Amended proposal for a Directive of the European Parliament and of the Council amending Directive 94/35/EC on sweeteners for use in foodstuffs (presented by the Commission pursuant to Article 250 (2) of the EC Treaty)
Date: 2003-05-16
Institutions: European Commission
Subjects: food safety, foodstuff, foodstuffs legislation, sweetener

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 16.5.2003
COM(2003) 277 final

2002/0152 (COD)

Amended proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending Directive 94/35/EC on sweeteners for use in foodstuffs

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

EXPLANATORY MEMORANDUM

1.

PROCEDURE

On 11 July 2002, the Commission adopted a proposal for a European Parliament and
Council Directive amending Directive 94/35/EC on sweeteners for use in foodstuffs1.
The proposal was sent to the European Parliament and Council on the same day. The
Economic  and  Social  Committee  issued  its  opinion  supporting  the  Commission
proposal on 11 December 2002.

On 10  April 2003, the  European  Parliament  has  in  first  reading  given  a  favourable
opinion  on  the  proposal.  The  Parliament  adopted  8  amendments,  2  of  which  were
accepted by the Commission.

2.

OBJECTIVE OF THE COMMISSION PROPOSAL

The  Commission  proposal  aims  at  adapting  Directive  94/35/EC  on  sweeteners  for
use  in  foodstuffs  to  recent  technical  and  scientific  developments.  To  this  end  it
foresees:

– 

– 

– 

– 

To  authorise  two  new  sweeteners,  sucralose  and  the  salt  of  aspartame  and
acesulfame, after favourable opinions by the Scientific Committee on Food.

To reduce the intake of an already authorised sweetener, cyclamate, following
an  opinion  of  the  SCF  lowering  the  ADI  (Acceptable  Daily  Intake)  for  this
substance.  Since  soft  drinks  contribute  to  a  large  extent  to  the  intake  of
sweeteners,  and  there  are  indications  that  the  ADI  could  be  exceeded,  the
Commission  proposed  a  reduction  of  the  maximum  permitted  use  dose  of
cyclamates in soft drinks from 400 to 350 mg/l.

To confer on the Commission the power to decide whether a substance should
be considered as a sweetener according to the Directive.

To  clarify  the  meaning  of  the  food  category  ‘fine  bakery  wares  for  special
nutritional uses’ that is not interpreted in a homogeneous manner by Member
States.

3.

COMMISSION  OPINION  ON  THE  AMENDMENTS  ADOPTED  BY  THE  EUROPEAN
PARLIAMENT

In  total,  the  European  Parliament  adopted  8  amendments  to  the  Commission
proposal. Out of these 8 amendments, 2 can be accepted by the Commission without
changes:  Amendment  1  concerning  the  recital  number  3  on  cyclamates  and
amendment  6  concerning  article  2  on  the  transposition  of  the  Directive.  The
Commission refuses amendments 2, 3, 4, 5, 12rev and 13 (merged) and 9.

1

COM(2002) 375 final, 11 July 2002.

2

                                                
The  Commission  had  agreed  to  an  amendment  of  the  Parliament  tabled  for  the
Plenary  requesting  to  reduce  the  maximum  permitted  dose  of  cyclamates  for  soft
drinks to 250 mg/l and to extend this reduction to milk and juice based drinks. This
amendment  fell  when  amendment  9  requesting  a  value  of  100  mg/l  for  these  food
categories  was  adopted  by  Parliament.  In  line  with  its  position  expressed  in  the
Plenary, the Commission now proposes to reduce the dose of cyclamates to 250 mg/l
in soft drinks and to extend this reduction to milk and juice based drinks.

4.

CONCLUSION

Having  regard  to  Article  250  paragraph  2  of  the  EC  Treaty,  the  Commission
modifies its proposal as follows.

