MT
108 tal-1993
Table of Provisions (6)
Statutory Text (6 Articles)
L.N. 108 of 1993
FOOD, DRUGS AND DRINKING WATER Aer
(CAP. un
SWfttmerl In t·ood R",,'''1om, 1"3
IN e~erci5e of the powers conferred by section 12 of the Food.
Drugs and Drinking Water Act , the Minister for Home Affai rs Ind
Social Development , on the ad"" of the Food Standards Board . hl.$
made .he following regulations
Th~ regulations may be tited 1.$ the Sw~tencn in Food
k egul ations. 1993 and shall QC)mC into force on the 1st October. 1993.
PART!
PERMITIED SWEETENE RS
COLUMN I
N"-M EOFSWEETENER
Accsulfame potassium ..... ., ...... ..... .... ., .............. , ...... ... ....... .
Aspanamc . ............
Hydrogenated glucose syrup ........... ,. .............................. ,.,. ..
l somalt ....•...............•••.•.............•••..............••...........•.••...
Lact;tol
Mannitol .•............ .............. ... ..... . ' ..................... .. .......... .
.............. , ............... , ...... .
Saccharin
Sodium r.accharin ........................ ............. .. ....... ...... .. .. ...... .
Calcium r.accharin ................................................... .
Sorbitol
.................. .... .......... ......... .. ., .. ......... . " .... ...... .
Sorbitol syrup .. . ..• .... ... ..... .. •..
Thaumatin ....... ... ................ , ...... ................ .............. ... .... .
Xylitol ..............................••............•.•............•.•.............•
•
PA RT 11
Specific: Purity Crllen. for Pumhled S .. eeltMn
Ace5ulfarnc:: K.
Synonym ... .... ....................... .
PotUfium 3,4 .. dihydr<>-O-mcthyJ .. Z,Z,.(.,OOxo.i ,2 )..,J.
Chemical name .....................•.
OQtbiazln .. )..idc.
Empiri<.:al form ula .................. .
C.H.KNO.S .
MoIe",,":u weight .................•..
201 .2.
Whilc. odourlcss. cryst..tlinc powtkr or panulc.
Description .....••.•••••••.•••........
wil h In intcnsely swecltaslC .
Not lcss than 99 .. O'Y. of C. H.KNO.S on a
Conlenl ............................... .
volatilc m. ner .. frec basis.
Not morc than 1.0% (dclennincd by drying at
Volatile matter ..... ............. .... .
IOS"C 10 con~tanl wcight) .
Notlc" tban 6.S and not mOrC than 7.5.
pH of a 1% aqueous solution .... .
Not more tbanO.5%.
Potassium acetale ............. .... .
Not more Ih an 30 mglkg.
fluoride .............. .... ............. .
(ls) .. 3 .. Amino.N [(<<5)" « .. mctboxycarbonyl ..
Chem ical name
pbcnctbylJ suronamic acid.
L-Aspartyl . L-phenylalaninc methyl ester.
Synonym .............................. .
Enlpirical formula ........ . .
C,.H ,"Nl0~.
294.3.
Mo lecular weight .......•..•••.....••
White , odourless, crystalline powder witb an
Description .......................... .
intensely swectlaste.
Notlcss than 98.0% ofC,.H 'AN 20 J on a yolatilc
Conlent ............................... .
maller .. free basis .
Not more Iban 4.5% (dctermincd by drying at
Volalik: malte . ...................... .
IO:S"C to conslant weight) .
Specifoe rGlalion . i"' l2O"C ....
Notlcss tban + 12.5" and 001 more tban + 17.5"
D
(dctcnnined by ~ng a 4% wcightkolume
solution on a yolatile matter·free basis in ISM
formic acid).
Not Jess t han 4.0 and not more Ihan 6 . 5.
pH of. 0.8% aqueous solution ..
Not moll: Ihan 0.2% ah er ignition at 800 ± lS"C.
Sulphate<! ash .......... ... .......... .
S· Be rlZ)' 1. 3, (Kiioxo. 2 .pipe rui ne a·
<:el K: acid ........................... .
NO! moll:ilian 1.5% ..
Synonym ........... .. ... ... .......... .
Hydrogenated high maltose gJuoosc ~yrup.
Ikscription
Qear . c:olOllrle~s. sweet tasting. aqueous SQlu·
tion of sorbitol. hydrogenated oIigosaa:ha -
rid~ and hydrogenated polysaccbarides pre-
pared by the catalylic h)'drogenalioo of
glucose syrup. When d ried o r crystallised tbe
product is white and crystalline.
D-gluciwl: nOt morc than g%.
Cootent
4-C-0::- D-glucopyraOO5yl-D-gluci tol: not less
than 50% and OOt more than 90%.
