EU, U.S., and Third World Country Regulations and Japanese Legislation - Sweeteners: Nutritional Aspects, Applications, and Production Technology - page 300

10.15 LegislationinEurope.......................................................................................................... 324
10.16 NewSweeteners.................................................................................................................. 325
References...................................................................................................................................... 325
InternetSources............................................................................................................................. 328
10.1 INtrODUCtION
Sweetenersformanimportantclassoffoodadditivesthatareusedinanincreasinglywiderange
offoodproductsandbeverages.
Directive 94/35/EC (European Commission 1994), as amended by Directives 96/83/EC
(European Commission 1997), 2003/115/EC (European Commission 2004b), and 2006/52/EC
(EuropeanCommission2006b),speciicallydealswithfoodadditivesusedtoimpartasweettaste
tofoodstuffs.
Thesedirectivesstipulatewhichsweetenersmaybeplacedonthemarketforconsumersaleor
for use in the production of foodstuffs. Prior to their authorization, sweeteners are evaluated for
theirsafetybytheEuropeanFoodSafetyAuthority(EFSA).Sweetenerscanthenbeauthorizedto
the quantum satis levelorforamaximumusabledoseormayremainunauthorized.
ThelistofauthorizedsweetenersisrevisedregularlybytheEuropeanCommissioninlinewith
theopinionofEFSA,whichtakesintoaccountthelatestscientiicadvancesintheield.
Atpresent,eighthigh-intensity(nonnutritive)sweetenersareincludedinEuropeanUnion(EU)
legislationforuseinfoods:acesulfameK(ACSK),aspartame(ASP),ASP-ACSsalt,cyclamate
(CYC),saccharin(SAC),sucralose(SCL),neohesperidinedihydrochalcone(NHDC),andthauma-
tin.Someofthemareeithersynthetic(ACSK,ASP,ASP-ACSsalt,CYC,SAC,andSCL)orsemi-
synthetic(NHDC),andthaumatinoccursnaturally(Yebra-Biurrun2000).
10.2 LeGISLatION
Directive2006/52/ECoftheEuropeanParliamentandtheCouncilof5July2006,amending
Directive95/2/EC(EuropeanCommission2004a)onfoodadditivesotherthancolorsandsweeten-
ersandDirective94/35/EConsweetenersforuseinfoodstuffs,coverthefollowing.
OnthebasisofanopinionoftheEFSA,expressedon26November2003,changesweremadeto
currentauthorizationsinordertokeepthelevelofnitrosaminesaslowaspossiblebybringingdown
thelevelsofnitritesandnitratesaddedtofoodwhilemaintainingthemicrobiologicalsafetyoffood
products.TheEFSArecommendsthelevelsofnitritesandnitratesaresetinthelegislationasan
“addedamount.”TheEFSAisoftheopinionthattheaddedamountofnitriteratherthantheresidual
amountcontributestotheinhibitoryactivityagainst C. botulinum .Thecurrentprovisionsshouldbe
amendedsuchthatthemaximumlevelspermitted,asmentionedbytheEFSA,innonheat-treated
orheat-treatedmeatproductsincheeseandinishareexpressedasaddedamounts.Exceptionally,
however,forcertaintraditionallymanufacturedmeatproducts,maximumresiduallevelsshouldbe
setontheconditionthattheproductsareadequatelyspeciiedandidentiied.Thelevelssetshould
ensurethattheacceptabledailyintake(ADI)establishedbytheScientiicCommitteeonFoodin
1990isnotexceeded.
Directive 2003/114/EC amending Directive 95/2/EC required the European Commission and
theEFSAtoreviewtheconditionsfortheuseofE214-E219p-hydroxybenzoatesandtheirsodium
saltsbefore1July2004.TheEFSAassessedtheinformationonthesafetyofp-hydroxybenzoates
andexpresseditsopinionon13July2004.TheEFSAestablishedafull-groupADIof0-10mg/
kg body weight for the sum of methyl and ethyl p-hydroxybenzoic acid esters and their sodium
salts.TheEFSAconsideredthatpropylparabenshouldnotbeincludedinthisgroup'sADIbecause
propylparaben,contrarytomethylandethylparaben,hadeffectsonsexhormonesandthemale