Food Supplements Regulations 2003

L.N. 239 of 2003

FOOD SAFETY ACT

(ACT NO. XIV OF 2002)

Food Supplements Regulations 2003

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

Act, the Minister of Health has made the following regulations>

The title of these regulations is the Food Supplements

Regulations 2003 and shall come into force on the 30th September,

2003.

Vitamins and minerals which may be used in the manufacture of food supplements

Vitamins

Minerals

Vitamin A (µg RE)

Calcium (mg)

Vitamin D (µg)

Magnesium (mg)

Iron (mg)

Vitamin E (mg α-TE)

Vitamin K (µg)

Copper (µg)

Vitamin B1 (mg)

Iodine (µg)

Vitamin B2 (mg)

Zinc (mg)

Niacin (mg NE)

Manganese (mg)

Pantothenic acid (mg)

Sodium (mg)

Vitamin B6 (mg)

Potassium (mg)

Folic acid (µg)

Selenium (µg)

Vitamin B12 (µg)

Chromium (µg)

Biotin (µg)

Molybdenum (µg)

Vitamin C (mg)

Fluoride (mg)

Chloride (mg)

Phosphorus (mg)

1 These regulations concern food supplements marketed as

foodstuffs and presented as such.

2.2 These regulations shall not apply to medicinal products, as

defined in the Medicines Act, 2003 (Act No. III of 2003).

Vitamin and mineral substances which may be used in the manufacture of food

supplements

A. Vitamins

1 In these regulations, unless the context otherwise requires,

the following definitions shall apply>

(a) “food supplements” means foodstuffs the purpose of

which is to supplement the normal diet and which are concentrated

sources of nutrients or other substances with a nutritional or

physiological effect, alone or in combination, marketed in dose

form, namely forms such as capsules, pastilles, tablets, pills and

other similar forms, sachets of powder, ampoules of liquids, drop

dispensing bottles, and other similar forms of liquids and powders

designed to be taken in measured small unit quantities<

(b) “nutrients” means the following substances>

(i) vitamins,

(ii) minerals<

(c) “other substances”, in the context of subparagraph (a)

of this regulation, shall mean any substances falling within one of

the categories listed in the Fourth Schedule to these regulations<

on the basis of a 60

Guidance Level

(per day)

kg adult

0.9 mg

1.0 mg

(d)

on the basis of a 60

Maximum Upper

(per day)

kg adult

Level

(c)

-

-

Folic Acid

Nutrient

Biotin

(b)

VITAMINS

e Number

Referenc

(a)

formulations of nicotinic acid.

Therefore, this level does not

There is a lack of data on the

Sustained release forms may

This guidance level is based

pregnancy, and there are no

on intakes of conventional

apply to pregnant women.

safety of nicotinamide in

relevant animal data.

not be used in food

Additional Notes

supplements.

(f)

-

-

active peptic ulcer disease,

hepatic

dysfunciton or a history of

liver disease, diabetes mellitus,

gout, cardiac arrhythmias,

and

alcoholism may be particularly

hyperbilirubinaemia may be at

photoactivation of riboflavin.

undergoing phototherapy for

susceptible to nicotinic acid.

possibility that neonates

There is a theoretical

risk at this time from

Vulnerable Groups

headaches

with

(e)

-

-

Individuals

migraine

on the basis of a 60

Guidance Level

(per day)

kg adult

1 Food supplements may only be marketed if they comply with General Provisions.

these Regulations.

4.2 Food supplements shall be delivered to the ultimate consumer

only in a pre-packaged form.

4.3 Food supplements may only be dispensed by a pharmacist,

doctor or a person with other suitable qualifications as may be laid

down by the Food Safety Commission.

4.4 In dispensing food supplements, the persons referred to in

regulation 4.3 shall ensure that consumers are sufficiently informed

about any known negative effects of the supplements, or contra-

indications for their use, particularly in the case of pregnant or lactating

women and any of the other vulnerable groups indicated in column (e)

of the Third Schedule.

4.5 Food supplements may not be specifically intended for infants

below the age of 12 months unless the manufacturer has detailed

evidence establishing the safety of the supplement for that purpose.

Only food supplements specifically intended for infants below the age

of 12 months may be dispensed to that category of persons.

Illustrative List of Categories of Substances other than Nutrients which may be

present in Food Supplements

Herbs

Botanical products

Other plant-derived substances

Amino acids

Fatty acids

Enzymes

Organ tissues

Glandular tissues

Constituents, concentrates, metabolites and extracts of plant or animal origin

1 Only vitamins and minerals listed in the First Schedule, in Manufacture of

the forms listed in the Second Schedule, may be used for the manufacture food supplements.

of food supplements, subject to regulation 5.4.

5.2 Purity criteria for substances listed in the Second Schedule,

specified by other provisions for their use in the manufacture of

foodstuffs for purposes other than those covered by these Regulations,

shall apply.

