ARCHIVESHISTORIQUES
DELACOMMISSION
COLLECTION RELIEEDES
DOCUMENTS "COM"
COM(73)797
Vol.1973/0151

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OFTHEEUROPEANCOMMUNITIES
COM(73)797 final
Brussels ,23May1973
PROPOSAL FOR A
COUNCIL DIRECTIVE
onaninth amendment tothe Directive onthe
approximation ofthelaws oftheMember States
concerning thepreservatives authorized foruse
infoodstuffs intended forhuman consumption
(submitted totheCouncil bythe Commission )
COKC73 )797final

EXFLM'ATOPY MjTOPASPrjM
I.
1,Article5(a)"theCouncilDirectiveof5November1963^ontheap­
proximation ofthelawsoftheMemberStatesconcerningthepreservatives
authorizedforuseinfoo&tuffsintendedforhumanconsumption empowers
theMemberStatestomaintainforacertainperiodtheirnationallaws
relatingtotheuseofformicacidanditssalts,boricacidandits
salts,organo-borated compoundsandhexamethylene-tetramine .Underthe
secondsentenceofArticle11ofthatDirective,asamendedbytheCouncil
Directivesof20December1968and20December1971^*"thebanon
theuseofthesesubstanceswilltakeeffecton1January1973»
Theresultingarrangements werenevertheless temporary,fortheirpurpose
wastopermittheacquisitionofcertainscientificandtechnological
knowledgeregardingthevariouspreservatives inquestionwithaviewto
thepossibleauthorization oftheirgeneraiusethroughouttheCommunity.
2,TheCommissionisnowabletoproposethattheCouncilinsert,definitively ,
formicaoidandcertainofitssaltsandhexamethylene-tetracaineinthe
AnnextotheDirectiveof5November1963,andshoulddeterminethecon­
ditionsfortheiruse,
Inaddition,theCommissionproposesthatthetreatmentofcaviarbyboric
acidandboraxshouldbeauthorizedsubjecttoareviewclause.
II.
ThefactorsonwhichthisproposalfromtheCommissionisbasedcanbesumma­
rizedasfollows:
♦•«/•••
1)OJN012,97January1964,P«l6l/o4»
2)OJIT0L309,24December1968,p.25
3)OJ1°L2,4January1972,p.22

\
-2-
1.Fommioacidanditssalts
(a)Formicaoidwasexamined "bytheJointFAO/WHOCommitteeofExperts*
onFoodAdditivesin1961and1964,andaconditionalacceptabledaily
intake(ADl)of5mg/kg"byweightwasattributedtoit(WHOTeohRep
Ser1962,228awlWHOTechRepSerI965,309).
Thescientificconceptoftheconditionalacceptsinceofanadditivemeans
thatitsusemay"beauthorizedwithoutrisktopublichealth,particu­
larlyindevelopedcountrieshavingthelegislative andadministrative means
ofassessingandverifyingthequantitiesactuallyinvolvedintheuse
oftheadditiveinquestioninfoodstuffs.
TheScientificCommitteeonFoodstuffs,whichwasconsultedonthis
matterinAugust1967andJanuary1972,approvedtheinsertionofformic
acidanditssaltsontheconditionslaiddowninthisproposal,
(b)Fromthetechnological pointofview,theuseofformicacidanditssalts
isnecessaryincertainsemi-preserved fisheryproduotsandvegetables
invinegar,forwhichnoneofthepreservatives alreadylistedinthe
Annextothe,.Directiveof5November1963cangiveadequateprotection
againstmicrobialdeterioration . ....
,Moreover,theuseofformioacidandfoiwfcesinplaceofsulphurdioxide
anditsderivativesisofparticularinterestforthepreservation ofcertain
basiopreparations intendedfortheproductionofnon-alcoholic beverages
inwhichtheSO^content(freeorcombined)mustbereducedinviewofthe
largequantities consumedebychildren.
Thequantitiesprovidedforinthisproposalrepresentonlyaverylow
proportionoftheADIofformioacid.
•••/•••

