine 
-  biscuits for ice-cream, with 
no added sugar 
-  prepared salads 
-  Essoblaten 

-  high-fibre breakfast cereals, 
energy-reduced or with no 
added sugar 
-  energy-reduced soups 
-  small  breath-freshening 
sweets, with no added sugar 
-  reduced-energy fruit wines 
-  carbohydrate-free  beer 
-  drinks consisting of a mixture 
of a non-alcoholic drink with 
beer, cider, perry, spirits or 
wine 
-  prepared salads 

} 

E952 

Cyclamic acid and its 
Na and Ca salts 

E954 

Saccharine and its Na, 
K and Ca salts 

-  high-fibre  breakfast cereals, 
energy-reduced or with no 
added sugar 
-  energy-reduced soups 
-  small  breath-freshening 
sweets, with no added sugar 
-  energy-reduced fruit wines 
-  food  supplements/diet 
integrators (e.g. vitamins, trace 
elements), syrup-type or 
chewable 
-  drinks consisting of a mixture 
of a non-alcoholic drink with 
beer, cider, perry, spirits or 
wine 

-  high-fibre breakfast cereals, 
energy-reduced or with no 
added sugar 
-  energy-reduced soups 
-  small  breath-freshening 
sweets, with no added sugar 
-  reduced-energy fruit wines 
-  drinks consisting of a mixture 
of a non-alcoholic drink with 
beer, cider, perry, spirits or 
wine 
-  biscuits for ice-cream, with 
no added sugar 
-  prepared salads 

E957 

Thaumatin 

-  edible ices, energy-reduced or 
with no added sugar 

250 mg/kg 

400 mg/l 
4000 mg/l 

400 mg/l 
2000 mg/kg 

400 mg/l 

100 mg/kg 

110 mg/l 
3000 mg/kg 

80 mg/l 
80 mg/l 

800 mg/kg 

160 mg/kg 

50 mg/kg 

S 

E959  Neohesperidine DC 

-  high-fibre breakfast cereais, 
energy-reduced or with no 
added sugar 
-  energy-reduced soups 
-  small  breath-freshening 
sweets, with no added sugar 
-  food  supplements/diet 
integrators (e.g. vitamins, trace 
elements), syrup-type or 
chewable 
-  energy-reduced fruit wines 
-  drinks consisting of a mixture 
of a non-alcoholic drink with 
beer, cider, perry, spirits or 
wine 
-  prepared salads 

50 mg/kg 

50 mg/l 
400 mg/kg 

400 mg/kg 

10 mg/l 
30 mg/l 

50 mg/kg 

y 

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