FLAVOURINGS FOR USE IN FOODSTUFFS 
AND SOURCE MATERIALS FOR THEIR PRODUCTION [S.L.231.38 1 
SUBSIDIARY LEGISLATION 231.38 
FLAVOURINGS FOR USE IN FOODSTUFFS AND 
SOURCE MATERIALS FOR THEIR PRODUCTION 
REGULATIONS 
1st January, 1999 
Legal Notice 257 of 1998. 
Title. 1. The title of these Regulations is Flavourings for Use in 
Foodstuffs and Source Materials for their Production Regulations. 
Interpretation. 2. 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

2 [S.L.231.38 
FLAVOURINGS FOR USE IN FOODSTUFFS 
AND SOURCE MATERIALS FOR THEIR PRODUCTION 
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. 
Ingredients of 
flavourings. 
3. 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. 
Applicability. 4. 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, 
imported 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. 
Criteria of purity. 5. (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. 
Sale of flavouring 
etc., and source 
materials. 
6. (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.

FLAVOURINGS FOR USE IN FOODSTUFFS 
AND SOURCE MATERIALS FOR THEIR PRODUCTION [S.L.231.38 3 
(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. 
Labelling of 
flavourings not 
intended for sale to 
the final consumer. 
7. 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

4 [S.L.231.38 
FLAVOURINGS FOR USE IN FOODSTUFFS 
AND SOURCE MATERIALS FOR THEIR PRODUCTION 
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. 
Labelling of 
flavourings 
intended for sale to 
the final consumer. 
8. 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; 
S.L.231.27 
(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; 
S.L.231.27 
(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. 
Use of the word 
"natural". 
9. (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.

FLAVOURINGS FOR USE IN FOODSTUFFS 
AND SOURCE MATERIALS FOR THEIR PRODUCTION [S.L.231.38 5 
(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. 
FIRST SCHEDULE 
(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 µg/kg 0.03 µg/kg 
SECOND SCHEDULE 
(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 
mg/kg 
Beverages 
mg/kg 
Exceptions and or 
special restrictions 
Agaric acid * 20 20 100 mg/kg in alcoholic 
beverages and foodstuffs 
containing mushrooms. 
Aloin* 0.1 0.1 5 0 m g / k g i n a l c o h o l i c 
beverages. 
Beta asarone * 0.1 0.1 1 m g / k g i n a l c o h o l i c 
beverages and seasonings 
used in snack foods. 
Berberine * 0.1 0.1 1 0 m g / k g i n a l c o h o l i c 
beverages. 
Coumarin * 2 2 10 mg/kg in certain types 
of caramel confectionery. 
50 mg/kg in chewing gum. 
1 0 m g / k g i n a l c o h o l i c 
beverages. 
Hydrocyanic acid * 1 1 5 0 m g / k g i n n o u g a t , 
marzipan or its substitutes 
or similar products.

6 [S.L.231.38 
FLAVOURINGS FOR USE IN FOODSTUFFS 
AND SOURCE MATERIALS FOR THEIR PRODUCTION 
1 mg/% volume of alcohol 
in alcoholic beverages. 
5 mg/kg in canned stone 
fruit. 
Hypericine * 0.1 0.1 1 0 m g / k g i n a l c o h o l i c 
beverages. 
1 mg/kg in confectionery. 
Pulegone * 25 100 2 5 0 m g / k g i n m i n t o r 
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 * 5 5 10 mg/kg in confectionery 
in pastille form. 
5 0 m g / k g i n a l c o h o l i c 
beverages. 
Safrole and isosafrol * 1 1 2 m g / k g i n a l c o h o l i c 
beverages with not more 
than 25% volume of 
alcohol. 
5 m g / k g i n a l c o h o l i c 
beverages with more than 
25% volume of alcohol. 
15 mg/kg in foodstuffs 
c o n t a i n i n g m a c e a n d 
nutmeg. 
Santonin * 0.1 0.1 1 m g / k g i n a l c o h o l i c 
beverages with more than 
25% volume of alcohol. 
Thuyone (µ and ß) * 0.5 0.5 5 m g / k g i n a l c o h o l i c 
beverages with not more 
than 25% volume of 
alcohol. 
1 0 m g / k g i n a l c o h o l i c 
beverages with more than 
25% volume of alcohol. 
25 mg/kg in foodstuffs 
containing preparations 
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. 
Substances Foodstuffs 
mg/kg 
Beverages 
mg/kg 
Exceptions and or 
special restrictions