Hexamethylene-tetramme
a)Atits15thsessionin197l»"theJointFAD/WHOCommitteeofExperts
onPoodAdditivesfixedaprovisional ADIof5mg/kg"byweightofthis
substance#
TheScientificCommitteeenFoodstuffs ywhichwasconsultedinJanuary
1972fapproveditsuseontheconditionslaiddowninthisproposal#
Itwasreluctantatthattimetorejectcertainmorerecentstudies
suggestinganADIofonly0.15mg/kg"byweigth,butwhichitisdifficult
toregardasconclusive#
"b)Theuseofhexamethylene-tetranine isessentialintheproductionof
"Provolone"and"Granapadano"cheesespreparedfromthemilkofcows
fedonsilagefodder#Hereinfactaphenomenonconsistingoftheswelling
ofthecheeseisobserved,knownas"tympanites"fcaused "bytheaction
ofaolostridium andmakingthecheeseunmarketable.Theuseofhexane-
thylene-tetramine canpreventsuchdeterioration#
Moreover,followingcertainrecenttests,itseemspossibletousehexameil
lene-tetramine forpreservingcaviar(andotherfisheggs)whicharestill
commonlytreatedwithboricacidandboraxinproducercountries.These
testsshouldbeencouragedbyauthorizingthesaleofcaviarcontaining
hexamethylene-tetramine .
Theresidualdosesspecifiedinthisproposalareaverylowpercentageof
theADI,.eveniftheADIistakenas0.15mg.
Boricacidanditssalts
SincetheDirectiveof5November1963wasadoptedresearchhasbeencarried
outinseveralcountriesonthedevelopmentofapreservation processfor
caviarnotusingboricacid,butnothingconclusivehasyetbeenfounda

TheScientificCommittee,towhichthematterwasreferredinDecember1967
andJanuary1972,raisednoobjectionstothetemporaryauthorization ofthe
useof"boricacidin"genuine"caviar.Indeedcaviarisaluxuryproductconsumed
onlyinsmallquantitiesatirregularintervals# Thequantityabsorbedtycaviar
consummerscanbeassumedtobe200g/o^llsj11111andchildrendonoeatcaviaron
thewhole#Themaximumdosefromuseofboricacidbeiri*0.4%,thetotalannual
intakeislessthan1g.Theharmfuleffectsofboricacidlieprincipallyinits
cumulativeeffect,whichisnocauseforconcerninthiscase#
Itshouldhoweverbestressedthatboricacidisbeingallowedonlytemporarily,
sothatthoseconcernedwillbeencouragedtooontinueresearchintoarempla-
scementproductsuchashexamethylene-tetramine associatedwithbenzoicacid.
ThSCommissionthereforeproposesthatareviewclausebeinsertedinthe
Directive.
III.
Whenthenewpreservatives areinoludedinthe.AnnextotheDirectiveof5Novembo
1963,theconditionsfortheiruseshouldalsobelaiddown.Infacttheiruse
reflectsadefinitetechnicalrequirement and,moreover,wecannotputforwarda
solutionwhichmaycreatenewbarrierstointra-Community traderesultingfrom
theintroduction ofdissimilarnationalconditionsofuse.
Thenationallawsatpresentgoverningtheuseofthethreegroupsofpreserva­
tivesooveredbythisproposalforaDirectiveauthorizecertainuseswhichthe
Commissionatthemomentdoesnotfinditnecessarytoproposeforthewhole
Community.

