Sweeteners for Use in Foodstuffs Regulations 2004

Minister of Health, the Elderly and Community

L.N. 254 of 2004

FOOD SAFETY ACT, 2002

(CAP. 449)

Sweeteners for Use in Foodstuffs Regulations 2004

IN exercise of the powers conferred by article 10 of the Food Safety

Act, the Minister of Health, the Elderly and Community Care has made

the following regulations>

(1) These regulations may be cited as the Sweeteners for Citation

commencement

Use in Foodstuffs Regulations 2004 and shall come into effect as from

1st May 2004.

(2) These regulations implement the provisions of>

(a) European Parliament and Council Directive 94#35#EC

on sweeteners for use in foodstuffs, amended by Directive

96#83#EC<

(b) Commission Directive 95#31#EC laying down specific

criteria of purity concerning sweeteners for use in foodstuffs,

amended by Directives 98#66#EC, 2000#51#EC and 2001#52#EC.

E No

Name

Foodstuffs

Maximum

usable dose

Sorbitol

quantum satis

Desserts and similar products

(i) Sorbitol

— Water-based flavoured desserts,

(ii) Sorbitol syrup

energy-reduced or with no added sugar

Mannitol

— Milk- and milk-derivative-based

Isomalt

preparations, energy-reduced or with no

Maltitol

added sugar

(i) Maltitol

— Fruit- and vegetable-based desserts,

(ii) Maltitol syrup

energy-reduced or with no added sugar

Lactitol

— Egg-based desserts, energy-reduced

Xylitol

or with no added sugar

— Cereal-based desserts, energy reduced

or with no added sugar

— Breakfast cereals or cereal-based

products, energy reduced or with no

added sugar

— Fat-based desserts, energy-reduced or

with no added sugar

— Edible ices, energy-reduced or with

no added sugar

— Jams, jellies, marmalades and

crystallized fruit, energy-reduced or with

no added sugar

— Fruit preparations, energy-reduced or

with no added sugar, with the exception

of those intended for the manufacture of

fruit-juice-based drinks

Confectionery

— Confectionery with no added sugar

— Dried-fruit-based confectionery,

energy-reduced or with no added sugar

— Starch-based confectionery, energy-

reduced or with no added sugar

— Cocoa-based products, energy

reduced or with no added sugar

— Cocoa-, milk-, dried-fruit- or fat-

based sandwich spreads, energy-reduced

or with no added sugar

— Chewing gum with no added sugar

— Sauces

— Mustard

— Fine bakery products, energy reduced

or with no added sugar

— Products intended for particular

nutritional uses

— Solid food supplements/dietary

integrators

E No

Name

Foodstuffs

Maximum

usable dose

Acesulfame K

Non-alcoholic drinks

350 mg/l

— Water-based flavoured drinks,

energy-reduced or with no added sugar

350 mg/l

— Milk- and milk-derivative-based or

fruit-juice-based drinks, energy-reduced

or with no added sugar

Desserts and similar products

350 mg/kg

— Water-based flavoured desserts,

energy-reduced or with no added sugar

350 mg/kg

— Milk- and milk-derivative-based

preparations, energy-reduced or with no

added sugar

350 mg/kg

— Fruit- and vegetable-based desserts,

energy-reduced or with no added sugar

350 mg/kg

— Egg-based desserts, energy-reduced

or with no added sugar

350 mg/kg

— Cereal-based desserts, energy reduced

or with no added sugar

350 mg/kg

— Fat-based desserts, energy-reduced or

with no added sugar

350 mg/kg

— ‘snacks’: certain flavours of ready to

eat, prepacked, dry, savoury starch

products and coated nuts

E No

Name

Foodstuffs

Maximum

usable dose

Confectionery

500 mg/kg

— Confectionery with no added sugar

500 mg/kg

—

Cocoa-

or

dried-fruit-based

confectionery, energy-reduced or with no

added sugar

1 000 mg/kg

— Starch-based confectionery, energy-

reduced or with no added sugar

1 000 mg/kg

— Cocoa-, milk-, dried-fruit- or fat-

based sandwich spreads, energy-reduced

or with no added sugar

2 000 mg/kg

— Chewing gum with no added sugar

350 mg/l

— Cider and perry

350 mg/l

— Alcohol-free beer or with an alcohol

content not exceeding 1,2 % vol

350 mg/l

— ‘Bière de table/Tafelbier/Table beer’

