Sweeteners for Use in Foodstuffs Regulations, 2000

L.N. 268 of 2000

FOOD, DRUGS AND DRINKING WATER ACT

(CAP. 231)

Sweeteners for Use in Foodstuffs Regulations, 2000

IN exercise of the powers conferred by article 12 of the Food,

Drugs and Drinking Water Act, the Minister of Health, on the advice of

the Malta Standards Authority, has made the following regulations

1 The title of these regulations is the Sweeteners for Use in

Foodstuffs Regulations, 2000 and they shall come into effect as from

the 1st January, 2001.

List of Pennitted Sweeteners

Foodstuffs

EC Number and name

Maximum usable dose

of sweeteners

Desserts and similar products (energy reduced or

Sorbitol

quantum satis

with no added sugar)

(i) Sorbitol

(ii) Sorbitol syrup

Water-based flavoured desserts

Mannitol

quantum satis

Milk- and milk-derivative-based preparations

Isomalt

quantum satis

Fruit- and vegetable-based desserts

Maltitol

quantum satis

(i) Maltitol

(ii) Maltitol syrup

Egg-based desserts

Lactitol

quantum satis

Cereal-based desserts

Xylitol

quantum satis

Breakfast cereals or cereal-based products

Fat-based desserts

OJ

N

-

W

-..J

tI:l

Foodstuffs

Maximum usable dose

EC Number and name

IV

-

of sweeteners

UJ

Edible ices

Jams, jellies, marmalades and crystallized fruit

Fruit preparations, with the exception of those intended for

the manufacture of fruit juice-based drinks

Confectionery

Sorbitol

quantum satis

(i) Sorbitol

Confectionery with no added sugar

(ii) Sorbitol syrup

Dried-fruit-based confectionery, energy reduced or with no

Mannitol

quantum satis

added sugar

Starch-based confectionery, energy-reduced or with no

Isomalt

quantum satis

added sugar

Cocoa-based products, energy reduced or with no added

Maltitol

quantum satis

sugar

(i) Mattitol

(ii) Mattitol syrup

Cocoa-, milk-, dried-fruit- or fat-based sandwich spreads,

Lactitol

quantum satis

energy reduced or with no added sugar

Chewing gum with no added sugar

E%7

Xylitol

quantum salis

Maximum usable dose

Foodstuft's

EC Number and name

of sweeteners

Sauces

Mustard

Fine bakery products, energy reduced or with no added

sugar

Products intended for particular nutritional uses

Solid food supplements/dietary integrators

IXI

--

tv

W

1.0

IJ:'

