CELEX: 51979PC0184
Language: en
Date: 1979-04-10
Title: Proposal for a COUNCIL DIRECTIVE amending for the second time Directive 74/329/EEC on the approximation of the laws of the Member States relating to emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffs (submitted to the Council by the Commission)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (79) 184
Vol. 1979/0078
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITI
                                               COM(79)184 final
                                               Brussels , 10 April 1979
                                     U- ,
                                      V '• '
                                      V;
                                Proposal for a
                              COUNCIL DIRECTIVE
         amending for the second time Directive 74 / 329 / EEC on the
         approximation of the laws of the Member States relating to
         emulsifiers , stabilizers , thickeners and gelling agents
                            for use in foodstuffs
               ( submitted to the Council by the Commission )
C0M(79 ) 184 final
 ---pagebreak---                                 EXPLANATORY NOTE
1 . The Council Directive on the approximation of the laws of the Member
    States relating to emulsifiers , stabilizers , thickeners and gelling
    agents for use in foodstuffs (74/329/ESC) 1 ( as modified by Council
                           2
    Directive 78/612/EEC) requires that within five years of notification
    of the Directive , the Commission should examine the status of two •
    groups of substances :
    ( a) Substances permitted for use in the Community by virt-ae of Article
         2.2 of Directive 74/329/sSC
         Council decisions have been taken on all these substances except
         E 460 (microcrystalline cellulose ).   The Commission has now
         completed its examination on this substance and proposes that
         E 460 should be subdivided into microcrystalline cellulose and
         powdered cellulose .  The Scientific Committee for Pood has advised
         that from the point of view of public health this proposal is
         acceptable"^.
    (b ) Substances not permitted for use in the Community as a whole but
         which may be permitted by individual Member States by virtue of
         Article 3 of Directive 74/329/SEC
         The Commission asked the Scientific Committee for Food whether the
         substances in this group , and which are listed in Annex II of the
         basic Directive , could be safely added to Annex I , ( i.e. substances
         which may be authorised throughout the Community).
2. The present proposal implements the Committee 's advice^by:
                                             1
    ( a) authorizing certain for a further limited period until 31 December 1984
         ( see the Annex to the attached proposal for Directive )
    (b) including certain in Annex I of the basic Directive ( see Article
         3.2 of the attached proposal for Directive ). The proposal recommends
         that Quillaia extract (E 44l ) should be authorized in soft drinks
         ( and beverages containing soft drinks ) , as the Scientific Committee
         for Pood saw no objection on health grounds to this use . However
         as the Commission is preparing proposals for Community measures on the
 ---pagebreak---            description and composition of soft drinks . the present proposal
           requires that S 441 should "be permitted only where national law
           allows its use .  It is envisaged that a more complete description
           of the " conditions of use " will "be possible only when the Community
          measures on soft drinks are accepted .
          The Scientific Committee for Pood advised that Karaya pnm should "be
          subjected to a number of preliminary toxicological studies which
          should be presented within one year so that a decision could be taken
          by the Committee as to whether it could accept a further temporary
          approval of the substance for a longer period to allow more
          extensive toxicological testing to be completed .     The Commission
          has been informed that the preliminary toxicological studies are
           expected to be undertaken and that the results of such studies
          would "be available within one year .
          The proposal therefore recommends that Karaya gum should be maintained
          in Annex II but that the situation be reviewed before 31 December 1980 .
    ( c ) deleting the reference to Ghatti gum from Annex II .     It is proposed
          that foodstuffs containing ghatti gum can be marketed until the
          30 June 1980 ( Article 5 ).
3 . The Commission has also received a number of requests for a reexamination
    of Tragacanth (s 413) • The Scientific Committee for Pood has advised "^
    that the substance should be subjected to extensive toxicological testing
    within four years but that in the meantime its use is acceptable .       The
    present proposal recommends that the situation be reviewed at the end of
    1982 so that the Scientific Committee for Pood can be informed of the
    progress of the studies and to allow the Commission to take appropriate
    action at an early stage .
X0J No L 189 , 12.7.1974 , P. 1
20J M0 L 197 of 22.7.1978 . p. 22
  Scientific Committee for Pood ( Seventh Series)
 ---pagebreak---  Propcr.c.I for a Council Directive amending for "the second time
 Directive 74/329/EEC on the approximation of the laws of the Member States
 relating to emulsifiers , stabilizers , thickeners and gelling agents for
 use in foodstuffs
 THE COUNCIL OF THE EUROPEAN COMMUNITIES ,
Having regard to the Treaty establishing the European Economic Community ,
and in particular Article 100 thereof ;
Having regard to the proposal from the Commission"'' :
                                                 _  _ .    ?
