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PERMITTED FOOD ADDITIVES REGULATIONS

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Laws of Malta — Subsidiary Legislation 449.48 — PERMITTED FOOD ADDITIVES REGULATIONS

PERMITTED FOOD ADDITIVES

SUBSIDIARY LEGISLATION 449.48

PERMITTED FOOD ADDITIVES REGULATIONS

27th July, 2005

LEGAL NOTICE 54 of 2005, as amended by Legal Notices 92 of 2008,

81 of 2010 and 171 of 2011.

Laws of Malta — Subsidiary Legislation 449.48 — PERMITTED FOOD ADDITIVES REGULATIONS

1. The title of these regulations is the Permitted Food

Additives Regulations.

1.2 Products not conforming with these regulations but which

conform with the provisions of the Permitted Food Additives

Regulations, 2003 * , and which have been placed on the market by

the 27 th January, 2006 at the latest, may be marketed until stocks

are exhausted.

1.3 These regulations shall complement the Additives in Food

Regulations.

1.4 These regulations implement the provisions of Directive

95/2/EC of the European Parliament and of the Council of the 20th

F e b r u a r y, 1 9 9 5 o n f o o d a d d i t i v e s o t h e r t h a n c o l o u r s a n d

sweeteners, as amended by the following Directives

-

Directive 96/85/EC of the European Parliament and of

the Council of the 19th December 1996

-

Directive 98/72/EC of the European Parliament and of

the Council of the 15th October 1998

-

Directive 2001/5/EC of the European Parliament and

of the Council of the 12th February 2001

-

Directive 2003/52/EC of the European Parliament and

of the Council of the 18th June 2003

-

Directive 2003/114/EC of the European Parliament

and of the Council of the 22nd December 2003

-

Directive 2006/52/EC of the European Parliament and

of the Council of the 5th July 2006

-

Commission Directive 2010/69/EU of the 22nd

October 2010

-

Commission Directive 2008/84/EC of the 27th August

2008 laying down specific purity criteria on food

additives other than colours and sweeteners, as

amended by the following Directives

-

Commission Directive 2009/10/EC of the 13th

February 2009

-

Commission Directive 2010/67/EU of the 20th

October 2010.

Laws of Malta — Subsidiary Legislation 449.48 — PERMITTED FOOD ADDITIVES REGULATIONS

Amended by

L.N. 92 of 2008.

Food Additives generally permitted for use in

Foodstuffs not referred to in Regulation 4.3.1

Note

1. Substances on this list may be added to all foodstuffs with the exception of

those referred to in regulation 4.3.1 following the quantum satis principle.

2. The substances listed under numbers E 407, E 407a and E 440 may be

standardised with sugars, on condition that this is stated in addition to the number

and designation.

3. Explanation of symbols used

*

The substances E 290, E 938, E 939, E 941, E 942, E 948 and E949 may

also be used in the foodstuffs referred to in regulation 4.3.1.

#

The substances E 410, E 412, E 415 and E 417 may not be used to

produce dehydrated foodstuffs intended to rehydrate on ingestion

4. The substances listed under numbers E 400, E 401, E 402, E 403, E 404, E

406, E 407, E 407a, E 410, E 412, E 413, E 414, E 415, E 417, E 418 and E 440 may

not be used in jelly mini-cups, defined, for the purpose of these regulations, as jelly

confectionery of a firm consistence, contained in semi-rigid mini-cups or mini-

capsules, intended to be ingested in a single bite by exerting pressure on the mini-

cups or mini-capsule to project the confectionery into the mouth..

E Number

Name

Calcium carbonate

Acetic acid

Potassium acetate

Sodium acetates

(i) sodium acetate

(ii) sodium hydrogen acetate (sodium diacetate)

Calcium acetate

Lactic acid

Carbon dioxide*

Malic acid

Ascorbic acid

Sodium ascorbate

Calcium ascorbate

Fatty acid esters of ascorbic acid

(i) Ascorbyl palmitate

(ii) Ascorbyl stearate

Tocopherol-rich extract

Alpha-tocopherol

Gamma-tocopherol

Delta-tocopherol

Lecithins

E Number

Name

Sodium lactate

Potassium lactate

Calcium lactate

Citric acid

Sodium citrates

(i) Monosodium citrate

(ii) Disodium citrate

(iii) Trisodium citrate

Potassium citrates

(i) Monopotassium citrate

(ii) Tripotassium citrate

Calcium citrates

(i) Monocalcium citrate

(ii) Dicalcium citrate

(iii) Tricalcium citrate

Tartaric acid (L(+)-)

Sodium tartrates

(i) Monosodium tartrate

(ii) Disodiumtartrate

Potassium tartrates

(i) Monopotassium tartrate

(ii) Dipotassium tartrate

Sodium potassium tartrate

Sodium malates

(i) Sodium malate

(ii) Sodium hydrogen malate

Potassium malate

Calcium malates

(i) Calcium malate

(ii) Calcium hydrogen malate

Calcium tartrate

Triammonium citrate

Alginic acid

Sodium alginate

Potassium alginate

Ammonium alginate

Calcium alginate

Agar

Carrageenan

E 407a

Processed eucheuma seaweed

Locust bean gum

Name

Guar gum

Tragacanth

Acacia gum (gum arabic)

Xanthan gum

Tara gum

Gellan gum

Glycerol

Pectins

(i) pectin

(ii) amidated pectin

Cellulose

(i) Microcrystalline cellulose

(ii) Powdered cellulose

Methyl cellulose

Ethyl cellulose

Hydroxypropyl cellulose

Hydroxypropyl methyl cellulose

Ethyl methyl cellulose

Carboxy methyl cellulose

Sodium carboxy methyl cellulose

Cellulose gum

Enzymetically hydrolysed carboxy methyl cellulose

Enzymetically hydrolysed cellulose gum

Sodium, potassium and calcium salts of fatty acids

Magnesium salts of fatty acids

Mono- and diglycerides of fatty acids

Acetic acid esters of mono- and diglycerides of fatty acids

Lactic acid esters of mono- and diglycerides of fatty acids

Citric acid esters of mono- and diglycerides of fatty acids

Tartaric acid esters of mono- and diglycerides of fatty acids

Mono- and diacetyl tartaric acid esters of mono- and diglycerides

of fatty acids

Mixed acetic and tartaric acid esters of mono- and diglycerides of

fatty acids

Sodium carbonates

(i) Sodium carbonate

(ii) Sodium hydrogen carbonate

(iii) Sodium sesquicarbonate

Potassium carbonates

(i) Potassium carbonate

(ii) Potassium hydrogen carbonate

Ammonium carbonates

E Number

Name

(i) Ammonium carbonate

(ii) Ammonium hydrogen carbonate

Magnesium carbonates

(i) Magnesium carbonate

(ii) Magnesium hydroxide carbonate

Hydrochloric acid

Potassium chloride

Calcium chloride

Magnesium chloride

Sulphuric acid

Sodium sulphates

(i) Sodium sulphate

(ii) Sodium hydrogen sulphate

Potassium sulphates

(i) Potassium sulphate

(ii) Potassium hydrogen sulphate

Calcium sulphate

Sodium hydroxide

Potassium hydroxide

Calcium hydroxide

Ammonium hydroxide

Magnesium hydroxide

Calcium oxide

Magnesium oxide

Fatty acids

Gluconic acid

Glucono-delta-lactone

Sodium gluconate

Potassium gluconate

Calcium gluconate

Glycine and its sodium salt

E 920 ( 2 )

L-cysteine

Argon*

Helium*

Nitrogen*

Nitrous oxide*

Oxygen*

Hydrogen*

Invertase

Polydextrose

Oxidised starch

E Number

Name

Monostarch phosphate

Distarch phosphate

Phosphated distarch phosphate

Acetylated distarch phosphate

Acetylated starch

Acetylated distarch adipate

Hydroxy propyl starch

Hydroxy propyl distarch phosphate

Starch sodium octenyl succinate

Acetylated oxidised starch

May only be used as a flour treatment agent.

Laws of Malta — Subsidiary Legislation 449.48 — PERMITTED FOOD ADDITIVES REGULATIONS

1. These regulations shall apply to all food additives other

than colours, sweeteners, and flavourings.

*Legal Notice 347 of 2003 - Revoked by these regulations.

PERMITTED FOOD ADDITIVES

2.2 These regulations shall apply without prejudice to specific

regulations permitting additives listed in the Schedules to be used

as sweeteners and colours.

2.3 These regulations shall not apply to enzymes other than

those mentioned in the Schedules.

Laws of Malta — Subsidiary Legislation 449.48 — PERMITTED FOOD ADDITIVES REGULATIONS

Amended by

L.N. 92 of 2008;

Foodstuffs in which a limited number of additives of L.N. 171 of 2011.

the First Schedule may be used

Foodstuff

Additive

Maximum level

Cocoa and chocolate products

E 330 Citric acid

0.5%

as defined the the Cocoa and

E 322 Lecithins

quantum satis

Chocolate

Products

E 334 Tartaric acid

0.5%

Regulations

E 422 Glycerol

quantum satis

E 471 Mono- and diglycerides of

fatty acids

quantum satis

E 472c Citric acid esters of mono-

and diglycerides of fatty

acids

quantum satis

E 170 Calcium carbonates

E 500 Sodium carbonates

E 501 Potassium carbonates

E 503 Ammonium carbonates

E 504 Magnesium carbonates

7% on dry matter

without fat

E 524 Sodium hydroxide

expressed as

E 525 Potassium hydroxide

potassium

E 526 Calcium hydroxide

carbonates

E 527 Ammonium hydroxide

E 528 Magnesium hydroxide

E 530 Magnesium oxide

E 414 Acacia gum

as glazing agents

only;

Foodstuff

Additive

Maximum level

E 440 Pectins

quantum satis

Fruit juices and nectars as

E 300 Ascorbic acid

quantum satis

defined in the Fruit Juices and

Similar Products Regulations

Pineapple juice as defined in

E 296 Malic acid

3 g/l

the Fruit Juices and Similar

Products Regulations

Nectars as defined in the Fruit

E 330 Citric acid

5 g/l

Juices and Similar Products

E 270 Lactic acid

5 g/l

Regulations

Grape juice as defined in the

E 170 Calcium carbonates

quantum satis

Fruit Juices and Similar

E 336 Potassium tartrates

quantum satis

Products Regulations

Fruit juices as defined in the

E 330 Citric acid

3 g/l

Fruit Juices and Similar

Products Regulations

Extra jam and extra jelly as

Pectins

quantum satis

defined in the Fruit Jams and

Lactic acid

quantum satis

Similar Products Regulations

Ascorbic acid

quantum satis

Calcium lactate

quantum satis

Citric acid

quantum satis

Sodium citrates

quantum satis

Calcium citrates

quantum satis

Tartaric acid

quantum satis

Sodium tartrates

quantum satis

Sodium malates

quantum satis

Mono- and diglycerides of

fatty acids

quantum satis

Jams, jellies and marmalades

Pectins

quantum satis

as defined in the Fruit Jams

Lactic acid

quantum satis

and

Similar

Products

Malic acid

quantum satis

Regulations and other similar

fruit spreads including

Ascorbic acid

quantum satis

low-calorie products

Calcium lactate

quantum satis

Citric acid

quantum satis

Sodium citrates

quantum satis

Calcium citrates

quantum satis

Tartaric acid

quantum satis

Sodium tartrates

quantum satis

Sodium malates

quantum satis

Alginic acid

Sodium alginate

Potassium alginate

Ammonium alginate

Foodstuff

Additive

Maximum level

Calcium alginate

10 g/kg

Agar

(individually or

Carrageenan

in combination)

Locust bean gum

Guar gum

Xanthan gum

Gellan gum

Mono and diglycerides of

fatty acids

quantum satis

Calcium chloride

quantum satis

Sodium hydroxide

quantum satis

Partially dehydrated and

E 300 Ascorbic acid

quantum satis

dehydrated milk as defined in

E 301 Sodium ascorbate

quantum satis

the

Preserved

Milk

E 304 Fatty acid esters of ascorbic

Regulations

acid

quantum satis

E 322 Lecithins

quantum satis

E 331 Sodium citrates

quantum satis

E 332 Potassium citrates

quantum satis

E 407 Carrageenan

quantum satis

E 500 (ii) Sodium bicarbonate

quantum satis

E 501 (ii) Potassium bicarbonate

quantum satis

E 509 Calcium chloride

quantum satis

Plain pasteurised cream

Sodium alginate

quantum satis

Potassium alginate

quantum satis

Carrageenan

quantum satis

Sodium carboxy methyl

cellulose

quantum satis

E 471 Mono- and diglycerides of

fatty acids

quantum satis

F r o z e n a n d d e e p -f r o z e n

E 296 Malic acid (only for peeled

unprocessed fruit and

potatoes

quantum satis

vegetables; pre-packed,

E 300 Ascorbic acid

quantum satis

refrigerated unprocessed fruit

E 301 Sodium ascorbate

quantum satis

and vegetables ready for

consumption and prepacked

E 302 Calcium ascorbate

quantum satis

unprocessed and peeled

E 330 Citric acid

quantum satis

potatoes

E 331 Sodium citrates

quantum satis

E 332 Potassium citrates

quantum satis

E 333 Calcium citrates

quantum satis

Fruit compote

Ascorbic acid

quantum satis

Sodium ascorbate

quantum satis

Calcium ascorbate

quantum satis

Citric acid

quantum satis

Foodstuff

Additive

Maximum level

Sodium citrates

quantum satis

Potassium citrates

quantum satis

Calcium citrates

quantum satis

Pectin (only for fruit

compote other than apple)

quantum satis

Calcium chloride (only for

fr uit compote oth er than

apple)

quantum satis

Unprocessed fish, crustaceans

Ascorbic acid

quantum satis

and molluscs, including such

Sodium ascorbate

quantum satis

products frozen and deep-

Calcium ascorbate

quantum satis

frozen

Citric acid

quantum satis

Sodium citrates

quantum satis

Potassium citrates

quantum satis

Calcium citrates

quantum satis

Quick-cook rice

E 471 Mono- and diglycerides of

fatty acids

quantum satis

E 472a Acetic acid esters of mono-

and diglycerides of fatty

acids

quantum satis

Non emulsified oils and fats of

E 304 Fatty acid esters of ascorbic

animal or vegetable origin

acid

quantum satis

(except virgin oils and olive

E 306 Tocopherol-rich extract

quantum satis

oils)