Maximum usable dose

tv

Foodstuffs

W

tv

Neohesperidine

Thaumatin

Acesulfame K Aspartame

Cyclamic acid Saccharin

DC

and its Na and and its Na, K

and Ca salts

Ca salts

Non-alcoholic drinks

Water-based flavoured drinks, energy-reduced

-

350 mgll

400 mgll

30 mgll

or with no added sugar

600 mgll

80 mgll

Milk- and milk derivative-based drinks, energy-

-

reduced or with no added sugar

350 mgll

400 mgll

50 mg/l

600 mgll

80 mgll

Fruit juice-based drinks, energy-reduced or with

-

no added sugar

350 mg/l

400 mg/l

600 mg/l

80 mg/l

30 mg/l

Gaseosa: non-alcoholic water-based drink with

added carbon dioxide, sweeteners and

-

-

-

flavourings

100 mg/l

Desserts and similar products

The following desserts, energy-reduced or with

no added sugar: water-based flavoured desserts,

milk- and milk derivative-based preparations,

fruit- and vegetable-based desserts, egg-based

desserts, cereal-based desserts, fat-based

-

desserts

350 mg/kg

1()()() mg/kg 250 mg/kg

100 mg/kg

50 mg/kg

Maximum usable dose

Foodstuffs

CyclanUcac~ Sa~rin

Neohesperidine

Thaumatin

Acesulfame K Aspartame

DC

and its Na and and its Na, K

Ca salts

and Ca salts

Snacks: certain flavours of ready-to-eat,

prepacked, dry, savoury starch products and

coated nuts

350 mglkg

500 mglkg

-

100 mglkg

-

50mglkg

Breakfast cereals with a fibre content of more

than 15 % and containing at least 20 % bran,

energy-reduced or with no added sugar

1200 mglkg 1000 mglkg -

100 mglkg

-

50mglkg

Confectionery

Confectionery with no added sugar

500 mglkg

1000 mglkg 500 mglkg

500 mglkg

50 mglkg

100 mglkg

Cocoa- or dried-fmit-based confectionery,

energy-reduced or with no added sugar

500 mglkg

2000 mglkg 500 mglkg

500 mglkg

50 mglkg

100 mglkg

Starch-based confectionery, energy-reduced or

with no added sugar

1000 mglkg 2000 mglkg 500 mglkg

300 mglkg

-

150 mglkg

Cocoa-, milk-, dried-fmit- or fat-based sandwich

spreads, energy-reduced or with no added sugar

1000 mglkg 1000 mglkg 500 mglkg

200 mglkg

-

50mglkg

ttl

Chewing gum with no added sugar

2000 mglkg 5500 mglkg 1500 mglkg 1200 mglkg 50 mglkg

400 mglkg

tv

~

-

tv

2000 mglkg -

Essoblaten

800 mglkg

-

t:C

Maximum usable dose

tv

Foodstuffs

v;l

tv

Neohesperidine

Thaumatin

Acesulfame K Aspartame

Cyclamic acid Saccharin

tv

DC

and its Na and and its Na, K

and Ca salts

Ca salts

Breath-freshening micro-sweets, with no added

sugar

400mglkg

2500 mglkg 6000 mglkg 2500 mg/kg 3000 mg/kg -

Energy-reduced tablet-form confectionery

500mglkg

Strongly flavoured freshening throat pastilles

with no added sugar

2000 mglkg -

Alcoholic drinks

Cider and perry

350 mgll

600mgll

20mgll

80mgll

Alcohol-free beer or with an alcohol content not

exceeding 1.2 % vol.

Biere de tablelTefelbierrrable beer (original

wort content less than 6 %) except Obergiiriges

Einfachbier

Beers with a minimum acidity of 30 milli-

equivalents expressed as NaOH

Brown beers of the oud bruin type

350mgll

600mgll

80mgll

10 mgll

Energy-reduced beer

25 mgll

25 mgll

10mgll

Maximum usable dose

Foodstuffs

Acesulfame K Aspartame

Cyclamic acid Saccharin

Thaumatin

Neohesperidine

and its Na and and its Na, K

DC

Ca salts

and Ca salts

Drinks consisting of a mixture of a non-

alcoholic drink and wine, beer, perry, cider or

30 mg/l

250 mg/l

80 mg/l

spirits

350 mg/l

600 mg/l

Spirit drinks containing less than 15 % alcohol

by volume

30 mg/l

80 mg/l

350 mg/l

6OOmg/l

Edible ices

Edible ices, energy-reduced or with no added

800 mglkg

800 mglkg

250 mglkg

100 mglkg

50 mglkg

50 mglkg

sugar

Comets and wafers for ice cream with no added

sugar

2000 mglkg -

-

800 mglkg

-

50 mglkg

Fruit and vegetables

Canned or bottled fruit, energy-reduced or with

no added sugar

350 mg/kg 1000 mg/kg 1000 mg/kg 200 mg/kg -

50mg/kg

Energy-reduced jams, jellies and marmalades

1000 mg/kg 1000 mg/kg 1000 mg/kg 200 mg/kg -

50mg/kg

t:D

tv

Energy-reduced fruit and vegetable preparations

350 mg/kg 1000 mg/kg 250 mg/kg 200 mg/kg -

50mg/kg

V)

tv

V)

ttl

Maximum usable dose

IV

Foodstuffs

W

IV

Neohesperidine

~

Thaumatin

Acesulrame K Aspartame

Cyclamic acid Saccharin

DC

and its Na and and its Na, K

and Ca salts

Ca salts

100 mg/kg

160 mg/kg -

200 mg/kg 300 mg/kg -

Sweet-sour preserves of fruit and vegetables

Fish, crustaceans, molluscs

Sweet-sour preserves and semi-preserves of

fish and marinades of fish, crustaceans and

30mg/kg

200 mg/kg 300 mg/kg -

160 mg/kg -

molluscs

Miscellaneous

350 mg/kg 350 mg/kg -

50mg/kg

Sauces

160 mg/kg -

350 mg/kg 350 mg/kg -

320 mg/kg -

50 mg/kg

Mustard

110 mg/l

110 mg/l

Energy-reduced soups

110 mg/l

50 mg/l

Feinkostsalat

. -'

350 mg/kg 350 mg/kg

160 mg/kg

50mg/kg

Bakery products

Fine bakery products for special nutritional uses

1000 mg/kg 1700 mg/kg 1600 mg/kg 170 mg/kg -

150 mg/kg

Maximum usable dose

Foodstuffs

Acesulfame K Aspartame

Cyclamic acid Saccharin

ThaumaCin

Neobesperidine

and its Na and and its Na, K

DC

Ca salts

and Ca salts

Special diets

Complete fonnulae for weight control intended

to replace total daily food intake or an individual

meal

450 mg/kg 800 mg/kg 400 mg/kg 240 mg/kg -

100 mg/kg

Complete fonnulae and nutritional supplements

for use under medical supervision

450 mg/kg 1000 mg/kg 400 mg/kg 200 mg/kg -

100 mg/kg

Liquid food supplements/dietary integrators

350 mg/l

400 mg/l

80 mg/l

600 mg/l

50 mg/l

Solid food supplements/dietary integrators

500 mg/kg 2000 mg/kg 500 mg/kg 500 mg/kg -

100 mg/kg

Food supplements/diet integrators based on

vitamins and/or mineral elements, syrup-type or

chewable

2000 mg/kg 5500 mg/kg 1250 mg/kg 1200 mg/kg 400 mg/kg 400 mg/kg

t;tj

N

W

N

VI

1

These regulations shall apply to sweeteners which are used

(a) in the preparation of foodstuffs to impart a sweet taste

to foodstuffs,

(b)

as table top sweeteners.

