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DOCUMENTS "COM"
COM(75)252
Vol.1975/0091

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• -TT\fTTT'TA'-T rf i?rm–T**rpT^r*/^.–A~VT T\aTTVr*TTTT*T.'rf,",Tr'*^O THEEUROPEAN COMMUNITEES COMMUNITEES*s?THE -EUROPEAN COMMUITEES
COM(75)252final
Brussels .5June1975
PROPOSAL FORACOUTCILDIRECTIVE (EEC)
amendingforthesecond "timeCouncildirective Ho65/66/EES
etheapproximation ofthelawsoftheMemberStates
layingdownspecificcriteria ofpurityforpreservatives
authorized foruseinfoodstuffs intended forhumanconsumption
(submitted totheCouncilbytheCommission )
C0Î'I(75)final

704A1/75-E
EaPLMATORY TOTE
1.CouncilDirective N°64/54/EECof5November 1963(l)established ,asingle
listofpreservatives intheCommunity authorized for"tt.seinfoodstuffs
intendedforhumaneonsumption .TheDirective alsoprovidesforthelaying
downofcriteriaofpuritywithwhichthesepreservatives mustcomply*
2.Thesecriteria ofpurityweredeveloped andincludedinCouncilDirective
N°65/66/EECof26January1965(2)«modifiedbyCouncilDirective
N°67A28/EECof27Juno1973<3)*"Stis-inevitable thatanymodifi-t -
ccitiontothelistofpreservatives referredtoinparagraph 1is
likelytoproduceaconsequential amendment tothisDirective#
3«ThepresentproposalforDirective relatestoadditives whichhavealready
beenaddedtothelistofpreservatives bymodifications tothebasicDirec­
tiveof5November 1963,namely:
-calciumsulphite(E226),addedbytheCouncilDirective tf°71/160/EECof
30March1974(3)
-methylparahydroxybenzoate (E218)andcalciumbisulphite (E227)»addedby
theagreement reachedattheentryofthethreenewMemberStatesintothe
Community (Annex1,chapterXI.2oftheActofAccession )(4)
-thiabendazole (E233)»added "bytheCouncilDirective N°74/394/EECof
22July1974(5)
-formicacid(E236)anditssodium(E237)andcalcium (E238)saltsand
hexamethylenetetramine (E239),addedbytheCouncilDirective N®74-/62/EEC
of12December 1973(6).
TheaimofthisproposalforDirective isthecompletion oftheDirective
of26January1965bytheadditionofthecriteria ofpurityfortheabove
mentioned substances .
(1)OJN012of27.1.1964 p»I61/64
(2)OJ22of9.2.1965P.373/65
(3)OJNMM O.£[ti/7/1967^10
(4)OJN°L/87of&7/V1971 T?V.12
(5)OJN°L73of27/3/1972p.121
(6)OJN°-L208o-f30/7/197^P»25
(7)OJN°L38of11/2/197^P-29

\
{
704M/75-E
ProposalforaCouncilDirective amendingforthesecondtime
CouncilDirective IT065/06/EEContheapproximation ofthe
lawsoftheMemberStateslayingdownspecificcriteria of
purityforthepreservatives authorized foruseinfoodstuffs
intendedforhumanconsumption .
THEC0U1TCIL OPTHEEUROPEM COMLIUNITIES
HavingregardtotheTreatyestablishing theEuropean Economic Community ;
HavingregardtotheCouncilDirective N®64/54/EEC(l)of5November1963
ontheapproximation ofthelawsoftheMemberStatesconcerning thepreserva­
tivesauthorized foruseinfoodstuffs intentedforhumanconsumption ,aslast
amendedbyCouncilDirective N°74/394/EEC(2)of22July1974andinparticular
Article8thereof ;
Havingregardtotheproposal fromtheCommission ; „ .(3)amended byCouncilDireptive H®16?/428/EEC(4)
WhereastheCouncilDirective K°65/66/EEC/laiddownspecificoriteriaofpurityfor
thepreservatives listedintheAnnextotheCouncilDirective N°64/54/EEC;
whereasthatAnnexwassupplemented bytheCouncilDirective 71/I60/EEC(4)
of30March1971whichaddedcalciumsulphite ;bytheAct.ofAccession (5)
ofDenmark,IrelandandtheUnitedKingdomwhichaddedmethylp-hydroxybenzoate
andcalciumbisulphite ;bytheCouncilDirective IT074/62/EECof12December
1973(6)whichaddedformicacid,sodiumformate,calciumformateandhexame-
thylenetetraaine ;andbyCouncilDirective N®74/394/EECof22July1974(7)
whichaddedthiabendazole tothelistofauthorized preservatives ;
Whereasitisnecessary tolaydownspeoificcriteriaofpurityfortheeight
preservatives mentioned above;
HASADOPTED THISDIRECTIVE
CI)OJIP12,27.1.1964 ,P.161/64(6)OJN®L73of27.3.1972p.121
(2)OJN®L208,30.7.1974 ,p.25 (7)OJN®L38of11.2.1974p.29
(3).OJN.®22,9.2.1965,P.373/65(.8)OJN®L208of30.7.1974 p.25
(4)OJ148ofJia/7p.10
(5)OJN®L87of17/V1971