E 307 Alpha-tocopherol

quantum satis

E 308 Gamma-tocopherol

quantum satis

E 309 Delta-tocopherol

quantum satis

E 322 Lecithins

30 g/l

E 471 Mono- and diglycerides of

fatty acids

10 g/l

E 330 Citric acid

quantum satis

E 331 Sodium citrates

quantum satis

E 332 Potassium citrates

quantum satis

E 333 Calcium citrates

quantum satis

Non emulsified oils and fats of

E270 Lactic acid

animal or vegetable origin

E300 Ascorbic acid

(except virgin oils and olive

E 304 Fatty acid esters of ascorbic

oils) specifically intended for

acid

quantum satis

cooking and/or frying purposes

or for the preparation of gravy

E 306 Tocopherol-rich extract

quantum satis

E 307 Alpha-tocopherol

quantum satis

E 308 Gamma-tocopherol

quantum satis

E 309 Delta-tocopherol

quantum satis

E 322 Lecithins

30 g/l

E 471 Mono- and diglycerides of

fatty acids

10 g/l

Foodstuff

Additive

Maximum level

E 472c Citric acid esters of mono-

and diglycerides of fatty

acids

quantum satis

E 330 Citric acid

quantum satis

E 331 Sodium citrates

quantum satis

E 332 Potassium citrates

quantum satis

E 333 Calcium citrates

quantum satis

Refined olive oil, including

E 307 Alpha-tocopherol

200 mg/l

olive pomace oil

Ripened cheese

E 170 Calcium carbonates

quantum satis

E 504 Magnesium carbonates

quantum satis

E 509 Calcium chloride

quantum satis

E 575 Glucono-delta-lactone

quantum satis

E 500(ii) Sodium hydrogen

quantum satis

carbonate

(only for sour

milk cheese)

Mozzarella and whey cheese

E 260 Acetic acid

quantum satis

E 270 Lactic acid

quantum satis

E 330 Citric acid

quantum satis

E 460ii Powdered cellulose (only

for grated and sliced

cheese)

quantum satis

E 575 Glucono-delta-lactone

quantum satis

Canned and bottled fruit and

Acetic acid

quantum satis

vegetables

Potassium acetate

quantum satis

Sodium acetates

quantum satis

Calcium acetate

quantum satis

Lactic acid

quantum satis

Malic acid

quantum satis

Ascorbic acid

quantum satis

Sodium ascorbate

quantum satis

Calcium ascorbate

quantum satis

Sodium lactate

quantum satis

Potassium lactate

quantum satis

Calcium lactate

quantum satis

Citric acid

quantum satis

Sodium citrates

quantum satis

Potassium citrates

quantum satis

Calcium citrates

quantum satis

Tartaric acid

quantum satis

Sodium tartrates

quantum satis

Potassium tartrates

quantum satis

Sodium potassium tartrate

quantum satis

Calcium chloride

quantum satis

Foodstuff

Additive

Maximum level

E 575 Glucono-delta-lactone

quantum satis

Gehakt

Ascorbic acid

quantum satis

Sodium ascorbate

quantum satis

Calcium ascorbate

quantum satis

Citric acid

quantum satis

Sodium citrates

quantum satis

Potassium citrates

quantum satis

Calcium citrates

quantum satis

P r e -p a c k e d p r e p a r a t i o n s o f

E 261 Potassium acetate

quantum satis

fresh minced meat

E 262i Sodium acetate

quantum satis

E 262ii Sodium hydrogen acetate

quantum satis

E 300 Ascorbic acid

quantum satis

E 301 Sodium ascorbate

quantum satis

E 302 Calcium ascorbate

quantum satis

E 325 Sodium lactate

quantum satis

E 326 Potassium lactate

quantum satis

E 330 Citric acid

quantum satis

E 331 Sodium citrates

quantum satis

E 332 Potassium citrates

quantum satis

E 333 Calcium citrates

quantum satis

Bread prepared solely with the

E 260 Acetic acid

quantum satis

following

ingredients

E 261 Potassium acetate

quantum satis

wheat-flour, water, yeast or

E 262 Sodium acetates

leaven, salt

quantum satis

Calcium acetate

quantum satis

Lactic acid

quantum satis

Ascorbic acid

quantum satis

Sodium ascorbate

quantum satis

Calcium ascorbate

quantum satis

Fatty acid esters of ascorbic

acid

quantum satis

E 322 Lecithins

quantum satis

E 325 Sodium lactate

quantum satis

E 326 Potassium lactate

quantum satis

E 327 Calcium lactate

quantum satis

E 471 Mono- and diglycerides of

fatty acids

quantum satis

E 472a Acetic acid esters of mono-

and diglycerides of fatty

acids

quantum satis

E 472d Tartaric acid esters of

mono- and diglycerides of

fatty acids

quantum satis

Foodstuff

Additive

Maximum level

E 472e Mono- and diacetyl tartaric

acid esters of mono- and

diglycerides of fatty acids

quantum satis

E 472f Mixed acetic and tartaric

acid esters of mono- and

diglycerides of fatty acids

quantum satis

Pain courant francais

E 260 Acetic acid

quantum satis

F r i s s b ú z a k e n y é r, f e h é r é s

E 261 Potassium acetate

félbarna kenyerek

quantum satis

Sodium acetates

quantum satis

Calcium acetate

quantum satis

Lactic acid

quantum satis

Ascorbic acid

quantum satis

Sodium ascorbate

quantum satis

Calcium ascorbate

quantum satis

Fatty acid esters of ascorbic

acid

quantum satis

Lecithins

quantum satis

Sodium lactate

quantum satis

Potassium lactate

quantum satis

Calcium lactate

quantum satis

Mono- and diglycerides of

fatty acids

quantum satis

Fresh pasta

Lactic acid

quantum satis

Ascorbic acid

quantum satis

Sodium ascorbate

quantum satis

Lecithins

quantum satis

Citric acid

quantum satis

Tartaric acid

quantum satis

Mono- and diglycerides of

fatty acids

quantum satis

E 575 Glucono-delta-lactone

quantum satis

Wines and sparkling wines and

Additives authorised

pro memoria

partially fermented grape must

In accordance with Regulations

(EEC) No 822/87 ( 3 ), (EEC) No

4252/88 ( 4 ), (EEC) No 233292 ( 5 )

and (EEC) No 1873/84 ( 6 ) and their

implementing regulations

In accordance with Regulation

(EEC) No 1873/84 authorizing the

offer or disposal for direct human

consumption of certain imported

wines which may have undergone

oenological processes not provided

for in Regulation (EEC) No 337/79

Beer

E 270 Lactic acid

quantum satis

Foodstuff

Additive

Maximum level

Ascorbic acid

quantum satis

Sodium ascorbate

quantum satis

Citric acid

quantum satis

Acacia gum

quantum satis

Fo ie gras, fo ie gras ent ier,

E 300 Ascorbic acid

quantum satis

blocs de foie gras

E 301 Sodium ascorbate

quantum satis

Libamáj, libamáj egészben,

libamáj tömbben

Pin eapple and passion fruit

E 440 Pectins

3 g/l

juices and nectars

Sliced and grated ripened

Calcium carbonates

quantum satis

cheese

Magnesium carbonates

quantum satis

Calcium chloride

quantum satis

Glucono-delta-lactone

quantum satis

Cellulose

quantum satis

Soured-cream butter

E 500 Sodium carbonates

quantum satis

UHT goat milk

E 331 Sodium citrates

4 g/l

Chestnuts in liquid

E 410 Locust bean gum

quantum satis

E 412 Guar gum

quantum satis

E 415 Xanthan gum

quantum satis

Unflavoured live fermented

Agar

quantum satis

cream products and substitute

Carrageenan

quantum satis

products with a fat content of

Locust bean gum

quantum satis

less than 20%

Guar gum

quantum satis

Xanthan gum

quantum satis

Pectins

quantum satis

Cellulose

quantum satis

Carboxy methyl cellulose

quantum satis

Mono- and diglycerides of

quantum satis

fatty acids

E 1404 Oxidised starch

quantum satis

E 1410 Monostarch phosphate

quantum satis

E 1412 Distarch phosphate

quantum satis

E 1413 Phosphated

distarch

quantum satis

phosphate

E 1414 Acetylated

distarch

quantum satis

phosphate

E 1420 Acetylated starch

quantum satis

E 1422 Acetylated distarch adipate

quantum satis

Foodstuff

Additive

Maximum level

E 1440 Hydroxyl propyl starch

quantum satis

E 1442 Hydroxy propyl distarch

quantum satis

phosphate

E 1450 Starch

sodium

octenyl

quantum satis

succinate

E 1451 Acetylated oxidised starch

quantum satis

Cocoa and chocolate products energy-reduced or with no added sugars are not covered by the

Second Schedule.

May be used only as a flour treatment agent.

OJ No L 84, 27.3.1987, p.1

OJ No L 373, 31.12.1988, p.59

OJ No L 231, 13.8.1992, p.1

OJ No L 176, 3.7.1984, p.6

Laws of Malta — Subsidiary Legislation 449.48 — PERMITTED FOOD ADDITIVES REGULATIONS

1. In these regulations, unless the context otherwise requires

3.1.1

preservatives are substances which prolong the

shelflife of foodstuffs by protecting them against

deterioration caused by micro-organisms;

3.1.2

antioxidants are substances which prolong the

shelflife of foodstuffs by protecting them against

deterioration caused by oxidation, such as fat

rancidity and colour changes;

3.1.3

carriers, including carrier solvents, are substances

used to dissolve, dilute, disperse or otherwise

physically modify a food additive or flavouring

without altering its function (and without exerting

any technological effect themselves) in order to

facilitate its handling, application or use;

3.1.4

acids are substances which increase the acidity of a

foodstuff and,or impart a sour taste to it;

3.1.5

acidity regulators are substances which alter or

control the acidity or alkalinity of a foodstuff;

3.1.6

anti-caking agents are substances which reduce the

tendency of individual particles of a foodstuff to

adhere to one another;

3.1.7

anti-foaming agents are substances which prevent

or reduce foaming;

3.1.8

bulking agents are substances which contribute to

the volume of a foodstuff without contributing

significantly to its available energy value;

3.1.9

emulsifiers are substances which make it possible

to form or maintain a homogenous mixture of two

or more immiscible phases such as oil and water in

a foodstuff;

3.1.10 emulsifying salts are substances which convert

proteins contained in cheese into a dispersed form

and thereby bring about homogenous distribution

of fat and other components;

3.1.11 firming agents are substances which make or keep

tissues of fruit or vegetables firm or crisp, or

interact with gelling agents to produce or

strengthen a gel;

3.1.12 flavour enhancers are substances which enhance

the existing taste and,or odour of a foodstuff;

3.1.13 foaming agents are substances which make it

possible to form a homogenous dispersion of a

gaseous phase in a liquid or solid foodstuff;

PERMITTED FOOD ADDITIVES

3.1.14 gelling agents are substances which give a

foodstuff texture through formation of a gel;

3.1.15 glazing agents (including lubricants) are substances

which, when applied to the external surface of a

foodstuff, impart a shiny appearance or provide a

protective coating;

3.1.16 humectants are substances which prevent

foodstuffs from drying out by counteracting the

effect of an atmosphere having a low degree of

humidity, or promote the dissolution of a powder in

an aqueous medium;

3.1.17 modified starches are substances obtained by one or

more chemical treatments of edible starches, which

may have undergone a physical or enzymatic

treatment, and may be acid or alkali thinned or

bleached;

3.1.18 packaging gases are gases other than air,

introduced into a container before, during or after

the placing of a foodstuff in that container;

3.1.19 propellants are gases other than air which expel a

foodstuff from a container;

3.1.20 raising agents are substances or combinations of

substances which liberate gas and thereby increase

the volume of a dough or batter;

3.1.21 sequestrants are substances which form chemical

complexes with metallic ions;

3.1.22 stabilisers are substances which make it possible to

maintain the physico-chemical state of a foodstuff;

stabilisers include substances which enable the

maintenance of a homogenous dispersion of two or

more immiscible substances in a foodstuff and

include also substances which stabilise, retain or

intensify an existing colour of a foodstuff and

substances which increase the binding capacity of

the food, including the formation of cross links

between proteins enabling the binding of food

pieces into reconstituted food;

3.1.23 thickeners are substances which increase the

viscosity of a foodstuff;

3.1.24 flour treatment agents other than emulsifiers are

substances which are added to flour or dough to

improve its baking quality.

3.2 For the purposes of these regulations, the following are not

considered as food additives

3.2.1

substances used for the treatment of drinking water

as provided for in Directive 80/778/EEC;

3.2.2

products containing pectin and derived from dried

apple pomace or peel of citrus fruits, or from a

mixture of both, by the action of dilute acid

PERMITTED FOOD ADDITIVES

followed by partial neutralisation with sodium or

potassium salts (‘liquid pectin’);

3.2.3

chewing gum bases;

3.2.4

white or yellow dextrin, roasted or dextrinated

starch, starch modified by acid or alkali treatment,

bleached starch, physically modified starch and

starch treated by amylolitic enzymes;

3.2.5

ammonium chloride;

3.2.6

blood plasma, edible gelatine, protein hydrolysates

and their salts, milk protein and gluten;

3.2.7

amino acids and their salts other than glutamic

acid, glycine, cysteine and cystine and their salts

and having no additive function;

3.2.8

caseinates and casein;

3.2.9

inulin.

3.3 Within these regulations, the term ‘unprocessed’ means not

having undergone any treatment resulting in a substantial change in

the original state of the foodstuffs; however, the foodstuffs may

have been, for example, divided, parted, severed, boned, minced,

skinned, pared, peeled, ground, cut, cleaned, trimmed, deep-frozen

or frozen, chilled, milled or husked, packed or unpacked.

3.4 In these regulations and the Schedules thereto, quantum

satis means that no maximum level is specified. However, additives

shall be used in accordance with good manufacturing practice, at a

level not higher than is necessary to achieve the intended purpose

and provided that they do not mislead the consumer.

Laws of Malta — Subsidiary Legislation 449.48 — PERMITTED FOOD ADDITIVES REGULATIONS

Amended by

L.N. 92 of 2008;

Conditionally permitted preservatives and antioxidants

L.N. 171 of 2011.

PART A

Sorbates, benzoates and p-hydroxybenzoates

E Number

Name

Abbreviation

Sorbic acid

Sa

Potassium sorbate

Calcium sorbate

Ba 1

Benzoic acid

Sodium benzoate

Potassium benzoate

Calcium benzoate

Ethyl p-hydroxybenzoate

PHB

Sodium ethyl p-hydroxybenzoate

Methyl p-hydroxybenzoate

Sodium methyl p-hydroxybenzoate

1 Benzoic acid may be present in certain fermented products resulting from the fermentation process

following good manufacturing practice.