-5-
Infact,pursuantto
-Germanlegislation,formicacidanditssaltsmayalso"beusedforpreserving
fruitjuices-evenitintendedfortheproductionofsyrups;
-Dutchlegislation ,
•hexarnethylene-tetramine ispermittedforthetraetmentofsemi-preserved
fisheryproducts;
w"boricacidmay"beusedineggproducts.
TheCommissionproposestheretentionoftheseusesforthreeyearsatnational
levelforthefollowingreasons:
a)Formicacid
WithintheCommunitytheuseofthispreservative infruitjuicesistech­
nologically nolongernecessaryowingtotheintroduction ofdeep-freeze
techniques.Itmusthoweverberecognizedthatthesetechniquesarenotyet
ingeneraluseincertainthirdcountriesexportingfruitjuices.T6allow
tradeflowswiththesecountriestohemaintained,theMemberStateinquestion
shouldbeauthorizedtopermitthemarketinginitsterritoryofjuices
treatedxfithformicacidanditssaltsduringacertainperioduntilthe
countriesofOriginhaveconvertedtheirindustrialprocesses.
b)Kexanethylene-tetrsmne
Thispreservative hasnowbeengivenaprovisional ADIwhichmaybeexpected
tobeconvertedintoadefinitive ADI,ThismayleadtheCommunitytoaccept
hexamethylene-tetramine onlessstringentconditionsthanthosenowproposed,
anditwouldhardlybereasonable ,inthemeantimetoprohibitthecontinued
acceptanceoftheseconditionsbyaMemberStateinitsterritory.
c)Boricacid
Theadditionofboricacidtoeggproductsservestopreventsalmonellacon­
tamination.
#••/••*

-6-
Industrialpracticein"theMemberStateinquestionisnotyetsuchthat
thistraetmentcanbeabandonedandreplacedbyotherprocessessuchas
deep-freezing orpasteurization ,Atransitional periodisthereforenecessary.

Proposal foraCouncil Directive onaninth amendment totheDirective
ontheapproximation ofthelaws ofthe 'Member States concerning the
preservatives authorized foruseinfoodstuffs intended forhuman con­
sumption
TIIECOUIJCIL OFTHEEUROPEAN COMMUNITIES , ..
Having regard totheTreaty establishing theEuropean Economic Community ,
andinparticular Article .100thereof ,
Having regard totheOpinion 6ftheEuropean Parliament ; -
Having regard totheOpinion oftheEconomic andSocial Committee ;
Whereas theCouncil Directive of5November 1963 ^"ontheapproximation ofthe
laws oftheMember States concerning thepreservatives authorized foruse
infoodstuffs intended forhuman .consumption «aslast amended bytheCoun- .
(2)oilDirective of20December 1971 »fixed inparticular thelist ofpreser­
vatives authorized fortheprotection offoodstuffs intended forhuman
consumption against deterioration caused hymicro-organisme ;
Whereas the use offormic acid and ofsodium salts and calcium salts
proves tobenecessary forthepreservation ofcertain semi–preserved '
fishery products orvegetables invinegar andwhereas ,moreover ,these ■' ■
substances canbeused inplace ofsulphur dioxide .anditsderivatives for
preparations offruit juices andaromatice substances intended forthepro­
duction ofnon-alcoholic beverages ;
Whereas such uses represent only asmall proportion ofthedaily intake
offormic acid and its salts and therefore constitute norisk tothe
health of .consumers ;
Whereas theuseofsmall quantities ofhexamethylene –tetramine inthepro­
duction of"Provolone "and "Grano padano "cheeses makes itpossible to
prevent tympanites andwhereas .,moreover ,hexamethylene-tetramine istechnically
agood means ofpreserving fish eggs ,andwhereas current tests should be
/0•«
(1)OJN012,27January I964 ,p«I6I/64
(2)OJFL2,4January If72,p«22»

encouraged "byauthorizingitsuseintheseproducts;
Whereastheacceptabledailyintakeofhexanethylene-tetramine isconsiderably
higherthanthequantitieswhiohwouldresultfromthesetwouses,andwhereas
healthprotectionisthusensured;
Whereasboricacidandboraxhavetraditionally beenusedfor"preservinggenuine
caviar(sturgeoneggs)inproducercountriesandwhereasresearchintosubstitute
productshasnotreachedfirmconclusions ;
Whereasthetotalannualboricacidintakefromcaviarislessthan1g;whereas
thisquantityisnegligiblefromthehealthpointofviewandmaythereforebe
permittedintheCommunity;
Whereasthesituationmustbereviewedafteracertaintimeinthelightofcurrent
testsontheproductswhichmaybesubstitutedforboricacidandborax;\
WhereasthelawsofcertainMemberStatesstillauthorizetheuseofformicacid
arxiofitssaltsandofboricacidontermsotherthanthosepfthisDirective;
whereassuchlawsarebasedonparticularcircumstances whichwillnolonger
obtainafteracertaintime,andatransitional periodshouldbeprovidedfor
sothatthenecessaryadjustments maybemade;
Whereastherecentresultsoftoxicological researchshowthathexamethylene­
tetraminecouldbeusedtoagreaterextentthanatpresentprovidedfor,andother
usesWhicharealreadypermittedundernationallegislation maythereforebe
maintained;
HASADOPTEDTHISDIRECTIVE :