-2- 704AI/75-E
Article 1
TheAnnextotheCouncilDirective N°65/66/EECshallbeamendedasfollows:
1.Thefollowing specification shouldbeinserted betweenN°sE2X7andE220
E218Methylp-hydroxybenzoate (methylesterofparahydroxybenzoic acid)
Appearance : White*almostodourless crystalline powder
Meltingrange: 125°-128°C
Content: Notlessthan99»0$calculatedasCgHgO^after
dryingfor2hoursat80°C
Sulphated ash: Hotmorethan0.05$
Freeacidity: .Notmorethan0.7$expressed asp-hydroxybenzoic acid
Salicylio acid: :Notmorethan0.1$r
Lossondrying:Notmorethan0.5$afterdryingfor2hoursat80°C
2.Thefollowing specifications shouldbeinserted betweenN°sE225andE230
E226Calciumsulphite
Appearance : Whitecrystals orcrystalline powder
Content : Notlessthan95$ofCaSO.•2H0andnotlessthan" 32
j39$ofS02
Sulphate : Notmorethan0,1$
Chloride : Notmorethan0.0*4.Iron : NotmorethanO.OOp%Selenium J Notmorethan10mgperkgofthesulphurdioxide
content
E227Calcimibisulphite (caiciumhydrogensulphite)
Appearance : Cleargreenish-yellow aqueoussolutionhavinga
distinct odourofsulphurdioxide
Content: 6to8$(w/v)ofsulphurdioxideand2.5to3-5$
(w/v)ofoalciumoxidecorresponding to10-14$
(w/v)ofcalciumbisulphite/Ca(HS0,)2_7
Iron: Notmorethan30mgperkg
Selenium :- Notmorethan10mgperkgofthesulphurdioxide
♦• «
' content

-3-7 704M/75-E
Thefollowingspecifications shouldbeinsertedbetweenN°E232and
E250. , ,„_» .. «/■1«^ 1E2532-(4'thiazolyl )benzimidazole (thiabendazo ley
Appearance ":whiteoralmostwhiteodourless poweder
Meltingrangea .296-303°C •
Content.?98to101%yNScalculated on-theanhydrousproductSulphatedashsNotmorethan0.2%Moisture 1Notmorethan0.5%(Karl-Fischer)
XPJAbsorption :E1%at302+2m«-about1230.
(0-0005%w/vinE1%at.258+2nn=about200
0.1NHC1) E1%at243+2lira*about620
Ratioofabsorption at24l-245nms0.47-0.53
absorption at300–304nm
Ratioofabsorption at256-260nm_=0.14-0.18
absorption at300-304nm <•;.
Sélénium =30mg/kg
E236Foraioacid
Clearcolourless highlycorrosive liquidwithacharac­
teristic pungentodour
Containsnotlessthan98.0faofCIL0_.
lïotmorethan0.5%
Notmorethan<0mg/kg
Sulphite : Dilute25mlofformicacidwith25mlofwater.
Add0.1nlOf0.1IIiodinesolution .Thesolution should
retainadistinct yellowcolour.
Chloride : Notmorethan50mg/kg
Specifiogravity :1.216-1.220(20°/20°)
Nonvolatilematter:Notmorethan0.05$
Aldehydes ; Aslightlyalkaline jfosolution,onheatingmustnot
giveoffasharporburntsmell
Formaldehyde :Hotmorethan0.1%oftheformicacidcontent,estimated
.withchromotropic acid
Oxalicacid: Notmorethan0.5%oftheformicacidcontentestimated
ascalciumoxalateAppearance :
Content :
Aoeticacidî
Sulphate :
Sulphite :
Chloride :

-4- 704AI/75-E
E237Sodiunfoiraate "(sodiumsaltofformioacid)
Appearance :
Content :
f. ■''
Volatile matter :
Degreeofacidityoralkali-
rv. .
nity: v.
'•'*--•.'*,
Aldéhydes :
Formaldehyde :
Oxalioacid:Whitecrystalline powdefr
Notlessthan98$NaCEO-afterdryingfor
2hoursat105®C
Notmorethan2$determined "bydryingfor2hours
at105°'C
Neutralisation of1gramofsodiumformatein
thepresence ofphenolphthalein mustnotrequire
morethan0.5mlof0.1NHC1or0.1NNaOH
A5$solutiononheatingmustnotgiveoffa
sharpor"burntsmell
Notmorethan0.1$ofthecontentofsodium
formateestimated withchronotropic acid
Notmorethan0,5$ofthecontentofsodium
formateestimated ascalciumoxalate
E238Calcium ■formate (calciumsaltofformicacid)
Appearance :
Content :
Votalile matter Î
Water-insoluble matter :
Degreeofacidityor
alkalinity :
Aldéhydes :
Pormaldehyde :
Oxalicacid:Whitecrystalline powder
Notlessthan98$CaCgHgO.afterdryingfor
2hoursat105°C
Notmorethan2$determined bydryingfor
2hoursat105°C
Notmorethan0.5$ ,*
Neutralisation of1gramofcalciumformate
inthepresenceofphenolphthalfeifcn mustnot
requiremorethan0.5mlofO.l/NHC1or
0.1NNaOH
A5$solutiononheatingmustno#giveoff
asharf>orburntsmell.
Notemorethan0.1$ofthecontentofcaloium
formateestimated withchronotropic acid
Notmorethan0.3$ofthecontentofcalcium
formateestimated ascalciumoxalate

-5- 704Al /7§-E
E239Keyanetliylenetetranine
Appearence :
Content :
Loss ondrying :
Sublimation point s
Sulphated AP*1.:
Sulphate :
Chloride :Colourless orwhite crystalline powder
Hotlessthan99%CgH^N ^
Notmore than 0.5$after drying at105° C
invacuum over phosphorus pentoxide for
two hours .
Sublimes atabout 260° Cwithout melting
notmore than 0.05%
Notmore than O.OO5 fo
Notmore than 0.005f°
Article 2
Monber States shall ,within oneyear from thenotification ofthis
Directive ,amend their laws in -accordance with thepreceding provisions
end shall forthwith inform the Commission thereof *The laws thus emended
dltill beimplemented atthelatest twoyears after notification ofthis
DIrectlve - Article ^
This Directive isaddressed totheMember States .
For the Council
The Président