CELEX: 51993PC0609
Language: en
Date: 1993-12-01
Title: Proposal for a EUROPEAN PARLIAMENT AND COUNCIL REGULATION (EC) laying down a Community procedure for flavouring substances used in foodstuffs

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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)
 ---pagebreak---                                    - 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
 ---pagebreak---                                  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.
 ---pagebreak---                                - 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.
 ---pagebreak---                       r
                       Proposal for a
EUROPEAN PARLIAMENT AND COUNCIL REGULATION (EC)
  laying down a Community procedure for flavouring substances
                     used in foodstuffs
 ---pagebreak---                                    r Cx -
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing   the European           Community
and in particular Article 100a thereof.
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
 ---pagebreak---                                    - 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,
 ---pagebreak---                                    - 7 -
HAVE ADOPTED THIS REGULATION;
                                 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.
 ---pagebreak---                                    - 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
 ---pagebreak---                                     - 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
 ---pagebreak---                                     - 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
 ---pagebreak---                                                                      ISSN 0254-1475
                                                              COM(93) 609 final
                                                      DOCUMENTS
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