3

2002/0152 (COD)

Amended proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending 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  European  Community,  and  in  particular
Article 95 thereof,

Having regard to the proposal from the Commission2,

Having regard to the opinion of the European Economic and Social Committee3,

After  consultation  of  the  Scientific  Committee  on  Food,  pursuant  to  Article  6  of  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
consumption4,

Acting in accordance with the procedure laid down in Article 251 of the Treaty5,

Whereas:

(1)

(2)

(3)

2

3

4

5

6

European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners
for  use  in  foodstuffs6  lays  down  a  list  of  sweeteners  that  may  be  used  in  the
Community and their conditions of use.

Since 1996, two new sweeteners, sucralose and the salt of aspartame and acesulfame,
have been found acceptable for use in food by the Scientific Committee on Food.

The  opinion  of  the  Scientific  Committee  on  Food  has  now  established  a  new
concerning the Acceptable Daily Intake (ADI) for cyclamic acid and its sodium and
calcium salts. The opinion of the Scientific Committee on Food, in conjunction with a
rigorous  interpretation  of  intake  estimations,  and  recent  studies  on  the  intake  of
cyclamate lead to a reduction of the maximum usable doses of cyclamic acid and its
sodium and calcium salts.

OJ C …, …, p. …
OJ C …, …, p. …
OJ  L  40,  11.2.1989,  p.  27.  Directive  as  amended  by  European  Parliament  and  Council  Directive
94/34/EC (OJ L 237, 10.9.1994, p. 1).
OJ C …, …, p. …
OJ  L  237,  10.9.1994,  p.  3.  Directive  as  amended  by  European  Parliament  and  Council  Directive
96/83/EC (OJ L 48, 19.2.1997, p. 16).

4

                                                
(4)

(5)

(6)

The food additives concerned comply with the general criteria laid down in Annex II
to Directive 89/107/EEC.

It  is  desirable  that  when  a  decision  is  taken  on  whether  a  particular  substance  is  a
sweetener, the consultation of the Standing Committee on the Food Chain and Animal
Health procedure is followed.

Articles 53 and 54 of Regulation (EC) No 178/2002 of the European Parliament and of
the Council of 28 January 2002 laying down the  general principles and requirements
of  food  law,  establishing  the  European  Food  Safety  Authority  and  laying  down
procedures  in  matters  of  food  safety7  establish  procedures  for  taking  emergency
measures  in  relation  to  food  of  Community  origin  or  imported  from  a  third  country.
They allow the Commission to adopt such measures in situations where food is likely
to  constitute  a  serious  risk  to  human  health,  animal  health  or  the  environment  and
where such risk cannot be contained satisfactorily by measures taken by the Member
State(s) concerned.

(7)

The  provisions  of  Directive  94/35/EC  should  be  adapted  to  take  account  of  Council
Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of
implementing powers conferred on the Commission8.

(8)

Directive 94/35/EC should therefore be amended accordingly,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 94/35/EC is amended as follows:

(1)

Article 4 is replaced by the following:

”Article 4

1.

It may be decided in accordance with the procedure referred to in Article 7(2)
whether a substance is a sweetener within the meaning of Article 1(2).

2. Where there are differences of opinion as to whether sweeteners can be used in
a  given  foodstuff  under  the  terms  of  this  Directive,  it  may  be  decided  in
accordance  with  the  procedure  referred  to  in  Article  7  (2)  whether  that
foodstuff is to be considered as belonging to one of the categories listed in the
third column of the Annex.”

(2)

Article 7 is replaced by the following:

”Article 7

1.

The  Commission  shall  be  assisted  by  the  Standing  Committee  on  the  Food
Chain  and  Animal  Health  instituted  by  Article  58  (1)  of  Regulation  (EC)
No 178/2002 (hereinafter referred to as “the Committee”).

7

8

OJ L 31, 1.2.2002, p. 1.
OJ L 184, 17.7.1999, p. 23.

5

                                                
2. 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 three
months.

3.

The Committee shall adopt its rules of procedure.”

(3)

The Annex is amended in accordance with the Annex to this Directive.