5.3 For those substances listed in the Second Schedule for which

purity criteria are not specified by legislation, and until such

specifications are adopted, generally acceptable purity criteria

recommended by international bodies shall be applicable.

5.4 Until 31 December 2009, the use of vitamins and minerals

not listed in the First Schedule, or in forms not listed in the Second

Schedule, is allowed, provided that>

(a) the substance in question was used in one or more food

supplements marketed in the European Community on 12th July

2002,

(b) the European Food Safety Authority has not given an

unfavourable opinion in respect of the use of that substance, or its

use in that form, in the manufacture of food supplements,

5.5 Subject to the provisions of regulation 5.8, a food supplement

may not be a source of any nutrient at a level in excess of the maximum

upper level as may be established for that nutrient by the Third Schedule

to these regulations, where applicable.

5.6 Subject to the provisions of regulation 5.8, food supplements

providing a source of any nutrient at a level in excess of the guidance

level as may be established for that nutrient by the Third Schedule may

only be marketed if the manufacturer has established that usage of the

product does not cause damage to human health when used as instructed

by the manufacturer, taking account, in particular of the product’s

presentation, its labelling, any instructions for its use, as well as any

other indication or information provided by the manufacturer. The

provision of such warnings shall not, in any event, exempt any person

from compliance with the other requirements laid down in these

regulations.

5.7 Food supplements providing a source of any substance falling

within one of the categories listed in the Fourth Schedule to these

regulations, may only be marketed if the manufacturer has established

that usage of the product does not cause damage to human health when

used as instructed by the manufacturer, taking account, in particular of

the productís presentation, its labelling, any instructions for its use, as

well as any other indication or information provided by the manufacturer.

The provision of such warnings shall not, in any event, exempt any

person from compliance with the other requirements laid down in these

regulations.

5.8 The maximum upper levels and the guidance levels for the

nutrients prescribed by the Third Schedule are calculated on the basis

of an adult body weight of 60 kg. In the case of products specifically

intended for, or indicated as suitable for, persons under 18 years of age,

the guidance body weights for each age group shall be those indicated

in the Fifth Schedule to these regulations, and the values in columns (c)

and (d) of the Third Schedule shall be reduced proportionately.

Guidance Body Weights per Age Bracket

The following shall be taken as guidance body weights for the age brackets indicated, for

the purposes of regulation 5.8.

Age Group

Guidance Body Weight

(years)

(kg)

1 – 3

4 – 6

7 – 10

11 – 14

15 – 17

18 +

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

1 For the purposes of regulation 5.1 of the Labelling,

Presentation and Advertising of Foodstuffs Regulations, 2002, the name

under which products covered by these Regulations are sold shall be

“food supplement”.

6.2 The labelling, presentation and advertising must not attribute

to food supplements the property of preventing, treating or curing a

human disease, or refer to such properties.

6.3 Nothing in paragraph 6.2 shall be construed as preventing

the dissemination of any useful information or recommendations

exclusively intended for persons having qualifications in medicine,

nutrition or pharmacy.

6.4 Without prejudice to the Labelling, Presentation and

Advertising of Foodstuffs Regulations, 2002, the labelling shall bear

the following particulars>

(a) the names of the categories of nutrients or substances

that characterise the product or an indication of the nature of those

nutrients or substances<

(b) the portion of the product recommended for daily

consumption<

(c)

a warning not to exceed the stated recommended daily

dose<

(d) a statement to the effect that food supplements should

not be used as a substitute for a varied diet<

(e) a statement to the effect that the products should be stored

out of the reach of young children.

6.5 The labelling, presentation and advertising of food

supplements shall not include any mention stating or implying that a

balanced and varied diet cannot provide appropriate quantities of

nutrients in general.

1 The amount of the nutrients or substances with a nutritional Declaration of

Nutrients.

or physiological effect present in the product shall be declared on the

labelling in numerical form. The units to be used for vitamins and

minerals shall be those specified in the First Schedule.

7.2 The amounts of the nutrients or other substances declared

shall be those per portion of the product as recommended for daily

consumption on the labelling.

7.3 Information on vitamins and minerals shall also be expressed

as a percentage of the reference values mentioned, as the case may be,

in the Schedule to the Nutrition Labelling Regulations, 1998 (L.N. 247

of 1998).

7.4 The declared values mentioned in regulations 8.1 and 8.2

shall be average values based on the manufacturerís analysis of the

product.

7.5 The percentage of the reference values for vitamins and

minerals mentioned in regulation 7.3 may also be given in graphical

form.

1 To permit efficient official monitoring, when a food

supplement is placed on the market for the first time, the manufacturer

or the importer shall notify the Food Safety Commission by forwarding

a model of the label used for the product.

8.2 In the case of food supplements placed on the market prior

to the entry into force of these regulations, the notification prescribed

by regulation 8.1 shall take place by not later than 31st December 2004.