2.2 These regulations shall not apply to foodstuffs with

sweetening properties.

In these regulations, unless the context otherwise requires

1

"Act" means the Food, Drugs and Drinking Water Act;

"energy-reduced" means with an energy value reduced by at

least 30% compared with the original foodstuff or a similar product;

"food" has the same meaning as defined in the Act;

"infants" means children under the age of 12 months;

"quantum satis" means that no maximum level is specified;

however, sweeteners shall be used in accordance with good

manufacturing practice, at a dose level not higher than is necessary

to achieve the intended purpose and provided the consumer is not

misled;

"with no added sugar" means without any added mono- or

disaccharides or any other foodstuff used for its sweetening

properties;

"young children" means children aged between one and three

years.

1 Only sweeteners listed in the Schedule to these regulations Pennitted

may be placed on the market with a view to

sweeteners.

(a)

sale to the ultimate consumer, or

(b)

use in the manufacture of foodstuffs.

4.2 Sweeteners referred to in regulation 4.1 (b) may only be used

in the manufacture of those foodstuffs listed in the Schedule and in

accordance with the conditions specified therein.

4.3 The provisions of regulations 4.1 and 4.2 shall supersede

any other requirement in any other regulations which are in conflict

with these regulations.

4.4 Sweeteners may not be used in food for infants and young

children, including food for infants and young children who are not in

good health, unless otherwise laid down in specific provisions.

4.5 The maximum usuable doses indicated in the Schedule to

these regulations refer to ready-to-eat foodstuffs, prepared according to

the instructions for use, where appropriate.

4.6 Without prejudice to other provisions, the presence of a

sweetener in foodstuffs is also permissible

(a) in compound foods with no added sugar or energy-

reduced, in compound dietary foods intended for a low-calorie

diet and in compound foods with a long shelf-life, other than those

mentioned in regulation 4.4, provided the sweetener is permitted

in one of the ingredients of the compound foodstuffs;

(b) if the foodstuff is intended to be used solely in the

preparation of a compound foodstuff which conforms to these

regulations.

1 These regulations shall apply without prejudice to specific Provisions of L.N.

89 of 1994 and L.N.

regulations permitting additives listed in the Schedule to be used for 256 of 1998.

purposes other than sweetening.

5.2 These regulations shall also apply without prejudice to other

provisions governing the composition and the description of foodstuffs.

1 The sales description of a table-top sweetener must include

the term-

"

- based table-top sweetener", using all names of all

sweetening substances used in its composition.

6.2 The labelling of a table-top sweetener containing polyols and/

or aspartame must bear the following warnings

(a)

aspartame: "contains a source of phenylalanine";

(b) polyols: "excessive consumption may induce laxative

effects".

1 Foodstuffs may contain a permitted sweetener or a mixture

of two or more permitted sweeteners as specified in the Schedule to

these Regulations, provided that the amount of each sweetener added

does not exceed the respective maximum usable doses specified for

that sweetener, and that the total amount of the added sweeteners does

not exceed the highest value of the specified maximum usable doses

for the sweeteners used.

7.2 In addition to the provisions laid down in the Labelling and

Presentation of Foodstuffs Regulations, 1992, foodstuffs containing a

sweetener or sweeteners shall be labelled with the words "with

sweetener(s)" accompanying the name under which the product is sold.

7.3 For sweeteners containing both an added sugar or sugars and

a sweetener or sweeteners, the provisions of regulation 7.2 shall apply

except that the words "with sweetener(s)" shall be substituted by the

words "with sugar(s) and sweetener(s)".

7.4 In addition to the provisions of regulations 7.2 or 7.3,

foodstuffs containing aspartame and/or more than 10% added polyols

shall bear the warnings specified in regulation 6.2 (a) and (b).

1 Sweeteners intended for use in foodstuffs or as table-top

sweeteners must comply with the criteria of purity laid down in European

Community Directive 95/311EC, as amended.

1 The Sweeteners for Use in Foodstuffs Regulations, 1997 are

hereby repealed.

9.2 Any reference in any other regulations to the Sweeteners in

Food Regulations, 1997 shall be construed as a reference to these

regulations.