Sweeteners fo r Use in Foodstu ffs Regul utiuns, 1997

L.N. 209 or 1997

f-'OOU, IJR UGS AN D IJ RI NK I NG WATER ACT

(C AP. 23 1)

Sweeteners fo r Use in Foodstu ffs Regul utiuns, 1997

IN exercise of the powers con ferred by section 12 of the Food,

Drugs and Drinking Water Act.lhe Minister of Health . Care of the

Elderl y and Fam il y AHa irs. on the advice of the Malta

Standardi sation Aut hori ty, has made the followin g regu lations: -

These regulations may be cited as the sweete ne rs fo r c;, .. "," -.I

( I)

use in Foodstuffs Regu lations, 1997 .

(2) These regu lations shall come into force on the 1st

January, 1998 .

( Regulation 4)

U s t or I't' rmillcd Sweeteners

...

Ma~im u m

EC No.

Foodstu ffs

""""

E 4'20

s.x;;",

J)t lWcrU a nd 51 mlta r ~rod l>(tI

(i) Sorbitol

(i i) Sorbitol ~)'1'\1~

- Waler-based flovoumi ~nerts, ellC''ly-rfflucW or witll no

""""~'"

MannilOI

I ... ",,,

E9SJ

_ Mitt and mHt-derivative-bued ~ntiom .enerlY-rfflucN

'%.I

Maltilol

(I) Maltitol

Of with no added SUI Ilr

(ii) MaltilOl S)TU~

_ Fmit- and ''elet.lblc-based ~ucrll. cnerSy-rffluced Of with

'966

Li<:titol

EO"

no added SIIIIlr

XylilOI

- Brukfast cereals Of cereat-based products. tllC'rlY-l'educed or

with DD IIdI.kd $lip'

- Fat-based ~sKru.enerlY-redllCCd or with 00 added sup

- lams.~ tlie:s. m.malM:oiIfld ~Iiud fTuit, enrfIY-reduoed

01' with 00 IIdI.kd Slip

- Fruit prepantions. cneray-redllCCd or wi th no lidded Slipi' _ with

tht excrpbon of those inlCncitd for me manu fx tllft of fruit-juice-

based drinks

-"""

ConfKoonuy

- Dried-fruiHwed confectionery. entfJ)'-mlucN Of with no

""""~ ...

_ SLaI'(II-.. sed conf«1ionery. entrlY-reduced 01' with no Idded

slilar

- Cocoa-biased products .eroef3Y-reduced 01' w ith no added IUp

_ Coooa-, .,ilk- _ driN-fruit- or fit-based Wldwich ~ack ,

eroef3Y-redoced or with no added SUpI'

- Che ... ·ing gum with roo added sugar

- Sauces

- Mu s{ard

- fine bakery produa • . etrrgy_reducN or with roo added SlIgar

- Prodocl$ inu.O<kd for par1j~u lar nutri!ion~1 uscs

- Solid food supple""'ntsldieury in{"sraton

Non-i lroholic dri nks

- Wa{er·based fll\oored drinh.energy-redu«d or Wilh roo:xldcd

sugar

- Milk· and milk:-<k-rivative-based or frui{·juict·based drinks _

energy-reduced or with no added sugar

[)esseru and similar products

- Wa~r· based flavOlIred de$len., ellCrly_n.'<Juced or with n()

added sugar

- Milk· and milk.<Jerivative-based prqW'ations .energy·rcduced

or with no added sUlar

- Frui!- and vege{able-baled dessens. enc:rgy-reduced or with

no IkIded sugar

- EU-based desseru,energy·redu.ced or with no IkIded SlIgar

- ecre.l· based dessens, "nergy-redu<:ed or with roo added SUBar

- FM'based dessens. energy·redua-d or Wilh roo added sugar

- S nacb: ecnaln flnoun of ready 10 UI, prl'packed. dry • !.I. "OUr)'

~larl:h prodUCl$and coated nuts

Confectioner}'

- Confeclionery with no added sugar

- Cocoa· or dried·fruil·based oonfeclionery. eroergy·reduced or

with no addod sugar

_ Starch·based oonfecl~ry ."""rly· reduced or with no added

wpr

_ Coroa- , milk_, dried.fru i!_ or fal _based sandwich spreads.

energy· ... doced or wilh no added lugar

Foo<htuffs

- Chewing gum with no added sugar

- Cider and perry

- Alcohol-free beer or with an alcohol content 001 exceeding

1,2% vol

- • Him de tablcrrafeibierrrable beer' (original wort content less

than 6%) e xcept fo.- 'Obergliriges Ei nfachbier'

- Bee .. with a minimum acidily of3O milh-equivalents upressed

as NaOH

.".

- Brown beers of the 'ou<l bruin'

- Edible ices. energy-reduced or Wilh no added sugar

- Canned or bonle<! fruit, energy-reduced or with no added sugar

- E"" ' gy-..,duced jams. jell~s and marms!",,".

- Energy-reduced fruit and "egetable preparations

- Sweet-sour preserves of fruit and vegetables

- Swe<:I-sour preserves and semi-preserves of fish and marinades

of tish, crus~an5 and molluscs

- Sauces

- Mu stard

_ Firw: bakery pnxlucl$ for special nutritional uses

- Complete formulae for weight control intended IOreploce total

daily food intake OJ an individual meal

- Complete formulae and nutritional sUflPkments for us.o under

medical supervision

- Liquid food supplements/dietary integrators

- Solid food sUfIPlementsldietary integratOfS

Vi tamins and dietary preparations

Non-aJco hoHc drinks

_ Water-based llavouA!<i drinb. energy-reduced or with 00 added

sugar

FO<JoJ,tuff,

- Milk·and mitk.<Jerivati,'( -bas.e<;i or frui l·juke·b;l<.cd <lrinh,

eflCfgy-~uccd or wilh 00 added sugar

~rts and si milar producu

- Water-base<! n.Y()urfd desserts, encrgy,rfduccd or wilh no

added ,ugar

- Milk-and milk-derivate-based preparaliom, energy·",duced Of

with no added wgar

- Froil-and vegetabk-bMCd desserts, eflC'Iy-rfduccd or " 'ith no

added ... gar

- Egg-based dc:sserts,ene'ly·reduced or with no added sugar

- Ce",al-base{I dessens, energy-reduced or with no added Stogar

- Fat·based <lelsens,ellC'rgy-rfduced or with no added sugar

_ Snack: orruin na_rs of ",ady 10 eai, prel*'kcd ,<lry ,.avoury

starch prodoclS and coaled nuts

Confectio~ry

- Confectionery wilh no &dded sugar

- Cocoa- or dried- fruil·based oonfectionc:ry. ellC'lgy-reduced or

with no added !-Ug...

