PROCESSED CEREAL-BASED FOODS AND OTHER FOODS FOR INFANTS AND YOUNG CHILDREN REGULATIONS

PROCESSED CEREAL-BASED FOODS AND OTHER

FOODS FOR INFANTS AND YOUNG CHILDREN

SUBSIDIARY LEGISLATION 449.51

PROCESSED CEREAL-BASED FOODS AND OTHER

FOODS FOR INFANTS AND YOUNG CHILDREN

REGULATIONS

14th August, 2007

LEGAL NOTICE 227 of 2007.

The title of these Regulations is the Processed Cereal-

Based Foods and Other Foods for Infants and Young Children

Regulations.

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 (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

efficiency 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 shall be

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 (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 (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 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)

-

the amount of lauric acid shall not exceed 15% of the total lipid content,

-

the amount of myristic acid shall not exceed 15% of the total lipid

content,

-

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/100 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 µ g/100 kJ (100 µ g/100 kcal).

6.2. For products mentioned in regulation 2(1)(a)(ii)

Per 100 kJ

Per 100 kcal

Minimum Maximum

Minimum Maximum

Vitamin A (µ g RE) (1)

Vitamin D (µ g) (2)

0,25

0,75

(1) RE = all trans retinol equivalents.

These limits shall also be applicable if vitamins A and D are added to other

processed cereal-based foods.

7. MAXIMUM LIMITS FOR VITAMINS, MINERALS AND TRACE

ELEMENTS, IF ADDED

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 (µ g RE)

Vitamin E (mg α-TE) (1)

Vitamin D (µ g)

12,5/25 (2)

Vitamin C (mg)

Thiamin (mg)

0,5

Riboflavin (mg)

0,4

Niacin (mg NE) (3)

4,5

Vitamin B6 (mg)

0,35

Folic acid (µ g)

PROCESSED CEREAL-BASED FOODS AND OTHER

FOODS FOR INFANTS AND YOUNG CHILDREN

Nutrient

Maximum per 100 kcal

Vitamin B12 (µ g)

0,35

Pantothenic acid (mg)

1,5

Biotin (µ g)

Potassium (mg)

80/180 (4) /100 (5)

Calcium (mg)

Magnesium (mg)

Iron (mg)

Zinc (mg)

Copper (µ g)

Iodine (µ g)

Manganese (mg)

0,6

(1)

α-TE = d-α-tocopherol equivalent.

(2)

Limit applicable to products fortified with iron.

(3)

NE = Niacin equivalents = mg nicotinic acid + mg tryptophan/60.

(4)

Limit applicable to products mentioned in paragraph 2(1)(a)(i) and (ii).

(5)

Limit applicable to products mentioned in paragraph 2(1)(a)(iv).

(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 and, or 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) These regulations do not apply to milks intended for young

children.

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 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 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).

1.5. If the product is designated on the label as a meal, but does not mention

meat, poultry, fish, offal or other traditional source of protein in the name of the

product, the total protein in the product from all sources shall not be less than 0,7 g/

100 kJ (3 g/100 kcal).

1.6. Sauces presented as an accompaniment to a meal shall be exempt from the

requirements of points 1.1 to 1.5 inclusive.

1.7. 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 shall be exempt from the requirements in points 1.1 to 1.5.

1.8. The addition of amino acids shall be permitted solely for the purpose of

improving the nutritional value of the protein present, and only in the proportions

necessary for that purpose.

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 point 1.1

If meat or cheese are the only ingredients or are mentioned first in the name of a

product, the total fat in the product from all sources shall not exceed 1,4 g/100 kJ (6

g/100 kcal).

PROCESSED CEREAL-BASED FOODS AND OTHER

FOODS FOR INFANTS AND YOUNG CHILDREN

3.2. For all other products, the total fat in the product from all sources shall not

exceed 1,1 g/100 kJ (4,5 g/100 kcal).

4. SODIUM

4.1. The final sodium content in the product shall 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 shall not be more than 70 mg/100 kJ (300 mg/100 kcal).

4.2. Sodium salts may not be added to products based on fruit, 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 shall 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 shall be not less

than 25 µ g RE/100 kJ (100 µ g RE/100 kcal).

Vitamin A shall not be added to other baby foods.

Vitamin D

Vitamin D shall not be added to baby foods.