Note

1. The levels of all substances mentioned above are expressed as the free acid.

2. The abbreviations used in the table mean the following

-

Sa + Ba: Sa and Ba used singly or in combination

-

Sa + PHB: Sa and PHB used singly or in combination

-

Sa + Ba + PHB: Sa, Ba and PHB used singly or in combination.

3. The maximum levels of use indicated refer to foodstuffs ready for consumption

prepared following manufacturers’ instructions

Foodstuff

Maximum level (mg/kg or mg/l as appropriate)

Sa+Ba+

Sa

Ba

PHB

Sa+Ba

Sa+PHB

PHB

Wine-based flavoured drinks

including products covered

by Regulation (EEC) No

1601/91

N o n -a l c o h o l i c f l a v o u r e d

250 Sa +

drinks 2

150 Ba

Liquid tea concentrates and

liquid fruit and herbal

infusion concentrates

Grape juice, unfermented,

for sacramental use

Wi n e s a s r e f e r r e d t o i n

Regulation (EEC) no. 822/

87; alcohol-free wine, fruit

wine

(including

alcohol-free), Made wine,

cider and perry (including

alcohol-free)

Sød ... Saft or Sødet ... Saft

Alcohol-free beer in keg

Mead

Spirits with less than 15%

alcohol by volume

Fillings of ravioli and

similar products

L o w -s u g a r j a m s , j e l l i e s ,

marmalades and similar low

c a l o r i e o r s u g a r -f r e e

products

and

other

fruit-based spreads

Mermeladas

Candied, crystallized and

glacé fruit and vegetables

Dried fruit

This entry does not include dairy-based drinks.

Frugtgrød and Rote Grütze

Fruit

and

vegetable

preparations including

fruit-based sauces, excluding

purée, mousse, compote,

salads and similar products,

canned or bottled

Vegetables in vinegar, brine

or oil (excluding olives)

Potato dough and pre-fried

potato slices

Gnocchi

Polenta

O l i v e s a n d o l i v e -b a s e d

preparations

Foodstuff

Maximum level (mg/kg or mg/l as appropriate)

Sa+PHB Sa+Ba+

Sa

Ba

PHB

Sa+Ba

PHB

Jelly coatings of meat

products (cooked, cured or

dried); Paté

Surface treatment of dried

quantum

meat products

satis

S e m i -p r e s e r v e d

fish

products including fish roe

products

Salted, dried fish

Crangon crangon and

Crangon vulgaris, cooked

Cheese, pre-packed, sliced

Unripened cheese

Processed cheese

Layered cheese and cheese

with added foodstuffs

N o n -h e a t -t r e a t e d

dairy-based desserts

Curdled milk

Liquid egg (white, yolk or

whole egg)

Dehydrated, concentrated,

frozen and deep-frozen egg

products

Pre-packed sliced bread and

rye bread

Partially baked, pre-packed

bakery wares intended for

retail sale and energy

reduced bread intended for

retail sale

Fi n e ba k er y wa r es wit h a

water activity of more than

0.65

C e r e a l - o r p o t a t o -b a s e d

snacks and coated nuts

(max.

PHB)

Batters

Confectio nery (excluding

chocolate)

(max.

PHB)

Chewing gum

To p p i n g s ( s y r u p s f o r

pancakes, flavoured syrups

for

milkshakes

and

ice-cream; similar products)

Fa t em ul si on s ( ex cl u d in g

butter) with a fat content of

60% or more

Foodstuff

Maximum level (mg/kg or mg/l as appropriate)

Sa+PHB Sa+Ba+

Sa

Ba

PHB

Sa+Ba

PHB

F a t e m u l s i o n s w i t h a f a t 2000

content less than 60%

Emulsified sauces with a fat 1000

content of 60% or more

Emulsified sauces with a fat 2000

content less than 60%

Non-emulsified sauces

Prepared salads

Mustard

Seasonings and condiments

Liquid soups and broths

(excluding canned)

Aspic

D i e t ar y f o o d s f o r s p e c i al

medical purposes, as defined

in the Dietary Foods for

Special Medical Purposes

Regulations, excluding foods

for infants and young

c h il d r e n a s r ef e r r ed t o in

Directive 89/398/EEC;

dietetic formulae for weight

control intended to replace

total daily food intake or an

individual meal

..... Mehu and Makeuttetu

..... Mehu

A n a l o g u e s o f m e a t , f i s h , 2000

crustaceans and cephalopods

and cheese based on protein

Dulce de membrillo

Marmelada

Ostkaka

Pasha

Semmelknödelteig

Cheese and cheese analogues quantum

(surface treatment only)

satis

Cooked red beet

Collagen-based casings with quantum

a water activity greater than satis

0.6

Flavourings

Crustaceans and molluscs,

cooked

Food

supplements as

defined in the Food

S u p p l e me n t s Re g u l a t i o n s

supplied in liquid form

Seaweed-based

f i s h 1 000

analogue products

Foodstuff

Maximum level (mg/kg or mg/l as appropriate)

Sa+PHB Sa+Ba+

Sa

Ba

PHB

Sa+Ba

PHB

Beer in kegs containing

more than 0,5% added

fermentable sugar and/or

fruit juices or concentrates

Unpeeled fresh citrus fruit

1 000 in the

(surface treatment only)

product

ready for

con-

sumption

Food supplements as defined

in the Food Supplements

Regulations, supplied in

dried form containing

preparations of vitamin A

and of combinations of

vitamin A and D

PART B

Sulphur dioxide and sulphites

E Number

Name

Sulphur dioxide

Sodium sulphite

Sodium hydrogen sulphite

Sodium metabisulphite

Potassium metabisulphite

Calcium sulphite

Calcium hydrogen sulphite

Potassium hydrogen sulphite

Note

1. Maximum levels are expressed as SO 2 in mg/kg or mg/l as appropriate and relate to

the total quantity, available from all sources.

2. An SO 2 content of not more than 10 mg/kg or 10 mg/l is not considered to be present.

Foodstuff

Maximum level (mg/kg

or mg/l as appropriate)

expressed as SO 2

Burger meat with a minimum vegetable and/or cereal content of 4%

Breakfast sausages

Longaniza fresca and Butifarra fresca

Dried salted fish of the Gadidae species

Crustaceans and cephalopods

150 3

- fresh, frozen and deep-frozen

- crustaceans, Penaridae Solenceridae, Aristeidae family

150 3

- up to 80 units

200 3

- between 80 and 120 units

Foodstuff

Maximum level (mg/kg

or mg/l as appropriate)

- over 120 units

Crustaceans and cephalopods

- cooked

- crustaceans, Penaridae Solenceridae, Aristeidae family

- up to 80 units

- between 80 and 120 units

- over 120 units

Dry biscuit

Starches (excluding starches in infant formulae, follow-on formulae

and processed cereal-based foods and baby foods)

Sago

Pearl barley

Dehydrated potatoes

Cereal- and potato-based snacks

Peeled potatoes

Processed potatoes (including frozen and deep-frozen potatoes)

Potato dough

White vegetables, dried

White vegetables, processed (including frozen and deep-frozen

white vegetables)

Dried ginger

Dried tomatoes

Horseradish pulp

Onion, garlic and shallot pulp

Vegetables and fruits in vinegar, oil or brine (except olives and

golden peppers in brine)

Golden peppers in brine

Processed mushrooms (including frozen mushrooms)

Dried mushrooms

Dried fruits

- apricots, peaches, grapes, prunes and figs

- bananas

- apples and pears

- other (including nuts in shell)

Dried coconut

Candied, crystallized or glacè fruit, vegetables, angelica and citrus

peel

Jam, jelly and marmalade as defined in the Fruit Jams and Similar

Products Regulations (except extra jam and extra jelly) and other

similar fruit spreads including low-calorie products

Jams, jellies and marmelades made with sulphited fruit

Fruit-based pie filling

Citrus-juice-based seasonings

Concentrated grape juice for home wine-making

Mostarda di frutta

PERMITTED FOOD ADDITIVES

Foodstuff

Maximum level (mg/kg

or mg/l as appropriate)

Jellying fruit extract, liquid pectin for sale to the final consumer

Bottled whiteheart cherries, rehydrated dried fruit and lychees

Bottled, sliced lemon

Sugars, as defined in he Fruit Jams and Similar Products

Regulations, except glucose syrup, whether or not dehydrated

Glucose syrup, whether or not dehydrated

Treacle and molasses

Other sugars

Toppings (syrups for pancakes, flavoured syrups for milkshakes and

ice cream; similar products)

Orange, grapefruit, apple and pineapple juice for bulk dispensing in

catering establishments

Lime and lemon juice

Concentrates based on fruit juice and containing not less than 2.5%

barley (barley water)

Other concentrates based on fruit juice or comminuted fruit; capilé

groselha

Non-alcoholic flavoured drinks containing fruit juice

Non-alcoholic flavoured drinks containing at least 235 g/l glucose

syrup

Grape juice, unfermented, for sacramental use

Glucose-syrup-based confectionery

Beer including low-alcohol and alcohol-free beer

Beer with a second fermentation in the cask

Wines

Regulations (EEC) No.

No.4252/88, (EEC) No.

2332/92 and (EEC) No.

Regulation (EEC) No.

1873/84 authorizing the

consumption of certain

imported wines which

Regulation (EEC) No.

Alcohol-free wine

Made wine

Cider, perry, fruit wine, sparkling fruit wine (including alcohol-free

products)

Foodstuff

Maximum level (mg/kg

or mg/l as appropriate)

expressed as SO 2

Mead

Fermentation vinegar

Mustard, excluding Dijon mustard

Dijon mustard

Gelatine

Vegetable- and cereal-protein-based meat, fish and crustacean

analogues

Analogues of meat, fish and crustaceans based on protein

Marinated nuts

Vacuum packed sweetcorn

Distilled alcoholic beverages containing whole pears

Salsicha fresca

Table grapes

Fresh lychees

10 (measured

on edible parts)

Blueberries (Vaccinium corymbosum only)

Cinnamon (Cinnamomum ceylanicum only)

In edible parts

PART C

Other preservatives

E No.

Name

Foodstuff

Maximum level

Orthophenyl phenol 3

Surface treatment of

12 mg/kg

citrus fruits

individually or in

Sodium orthophenyl

phenol 3

combination

expressed as

orthophenyl phenol

Nisin 4

Semolina and tapioca

puddings and similar

3 mg/kg

products

Ripened cheese and

Laws of Malta — Subsidiary Legislation 449.48 — PERMITTED FOOD ADDITIVES REGULATIONS

1. Only substances listed in the First, Third, Fourth and Fifth

Schedules may be used in foodstuffs for the purposes mentioned in

regulation 3.1.

4.2 Food additives listed in the First Schedule are permitted in

foodstuffs, for the purposes mentioned in regulation 3.1, with the

exception of those foodstuffs listed in the Second Schedule,

following the quantum satis principle.

4.3 Except where specifically provided for, regulation 4.2 does

not apply to

4.3.1

the following

-

unprocessed foodstuffs,

-

honey as defined in the Honey Regulations,

-

non-emulsified oils and fats of animal or

vegetable origin,

-

butter,

-

pasteurised and sterilised (including UHT

sterilisation) milk (including skimmed, plain

and semi-skimmed) and plain pasteurised

cream,

-

unflavoured, live fermented milk products,

-

natural mineral water as defined in the Natural

PERMITTED FOOD ADDITIVES

Mineral Waters Regulations and spring water,

-

coffee (excluding flavoured instant coffee) and

coffee extracts,

-

unflavoured leaf tea,

-

sugars as defined in the Sugar for Human

Consumption Regulations,

-

dry pasta, excluding gluten-free and, or pasta

intended for hypoproteic diets in accordance

with the Labelling, Presentation and

Advertising of Foodstuffs Regulations,

-

natural unflavoured buttermilk (excluding

sterilised buttermilk);

4.3.2

foods for infants and young children as referred to

in the Labelling, Presentation and Advertising of

Foodstuffs Regulations, including foods for infants

and young children not in good health; these

foodstuffs are subject to the provisions of the Sixth

Schedule;

4.3.3

the foodstuffs listed in the Second Schedule, which

may contain only those additives referred to in that

Schedule and those additives referred to in the

Third and Fourth Schedules under the conditions

specified therein.

4.4 Additives listed in the Third and Fourth Schedules may

only be used in the foodstuffs referred to in those Schedules and

under the conditions specified therein.

4.5 Only those additives listed in the Fifth Schedule may be

used as carriers or carrier solvents for food additives and must be

used under the conditions specified therein.

4.6 The provisions of these regulations shall also apply to the

corresponding foodstuffs intended for particular nutritional uses in

accordance with the Labelling, Presentation and Advertising of

Foodstuffs Regulations.

4.7 Maximum levels indicated in the Schedules refer to the

foodstuffs as marketed, unless otherwise stated.

4.8 The presence of a food additive in a foodstuff is

permissible

4.8.1

in a compound foodstuff other than one mentioned

in regulation 4.3 to the extent to which the food

additive is permitted in one of the ingredients of the

compound foodstuff, or

4.8.2

in foodstuff where a flavouring has been added, to

the extent to which the food additive is permitted in

the flavouring in compliance with these regulations

and this has been carried over to the foodstuff via

the flavouring, provided the food additive has no

technological function in the final foodstuff;

4.8.3

if the foodstuff is destined to be used solely in the

PERMITTED FOOD ADDITIVES

preparation of a compound foodstuff and to an

extent such that the compound foodstuff conforms

to the provisions of these regulations.

4.9 Regulation 4.8 does not apply to infant formulae, follow-

on formulae and processed cereal-based foods and baby foods, as

referred to in the Labelling, Presentation and Advertising of

Foodstuffs Regulations, except where specifically provided for by

these or other regulations concerning these foods.

4.10 The level of additives in flavourings shall be limited to the

m i n i m u m n e ce s sa r y t o g u a r a n t e e t h e s a f e t y a n d q u a l i t y o f

flavourings and to facilitate their storage. Furthermore, the

presence of additives in flavourings must not mislead consumers or

present a hazard to their health. If the presence of an additive in a

f o o d s t u ff , a s a c o n s e q u e n c e o f a d d i n g f l a v o u r i n g s , h a s a

technological function in the foodstuff, it shall be considered as an

additive of the foodstuff and not as an additive of the flavouring.

4.11 No person may import, sell, keep for sale, or supply by

way of compensation or otherwise, any food additive or any food

containing such additive in either case unless in compliance with

the provisions of these regulations.

