ARCHIVESHISTORIQUES
DELACOMMISSION
COLLECTION RELIEEDES
DOCUMENTS "COM"
COM(81)708
Vol.1981/0206

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COMMISSION OFTHEEUROPEAN COMMUNITIES
COM(81)708final.
Brussels.24November 1981
/
vv} :
N-,.^ ■
Proposalfora
CouncilDirective
amendingDirective 78/663/EEClayingdownspecificcriteriaof
purityforemulsifiers,stabiliseres ,thickeners andgelling
agents,foruseinfoodstuffs
(submittedtotheCouncilbytheCommission )
COM(81)708final.

COWN
EXPLANATORY NOTE
Themodifications inthepresentamendmenttotheDirectiveonspecific
puritycriteria*foremulsifiers,stabilisers,thickenersandgellingagents,
withtheexceptionofsmallmodifications tothepuritycriteriafor
alginicacid(E400)andalginates(E401-E404)1aretheresultof
previousCouncildecisionsincludedinthe"basicDirectiveonemulsifiers
(74/329/EEC)oronpuritycriteriaforemulsifiers(78663/EEC)thatmandate
theCommissiontomakeproposalsonthesespecifictopics.
1.Alginicacidandalginates(e400–E404)
Ithas"becomeapparentthatthemethodfor'insolublematterindiluteNaOH*is
inapplicable .Thefigurewastosomeextentsuperfluousgivenother
specificcriteriainthespecification andtheCommissionhasdecided
thatthereferenceshould "bedeleted.Ithasalso"beenputtothe
Commissionthatamorerealisticfigurefor'acidinsolubleash'for
theproductininternational tradewouldbeamaximumof2
2.Xanthangum(E415)»Powderedcellulose(E460(ii))
Theadditionofthesesubstancestothepermittedlistofemulsifiers ,
stabilisers ,thickenersandgellingagentsimposestherequirementto
determinespecificcriteriaofpurity.Thenumberformicro–crystalline
cellulosebecomesE460(i)asaconsequenceoftheadditiontothelist
ofpowderedcellulose(E460(ii)).
3.Sucrogl.ycerides (E474)
Technological advanceshaveledtotheuseofcyclohexane andisobutanol
fortheproductionofsucroglycerides .Thesesolventsareprovidedfor
intheproposedrevisiontosupplementthosealreadyincludedinthetext.
4.Propane-l 12-diolestersoffattyacids(E477)
WhentheScientificCommitteeforPood(SCP)evaluatedthismaterial
in1978theproductcontaining0.5dimerandtrimerwasconsidered
acceptable.TheCommitteerecommendedthatastheproductwith4$dimer
andtrimerwasonlytemporarilyacceptableitsauthorisation shouldbe
reviewedonthebasisoffurthertoxicological investigations the
resultsofwhichshouldbeavailable"withintwoyears"(ofthedateof
publicationofthereport–30.November1978)*®leCouncilDirective
appertainingtothismatter(78/66J/E3C)requiredthattheCommission
.reviewthesituationsothatanynecessaryamendmentscouldbemade
before31December1981.
3fccompositional parameterswhichdefinethepurityofthesubstance

TheCornninsionhasnowbeeninformedthatnoextratoxicologyis"being
carried ,outbutthatatpresentareductionof0.5Jawillputsome
manufacturers indifficulty .."TheCommissionhasalsobeeninformedthat-
development workhasbeenundertakentobringdownthelevelfrom4$to-
thelevelof0,5$consideredacceptablebytheSCF.Thepresentproposal
assumesthatthisworkcan.becompletedwithinthreeyearsandallows
MemberStates^'wfra.sorequire*to-authorizetheproductwiththehigh
levelofdimerandtrinrerintheinterveningperiod. ^'
Ammoniumphosnhatides poly^lycerol polyricinoleate ,sorbitanmonostearate
sorbitantristearate ,sorbitanmonolaurate ,sorbitanmonooleateandj
sorbitanmonor>almitate
ThisgroupofsubstanceswasincludedinArticle2(a)oftheCouncil
Directive74/329/eSCtinderthefollowingconditions: -
i)thesubstances maybeauthorizedinfoodstuffsbyrindividual
MemberStates.NoobligationisplacedonMemberStatesto
authorizethem;
ii).nolimitintimeisprovidedforthiaderogation; -
iii)theCouncilmay,inaccordancewiththeprocedurelaiddownin
Article100oftheTreaty,includeinAnnexIthesubstancesto
whichthisparagraphrefersatthesametimestipulatingthe
conditionsfortheiruseinfoodstuffs,providedthatin
accordancewithusualproceduretheirpuritycriteriaare
established *
The"usualprocedure"fortheestablishment ofpuritycriteriaisthat
theCounciladoptscriteriaonthebasisofaCommissionproposal.
Thepresentproposalappliesthisprooedure.

