PROCESSED CEREAL-BASED FOODS AND OTHER 
FOODS FOR INFANTS AND YOUNG CHILDREN ġ S.L.231.39 1
SUBSIDIARY LEGISLATION 231.39
PROCESSED CEREAL-BASED FOODS AND OTHER 
FOODS FOR INFANTS AND YOUNG CHILDREN 
REGULATIONS
1st August, 2002
Legal Notice 207 of 2002.
Title.
Foods and Other Foods for Infants and Young Children
Regulations.
Applicability of 
these regulations.
2..1 These Regulations shall apply to foodstuffs for particular
nutritional use fulfilling the particular requirements of infants and
young children in good health and which are intended for use by
infants while they are being weaned, and by young children as a
supplement to their diet andĦor for their progressive adaptation to
ordinary food. They comprise:
( a ) "Processed cereal-based foods" which are divided into
the following four categories:
(i) simple cereals which are or have to be
reconstituted with milk or other appropriate
nutritious liquids;
(ii) cereals with an added high protein food which
are or have to be reconstituted with water or
other protein-free liquid;
(iii) pastas which are to be used after cooking in
boiling water or other appropriate liquids;
(iv) rusks and biscuits which are to be used either
directly or, after pulverisation, with the addition
of water, milk or other suitable liquids.
( b ) "Baby foods" other than processed cereal-based foods.
2.2 These regulations shall not apply to milks intended for
young children.
2.3 For the purposes of these regulations -
- "infants" shall mean children under the age of twelve
months,
- "young children" shall mean children aged between 1
and 3 years,
- "pesticide residue" means the residue in processed
cereal-based foods and baby foods of a plant
protection product, as defined in point 1 of Article 2 of
Council Directive 91/414/EEC * , including its
metabolites and products resulting from its
degradation or reaction.
*OJ L230, 19.8.1991, p.1.
2 ġ S.L.231.39
PROCESSED CEREAL-BASED FOODS AND OTHER 
FOODS FOR INFANTS AND YOUNG CHILDREN
Sale of processed 
cereal-based foods 
and baby foods for 
infants and young 
children.
3.1 No person shall import, keep or sell any processed cereal-
based food or other baby food intended for infants and young
children which does not comply with the requirements of these
regulations.
Manufacture of 
processed 
cereal-based foods 
and baby foods.
4.1 Processed cereal-based foods and baby foods shall be
manufactured from ingredients whose suitability for particular
nutritional use by infants and young children has been established
by generally accepted scientific data.
4.2 Processed cereal-based foods shall comply with the
compositional criteria specified in the First Schedule.
4.3 Baby foods which are described in the Second Schedule
shall comply with the compositional criteria specified therein.  
4.4 Only the nutritional substances listed in the Fourth
Schedule may be added in the manufacture of processed cereal-
based foods and baby foods.
4.5 Processed cereal-based foods and baby foods shall not
contain any substance in such quantity as to endanger the health of
infants and young children.
4.6 Processed cereal-based foods and baby foods shall not
contain residues of individual pesticides at levels exceeding 0.01
mg/kg of the product as proposed ready for consumption or as
reconstituted according to the instructions of the manufacturer.
4.7 Analytical methods for determining the levels of pesticide
residues shall be generally acceptable standardised methods.
4.8 The maximum limits for vitamins, minerals and trace
elements laid down in the Sixth Schedule shall be observed if such
vitamins, minerals and trace elements are added to processed
cereal-based foods and baby foods intended for infants and young
children.
Labelling of 
processed cereal-
based foods and 
baby foods 
intended for infants 
end young 
children.
S.L.231.27
5.1 The labelling of the products concerned shall bear, in
addition to the particulars provided for in the Labelling and
Presentation of Foodstuffs Regulations, the following mandatory
particulars, in Maltese, English or Italian:
( a ) a statement as to the appropriate age from which the
product may be used, regard being had to its
composition, texture or other particular properties. The
stated age shall not be less than four months for any
product. Products recommended for use from the age
of four months may indicate that they are suitable from
that age unless independent persons having
qualifications in medicine, nutrition or pharmacy, or
other professionals responsible for maternal and child
care, advise otherwise;
( b ) information as to the presence or absence of gluten if
the indicated age from which the product may be used
is below six months;
( c ) the available energy value expressed in kJ and kcal,
and the protein, carbohydrate and lipid content,
expressed in numerical form, per 100 g or 100 ml of
PROCESSED CEREAL-BASED FOODS AND OTHER 
FOODS FOR INFANTS AND YOUNG CHILDREN ġ S.L.231.39 3
the product as sold and, where appropriate, per
specified quantity of the product as proposed for
consumption;
( d ) the average quantity of each mineral substance and of
each vitamin governed by a specific level in the First
and Second Schedule respectively, expressed in
numerical form, per 100 g or 100 ml of the product as
sold and, where appropriate, per specified quantity of
the product as proposed for consumption;
( e ) instructions for appropriate preparation, when
necessary, and a statement as to the importance of
following those instructions.