(original wort content less than 6 %)

except for ‘Obergäriges Einfachbier’

350 mg/l

— Beers with a minimum acidity of 30

milli-equivalents expressed as NaOH

350 mg/l

— Brown beers of the ‘oud bruin’ type

800 mg/kg

— Edible ices, energy-reduced or with

no added sugar

350 mg/kg

— Canned or bottled fruit, energy-

reduced or with no added sugar

1 000 mg/kg

— Energy-reduced jams, jellies and

marmalades

350 mg/kg

— Energy-reduced fruit and vegetable

preparations

200 mg/kg

— Sweet-sour preserves of fruit and

vegetables

200 mg/kg

—

Sweet-sour

preserves

and

semipreserves of fish and marinades of

fish, crustaceans and molluscs

350 mg/kg

— Sauces

350 mg/kg

— Mustard

1 000 mg/kg

— Fine bakery products for special

nutritional uses

450 mg/kg

— Complete formulae for weight control

intended to replace total daily food

intake or an individual meal

450 mg/kg

— Complete formulae and nutritional

supplements for use under medical

supervision

350 mg/l

— Liquid food supplements/dietary

integrators

500 mg/kg

— Solid food supplements/dietary

integrators

E No

Name

Foodstuffs

Maximum

usable dose

— Food supplements/diet integrators 2 000 mg/kg

based on vitamins and/or mineral

elements, syrup-type or chewable

— Breakfast cereals with a fibre content 1 200 mg/kg

of more than 15 %, and containing at

least 20 % bran,energy-reduced or with

no added sugar

— Energy-reduced soups

110 mg/l

— Breath-freshening micro-sweets, with 2 500 mg/kg

no added sugar

— Energy-reduced beer

25 mg/l

— Drinks consisting of a mixture of a 350 mg/l

non-alcoholic drink and beer, cider,

perry, spirits or wine

— Spirit drinks containing less than 15 350 mg/kg

% alcohol by volume

— Cornets and wafers, for icecream, 2 000 mg/kg

with no added sugar

—

Energy-reduced

tablet-form 500 mg/kg

confectionery

— Feinkostsalat

350 mg/kg

— Eßoblaten

2 000 mg/kg

Aspartame

Non-alcoholic drinks

— Water-based flavoured drinks, 600 mg/l

energy-reduced or with no added sugar

— Milk- and milk-derivative-based or 600 mg/l

fruit-juice-based drinks, energy-reduced

or with no added sugar

Desserts and similar products

— Water-based flavoured desserts, 1 000 mg/kg

energy-reduced or with no added sugar

— Milk- and milk-derivate-based 1 000 mg/kg

preparations, energy-reduced or with no

added sugar

— Fruit- and vegetable-based desserts, 1 000 mg/kg

energy-reduced or with no added sugar

— Egg-based desserts, energy-reduced 1 000 mg/kg

or with no added sugar

— Cereal-based desserts, energy reduced 1 000 mg/kg

or with no added sugar

— Fat-based desserts, energy-reduced or 1 000 mg/kg

with no added sugar

— ‘snacks’: certain flavours of ready to 500 mg/kg

eat, prepacked, dry, savoury starch

products and coated nuts

E No

Name

Foodstuffs

Maximum

usable dose

Confectionery

1 000 mg/kg

— Confectionery with no added sugar

2 000 mg/kg

—

Cocoa-

or

dried-fruit-based

confectionery, energy-reduced or with no

added sugar

2 000 mg/kg

— Starch-based confectionery, energy-

reduced or with no added sugar

1 000 mg/kg

— Cocoa-, milk-, dried-fruit- or fat-

based sandwich spreads, energy-reduced

or with no added sugar

5 500 mg/kg

— Chewing gum with no added sugar

— Cider and perry

600 mg/l

— Alcohol-free or with an alcohol

600 mg/l

content not exceeding 1,2 % vol

— ‘Bière de table/Tafelbier/Table beer’

