Young Children Regulations, 2007

L.N. 227 of 2007

FOOD SAFETY ACT

(CAP. 449)

Processed Cereal-Based Foods and Other Foods for Infants and

Young Children Regulations, 2007

IN exercise of the powers conferred by article 10 of the Food Safety

Act, the Minister of Health, the Elderly and Community Care has made

the following regulations>-

The title of these regulations is Processed Cereal-based Foods

and Other Foods for Infants and Young Children Regulations, 2007.

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 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).

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 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.

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 (µg RE)

Vitamin E (mg α-TE)

Vitamin C (mg)

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

Thiamin (mg)

0,25

Riboflavin (mg)

0,4

Niacin (mg NE)

4,5

Vitamin B6 (mg)

0,35

Folic acid (µg)

Vitamin B12 (µg)

0,35

Pantothenic acid (mg)

1,5

Biotin (µg)

Potassium (mg)

Calcium (mg)

Magnesium (mg)

Iron (mg)

Zinc (mg)

Copper (µg)

Iodine (µg)

Manganese (mg)

0,6

( 1 ) In accordance with the provisions of point 5.

( 2 ) Limit applicable to products fortified with iron.

(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.

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

For the purpose of this Directive, the following definitions

shall apply>

(a)

“infants” means children under the age of 12 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.

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

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

L-cystine

Niacin

L-histidine

Nicotinamide

L-isoleucine

and their hydrochlorides

Nicotinic acid

L-leucine

L-lysine

L-cysteine

Vitamin B6

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 acid

Cupric carbonate

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 orthophosphoric acid

Zinc lactate

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) No person shall import, keep or sell any processed cereal- Sales of processed

based food or other baby food intended for infants and young children cereal-based

and baby foods for

which does not comply with the requirements of these regulations.

infants and young

children.

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 B12

(µg) 0,7

Calcium

(mg) 400

Iron

(mg) 6

Zinc

(mg) 4

Iodine

(µg) 70

Selenium

(µg) 10

Copper

(mg) 0,4

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

criteria.

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.

SPECIFIC MAXIMUM RESIDUE LEVELS OF PESTICIDES OR METABOLITES OF

PESTICIDES IN PROCESSED CEREAL-BASED FOODS AND BABY FOODS

Maximum residue

Chemical name of the substance

level (mg/kg)

Cadusafos

0,006

0,006

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

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

Ethoprophos

0,008

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

0,004

Propineb/propylenethiourea (sum of propineb and propylenethiourea)

0,006

(1) Processed cereal-based foods and baby foods shall be Manufacture of

processed cereal-

manufactured from ingredients whose suitability for particular nutritional based foods and

use by infants and young children has been established by generally baby foods for

infants and young

accepted scientific data.

children.

(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 paragraphs 6(4) and 6(5) shall

apply to the products as proposed ready for consumption or as

reconstituted according to the instructions of the manufacturers.

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

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press

Lm0.72 (€1.68)

(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 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 paragraph 7(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.

PESTIĊIDI LI M’GĦANDHOMX JINTUŻAW FI PRODUZZJONI AGRIKOLA INTIŻA GĦALL-

PRODUZZJONI TA’ IKEL IPPROĊESSAT B’BAŻI TA’ ĊEREJALI U IKEL GĦAL TRABI

Tabella I

Isem kimiku tas-sustanza (definizzjoni tar-residwu)

Disulfoton (somma ta’ disulfoton, disulfoton sulfoxide u disulfoton sulfone espressi bħala disulfoton)

Fensulfothion (somma ta’ fensulfothion, l-analogu tal-ossiġenu tiegħu u ssulfoni tagħhom, espressi bħala

fensulfothion)

Fentin, espressi bħala katijon tat-triphenyltin

Haloxyfop (somma ta’ haloxyfop, l-imlieħ tiegħu u esteri inklużi konġugati, espressi bħala haloxyfop)

Heptachlor u trans-heptachlor epoxide, espressi bħala heptachlor

Hexachlorobenzene

Nitrofen

Omethoate

Terbufos (somma ta’ terbufos, is-sulfossidu tiegħu u sulfon, espressi bħala terbufos)

Tabella II

Isem kimiku tas-sustanza

Aldrin u dieldrin, espressi bħala dieldrin

Endrin

The Processed Cereal-based Foods and Other Foods for Infants Repeal of L.N. 207

of 2002.

and Young Children Regulations, 2002 are hereby repealed and any

reference to those regulations shall be construed as a reference to these

regulations.

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 (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 Article 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 Article 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)

Per 100 kJ

Per 100 kcal

Minimum

Maximum

Minimum

Maximum

Vitamin A (µg RE) ( 1 )

0,25

0,75

Vitamin D (µg) ( 2 )

( 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 (µg RE)

Vitamin E (mg α-TE) ( )

Vitamin D (µg)

Vitamin C (mg)

12,5/25 (2)

Thiamin (mg)

0,5

Riboflavin (mg)

0,4

Niacin (mg NE) ( )

4,5

Vitamin B6 (mg)

0,35

Folic acid (µg)

Vitamin B12 (µg)

0,35

Pantothenic acid (mg)

1,5

Biotin (µg)

Potassium (mg)

80/180 ( 4 )/100 ( 5 )

Calcium (mg)

Magnesium (mg)

Iron (mg)

Zinc (mg)

Copper (µg)

Iodine (µg)

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).

5

Lisina

8.1

Metionina

2.8

Fenilalanina

5.2

Treonina

4.7

Triptofan

1.6

Tirosina

5.8

Valina

6.7

*RE = l-ekwivalenti trans retinol kollha.