5.2 The labelling may bear:
( a ) the average quantity of the nutrients set out in the
Fourth Schedule when such declaration is not covered
by the provisions of regulation 5.1( d ), expressed in
numerical form, per 100 g or 100 ml of the product as
sold and, where appropriate, per specified quantity of
the product as proposed for consumption;
( b ) in addition to numerical information, information on
vitamins and minerals shown in the Fifth Schedule,
expressed as a percentage of the reference values
given therein, per 100 g or 100 ml of the product as
sold and, where appropriate, per specified quantity of
the product as proposed for consumption, provided
that the quantities present are at least equal to 15% of
the reference values.
4 ġ S.L.231.39
PROCESSED CEREAL-BASED FOODS AND OTHER 
FOODS FOR INFANTS AND YOUNG CHILDREN
FIRST SCHEDULE
Essential Composition of Processed Cereal-Based Foods for Infants 
and Young Children
The requirements concerning nutrients refer to the products
ready for use marketed as such or reconstituted as instructed by the
manufacturer.
1. Cereal content
Processed cereal-based foods are prepared primarily from
one or more milled cereals and/or starchy root products.
The amount of cereal and/or starchy root shall not be less
than 25% of the final mixture on a dry weight for weight basis.
2. Protein
2.1 For products mentioned in regulation 2.1( a )(ii) and ( a )(iv),
the protein content shall not exceed 1.3 g/100 kJ (5.5 g/100 kcal).
2.2 For products mentioned in regulation 2.1( a )(ii), the added
protein shall not be less than 0.48 g/100 kJ (2 g/100 kcal).
2.3 For biscuits mentioned in regulation 2.1( a )(iv), made with
the addition of a high protein food, and presented as such, the
added protein shall not be less than 0.36 g/100 kJ (1.5 g/100 kcal).
2.4 The chemical index of the added protein shall be equal to
at least 80% of that of the reference protein (casein as defined in
the Third Schedule), or the protein energy ratio (PER) of the
protein in the mixture shall be equal to at least 70% of that of the
reference protein. In all cases, the addition of amino acids is
permitted solely for the purpose of improving the nutritional value
of the protein mixture, and only in the proportions necessary for
that purpose.
3. Carbohydrates
3.1 If sucrose, fructose, glucose, glucose syrups or honey are
added to products mentioned in regulation 2.1( a )(i) and ( a )(iv):
- the amount of added carbohydrates from these sources
shall not exceed 1.8 g/100 kJ (7.5 g/100 kcal),
- the amount of added fructose shall not exceed 0.9 g/
100 kJ (3.75 g/100 kcal).
3.2 If sucrose, fructose, glucose syrups or honey are added to
products mentioned in regulation 2.1( a )(ii):
- the amount of added carbohydrates from these sources
shall not exceed 1.2 g/100 kJ (5 g/100 kcal),
- the amount of added fructose shall not exceed 0.6 g/
100 kJ (2.5 g/100 kcal).
4. Lipids
4.1 For products mentioned in regulation 2.1( a )(i) and ( a )(iv),
the lipid content shall not exceed 0.8 g/100 kJ (3.3 g/100 kcal).
4.2 For products mentioned in regulation 2.1( a )(ii), the lipid
PROCESSED CEREAL-BASED FOODS AND OTHER 
FOODS FOR INFANTS AND YOUNG CHILDREN ġ S.L.231.39 5
content shall not exceed 1.1 g/100 kJ (4.5 g/100 kcal). If the lipid
content exceeds 0.8 g/100 kJ (3.3 g/100 kcal) -
( a ) the amount of lauric acid shall not exceed 15% of the
total lipid content;
( b ) the amount of myristic acid shall not exceed 15% of
the total lipid content;
( c ) the amount of linoleic acid (in the form of glycerides =
linoleates) shall not be less than 70 mg/100 kJ (300
mg/100 kcal) and shall not exceed 285 mg/100 kJ
(1,200 mg/100 kcal).
