CELEX: 51981PC0708
Language: en
Date: 1981-11-24
Title: Proposal for a Council Directive amending Directive 78/663/EEC laying down specific criteria of purity for emulsifiers, stabiliseres, 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 (81) 708
Vol. 1981/0206
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 ---pagebreak---             COMMISSION OF THE EUROPEAN COMMUNITIES
                                                                COM(81 ) 708 final .
                                                                Brussels . 24 November 1981
                        /
                        v v                       }                             :
                            N-,           .^                                 ■
                                            Proposal for a
                                          Council Directive
                  amending Directive 78 / 663 / EEC laying down specific criteria of
                  purity for emulsifiers , stabiliseres , thickeners and gelling
                                   agents , for use in foodstuffs
                          ( submitted to the Council by the Commission )
COM ( 81 ) 708 final .
 ---pagebreak---                                                     COWN
                                   EXPLANATORY NOTE
   The modifications in the present amendment to the Directive on specific
    purity criteria*for emulsifiers , stabilisers , thickeners and gelling agents ,
   with the exception of small modifications to the purity criteria for
   alginic acid (E 400 ) and alginates (E 401 - E 404)1 are the result of
   previous Council decisions included in the "basic Directive on emulsifiers
  ( 74/329/EEC ) or on purity criteria for emulsifiers (78663/EEC) that mandate
    the Commission to make proposals on these specific topics .
   1 . Alginic acid and alginates (e 400 – E 404)
        It has "become apparent that the method for 'insoluble matter    in dilute NaOH * is
        inapplicable . The figure was to some extent superfluous given other
        specific criteria in the specification and the Commission has decided
        that the reference should "be deleted .  It has also "been put to the
        Commission that a more realistic figure for 'acid insoluble ash' for
        the product in international trade would be a maximum of2
    2 . Xanthan gum (E 415 ) »  Powdered cellulose (E 460(ii ))
        The addition of these substances to the permitted list of emulsifiers ,
        stabilisers , thickeners and gelling agents imposes the requirement to
        determine specific criteria of purity .   The number for micro–crystalline
        cellulose becomes E 460 ( i ) as a consequence of the addition to the list
        of powdered cellulose (E 460 ( ii )).
    3 . Sucrogl.ycerides (E 474)
        Technological advances have led to the use of cyclohexane and isobutanol
        for the production of sucroglycerides . These solvents are provided for
        in the proposed revision to supplement those already included in the text .
    4 . Propane-l 1 2-diol esters of fatty acids (E 477 )
        When the Scientific Committee for Pood ( SCP) evaluated this material
        in 1978 the product containing 0.5    dimer and trimer was considered
        acceptable . The Committee recommended that as the product with 4$ dimer
        and trimer was only temporarily acceptable its authorisation should be
        reviewed on the basis of further toxicological investigations the
        results of which should be available "within two years " ( of the date of
        publication of the report – 30 . November 1978 )* ®le Council Directive
        appertaining to this matter (78/66J/E3C ) required that the Commission
        .review the situation so that any necessary amendments could be made
        before 31 December 1981 .
3fc
    compositional parameters which define the purity of the substance
 ---pagebreak---  The Cornninsion has now been informed that no extra toxicology is "being
 carried, out but that at present a reduction of 0.5Ja will put some
manufacturers in difficulty .. " The Commission has also been informed that -
development work has been undertaken to bring down the level from 4$ to -
the level of 0,5$ considered acceptable by the SCF . The present proposal
assumes that this work can. be completed within three years and allows
Member States^' wfra .so require * to- authorize the product with the high
level of dimer and trinrer in the intervening period .            ^ '
Ammonium phosnhatides poly^lycerol polyricinoleate , sorbitan monostearate
sorbitan tristearate , sorbitan monolaurate , sorbitan monooleate and        j
sorbitan monor>almitate
This group of substances was included in Article 2(a) of the Council
Directive 74/329/eSC tinder the following conditions :                 -
i)    the substances may be authorized in foodstuffs byr individual
      Member States .   No obligation is placed on Member States to
      authorize them ;
ii ). no limit in time is provided for thia derogation ;                   -
iii ) the Council may , in accordance with the procedure laid down in
      Article 100 of the Treaty , include in Annex I the substances to
      which this paragraph refers       at the same time stipulating the
      conditions for their use in foodstuffs , provided that in
      accordance with usual procedure       their purity criteria are
      established*
The "usual procedure " for the establishment of purity criteria is that
the Council adopts criteria on the basis of a Commission proposal .
