ADDITIVES IN FOOD ġ S.L.231.29 1
SUBSIDIARY LEGISLATION 231.29
ADDITIVES IN FOOD REGULATIONS
17th August, 1994
Legal Notice 89 of 1994.
Title.
Regulations.
Applicability.
various categories of which are listed in the First Schedule, and
which are used, or intended to be used, as ingredients during the
manufacture or preparation of food and are still present in the final
product, even if in altered form.
(2) For the purposes of these regulations, "food additive"
means any substance not normally consumed as a food in itself and
not normally used as a characteristic ingredient of food whether or
not it has nutritive value, the intentional addition of which to food
for a technological purpose in the manufacture, processing,
preparation, treatment, packaging, transport or storage of such food
results, or may be reasonably expected to result, in it or its
by-products becoming directly or indirectly a component of such
foods.
(3) These regulations shall not apply to:
( a ) processing aids, which means any substance, not
consumed as a food ingredient by itself, which is
intentionally used in the processing of raw materials,
foods or their ingredients to fulfill a certain
technological purpose during treatment or processing
and which may result in the unintentional but
technically unavoidable presence of residues of the
substance or its derivatives in the final product, always
provided that such residues do not present any health
risk and do not have any technological effect on the
finished product;
( b ) substances used in the protection of plants and plant
products in conformity with the European Community
rules relating to plant health;
( c ) flavourings for use in foodstuffs, falling within the
scope of Council Directive 88/388/EEC of the
European Community;
( d ) substances added to foodstuffs as nutrients.
Permitted 
additives.
3. (1) Only food additives listed under regulations as may
from time to time be published in respect of any categories of
additives listed additives in the First Schedule may be used in the
manufacture or preparation of food, and such use shall be subject to
the conditions of use specified in any such other regulations to be
made.
(2) The inclusion of a food additive in one of the categories in
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such Schedule shall be on the basis of the principal function
normally associated with the food additive in question. However,
the allocation of an additive to a particular category does not
exclude the possibility of such additive being authorised for several
functions.
(3) Food additives shall satisfy general criteria laid down in
the Second Schedule.
Labelling of food 
additives not 
intended for sale to 
ultimate consumer.
4. (1) Food additives not intended for sale to the ultimate
consumer may be marketed only if their packaging or container
bears the following information, which must be conspicuous,
clearly legible and indelible:
( a ) for food additives sold singly or nixed with each other,
for each additive, the name of such additive as may be
laid down by any applicable European Community
provisions and its EEC number or serial number, or, in
the absence of any such provision, a description of the
additive that is sufficiently precise to enable it to be
distinguished from additives with which it could be
confused, in descending order of the proportion by
weight in the total:
Provided that when other substances or materials
or food ingredients are incorporated in any food
additive or additives, to facilitate storage, sale,
standardization, dilution or dissolution of such
additive or additives, there shall be included the name
of the additive and an indication of each component in
descending order of the proportion by weight in the
total;
( b ) - either the statement "for use in food";
- or the statement "restricted use in food";
- or a more specific reference to its intended food use;
( c ) the special conditions of storage and use if omission
thereof would preclude appropriate use of the additive;
( d ) the directions for use, if the omission thereof would
preclude appropriate use of the additive;
( e ) a mark identifying the batch or lot;
( f ) the name or business name and address of the
manufacturer or packager, or of a seller;
( g ) an indication of the percentage of any component
which is subject to a quantitative limitation in a food
or adequate compositional information to enable the
purchaser to comply with any European Community
provision applicable to the food. Where the same
quantitative limitation applies to a group of
components used singly or in combination, the
combined percentage may be given as a single figure;
( h ) the net quantity; and
( i ) any other information as may be requested under
regulations published in respect of specific food
ADDITIVES IN FOOD ġ S.L.231.29 3
additives.
(2) Notwithstanding the provisions of sub-regulation (1), the
information required under the proviso to paragraph ( a ), and under
paragraphs ( d ), ( e ), ( f ) and ( g ) of the said sub-regulation may
appear merely on the documents relating to the consignment which
are to be supplied with or prior to the delivery, provided that the
indication "intended for the manufacture of foodstuffs and not for
retail sale" appears on a conspicuous part of the packaging or
container of the product in question.
Labelling of food 
additives intended 
for sale to ultimate 
consumer.