5. Minerals
5.1 Sodium
- sodium salts may only be added to processed cereal-based
foods for technological purposes,
- the sodium content of processed cereal-based foods shall
not exceed 25 mg/100 kJ (100 mg/ kcal).
5.2 Calcium
5.2.1 For products mentioned in regulation 2.1( a )(ii), the amount
of calcium shall not be less than 20 mg/100 kJ (80 mg/100 kcal).
5.2.2 For products mentioned in regulation 2.1( a )(iv),
manufactured with the addition of milk (milk biscuits) and
presented as such, the amount of calcium shall not be less than 12
mg/100 kJ (50 mg/100 kcal).
6. Vitamins
6.1  For processed cereal-based foods the amount of thiamin
shall not be less than 25 µg/100 kJ (100 µg/100 kcal).
6.2 For products mentioned in regulation 2.1( a )(ii):
These limits are also applicable if vitamins A and D are
added to other processed cereal-based foods.
Per 100 kJ Per 100 kcal
Minimum Maximum Minimum Maximum
Vitamin A (µg RE) 1 14 43 60 180
Vitamin D (µg) 2 0.25 0.75 1 3
1 RE = all bans retinol equivalents
2 In the fonn of cholecalciferol, of which 10 µg = 400 i.u. of vitamin D.
6 ġ S.L.231.39
PROCESSED CEREAL-BASED FOODS AND OTHER 
FOODS FOR INFANTS AND YOUNG CHILDREN
SECOND SCHEDULE
Essential Composition of Baby Foods for Infants and Young 
Children
The requirements concerning nutrients refer to the products
ready for use, marketed as such or reconstituted as instructed by the
manufacturer.
1. Protein
1.1 If meat, poultry, fish, offal or other traditional source of
protein are the only ingredients mentioned in the name of the
product, then:
- the named meat, poultry, fish, offal or other traditional
protein source, in total shall constitute not less than
40% by weight of the total product,
- each named meat, poultry, fish, offal or other
traditional source of protein shall constitute not less
than 25% by weight, of total named protein sources,
- the total protein from the named sources shall not be
less than 1.7 g/100 kJ (7 g/100 kcal).
1.2 If meat, poultry, fish, offal or other traditional source of
protein, singularly or in combination, are mentioned first in the
name of the product, whether or not the product is presented as a
meal, then:
- the named meat, poultry, fish, offal or other traditional
protein source, in total, shall constitute not less than
10% by weight of the total product,
- each named meat, poultry, fish, offal or other
traditional source of protein shall constitute not less
than 25% by weight, of total named protein sources,
- the protein from the named sources shall not be less
than 1 g/100 kJ (4 g/100 kcal).
1.3 If meat, poultry, fish, offal or other traditional source of
protein, singularly or in combination are mentioned, but not first, in
the name of the product, whether or not the product is presented as
a meal, then:
- the named meat, poultry, fish, offal or other traditional
protein source, in total, shall constitute not less than
8% by weight of the total product,
- each named meat, poultry, fish, offal or other
traditional source of protein shall constitute not less
than 25%, by weight, of total named protein sources,
- the protein from the named sources shall not be less
than 0.5 g/100 kJ (2.2 g/ 100 kcal),
- the total protein in the product from all sources shall
not be less than 0.7 g/ 100 kJ (3 g/100 kcal).
1.4 If the product is designated on the label as a meal, but does
not mention meat, poultry, fish, offal or other traditional source of
PROCESSED CEREAL-BASED FOODS AND OTHER 
FOODS FOR INFANTS AND YOUNG CHILDREN ġ S.L.231.39 7
protein in the name of the product, then:
- the total protein in the product from all sources shall
not be less than 0.7 g/100 kJ (3 g/100 kcal).
1.5 The addition of amino acids is permitted solely for the
purpose of improving the nutritional value of the protein present,
and only in the proportions necessary for that purpose.
1.6 If cheese is mentioned together with other ingredients in
the name of a savoury product, whether or not the product is
presented as a meal, then:
- the protein from the dairy sources shall not be less
than 0.5 g/100 kJ (2.2 g/100 Kcal)
- the total protein in the product from all sources shall
not be less than 0.7 g/100 kJ (3 g/100 Kcal).
1.7 Sauces presented as an accompaniment to a meal are
exempt from the requirements of paragraphs 1.1 to 1.4.
1.8 Sweet dishes that mention dairy products as the first or
only ingredient in the name shall contain not less than 2.2 g dairy
protein/100 kcal. All other sweet dishes are exempt from the
requirements of paragraphs 1.1 to 1.4.