Laws of Malta — Subsidiary Legislation 449.48 — PERMITTED FOOD ADDITIVES REGULATIONS

Amended by

L.N. 92 of 2008;

Other Permitted Additives

L.N. 171 of 2011.

The maximum levels of use indicated refer to foodstuffs ready for consumption prepared

following manufacturers’ instructions.

E No.

Name

Foodstuff

Maximum level

Fumaric acid

Wine in accordance with Regulation

pro memoria

(EEC) No. 1873/84 authorizing the

offer or disposal for direct human

consumption of certain imported

wines which may have undergone

oenological processes not provided

for in Regulation (EEC) No. 337/79

PERMITTED FOOD ADDITIVES

Name

Foodstuff

Maximum level

Fillings and toppings for fine bakery

2.5 g/kg

wares

Sugar confectionery

1 g/kg

Gel-like desserts

4 g/kg

Fruit-flavoured desserts

Dry powdered dessert mixes

Instant powders for fruit based

1 g/l

drinks

Instant powders for the preparation

1 g/kg

of flavoured tea and herbal infusions

Chewing gum

2 g/kg

In the following applications, the indicated maximum levels of phosphoric acid

and the phosphates E 338, E 339, E 340, E 341, E343, E 450, E 451 and E 452 may

be added individually or in combination (expressed as P 2 O 5 )

Name

Foodstuff

Maximum level

Phosphoric acid

Non-alcoholic flavoured drinks

700 mg/l

Sodium phosphates

Sterilised and UHT milk

1 g/l

(i)

Monosodium

Candied fruits

800 mg/kg

phosphate

Fruit preparations

800 mg/kg

(ii)

Disodium

Partly dehydrated milk with less

1 g/kg

phosphate

than 28% solids

(iii)

Trisodium

Partly dehydrated milk with more

1.5 g/kg

phosphate

than 28% solids

Dried milk and dried skimmed milk

2.5 g/kg

Potassium phosphates

Past eu r ised , ste ri li sed a nd UHT

5 g/kg

(i)

Mono-

creams

potassium phosphate

Whipped cream and vegetable fat

5 g/kg

(ii)

Dipotassium

analogues

phosphate

Unripened cheese (except

2 g/kg

(iii)

Tripotassium

Mozzarella)

phosphate

Calcium phosphates

Pro cessed che ese an d p ro cessed

20 g/kg

cheese analogues

(i)

Monocalcium

phosphate

Meat products

5 g/kg

(ii) Dicalcium

Sp o r t d r i n k s a n d p r e p a r e d t ab l e

0.5 g/l

phosphate

waters

(iii) Tricalcium

Food supplements as defincd in the

quantum satis

phosphate

Food Supplements Regulations

Salt and its substitutes

10 g/kg

Magnesium phosphates

Vegetable protein drinks

20 g/l

(i)

Monomagnesium

Whey protein containing sport

4 g/kg

phosphate

drinks

(ii) Dimagnesium

Beverage whiteners

30 g/kg

phosphate

Be ver age wh ite ner s fo r ven din g

50 g/kg

machines

Edible ices

1 g/kg

Desserts

3 g/kg

Diphosphates

Dry powdered dessert mixes

7 g/kg

E No.

Name

Foodstuff

Maximum level

(i)

Disodium

Fine bakery wares

20 g/kg

diphosphate

Flour

2.5 g/kg

(ii) Trisodium

Flour, self-raising

20 g/kg

diphosphate

Soda bread

20 g/kg

(iii) Tetrasodium

Liquid egg (white, yolk or whole

10 g/kg

diphosphate

egg)

(iv) Tetrapotassium

Sauces

5 g/kg

diphosphate

Soups and broths

3 g/kg

(v) Dicalcium

diphosphate

Tea and herbal infusions

2 g/l

Cider and perry

2 g/l

(vi) Calcium

dihydrogen

diphosphate

Triphosphates

Chewing gum

quantum satis

(i)

Pentasodium

Dried powdered foodstuffs

10 g/kg

triphosphate

(ii) Pentapotassium

Ch o c o l a t e a n d m a l t d a i r y -b a s e d

2 g/l

triphosphate

drinks

Alcoholic drinks (excluding wine

1 g/l

and beer)

Polyphosphates

Breakfast cereals

5 g/kg

(i)

Sodium

Snacks

5 g/kg

polyphosphate

(ii) Potassium

Surimi

1 g/kg

polyphosphate

(iii) Sodium calcium

Fish and crustacean paste

5 g/kg

polyphosphate

(iv) Calcium

To p p i n g s ( s y r u p s f o r p a n c a k e s ,

3 g/kg

polyphosphates

flavoured syrups for milkshakes and

ice cream; similar products)

Special formulae for particular

5 g/kg

nutritional uses

Glazings for meat and vegetable

4 g/kg

products

Sugar confectionery

5 g/kg

Icing sugar

10 g/kg

Noodles

2 g/kg

Batters

12 g/kg

Fillets of unprocessed fish, frozen

5 g/kg

and deep-frozen

Unprocessed and processed

5 g/kg

molluscs and crustaceans frozen and

deep-frozen

Processed potato products

5 g/kg

(including frozen, deep-frozen,

chilled and dried processed

products) and pre-fried frozen and

deep-frozen potatoes

Spreadable fats excluding butter

5 g/kg

Beurre de crème acide

2 g/kg

Canned crustacean products

1 g/kg

E No.

Name

Foodstuff

Maximum level

Wat er base d emu lsi on sp ra ys fo r

30 g/kg

coating baking tins

Coffee based drinks for vending

2 g/l

machines

Flavourings

40 g/kg

Crosslinked sodium

Food supplements as defined in the

30 g/kg

carboxy

methyl

Food Supplements Regulations,

cellulose

supplied in solid form

Polyoxyethylene (40)

(pro memoria) Wine in accordance

stearate

with Regulation (EEC) No 1873/84

authorizing the offer or disposal for

direct human consumption of certain

imp orted wines which may have

undergone oenological processes not

provided for in Regulation (EEC)

No 337/79

Metatartaric acid

Win e i n ac c o r d a n c e w i t h

Regulations (EEC) No. 822/87,

(EEC) No. 4252/88, (EEC) No.

2332/92 and (EEC) No. 1873/84 and

their implementing regulations

Made wine

100 mg/l

Adipic acid

Fillings and toppings for fine bakery

2 g/kg

wares

Sodium adipate

Dry powdered dessert mixes

1 g/kg

Potassium adipate

Gel-like desserts

6 g/kg

Fruit-flavoured desserts

1 g/kg

Powders for home preparation of

10 g/l

drinks

(all above

expressed as adipic

acid)

Succinic acid

Desserts

6 g/kg

Soups and broths

5 g/kg

Powders for home preparation of

3 g/l

drinks

Calcium disodium

Emulsified sauces

75 mg/kg

ethylene

diamine

Canned and bottled pulses, legumes,

250 mg/kg

tetra-acetate (calcium

mushrooms and artichokes

disodium EDTA)

Canned and bottled crustaceans and

75 mg/kg

molluscs

Canned and bottled fish

75 mg/kg

Spreadable fats as defined in

100 mg/kg

An n e x e s B an d C o f R e g u l a t i o n

(EC) No. 2991/94 (1) having a fat

content of 41% or less

Frozen and deep-frozen crustaceans

75 mg/kg

Libamáj, egèszben ès tömhhen

250 mg/kg

P r o p a n e -1 , 2 -d i o l

Fat emulsions

3 g/kg

alginate

Fine bakery wares

2 g/kg

Fillings, toppings and coatings for

5 g/kg

fine bakery wares and desserts

Sugar confectionery

1.5 g/kg

Water-based edible ices

3 g/kg

E No.

Name

Foodstuff

Maximum level

Cereal- and potato-based snacks

3 g/kg

Sauces

8 g/kg

Beer

100 mg/l

Chewing gum

5 g/kg

Fruit and vegetable preparations

5 g/kg

Non-alcoholic flavoured drinks

300 mg/l

Emulsified liqueur

10 g/l

Dietary foods for special medical

1.2 g/kg

purposcs as defined in the Dietary

Foods for Special Medical Purposes

Regulations - Dietetic formulae for

weight control intended to replace

total daily food intake or an

individual meal

Food supplements as defincd in the

1 g/kg

Food Supplements Regulations

Cider excluding cidre bouchè

100 mg/l

Karaya gum

Cereal- and potato-based snacks

5 g/kg

Nut coatings

10 g/kg

Fillings, toppings and coatings for

5 g/kg

fine bakery wares

Desserts

6 g/kg

Emulsified sauces

10 g/kg

Egg-based liqueurs

10g/l

Food supplements as defincd in the

quantum satis

Food Supplements Regulations

Chewing gum

5 g/kg

Flavourings

50 g/kg

Sorbitol

Foodstuffs in general (except drinks

quantum satis

and those foodstuffs referred to in (for purposes other

(i)

Sorbitol

regulation 4.3.1)

than sweetening)

(ii) Sorbitol syrup

Mannitol

Frozen and deep-frozen unprocessed

fish, crustaceans, molluscs and

Isomalt

cephalopods

Maltitol

(i)

Maltitol

(ii) Maltitol syrup

Lactitol

Liqueurs

Xylitol

Erythritol

Foodstuffs in general (except drinks

quantum satis

and those foodstuffs referred to in

regulation 4.3

Frozen and deep-frozen unprocessed

quantum satis

fish, crustaceans, molluscs and

cephalopods

Liqueurs

quantum satis

For purposes other

than sweetening

Soybean hemicellulose

Dairy-based drinks intended for

5 g/l

retail sale

E No.

Name

Foodstuff

Maximum level

Food supplements as defined in the

1,5 g/l

Food Supplements Regulations

30 g/l

Emulsified sauces

10 g/kg

Pre- pa ckag ed fi ne b ak ery ware s

10 g/kg

intended for rerail sale

Pre-packaged ready to eat oriental

10 g/kg

noodles intended for retail sale

Pre-packaged ready to eat rice

10 g/kg

intended for retail sale

Pre-packaged processed potato and

10 g/kg

rice products (including frozen, deep

frozen, chilled and dried processed

products) intended for retail sale

Dehydrated, concentrated, frozen

10 g/kg

and deep-frozen egg products

Jelly confectionery, except jellv

mini-cups

Cassia gum

Edible ices

2 500 mg/kg

Fermented milk products with the

exception of unflavoured live

fermented milk products

Dai ry - ba sed d esse rt an d sim il ar

products

Filling, topping and coating for fine

bakery wares and dessert

Processed cheese

Sauces and salads dressing

Dehydrated soups and broths

Heat-treated meat products

1 500 mg/kg

Polyoxyethylene

Fine bakery wares

3 g/kg

sorbitan monolaurate

Fat emulsions for baking purposes

10 g/kg

(polysorbate 20)

Polyoxyethylene

Milk and cream analogues

5 g/kg

sorbitan monooleate

Edible ices

1 g/kg

(polysorbate 80)

Polyoxyethylene

Desserts

3 g/kg

sorbitan monopalmitate

Sugar confectionery

1 g/kg

(polysorbate 40)

Polyoxyethylene

Emulsified sauces

5 g/kg

sorbitan monostearate

Soups

1 g/kg

(polysorbate 60)

Polyoxyethylene

Chewing gum

5 g/kg

sorbitan tristearate

Food supplements as defincd in the

quantum satis

(polysorbate 65)

Food Supplements Regulations

Dietary foods for special medical

1 g/kg

purposcs as defined in the Dietary Individually or in

Foods for Special Medical Purposes

combination

Regulations - Dietetic formulae for

weight control intended to replace

total daily food intake or an

individual meal

Flavourings, except liquid smoke

10 g/kg

flavourings and flavourings based

(2)

on spice oleoresins

E No.

Name

Foodstuff

Maximum level

Foodstuffs containing liquid smoke

1 g/kg

flavourings and flavourings based

on spice oleoresins

Ammonium

Cocoa and chocolate products as

10 g/kg

phosphatides

defined in the Cocoa and Chocolate

Pr odu cts Regu lations, in cludin g

fillings

Confectionery based on these

10 g/kg

products

Sucrose

acetate

No n -a lc o h o l i c f l a v o u r ed cl o u d y

300 mg/l

isobutyrate

drinks

Flavoured cloudy spirit drinks

300 mg/l

containing less than 15% alcohol by

volume

Glycerol esters of wood

No n -a lc o h o l i c f l a v o u r ed cl o u d y

100 mg/l

rosins

drinks

Surface treatment of citrus fruits

50 mg/kg

Cloudy spirit drinks in accordance

100 mg/l

with Council Regulation (EEC) No

1576/89 laying down general rules

on the definition, description and

presentation of spirit drinks (3)

Cloudy spirit drinks containing less

100 mg/l

than 15% alcohol by volume

Sucrose esters of fatty

Canned liquid coffee

1 g/l

acids

Heat treated meat products

5 g/kg (on fat)

Sucroglycerides

Fat emulsions for baking purposes

10 g/kg

Fine bakery wares

10 g/kg

Beverage whiteners

20 g/kg

Edible ices

5 g/kg

Sugar confectionery

5 g/kg

Desserts

5 g/kg

Sauces

10 g/kg

Soups and broths

2 g/kg

Fresh fruits, surface treatment

quantum satis

Non-alcoholic aniseed-based drinks

5 g/l

Non-alcoholic coconut and almond

5 g/l

drinks

Spirituous beverages (excluding

5 g/l

wine and beer)

Powders for the preparation of hot

10 g/l

beverages

Dairy-based drinks

5 g/l

Food supplements as defincd in the

quantum satis

Food Supplements Regulations

Dietary foods for special medical

5 g/kg

purposcs as defined in the Dietary

Foods for Special Medical Purposes

Regulations - dietetic formulae for

weight control intended to replace

total daily food intake or an

individual meal

E No.

