CELEX: 51995PC0482
Language: en
Date: 1995-10-18
Title: Proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE amending European Parliament and Council Directive 94/35/EC on sweeteners for use in foodstuffs

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)
 ---pagebreak---  ---pagebreak--- 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.
 ---pagebreak--- 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
 ---pagebreak---                                           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
 ---pagebreak---                                             Article 1
Directive 94/35/EC is hereby amended as follows:
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
 ---pagebreak--- 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.
                                        AOkkA
Thk Directive is addressed to the Member Stales.
Done et Brussels,
For the European Parliament                   For the Council
The President                                 The President
 ---pagebreak---                                                    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.
 EC No                Name                            Foodstuffs                    Maximum
                                                                                   usable dose
 E950        Acesulfame K.                - high-fibre breakfast cereals,
                                          energy-reduced or with no                1200 mg/kg
                                          added sugar
                                          - energy-reduced soups                     110 mg/l
                                          - small breath-freshening                2500 mg/kg
                                          sweets, with no added sugar
                                          - reduced-energy fruit wines               350 mg/l
                                          - carbohydrate-free beer                    25 mg/l
                                          - drinks consisting of a mixture
                                          of a non-alcoholic drink with              350 mg/l
                                          beer, cider, perry, spirits or
                                          wine
                                          - biscuits for ice-cream, with           2000 mg/kg
                                          no added sugar
                                          - prepared salads                         350 mg/kg
                                          - Essoblaten                             2000 mg/kg
  E951       Aspartame                    - high-fibre breakfast cereals,
                                          energy-reduced or with no                1000 mg/kg
                                          added sugar
                                          - energy-reduced soups                     110 mg/l
                                          - small breath-freshening                6000 mg/kg
                                          sweets, with no added sugar
                                          - reduced-energy fruit wines               600 mg/l
                                          - carbohydrate-free beer                    25 mg/l
                                          - drinks consisting of a mixture           600 mg/l
                                          of a non-alcoholic drink with
                                          beer, cider, perry, spirits or
                                          wine
                                          - prepared salads                         350 mg/kg
                                                   }
 ---pagebreak--- E952 Cyclamic acid and its  - high-fibre breakfast cereals,
     Na and Ca salts        energy-reduced or with no          250 mg/kg
                            added sugar
                            - energy-reduced soups              400 mg/l
                            - small breath-freshening          4000 mg/l
                            sweets, with no added sugar
                            - energy-reduced fruit wines        400 mg/l
                            - food supplements/diet           2000 mg/kg
                            integrators (e.g. vitamins, trace
                            elements), syrup-type or
                            chewable
                            - drinks consisting of a mixture    400 mg/l
                            of a non-alcoholic drink with
                            beer, cider, perry, spirits or
                            wine
E954 Saccharine and its Na, - high-fibre breakfast cereals,
     K and Ca salts         energy-reduced or with no          100 mg/kg
                            added sugar
                            - energy-reduced soups              110 mg/l
                            - small breath-freshening         3000 mg/kg
                            sweets, with no added sugar
                            - reduced-energy fruit wines         80 mg/l
                            - drinks consisting of a mixture     80 mg/l
                            of a non-alcoholic drink with
                            beer, cider, perry, spirits or
                            wine
                            - biscuits for ice-cream, with     800 mg/kg
                            no added sugar
                            - prepared salads                  160 mg/kg
E957 Thaumatin              - edible ices, energy-reduced or    50 mg/kg
                            with no added sugar
                                          S
 ---pagebreak--- E959 Neohesperidine DC - high-fibre breakfast cereais,    50 mg/kg
                       energy-reduced or with no
                       added sugar
                       - energy-reduced soups              50 mg/l
                       - small breath-freshening         400 mg/kg
                       sweets, with no added sugar
                       - food supplements/diet           400 mg/kg
                       integrators (e.g. vitamins, trace
                       elements), syrup-type or
                       chewable
                       - energy-reduced fruit wines        10 mg/l
                       - drinks consisting of a mixture    30 mg/l
                       of a non-alcoholic drink with
                       beer, cider, perry, spirits or
                       wine
                       - prepared salads                  50 mg/kg
                                      y
 ---pagebreak---  ---pagebreak---                                                                    ISSN 0254-1475
                                                             COM(95) 482 final
                                              DOCUMENTS
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                                     Catalogue number : CB-CO-95-522-EN-C
                                                              ISBN 92-77-94406-4
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