2. Carbohydrates
The quantities of total carbohydrates present in fruit and
vegetable juices and nectars, fruit-only dishes, and desserts or
puddings shall not exceed:
- 10 g/100 ml for vegetable juices and drinks based on
them,
- 15 g/100 ml for fruit juices and nectars and drinks
based on them,
- 20 g/100 g for fruit-only dishes,
- 25 g/100 g for desserts and puddings,
- 5 g/100 g for other non-milk-based drinks.
3. Fat
3.1 For products referred to in paragraph 1.1:
If meat or cheese are the only ingredients or are mentioned
first in the name of a product, then:
- the total fat in the product from all sources shall not
exceed 1.4 g/100 kJ (6 g/100 kcal).
3.2 For all other products:
- the total fat in the product from all sources should not
exceed 1.1 g/100 kJ (4.5 g/100 kcal).
4. Sodium
4.1 The final sodium content in the product should be either
not more than 48 mg/100 kJ (200 mg/100 kcal) or not more than
200 mg per 100 g. However if cheese is the only ingredient
mentioned in the name of the product, the final sodium content in
the product should not be more than 70 mg/100 kJ (300 mg/100
8 ġ S.L.231.39
PROCESSED CEREAL-BASED FOODS AND OTHER 
FOODS FOR INFANTS AND YOUNG CHILDREN
kcal).
4.2 Sodium salts may not be added to products based on fruits,
nor to desserts. puddings except for technological purposes.
5. Vitamins
Vitamin C
In a fruit juice, nectar, or vegetable juice the final content
of Vitamin C in the product should be either not less than 6 mg/100
kJ (25 mg/100 kcal) or not less than 25 mg per 100 g.
Vitamin A
In vegetable juices, the final content of Vitamin A in the
product should not be less than 25 µg RE/100 kJ (100 µg RE/100
kcal) * .
Vitamin A shall not be added to other baby foods.
Vitamin D
Vitamin D shall not be added to baby foods.
THIRD SCHEDULE
Amino Acid Composition of Casein
*RE = all trans retinol equivalents.
g per 100 g of protein
Arginine 3.7
Cystine 0.3
Histidine 2.9
Isoleucine 5.4
Leucine 9.5
Lysine 8.1
Methionine 2.8
Phenylananine 5.2
Threonine 4.7
Tryptophan 1.6
Tyrosine 5.8
Valine 6.7
PROCESSED CEREAL-BASED FOODS AND OTHER 
FOODS FOR INFANTS AND YOUNG CHILDREN ġ S.L.231.39 9
FOURTH SCHEDULE
Nutritional Substances
1. Vitamins
Vitamin A
Retinol
Retinyl acetate
Retinyl palmitate
beta carotene
Vitamin D
Vitamin D2 (= ergocalciferol)
Vitamin D3 (= cholecalciferol)
Vitamin B1
Thiamin hydrochloride
Thiamin mononitrate
Vitamin B2
Riboflavin
Riboflavin-5-phosphate, sodium
Niacin
Nicotinamide
Nicotinic acid
Vitamin B6
Pyridoxine hydrochloride
Pyridoxine-5-phosphate
Pyridoxine dipalmitate
Pantothenic acid
D-pantothenate, calcium
D-pantothenate, sodium
Dexpanthenol
Folate
Folic acid
10 ġ S.L.231.39
PROCESSED CEREAL-BASED FOODS AND OTHER 
FOODS FOR INFANTS AND YOUNG CHILDREN
Vitamin B12
Cyanocobalamin
Hydroxocobalamin
Biotin
D-biotin
Vitamin C
L-Ascorbic acid
Sodium L-ascorbate
Calcium L-ascorbate
6-Palmityl-L-ascorbic acid (ascorbyl palmitate)
potassium ascorbate
Vitamin K
Phylloquinone (Phytomenadione)
Vitamin E
D-alpha tocopherol
DL-alpha tocopherol
D-alpha tocopherol acetate
DL-alpha tocopherol acetate
2. Amino acids
L-arginine (and hydrochloride)
L-cystine (and hydrochloride)
L-histidine (and hydrochloride)
L-isoleucine (and hydrochloride)
L-leucine (and hydrochloride)
L-lysine (and hydrochloride)
L-cysteine (and hydrochloride)
L- methionine
L-phenylalanine
L-threonine
L-tryptophan
L-tyrosine
L-valine