Name

Foodstuff

Maximum level

Chewing gum

10 g/kg

Individually or in

combination

Cream analogues

5g/kg

Sterilised cream and sterilised cream

5g/kg

with a reduced fat content

Polyglycerol esters of

Fine bakery wares

10 g/kg

fatty acids

Emulsified liqueurs

5 g/l

Egg products

1 g/kg

Beverage whiteners

0.5 g/kg

Chewing gum

5 g/kg

Fat emulsions

5 g/kg

Milk and cream analogues

5 g/kg

Sugar confectionery

2 g/kg

Desserts

2 g/kg

Food supplements as defincd in the

quantum satis

Food Supplements Regulations

Dietary foods for special medical

5 g/kg

purposes as defined in the Dietary

Foods for Special Medical Purposes

Regulations - dietetic formulae for

weight control intended to replace

total daily food intake or an

individual meal

Granola-type breakfast cereals

10 g/kg

Polyglycerol

Spreadable fats as defined in

4 g/kg

polyricinoleate

An n e x e s B an d C o f R e g u l a t i o n

(EC) No. 2991/94 having a fat

content of 41% or less

Similar spreadable products with a

4 g/kg

fat content of less than 10%

Dressings

4 g/kg

C o c o a -b a s e d c o n f e c t i o n e r y,

5 g/kg

including chocolate

Propane-1,2-diol

Fine bakery wares

5 g/kg

esters of fatty acids

Fat emulsions for baking purposes

10 g/kg

Milk and cream analogues

5 g/kg

Beverage whiteners

1 g/kg

Edible ices

3 g/kg

Sugar confectionery

5 g/kg

Desserts

5 g/kg

Whipped dessert toppings other than

30 g/kg

cream

Dietary foods for special medical

1 g/kg

purposcs as defined in the Dietary

Foods for Special Medical Purposes

Regulations - dietetic formulae for

weight control intended to replace

total daily food intake or an

individual meal

E No.

Name

Foodstuff

Maximum level

E 479b T h e r m a l l y o x i d i s e d

Fat emulsions for frying purposes

5 g/kg

soya bean oil interacted

with

m o n o -a n d

diglycerides of fatty

acids

E 481 S o d i u m s t e a r o y l -2 -

Fine bakery wares

5 g/kg

lactylate

Quick-cook rice

4 g/kg

C a l c i u m s t e a r o y l -2 -

Breakfast cereals

5 g/kg

lactylate

Emulsified liquer

8 g/kg

Spirits with less than 15% alcohol

8 g/l

by volume

Cereal-based snacks

2 g/kg

Chewing gum

2 g/kg

Fat emulsions

10 g/kg

Desserts

5 g/kg

Sugar confectionery

5 g/kg

Beverage whiteners

3 g/kg

Cereal- and potato-based snacks

5 g/kg

Minced and diced canned meat

4 g/kg

products

Powders for the preparation of hot

2 g/l

beverages

Dietary foods for special medical

2 g/kg

purposcs as defined in the Dietary

Foods for Special Medical Purposes

Regulations - dietetic formulae for

weight control intended to replace

total daily food intake or an

individual meal

Bread (except that referred to in the

3 g/kg

Second Schedule)

Mostarda di frutta

2 g/kg

Individually or in

combination

Stearyl tartrate

Bakery wares (except breads

4 g/kg

referred to in the Second Schedule)

Desserts

5 g/kg

Sorbitan monostearate

Fine bakery wares

10 g/kg

Sorbitan tristearate

To p p i n g s a n d c o a t i n g s f o r f i n e

5 g/kg

bakery wares

Sorbitan monolaurate

25 mg/kg (4)

Sorbitan monooleate

Jelly marmalade

Sorbitan monopalmitate

Fat emulsions

10 g/kg

Milk and cream analogues

5 g/kg

Beverage whiteners

5 g/kg

Liquid tea concentrates and liquid

0.5 g/l

fruit and herbal infusions

concentrates

Edible ices

0.5 g/kg

Desserts

5 g/kg

Sugar confectionery

5 g/kg

E No.

Name

Foodstuff

Maximum level

10 g/kg (5)

C o c o a -b a s e d c o n f e c t i o n e r y,

including chocolate

Emulsified sauces

5 g/kg

Food supplements as defincd in the

quantum satis

Food Supplements Regulations

Yeast for baking

quantum satis

Chewing gum

5 g/kg

Dietary foods for special medical

5 g/kg

purposcs as defined in the Dietary Individually or in

Foods for Special Medical Purposes

combination

Regulations - dietetic formulae for

weight control intended to replace

total daily food intake or an

individual meal

(pro memoria) For E 491 only, wine

in accordance with Regulation

(EEC) No 1873/84 authorizing the

offer or disposal for direct human

consumption of certain imported

wines which may have undergone

oenological processes not provided

for in Regulation (EEC) No 337/79

Individually or in

combination

Stannous chloride

Canned and bottled white asparagus

25 mg/kg as Sn

Aluminium sulphate

Egg white

30 mg/kg

Aluminium sodium

Candied, crystallized and glace fruit

200 mg/kg

sulphate

and vegetables

Aluminium potassium

sulphate

Aluminium ammonium

Individually or in

sulphate

combination,

expressed as

aluminium

Sodium aluminium

Fine bakery wares (scones and

1 g/kg

phosphate, acidic

sponge wares only)

expressed as

aluminium

Sodium ferrocyanide

Salt and its substitutes

Individually or in

combination,

Potassium ferrocyanide

20 mg/kg as

Calcium ferrocyanide

anhydrous

potassium

ferrocyanide

Silicon dioxide

Flavourings

50 g/kg

Silicon dioxide

Dried powdered foodstuffs

10 g/kg

(including sugars)

Calcium silicate

E 553a

(i)

Magnesium

Salt and its substitutes

10 g/kg

silicate

(ii) Magnesium

Food supplements as defincd in the

quantum satis

trisilicate (6)

Food Supplements Regulations

E 553b Talc

F o o d s t u ff s i n t a b l e t a n d c o a t e d

quantum satis

tablet form

Sodium aluminium

Sliced or grated hard, semi-hard and

10 g/kg

silicate

processed cheese

E No.

Name

Foodstuff

Maximum level

Potassium aluminium

Sliced or grated cheese analogues

10 g/kg

silicate

and processed cheese analogues

quantum satis (7)

Calcium aluminium

Chewing gum

silicate

quantum satis (7)

Rice

quantum satis (7)

Aluminium silicate

Sausages (surface treatment only)

(Kaolin)

Seasonings

30 g/kg

quantum satis (7)

Confectionery excluding chocolate

(surface treatment only)

Tin-greasing products

30 g/kg

Ferrous gluconate

Olives darkened by oxidation

150 mg/kg as Fe

Ferrous lactate

Glutamic acid

Foodstuffs in general (except those

10 g/kg

referred to in regulation 4.3.1)

Individually or in

Monosodium glutamate

combination

Monopotassium

glutamate

Calcium diglutamate

Condiments and seasonings

quantum satis

Monoammonium

glutamate

Magnesium

diglutamate

Guanylic acid

Foodstuffs in general (except those

500 mg/kg

referred to in regulation 4.3.1)

individually or in

Disodium guanylate

combmation,

Dipotassium guanylate

expressed as

guanylic acid

Calcium guanylate

Inosinic acid

Disodium inosinate

Dipotassium inosinate

Seasonings and condiments

quantum satis

Calcium inosinate

Calcium 5'-

ribonucleotides

Dimethylpolysiloxane

Jam, jellies and marmalades as

10 mg/kg

defined in the Fruit Jams and Similar

Products Regulations and similar

fruit spreads, including low calorie

products

Soups and broths

10 mg/kg

Oils and fats for frying

10 mg/kg

Confectionery (excluding chocolate)

10 mg/kg

Non-alcoholic flavoured drinks

10 mg/l

Pineapple juice

10 mg/l

Canned and bottled fruit and

10 mg/kg

vegetables

Chewing gum

100 mg/kg

E No.

Name

Foodstuff

Maximum level

(pro memoria) For E 491 only, wine

in accordance with Regulation

(EEC) No 1873/84 authorizing the

offer or disposal for direct human

consumption of certain imported

wines which may have undergone

oenological processes not provided

for in Regulation (EEC) No 337/79

Sød ... saft

10 mg/l

Batters

10 mg/kg

Ciders excluding cidre bouchè

10 mg/l

Flavourings

10 mg/l

Beeswax, white and

As glazing agents only for

yellow

- Confectionery

(including

quantum satis

chocolate)

Candelilla wax

- Pre-packed wafers containing ice

quantum satis

cream (only for E 901)

Shellac

- Small products of fine bakery

wares coated with chocolate

- Snacks

- Nuts

- Coffee beans

Food supplements as defincd in the

quantum satis

Food Supplements Regulations

Fresh citrus fruits, melons, apples

quantum satis

and pears (surface treatment only)

Peaches and pineapples (surface

quantum satis

treatment only)

Flavourings in non-alcoholic

0,2 g/kg in the

flavoured drinks (only for E 901)

flavoured drinks

Carnauba wax

As glazing agents only for

500 mg/kg

- Confectionery

(including 1200 mg/kg (only

chocolate)

for chewing gum)

- Small products of fine bakery

200 mg/kg

wares coated with chocolate

- Snacks

200 mg/kg

- Nuts

200 mg/kg

- Coffee beans

200 mg/kg

Food supplements as defincd in the

200 mg/kg

Food Supplements Regulations

Fresh citrus fruits, melons, apples

200 mg/kg

and pears (surface treatment only)

Microcrystalline wax

Surface treatment of

quantum satis

-

Confectionery

(including

chocolate)

-

Chewing gum

-

melons, papaya, mango and

avocado

Montan acid esters

Fresh citrus fruits (surface treatment

quantum satis

only)

Oxidised polyethylene

Fresh melon, mango, papaya,

quantum satis

wax

avocado and pineapple (surface

treatment only)

E No.

Name

Foodstuff

Maximum level

E 927b Carbamide

Chewing gum without added sugars

30 g/kg

E 950 Acesulfame-K

Chewing gum with added sugars

800 mg/kg

(as flavour

enhancer only) (8)

Wa t e r - b a s e d f l a v o u r e d n o n -

0.5 mg/l

alcoholic drinks

Desserts - dairy and non-dairy

5 mg/kg

(as flavour

enhancer only)

Aspartame

Chewing gum with added sugars

2500 mg/kg

(as flavour

enhancer only) (8)

Wa t e r - b a s e d f l a v o u r e d n o n -

0.5 mg/l

alcoholic drinks

Desserts - dairy and non-dairy

5 mg/kg

(as flavour

enhancer only)

Thaumatin

Chewing gum with added sugars

10 mg/kg

(as flavour

enhancer only) (8)

Wa t e r - b a s e d f l a v o u r e d n o n -

0.5 mg/l

alcoholic drinks

Desserts - dairy and non-dairy

5 mg/kg

(as flavour

enhancer only)

Neohesperidine DC

Chewing gum with added sugars

150 mg/kg

5 mg/kg (8)

Spreadable fats as defined in

An n ex e s B a n d C o f Re g u l a ti o n

(EC) No. 2991/94

Meat products

5 mg/kg

(as flavour

Fruit jellies

enhancer only)

Vegetable proteins

Neotame

Wa t e r- b a s e d f l a v o u r e d d r i n k s , 2 mg/l as flavour

energy-reduced or with no added

enhancer

sugar

Milk- and milk-derivative-based or 2 mg/l as flavour

fruit-juice-based drinks, energy-

enhancer

reduced or with no added sugar

“Snacks”: certain flavours of ready- 2 mg/kg as flavour

to-eat, pre- packed, dry, savoury

enhancer

starch products and coated nuts

Starch-based confectionery, energy- 3 mg/kg as flavour

reduced or with no added sugar

enhancer

Breath-freshening micro-sweets, 3 mg/kg as flavour

with no added sugar

enhancer

Strongly flavoured throat pastilles 3 mg/kg as flavour

with no added sugar

enhancer

Chewing gum with added sugar

3 mg/kg as flavour

enhancer

Energy-reduced jams, jellies and 2 mg/kg as flavour

marmalades

enhancer

Sauces

2 mg/kg as flavour

enhancer

E No.

Name

Foodstuff

Maximum level

Food supplements as defined in the 2 mg/kg as flavour

F o o d S u p p l e m e n t s Re g u l a t i o n s ,

enhancer form

supplied in a liquid form

Food supplements as defined in the 2 mg/kg as flavour

F o o d S u p p l e m e n t s Re g u l a t i o n s ,

enhancer

supplied in a solid form

Food supplements as defined in the 2 mg/kg as flavour

Food Supplements Regulations,

enhancer

based on vitamins and/or mineral

elements and supplied in a syrup-

type or non-chewable form

Quillaia extract

Wa t e r -b a s e d f l a v o u r e d n o n -

200 mg/l

alcoholic drinks

(calculated as

anhydrous extract)

Cider excluding cider bouchè

200 mg/l

(calculated as

anhydrous extract)

E 1201 Polyvinylpyrrolidone

Food supplements as defincd in the

quantum satis

Food Supplements Regulations in

E 1202 Polyvinylpolypyrroli-

tablet and coated tablet form

done

E 1203 Polyvinyl alcohol

Food supplements as defined in the

18 g/kg

Food Supplements Regulations, in

capsule and tablet form

E 1505 Triethyl citrate

Food supplements as defined in the

3.5 g/kg

Food Supplements Regulations, in

capsule and tablet form

Dried egg white

quantum satis

E 1518 Glyceryl triacetate

Chewing gum

quantum satis

(triacetin)

E 459 Beta-cyclodextrine

F o o d s t u ff s i n t a b l e t a n d c o a t e d

quantum satis

tablet form

Encapsulated flavourings in

- flavoured teas and flavoured

500 mg/kg

powdered instant drinks

- flavoured snacks

1 g/kg in foodstuffs

as consumed or as

reconstituted

according to the

instructions of the

manufacturer

Konjac (9)

Foodstuffs in general (except those

10 g/kg

referred to in paragraph 4.3.1) and (individually or in

(i) Konjac gum

jelly confectionery including jelly-

combination)

(ii) Konjac

mini-cups

glucomannane

E 650 Zinc acetate

Chewing gum

1000 mg/kg

E 943a Butane

Ve g e t a b l e o i l p a n s p r a y ( f o r

quantum satis

professional use only)

E 943b Iso-butane

E 944 Propane

Water based emulsion spray

quantum satis

E 907 Hydrogenated poly-1-

As glazing agent for

decene

- sugar confectionery

2 g/kg

- dried fruits

2 g/kg

E No.

Name

Foodstuff

Maximum level

E 1505 Triethyl citrate

Flavourings

3 g/kg from all

sources in

E 1517 Glyceryl diacetate

foodstuffs as

(diacetin)

consumed or as

E 1518 Glyceryl triacetate

reconstituted

(triacetin)

according to the

instructions of the

E 1520 Propan-1,2-diol

manufacturer;

(propylene glycol)

individually or in

combination. In the

case of beverages,

with the exdeption

of cream liquers,

the maximum level

of E 1520 shall be

1 g/l

E 1519 Benzyl alcohol

Flavourings for

100 mg/l

- liqueurs,

aromatised

wines,

aromatised wine-based drinks and

aromatised wine-products cocktails

- confectionery including chocolate 250 mg/kg from all

and fine bakery wares

sources in food-

stuffs as consumed

or as reconstituted

according to the

instructions of the

manufacturer

E 1204 Pullulan

Food supplements as defined in the

quantum satis

Food Supplements Regulations, in

capsule and tablet form

Breath freshening micro-sweets in

quantum satis

the form of films

E 1452 Starch Aluminium

Encapsulated vitamin preparations 35 g/kg in food

Octenyl Succinate

in food supplements as defined in

supplement

the Food Supplements Regulations

OJ L 316, 9.12.1994, p.2.

