ARCHIVESHISTORIQUES
DELACOMMISSION
COLLECTION RELIEEDES
DOCUMENTS "COM"
COM(75)254
Vol.1975/0091

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COMMISSION OFTHEEUROPEANCQMMUMTÏES
COM(75)254final
Brussels.5June1975.
PROPOSAL FORA
COUNCILDIRECTIVE
foranamendmenttoDirective64/54/ESConthe
approximation ofthelawsoftheMemberStatesconcerningthe
preservatives authorizedforuseinfoodstuffsintendedforIonianconsumption
{submittedtotheCouncilbytheCommission)
COI.î(75)254final

E3PLATAT0RY TEKORflMDIJM
1.TheCouncil Directive onPreservatices foruseinfoodstuffs (1)
aslast amended "bytheDirective of22July 1974(2 )provides for
theuseofmethyl p-hydroxybenzoate ('2218 )as-preservative ,and
sodium nitrite andsodium propionate assubstances having asubsidary
preservative effect .
2.TheTreaty ofAccession ,Annex VII (lX.2 )(3)allows newMember
States tousesodium derivative ofmethyl p-hydroxybenzoate ,potassium
nitrite andpotassium propionate ,where this usewasauthorised "by
national Legislation atthe tirae ofAccession .This derogation
expires on31December 1977 *There isagreat deal ofchemical
similarity "between thesodium derivative oxmethyl p-hydroxybenzoate -
sndtheester itself ,between sodium andpotassium nitrite andbetween
sodium andpotassium propionate .Theequivalent compounds canbe
used asalternatives .
3.Theaimofthepresent Directive istoallow alltheMember States the
facility tousethese latter additives since itisclear that
permission tousethese substances throughout theCommunity has
economic advantages .
4.Prom thetcxicological point ofview theassessment ofthesafety in
useofthesodium derivative ofmethyl p-hydroxybenzoate issosimilar
tothat ofthe ester that the Scientific Committee for Pood has no
objection totheinclusion ofthesodium salt aswell astheester »
intheDirective ,Similarily ,theScientific Coacfittee forPood
hasnoobjection ,from thepoint ofview ofsafety inusetothe
extension oftheXist ofPreservatives toinclude thetwopotassium
salts since theuseofpotassium nitrite orpotassium propionate
instead ofthesodium salt creates noproblems ofsafety inuseand ,indeed ,in
eome cases maybeadvantageous <.Theadvice oftheCommittee isattached tothis
note .
5.Itisalready provided forinthebasic Directive that atasecond
stage theCommunity will actontheapproximation ofthelaws concern ?-
ingindividual foodstuffs towhich thepreservatives listed inthe
Directive maybeadded .
(1)CJNo12,27.1.1964 »p.161/64. ./•
(2)CJ!foL2O0 ,30.7-74 ,p.25-
(3)CJSpécial Edition (L73)27.3.1972»

2-
However,itisnottheintentionofthepresentproposaltoenter
intothisfield,"butmerelytoamendinalimitedmannertheexisting
provisions *
6.TheamendmenttoArticle7oftheDirective "bringsthewordingin
linewiththatrecentlyagreedinsimilarcircumstances duringthe
elaborationoftheDirectiveonEmulsifiers,Stabilisers,Thickeners
andGellingAgents.Thisisaninterimmodification whichwillbe,
opentochangewhenmeasuresaretakenconcerningcontaminants .in
food#
,1J
7«Similarmodificationswillshortlybeincludedinthecorresponding
paragraphsoftheDirectiveonColoursandAntioxidants inFoodon
theoccasionofthenextamendments ,oftheseDirectives.
/