The present proposal     applies this prooedure .
 ---pagebreak---  Proposal for a Council Directive amending Directive
7fi/C63/?SC laying down specific criteria of purity for emulsifiers ,
stabilisers , thickeners and gelling agents for use in foodstuffs
THE COUNCIL OP THE EUROPEAN COMMUNITIES ,
Having regard to the Treaty establishing the European Economic Community ,
Having regard to the proposal from the Commission"'",
Whereas Council Directive 78/663/EEC 2 provides that , as regards substances
E 474 and E 477 , the Council may , acting unanimously on a proposal from
the Commission , decide on any necessary amendments by 31 December 1981 ;
Whereas the criteria of purity for        substances E 400 , E 401 ? E 402 ,
E 403 and E 4O4 should be modified to take account of scientific
developments , particularly of methods of analysis ;
Whereas Council Directive 74/329/EEC of 18 June 1974 on the approcimation of the
 laws of the Member States relating to emulsifiers , stabilisers , thickeners
and gelling agents for use in foodstuffs^, as last amended by Directive
80/597/EEC^ specifies that the Council may include in Annex I of the
Directive ammonium phosphatides , polyglycerol polyricinoleate , sorbitan
monostearate , sorbitan tristearate , sorbitan monolaurate , sorbitan
monooleate and sorbitan monopalmitate only when inter alia their purity
criteria are established ;       whereas Directive 8o/597/EEC also amended
Annex I of Directive 74/329/EEC to permit Xanthan gum (E 415) and
powdered cellulose (E 460 ( ii ) ) and whereas therefore purity criteria for these
materials should be prescribed and the nomenclature of E 460 modified
accordingly ;
 ■OJ L 223 ,  14.8.1978 , p . 7
 *0J L 189,   12.7.1974 , P. 1
 *0J L 155/   23.6.1980 , p . 23
 ---pagebreak--- HAS ADOPTED THIS DIRECTIVE :
                                       Article 1
Directive 78/663/EEC is hereby amended, as follows :
1 . Article 2 is replaced by the following :
                                      "Article 2
    As regards the substance referred to in the Annex tinder E 477 » Member
    States may , until 31 December 1984 , authorize for use in foodstuffs a
    product containing not more than 4e dimer and trimer of propane-1,2-
    diol
2 . The Annex is amended as follows :
     ( a) Under E 400 , E 401 , E 402 , E 403 and E 404/ the entries relating to
            Insoluble matter in dilute NaOH are deleted , and the entries relatin
          to      .cid-insoluble ash are amended   to " Not more than 2
     (b) The following is inserted between E 414 and E 420 ( i )
            E 415 – Xanthan gum
            Chemical description :    Xanthan gum is a high molecular weight
                                      polysaccharide gum produced by a pure-
                                      culture fermentation of a carbohydrate with
                                      Xanthomonas campestris , purified by recovery
                                      with ethanol or isopropanol , dried
                                      and milled . It contains D-glucose and D-
                                      mannose as the dominant hexose units , along
                                      with D-glucuronic acid and pyruvic acid ,
                                      and is prepared as the sodium , potassium or
                                      calcium salt .  Its solutions axe neutral .
            Description :             Cream coloured powder             (
            Content :                 Xanthan gum yields , on a volatile matters-
                                      free basis , not less than 4»2$ and not more
                                      than 5»0$ of carbon dioxide .
            Volatile matter :         Not more than 15$ determined by drying at
                                      105°C for 2 1/2 hours .
          . Ash :                     Not more than 16$ on a volatile matter-free
                                      basis determined at 600°C after drying at
                                      105° C for 4 hours .
 ---pagebreak---                                   - 3 -
      Pyruvic ncids              Not less than 1.5/3
      Nitrorons                  Not more than 1.5$
      Inopromnol :               Not more them 750 rag/kg
      Microbiological criteria:Viable cells of Xanthoraonas carapestris shall
                                 be absent ."