6. MAXIMUM LIMITS FOR VITAMINS, MINERALS AND TRACE

ELEMENTS, IF ADDED

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

180 (1)

Vitamin A (µ g RE)

Vitamin E (mg α-TE)

12,5/25 (2) /125 (3)

Vitamin C (mg)

Thiamin (mg)

0,25

Riboflavin (mg)

0,4

Niacin (mg NE)

4,5

Vitamin B6 (mg)

0,35

Folic acid (µ g)

Vitamin B12 (µ g)

0,35

Pantothenic acid (mg)

1,5

Biotin (µ g)

Potassium (mg)

Calcium (mg)

Magnesium (mg)

Iron (mg)

Zinc (mg)

Nutrient

Maximum per 100 kcal

Copper (µ g)

Iodine (µ g)

Manganese (mg)

0,6

(1)

In accordance with the provisions of point 5.

(2)

Limit applicable to products fortified with iron.

For the purpose of these regulations, the following

definitions shall apply

(a) "infants" means children under the age of twelve

months;

(b) "young children" means children aged between one

and three years;

(c) "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

Directive 91/414/EEC (OJ L230, 19.8.1991, p.1),

including its metabolites and products resulting from

its degradation or reaction.

PROCESSED CEREAL-BASED FOODS AND OTHER

FOODS FOR INFANTS AND YOUNG CHILDREN

AMINO ACID COMPOSITION OF CASEIN

(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

Phenylalanine

5,2

Threonine

4,7

Tryptophan

1,6

Tyrosine

5,8

Valine

6,7

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.

NUTRITIONAL SUBSTANCES

1. VITAMINS

Vitamin A

Vitamin C

Retinol

L-ascorbic acid

Retinyl acetate

Sodium L-ascorbate

Retinyl palmitate

Calcium L-ascorbate

Beta carotene

6-palmityl-L-ascorbic acid (ascorbyl palmitate)

Potassium ascorbate

Vitamin D

Vitamin D2 (= ergocalciferol)

Vitamin K

Vitamin D3 (= cholecalciferol)

Phylloquinone (Phytomenadione)

Vitamin B1

Vitamin E

PROCESSED CEREAL-BASED FOODS AND OTHER

FOODS FOR INFANTS AND YOUNG CHILDREN

Thiamin hydrochloride

D-alpha tocopherol

Thiamin mononitrate

DL-alpha tocopherol

D-alpha tocopherol acetate

Vitamin B2

DL-alpha tocopherol acetate

Riboflavin

Riboflavin-5'-phosphate, sodium

2. AMINO ACIDS

}

L-arginine

Niacin

L-cystine

L-histidine

Nicotinamide

L-isoleucine

and their hydrochlorides

Nicotinic acid

L-leucine

L-lysine

Vitamin B6

L-cysteine

Pyridoxine hydrochloride

L-methionine

Pyridoxine-5-phosphate

L-phenylalanine

Pyridoxine dipalmitate

L-threonine

L-tryptophan

Pantothenic Acid

L-tyrosine

D-pantothenate, calcium

L-valine

D-pantothenate, sodium

Dexpanthenol

3. OTHERS

Choline

Folate

Choline chloride

Folic acid

Choline citrate

Choline bitartrate

Vitamin B12

Inositol

Cyanocobalamin

L-carnitine

Hydroxocobalamin

L-carnitine hydrochloride

Biotin

D-biotin

4. SALTS OF MINERALS AND TRACE ELEMENTS

Calcium

Ferrous fumarate

Calcium carbonate

Ferric diphosphate (ferric pyrophosphate)

Calcium chloride

Elemental iron (carbonyl + electrolytic +

hydrogenreduced)

Calcium salts of citric acid

Ferric saccharate

Calcium gluconate

Sodium ferric diphosphate

Calcium glycerophosphate

Ferrous carbonate

Calcium lactate

Calcium oxide

Copper

Calcium hydroxide

Copper-lysine complex

Calcium salts of orthophosphoric Cupric carbonate

acid

Cupric citrate

Magnesium

Cupric gluconate

Magnesium carbonate

Cupric sulphate

Magnesium chloride

Magnesium salts of citric acid

Zinc

Magnesium gluconate

Zinc acetate

Magnesium oxide

Zinc chloride

Magnesium hydroxide

Zinc citrate

Magnesium salts of

Zinc lactate

orthophosphoric acid

Magnesium sulphate

Zinc sulphate

Magnesium lactate

Zinc oxide

Magnesium glycerophosphate

Zinc gluconate

Potassium

Manganese

Potassium chloride

Manganese carbonate

Potassium salts of citric acid

Manganese chloride

Potassium gluconate

Manganese citrate

Potassium lactate

Manganese gluconate

Potassium glycerophosphate

Manganese sulphate

Manganese glycerophosphate

Iron

Ferrous citrate

Iodine

Ferric ammonium citrate

Sodium iodide

Ferrous gluconate

Potassium iodide

Ferrous lactate

Potassium iodate

Ferrous sulphate

Sodium iodate

(1) Processed cereal-based foods shall comply with the

compositional criteria specified in the First Schedule.