_ Starch_based confectionery, enerlY-~uced or with 00 added

sugar

- Coccn-, mitk-. dried·fruit- or fat·based n.ndwkh Ipll'ads,

energy-rt<;luce<! or with no added sugar

- Cho:wing gum with no adde<! ,ugar

- Cider and pl'TT)'

- Alcohol-free bttr or with an aJcoItoI content not ucoe<ling

I ,n. vol

- 'Bim de tableffafeibierrrable beer' (original wort oontent less

than 6%) except for 'Obe rgllrige, Einfachbier'

- Beers with a minimum acidity of 30 milli~ivalenlS expre~

a.. NaOH

- Brown been of the 'oud bruin' IYJK

" 1690

\I:u,,,,um

ECNo

w...

u ... ,"I~

E9S1

(C.-I'd)

1000 Il1&1'0:,

- Ener1)'-milJCed jams. jellies and marnWades

- S"'eet-SOUf pt'\'SeI'\'eS and semi-prnnves of fish and mari~

offish. cru$UlCCanS aoo molluscs

JOO mglkg

- M u~rd

3.50 mglk,

- Fine b ..... ~1')' prodocl:$ for special nutritional uses

1700 mglk,

- Complet' forrrwlx for ,",,'eight romrol in\ellded 10 repllCe IOlaI

daily food intake or an individual mul

800 mgI1I;,

- Complcle (ormul. and nutritional wppkmenlS for uSoe un&.

1000 mgIk,

mtdical wpt'rvision

- Liquid food lupplemtmsldicwy im~lraton

1500 mgll

lIXJO IIJ&I'Iq

- Solid food wpplcnwnu/diewy ilUpalon

Cyclamk acid and iu

Non-alroholk drill'"

Na ond C. Ioalu

_ WaIrr_based na~ drinks.~~ or with noadded

400 m&II

lugar

- Milk ·and mllk-do:T .... u\..,. ba§N or fruil-jui~-ba5Cd drinks .

tno.rJ)'·~ ()( .... jlh no ~ sUp!"

400 mgll

(}U~I'ft5 and $Imlla r products

_ WlleT·ba~ navou=l OOr.cIU, '''"lY-m:lU«d Of with no

su,...

2Xl mg/k.

added

_ Milk·and mil ~ «rivaliv .. -ba$ed prepantions. cnergy.=luced

or ... ·illl no ~ sup

250 mgJ\:.,

_ FIlII!·.nd "'i"t.;Iblt-balofd \kSs.efU. tflf'lly·mlU«d or with no

iW.kIed sug...

2.50 mglkj

F'lOo.hturrs

- Egg-basnl dc:s\erts , e nergy-reduced Of' witll 00 addm .... gar

- Cereal -based desserts, ene'lly-reduced or with 00 addm su,ar

- Fat-baled dessert • • enerlY-m:llICed or " 'itll 00 add.<! su,ar

Con r« tiontl")'

_ Conf«.ionery with oo.dded SlIgar

- Cocoa- Of' dried-fruit-based conf«lionery. ~'lIy-redoced Of

with 00 added st',ar

- Slarch-based c""feclionery, energy-reduo.:ed or wi'h 00 added

sugar

- Coco. -, milko, dried-frui.- or fa t-based sand .... ich spreads,

energy_reduced or wilh no added sugar

-Che .... ing gum with no added sugar

- Edible ices , cne'lly-reduced or .... ilh no added sugar

-Canned or bottled fruil, energy-reduced or with no added $U8111'

- Energy-reduced jams, jellies and marmalades

- Energy-reduced fruit and vegetable preparalions

- Fine bakny products for special nutritional U~5

_Complete form .. l"" for "~ighl control intended 10 ..,pla.:.: IOIal

daily food intake or an indi"idua] me.1

- Complete form"l"" .nd nUlritional supplements for use under

mtdical 5UptfVision

- Liquid food suppkmentsfdiclafy inlC&nolOn

- Solid food supplemenWdielafy integrators

Non-a1coholk drlw

_ Water-based navou,..,d drink s,energy-redu.ced or wilh no add.<!

sugar

- Milk- and milk-derivative-based or fruil-julce-based drinks,

energy-reduced or wilh no added sugar

- 'Gaseosa ': non-akoholic water-based drink wjth added carbon

dioxide ,.weete""rs and navourings

~rts and .sInlilnr prooucl§

- Water-based Cla\"ourc:d desserts. eOo..'1gy·rt.'tluced or wilh 00

added sugar

- Milk_and milk-do:rivalive-based pre~ti0fl5. cnerg)"roducW

orwith no added sugar

- Fruit- and wgelable-based desserts. energy ·mlucW or with

noadded suillf

_ Egg-ha..-d dcu . . ·rn. ~""rgy·rc:ducm or wilh 00 added SlIgar

-Cereal-base<.! desserts. energy-reducm or with no lidded sugar

- S ..... ks: cen.ain fla"ours of l"l'1dy 10 eal . prepacktd.dIy .108\0"(01)1

starch product.< and C"UlIIW nuts

Con rectionery

- Confectionery with no added s ugar

_ Cocoa· or dried ·fruit·based confecliooel)' . energy·reductd or

with no added sugar

- Starch-b,nN confec"lionery. e,"",fgy-reduced Of .... ith no added

<u,ar

- Enoblaten

_ Coco.·. milk-. dried-fru it. or fal . based sandwich spruell.

eroergy·redured or with no added sugar

- Chewing gum with no added l ugar

- Cider and perry

- .... 1cohoI·flft bttr Of with an alcohol ron~nt not ucct"ding

I .No ~ol

- . 8i~re de tableff afeibierrrable ~T' (original ... ·ort content less

than 6%) ~Acept for 'Obergliriges Einfo>e.:hbier ·

-8«rs with a minimum acidity o f JO milli~ui"alents npresS«!

as NaOH

- 8ro"'n beers of the 'oud bruin' type

- Edible ices. e""'Iy·reducN or wilh no added sugar

8 1693

Ma"n" .. n

ECNo.

u ~abk <ill'i<

s,,',.,. 200 ""'"

S~lLarin and ilS Na. K

- Cannnl or bouted frujl,ft>e' n-m!ucW or with no ad<.kd

E9S4

and C. NI15

(CooL"d)

- Energy-reducedjaJ!1$,jelti." and mamuol~s

200 ""'"

- EnerJY-mllad fruillrlll ~ Pftpll"lliolu

lOO . . . .

