FLAVOURINGS FOR USE IN FOODSTUFFS AND SOURCE MATERIALS FOR THEIR PRODUCTION REGULATIONS

SUBSIDIARY LEGISLATION 449.21

FLAVOURINGS FOR USE IN FOODSTUFFS AND

SOURCE MATERIALS FOR THEIR PRODUCTION

REGULATIONS

1st January, 1999

LEGAL NOTICE 257 of 1998.

The title of these regulations is Flavourings for Use in

Foodstuffs and Source Materials for their Production Regulations.

(Regulation 5(3))

Maximum limits for certain undesirable substances present

in foodstuffs as consumed as a result of the use of flavourings.

SUBSTANCE

FOODSTUFFS

BEVERAGES

3,4 benzopyrene

0.03 µ g/kg

0.03 µ g/kg

In these regulations, unless the context otherwise requires -

(a) "flavouring" means flavouring substances, flavouring

preparations, process flavourings, smoke flavourings

or mixtures thereof;

(b) "flavouring substance" means a defined chemical

substance with flavouring properties which is

obtained -

(i)

by appropriate physical processes, including

distillation and solvent extraction, or by

enzymatic or microbiological processes from

material of vegetable or animal origin either in

the raw state or after processing for human

consumption by traditional food-preparation

processes, including drying, torrefaction and

fermentation,

(ii) by chemical synthesis or isolated by chemical

processes and which is chemically identical to a

substance naturally present in material of

vegetable or animal origin as described in

subparagraph (i),

(iii) by chemical synthesis but which is not

chemically identical to a substance naturally

present in material present in material of

vegetable or animal origin as described in

subparagraph (i);

(c) "flavouring preparation" means a product, other than

the substances defined in paragraph (b)(i), whether

concentrated or not, with flavouring properties, which

is obtained by appropriate physical processes,

including distillation and solvent extraction, or by

enzymatic or microbiological processes from material

of vegetable or animal origin, either in the raw state or

after processing for human consumption by traditional

food preparation processes, including drying,

torrefaction and fermentation;

(d) "process flavouring" means a product which is

obtained according to good manufacturing practices by

heating to a temperature not exceeding 180 degrees

Celsius for a period not exceeding fifteen minutes a

mixture of ingredients, not necessarily themselves

having flavouring properties, of which at least one

contains nitrogen (amino) and another is a reducing

sugar;

(e) "smoke flavouring" means a smoke extract used in

traditional foodstuffs smoking processes.

(Regulation 5(4))

Maximum limits for certain substances obtained from flavorings

and other food ingredients with flavouring properties present in

foodstuffs as consumed in which flavourings have been used.

Substances

Foodstuffs Beverages

Exceptions and or

mg/kg

mg/kg

special restrictions

Agaric acid *

1 0 0 m g /k g i n a lc o h o l ic

beverages and foodstuffs

containing mushrooms.

Aloin*

0.1

0.1

50 mg/kg in alcoholic

beverages.

Beta asarone *

0.1

0.1

1 mg/kg in alcoholic

beverages and seasonings

used in snack foods.

Berberine *

0.1

0.1

10mg/kg in alcoholic

beverages.

Coumarin *

10 mg/kg in certain types

of caramel confectionery.

50 mg/kg in chewing gum.

10 mg/kg in alcoholic

beverages.

Hydrocyanic acid *

50 mg/kg in nougat,

marzipan or its substitutes

or similar products.

Substances

Foodstuffs Beverages

Exceptions and or

mg/kg

mg/kg

special restrictions

1 mg/% volume of alcohol

in alcoholic beverages.

5 mg/kg in canned stone

fruit.

Hypericine *

0.1

0.1

10 mg/kg in alcoholic

beverages.

1 mg/kg in confectionery.

Pulegone *

250 mg/kg in mint or

p e p p e r m i n t -f l a v o u r e d

beverages.

350 mg/kg in mint

confectionery.

Quassine *

10 mg/kg in confectionery

in pastille form.

50 mg/kg in alcoholic

beverages.

Safrole and isosafrol *

2 mg/kg in alcoholic

beverages with not more

than 25% volume of

alcohol.

5 mg/kg in alcoholic

beverages with more than

25% volume of alcohol.

1 5 m g / k g i n f o o d s t u ff s

containing mace and

nutmeg.

Santonin *

0.1

0.1

1 mg/kg in alcoholic

beverages with more than

25% volume of alcohol.

Thuyone (∝ and ß) *

0.5

0.5

5 mg/kg in alcoholic

beverages with not more

than 25% volume of

alcohol.

10 mg/kg in alcoholic

beverages with more than

25% volume of alcohol.

2 5 m g / k g i n f o o d s t u ff s

co nta in ing prep aratio ns

based on sage.

35 mg/kg in bitters.

* May not be added as such to foodstuffs or to flavourings. May be present in a

foodstuff either naturally or following the addition of flavourings prepared from

natural raw materials.

Flavourings may contain foodstuffs as well as -

-

additives necessary for the storage and use of

flavourings,

-

products used for dissolving and diluting flavourings,

-

additives necessary for the production of flavourings

(processing aids) where such additives are not covered

by any other provisions.