O-ot_ D_gluoopyra.nosyl_l l-+ 41-0-« - D-glucopy-
"'OO5yl-]1-o 4J- D-gtucitol: OOt ler.s than 5%
and nOI more than20%.
Hydrogenated telrasaccharides and hydroge_
na ted higber polysacdlarides: nOI less lhan
2% and oot more than 30%.
Hydrogenated pol)'N\Aharides conlaining 2 1 or
more D-gluoopyranosyl o r D-glucitol UnilS
notmoret han 3%.
The percentages refe rred to are cakulated o n a
dryweigbt basisin each case.
Water .....
Not mo re than 26% ( Karl Fischer) .
NO! more than 0.3% on a dry weigh t basis. ex -
Reduci ng sugan
pressed as dextrose .
pH of a 40% aqueous $OIu tion .. .
NOl less Ihan 4.0 and nOI more than 7.0.
Sulphur dioxide ............... ..... . .
NOI more Ihan IOmgftgon adry weigh t basis.
No t mo re thanO .l % aft er ignition 11800 I 25"C,
Sulphated ash ...... ........... ....... .
ukulated o n I dry .... eighl basis.
Not more than 0.01 % o n a dry weight basis, u -
Sulphate
pressed as SO,.
NOI mo re than 50 mg/kg on a d ry weight basis,
Chloride
elpresscd as Cl.
Nickel ............ .............. ...... . .
NOI more than 2 mg/kg on a dry weigh t basis ,
expressedasNi.
Lead ........ ........... ................ .
NO! more than I m&lkg on a dry weight basis ,
upre!oSCd as Pb .
Chemic.lll description
An
approximately
equ imolar
mix ture
of
6-0-'1'- D-gluoopyranosyl-D-glucilol
and
l .{). 0:: -D. ·gl ... copyra nos y 1- D-m a n nilol.
Empirical formu la
Clli-f:z.oO Il ·
Molecular weight
6-0-<>< .D -gluoopyra nosyl-D_glucilol
(CI2 H ~.O ,I ) : 344.3_
1-0-", -D-glucopyranosyl- D_m an nilol ( Cl1 H~,
O Il2 H z O): 380.3.
Ikscription
Wh ite, odourless, cryslalline . slightly hygm-
scopic50lid wit h I sweeltaste.
Not less Ihan 98.0'% of6-0- <><- D-g1uoopyraoosyl-
Content
0-glOO101 and 14"'·D-glucopyraoosyl- D·
mannitol ; each shall be pre5Cnl in a propol'
lion of 00\ less Ihan 43 % (on a dry weight
basis in each case).
Not mo~ than 7.0% ( Karl Fischer) .
Waler
l"'l 2O"C ....
Not Ies$ than + 91.5 % (using a 4% weight!
Specific rotalion,
D
volume aqueous solu tio n).
Not more than I.S% o n.a dry weight basis, ex-
Reducinl sugars .... •...•••••••......
prc:ssc:d as dcXII"OK .
NOI more than 0.5% on a dry weight bOlS~.
D- Ma nnilol .•.. ....•.....•.••••••••.••
Not more than 0.5% on a dry weight b3$i$.
O-Sorbilo l ............................ •
No t morC tha n 50 mg/kg after ignition at 800
Ash .................................... .
± 25"<:. calculated o n a dry weight hasis.
Not more than 2 mglkg on a dry weight basis,
Nickel ••••.•...........•.•••••..........
eJpresscd as Ni.
Not more than I m;V'kg on a dry weight hasis.
Lead ..•. .......... ......••• .......... ...
npressed as Ph.
E411M ... ikN
TIle criteria for mannitol contained in Counci l Directive 7&'663 EEC Ca) and in
article 6(1) (a) o f Cou ncil Directive 741329IEEC (b). as amended (c).
Sou .....
1ltc m tcria in the mono&f1lpb for SiKrliarin contained in the Brilidl Pharma-
copoeia 1980at pa~ 39).
Soe_ S4CCIuuitt
TIle criteria in the monograph for sacchari n sodium contained in the British
Pharmacopoeia 1980 at pa~ 394. as amended by Ihc British Pharmacopoc:ia 1980
Addendum 1982 at page 99.
C.JcI .. ". SGCcluJrin
Chem ical name ...................... .
1.2-Benzi$Olhiazol-) (2 H)-one i .l ·dioxide . 011-
ciumul t .
Empiric:al form ula .••....... .... .•...
C1 JiaCaNz°"sz·
404.4.
Mo lecular weight ......... ... .... ... .
Descnptlon ....•..•••..........•......
White crystals Or a white. crystalline powder;
odourleS$ or with a fai nt aromatic odour;
with a n inte nsel y sweet taste.