Proposal foraCouncil Directive amending Directive
7fi/C63/?SClaying downspecific criteria ofpurity foremulsifiers ,
stabilisers ,thickeners andgelling agents foruseinfoodstuffs
THECOUNCIL OPTHEEUROPEAN COMMUNITIES ,
Having regard totheTreaty establishing theEuropean Economic Community ,
Having regard totheproposal fromtheCommission"' ",
2Whereas Council Directive 78/663/EEC provides that ,asregards substances
E474and E477,theCouncil may,acting unanimously onaproposal from
theCommission ,decide onanynecessary amendments by31December 1981 ;
Whereas thecriteria ofpurity for substances E400 ,E401 ?E402 ,
E403 andE4O4 should bemodified totake account ofscientific
developments ,particularly ofmethods ofanalysis ;
Whereas Council Directive 74/329/EECof18June1974ontheapprocimation ofthe
laws oftheMember States relating toemulsifiers ,stabilisers ,thickeners
andgelling agents foruseinfoodstuffs ^,aslastamended byDirective
80/597/EEC^specifies thattheCouncil mayinclude inAnnex Iofthe
Directive ammonium phosphatides ,polyglycerol polyricinoleate ,sorbitan
monostearate ,sorbitan tristearate ,sorbitan monolaurate ,sorbitan
monooleate andsorbitan monopalmitate only when inter alia their purity
criteria areestablished ; whereas Directive 8o/597/EECalso amended
Annex IofDirective 74/329/EECtopermit Xanthan gum(E415)and
powdered cellulose (E460 (ii))andwhereas therefore purity criteria forthese
materials should beprescribed andthenomenclature ofE460modified
accordingly ;
■OJL223,
*0JL189,
*0JL155/14.8.1978,p.7
12.7.1974,P.1
23.6.1980,p.23

HAS ADOPTED THIS DIRECTIVE :
Article 1
Directive 78/663/EECishereby amended ,asfollows :
1.Article 2isreplaced bythefollowing :
"Article 2
Asregards thesubstance referred tointheAnnex tinder E477 »Member
States may,until 31December 1984 ,authorize foruse infoodstuffs a
product containing notmore than 4edimer andtrimer ofpropane-1,2 -
diol
2.TheAnnex isamended asfollows :
(a)Under E400,E401 ,E402,E403andE404/theentries relating to
Insoluble matter indilute NaOH aredeleted ,andtheentries relatin
to .cid-insoluble ash are amended to"Notmore than 2
(b)Thefollowing isinserted between E414andE420 (i)
E415–Xanthan gum
Chemical description :
Description :
Content :
Volatile matter :
.Ash :Xanthan gumisahigh molecular weight
polysaccharide gumproduced byapure-
culture fermentation ofacarbohydrate with
Xanthomonas campestris ,purified byrecovery
with ethanol orisopropanol ,dried
andmilled .Itcontains D-glucose andD-
mannose asthedominant hexose units ,along
with D-glucuronic acid andpyruvic acid ,
andisprepared asthe sodium ,potassium or
calcium salt .Its solutions axe neutral .
Cream coloured powder (
Xanthan gumyields ,onavolatile matters -
free basis ,notless than 4»2$ andnotmore
than 5»0$ ofcarbon dioxide .
Notmore than 15$determined bydrying at
105°C for21/2hours .
Notmore than 16$onavolatile matter-free
basis determined at600°C after drying at
105° Cfor4hours .