- Sw«t·JOU rPfn"rves of fru it and '·tle~bles

160 mgl\:,

II.""'"

-Sweet_sour preseronlnd semj-praervaoffish Ind marinade!

offidl ,(rus~ans and moIlulOi

- SallUs

160 mg/t:8

". ""'"

- Mu~ard

- Fil'lt 1W;e-ry prodllCU for special nutritional uSoes

110 pW1c.&

-CoonpkIC fonnlllK for '.ffiah1conlrol intended 10 ~ace IOlaI

,.. ""'"

daily food intake or III indiv~I_.1

....

- (:Qmp)etc formulae and nutri tional $uJlPlcmc:nlJ fo r ule under

""

medical , upervi sion

- Uquid food wpplu_uldktary in~JI*IOI"S

lOOm ....

- Solid food ",ppkllll'nWditwy intc:v-on

Villmins Ind dietary ,,"epilations

IlOO ""'"

E 9~7

ConfrcUOnerr

Thaumatin

- Coofecliooery .... ith no lidded sugar

"'m ....

- eoco. Of drkd-fruil-bued oonJec"liooery, e"""l)"n:o;Iuced or

SO m&lk&

.... ilb no lidded "'liar

_ a.e,..in, , um .. ·ith no.tded SlIp

'" ""'"

<OOm ....

Vi~ins and dietary preparation s

E9S9

Non-alcoholic drink.

Neohesperidi~ IX

. '"

- WaICr-bued na_red drinks.mrrzy-mJucood or with no ~

30 .....

- Milk - IrIII milk -dnivati",,-bafcd oiinb, energy·ftIdootd Of" 1th

"' .....

no.tded IUp!"

.. '"

_ Fru it-ju ice-based drinb. erw;:'IlY-ruluced or with no added

30m'"

FlX •. hIUff,

l}t,sStI"l$ lInd )imilar products

- Wal<'r-basc-d flo'·oun.<! des~ru. ~ncrg}·-.-NU«d tlr "'till no

added sugar

- Milk and milk ... "'rivalive-baYd prtpar:lIions.energy-.-NU«d

",·illl no added .ugar

()I"

- Fruit· and \·~gctable·OOsed desserts. energy-..... duted Or with

no IKlded sugar

CunrKlioMr")·

- Confccliomry willi no added suga r

- Cocoa· or dried-fruil·based ronfcelionry. ~n"rgy·reduced Of

with no 1Klde<i sugll!"

- Sl.an:h-Das.!d confectionery. energy-reducoo tlr wilh no added

sugar

- Cocoa·. milk·. dried·fruil- Qr fll-based saod",·kll Sp1t"ads .

.,n.-rgy-redlll."ed Of" ... ;tII no added sugar

- (he",·ing gum lIIilll 00 added Mlgar

_ Cider and ptrry

_ Almool_f ..... e Iw~r or wilh an alcohol cOmenl mX excee<ling

1.2% VQI

- ·B;w,de tabletrafclbiertrabie beer" (original wonronlenlless

than 6%) excepl for ·ObelJ.iiriges Einfachbier·

- Bens ",·i,b a minimun, acidilyuf 30 mill i-equil"alenls eA~ssed

as NaOH

_ Edible ices. en.-rgy-reduced or lIIilh no added .ugar

_ Canned ()I" boliled fruil. en..rgy- ..... dllced Or Willi no added sugar SO mglkg

- En.-rgy-redlJ("N jams. jl'liies and marmalades

r"",Nuffs

_ S ..... eel·sour presel'\'e$ of fru;l and wtgelables

- Sweel·sour I""sel"Yn and semi-preserves of fish and marinades

offish. crustaceans and moIl uSC$

- Sau<:es

- Muslard

- Fine bakery products for .pecial nulril ional uses

- Complete fOlTJ1ulae for "l:ighl control inlcnded lO replll1Ce IOIal

dail y food ;nuke or an individual ""'31

- Wquid food supplemellls/d ietary inlegrlllOl':S

- Solid food supplements/dietary inlegrators

SECON D SCHEDULE

Criteria of I'urity

O-gluc itol

E 420 (i)

182,11

Content not leu than 97% o f total g lycitols and not less than 91% of D·

SOI'bilOl on It.. dry weighl b.1sis

Glycilols_OOII'lpOUI'ds ... i thlhe struc!\lral fomltIla CH,oH-{CHOII»-Ol,OH,

... t.ert 'n' is an ill1<."ger

Whi1<." hyg""""l'k powder. CT)'s\aUi"" powder. flakes o r gnnute. luving_

SW~llaSIe

Very soluble in water. slighUy soluble in eillanol

&8 10 102 "C

To 5g ofihe sample add 7011 of methanol. 1011 of b<'lQaldeh)'de and Imt of

hydrochloric acid, Mi~ and shake in a mechanical shaker unli l CT)' i1als appear.

Filler .... ilh Ihe aid of suctiOf'L . dissolve lhe ~rY'lali in 20 nil of boiling .... aler

CO<1lainillg 18 of sodium bicarbonate. filter wh ile hOi. COOII~ filtrale. filler

.... ith suction. ,,·a.h " ';111 Sml of methanol,,,·al.,. mix lure ( I in 2) and dry in

.i,. TIle CT)'SI~.b SO obtained ,"",II b<'1 .... ~1l 173 and 179 · C

NO! more than 1% (Karl Fischer III('thod)

Not more than 0.1% Hp!\'s~d on dry .... eighl bas is

NO! more lhan OJ ~ expressed IS glucose on dry ... ·eight buis

NOI more Ihnn 3 mglkg up,.,ss..d Of! dry wdghl hasi.'

