Chemistry Reference
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TheseareaslastamendedbyDirective2003/115/EC(EuropeanCommission2004b).
Sweetenersauthorizedbycommunityregulationsmustcomplywiththespeciicpuritycriteria
deinedbyDirective2008/60/EC(EuropeanCommission2008b).
10.2.2 regulation (eC) No 1333/2008 of the european parliament and
of the Council of 16 December 2008 on Food additives
This regulation replaces previous directives and decisions concerning food additives permit-
tedforuseinfoods,withaviewofensuringtheeffectivefunctioningoftheinternalmarketwhile
ensuringahighlevelofprotectionofhumanhealthandahighlevelofconsumerprotection,includ-
ingtheprotectionofconsumerinterestsviacomprehensiveandstreamlinedprocedures(European
Commission2008c)
Thisregulationharmonizestheuseoffoodadditivesinfoodsinthecommunity.Thisincludes
theuseoffoodadditivesinfoodscoveredbyCouncilDirective89/398/EEC(EuropeanCommission
1989) and the use of certain food colors for the health marking of meat and the decoration and
stamping of eggs. It also harmonizes the use of food additives and food enzymes, thus ensuring
their safety and quality and facilitating their storage and use. This has not been regulated at the
communitylevel.
Food additives should be approved and used only if they fulill the criterialaid down in this
regulation.Foodadditivesmustbesafewhenused,theremustbeatechnologicalneedfortheiruse,
andtheirusemustnotmisleadtheconsumerandmustbeofbeneittotheconsumer.Misleading
theconsumerincludes,butisnotlimitedto,issuesrelatedtothenature,freshness,andqualityof
ingredientsused;thenaturalnessofaproductoroftheproductionprocess;orthenutritionalqual-
ityoftheproduct,includingitsfruitandvegetablecontent.Theapprovaloffoodadditivesshould
alsotakeintoaccountotherfactorsrelevanttothematterunderconsideration,includingsocietal,
economic,traditional,ethical,andenvironmentalfactorsandtheprecautionaryprincipleandthe
feasibility of controls. The use and maximum levels of a food additive should take into account
theintakeofthefoodadditivefromothersourcesandtheexposuretothefoodadditivebyspecial
groupsofconsumers(e.g.,consumerswithallergies).
Sweetenersauthorizedunderthisregulationmaybeusedintabletopsweetenerssolddirectly
toconsumers.Manufacturersofsuchproductsshouldmakeinformationavailabletoconsumersby
appropriatemeanstoallowthemtousetheproductinasafemanner.Suchinformationcouldbe
madeavailableinanumberofways,includingon-productlabels,Internetwebsites,consumerinfor-
mationlines,oratthepointofsale.Inordertoadoptauniformapproachtotheimplementationof
thisrequirement,guidancedrawnupatthecommunitylevelmaybenecessary.
Followingtheadoptionofthisregulation,thecommission,assistedbytheStandingCommittee
on the Food Chain and Animal Health, should review all the existing authorizations for crite-
ria, other than safety, such as intake, technological need, and the potential of misleading the
consumer.
Allfoodadditivesthataretocontinuetobeauthorizedinthecommunityshouldbetransferred
tothecommunitylistsinAnnexesIIandIIItothisregulation.
AnnexIIItothisregulationshouldbecompletedwiththeotherfoodadditivesusedinfoodaddi-
tivesandfoodenzymes,aswellascarriersfornutrientsandtheirconditionsofuseinaccordance
withRegulation(EC)No1331/2008(establishingacommonauthorizationprocedureforfoodaddi-
tives,foodenzymes,andfoodlavorings).
Toallowasuitabletransitionperiod,theprovisionsinAnnexIII,otherthantheprovisionscon-
cerningcarriersforfoodadditivesandfoodadditivesinlavorings,shouldnotapplyuntil1January
2011.
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