CELEX: 51988PC0322
Language: en
Date: 1988-06-13
Title: Proposal for a COUNCIL DIRECTIVE amending for the fifth time Directive 74/329/EEC on the approximation of the laws of the Member States relating to Emulsifiers, Stabilisers, Thickeners and Gelling agents for use la foodstuffs (presented by the Commission)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (88) 322
Vol. 1988/0121
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                          COM(88 ) 322 final - SYN 138
                                          Brussels , 13 June 1988
                           Proposai for a
                         COUNCIL DIRECTIVE
     amending for the fifth time Directive 74 /329 / EEC on the
   approximation of the laws of the Member States relating to
     Emulsifiers , Stabilisers , Thickeners and Gelling agents
                       for use la foodstuffs
                                  \
                                    I
                   (presented by the Commission )
 ---pagebreak---                                                                                     4
                                Explanatory Note
                                                                                       I
The       Council Directive on the approximation of the laws of
the       Member States on emulsifiers , stabilisers , thickeners
and       gelling agents requires that before 31 December 1988 the
use of a number of substances should be reviewed .
The      present      proposai       is   intended      to    resolve       these
outstanding        questions      which were introduced       following        the
Commission 's proposal for a                third modification to              the
                                                                               the
Directive ( 13 January 1984 ) which was incorporated          ated into        the
                                                                               the
the      basic    Directive as the third and fourth           modifications
                                                              mod i f 1 cat i ons .
 ( 85 / 6 / BBC OJ L2 , 3.1 . 85 p21 and 86 / 102 / EBC OJ L 88,3.4.86 p40 )           I
The      situation in respect of the substances is not                ident ical
and is described in more detail below .
                                                                                     ? I
                                                                                     ί
Tragacanth 0um
                                                                                     y
                                                                                       i
Tragacanth        gum is currently permitted in the Community under
the      number    E413 .     Its  use was made      subject   to     a   review
following        the    advice of the Scientific Committee for              Food ,
which has been keDt reeularlv informed of orogress on the
further work suggested by the Committee .                  This work has now
been completed and the Scientific Committee for Food has
advised          that       the    substance      can    be    allocated         a
" non-specif ied " Acceptable Daily Intake .
The      Commission      is now proposing that ths review           clause      be
removed and that the substance remain on the Community list .
Karaya Gum
The Commission proposed on 17 January 1984 that karaya gum .,
which at that time was included in Annex II ( i.e temporary
authorisation         in those Member States which so wished ) of the
Directive        should     be transferred to Annex I ( i.e         authorised
for      use at Community level ) and that a review clause                should
be inserted comparable to that for tragacanth gum .
The      Economic     and     Social    Committee      and   the    Parliament
approved        this    proposal .    However   the    Council    decided       to
maintain        the substance in the Annex II of the Directive with
a    deadline      for a further decision for its continued use                 at
31   December 1988 .
) f)#The Scientific Committee for Food at              its meeting on 15 April
1988 . on the basis of recently submitted data , decided that
the substance should be accepted with an Acceptable Daily
Intake of 0-12.5 mg / kg bw .
The      Commission feels that there is now no reason to maintain
the      substance      in Annex II and is reintroducing its earlier
proposal to include karaya gum in Annex I.
                                                                                    г
 ---pagebreak--- Thermally oxidised soya bean oil interacted with mono-                   and
di-glycerides of fatty acids .
The Commission initially              suggested      in     1984 that the
substance should continue to be allowed by those States that
wished until 31 December 1987 to allow ongoing studies on
the safety of the substance to be completed . The Council
decided      that    on    the basis of information on        the   type  of
study     underway that the date should, be fixed at 31             December
1988 .
The     results    of the studies have now been evaluated            by  the
Scientific       Committee     for Food which has concluded that         the
material of composition tested is acceptable and that an
Acceptable Daily Intake of 0-25 mg / kg bw can be allocated to
this material .            The substance
                           The  substance     is     mainly used as an
emulsifier in certain fats for frying .
The     Economic     and    Social    Committee
                                              ee     and   the    Parliament
endorsed      the    Commission 's    1984    pr
                                              proposai .       The   Council
maintained       the    substance in Annex II subject to a further
review in 1988 .
> f>4*
The     Commission      is   of ths opinion that the       advice    of  the
Scientific       Committee     for   Food and the information        on  the
technicoloQical necessity for the substance are now adequate
to propose its inclusion in Annex I.
Polyoxyethylene ( 20 ) sorbitan esters of fatty acids
( Polysorbates )
The safety of these              substances
                                 substances
                                     stances     was
                                                 was     assessed by the
Scientific Committee for Food ( Reports of the Scientific
Committee for Food 15th Series ; EUR9357 ) , and an ADI set .
The Commission 's proposal to include polysorbates in Annex I
of the Directive was endorsed by the Economic                   and Social
Committee and the Parliament .
However      the Council     refused the transfer and maintained them
in Annex II so that " the substances may be reevaluated in the
light of any new information not previously assessed **
The     Commission continues to hold the view that            its   advisers
on     safety    and    technological    need     had already in 1984
assessed      all the relevant information which might affect the
decision      on   the substances in question and their            inclusion
in Annex I of the Directive .
No     other     information     has   been    made     available    to  the
Commission since that date .
For     these    reasons     the   Commission     is    now   reintroducing
                                                              reintra
measures to include polysorbates 20 , 40 , 60 , 65 , and 80
into Annex I .
                                                                             3
 ---pagebreak---                                                                    У
Article 2A
Article    2A allows certain substances , not included in    Annex
I   or Annex II , to be used by Member States for an    unlimited
period until conditions of use for the substances and purity
criteria are laid down aimultanously at Community level .