Having regard to the opinion of the European Parliament ;
Having regard to the opinion of the Economic and Social Committee^;
Whereas Directive 74/329/EEC^, as last amended by Directive 78/612/EEC"^
lays down a single list of emulsifiers , stabilizers , thickeners and gelling
agents which may be authorized for use in foodstuffs by the Member
States ;
Whereas having regard to the most recent scientific and technical knowledge
the reference to microcrystalline cellulose (E 460 ) in Annex I to Directive
78/6I2/EEC must be reworded ; and whereas the use of tragacanth (E 413 )
should be reevaluated after an enquiry by the Commission ;
Whereas Annex II to Directive 74/329/EEC indicates the designations of the substances
which may be temporarily authorized by Member States for use in foodstuffs ;
Whereas Article 3,(1 )           . of Directive 74/329/EEC authorizes this
derogation for a period of five years from the date of notification of the Directive ;
Whereas having regard to the most recent scientific and technical knowledge
 the said Annex II must be revised ; whereas , therefore , for certain substances
period of temporary authorization must be prolonged to permit the
completion of certain toxicological investigations necessary in the light
1 CJ 7,0
2 oj ;;0
3 OJ Mo
4 OJ Ho L 189 , 12.7.1974 , p. 1
5 OJ ïlo L 197 , 22.7.1978 , p. 22
 ---pagebreak---      of present-day requirements regarding the safety of their use in foodstuffs ;
     Whereas for certain        substances the scientific and technical knowledge is
      satisfactory thus allowing t.heir transfer to Annex I to the above mentioned
   . Directive ; and whereas ghatti gum must no longer be used after a temporary
     period to allow the sale of foodstuffs containing this substance which are
     already 'on the market ;
     HAS ADOPTED THIS DIRECTIVE                     ,
                                          Article 1
                   * Directive 74/329/SEC . is hereby amended as follows :
1 . Paragraphs 2 and 3 of Article 2 are replaced by the following :
     " 2 . However, as regards the substances referred to in Annex I under
           E 413 and E 440 the Council, acting in accordance with the procedure
           provided for in Article 100 of the Treaty, may decide, by 31
           December 1982 and after an enquiry "by the Commission, to delete
           them from the Annex or otherwise change their status ."
2 . Article 3(1 ) is replaced by the following :
           "By way of derogation from Article 2 (l ),Member States may authorize until
           31 December 19&4 the use in foodstuffs of the substances listed in Annex
           II , and until 30 June 1980 the marketing of foodstuffs containing ghatti
           gum. However as regards Karaya gum the Council acting in accordance with
           the procedure provided for in - Article 100 of the Treaty, may decide, before
           31 December 1980 and after an enquiry by the Commissi on, to delete it from
           the Annex or otherwise change its status."
3 . Annex I      is amended as follows :
    (a ) The indent relating to E 460 microciystalline cellulose is replaced
        by the following :
          EEC No                       Designation         Conditions of use
                     I
          E 460         i ) Microcrystalline cellulose
                       ii ) Powdered cellulose
 ---pagebreak--- (b )   The following is inserted :
          2C No               Designation                   Conditions of use
                                                   I
        E  415      Xantnan gum                     1
        E  441      Quillaia extract           Exclusively in soft drinks and
                                               in beverages where soft drinks
                                               are' an ingredient/, a'nd at a .
                                              Level of not more than 200
                                              mg / kg where this use is permit­
                 I                            ted under national law
        E  442      Ammonium phospnatides
        E 476       Polyglycerol poly–
                    ricinoleate
        E  491      S orbit an monostearate
        E   92      Sort) it an tristearate
        E  493      Sortait an monolaurate
        E  494      S orbit an monooleate
      Lì 495        Sortit an monopalmrtate
   4 . Annex II is replaced by the Annex to this Directive ..
                                        Article 2
 15 ember States shall , within one year of the notification of this Directive ,
 amend their laws in accordance with the preceding provisions , and shall
 forthwith inform the Commission thereof .            The laws thus amended shall be
  implemented two years after notification of this Directive .
                                        Article 3
                                          i »                                        \
  This Directive is addressed to the Member States .
 Done at Brussels ,                                             For the Council
                                                                The President
 ---pagebreak---                                       ANNSX
                                   " ANïïEX II
                                 Designation
Karaya gum ( synonym : sterculia gum )
Polyoxyethylene ( 20 ) sorbitan monolaurate ( synonym : polysorbate 20 )
Polyoxyethylene ( 20 ) sorbitan monopalmitate ( synonym : polysorbate 40 )
Polyoxyethylene ( 20 ) sorbitan monostearate ( synonym : polysorbate 60 )
Polyoxyethylene ( 20 ) sorbitan tristearate ( synonym : polysorbate 65 )
Polyoxyethylene ( 20 ) sorbitan monooleate ( synonym : polysorbate 80 )
Polyoxyethylene ( 8 ) stearate
Polyoxyethylene ( 40 ) stearate
Oxidatively thermally polymerised soya bean oil interacted with mono– and
     and di–glycerides of fatty acids
Lactylated fatty acid esters of glycerol and propylene glycol
Dioctyl sodium sulphosuccinate "