(2) Baby foods which are described in the Second Schedule

shall comply with the compositional criteria specified therein.

REFERENCE VALUES FOR NUTRITION LABELLING FOR FOODS INTENDED

FOR INFANTS AND YOUNG CHILDREN

Nutrient

Labelling reference value

Vitamin A (µ g)

Vitamin D (µ g)

Vitamin C (mg)

Thiamin (mg)

0,5

Riboflavin (mg)

0,8

Niacin equivalents (mg)

Vitamin B6 (mg)

0,7

PROCESSED CEREAL-BASED FOODS AND OTHER

FOODS FOR INFANTS AND YOUNG CHILDREN

Nutrient

Labelling reference value

Folate (µ g)

Vitamin B12 (µ g)

0,7

Calcium (mg)

Iron (mg)

Zinc (mg)

Iodine (µ g)

Selenium (µ g)

Copper (mg)

0,4

(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.

(2) Only the nutritional substances listed in the Fourth

Schedule may be added in the manufacture of processed cereal-

based foods and baby foods.

(3) 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) Processed cereal-based foods and baby foods shall not

contain residues of individual pesticides at levels exceeding 0,01

mg/kg, except for those substances for which specific levels have

been set in the Sixth Schedule, in which case these specific levels

shall apply. Analytical methods for determining the levels of

pesticide residues shall be generally acceptable standardised

methods.

(5) The pesticides listed in the Seventh Schedule shall not be

used in agricultural products intended for the production of

processed cereal-based foods and baby foods.

However, for the purpose of control

(a) pesticides listed in Table I of the Seventh Schedule are

considered not to have been used if their residues do

not exceed a level of 0,003 mg/kg. This level, which is

considered to be the limit of quantification of the

analytical methods, shall be kept under regular review

in the light of technical progress;

(b) pesticides listed in Table II of the Seventh Schedule

are considered not to have been used if their residues

do not exceed a level of 0,003 mg/kg. This level shall

be kept under regular review in the light of data on

environmental contamination.

(6) The levels referred to in sub-regulations (4) and (5) shall

apply to the products as proposed ready for consumption or as

reconstituted according to the instructions of the manufacturers.

SPECIFIC MAXIMUM RESIDUE LEVELS OF PESTICIDES OR METABOLITES

OF PESTICIDES IN PROCESSED CEREAL-BASED FOODS AND BABY FOODS

Chemical name of the substance

Maximum residue

Cadusafos

Demeton-S-methyl/demeton-S-methyl sulfone/oxydemeton-

methyl (individually or combined, expressed as demeton-S-

methyl)

Ethoprophos

Fipronil (sum of fipronil and fipronil-desulfinyl, expressed as

fipronil)

Propineb/propylenethiourea (sum of propineb and

propylenethiourea)

(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

PROCESSED CEREAL-BASED FOODS AND OTHER

FOODS FOR INFANTS AND YOUNG CHILDREN

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

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 as specified

in the First and Second Schedules 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.

(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 sub-regulation (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.

PROCESSED CEREAL-BASED FOODS AND OTHER

FOODS FOR INFANTS AND YOUNG CHILDREN

PESTICIDES WHICH SHALL NOT BE USED IN AGRICULTURAL

PRODUCTION INTENDED FOR THE PRODUCTION OF PROCESSED

CEREAL-BASED FOODS AND BABY FOODS

Table 1

Chemical name of the substance (residue definition)

Disulfoton (sum of disulfoton, disulfoton sulfoxide and disulfoton sulfone

expressed as disulfoton)

Fensulfothion (sum of fensulfothion, its oxygen analogue and their sulfones,

expressed as fensulfothion)

Fentin, expressed as triphenyltin cation

Haloxyfop (sum of haloxyfop, its salts and esters including conjugates, expressed

as haloxyfop)

Heptachlor and trans-heptachlor epoxide, expressed as heptachlor

Hexachlorobenzene

Nitrofen

Omethoate

Terbufos (sum of terbufos, its sulfoxide and sulfone, expressed as terbufos)

Table 2

Chemical name of the substance

Aldrin and dieldrin, expressed as dieldrin

Endrin