These regulations shall apply to flavourings, imported into

Malta or manufactured in Malta, used or intended for use in or on

foodstuffs to impart odour and, or, taste and to source materials,

im ported into Malta or manufactured in Malta, used for the

production of flavourings. These regulations, however, shall not

apply to

(a) edible substances and products intended to be

consumed as such, with or without reconstitution,

(b) substances which have exclusively a sweet, sour or salt

taste,

(c) material of vegetable or animal origin, having inherent

flavourings properties, where they are not used as

flavouring sources.

(1) No flavouring may contain any element or substance in

a toxicologically dangerous quantity.

(2) Subject to any exceptions provided for in any specific

criteria of purity prescribed under these regulations or otherwise by

any other law, flavourings may not contain more than

-

3 mg/kg of arsenic,

-

10 mg/kg of lead,

-

1 mg/kg of cadmium, and

-

1 mg/kg of mercury.

(3) The use of flavourings must not result in the presence in

foodstuffs, as consumed, of undesirable substances listed in the

First Schedule in quantities greater than those specified therein.

(4) The use of flavourings and of other food ingredients with

flavouring properties must not result in the presence in foodstuffs,

as consumed, of substances listed in the Second Schedule in

quantities greater than those specified therein.

(1) No person shall, for the purpose of a food business,

import, keep or sell any food in which or on which there is any

flavouring which does not comply with the requirements of these

regulations.

(2) No person shall keep or suffer to be kept on, or use in, any

food premises used for the preparation, or for the preparation for

sale, of food, any flavouring or source material for its production,

not being respectively a flavouring or source material for the

production of such food which complies with the requirements of

these regulations.

Flavourings not intended for sale to the final consumer

may not be marketed unless their packagings or containers bear in

at least one of the official languages of Malta the following

information, which should be easily visible, clearly legible and

indelible

(a) the name or business name and address of the

manufacturer, or packer, or of a seller established in

Malta;

(b) the sales description: either the word "flavouring" or a

more specific name or description of the flavouring;

(c) either the statement "'for foodstuffs" or a more specific

reference to the foodstuff for which the flavouring is

intended;

(d) a list in descending order of weight, of categories of

flavouring substances, and flavouring preparations

present classified as follows

-

natural flavouring substances in the case of

flavouring substances defined in regulation

2(b)(i),

-

flavouring substances identical to natural

substances in the case of flavouring substances

defined in regulation 2(b)(ii),

-

artificial flavouring substances in the case of

flavouring substances defined in regulation

2(b)(iii),

-

flavouring preparations in the case of

preparations defined in regulation 2(c),

-

process flavourings in the case of flavourings

defined in regulation 2(d),

-

smoke flavourings in the case of flavourings

defined in regulation 2(e);

(e) in the case of a mixture of flavourings with additives

necessary for the storage and use of flavourings or

with products used for dissolving and diluting

flavourings, a list in descending order of weight in the

mixture of

-

the categories of flavourings classified as in

paragraph (d),

-

the names of each of the other substances or

materials or, where appropriate, their EEC

numbers;

(f)

an indication of the maximum quantity of each

component or group of components subject to

quantitative limitation in a foodstuff, or appropriate

information;

(g) an indication identifying the consignment;

(h) the nominal quantity expressed in units of mass or

volume

Provided that the information required in paragraphs (d),

(e) and (f) may appear merely on the trade documents relating to

the consignment which are to be supplied with or prior to delivery,

sohowever that the indication "intended for the manufacture of

foodstuffs and not for retail" appears in a conspicuous part of the

packaging or container of the products in question.

Flavorings intended for sale to the final consumer may not

not be marketed unless their labels indicate in at least one of the

official languages of Malta, the following obligatory information,

which should be easily visible, clearly legible and indelible

(a) either the word "flavouring" or a more specific name

or description of the flavouring;

(b) either the words "for foodstuffs" or a more specific

reference to the foodstuff for which the flavouring is

intended;

(c) the date of minimum durability as provided for in the

Labelling, Presentation and Advertising of Foodstuffs

Regulations;

(d) where necessary, the special conditions for storage and

use;

(e) the instructions for use if omission thereof would

prevent appropriate use of the flavouring;

(f)

the nominal quantity expressed in units of mass or

volume;

(g) the name or business name and address of the

manufacturer, or packer, or of a seller established in

Malta;

(h) an indication or mark identifying the batch as provided

for in the Labelling, Presentation and Advertising of

Foodstuffs Regulations;

(i)

in the case of a mixture of flavouring(s) with other

substances, a list in descending order of weight in the

mixture of

-

the categories of flavourings classified as in

regulation 7(d);

-

the names of each of the other substances or

materials or, where appropriate, their EEC

numbers.

(1) The word "natural", or any other word having

substantially the same meaning, may be used only for flavourings

in which the flavouring component contains exclusively flavouring

substances as defined in regulation 2( b )(i), or flavouring

preparations as defined in regulation 2.

(2) If the sales description of the flavourings contains a

reference to a foodstuff or a flavouring source, the word "natural",

or any other word having substantially the same meaning, may not

be used unless the flavouring component has been isolated by

appropriate physical processes, enzymatic or microbiological

processes or traditional food-preparation processes solely or almost

solely from the foodstuff or the flavouring source concerned.

(3) The provisions of sub-regulations (1) and (2) shall apply to

the labelling of flavourings referred to in regulations 7 and 8.