Article 2

Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative  provisions
necessary  to  comply  with  this  Directive  by  […]  at  the  latest.  The  purpose  of  those  laws,
regulations and administrative provisions shall be to:

– 

– 

authorise, by …* at the latest, the marketing and the use of products which
comply with this Directive;

ban, by … * at the latest, the marketing and the use of products which do
not comply with this Directive

They Member States shall forthwith inform the Commission thereof.

When Member States adopt those provisions, they shall contain a reference to this Directive
or be accompanied by such a reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.

This Directive shall enter into force on the day following that of its publication in the Official
Journal of the European Union.

Article 3

Article 4

This Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament
The President

For the Council
The President

*

Twelve months from the date of entry into force of this Directive

6

                                                
The Annex to Directive 94/35/EC is amended as follows:

ANNEX

(1)

The  category  ‘fine  bakery  products  for  special  nutritional  uses’  shall  be  renamed
‘fine bakery products, energy-reduced or with no added sugar’;

(2)

For E 951 aspartame the following category is added:

‘- Cornets and wafers, for ice cream, with no added sugar

1000 mg/kg’

(3)

For E 952 cyclamic acid and its sodium and calcium salts:

(a)

for  the  category  ‘water-based  flavoured  drinks,  energy-reduced  or  with  no
added  sugar’  and  ‘milk-  and  milk-derivative-based  or  fruit-juice-based
drinks, energy-reduced or with no added sugar’ the maximum usable dose
of ‘400 mg/l’ is replaced by ‘350 250 mg/l’;

(b)

the following categories and maximum usable doses are deleted:

‘- Confectionery with no added sugar

500 mg/kg

- Cocoa- or dried-fruit-based confectionery, energy-reduced or with

500 mg/kg

no added sugar

- Starch-based confectionery, energy-reduced or with no added

500 mg/kg

sugar

- Chewing gum with no added sugar

- Breath-freshening micro-sweets, with no added sugar

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

1500 mg/kg

2500 mg/kg

250 mg/kg’

(4)

The following tables are added:

7

‘EC-No

Name

Foodstuff

Maximum usable
dose

E 955

Sucralose

Non-alcoholic drinks

-  Water-based  flavoured  drinks,  energy-reduced  or  with  no  added

300 mg/l

sugar

- Milk- and milk-derivative-based or fruit-juice-based drinks,

300 mg/l

energy-reduced or with no added sugar

Desserts and similar products

- Water-based flavoured desserts, energy-reduced or with no added

400 mg/kg

sugar

- Milk- and milk-derivative-based preparations, energy-reduced or

400 mg/kg

with no added sugar

- Fruit- and vegetable-based desserts, energy-reduced or with no

400 mg/kg

added sugar

- Egg-based desserts, energy-reduced or with no added sugar

400 mg/kg

- Cereal-based desserts, energy-reduced or with no added sugar

400 mg/kg

- Fat-based desserts, energy-reduced or with no added sugar

- ‘Snacks’: certain flavours of ready to eat, pre-packed, dry,

savoury starch products and coated nuts

400 mg/kg

200 mg/kg

Confectionery

- Confectionery with no added sugar

1000 mg/kg

- Cocoa- or dried-fruit-based confectionery, energy-reduced or with

800 mg/kg

no added sugar

- Starch-based confectionery, energy-reduced or with no added

1000 mg/kg

sugar

- Cornets and wafers, for ice cream, with no added sugar

- Eßoblaten

800 mg/kg

800 mg/kg

- Cocoa-, milk-, dried-fruit- or fat-based sandwich spreads, energy-

400 mg/kg

reduced or with no added sugar

- Breakfast cereals with a fibre content of more than 15%, and

400 mg/kg

containing at least 20% bran, energy-reduced or with no added
sugar

- Breath-freshening micro-sweets, energy reduced or with no added

2400 mg/kg

sugar

- Strongly flavoured freshening throat pastilles with no added sugar

1000 mg/kg

- Chewing gum with no added sugar

3000 mg/kg

8

- Energy-reduced tablet form of confectionery

- Cider and Perry

200 mg/kg

50 mg/l

- Drinks consisting of a mixture of a non-alcoholic drink and beer,

250 mg/l

cider, perry, spirits or wine

- Spirit drinks containing less than 15% alcohol by volume

250 mg/l

- Alcohol-free beer or with an alcohol content not exceeding 1,2%

250 mg/l

vol

-‘Bière de table/Tafelbier/Table beer’ (original wort content less

250 mg/l

than 6%) except for ‘Obergäriges Einfachbier’

- Beers with a minimum acidity of 30 milli-equivalents expressed

250 mg/l

as NaOH

- Brown beers of the ‘oud bruin’ type

- Energy-reduced beer

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

250 mg/l

10 mg/l

320 mg/kg

- Canned or bottled fruit, energy-reduced or with no added sugar

400 mg/kg

- Energy-reduced jams, jellies and marmalades

- Energy-reduced fruit and vegetable preparations

- Sweet-sour preserves of fruit and vegetables

- Feinkostsalat

400 mg/kg

400 mg/kg

180 mg/kg

140 mg/kg

- Sweet-sour preserves and semi-preserves of fish and marinades of

120 mg/kg

fish, crustaceans and molluscs

- Energy-reduced soups

- Sauces

- Mustard

45 mg/l

450 mg/kg

140 mg/kg

- Fine bakery products, energy-reduced or with no added sugar

700 mg/kg

- Complete formulae for weight control intended to replace total

320 mg/kg

daily food intake or an individual meal

- Complete formulae and nutritional supplements for use under

400 mg/kg

medical supervision

- Liquid food supplements/dietary integrators

- Solid food supplements/dietary integrators

Food supplements/diet integrators based on vitamins and/or
mineral elements, syrup-type or chewable

240 mg/kg

800 mg/kg

2400 mg/kg

9

EC-No

Name

Foodstuffs

Maximum usable dose9

E 962

Salt of
aspartame-
acesulfame

Salt of
aspartame-
acesulfame

Aspartame
equivalent

Acesulfame-K
equivalent

Non-alcoholic drinks

- Water-based flavoured drinks, energy-

796 mg/l

512 mg/l

350 mg/l

reduced or with no added sugar

- Milk- and milk-derivative-based or
fruit-juice-based drinks, energy-
reduced or with no added sugar

Desserts and similar products

796 mg/l

512 mg/l

350 mg/l

- Water-based flavoured desserts,

796 mg/kg

512 mg/kg

350 mg/kg

energy-reduced or with no added
sugar

- Milk- and milk-derivative-based

796 mg/kg

512 mg/kg

350 mg/kg

preparations, energy-reduced or with
no added sugar

- Fruit- and vegetable-based desserts,
energy-reduced or with no added
sugar

796 mg/kg

512 mg/kg

350 mg/kg

- Egg-based desserts, energy-reduced or

796 mg/kg

512 mg/kg

350 mg/kg

with no added sugar

- Cereal-based desserts, energy-reduced

796 mg/kg

512 mg/kg

350 mg/kg

or with no added sugar

- Fat-based desserts, energy-reduced or

796 mg/kg

512 mg/kg

350 mg/kg

with no added sugar

- ‘Snacks’: certain flavours of ready to
eat, prepacked, dry, savoury starch
products and coated nuts

Confectionery

777 mg/kg

500 mg/kg

342 mg/kg

- Confectionery with no added sugar

1137 mg/kg

731 mg/kg

500 mg/kg

- Cocoa- or dried-fruit-based

1137 mg/kg

731 mg/kg

500 mg/kg

confectionery, energy-reduced or
with no added sugar

- Starch-based confectionery, energy-
reduced or with no added sugar

2273 mg/kg

1462 mg/kg

1000 mg/kg

9

Maximum  usable  doses  for  the  salt  of  aspartame-acesulfame  are  derived  from  the  maximum  usable
doses for its constituent parts aspartame (E 951) and acesulfame-K (E950). The maximum usable doses
for aspartame (E 951) and acesulfame-K (E950) shall not be exceeded by their use in combination with
the salt of aspartame-acesulfame.