Proposal foraCouncil Directive foran11th amendment toDirective 64/54/EEC
ontieapproximation ofthelaws oftheMember States concerning thepreserva­
tives authorized foruse infoodstuffs intended fcrhuman consumption
THECOUNCIL OFTHEEUROPEAN .COMMUNITIES , .
Having regard ,totheTreaty establishing theEuropean Economic Community and
inparticular Article 100thereof )
Having regard totheproposal from -theCommission ,
Having regard totheOpinion oftheEuropean Parliament ,
Having regard totheOpinion oftheEconomics andSocial Committee , .
Ifcereas theCouncil Directive 64/54/EECof5November 19^3 (l)ontheapproxi­
mation ofthe laws ofMember States concerning thepreservatives authorized f&r
useinfood intended forhuman consumption ,aslast amended bytheCouncil Di­
rective 74/354/EECof22July 1974 (2)provides fortheuseofthepreservative
methyl p-hydrcxybensoate (E2lC )"butnotitssodium derivative ?
Whereas the aformentioned Directive also authorizes the use ofsodium nitrite
(E250 )andsodium propionate (E28l )assubstances havirg asubsidiary preserva­
tive effect butnotpotassium nitrite ar.dpotassium propionate ;
Whereas theusafulnssg ofthesodium derivative ofmethyl p-hydroxybenzoate ,
potassium nitrite andpotassium propionate hasbeen demonstrated onatechno­
logical plans atCommunity level toreplace partially orwholly theuseof
methyl p-hydrexybensoate ,sodium nitrite andsodium propionate respectively :
Khereas theaddition ofthese substances tathelist ofpermitted preservatives
creates nohazards tohealth ,having regard tothetoxicological examinations
carried outonthis subject ?
Whereas itisconvenient atthesame time tomodify theprovisions intheDirec­
tive concerning thepresence oftoxicologically dangerous elements asaninterim
measure until theCommunity legislation orithese contaminants tofood iscomplete
andtobring thisDirective inconformity with thsCouncil Directive 74./329/EI2C0
18June 1974 ontheapproximation of/thelaws ofthe Men-.ber States relating to
Smulsifiercjj Stabilisers ,Thickeners andGelling Agents foruseinfoodstuffs ?
/...
(1)0.TNo.12of27.1.1964 ,p.161/64,
(2)OJNo.L208of30.7-1974 »p.25 »
(3)OJNo.L189of12.7.1974 ,p..!♦(2
(3)

-4-
HASADOPTE® THIS DIRECTIVE ,.. ,
*- i,....... .'. "'
Article 1
Article 1oftheDirective 64/54/2ECisamended asfollows :
Article 7fparagraph (a)isreplaced by:
"(a)thefollowing general criteria ofpurity
-they shall notcontain atoxicologicaily dangerous amount ofany
element ,inparticular heavy metals ;
-they shall notcontain more than 3mg/kgofarsenic ormore than
10irg/kgoflead }
-they shall notcontain more than 50mg/kgofcopper andzinc taken
together ofwhich thezinc content must innocase exceed 25mg/kg
subject toanyexception deriving from thespecific criteria ofpurity
refarred toin(b)
••Article 2
>• •„1; . '.• V,'
Part 1oftheAnnex oftheDirective 64/54/EECismodified ,asfollows :. .
ESC Number Marne (Conditions ofuse i
IJ ;
i ;
E219|Sodium derivative of
Imethyl p-hydrOTcy -
[berxzo&te
Artic le3
! mil■■■«i«t»–rf»
Part IIoftheAnnex oftheDirective 64/54/EECismodified asfollows :
! 1
i EEC Number Name Conditions ofuse
:E249 potassium nitrite Solely inamixture
with sodium chloride
E283 potassium propionate
(potaesium ealt òf
propionic acid )) ,
•••I

Article4
MemberStatesshall"bringintoforcenotlaterthan12monthsafternotifi­
cationefthisDirective,thelaws,regulationsoradministrative pro-srisiaEs,
necessarytocomplywiththisdirectivear^dshallforthwithinformthe
Commission .
Article5
TheDirectiveicaddressedtoMemberStates.
DonsatBrassais, FortheCounci1,
TheChairman.

Anr.9.xI
OPINION0?TEESCIENTIFIC COMMITTEE FORPOOD
on
Scdiurametbjlparahydroy.y'berzoa^e.
potassrumnitriteandpoiassiumpropionate
Cpinisnexpressed15Novernber1974

-2-
(Annex I
TERMS OFRHFERENCE
Togive anepinion onwhether thesodium derivative ofmethyl parahydroxy -
csnzoaxof potassium nitrite andpotassium propionate could from thepoint cf
view ofsafety inusebeadded totheCommunity list ofPreservatives for
use infood .
CONCLUSIONS
1.Thesodium derivative ofmethyl parahydroxybenzoate could "beadded to
theCommunity list ofpreservatives foruseinfood .
2.Potassium propionate could "beaddod totheCommunity list ofpreservatives
for use infood . % ~
3.Potassium nitrite could beadded totheCommunity list ofpreservatives
for use infood under the saiiie conditions asfor the sodium salt .
4»TheCommittee draws the attention cftheCommission totheneed for a
review of
a)theuseofnitrite andnitrate ?
b)thebalance inhmuan nutrition ofmineral ions ,inparticular ,
ofsodium andpotassium .