Not more IlIan 1 mglkg ex~$.<Cd on dry .... eight hasis

Not more than 10 mglkg n~ a'I''' on dry .. ..,ight ~i,

D<luc;101 syrup

Sort>ilol 'Y"'P formed by hydro~lulion o f 1'1~ .pup is composed of D-

sorbilol. [).mannilol and hydrog(nated .acrharKIM

T~

part o f tlte product which is nolO-sorbitol i. composed mainly of

hydrogenated oligosaccharide s formed by lhe hydrogenatiOIl of glucose syrup

u~ as raw material (in which case I~ syrup is lIOO-ery sl:lllil"ngJ or manniloL

Minor quantities of glycitol5 w~..., ~ S 4 may be ~sent . Glyc;tol. are

compounds with the structural formula CH,OH -{CH O H)n-CHpH. wllere

',, ' is an integer.

210-337-8

E 420 (ii)

Content not I~, than 69% total solids and not less (loan 50% of D·,orbitol Of!

the anhydrous basis

Mi seible with water. w;(Io 81YCtrol, and with propant. I ,2-diol

To 58 of tile s.ample add 7m l o f melhanol. Iml of benuldehyde and I ml of

hydrochlork ac;id . Mix and shake in a mechankal sllaker until cf)'stah appnr.

Filter wilh!he aid ofsuction.dinol...,!he cry.llls in 20 ml of boiling watn

f;()I"ttaining Ig of sodium bicarbonate. filter wh ile 11<It. Cool !he filtrate. "Iter

w,th suction. " 'ash "';th 5 ml of methanol· .. ·ater mixture 11 in 2)and dry ,n

air. 'fhc, crystals so obtai ned melt bel"'een 173 and 179 "C

Not mo,., than 31 % (Karl Fl ~her tmlhod)

NO! tnOro: than O. I ~ el~swd on dry ... ·~igltl ~is

Not ,oo.-c lhan 03% npn:ssed as glll .. -ose OI' dry " • .:ighl b.uis

Not more than 100 mgi\g expressed on dry w~ight basis

NOIItIO;n lhan 10 m!lk3 Upre5sm AI !'bOIl dry ",..,ight basis

D·mannilol

D-m:Ll1nitol

2Q(). 7 JI ·8

182.2

Conttnl ll(llEu than 96% 1)." .... lIlilOl Mille dried basis

Swcet tasting. whitt. odourless, crystalline powder

Soluble

NOot more than 0.)% (105 "C, four hours)

ik ... -een S and 8

Add OJ ml of a IoIIturaled solution of potassium chloride to 10ml of. 10%>

wN wluton of the $ample !hen m.,!Uu.., the pH

(a) ..

o

Spec ific rotation in a bonlled wlution clikulattd with ..,fe"nee 10 !he

anhydrous tUbstllllU i . belWteft + 2) iUId + 2S~

,'1101 more than 0 .1% (expl'eSsm on dry weight basis)

Not """" than 3 mafkg c~p!U$e:d on dry ....,i&hl bIIsis

Not more than 10 mg/kg upres"ld as Pb on dry ",'dahl basis

JsomaIl is • miIIII~ of

D-Jluropyran06yl- I.6-D-llucilol .nd

D_g! ucopyranosyl - l _l-D-mannilOl dihydnue

D-lhIC09Yran06 yl- l.6- D- JllICilOl

C" Ii .. O"

O-Ihloopy_ y l- I ,1-D-lNI\fIilOl di hydnlc

C"H .. O".2H,O

"'"

D-&lPC:Opyranosyl-1 .6-D-JllICilOl

D-g!uoopyraoosyl-I ,1_ D_mannitoi dihydr.Le

380,.12

ConIC:!H no! ks. 1Iwl95'1o oClhI: millu~ 01 O-alllCOpyrallOS)'I-I.6- D-glucilOI

and D-IIIIC'C!9yr.nosyl- I ,I-D-m. nnitol dihydr.te delerm ine d on the

anhydrou s basi.

Odourku_ while, , weel lu ting , crystalline: slightly hygroscopic $U MI.an<:t

Sliahtly wlubIe in Wiler _ imoillblc in ctIw>oI

(a) D : btlWffn + 90 and + 92" (4'i11 ,",Iv solution)

IJ Sto 1j() "C

NO! tIIOIl' th..., 7'>i (K;u'1 Fi..,IYr ~hod)

NO! ~ th;on O.oS%\'lpressed on dry weight bali $

Su"l/hllt'd IJJh

than I j 'l> uplnSC'd as I lurow on dry wf'shl basil

RedJ«'ittR ~~I'l

Not!ll()R

Not ~ lhan 2 mJlk&u~utd on dry _ighl balis

Nk lt:t'I

Kot man: than) mglkgupreutd on dry "'eighl bilsis

Not nlOR liI;on I m""g elpreued on dry weir-hi basis

IA'",I

Not man: III3n 10 m""g uprtised on dry "'"fight bilsis

Il %5 (i) _ MALT ITOL

Synonym.

Definition

Ch.,,,,irol """'f

(o.}-O- ,I uoopyranos y 1- 1.4-0-11111: i 101

209·567.(1

Ein«$

E~(i)

En_lNr

Chemirol jonttw/IJ

C"H" O"

344.31

RtI/JIiw "'meru/ar 1tI/J11

Conlrnl not Ins tlw1 98'>i O-mannilol C " Hj<O"on IIY anhydrous basil

S","C'!:t IUtinl ' \II'hi'" crystll!ine po",oo

Identification

Very soluble In Wlter. slightly soI"b~ in C1JunoI

A . SoI"bUil1

148 1015 1"C

8 . MellinN ronNe

c. Sr>«i/ir l"OIali""

Puri ty

Not !ll()R than l'>i ( Karl Fiso:hH method)