10

                                                
- Cornets and wafers, for ice cream,

1554 mg/kg

1000 mg/kg

684 mg/kg

with no added sugar

- Cocoa-, milk-, dried-fruit or fat-based
sandwich spreads, energy-reduced or
with no added sugar

- Breakfast cereals with a fibre content
of more than 15%, and containing at
least 20% bran, energy-reduced or
with no added sugar

- Breath-freshening micro-sweets,
energy reduced or with no added
sugar

1554 mg/kg

1000 mg/kg

684 mg/kg

1554 mg/kg

1000 mg/kg

684 mg/kg

5683 mg/kg

3656 mg/kg

2500 mg/kg

- Chewing gum with no added sugar

4546 mg/kg

2925 mg/kg

2000 mg/kg

- Cider and perry

796 mg/l

512 mg/l

350 mg/l

- Drinks consisting of a mixture of a

796 mg/l

512 mg/l

350 mg/l

non-alcoholic drink and beer, cider,
perry, spirits or wine

- Spirit drinks containing less than 15%

796 mg/l

512 mg/l

350 mg/l

alcohol by volume

- Alcohol-free beer or with an alcohol
content not exceeding 1,2 % vol

- ‘Bière de table/Tafelbier/Table beer’
(original wort content less than 6%)
except for ‘Obergäriges Einfachbier’

796 mg/l

512 mg/l

350 mg/l

796 mg/l

512 mg/l

350 mg/l

- Beers with a minimum acidity of 30

796 mg/l

512 mg/l

350 mg/l

milli-equivalents expressed as NaOH

- Brown beers of the ‘oud bruin’ type

796 mg/l

512 mg/l

350 mg/l

- Energy-reduced beer

39 mg/l

25 mg/l

17 mg/l

- Edible ices, energy-reduced or with

1243 mg/kg

800 mg/kg

547 mg/kg

no added sugar

- Canned or bottled fruit, energy-
reduced or with no added sugar

796 mg/kg

512 mg/kg

350 mg/kg

- Energy-reduced jams, jellies and

1554 mg/kg

1000 mg/kg

684 mg/kg

marmalades

- Energy-reduced fruit and vegetable

796 mg/kg

512 mg/kg

350 mg/kg

preparations

- Sweet-sour preserves of fruit and

455 mg/kg

292 mg/kg

200 mg/kg

vegetables

- Feinkostsalat

544 mg/kg

350 mg/kg

239 mg/kg

11

- Sweet-sour preserves and semi-

455 mg/kg

292 mg/kg

200 mg/kg

preserves of fish and marinades of
fish, crustaceans and molluscs

- Energy-reduced soups

171 mg/l

110 mg/l

75 mg/l

- Sauces

- Mustard

544 mg/kg

350 mg/kg

239 mg/kg

544 mg/kg

350 mg/kg

239 mg/kg

- Fine bakery products, energy-reduced

2273 mg/kg

1462 mg/kg

1000 mg/kg

or with no added sugar

- Complete formulae for weight control
intended to replace total daily food
intake or an individual meal

- Complete formulae and nutritional
supplements for use under medical
supervision

1023 mg/kg

658 mg/kg

450 mg/kg

1023 mg/kg

658 mg/kg

450 mg/kg

- Liquid food supplements/dietary

796 mg/kg

512 mg/kg

350 mg/kg

integrators

- Solid food supplements/dietary

1137 mg/kg

731 mg/kg

500 mg/kg

integrators

Food supplements/diet integrators
based on vitamins and/or mineral
elements, syrup-type or chewable

4546 mg/kg

2925 mg/kg

2000 mg/kg’

12