-3-
" Artikeli
TheCouncilDirectiveof5November1963ontheapproximation ofthelaws
oftheMemberStatesconcerningpreservatives authorizedforuseinfoodstuffs
intendedforhumanconsumption ,asl^sbamended "bytheCouncilDirectiveof
20December19711Isamendedasfollows:
1,ThefollowingArticleisinsertedafterArticle1:
"Artfole1a
After1July1976andfollowingareview "bytheCommission,theCouncil,acting
inaccordancewithArticle100offae-Treaty,maydecidetodeletetiiepro­
ductsspecifiedintheAnnexunderNosE240andE241ortomakearyo';her
amendmenttotheprovisionsgoverningthem."
2.Article5isaoendedtoreadasfollows:
"Ar^icje5
BywayorderogationfromArticle2(l),theMealierStatesmayuntil30June
1976maintaininforcetheprovisionsoftheirnationallawsrelatingtotheuse:
k)offormicacidanditssaltsinfruitjuicesintendedfortheproductionof
syrups;
b)ofhexamethylene-tetracaineinsemi-preserved fisheryproducts;
c)ofboricacidineggproducts*11
3.Thefollowingpreservatives areaddedinSectionIoftheAnnex:

-4
■H
;ESC
IB°ÎTameConditions oruse
E236Pormioacid
E237Sodiumformate(a)Solelyin
(i)Semi-preserved
-seasalmonj
-Prooessedfish
•marinated;
•saltedorsweetened(sodiumsaltsof
formicacid)
E238Calciumformata
(calciumsaltsof
formicacid) -fisheggs,notsmoked
-shrimps}
-vegetablesinvinegar;
(ii)Preparations basedonfruitjuices,
whitherornotconcentrated ,andon
••aromaticsubstances,intendedfor
theproductionofnon-alcoholic be­
verages,theuseofthesepreserva­
tivestogetherwithsubstancesunder
E220-E227beingprohibited.
(b)Whentheproductismarketed,thecontent
inthesesubstances,expressedinformicacid,i
mustnotexceed
(i)1g/kgfor
.-processedfish,
saltedorsweetened; '
-fisheggs;
-vegetablesinvinegar;
(ii)0.3g/lcgforothersemi-preserved
produots; -
(iii)10mg/lforbeveragesobtained
fromthepreparations specified
under(a)(ii).

-5-
EEC
N° Name!
IConditionsofuse
·_
E239Hexamethylene-tetrammeI
II(a)Solelyin
I
l
i(i)cheesesofthetypes
'·
i-Provolone;
jE240Boricacid
;E241Sodiumtetraborate
!("borax)-Granapadano:
(ii)Caviarandotherfish
eggs,notsmoked,theuse
ofthispreservative
together substances
11°EÎ1C6,E2J7?"523»,E240
andE24Ibeingprohibited.
(b)Whentheproductismarketed,
thecontentinthesesubstances
mustnotexceed
(i)25mg/kgforProvolone;
(ii)5rng/kg(expressedasforer-
aldehyde)forGranapadano;
(iii)1g/kgforcaviarandother
fisheggs.
(a)Solelyincaviar,
(b)Whentheproductismarketed,the
contentinthesesubstances,
expressedasboricacid,must
exceed4g/kgofcaviar.
•••/

-β-
Article2
TheMemberStatesshallputintoforcenotlaterthan1January1974the
measuresnecessarytocomplywiththisDirectiveandshallforthwithinform
theDommissionthereof.
Article3
ThisDireotiveisaddressedtotheMemberStates.
DoneatBrussels, PortheCouncil
ThePresident