Waler OMltN

Not man: tllM 0.1% uprelsed on dfy ... ·eilhl basil

Not m<J1l' th'''' 0.1 % ~'pn'ssed as glucoS'.' OIl dry weight ba~ i l

Not lOO1l' than 2 m"k g upn'~,ed on dry w~ight basi l

NO! ~ Ih3" 3 mglkgupn'sscd 00 dry " 'eight bas is

Not ~ than I mglkg uptl'S>.Cd on dry weight basi s

Hydrogcnal<:d high mallO>e_gJucose $yn.p. hydrogenated gluUlS'.' s yrup

A mi.lUr" consi"ing o f mainly m311,I0I Wilh I01"oi,oI and h)'drog~nated oligo·

and polysoccharidcs . It is manufactured by ,he cata lytic hydrogenation of

IUgh malU»e-contenl glucose syrup . Tile mid" of CQmme= is wpplied

both as a sy"'p and as a iOlid product

270-337-g

E %1(i i)

The fo llowing ranges apply On 1M anhydrous has.is

Malt;101

Il<)Ilc$s than 50%

Sorbitol

not nlOn' than 8%

not ITlOI1: than 23%

MaJlotriilOl

Hydrogenated poly",c..-d w;des containing

m(m, than three glucose or gl~citol units

nol RlOR: than 30%

S ,,'eeHI" ti ng. coIourl"" and odou rlus. dear vi 100II$ liquids or I wC(',-us,;ng

white cryi tallinc masses

Ve ry loOIuble in water . 51 ightJy loOIublc in ethanol

u.aminc by 1M th,n layer chromatograrhy using. pla~ coaled with II 0.2!)

mm layerof ch romatographic silica lei

NO! ~ 'h"" 31 % ( Karl FiSCher method)

Not IOO1l' than 0.1 % upresscd on dry "'eight basis

Not ~ than OJ'*' upressed as glllC"OSC on dr)' " 'eigh' basis

4-O-1l-D-g;lI...:lOpy"u""yl-O-&Iucitol

' '''

S~ ·WIi", "'Y.wljne powdm; or coIourbs IOIllticm . CryMalJ,,,,, prod_

OCC:llr In ... hydrous , monoh)-dnlloe'" dihydnle forms

Very JOI~ble in .... alel'

( a~ ' a + I) 10 ... ItI' cakllb lNon tilt IrIh)'<Wu~ twi, ( IK wlv ~

o M)/Illion)

NO! 111O~ thaI! 0, 1% npl'l"sscd o n dry wdghl b:L~ il

..-"i,'

,tr .

Nm n)l)n: lhan 10 mgl\& e~pre'sed .~ Pb on dry ""ei&lll N;§i~

E %7 - XYLITOL

Synonyms

XylilOl

()::fmition

Ch"nr;"u/"",,,,

201 -788~

E tlumhl'r

eMm;"ui /ormllw

ISZ.I ~

NOlless than 98.5% as ~yli!01 on Ihe Mhydrous ba,is

Au"y

ldenlification

A. SoJllbiliry

Very solu ble in "'aler. s paringly soluble in ethanol

, 10 7 (10% ",Iv aqueous sol ution)

c.pU

Not moll' than 0.5% , Dry 0..'5 8 OfSartlple in a .acuum ovc r phosphono s I

Lvss nf drying

60°C for four hoUr!

SIl/pJroIHl aslt

Rrdll( ing S~R"rs

NOI """'" than 0 .2% C'X~ssed as gl~ on dry " 'eight basi.

NOI more than 1% expressed OIl dry weigh! basi.

Nidt/

NOI I!1oOn' tkan I mg/1>g tx ~ssed on dr)' weight I>:Isi$

NOI I!1oOn' than 10 .uglkg .. ~pres>N 3S Pb on dry wdght bam

Not mo re than 100 nlgll:g npre.sed on dry weight basi s

NOI n~ than 200 mg/l;.g expressed on dry ... <eight b.lsis

Acesulfamc potassium. aa.sulfam. potassium salt of 3.4-dihydr0-6-methyl·

I ,2,3. onthiazin-4(3H)-2 ,2-dioxide

6·melhyl· 1 ,2 J. outhiatin·4(JH}-one·2 ,2-dio xide potassium sail

2!i9-71 ~·3

EO"

C,H,NO,SK

201,24

NOiles. IlIan 99'% ofC,H,NO,S K on the anhydrous basi '

OdotJr1c u , ... 'hilC'. t,:IYsuJlilM' powder having an intensively sweet WIC' .

Approlimalely 200 times as sweel as suc:ros.e

Very sol uble in WaIC'r , ""'Y slightly SOluble in ethaool

Maximum 227 i 2 nm for a solution of IOmg in 1000 ml of ... ·ater

NOI more than 1% ( lOS ·C, two houn)

Not IllOfe thall ) mgll;.g upre n ed Of! dry weight basis

Not more than JO mglkg expressed on dry ""eight basis

NQI more than 3 mg/ltg exprnsed on dry weight basis

Not IllOfe than 1 ntglkg upre n ed on dry "'eight basis

Not I!1oOn' than 10 mglkg UpRsSftJ as Pb on dry weight basil

N·L-u-{Asparlyl·L.-phen) Ilalllline· l ·me(hyl est~.

J .• mil'O- N of (I -c:arbomclho~ y·~nethyl)- lllCCinarn K: Kid-N .lM'th)' 1 nta"

245·261 -J

29~,3 1

....

NO! ku t1W198t..nd not _

(/un I02'liO(C,,I. ,,N,o, on!he anhydrous

Whiu.. Qdourk", cry.l3lline powde r hav ing ... SW«( 1a.1I!. Appro~i matdy

200 times a. s~et l' sucrose

Slipuly soluble in water !I'd in elhanol

NO( man: than 4 J'iII, (105"C. foor hours)

Between " ,5 and 6.0 (1 in 125 solution)

The U'anSmiaann of. l'li solution in 2N hydrochloric , Kid . dI:1tnni~ in

• I-c:m cell .1 430 nm .... ilb .,uII_ble spectrop/locometer. IIsing 2N

hydroo.:hlorie Kid IS. ,deren<:<:. i, I'lOl leS! Iban 0,95. equl"al~nt ((l an

absorbance of JlOI rt1OI'e than appnu imall!ly 0.022

~ ; + 14,5 10 + 16oS·

«(I)

lXII!nnilll' in a 4 in 100113 .... formK: Kid IOlution within 10 miRY,,"s Ifle.