( c ) The number "E 460" becomes "E 460 ( i )".
( d) The following           is inserted between E 460 ( i ) and E 46I
     "S 460 ( ii ) - Powdered Cellulose
      Chemical description :     Powdered cellulose is purified mechanically
                                 disintegrated cellulose prepared by-
                                 processing alpha–cellulose obtained directly
                                 from fibrous plant material . It has a
                                                               Cy
                                 molecular weight of 1.6 x 10 or greater.
      Description :              A white , odourless powder .
      Content :                  Not less than 92$ (°12E20°loK
      Volatile matter :          Not more than 7$ determined by drying at
                                 105° C for 3 hours .
      pH :                       Shake about 5 g with 40 ml of carbon
                                 dioxide-free water for 20 minutes and
                                 centrifuge . The pH of the supernatant
                                 liquid is between 5«0 and 7»5 »
      Sulphated ash :            Not more than 0.3$ determined at 800 – 25°C .
      Water soluble substances : Not more than 1% .
      Diethyl ether
      extract able matter :      Not more than 0.15$.
      Chloride :                 Not more than $00 mg/kg expressed, as CI .
      Sulphate :                 Not more than 500 mg/kg expressed as SO .."
( e ) Under E 474
      - the last sentence in the entry relating torn Chemical description is
         replaced by the following :
         "No organic solvents shall be used in their preparation other than
        cyclohexane , dimethylformamide , ethyl acetate , isobutanol and
        isopropanol ."
 ---pagebreak---                                      - 4 -
      – a new entry    is added as follov/ s :
         "Total Cyclo'nexane and
          Isobutanol con-tent :     Not more than 10 mg/kg singly or in
                                    combination."
(f ) Under E 477 "the entry relating to Dimer and trimer of propane-1 , 2-diol
      is amended to               " Not more than 0.5%".
( g) The following substances are added :
    " Ammonium Phosphatides
      Chemical description :       Ammonium phosphatides consist essentially
                                    of a mixture of the ammonium salts of
                                   phosphatidic acids derived from partially
                                   hardened rapeseed oil , or other edible
                                    oils , together with unreacted partially
                                   hardened oil .
      Description :
      Description                  An unctuous semi-solid ( at 25°c).
     Matter insoluble in           Total : Not more than 2.5 per centum ,
      lip-ht oetroleum
      (40°G l"
     T4Ô6 c-6Ô°CT~                  Inorganic matter: Not more than 0.2 per centum,
      pH of an acrueous extract Not less than 6.0 and not more than 8.0
      of melted ammonium
      phosahatides :
      Phosphorus :                 Not less than 3.0^b and not more than 3*4% »
      Ammonium nitrogen :          Not less than 1.2$ and not more than 1.5
      Unreacted oil :              Not more than 42%.
      Arsenic :                    Not more than 5 mg/kg.
      Polvglycerol Polyncinoleate
      Chemical description:        Polyglycerol polyricinoleate is essentially
                                   a complex mixture of ethers and partial
                                    esters of polyglycerol with linearly
                                    interesterified (polycondensed) fatty
                                   acids derived from castor oil . The poly­
                                    condensed castor oil fatty acids are
                                *
                                   prepared by condensation in the absence of
                                    oxygen and have an average of about 5
                                   fatty acid residues per molecule .
 ---pagebreak---                          - 5 -
flonnrif>t ion !       Polyglyoerel polyrieinol&ato is a highly
                       viscous liquid ( at 25°C).
Polv/rlycerols :       The polyglycerol moiety is predominantly
                       di , tri and tetra-glycerol and may contain
                       not more than 10$ of polyglycerols equal
                       to or higher than heptaglycerol .
Refractive index :     Not less than 1.4630 and not more than
                       I.4&65 .
Hydroxyl value :       Not less than 80 and not more than 100
                       mg KOH/g.
Iodine value :         Not less than 72 and not more than 103 ( Wijs ).
Acid value :           Not more than 6 mg K0H/g .