Only    at  that    time does the Council expect to  discuss   the
inclusion of these substances in Annex I.
The Directive already provides for the laying down of
conditions of use ( Article 4 ) and purity criteria ( Article
7 ), and the relationship between Articles 2 , 2A , 3 , 4 , and 7
does give legal uncertainty which should not be exacerbated .
The    substances already included in Article 2A pose no health
risk ,   and are technologically necessary in certain    products
in at   least some Member States .
The Commission has not included suggestions to remove the
anomaly in this proposal in view of the proximity of an
agreement in the Council for addressing these problems
generally for food additives by a simplified procedure .
The Commission agrees that the Directive should be completed
by the application of Articles 4 and 7 using the procedures
which will be agreed for food additives in general . Indeed ,
the    subject   is   an  essential   part  of  tthe Commission' s
strategy towards the Internal Market by 1992 .
                                                                   4
 ---pagebreak---                                                                              3
                              Proposai for a
                             Council Directive
    amending for the fifth time Directive 74 / 329 / EEC on the
          approximation of the laws of the Member States
                                relating to
     Emulsifiers , Stabilisers , Thickeners and Gelling agents
                          for use  in foodstuffs
THE COUNCIL OP THE EUROPEAN COMMUNITIES
Having regard to the             Treaty establishing the European Europe
Economic Community , and in particular Article 100A thereof ,
Having regard to the proposal from the CommissionO ,
In cooperation with the European Par 1 lament () ,
Having     regard    to   the opinion of the      Economic    and   Social
Committee () ,
Whereas Council Directive 74 / 329 / EEC ( 4 ) , as last amended by
Directive 86 / 102 / EEC ( 5 ) lays down a list of emulsifiers ,
stabilisers , thickeners and gelling agents which may be
authorised in foods by the Member States ;
Whereas     Annex    II   to   Directive   74 / 329
                                                  9 / EEC  indicates   the
designations of          substances
                         substances    which
                                       which      may     be temporarily
authorised by Member States for use in foods ., and whereas
the    validity of each authorisation is limited to 31 December
1988 ;
Whereas     the scientific and technical knowledge on the safety
or    and   use   of    the   substances in     the    Annex  II   is  now
sufficient to allow their transfer to Annex I.
Whereas for Tragacanth gum ( E413 ) new data have confirmed
the acceptability of this substance at Community level
HAS ADOPTED THIS DIRECTIVE :
                                 Article 1
Directive 74 / 329 / EEC is hereby amended as follows ;
1 . Paragraph 2 of Article 2 is deleted .
2 . Article 3 is deleted .
3 . Annex I is amended in accordance with the Annex hereto .
4.   Annex II   is deleted .
( 4 ) OJ L 189,12.7.1974 page 1 .
( 5 ) OJ L 88 , 3.4.1986 page 40 .
                                                                           Г
 ---pagebreak---                                                              i0
                          Article 2
Member States shall take all measures necessary to comply
with this Directive not later than 1 January 1989 . They
shall immediately inform the Commission thereof .
                          Article 3
This Directive is addressed to the Member States .
                                             For the Council
Done at
                                             The President
                                                                ζ
 ---pagebreak---                                                                      1'>
                                     ANNEX
( a ) the following is inserted between items E415 and E420
EEC No            Désignât ion               Conditions of use
E 416             Karaya gum
< b ) the following is inserted between items E422 and E440
EEC No               Desigat ion               Conditions of use
E 432         Polyoxyethylene ( 20 )
              sorbitan monolaurate
              ( synonym ;   polysorbate 20 )
E 433         Polyoxyethylene ( 20 )
              sorbitan monooleate
              ( synonym ;   polysorbate 80 )
E 434         Polyoxyethylene ( 20 )
              sorbitan monopalmitate
              ( synonym ;   polysorbate 40 )
E 435         Polyoxyethylene ( 20 )
              sorbitan monostearate
              ( synonym ;   polysorbate 60 )
E 436         Polyoxyethylene ( 20 )
              sorbitan tri stearate
              ( synonym ;   polysorbate 65 )
( c ) the following is inserted between items E477 and E481
EEC No .               Désignât ion             Conditions of use
E4 79         Therma 1 1 y ox i d i sed
              soya bean oil interacted
              with mono - and di -
              glycerides of fatty acids
                                                                  1-
 ---pagebreak---                                                           – Tasic Force PME
                   COMPETITIVENESS AND EMPLOYMENT IMPACT STATEMENT
     Proposal for a Council Directive amending for the fifth time ...
     Emulsifiers, Stabilisers, Thickeners and Gelling agents for use in foodstuffs .
1.      What is the main reason for introducing the measure?
        Formal extension of use of approved substances .
III .   Features on the businesses in question .       In particular :
        None .
        (a )    Are there many SMEs?
        (b )    Are they concentrated in regions which are :
                (i )   eligible for regional aid in the Member States?
                ( ii ) eligible under the ERDF ?
III .   What direct obligations does this measure impose on businesses?
        None .
IV .    What indirect obligations are local authorities likely to impose
        on businesses ?
        None .
V.      Are there are special measures in respect of SMEs?        Please
        specify .
        No .
VI .    What is the likely effect on :
        (a)     thè competi tiveness of business?        None .
        (b )   employment ?                              None .
VII .   Have both sides of industry been consulted?
         N / A on this occasion .
        Please indicate their opinions .
     . This text is a resubmission of measures already agreed by
         Parliament , ESC and the Advisory Committee for Foodstuffs .
                                                                                     8