~paralion o f the sample toIulion

than 1,Sq.. u~ssed on dry weo"" basis

Not _

Cydohnyl~ulp/lamjc ocid. c)'Clanule

CydQhuarIC'suJphamk acid, cydohC'~ )"Iarrumsulphonic acid

201.898·,

179.24

Cyclobo.-J.ybulplwnic ..,id conlains not Ics.illlan 98 .. and not ~ 1!wI th!

equiV1l~l of ION ofC.Il"SO,S,cakulalCd on the anhydrous basis

A practically coIourku .... hi~ crystalline po~ ... ·;Ih. s ... "ftl·_r~.

Appro~imalfly 40 IilIM" Illweet as sucrmc

Soluble in w.~ and in ethanol

Acidify. 2% solmOIl with hydroc hloric acid,add I ml ofan appro~imalely

molar solution of barium d.1oride in ..... 1eT and filler if ."y hW: or precipiwe

rQnM . To !he <;Ifar JOIution add I ml of. 10'1. solution 0( sodium nitrile. A

while precipitale fonns

Not rtl(Jft than 10 m~ upr=ed on dry _igllt boIsi.

C)'clam~IC. roJi li m sail of cyd~mic ",""J

Sodium cyclohennesulpllBmale .l<XIium c)"c~ Ayl>ulpll:im~te

W5·)48 ·9

201.22 calculated on the anhydrous fonn

231J2 calcul aiW on the hydraled fOllTl

Noe l..,. Ihan 98% and not """" Ihan 10 2% on ,'''' dried bar.is

Dihydral~ form : not I~ss!han 84% on the dried basi$

While. odoorless cryslal, CO" crystalli"" powder. Approxinmel)' 30 limes as

swn:l., .UCTQSC

Soluble in water. prac.ically in>oluble in (lh3/101

NoelllOR' than I % (lOS "C. one hoor)

Not more lhan ISJ'h (105 "C. lWO hours) for the di hydrale fOllTl

Not mort' than 30 mglkg u!'«ssed as se lenium on dry weight basi'

NoIIllOR' lhan 3 mglkgujlRs§C"d 00 dry weight basis

Not ~ than I nlgll;.g expressed on dry .... eight basis

No. more lhan 10 mg!kg upressed as I'b o n dry weighl ba,i,

Not more lhlln 1 mgl~ g expre,",d on dry wei ght basis

Cyclamate. calcium sail of cycl3mic acid

Calciu m cycloMxane.ulpham ..... calcium cyclohcox} Isulplwnale

C,.H " CaN.,O,S,.2H,o

432.57

NO! le'llhan 98% and nOi fI"IOre than 10% on lhe dlied basis

While . colourless crystals Of" eryslal!i~ powokr. Appro~imately 30 Ii mes "

' weelas,~

Solubl<! in water, Jparingly $Olubl<! in cihanol

NOI. ITlOfC Ihan 1% (105 "C. o~ hoor)

NO! more lllan 8.'i'lo ( 140 "C. (our houn) (or the dihydr:alt (orm

Not more Ihan 30 mglkg upressed as Iclenium On dry weighl basis

Not moll' thal! J mglkg upressW on dry wrig/1! balis

NOIII"OOR: Ullin I mglkgu prt' lsed on dry weigh! basil

NOI moll' than 10 mgl ~gupressed as Pbon dry weight N,i.

No;>L mort ,han 10 mglk.g t~p"'$sed on dry w.:ighl basis

1'001 more ,han 1 mglkg el~sed on dry _ighl basis

Nol mOre than r mglkg c~pre...,d On dry weighl basis

)..,xo·2.) dibydlt>bcnzo(d)i SOlhinol ·1 .I-<liol;de

201-321-0

1:.954

C,H.NO,S

18~,18

NOI ito" th,1O ?'l-:f. and no, mOlt: [han 10 I .0% or (" ,fI /"0 ,S on l~ anhydrotJ'

basi'

W hi l~ cry, lall or a wh; l~ cryllall i'''' po"'·d~r . odourl~" or w;lh a fai nl.

aroma, i, odour having a sweet lasle e'en in very di l ,,'~ so lullon, .

Appro' ima l. ly belween 31)0 and 500 Ii rt"oe$ a, 'weel as , ucros.

Slighily soluble in wate' , ,o luble in ba.ic solul ions. ' raringly soluble in

ethanol

NOI more lrum 1% (105 "C, lwO houri)

22610 230"C

NOI more than 3 IOgI ~ g Hpre~Sed on dry weighl bas is

Not more lhan)O nl~ ~ \p"',sed 00 dry we ighl ba~;s

Not mOre lhan ! mglkg HP'"""ed on dry w~ighl nui,

NOI more lroan JO mglkg expressed as Pb on dry weight basis

NOI more lhan 0.2% expressed 00 dry wtigl>! b;u;s

To 10 ml of a I in 20 so lu lion. previously oc idifled wilh five drops of ace lie

acid.add lhreedropso f an approximate ly m<l larsolUlion of ferric ch lori de in

water. t\o precipitale or vlokl colour appear~

Nol more lroan 10 mglkg e xpressed on d ry weighl OO,i.

Not mOre lroan 10 mg/kg expressed on dry weight basi.

NO! mort [roan 25 mglkg H prt<;sed on dry weight basis

Abs.m

Sac<:harin. sodium ,all of saccharin

Sodium o-bo nzosulphimidt.

sodium sal! of 2J·dih)·dro·3·oxobenzisosu lfonawle.

o~obenziso,ulfonarole .

l.2·benziso lhi azolin·J·one·l.

l...:I io. ide sodium ,all d ihydra~

2O-l·88f>./

E '"

C, H ..... N~O,S.2 1 Ip

241.19

.... otless than 99% and not men: than 10 I % ofC,H ,NNa(\S on !he anhydroos

basis

While cl)"l.3l. or 8 while cl)'~l8l1 ine efnore.Kt'n( pow<lo.r. odourles$ or with

a fainl odour. having lin intensely ' ... ·eel taste. e"en in vny dilutt: solutions .

