108 tal-1993

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.