-3-
Pyruvic ncids
Nitrorons
Inopromnol :Notless than 1.5 /3
Notmore than 1.5$
Notmore them 750 rag/kg
Microbiological criteria:Viable cells ofXanthoraonas carapestris shall
beabsent ."
(c)Thenumber "E460"becomes "E460 (i)".
(d)Thefollowing isinserted between E460 (i)andE46I
"S460 (ii)-Powdered Cellulose
Chemical description :
Description :
Content :
Volatile matter :
pH:
Sulphated ash :Powdered cellulose ispurified mechanically
disintegrated cellulose prepared by -
processing alpha –cellulose obtained directly
from fibrous plant material .Ithas a
Cymolecular weight of1.6x10orgreater .
Awhite ,odourless powder .
Notlessthan92$(°12E20°loK
Notmore than 7$determined bydrying at
105° Cfor 3hours .
Shake about 5gwith 40mlofcarbon
dioxide-free water for 20minutes and
centrifuge .ThepHofthe supernatant
liquid isbetween 5«0and7»5 »
Notmore than 0.3$ determined at800–25°C .
Water soluble substances :Not more than 1%.
Diethyl ether
extract able matter :
Chloride :
Sulphate :Notmore than 0.15$ .
Notmore than $00mg/kgexpressed ,asCI.
Notmore than 500mg/kgexpressed asSO.."
(e)Under E474
-the last sentence intheentry relating tornChemical description is
replaced bythefollowing :
"Noorganic solvents shall beused intheir preparation other than
cyclohexane ,dimethylformamide ,ethyl acetate ,isobutanol and
isopropanol ."

-4-
–anewentry isadded asfollov /s:
"Total Cyclo'nexane and
Isobutanol con-tent :Notmore than 10mg/kgsingly orin
combination ."
(f)Under E477 "the entry relating toDimer andtrimer ofpropane-1 ,2-diol
isamended to "Notmore than 0.5% ".
(g)Thefollowing substances areadded :
"Ammonium Phosphatides
Chemical description : Ammonium phosphatides consist essentially
ofamixture ofthe ammonium salts of
phosphatidic acids derived from partially
hardened rapeseed oil ,orother edible
oils ,together with unreacted partially
hardened oil .
Description
Matter insoluble in
lip-ht oetroleum
T4Ô6c-6Ô°CT~Description : Anunctuous semi-solid (at25°c ).
Matter insoluble in Total :Notmore than 2.5per centum ,
(40°Gl" Inorganic matter :Notmorethan0.2percentum ,
pHofanacrueous extract Not less than 6.0and notmore than 8.0
ofmelted ammonium
phosahatides :
Phosphorus :
Ammonium nitrogen :
Unreacted oil :
Arsenic :Notless than 3.0^b andnotmore than 3*4% »
Notless than 1.2$ andnotmore than 1.5
Notmore than 42%.
Notmore than 5mg/kg.
Polvglycerol Polyncinoleate
Chemical description : Polyglycerol polyricinoleate isessentially
acomplex mixture ofethers andpartial
esters ofpolyglycerol with linearly
interesterified (polycondensed )fatty
acids derived from castor oil .Thepoly­
condensed castor oilfatty acids are
prepared bycondensation intheabsence of
*
oxygen andhave anaverage ofabout 5
fatty acid residues permolecule .

-5-
flonnrif>tion!
Polv/rlycerols:
Refractive index:
Hydroxylvalue:
Iodinevalue:
Acidvalue:
SorbitanMonostearate
Chemicaldescription :
Description :
Content:
Water:
Acidvalue:
Hydroxylvalue:
Saponification value:
Sulphatedash:Polyglyoerel polyrieinol&ato isahighly
viscousliquid(at25°C).
Thepolyglycerol moietyispredominantly
di,triandtetra-glycerol andmaycontain
notmorethan10$ofpolyglycerols equal
toorhigherthanheptaglycerol .
Notlessthan1.4630andnotmorethan
I.4&65.
Notlessthan80andnotmorethan100
mgKOH/g.
Notlessthan72andnotmorethan103(Wijs).
Notmorethan6mgK0H/g.
Sorbitanmonostearate consistsofapprox­
imately95i0°famixtureofpartialesters
ofsorbitolanditsmonoanddi-anhydrides
withpredominantly stearicandpalmiticacids.
Lightcreamtotan–coloured "beadsorflakes
orahard,waxysolidwithaslight
characteristic odourandblandtaste.
Seechemicaldescription .
Notmorethan2$(KarlFisher).
Notlessthan5andnotmorethan10mg
K0H/g.
Notlessthan235andnotmorethan260mg
K0H/g.
Notlessthan147andnotmorethan157nig
K0H/g.
Notmorethan0.5$(800i25°c).