AppR)1im:uely belwft'n )(XI and ~ Ii~ as " "ffl as SOCI"OSe in dilu~

soIUlions

F",dy soluble in wnlcr. sparingly ""Iuble in elh~n()1

NOI more lhan 30 mglkg uprused on dry weight basis

Not men: lhan I mglkg upres$('(\ on dry ""';gh! bas;s

NO! more llIan 10 m&lkg exprt'ssed as Pb on dry weight basi s

To 10 ml of a I in 20 solution. prt',·iO.Hly acidiforo with fi~ drop'! of a.ceIic

acid. add three drops of an approximately molar ""Iulion of ferric chloride

in w.ler. No pr<'Cipitale or violet coiOll. appean

Not mo", tllan 10 mglkg uprt'ssed on d.y ... ·eight basi l

Not more lhan 10 m&lkg e~pressed o n dry weight basil

Nol more lllan 25 mglkg up!\'ssed o n dry " 'ei ght basis

Sacrh";n. $Odiu m o.alt of sacdlari n

Calcium o--Mnzo.ulphimide.

cakiu m IlIIt of 2 J·d ihydro. 3.oxoboenliso,ulphona>!ole.

B 11 11

1 J-~n~i""hiDlo1,n ·J-one- I.I-dIOAilk

c~k,"m <al. h)"<lr:l!~ 12:71

C"N,C",," ,O,S,J'I,II,o

4117 ,48

While Cl)'suolS or • whilt: crySlalliM ~ .odourirss Of wi\h • flint odour.

hiving an intensely ''''eel 1M'" . ~~<!n in I'err di lult: $OIu,iom . Appro~in'3,ely

bclwct:n 300 and 500 time:s as Iwee l as """rose in dilu", 9)1 ulions

1' =1)' ~ublc in " 'Itn", ~ublc in c1hanol

NoIIn!)ft lhan 13"" ( 131"C. four hours)

NO! mo~ lhan J mgl\;g ex~s~ on dry weigh. bui.

To 10 ml of. I in 20 solution, pn-viooisly a.idificd with live drops of oa:I.ic

Idd.1dd ~ drops o f an appn)limltely molar soIUlion offemc chloride in

W''''T. No prl'(:ipitale or violcl coIOtlr appean.

AlKenl

Saccharin. JQdium $all of sac:charin

Potauium o-bcntosulphimide.

pola"ium salt of 2 J-<lihydl'Q·.l -Q~ob<:"l.iSO$ul pho"lIzolc.

pota<siuUl sa it of I .:2·J:,c nlisot hia lOli"·.l .." ,,,. I .I.,jioxi"'· "Kl' lO il)'d n ll~

C, H, KNO, S.H,Q

239.17

NOI les. tl\an 99% and 001 ~ Ihan 10 I %of C,II ,KNO ,S on Ihr anhydrous

basis

Wh ite cl)·'tal ~ Of a wh ite crysllInine po"'do:'r . ocIoorlen Of .... ilb • fai nt odour.

Il: ... ;ng an intensely S"'eellaS~ .e >l.'n in >'cry dilute solutions . ApproAimaldy

OOWCl'f! 300 and SOO limes M ' ''ffl alsucrose

FlUly soIuhle in " ·oter.sparingly soluble in eth;moI

1'101 ~ (han g'J, (IZOOC . four hours)

NO! mOre (Mn 30 mgJkg upressed on dry weight bas;,

Not more (han I mgJkg upresKd on dry weight basis

1'0101 more Ihan 10 mgJkg e~ pre,sed as Pb on dry weight !>.uis

To 10 IlII of a I in 20 $O lu(ion. previously acidified wilh five drops oracelic

""id . fkId Ih~ drops o f an apJl"Oxim3Iel)' molar wlution of feme chloride in

water, No plUipitate Of violel colour appears

1'101 ~ Ihan 10 mgJkg exprelsrd on dl)' weighl bas;,

1'101 more IMn 10 mglkg expressrd on dry " 'e ight hasis

"'01 more IMn 2S mglkg e~ prelsrd on dl)' weight !>.ui,

AbK nt

Thaum.lin i. obtained by ""l ........ eJ.trncUon ( pH 2 j to 4) o f I"" "';Is o f lho

B 17 13

fru it of t~ '~'lUr~1 s,ra;n of rll"''''UlII~ ''~'I''u d<llli~/lii (Benlh) :u>d com;'1>

1>""'''"'\

~.<~~'" ial ly o r II",

,h;oum;J(i.t I ~nd (hluntnl;1I IIIOtcl~r w;lh m;oor

nmOulll, of plant ' ·"II!.III"CII' 1 tJcr;vcll (""1Il1h" SOli"''' rna'crill

2~8-822-2

E9~7

Polypc:ptide of 207 aminoacid!

Thaumalin 122209

Thaurrull1in II 22293

Not less than 1611> n,tlO,en on the dried ba5is equivalent to Ihlt kss than

94'1, proteins (N l S.8)

(}dou rleu. crum-coloured po .... der w,lh an inle n ... ly sweet la"e.

Approlim3lely 2000 10 3000 t;mes as 5w.,.,1 as sue"""

Very soluble in water. insoluble in ace\One

Not ~!han 9'*' (IO.5"C toconSlln1 ..... "hl»)

Not ~ than 1% expressed on dry ... ·eight basis

Not mof"t than 2% u~sed on dry wc"hl basis

Not more than 100 mglk, uprn..,d on dry ..... ;'ht basi.

1"01 more than 3 mJlk, up"''''''' on dry "'ei,ht ba,i.

3 mJlk, upre.sed on dry ",eiJllt basi,

Total aerobic microbial count: Max 10001, E. Coli: allscnt in I,

Nrohespc:ndin d,hydrochalcooe, NHDC. hesperetin dihydnx:halt<>nc-4'- B

neohesperidostde, neohesperidin DC

2-a-a- L- rhamnop yrano. yl- 4 • -6- D-gi ucopy ranos yl

hnpere l i n

dihydnx:h.akont obtained by catalytic h)'d~nation of nrohtspc:ridin

243-978-6

Off ... 'II.k'.~ .Cf}'ScaUine l'O'"'tkr 11:1. i", a d\¥lICtni~. i~~I\'e ~'WftI

Wk' ,\ppnum\;l\Cly I!r .... ftft HlOO ~ 1800 ''''~s IS ."''« ... ...aooe

F=ly KIIubko In hot "'"alCr. \'t'ry Ili&h,ly soluble on cold ......... .,..,lkally

insoluble in et,," anoJ benU'llo!

282 LQ 283 11m fOO' I srn ~tion of 2 ms in 100 ml meli>anol

Dmolw:>boo. 10 ms o f ntOhnpend,nr DC in I IIlI melhanol.1Ild I ml of.