600 mg/l

(original wort content less than 6 %)

except for ‘Obergäriges Einfachbier’

— Beers with a minimum acidity of 30

600 mg/l

milli-equivalents expressed as NaOH

— Brown beers of the ‘oud bruin’ type

600 mg/l

E No

Name

Foodstuffs

Maximum

usable dose

— Edible ices, energy-reduced or with 800 mg/kg

no added sugar

— Canned or bottled fruit, energy 1 000 mg/kg

reduced or with no added sugar

— Energy-reduced jams, jellies and 1 000 mg/kg

marmalades

— Energy-reduced fruit and vegetable 1 000 mg/kg

preparations

— Sweet-sour preserves of fruit and 300 mg/kg

vegetables

—

Sweet-sour

preserves

and 300 mg/kg

semipreserves of fish and marinades of

fish, crustaceans and molluscs

— Sauces

350 mg/kg

— Mustard

350 mg/kg

— Fine bakery products for special 1 700 mg/kg

nutritional uses

— Complete formulae for weight control 800 mg/kg

intended to replace total daily food

intake or an individual meal

— Complete formulae and nutritional 1 000 mg/kg

supplements for use under medical

supervision

— Liquid food supplements/dietary 600 mg/kg

integrators

— Solid food supplements/dietary 2 000 mg/kg

integrators

— Food supplements/diet integrators 5 500 mg/kg

based on vitamins and/or mineral

elements, syrup-type or chewable

— Breakfast cereals with a fibre content 1 000 mg/kg

of more than 15 %, and containing at

least 20 % bran, energy-reduced or with

no added sugar

— Energy-reduced soups

110 mg/l

— Breath-freshening micro-sweets, with 6 000 mg/kg

no added sugar

— Strongly flavoured freshening throat 2 000 mg/kg

pastilles with no added sugar

— Energy-reduced beer

25 mg/l

— Drinks consisting of a mixture of a 600 mg/l

non-alcoholic drink and beer, cider,

perry, spirits or wine

— Spirit drinks containing less than 15 600 mg/kg

% alcohol by volume

— Feinkostsalat

350 mg/kg

Cyclamic acid and its

Non-alcoholic drinks

Na and Ca salts

— Water-based flavoured drinks, 400 mg/l

energy-reduced or with no added sugar

— Milk- and milk-derivative-based or 400 mg/l

fruit-juice-based drinks, energy-reduced

or with no added sugar

E No

Name

Foodstuffs

Maximum

usable dose

— Cocoa-, milk-, dried-fruit- or fat- 200 mg/kg

based sandwich spreads, energy-reduced

or with no added sugar

— Chewing gum with no added sugar

1 200 mg/kg

— Cider and perry

80 mg/l

— Alcohol-free beer or with an alcohol 80 mg/l

content not exceeding 1,2 % vol

— ‘Bière de table/Tafelbier/Table beer’ 80 mg/l

(original wort content less than 6 %)

except ‘Obergäriges Einfachbier’