C;)ntc nt ......•..•.••...... .... .........
Not less than 99.0% of C,.H.CaNPoS:t o n a
volalile matter-free basis •
""'.1..12.1. 1'."11. p.1.
I'. • 01 OJ.
OJ.
1..1". IU." . , .!.
No.
_ " Couooal Directi.c 7861l E£C(OJ . No. 1..197. 22.1.711. , .ll).
1<) T1oo .. _ . " ,......
B
'"
Volatile matter ...................... .
Not Irs.s than 11.0% and nQt more than 15.0%
(determined by drying at IOS"C to constant
weight).
Complies with the test in the monograph for
Free acid or alkali
saocllarin sodium in the Brit ish l'tIannaeo-
poeia 1980.
Melting point of i ... lated saccha rin
Complil$ with the test in the IT>OfIOgraph for
saccharin sodium in the British Pharma-
copoeia 1980.
Rc1~ted sub!;t ~nces
Complies with the test in th e monograph for
saccharin sodium in \l oe British l'tIarmaco-
poeia 1980.
Compl ie. with the t~ in the monograph for
Arsenic ..... .
saccharin sodium in the British Pharmaco-
poeia 1981
Heavy metals ......... ............... .
Complies with the test in the monograph for
saccharin sodiu m in the Brithh Ph armaco-
poe ia 1980.
1f:410 SorlHtol
The criteria for .... bitnl contained in Council Di rective 78166JIEEC and in article
6( 1)(,,) of Council Direclive 741l29lEEC. as amended.
10410 So:IrlHu1I " ....,
The criteria for sorbitol syrup contained in Council Directive 7816631EEC and in
article 6(1 )(02) of Council Direct ive 741l29IEEC. as amended .
Odourless. cream coloured. proleinaccom
powder with an intensely sweet taste obtained
from aqueous ClL"traelS of the arils of the frui t
of TIUlumalOCOCCUS lkuIicUii (Ben I h) .
'"
Not less than 12.0 and nOI more th an 12.5 (deter·
Spccificab50rplion, E
1=
mined at the wavelength of maximum ab50r-
bance , abou t V9 nm . usi ng a 0 .1% weigh"
volume aqueous solution al pH 2.7).
Not less IlIan 16.0% on a V(llatile matter-free
Nitroge n ................ . ............ .
basis.
NOt more th an 3.0% on a volatile maller·free
Carbollydrate ....•••••.••.•..........
basis.
Not more than 9.0% (de termined by drying at
Volatile matter ••.••••......... .......
105· C to constant weight) .
Not more than 2.0% after ignition atSOO ± 2S"C.
Sulpllatcd ash ..... ... ......... .
calculated on a volatik: matte r-Iree basis.
NOI more th~n 0 .01 % on a V(llalile matter-free
Aluminium ........ ........•.... .
basis.
x_
.
6l6
mQQ-Xylilol.
Chemical name .. .............. " .... .
C, Hu O,.
Empirical formula .................. .
Whil e. odourless. eryslall inc powde~ or CT)'$lals
Description
wit h a S\IIeet taste.
Not 1es5 tha n 98.0% of m~SQ·xylilol, C, H I2 O,.
Content ............ ............. .... .. .
on a volatile maner-free basis.
Not more than O.S % (~ Ierm ined by drying al
Vohllilt mallcr ................ .
6O"C OVe r phosphorus penlo1ide in I vacuum
for4hours).
NO! more Ihan 0.2% on a ~olalilc malter-free
Reducing sugars
basis, expressed as dCll,trO$e.
pH of a 10'% aqUOO\lS 5OIulioo .,'
Not less tha n 5.0 and J\Ot morC than 7 .0.
Othc' r poIyob •...••••.................
f'l0l more than 0.5% singly and not more than
1.0% in tOlal on a volatile matt er-fru basis
ineach case.
Not more thanO. I% after ignition at 8O'J ± 2S"C.
AslI ................... ........ ... ..... .
on a vola ti le m~lIe r- free basis.
Not more than 2 mglkg on a volatile matter-fru
Nickel .•........•..•••••.•.••. ', ..•.....
basis.exprus.ed uN i.
Not more than I mg/kgon a volatile mltter-fT«
Lead ....... ................. ......... .. .
basis, CJI:p~das Pb.
PART III
GneraI Purity Criteria applkloble 10 Pffmilltd Swtfttntrl eICt?t ..-me otherwlR
]II"Orldt.-d by Sptdfk Purlly Crllt n.
No permitted sweetener lIlaU contain more than -
(a) 3 milligrams per kilogram of arsenic;
(b) 10 milligrams per kilogram of lead .
r "",,_ 10, ,"j6.[)jPl'~ ""nt '"'. ~r nw""uzjoftl_ """oIj.