5. Food additives intended for sale to the ultimate consumer
may be marketed only if their packaging or containers bear the
following information, which must be conspicuous, clearly legible
and indelible:
( a ) the name under which the product is sold. Such name
shall be constituted by the name laid down by any
European Community provisions applying to the
product in question plus its EEC number or serial
number, or, in the absence of such provisions, by a
description of the product that is sufficiently precise to
enable it to be distinguished from products with which
it could be confused; and
S.L.231.27
( b ) the date of minimum durability within the meaning
given in the Labelling, Presentation and Advertising of
Foodstuffs Regulations; and
( c ) the information required under regulation 4(1)( a ) to
( f ), ( h ) and ( i ).
Language to be 
used.
S.L.231.27
6. The particulars referred to in regulations 4 and 5 shall at
least appear in one of the official languages of Malta, and the
provisions of regulation 10 of the Labelling, Presentation and
Advertising of Foodstuffs Regulations in respect of exemptions
shall likewise apply.
Prohibition of sale, 
etc., of additives 
not complying with 
regulations.
7. 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.
FIRST SCHEDULE
Regulation 2 (1)
CATEGORIES OF FOOD ADDITIVES
Colour
Preservative
Anti-oxidant
Emulsifier
Emulsifying salt
Thickener
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Gelling Agent
Stabiliser  (1)
Flavour enhancer
Acid
Acidity regulator  (2)
Anti-caking agent
Modified starch
Sweetener
Raising agent
Anti-foaming agent
Glazing agent  (3)
Flour treatment agent
Firming agent
Humectant
Sequestrant  (4)
Enzyme  (4)   (5)
Bulking agent
Propellant gas and packaging gas
(1) This category also comprises foam stabilisers.
(2) These can act as two-way acidity regulators.
(3) These substances include lubricants.
(4) Inclusion of these terms in this list is without prejudice to
any future decision or mention thereof in the labelling of foodstuffs
intended for the final consumer.
(5) Only those used as additives.
SECOND SCHEDULE
Regulation 3 (3)
GENERAL CRITERIA FOR THE USE OF FOOD ADDITIVES
1. Food additives may be approved only provided that:
- there may be demonstrated a reasonable technological
need and the purpose cannot be achieved by other
means which are economically and technologically
practicable,
- they present no hazard to the health of the consumer at
the level of use proposed, so far as can be judged on
ADDITIVES IN FOOD ġ S.L.231.29 5
the scientific evidence available,
- they do not mislead the consumer.
2. The use of food additives may be considered only where
there is evidence that the proposed use of the additive could have
demonstrable advantages of benefit to the consumer, in other words
it is necessary to establish the case for what is commonly referred
to as "need". The use of food additives should serve one or more of
the purposes set out from points ( a ) to ( d ) below, and only where
those purposes cannot be achieved by other means which are
economically and technologically practicable and do not present a
hazard to the health of the consumer:
( a ) to preserve the nutritional quality of the food; an
intentional reduction in the nutritional quality of a
food would be justified only where the food does not
constitute a significant item in a normal diet or where
the additive is necessary for the production of foods
for groups of consumers having special dietary needs;
( b ) to provide necessary ingredients or constituents for
foods manufactured for groups of consumers having
special dietary needs;
( c ) to enhance the keeping quality or stability of a food or
to improve its organoleptic properties, provided that
this does not so change the nature, substance or quality
of the food as to deceive the consumer;
( d ) to provide aids in manufacture, processing,
preparation, treatment, packing, transport or storage of
food, provided that the additive is not used to disguise
the effects of the use of faulty raw materials or of
undesirable (including unhygienic) practices or
techniques during the course of any of these activities.
3. Food additives shall at all times comply with the approved
criteria of purity.
4. Approval for food additives shall -
( a ) specify the foodstuffs to which these additives may be
added and the conditions under which they may be
added;
( b ) be limited to the lowest level of use necessary to
achieve the desired effect;
( c ) take into account any acceptable daily intake, or
equivalent assessment established for the food additive
and the probable daily intake of it from all sources.
Where the food additive is to be used in foods eaten by
special groups of consumers, account should be taken
of the possible daily intake of the food additive by
consumers in those groups.
5. Any food additive or any derivatives thereof, which are
used in food must have been fully subjected to appropriate
toxicological testing and evaluation with a view to assessing any
possible harmful effects.
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Such evaluation must also take into account any
cumulative, synergistic or potentiating effect of its use and the
phenomenon of human intolerance to substances foreign to the
human body.