I'll 2'lm'IIOl"I~1 di."...,yl bon.., _1NnoI1C iOIUllOl'l A bnJhC yellow ~

i, pmd"",nl

NOIII1<n than 10 mg/kg Up"' Jled as Pb on dry weiSh. balil .

IfIpubNb nO.J.~ f,I ' I·"iO'nwlpl - l. ~'" Ka>blp

1'oIJh,IW1n·tJt;~tfl ............. -1.Comn,,..,.....

p,;." '" h c;.,...",.,......

Molk¥/! n·I"""..,.",,. toJ.(ft"", -

Pn'1IIn6 Pi¥",

(I) These regulations shall apply to those food additives, Applic""~~<oI"

here inafter referred to as "sweetene rs" whic h arc used:-

' _ "lu i .. """.

- in the preparalion of foodstuffs to impart a sweet laste to

food stuffs,

- as table-lOp sweeteners .

(2) These regula tions shal l not apply to foodstuffs with

sweetening properties.

In Ihese regulations. unless the conleXi otherwise rcqu ires:-

',*"""""",.

"Acl"' means the Food. Drugs and Drin king Water Act

"energy· reduced" means with an energy value reduced by

at leasl 30% compared wi: h the original foodstu ff or a similar

product

" food" has the same meaning as defined in the Ac t

"infants" means children under the age of 12 mo nths;

"with no added sugar'" means withou t any added mono- o r

disacc harides or any other foodstufr used for its sweetening

properties;

"young children" means c hildre n aged Detween one and

three years.

(I) Only sweeteners listed in the Sc hed ule to these

regulations may be plaeed on the market with a view to

(a)

sale to the ultimate consumer. or

(b)

usc in the manufaclllre of foodstu ffs .

(2) Sweeteners referred to in sub-paragrap h (b) of

paragraph (1) of this regulation may only be used in the manufacture

of the foodslllffs listed in the Schedule to these regulations under

the conditions specified therein.

(3) The provisions of paragraphs ( I) and (2) of this

regu lat ion shall supersede any other requirement in any other

regulations which are in connict wi th these regulations.

(4) Except where specially provided for, sweeteners may

not be used in foods intended for infants or young c hildren .

(5) The maximum usable doses indicated in the FiTst

Schedule to these regulatio ns refer to ready-to -eat foodstu ffs,

prepared according to the instructions for use,

5_ Without prej udice to these regulations, the provisions

specified in the Additives in Food Regul ations, 1994 and in any

other regulations permitting any additives listed in the First Schedule

10 be used for purposes mher than sweetening, shall apply.

Minghajr ebda pregudizzj u ghal dawn ir.regolamenli, id-

dispoiizzjonijict spei:ilikali fir-Rcg olamcnti ta' 1-1994 dwar Addilivi

Ii Hwejjeg ta ' I-Ike!. u fku ll rcgolamen ti ohm Ii jippermctlu Ii xi

add iti vi elenkati O-Ewwc l Skeda jistghu jinluiaw ghal xi ghanijiet

ohra Ii majkunux clawk do li:ifikanli, ghandhom ikunu japplikaw "

6_ (I) Id-deskrizzjoni lal-bejgh la' doli:ifikanti ghal fuq il-

mejda ghandha linkludi I-fraii -

"cl ol('ifibnti ghn l fuq il ' l11cjda b:J l:Jt fuq .... ..... " . filw:Jlj!

Ii jintu i a/w I.iscrnlismijict ta' kulf suSl:Jn za dol':ifik:mti uj,ata

flI -kOllllWi izzjoni ticghu .

(2) Fit-Ii k kcttjar la' dolCi fi kan ti ghal f Ulj i I-rne jda I i j ku II

fih polyOIS uJjcw asptlrlame ghandu jklln hcmm dawn it-lwissijiclii

gen ln

(a)

asparlame: "fih SOTS la' phcnylalaninc ";

(b) polyo ls: "il -konsum ecccss iv jista ' jikkawlA crfett i

purganti".

( 1) The sales description of a table-top sweetener must

include the term ~

.................... - based table-top sweetener", usi ng the name(s)

of the sweetening substance(s) used in its composition.

(2) The labelling of a table-top sweetener contain ing

polyols andlor aspartame must bear the following warnings

(a)

aspartame: "contains a source of phenylalanine";

(b) polyols: "excessive consumption may induce laxative

effects'·.

(I) Foodstuffs may conllli n a pcrmil1ed sweetener or a "' .... ,,'ul[,

" " ... ~

111 i xtur.: of ' \\, 0 or more perm ifled sweelcn.:rs as sp.:ei fied in I he FirSI ,_"'"",,,

Sch.:dulc 10 Ihese regul;Jtions. provided Ihal Ihe aruount of eac h

sweelener added does nO( exceed Ihe respective maximum usable

doses specified for Ihal sweelener, and Ihallhe total amount of Ihe

added sweeleners does not exceed fhe highest value of the specified

maximum usable doses for the sweeteners used .

(2) In addi tion 10 the provis io ns la id down in the

Labell ing and Presen tation of Foodstuffs Regulations, 1992 ,

foodstuffs containing a sweetener or sweete ners shall be labelled

with the wo rds "wilh sweetener(s)" accompanying the name under

which the product is sold .

(3) For foodstu ffs containing both an added sugar or

sugars aod a sweetener o r sweeteners, the provisions of paragraph

(2) of this regu lat ion s hall apply except tha t the words "with

sweelener(s)" shall be substituted by the wo rds "with sugarls) and

sweetener(s)".

(4) In addition 10 the provisions of paragraphs (2) or (3)

of this regu lation, foodstuffs containing aspaname andlor more than

10% added polyo ls shall bear t he warnings speci fied in s ub -

paragraphs (a) and (b) of paragraph (2) of regulation 6 of these

regulations .

Sweeteners shall comply with the criteria of purity laid ""1"'_·

down in the Second Schedule to these regulations.

The Sweeteners in Food Regulations, 1993 arc hereby ~ oiL}; , rill

( I)

0111"1)

repealed.

(2) Any reference in any othe r regulations to the

Sweeteners in Food Regulations. 1993 shall be construed as a

reference to these regulations.