,."IIJ~W~"", Dot"..",...., '" /~_;""
C",4/k
101;,100", ~ . I ... mp<" .. ..r·o .. ," _ "","-.d .. Ilw (;0"'" __ , Pri"""~ ",-"
(1) In the$c regulations unless the context othe...,...;se
requires
"'tit<: Act"' means the Food. DOIgs and Drinking Water Act;
"'~~ r bohyd ra' e" ~ans a substa nce .... hich contains ~arbon.
hydroge n and o~ygen only. and in which the hydro&en Ind o~yge n
occur in the same proportion as in .... ater ;
"food" means food in ten ded for human consumption
"nat ural food substance" means any subslance. suitable for
Ul<~' food ~ nd commllnly used as food ..... hich i . .... hol1y a natural
prodUCI. whelher or notlh al subsla nce has been subjecled to any
process or tre atme nl ;
"permitted ilweetcntr"' mea ns any s .... ee tener as is refe rred 10
in Part I of the Schedule to these regu lations and subject to the
specific purity critcria refe rred to unde r Part 11 of such Schedule
and. unle~ otherwise pro\'ided under the lane rpart. to the general
purity criteria referred to unde r Part 1[1 of the said Schedule;
. 'sweetener" means an y substance. other than a carooh ydrate .
the primary o rganoleptic eharacte ri"ic of which is swee tness.
(2) Unless a con lmry inte ntion is ex pressed . all proport ions
mentioned in these regulations arc proportions calculated by weight of
the product as 501d.
J . No person shall sell or import any food which has in it or on it
any added sy,'eetene rs Olher than a permined ~weetene r .
N" poer..:.n . hal1 sell or imporl any sweetene r. including any
-I.
sw~tener with .... hich any olher substance has been mixed. whelher for
use as In ingrcdkn t in the preparation of food or otherwise. unless the
~ ... 'ec tcn.:r is a pe.milled _
. ... ·«IC1\(: •.
S. (I) No person shall ~U any food tlult is ~Iy. prepared or
intended for babies or you ng children if il has in LI or on 11 any added
swee te ner.
(2) P:. ragrHph (I) "f this " 'lIul. tl"lI ,h,,1I nHl "rpl~ I" any
food speci all y prep~rcd for any baby or )'Qung child who ha~ ~pecial
dietal")' needs.
(I) A permilled 1O,,·eetener. including permiued swect ener
" 'it h which any other additivc has been mixcd. whidl is not inte!lded for
sale tn the ultimate o;onsumer , may only be marketed if the padr.aging or
container bear the following information which must be conspicuous.
dca.ly legible and indelible
(a) the name of the c~tcgory (s wcctene ~) followed d thcr hy
lhe speci rIC naIDC Or ,;erial number o f the permitted swccte ner as
indicated in Pan I of the Schedule. in descending orde r of Ihe
proportion by " 'cighl in the total ;
(b)
eit her the statement "for IIM in f<XHi"
o r tile statement "rrJlrk lCd use in food"
or a morespcdfic reference to its intended food use:;
(c) the 5pCCial conditions of storage and use: if information
thereof is nccessal")' for proper storagc and use ;
(d) dircctions for use:. if the omission thereof would prccl ude
appropriate use of the swee tener ;
(e ) a ma rk ioerlifying Ihe hatch or lot
(t) Ihe namc or business name and address of IlIe
manufactu rer or package r. Or o f a leUe r established in Malta
(B) an indication of the perec:ntage of any com ponent which
is subject to a quanti tativc limitation in a food or adequate
OOmposilional information; and
(h)
the ne! quantity.
The information rcqu ired in sub-pa.ragraph~ (d) to (g) may
appear ()f1 the documen~ relaling 10 the con5ignment which arc to be
surplicd with or prior 10 the relativc delivcl")'. provided that the
indication "intrndt d for Ihe nwnufll("luu of food&luffs IJnd nOl fOT ,tlll;1
suit' appears on a conspicuous pan of thc packagingOfcontainerofthe
product in question.
(2) Permill~d sw« teners inlend~d for !\IIle 10 the ultimate
consumer may he mark~ted only if lheir packaging! or oontaine~ bear
the following information , which must be wnspicuous. clearly legible
and i ndcli bl~;
(a)
the name under which the product is sold;
(b) the information required by sub-paragraphs (a) to (f) and
(h) of paragraph (I) ofthis regulation ;
(c) the date of minimum durability ilJI $pecified in the
Labelling and Presentation of Foodstuffs Regulations, 1992,
The provisio ns of these regulations shall be wilhout prejudice So>-i ...
10 any specific requi rements in respect of a permitled sweetener under
th e Soft Drinks Regulations, 1978.