— Beers with a minimum acidity of 30 80 mg/l

milli-equivalents expressed as NaOH

— Brown beers of the ‘oud bruin’ type

80 mg/l

— Edible ices, energy-reduced or with 100 mg/kg

no added sugar

— Canned or bottled fruit, energy- 200 mg/kg

reduced or with no added sugar

— Energy-reduced jams, jellies and 200 mg/kg

marmalades

— Energy-reduced fruit and vegetable 200 mg/kg

preparations

— Sweet-sour preserves of fruit and 160 mg/kg

vegetables

—

Sweet-sour

preserves

and 160 mg/kg

semipreserves of fish and marinades of

fish, crustaceans and molluscs

— Sauces

160 mg/kg

— Mustard

320 mg/kg

— Fine bakery products for special 170 mg/kg

nutritional uses

— Complete formulae for weight control 240 mg/kg

intended to replace total daily food

intake or an individual meal

— Complete formulae and nutritional 200 mg/kg

supplements for use under medical

supervision

— Liquid food supplements/dietary 80 mg/kg

integrators

— Solid food supplements/dietary 500 mg/kg

integrators

— Food supplements/diet integrators 1 200 mg/kg

based on vitamins and/or mineral

elements, syrup-type or chewable

E No

Name

Foodstuffs

Maximum

usable dose

— Breakfast cereals with a fibre content 100 mg/kg

of more than 15 %, and containing at

least 20 % bran, energy-reduced or with

no added sugar

— Energy-reduced soups

110 mg/l

— Breath-freshening micro-sweets, with 3 000 mg/kg

no added sugar

— Drinks consisting of a mixture of a 80 mg/l

non-alcoholic drink and beer, cider,

perry, spirits or wine

— Spirit drinks containing less than 15 80 mg/kg

% alcohol by volume

— Cornets and wafers, for ice-cream, 800 mg/kg

with no added sugar

— Feinkostsalat

160 mg/kg

Thaumatin

Confectionery

50 mg/kg

— Confectionery with no added sugar

dried-fruit-based 50 mg/kg

—

Cocoa-

or

confectionery, energy-reduced or with no

added sugar

50 mg/kg

— Chewing gum with no added sugar

— Food supplements/diet integrators 400 mg/kg

based on vitamins and/or mineral

elements, syrup-type or chewable

— Edible ices, energy-reduced or with 50 mg/kg

no added sugar

Neohesperidine DC

Non-alcoholic drinks

— Water-based flavoured drinks, 30 mg/l

energy-reduced or with no added sugar

— Milk- and milk-derivative-based 50 mg/l

drinks, energy-reduced or with no added

sugar

— Fruit-juice-based drinks, energy 30 mg/l

reduced or with no added sugar

Desserts and similar products

— Water-based flavoured desserts, 50 mg/kg

energy-reduced or with no added sugar

— Milk- and milk-derivative-based 50 mg/kg

preparations, energy-reduced or with no

added sugar

— Fruit- and vegetable-based desserts, 50 mg/kg

energy-reduced or with no added sugar

— Egg-based desserts, energy-reduced 50 mg/kg

or with no added sugar

— Cereal-based desserts, energy reduced 50 mg/kg

or with no added sugar

— Fat-based desserts, energy-reduced or 50 mg/kg

with no added sugar

E No

Name

Foodstuffs

Maximum

usable dose

Confectionery

100 mg/kg

— Confectionery with no added sugar

100 mg/kg

—

Cocoa-

or

dried-fruit-based

confectionery, energy-reduced or with no

added sugar

150 mg/kg

— Starch-based confectionery, energy-

reduced or with no added sugar

50 mg/kg

— Cocoa-, milk-, dried-fruit- or fat-

based sandwich spreads, energy-reduced

or with no added sugar

400 mg/kg

— Chewing gum with no added sugar

— Cider and perry

20 mg/l

— Alcohol-free beer or with an alcohol

10 mg/l

content not exceeding 1,2 % vol

— ‘Bière de table/Tafelbier/Table beer’

10 mg/l

(original wort content less than 6 %)

except ‘Obergäriges Einfachbier’