PROCESSED CEREAL-BASED FOODS AND OTHER 
FOODS FOR INFANTS AND YOUNG CHILDREN ġ S.L.231.39 11
3. Others
Choline
Choline chloride
Choline citrate
Choline bitartrate
Inositol
L-Carnitine
L-Carnitine hydrochloride 
4. Salts of minerals and trace elements
Calcium
Calcium carbonate
Calcium chloride
Calcium salts of citric acid
Calcium gluconate
Calcium glycerophosphate
Calcium lactate
Calcium oxide
Calcium hydroxide
Calcium salts of orthophosphoric acid
Magnesium
Magnesium carbonate
Magnesium chloride
Magnesium salts of citric acid
Magnesium gluconate
Magnesium oxide
Magnesium hydroxide
Magnesium salts of orthophosphoric acid
Magnesium sulphate
Magnesium lactate
Magnesium glycerophosphate
Potassium
Potassium chloride
Potassium salts of citric acid
12 ġ S.L.231.39
PROCESSED CEREAL-BASED FOODS AND OTHER 
FOODS FOR INFANTS AND YOUNG CHILDREN
Potassium gluconate
Potassium lactate
Potassium glycerophosphate
Iron
Ferrous citrate
Ferric ammonium citrate
Ferrous gluconate
Ferrous lactate
Ferrous sulphate
Ferrous fumarate
Ferric diphosphate (ferric pyrophosphate)
Elemental iron (carbonyl + electrolytic + hydrogen-reduced)
Ferric saccharate
Sodium ferric diphosphate
Ferrous carbonate
Copper
Copper-lysine complex
Cupric carbonate
Cupric citrate
Cupric gluconate
Cupric sulphate
Zinc
Zinc acetate
Zinc citrate
Zinc lactate
Zinc sulphate
Zinc oxide
Zinc gluconate
Manganese
Manganese carbonate
Manganese chloride
Manganese citrate
Manganese gluconate
PROCESSED CEREAL-BASED FOODS AND OTHER 
FOODS FOR INFANTS AND YOUNG CHILDREN ġ S.L.231.39 13
Manganese sulphate
Manganese glycerophosphate
Iodine
Sodium iodide
Potassium iodide
Potassium iodate
Sodium iodate
FIFTH SCHEDULE
Reference Values for Nutrition Labelling for Foods intended for 
Infants and Young Children
Nutrient Labelling Reference Value
Vitamin A (µg) 400
Vitamin D (µg) 10
Vitamin C (mg) 25
Thiamin (mg) 0.5
Riboflavin (mg) 0.8
Niacin equivalents (mg) 9
Vitamin B6 (mg) 0.7
Folate (µg) 100
Vitamin B 12 (µg) 0.7
Calcium (mg) 400
Iron (mg) 6
Zinc (mg) 4
Iodine (µg) 70
Selenium (µg) 10
Copper (mg) 0.4
14 ġ S.L.231.39
PROCESSED CEREAL-BASED FOODS AND OTHER 
FOODS FOR INFANTS AND YOUNG CHILDREN
SIXTH SCHEDULE
Maximum Limits for Vitamins, Minerals and Trace Elements, if 
added, in Processed Cereal-based Foods and Baby Foods intended 
for Infants and Young Children
The requirements concerning nutrients refer to the products
ready for use, marketed as such or reconstituted as instructed by the
manufacturer, except for potassium and calcium for which the
requirements refer to the product as sold.
Nutrient Maximum per 100 kcal
Vitamin A (µg) RE 180 1
Vitamin E (mg a-TE) 3
Vitamin C (mg) 12.5/25 2 /125 3
Thiamin (mg) 0.25/0.5 4
Riboflavin (mg) 0.4
Niacin (mg NE) 4.5
Vitamin B6 (mg) 0.35
Folic acid (µg) 50
Vitamin B 12 (mg) 0.35
Pantothenic acid (mg) 1.5
Biotin (µg) 10
Potassium (mg) 160
Calcium (mg) 80/160 5 /100 6
Magnesium (mg) 40
Iron (mg) 3
Zinc (mg) 2
Copper (µg) 40
Iodine (µg) 35
Manganese (mg) 0.6
1 In accordance with the provisions of the First and Second Schedules.
2 Limit applicable to fruit based dishes and for products fortified with iron.
3 Limit applicable to fruit juices, nectars and vegetable juices.
4 Limit applicable to processed cereal-based foods.
5 Limit applicable to products mentioned in regulation 2.1 ( a ) (ii).
6 Limit applicable to products mentioned in regulation 2.1 ( a ) (iv).