Sorbitan Monostearate
Chemical description : Sorbitan monostearate consists of approx­
                       imately 95i0 °f a mixture of partial esters
                       of sorbitol and its mono and di-anhydrides
                       with predominantly stearic and palmitic acids .
Description :          Light cream to tan–coloured "beads or flakes
                       or a hard , waxy solid with a slight
                       characteristic odour and bland taste .
Content :              See chemical description .
Water :                Not more than 2$ (Karl Fisher).
Acid value :           Not less than 5 and not more than 10 mg
                       K0H/g .
Hydroxyl value :       Not less than 235 and not more than 260 mg
                       K0H/g.
Saponification value : Not less than 147 and not more than 157 nig
                       K0H/g.
Sulphated ash :        Not more than 0.5$ (800 i 25°c).
 ---pagebreak---                          - 6 -
SorMtan Tri nt cir.it e
Cheminai description :  Sorbitan tristearate consists of approximately
                        95$ of a mixture of partial esters of
                        sorbitol and its mono and di–anhydrides with
                        predominantly stearic and palmitic acids .
Description :           Light cream to tan-coloured "beads or
                        flakes , or a hard , waxy solid with a slight
                        characteristic odour and bland taste ,
Conterrt î              See chemical description .
Water :                 Not more than 2°Ja (Karl Fisher).
AciA value :            Not less than 12 and not more than 15 mg
                        KOH/g
Hydroxyl value :        Not less than 66 and not more than 80 mg
                        KOH/g.
Saponification value :  Not less than 176 and not more than 188 mg
                        KOH/g.
Sulphated ash :         Not more than 0.5^ (800 1 25° C).
Sorbitan Monolaurate
Chemical description :  Sorbitan monolaurate consists of approx­
                        imately 95$ of a mixture of partial esters
                        of sorbitol and its mono and di–anhydrides
                        with predominantly lauric acid .
Description :           Amber coloured viscous liquid with
                        characteristic odour .
Content :               See chemical description .
Water :          1      Not more than 2$ (Karl Fisher). t
Acid value :            Not less than 4*0 and not more than 8 mg
                        KOH/g.
Hydroxy1 value :        Not less than 330 and not more than 358 nig
                        K0H/g .
Saponification value :  Not less than 158 and not more than 170 mg
                        KOH/g.
Sulphated ash :         Not more than 0.5$ (800 +- 25°C).
 ---pagebreak---                          - 7 -
Sorhitan T' onoolerte
Chnmical dcncription : Sorbitan monooleate consists of approx­
                       imately SJ/o of a mixture of partial esters
                       of sorbitol and its mono and di–anhydrides
                       with predominantly oleic acid .
Description :          Amber coloured viscous liquid with odour
                       characteristic of fatty acids .
Content :              See chemical description .
Water :                Not more than 2?o (Karl Fisher).
Acid value :           Not less than 5»0 and not more than 8.0 mg
                       KOH/g.
Hydroxy! value :       Not less than 193 and not more than 210 mg
                       K0H/ .
Saponification value : Not less than 145 and not more than 160 mg
                       KOH/g.
Sulphated ash :        Not more than Q.tfo (800 i 25°C)
Sorbitan Monopalmitate
Chemical description : Sorbitan monopalmitate consists of approx­
                       imately 95%     a mixture of partial esters
                       of sorbitol and its mono and di–anhydries
                                                               Λ .
                       with predominantly palmitic acid .
Description :          Light cream or tan-coloured beads or flakes
                       or a hard , waxy solid with a characteristic
                       odour and bland taste .
Content :              See chemical description .
Water :                Not more than 2fo (Karl Fisher) •
Acid value :           Not less than 4.0 and not more than 7.5 nig
                       KOH/g.
Hvdroxvl value :       Not less than 270 and not more than 305 mg
                       KOH/g.
Saponification value : Not less than 140 and not more than 150 mg
                       KOH/g.
Sulphated ash :        Not more than 0.5$ ( 800 – 25°C )."
 ---pagebreak---                                     -6 -
                               Article 2
K enter States shall "bring into force the laws , regulations and administrative
provisions necessary to comply with this Directive not later than
1 July 1983®   They shall forthwith inform the Commission thereof .
                               Article 3
This Directive is addressed to the Member States .
Done at                                   For the Council