— Beers with a minimum acidity of 30

10 mg/l

milli-equivalents expressed as NaOH

— Brown beers of the ‘oud bruin’ type

10 mg/l

E No

Name

Foodstuffs

Maximum

usable dose

— Edible ices, energy-reduced or with 50 mg/kg

no added sugar

— Canned or bottled fruit, energy 50 mg/kg

reduced or with no added sugar

— Energy-reduced jams, jellies and 50 mg/kg

marmalades

— Sweet-sour preserves of fruit and 100 mg/kg

vegetables

— Energy-reduced fruit and vegetable 50 mg/kg

preparations

—

Sweet-sour

preserves

and 30 mg/kg

semipreserves of fish and marinades of

fish, crustaceans and molluscs

— Sauces

50 mg/kg

— Mustard

50 mg/kg

— Fine bakery products for special 150 mg/kg

nutritional uses

— Complete formulae for weight control 100 mg/kg

intended to replace total daily food

intake or an individual meal

— Liquid food supplements/dietary 50 mg/kg

integrators

— Solid food supplements/dietary 100 mg/kg

integrators

— Breakfast cereals with a fibre content 50 mg/kg

of more than 15 %, and containing at

least 20 % bran, energy-reduced or with

no added sugar

— Energy-reduced soups

50 mg/l

— Breath-freshening micro-sweets, with 400 mg/kg

no added sugar

— Food supplements/diet integrators 400 mg/kg

based on vitamins and/or mineral

elements, syrup-type or chewable

— Drinks consisting of a mixture of a 30 mg/l

non-alcoholic drink and beer, cider,

perry, spirits or wine

— Spirit drinks containing less than 15 30 mg/kg

% alcohol by volume

— Cornets and wafers, for icecream, 50 mg/kg

with no added sugar

— Feinkostsalat

50 mg/kg

— Energy reduced beer

10 mg/kg

— Complete formulae and nutritional 100 mg/kg

supplements for use under medical

supervision

— ‘Snacks’: certain flavours of ready to 50 mg/kg

eat, prepacked, dry, savoury starch

products and coated nuts

Note

1. For the substance E 952, cyclamic acid and its Na and Ca salts, maximum usable

doses are expressed in free acid.

2. For the substance E 954, saccharin and its Na, K and Ca salts, maximum usable

doses are expressed in free imide.

Mitbug] fl-Istamperija tal-Gvern - Printed at the Government Printing Press

(1) These regulations shall apply to sweeteners which are Scope and

applicability

used>

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

to foodstuffs,

(b) as table top sweeteners.

(2) These regulations shall not apply to foodstuffs with

sweetening properties.

In these regulations, unless the context otherwise requires>

Interpretation

“Act” means the Food Safety 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 may be placed on the market with a view to>

(a)

sale to the ultimate consumer, or

(b) use in the manufacture of foodstuffs.

(2) Sweeteners referred to in paragraph 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.

(3) The provisions of paragraphs 4.1 and 4.2 of these

regulations shall supersede any other requirement in any other

regulations which are in conflict with these regulations.

(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.

(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.

(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 paragraph 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 Provisions

89 of 1994 and L.N.

specific regulations permitting additives listed in the Schedule to be 310 of 2001

used for purposes other than sweetening.

(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 Table-top

Sweeteners

include the term - “………. - based table-top sweetener”, using the

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

(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”.

Sweeteners intended for use in foodstuffs or as table-top Purity Criteria

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

Community Directive 95#31#EC, as amended.

(1) The Sweeteners for Use in Foodstuffs Regulations, 2000 Repeal

of 2000

are hereby repealed.

(2) Any reference in any other regulations to the Sweeteners

in Food Regulations, 2000 shall be construed as a reference to these

regulations.

B

(1) Ir-Regolamenti ta’ l-2000 dwar Dol/ifikanti li Jintu]aw T[assir ta’ A.L.

268 ta’ l-2000

f’ O;;etti ta’ l-Ikel, huma b’ dan im[assra.

(2) Kull riferenza f’ xi regolamenti o[ra g[ar-Regolamenti

ta’ l-2000 dwar Dol/ifikanti li Jintu]aw f’ O;;etti ta’ l-Ikel, g[andha

tiftiehem b[ala riferenza g[al dawn ir-regolamenti.