Spice oleoresins are defined as extracts of spices from which the extraction solvent has been

evaporated leaving a mixture of the volatile oil and resinous material from the spice

OJ L 160,12.6.1989, p.1.

E 493 only.

E 492 only.

Asbestos free.

E 553B only.

If E 950, E 951, E 957 and E 959 are used in combination in chewing gum, the maximum level for

each is reduced proportionally.

These substances may not be used to produce dehydrated foodstuffs intended to rehydrate on

ingestion.

Laws of Malta — Subsidiary Legislation 449.48 — PERMITTED FOOD ADDITIVES REGULATIONS

1. The additives permitted for use by these regulations shall

satisfy the purity criteria laid down by Commission Directive 2008/

84/EC, as amended by Directives 2009/10/EC and 2010/67/EU. A

list of the food additives for which purity criteria have been

established is given in the Seventh Schedule.

5.2 The methods of analysis described in Commission

Directive 81/712/EEC shall be used in order to ascertain for

purposes of official control whether certain additives permitted for

use by these regulations satisfy the prescribed purity criteria.

5.3 The taking of samples and the qualitative and quantitative

analysis of biphenyl, orthophenyl phenol and sodium

orthophenylphenol in and on citrus fruit shall be carried out in

accordance with the provisions of Annexes I, II, III and IV to

Council Directive 67/427/EEC.

Laws of Malta — Subsidiary Legislation 449.48 — PERMITTED FOOD ADDITIVES REGULATIONS

Amended by

L.N. 92 of 2008;

Permitted Carriers and Carrier Solvents

L.N. 171 of 2011.

Note

Not included in this list are

1. Substances generally considered as foodstuffs;

2. Substances referred to in regulation 4.3;

3. Substances having primarily an acid or acidity regulator function, such as

citric acid and ammonium hydroxide. .

E No.

Name

Restricted use

E 1520 Propan-1,2-diol (propylene glycol)

Colours,

emulsifiers,

antioxidants and

enzymes (maximum

1 g/kg in the

foodstuff)

Glycerol

Sorbitol

Mannitol

Isomalt

Maltitol

Lactitol

Xylitol

Erythirol

E 400 -

Alg in ic aci d a nd i ts so di um , p ot assiu m, c alci um an d

ammonium salts

Propan-1,2-diol alginate

Agar

Carrageenan

Locust bean gum

Guar gum

Tragacanth

Acacia gum (gum arabic)

Xanthan gum

Pectins

Polyoxyethylene sorbitan monolaurate (polysorbate 20)

Antifoaming agents

Polyoxyethylene sorbitan monooleate (polysorbate 80)

Polyoxyethylene sorbitan monopalmitate (polysorbate 40)

Polyoxyethylene sorbitan monostearate (polysorbate 60)

Polyoxyethylene sorbitan tristearate (polysorbate 65)

Ammonium phosphatides

Antioxidants

Cellulose (microcrystalline or powdered)

Methyl cellulose

Hydroxypropyl cellulose

Hydroxypropyl methyl cellulose

Ethyl methyl cellulose

PERMITTED FOOD ADDITIVES

E No.

Name

Carboxy methyl cellulose

Sodium carboxy methyl cellulose

E 462 Ethyl cellulose

E 322 Lecithins

E 432 - Polysorbates 20, 40, 60, 65 and 80

E 470b Magnesium salts of fatty acids

E 471 Mono- and diglycerides of fatty acids

E 472a Acetic acid esters of mono- and diglycerides of fatty acids

E 472c Citric acid esters of mono- and diglycerides of fatty acids

E 472e Mono - an d di acetyl t artari c acid ester s o f mo no - and

diglycerides of fatty acids

E 473 Sucrose esters of fatty acids

E 475 Polyglycerol esters of fatty acids

E 491 Sorbitan monostearate

antifoaming agents

E 492 Sorbitan tristearate

E 493 Sorbitan monolaurate

E 494 Sorbitan monooleate

E 495 Sorbitan monopalmitate

E 1404 Oxidised starch

E 1410 Monostarch phosphate

E 1412 Distarch phosphate

E 1413 Phosphated distarch phosphate

E 1414 Acetylated distarch phosphate

E 1420 Acetylated starch

E 1422 Acetylated distarch adipate

E 1440 Hydroxypropyl starch

E 1442 Hydroxypropyl distarch phosphate

E 1450 Starch sodium octenyl succinate

E 170 Calcium carbonates

E 263 Calcium acetate

E 331 Sodium citrates

E 332 Potassium citrates

E 341 Calcium phosphates

E 501 Potassium carbonates

E 504 Magnesium carbonates

E 508 Potassium chloride

E 509 Calcium chloride

E 511 Magnesium chloride

E 514 Sodium sulphate

E 515 Potassium sulphate

E 516 Calcium sulphate

E 517 Ammonium sulphate

E 577 Potassium gluconate

E 640 Glycine and its sodium salt

E No.

Name

Restricted use

Triethyl citrate

Glyceryl triacetate (triacetin)

Silicon dioxide

Emulsifiers and

colours, max. 5%

Calcium silicate

For E 551: in E 171

titanium dioxide

and E 172 iron

oxides and

hydroxides (max.

90 % relative to the

pigment)

E 553b Talc

Colours, max. 5%

E 558 Bentonite

E 559 Aluminium silicate (Kaolin)

E 901 Beeswax

Colours

E 1200 Polydextrose

E 1201 Polyvinylpyrrolidone

Sweeteners

E 1202 Polyvinylpolypyrrolidone

E 322 Lecithins

Glazing agents for

fruit

E 432 - Polysorbates

E 470a Sodium, potassium and calcium salts of fatty acids

E 471 Mono- and diglycerides of fatty acids

E 491 - Sorbitans

E 570 Fatty acids

E 900 Dimnethylpolysiloxane

E 1521 Polyethylene glycol 6000

Sweeteners

E 425 Konjac

- Konjac gum

- Konjac glucomannane

E 459 Beta-cyclodextrine

1 g/kg

E 1451 Acetylated oxidised starch

E 468 Cross-linked sodium carboxy methyl cellulose

Sweeteners

Cross-linked cellulose gum

E 469 Enzymatically hydrolysed carboxy methyl cellulose

E 555 Potassium aluminium silicate

In E 171 titanium

dioxide and E 172

iron oxides and

hydroxides (max

90% relative to the

pigment)

Laws of Malta — Subsidiary Legislation 449.48 — PERMITTED FOOD ADDITIVES REGULATIONS

Amended by

L.N. 92 of 2008;

Food Additives Permitted in Foods for Infants

L.N. 171 o9f 2011.

and Young Children

Note

Formulae and processed cereal-based foods and baby foods for infants and young

children may contain E 414 (acacia gum, gum arabic) and E 551 (silicon dioxide)

resulting from the addition of nutrient preparations containing not more than 150 g/

kg of E 414 and 10 g/kg of E 551, as well as E 421 (mannitol) when used as a carrier

for vitamin B12 (not less than one part vitamin B12 to 1 000 parts mannitol). The

carry over of E 414 in the product ready for consumption should not be more than 10

mg/kg.

Formulae and processed cereal-based foods and baby foods for infants and young

children may contain E 1450 starch sodium octenyl succinate resulting from the

addition of vitamin preparations or polyunsaturated fatty acid preparations. The

carry over of E 1450 in the product ready for consumption is not to be more than 100

mg/kg from vitamin preparations and 1000 mg/kg from polyunsaturated fatty acid

preparations.

Formulae and processed cereal-based foods and baby foods for infants and young

children may contain E 301 (sodium L-ascorbate), used at QS level in coatings of

nutrient preparations containing polyunsaturated fatty acids. The carry over of E 301

in the product ready for consumption should not be more than 75 mg/l.

The maximum levels of use indicated refer to foodstuffs ready for consumption

prepared following manufacturers' instructions.

PART 1

Food Additives Permitted in Infant Formulae for Infants in Good Health

Notes

1. For the manufacture of acidified milks, non-pathogenic L(+)- lactic acid

producing cultures may be used.

2. If more than one of the substances E 322, E 471, E 472c and E 473 are added

to a foodstuff, the maximum level established for that foodstuff for each of those

substances is lowered with that relative part as is present of the other substances

together in that foodstuff.

E No.

Name

Maximum level

Lactic acid (L(+)-form only)

quantum satis

Citric acid

quantum satis

Phosphoric acid

In conformity with the limits set in the First

Schedule to the Infant Formulae and Follow-On

Formulae Regulations.

Tocopherol-rich extract

10 mg/l individually or in combination

Alpha-tocopherol

Gamma-tocopherol

Delta-tocopherol

Lecithins

1 g/l

Mono- and diglycerides

4 g/l

L-ascorbyl palmitate

10 mg/l

Sodium citrates

2 g/l

E No.

Name

Maximum level

Potassium citrates

individually or in combination and in conformity

with the limits set by the First Schedule to the

Infant Formulae and Follow-On Formulae

Regulations

E 331 Sodium phosphates

1 g/l expressed as P 2 O 5

E 332 Potassium phosphates

individually or in combination and in conformity

with the limits set by the First Schedule to the

Infant Formulae and Follow-On Formulae

Regulations

E 412 Guar gum

1 g/l, where the liquid product contains partially

hydrolysed proteins and is in conformity with the

conditions set in the Fourth Schedule to the Infant

Formulae and Follow-On Formulae Regulations

E 472c Citric acid esters of mono-

75 g/l sold as powder

a n d d i g l y c e r i d e s o f f a t t y 9 g/l sold as liquid where the products contain

acids

partially hydrolysed proteins, peptides or amino

acids and are in conformity with the conditions set

in the Fourth Schedule to the Infant Formulae and

Follow-On Formulae Regulations

E 473 Sucrose esters of fatty acids

120 mg/l in products containing hydrolysed

proteins, peptides or amino acids

PART 2

FOOD ADDITIVES PERMITTED IN FOLLOW-ON FORMULAE

FOR INFANTS IN GOOD HEALTH

Note

1. For the manufacture of acidified milks, non-pathogenic L(+)- lactic acid

producing cultures may be used.

2. If more than one of the substances E 322, E 471, E 472c and E 473 is added

to a foodstuff, the maximum level established for that foodstuff for each of those

substances is lowered with that relative part as is present of the other substances

together in that foodstuff.

3. If more than one of the substances E 407, E 410 and E 412 is added to a

foodstuff, the maximum level established for that foodstuff for each of those

substances is lowered with that relative part as is present of the other substances

together in that foodstuff. .

E No.

Name

Maximum level

Lactic acid (L(+)-form only)

quantum satis

Citric acid

quantum satis

Tocopherol-rich extract

10 mg/l individually or in combination

Alpha-tocopherol

Gamma-tocopherol

Delta-tocopherol

Phosphoric acid

In conformity with the limits set in the First

Schedule to the Infant Formulae and Follow-On

Formulae Regulations.

Pectins

5 g/l in acidified follow-on formulae only

Lecithins

1 g/l

Mono- and diglycerides

4 g/l

Carrageenan

0.3g/l

E No.

Name

Maximum level

Locust bean gum

1 g/l

Guar gum

1 g/l

L-ascorbyl palmitate

10 mg/l

Sodium citrates

2 g/l

Potassium citrates

individually or in combination and in conformity

with the limits set by the First Schedule to the

Infant Formulae and Follow-On Formulae

Regulations

E 339 Sodium phosphates

1 g/l expressed as P 2 O 5

E 340 Potassium phosphates

individually or in combination and in conformity

with the limits set by the First Schedule to the

Infant Formulae and Follow-On Formulae

Regulations

E 472c Citric acid esters of mono-

75 g/l sold as powder

a n d d i g l y c e r i d e s o f f a t t y 9 g/l sold as liquid where the products contain

acids

partially hydrolysed proteins, peptides or amino

acids and are in conformity with the conditions set

in the Fourth Schedule to the Infant Formulae and

Follow-On Formulae Regulations

E 473 Sucrose esters of fatty acids

120 mg/l in products containing hydrolysed

proteins, peptides or amino acids

PART 3

Food Additives permitted in processed cereal-based foods and baby foods

for Infants and Young Children in Good Health

E No.

Name

Foodstuff

Maximum level

Calcium carbonates

Processed cereal-based

quantum satis

foods and baby foods

(only for pH adjustment)

Acetic acid

Potassium acetate

Sodium acetates

Calcium acetate

Lactic acid*

Malic acid*

Sodium lactate*

Potassium lactate*

Calcium lactate*

Citric acid

Sodium citrates

Potassium citrates

Calcium citrates

Hydrochloric acid

Sodium hydroxide

Potassium hydroxide

Calcium hydroxide

L-cysteine

Biscuits for infants and

1 g/kg

young children

E No.

Name

Foodstuff

Maximum level

Sodium carbonates

Processed cereal-based

quantum satis

foods and baby foods

(only as raising agents)

Potassium carbonates

Ammonium carbonates

L-ascorbic acid

Individually or in

combination, expressed as

ascorbic acid

Sodium L-ascorbate

Fruit- and vegetable- based

0.3 g/kg

drinks, juices and baby

Calcium L-ascorbate

foods

Fat-containing cereal-based

0.2 g/kg

foods including biscuits and

rusks

L-ascorbyl palmitate

F a t -c o n t a i n i n g c e r e a l s ,

0.1 g/kg

biscuits, rusks and baby

Individually or in

Tocopherol-rich extract

foods

combination

Alpha-tocopherol

Gamma-tocopherol

Delta-tocopherol

Phosphoric acid

Processed cereal-based

1 g/kg as P 2 O 5

foods and baby foods

Sodium phosphates

Cereals

1 g/kg

Potassium phosphates

Individually or in

combination, expressed as

Calcium phosphates

P 2 O 5

Lecithins

Biscuits and rusks

10 g/kg

Cereal-based food

Baby foods

E 471 Mono- and diglycerides Biscuits and rusks

5 g/kg

of fatty acids

individually or in

combination

E 472a A c e t i c a c i d e s t e r s o f Cereal-based foods

mono- and diglycerides

of fatty acids

E 472b L a c t i c a c i d e s t e r s o f Baby foods

mono- and diglycerides

of fatty acids

E 472c C i t r i c a c i d e s t e r s o f

mono- and diglycerides

of fatty acids

E 400 Alginic acid

Desserts

0.5 g/kg

E 401 Sodium alginate

Individually or in

combination

E 402 Potassium alginate

Puddings

E 404 Calcium alginate

E 410 Locust bean gum

Processed cereal-based

10 g/kg

foods and baby foods

E 412 Guar gum

Individually or in

combination

E 414 Acacia gum (gum arabic)

E 415 Xanthan gum

G l u t e n -f r e e c e r e a l -b a s e d

20 g/kg

foods

Individually or in

E 440 Pectins

combination

Silicon dioxide

Dry cereals

2 g/kg

Tartaric acid*

Biscuits and rusks

5 g/kg as a residue

Sodium tartrate*

E No.