-6-
SorMtanTrintcir.ite
Cheminaidescription :
Description :
Conterrtî
Water:
AciAvalue:
Hydroxylvalue:
Saponification value:
Sulphatedash:
SorbitanMonolaurate
Chemicaldescription :
Description :
Content:
Water: 1
Acidvalue:
Hydroxy1value:
Saponification value:
Sulphatedash:Sorbitantristearateconsistsofapproximately
95$ofamixtureofpartialestersof
sorbitolanditsmonoanddi–anhydrideswith
predominantly stearicandpalmiticacids.
Lightcreamtotan-coloured "beadsor
flakes,orahard,waxysolidwithaslight
characteristic odourandblandtaste,
Seechemicaldescription .
Notmorethan2°Ja(KarlFisher).
Notlessthan12andnotmorethan15mg
KOH/g
Notlessthan66andnotmorethan80mg
KOH/g.
Notlessthan176andnotmorethan188mg
KOH/g.
Notmorethan0.5^(800125°C).
Sorbitanmonolaurateconsistsofapprox­
imately95$ofamixtureofpartialesters
ofsorbitolanditsmonoanddi–anhydrides
withpredominantly lauricacid.
Ambercolouredviscousliquidwith
characteristic odour.
Seechemicaldescription .
Notmorethan2$(KarlFisher).t
Notlessthan4*0andnotmorethan8mg
KOH/g.
Notlessthan330andnotmorethan358nig
K0H/g.
Notlessthan158andnotmorethan170mg
KOH/g.
Notmorethan0.5$(800+-25°C).

-7-
Sorhitan T'onoolerte
Chnmicaldcncription :
Description :
Content:
Water:
Acidvalue:
Hydroxy!value:
Saponification value:
Sulphatedash:
SorbitanMonopalmitate
Chemicaldescription :
Description :
Content:
Water:
Acidvalue:
Hvdroxvlvalue:
Saponification value:
Sulphatedash:Sorbitanmonooleateconsistsofapprox­
imatelySJ/oofamixtureofpartialesters
ofsorbitolanditsmonoanddi–anhydrides
withpredominantly oleicacid.
Ambercolouredviscousliquidwithodour
characteristic offattyacids.
Seechemicaldescription.
Notmorethan2?o(KarlFisher).
Notlessthan5»0andnotmorethan8.0mg
KOH/g.
Notlessthan193andnotmorethan210mg
K0H/.
Notlessthan145andnotmorethan160mg
KOH/g.
NotmorethanQ.tfo(800i25°C)
Sorbitanmonopalmitate consistsofapprox­
imately95%amixtureofpartialesters
ofsorbitolanditsmonoanddi–anhydries
Λ.
withpredominantly palmiticacid.
Lightcreamortan-coloured beadsorflakes
orahard,waxysolidwithacharacteristic
odourandblandtaste.
Seechemicaldescription.
Notmorethan2fo(KarlFisher)•
Notlessthan4.0andnotmorethan7.5nig
KOH/g.
Notlessthan270andnotmorethan305mg
KOH/g.
Notlessthan140andnotmorethan150mg
KOH/g.
Notmorethan0.5$(800–25°C)."

-6-
Article2
KenterStatesshall"bringintoforcethelaws,regulations andadministrative
provisionsnecessarytocomplywiththisDirectivenotlaterthan
1July1983®TheyshallforthwithinformtheCommissionthereof.
Article3
ThisDirectiveisaddressedtotheMemberStates.
Doneat FortheCouncil