Name

Foodstuff

Maximum level

E 336 Potassium tartrate*

E 354 Calcium tartrate*

E 450a Disodium diphosphate

E 575 Glucono-delta-lactone

E 1404 Oxidised starch

Processed cereal-based

50 g/kg

foods and baby foods

E 1410 Monostarch phosphate

E 1412 Distarch phosphate

E 1413 P h o s p h a t e d d i s t a r c h

phosphate

E 1414 A c e t y l a t e d d i s t a r c h

phosphate

E 1420 Acetylated starch

E 1422 A c e t y l a t e d d i s t a r c h

adipate

E 1450 Starch sodium octen yl

succinate

E 333 Cacium citrates **

In low-sugar based products

quantum satis

E 341 Tricalcium phosphate ** In fruit-based desserts

1 g/kg as P 2 O 5

E 1451 A c e t y l a t e d o x i d i s e d P r o c e s s e d c e r e a l - b a s e d

50 g/kg

starch

foods and baby foods

*

L(+)-form only.

** The note in Part 4 does not apply.

PART 4

Food Additives permitted in Dietary Foods for Infants and Young Children

for Special Medical Purposes as defined in the Dietary Foods for Special Medical

Purposes Regulations

The tables in Parts 1 to 3 of the Sixth Schedule are applicable. .

Maximim

E No.

Name

Special conditions

level

Sodium alginate

1 g/l

From 4 months onwards in special food

products with adapted composition, required for

me tab oli c d iso rd ers and f or g ene ral tu be -

feeding

P r o p a n e 1 , 2 d i o l 200 mg/l

From 12 months onwards in specialised diets

alginate

intended for yound children who have cow’s

milk intolerance or inborn errors of metabolism

Locust bean gum

10 g/l

From birth onwards in products for reduction

of gastro-oesophageal reflux

Guar gum

10 g/l

From birth onwards in products in liquid

formulae containing hydrolised proteins,

peptides or amino acids in conformity with the

conditions set out in the Infant Formulae and

Follow-On Formulae Regulations

Xanthan gum

1.2 g/l

From birth onwards for use in products based

on amino acids or peptides for use with patients

who have problems with impairment of the

gastrointestinal tract, protein malabsorbtion or

inborn errors of metabolism

Maximim

E No.

Name

Special conditions

level

Pectins

10 g/l

From birth onwards in products used in case

of gastro-intestinal disorders

E 466 S o d i u m c a r b o x y l 10 g/l or

Fro m b i rt h o n war d s in p r o d uc ts f o r th e

methyl cellulose

k/g

dietary management of metabolic disorders

E 471 M o n o - a n d d i g l y -

5 g/l

From birth onwards in specialised diets,

cerides of fatty acids

particularly those devoid of proteins

E 1450 S t a r c h

s o d i u m 20 g/l

In infant formulae and follow-on formulae

octenyl succinate

E 472c Citric acid esters of 7.5 g/l

From birth onwards

mono-

a n d sold as

diglycerides of fatty powder

acids

9 g/l sold

as liquid

E 473 S u c r o s e e s t e r s o f 120 mg/l

Products containing hydrolysed proteins,

fatty acids

peptides and amino acids

Substituted by

Laws of Malta — Subsidiary Legislation 449.48 — PERMITTED FOOD ADDITIVES REGULATIONS

L.N. 81 of 2010;

Purity Criteria

L.N. 171 of 2011.

P u r i t y c r i te r i a f o r t he f o ll o w i n g a dd i t i v es a r e p r es cr i b ed i n An n e x I o f

Commission Directive 2008/84/EC (OJ L 253, 20.9.2008, p. 1-175), as amended by

Commission Directive 2009/10/EC (OJ L 44, 14.2.2009, p. 62-78) and Commission

Directive 2010/67/EU (OJ L 277, 21.10.2010, p. 17-26).

(i) Calcium carbonate

Sorbic acid

Potassium sorbate

Calcium sorbate

Benzoic acid

Sodium benzoate

Potassium benzoate

Calcium benzoate

Ethyl p-Hydroxybenzoate

Sodium ethyl p-hydroxybenzoate

Methyl p-Hydroxybenzoate

Sodium Methyl p-Hydroxybenzoate

Sulphur dioxide

Sodium sulphite

Sodium bisulphate

Sodium metabisulphite

Potassium metabisulphite

Calcium sulphite

Calcium bisulphite

Potassium bisulphite

Ortophenylphenol

Sodium ortophenylphenol

Nisin

Natamycin

Hexamethylene tetramine

Dimethyl dicarbonate

Potassium nitrite

Sodium nitrite

Sodium nitrate

1. Solid sodium nitrate

2. Liquid sodium nitrate

Potassium nitrate

Acetic acid

Potassium acetate

(i) Sodium acetate

(ii) Sodium diacetate

Calcium acetate

Lactic acid

Propionic acid

Sodium propionate

Calcium propionate

Potassium propionate

Boric acid

Sodium tetraborate (borax)

Carbon dioxide

Malic acid

Fumaric acid

Ascorbic acid

Sodium ascorbate

Calcium ascorbate

(i) Ascorbyl palmitate

(ii) Ascorbyl stearate

Tocopherol-rich extract

Alpha-tocopherol

Gamma-tocopherol

Delta-tocopherol

Propyl gallate

Octyl gallate

Dodecyl gallate

Erythorbic acid

Sodium erythorbate

Tertiary-butylhydroquinone (TBHQ)

Butylated hydroxyanisole (BHA)

Butylated hydroxytoluene (BHT)

Lecithins

Sodium lactate

Potassium lactate

Calcium lactate

Citric acid

(i) Monosodium citrate

(ii) Disodium citrate

(iii) Trisodium citrate

(i) Monopotassium citrate

(ii) Tripotassium citrate

(i) Monocalcium citrate

(ii) Dicalcium citrate

(iii) Tricalcium citrate

L (+) – Tartaric acid

(i) Monosodium tartrate

(ii) Disodium tartrate

(i) Monopotassium tartrate

(ii) Dipotassium tartrate

Potassium sodium tartrate

Phosphoric acid

(i) Monosodium phosphate

(ii) Disodium phosphate

(i) Monopotassium phosphate

(ii) Dipotassium phosphate

(iii) Tripotassium phosphate

(i) Monocalcium phosphate

(ii) Dicalcium phosphate

(iii) Tricalcium phosphate

(i) Monomagnesium phosphate

(ii) Dimagnesium phosphate

(i) Sodium malate

(ii) Sodium hydrogen malate

Potassium malate

(i) Calcium malate

(ii) Calcium hydrogen malate

Metatartaric acid

Calcium tartrate

Adipic acid

Sodium adipate

Potassium adipate

Succinic acid

Triammonium citrate

Calcium disodium ethylenediaminetetraacetate

Extracts of Rosemary

Alginic acid

Sodium alginate

Potassium alginate

Ammonium alginate

Calcium alginate

Propane-1,2-diol alginate

Agar

Carrageenan

E 407a

Processed eucheuma seaweed

Locust bean gum

Guar gum

Tragacanth

Acacia gum

Xanthan gum

Karaya-gum

Tara gum

Gellan gum

(i) Sorbitol

(ii) Sorbitol syrup

Mannitol

Glycerol

(i) Konjac gum

(ii) Konjac glucomannan

Soybean hemicellulose

Cassia gum

Polyoxyethylene (40) stearate

Polyoxyethylene sorbitan monolaurate (polysorbate 20)

Polyoxyethylene sorbitan monooleate (polysorbate 80)

Polyoxyethylene sorbitan monopalmitate (polysorbate 40)

Polyoxyethylene sorbitan monostearate (polysorbate 60)

Polyoxyethylene sorbitan tristearate (polysorbate 65)

(i) Pectin

(ii) Amidated pectin

Ammonium phosphatides

Sucrose acetate isobutyrate

Glycerol esters of wood rosin

(i) Disodium diphosphate

(ii) Trisodium diphosphate

(iii) Tetrasodium diphosphate

(v) Tetrapotassium diphosphate

(vi) Dicalcium diphosphate

(vii) Calcium dihydrogen diphosphate

(i) Pentasodium triphosphate

(ii) Pentapotassium triphosphate

(i) Sodium polyphosphate

1. Soluble polyphosphate

2. Insoluble polyphosphate

(ii) Potassium polyphosphate

(iii) Sodium calcium polyphosphate

(iv) Calcium polyphosphate

Beta-cyclodextrin

(i) Microcrystalline cellulose

(ii) Powdered cellulose

Methyl cellulose

Ethyl cellulose

Hydroxypropyl cellulose

Hydroxypropyl methyl cellulose

Ethyl methyl cellulose

Sodium carboxy methyl cellulose

Cross-linked sodium carboxymethylcellulose

Enzymatically hydrolysed carboxymethylcellulose

Sodium, Potassium and Calcium salts of fatty acids

Magnesium salts of fatty acids

Mono- and diglycerides of fatty acids

Acetic acid esters of mono- and diglycerides of fatty acids

Lactic acid esters of mono- and diglycerides of fatty acids

Citric acid esters of mono- and diglycerides of fatty acids

Tartaric acid esters of mono- and diglycerides of fatty acids

Mono- and diacetyltartaric acid esters of mono- and diglycerides of

fatty acids

Mixed acetic and tartaric acid esters of mono- and diglycerides of fatty

acids

Sucrose esters of fatty acids

Sucroglycerides

Polyglycerol esters of fatty acids

Polyglycerol polyricinoleate

Propane-1,2-diol esters of fatty acids

Thermally oxidized soya bean oil interacted with mono- and

diglycerides of fatty acids

Sodium stearoyl-2-lactylate

Calcium stearoyl-2-lactylate

Stearyl tartrate

Sorbitan monostearate

Sorbitan tristearate

Sorbitan monolaurate

Sorbitan monooleate

Sorbitan monopalmitate

(i) Sodium carbonate

(ii) Sodium hydrogen carbonate

(iii) Sodium sequicarbonate

(i) Potassium carbonate

(ii) Potassium hydrogen carbonate

(i) Ammonium carbonate

(ii) Ammonium hydrogen carbonate

(i) Magnesium carbonate

(ii) Magnesium hydroxide carbonate

Hydrochloric acid

Potassium chloride

Calcium chloride

Magnesium chloride

Stannous chloride

Sulphuric acid

(i) Sodium sulphate

(ii) Sodium hydrogen sulphate

(i) Potassium sulphate

(ii) Potassium hydrogen sulphate

Calcium sulphate

Ammonium sulphate

Aluminium sulphate

Aluminium sodium sulphate

Aluminium potassium sulphate

Aluminium ammonium sulphate

Sodium hydroxide

Potassium hydroxide

Calcium hydroxide

Ammonium hydroxide

Magnesium hydroxide

Calcium oxide

Magnesium oxide

Sodium ferrocyanide

Potassium ferrocyanide

Calcium ferrocyanide

Sodium aluminium phosphate, acidic

Silicon dioxide

E 553a

(i) Magnesium silicate

E 553a

(ii) Magnesium trisilicate

E 553b

Talc

Sodium aluminium silicate

Potassium aluminium silicate

Calcium aluminium silicate

Bentonite

Aluminium silicate (Kaolin)

Fatty acids

Gluconic acid

Glucono-delta-lactone

Sodium gluconate

Potassium gluconate

Calcium gluconate

Ferrous gluconate

Ferrous lactate

4-Hexylresorcinol

Glutamic acid

Monosodium glutamate

Monopotassium glutamate

Calcium diglutamate

Monoammonium glutamate

Magnesium diglutamate

Guanylic acid

Disodium guanylate

Dipotassium guanylate

Calcium guanylate

Inosinic acid

Disodium inosinate

Dipotassium inosinate

Calcium inosinate

Calcium 5’-ribonucleotide

Disodium 5’-ribonucleotide

Glycine and its sodium salt

Zinc acetate

Dimethyl polysiloxane

Beeswax

Candelilla wax

Carnauba wax

Shellac

Microcrystalline wax

Hydrogenated poly-1-decene

Montan acid esters

Oxidised polyethylene wax

L-cysteine

E 927b

Carbamide

Argon

Helium

Nitrogen

Nitrous oxide

E 943a

Butane

E 943b

Isobutane

Propane

Oxygen

Hydrogen

Acesulfame K

Aspartame

Isomalt

Thaumatin

Neohesperidine dihydrochalcone

(i) Maltitol

(ii) Maltitol syrup

Lactitol

Xylitol

Quillaia extract

Invertase

Lysozyme

Polydextrose

Polyvinylpyrrolidone

Polyvinylpolypyrrolidone

Polyvinyl alcohol

Pullulan

Oxidised starch

Monostarch phosphate

Distarch phosphate

Phosphated distarch phosphate

Acetylated distarch phosphate

Acetylated starch

Acetylated distarch adipate

Hydroxypropyl starch

Hydroxypropyl distarch phosphate

Starch sodium octenyl succinate

Acetylated oxidized starch

Starch aluminium octenyl succinate

Triethyl citrate

Glyceryl diacetate

Glyceryl triacetate

Benzyl alcohol

Propane-1,2-diol Polyethylene glycol 6000

Polyethylene glycols.

Laws of Malta — Subsidiary Legislation 449.48 — PERMITTED FOOD ADDITIVES REGULATIONS

5 mg/kg

processed cheese

Clotted cream

10 mg/kg

Mascarpone

10 mg/kg

Pa s te u r i s ed l i q u i d e g g

(white, yolk or whole egg)

6,25 mg/l

Natamycin

Surface treatment of

- hard, semi-hard and 1 mg/dm surface (not

present at a depth of 5

semi-soft cheese

mm)

- dried, cured sausages

E No.

Name

Foodstuff

Maximum level

Hexamethylene tetramine

Provolone cheese

25 mg/kg residual

amount, expressed as

formaldehyde

Dimethyl dicarbonate

Non-alcoholic flavoured

250 mg/l ingoing

drinks

amount, residues not

Alcohol-free wine

detectable

Liquid tea concentrate

Cider, perry, fruit wines

250 mg/l ingoing

Alcohol-reduced wine

amount, residues not

Wi n e - b a s e d d r i n k s a n d

detectable

products covered by

Regulation (EEC) No

1601/91

Boric acid

Sturgeons’ eggs (Caviar) 4 g/kg expressed as

boric acid

Sodium

tetraborate

(borax)

Indicative

Residual

ingoing

E No.

Name

Foodstuff

amount

amount

(mg/kg)

(mg/kg)

Potassium nitrite 5

Meat products

150mg/kg

Sodium nitrite 5

St e r i l i s e d m e a t p r o d u c t s ( F o > 100mg/kg

3,00) Y

Traditional immersion cured meat

products (l)

Wiltshire bacon (1.1);

175mg/kg

Entremeada, entrecosto, chispe,

orelheira e cabeça (salgados)

Toucinho fumado (1.2);

and similar products

Wiltshire ham (1.1); and similar

100mg/kg

products

Rohschinken, nassgepökelt (1.6);

50mg/kg

and similar products

Cured tongue (1.3)

50mg/kg

Traditional dry cured meat products

(2)

Dry cured bacon (2.1);

175mg/kg

and similar products

Dry cured ham (2.1);

100mg/kg

Jamón curado, paleta curada, lomo

embuchado y cecina (2.2);

Presunto, presunto dá and paio do

lombo (2.3); and similar products

R o h s c h i n k e n , t ro c k e n g e p ö k e l t

50mg/kg

(2.5); and similar products

Other traditionally cured meat

products (3)

Indicative

Residual

ingoing

E No.

Name

Foodstuff

amount

amount

(mg/kg)

(mg/kg)

Vysočina Selský salám

180mg/kg

Turistický trvanlivý salám

Poličan

Herkules

Lovecký salám

Dunajská klobása

Paprikás (3.5);

and similar products

Rohschinken,

t ro ck e n - /

50mg/kg

nassgepökelt (3.1); and similar

products

Jellied veal and brisket (3.2)

Potassium nitrate

Non-heat-treated meat products

150mg/kg

(z)

Sodium nitrate (z)

Traditional immersion cured meat

products (1)

Kylmäsavustettu poronliha/

300mg/kg

Kallrökt renkött (1.4);

Wiltshire bacon and Wiltshire ham

250mg/kg

(1.1);

Entremeada, entrecosto, chispe,

orelheira e cabeça (salgados)

Toucinho fumado (1.2);

Rohschinken, nassgepökelt (1.6);

and similar products

Bacon, Filet de bacon (1.5); and

250 mg/kg

similar products

without

added E

249 or E

Cured tongue (1.3)

10 mg/kg

Traditional dry cured meat products

(2)

Dry cured bacon and Dry cured ham

250mg/kg

(2.1);

Jamón curado, paleta curada, lomo

embuchado y cecina (2.2);

Presunto, presunto da pá and paio

do lombo (2.3);

Rohschinken, trockengepökelt (2.5);

and similar products

Jambon sec, jambon sel sec et

250 mg/kg

a u t re s p iè c e s m a t u n i è s s è c h é e s

without

similaires (2.4)

added E

249 or E

Other traditionally cured meat

products (3)

Indicative

Residual

ingoing

E No.

Name

Foodstuff

amount

amount

(mg/kg)

(mg/kg)

Rohwürste (Salami and Kantlvurst) 300 mg/kg

(3.3);

(without

added E

249 or E

250)

Rohschinken,

t ro c k e n - /

250mg/kg

nassgepökelt (3.1); and similar

products

Salchichón y chorizo tradicionales 250 mg/kg

de larga curación (3.4);

(without

added E

249 or E

250)

Saucissons secs (3.6); and similar

products

Jellied veal and brisket (3.2);

10 mg/kg

Hard, semi-hard and semi-soft the 150 mg/kg

in cheese

cheese

milk or

Dairy-based level cheese analogue equivalent

if added

after

removal

of whey

and

addition

of water

Pickled herring and sprat

500 mg/kg

50 8

Potassium nitrate

H a r d , s e m i -h a r d e n d s e m i -s o f t

cheese

Dairy-based cheese analogue

200 9

Pickled herring and sprat

50 6

Foie gras, foie gras entier, blocs de

foie gras

E No.

Name

Foodstuff

Maximum level

Propionic acid 10

Pre-packed sliced bread 3000 mg/kg expressed

and rye bread

as propionic acid

Sodium propionate 10

Calcium propionate 10

Energy reduced bread

2000 mg/kg expressed

as propionic acid

Partially

baked,

pre-packed bread

Potassium propionate 10

Pre-packed fine bakery

wares (including flour

confectionery) with a

water activity of more

than 0.65

Pr e -p a ck e d r o l ls , b u n s

and pitta

PERMITTED FOOD ADDITIVES

E No.

Name

Foodstuff

Maximum level

Christmas pudding

1000 mg/kg expressed

as propionic acid

Pre-packed bread

Pr e- p a ck ed pø l se br ød , 2000 mg/kg expressed

boller and dansk flutes

as propionic acid

Cheese and cheese

quantum satis

analogues

(surface

treatment only)

Lysozyme

Ripened cheese

quantum satis

Wine in accordance with

pro memoria

Regulation (EC) 1493/

19 99 11

and

its

implementing Regulation

(EC) 1622/2000 12

The use of biphenyl (diphenyl) for the surface treatment of citrus fruit is not permitted. The use of

E 231 orthophenyl phenol and E 232 sodium orthophenyl phenol for this same purpose shall no

longer be permitted as soon as requirements for the labelling of foodstuffs treated with these

substances become applicable under the Pesticides Control Act.

This substance may be present naturally in certain cheeses as a result of fermentation processes.

When labelled 'for food use', nitrite may only be sold in a mixture with salt or a salt substitute.

(x) When labelled "for food use", nitrite may be sold only in a mixture with salt or a salt substitute.

(y)

Fo-value 3 is equivalent to 3 minutes heating at 121ºC (reduction of the bacterial load of one

billion spores in each 1000 cans to one spore in a thousand cans).

(z)

Nitrates may be present in some heat-treated meat products resulting from natural conversion

of nitrites to nitrates in a low-acid environment.

1. Meat products are immersed in curing solution containing nitrites and/or nitrates, salt and

other components. The meat products may undergo further treatments e.g. smoking.

Meat is injected with curing solution followed by immersion curing for 3 to 10 days. The

immersion brine solution also includes microbiological starter cultures.

Immersion cured for 3 to 5 days. Product is not heat-treated and has a high water activity.

Immersion cured for at least 4 days and pre-cooked.

Meat is injected with curing solution followed by immersion curing. Curing time is 14 to 21

days followed by maturation in cold-smoke for 4 to 5 weeks.

Immersion cured for 4 to 5 days at 5 to 7°C, matured for typically 24 to 40 hours at 22°C,

possibly smoked for 24hrs at 20 to 25°C and stored for 3 to 6 weeks at 12 to 14°C.

Curing time depending on the shape and weight of meat pieces for approximately 2 days/kg

followed by stabilisation/maturation.

2. Dry curing process involves dry application of curing mixture containing nitrites and/or

nitrates, salt and other components to the surface of the meat followed by a period of stabilisation/

maturation. The meat products may undergo further treatments e.g. smoking.

Dry curing followed by maturation for at least 4 days.

Dry curing with a stabilisation period of at least 10 days and a maturation period of more than

45 days.

Dry cured for 10 to 15 days followed by a 30 to 45 day stabilisation period and a maturation

period of at least 2 months.

Dry cured for 3 days + 1 day/kg followed by a 1 week post-salting period and an ageing/

ripening period of 45 days to 18 months.

Curing time depending on the shape and weight of meat pieces for approximately 10 to 14

days followed by stabilisation/maturation.

3. Immersion and dry cured processes used in combination or where nitrite and/or nitrate is

included in a compound product or where the curing solution is injected into the product prior to

cooking. The products may undergo further treatments e.g. smoking.

Dry curing and immersion curing used in combination (without injection of curing solution).

Curing time depending on the shape and weight of meat pieces for approximately 14 to 35 days followed

by stabilisation/maturation.

E No.

Name

Foodstuff

Maximum level

Injection of curing solution followed, after a minimum of 2 days, by cooking in boiling water

for up to 3 hours.

Product has a minimum 4-week maturation period and a water/protein ratio of less than 1,7.

Maturation period of at least 30 days.

Dried product cooked to 70°C followed by 8 to 12 day drying and smoking process. Fermented

product subject to 14 to 30 day three-stage fermentation process followed by smoking.

Raw fermented dried sausage without added nitrites. Product is fermented at temperatures in

the range of 18 to 22°C or lower ( 10 to 12°C) and then has a minimum ageing/ripening period of 3

weeks. Product has a water/protein ratio of less than 1,7.

10 Propionic acid and its salts may be present in certain fermented products resulting from the

fermentation process following good manufacturing practice.

11 Council Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the

market in wine (OJ L 179, 14.7.1999, p.1). Regulation as last amended by Commission

Regulation (EC) No 1795/2003 (OJ L 262, 14.10.2003, p.1).

12 Commission Regulation (EC) No 1622/2000 of 24 July 2000 laying down certain detailed rules

for implementing Regulation (EC) No 1493/1999 on the common organisation of the market in

wine and establishing a Community code of oenological practices and processes (OJ L 194,

Laws of Malta — Subsidiary Legislation 449.48 — PERMITTED FOOD ADDITIVES REGULATIONS

7.2000, p.1). Regulation as last amended by Regulation (EC) No 1410/2003 (OJ L 201,

8.8.2003, p.9).

PART D

Other antioxidants

Note

The * in the table refers to the proportionality rule: when combinations of gallates, TBHQ,

BHA. and BHT are used, the individual levels must be reduced proportionally.

E No.

Name

Foodstuff

Maximum level (mg/kg)

Propyl gallate

F a t s a n d o i l s f o r t h e 200 * (gallates, TBHQ

professional manufacture and BHA, individually or

of heat-treated foodstuffs

in combination)

Octyl gallate

Frying oil and frying fat,

100* (BHT)

excluding olive pomace

oil

Dodecyl gallate

Te r t i a r y - b u t y l

Lard; fish oil; beef,

both expressed on fat

hydroquinone (TBHQ)

poultry and sheep fat

Butylated

Cake mixes

200 (gallates, TBHQ and

hydroxyanisole (BHA)

Cereal-based snack foods BHA, individually or in

Milk powder for vending

combination)

machines

Dehydrated soups and

broths

Butylated

Dehydrated soups and

expressed on fat

hydroxytoluene (BHT)

broths

Sauces

Dehydrated meat

Processed nuts

Pre-cooked cereals

Seasonings

a n d 200 (gallates, and BHA,

condiments

individually or in

combination) expressed

on fat

E No.

Name

Foodstuff

Maximum level (mg/kg)

Dehydrated potatoes

25 (gallates, TBHQ and

BHA, individually or in

combination)

Chewing gum

400 (gallates, TBHQ,

BHT and BHA,

Food supplements as

individually or in

defined in the Food

combination)

Supplements Regulations

Essential oils

1 000 (gallates, TBHQ

and BHA, individually or

in combination)

Flavourings other than

100 * (gallates,

essential oils

individually or in

combination)

200 * (TBHQ and BHA,

individually or in

combination)

Erythorbic acid

Cured meat products and

500 (expressed as

preserved meat products

erythorbic acid

Sodium erythorbate

Preserved

and

1500 (expressed as

s e m i -p r e s e r v e d f i s h

erythorbic acid)

products

Frozen and deep-frozen

fish with red skin

Extracts of rosemary

Vegetable oils (excluding 30 mg/kg (expressed as

virgin oils and olive oils) the sum of carnosol and

and fat where content of

carnosic acid)

p o l y u n s a t u r a t e d f a t t y Expressed on fat basis

acids is higher than 15%

w/w of the total fatty acid,

for the use in non heat

treated food products

Fish oils and algal oil

50 mg/kg (expressed as

Lard, beef, poultry, sheep the sum of carnosol and

carnosic acid)

and porcine fat

Expressed on fat basis

Fats and oils for the

professional manufacture

of heat-treated foodstuffs

Frying oil and frying fat,

excluding olive oil and

olive pomace oil

Snack foods (snack based

on cereals, potatoes or

starch)

Sauces

100 mg/kg (expressed as

the sum of carnosol and

carnosic acid)

Expressed on fat basis

Fine bakery wares

200 mg/kg (expressed as

the sum of carnosol and

carnosic acid)

Expressed on fat basis

F o o d s u p p l e m e n t s a s 400 mg/kg (expressed as

d e f i n e d i n t h e F o o d the sum of carnosol and

Supplements Regulations

carnosic acid)

E No.

Name

Foodstuff

Maximum level (mg/kg)

Dehydrated potatoes

200 mg/kg (expressed as

the sum of carnosol and

Egg products

carnosic acid)

Chewing gum

Milk powder for vending

200 mg/kg (expressed as

machines

the sum of carnosol and

carnosic acid)

Seasoning

and

Expressed on fat basis

condiments

Processed nuts

Dehydrated soups and

50 mg/kg (expressed as

broths

the sum of carnosol and

carnosic acid)

Dehydrated meat

150 mg/kg (expressed as

the sum of carnosol and

carnosic acid)

Meat and fish products, 150 mg/kg (expressed as

e x c l u d i n g d e h y d r a t e d the sum of carnosol and

meat and dried sausage

carnosic acid)

Expressed on fat basis

Dried sausage

100 mg/kg (expressed as

the sum of carnosol and

carnosic acid)

Flavourings

1 000 mg/kg (expressed

as the sum of carnosol

and carnosic acid)

D r i e d m i l k f o r t h e 30 mg/kg (expressed as

m a n u f a c t u r i n g o f i c e the sum of carnosol and

cream

carnosic acid)

Propyl gallate

Essential oils

1000 mg/kg (gallates

and BHA, individually or

Octyl gallate

in combination)

Dodecyl gallate

Flavourings other than

100 mg/kg (gallates,

essential oils

individually or in

Butylated

combination) or 200 mg/

hydroxyanisole (BHA)

kg (BHA)

4-Hexylresorcinol

Fresh, frozen and deep- 2 mg/kg as residues in

frozen crustaceans

crustacean meat

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