Food supplements which have not been notified by that date shall be

removed from the market at the expense of the manufacturer or importer.

8.3 Where necessary, the Superintendent of Public Health may

require the manufacturer or the importer to produce the scientific work

and the data establishing the productís compliance with the provisions

of these regulations. If such work is contained in a readily available

publication, a mere reference to this publication shall suffice.

1 The Food Safety Commission may, on the advice of the

Directorate responsible for foodstuffs within the Malta Standards

Authority, temporarily suspend or restrict the marketing of any product

which complies with these Regulations if he has detailed grounds for

establishing that the product endangers human health.

VITAMIN B12

(a) cyanocobalamin

1. VITAMIN A

(b) hydroxocobalamin

(a) retinol

(b) retinyl acetate

BIOTIN

(c) retinyl palmitate

(a) D-biotin

(d) beta-carotene

VITAMIN C

2. VITAMIN D

(a) L-ascorbic acid

(a) cholecalciferol

(b) sodium-L-ascorbate

(b) ergocalciferol

(c) calcium-L-ascorbate

(d) potassium-L-ascorbate

3. VITAMIN E

(e) L-ascorbyl 6-palmitate

(a) D-alpha-tocopherol

(b) DL-alpha-tocopherol

(c) D-alpha-tocopheryl acetate

(d) DL-alpha-tocopheryl acetate

B. Minerals

(e) D-alpha-tocopheryl acid succinate

calcium carbonate

4. VITAMIN K

calcium chloride

(a) phylloquinone (phytomenadione)

calcium salts of citric acid

calcium gluconate

5. VITAMIN B1

calcium glycerophosphate

(a) thiamin hydrochloride

calcium lactate

(b) thiamin mononitrate

calcium salts of orthophosphoric acid

calcium hydroxide

6. VITAMIN B2

calcium oxide

(a) riboflavin

magnesium acetate

(b) riboflavin 5’-phosphate, sodium

magnesium carbonate

magnesium chloride

7. NIACIN

magnesium salts of citric acid

(a) nicotinic acid

magnesium gluconate

(b) nicotinamide

magnesium glycerophosphate

magnesium salts of orthophosphoric acid

8. PANTOTHENIC ACID

magnesium lactate

(a) D-pantothenate, calcium

magnesium hydroxide

(b) D-pantothenate, sodium

magnesium oxide

(c) dexpanthenol

magnesium sulphate

ferrous carbonate

9. VITAMIN B6

ferrous citrate

(a) pyridoxine hydrochloride

ferric ammonium citrate

(b) pyridoxine 5’-phosphate

ferrous gluconate

ferrous fumarate

10. FOLIC ACID

ferric sodium diphosphate

(a) pteroylmonoglutamic acid

ferrous lactate

manganese sulphate

ferrous sulphate

sodium bicarbonate

ferric diphosphate (ferric pyrophosphate)

ferric saccharate

sodium carbonate

sodium chloride

elemental iron

(carbonyl+electrolytic+hydrogen

sodium citrate

reduced)

sodium gluconate

cupric carbonate

sodium lactate

cupric citrate

sodium hydroxide

sodium salts of orthophosphoric acid

cupric gluconate

cupric sulphate

potassium bicarbonate

copper lysine complex

potassium carbonate

sodium iodide

potassium chloride

sodium iodate

potassium citrate

potassium gluconate

potassium iodide

potassium iodate

potassium glycerophosphate

zinc acetate

potassium lactate

zinc chloride

potassium hydroxide

zinc citrate

potassium salts of orthophosphoric acid

sodium selenate

zinc gluconate

zinc lactate

sodium hydrogen selenite

zinc oxide

sodium selenite

zinc carbonate

chromium (III) chloride

zinc sulphate

chromium (III) sulphate

ammonium molybdate (molybdenum

manganese carbonate

manganese chloride

(VI))

manganese citrate

sodium molybdate (molybdenum (VI))

manganese gluconate

potassium fluoride

manganese glycerophosphate

sodium fluoride

Additional Notes

(f)

-

-

Individuals at risk of vitamin

B12 deficiency, in whom folic

acid supplementation may

mask the haematological signs

this

the

associated myeloneuropathy to

Patients treated with drugs

which interfere with folate

metabolism, and in whom folic

acid supplementation may be

reduced

effectiveness of the therapy or

increased incidence of side

Maximum Permitted Levels and Guidance Levels for Vitamins and Minerals

Vulnerable Groups

allowing

of

with

symptoms

(e)

-

deficiency,

associated

develop.

effects.

and

0 mg

500 mg

200 mg

100 mg

(d)

on the basis of a 60

Maximum Upper

(per day)

kg adult

Level

(c)

-

-

-

-

Pantothenic acid

Nicotinic acid

Nicotinamide

(Vitamin B 2 )

Riboflavin

Nutrient

(b)

e Number

Referenc

(a)

3b

3a

have been identified; however, water-soluble forms of thiamin

No potential vulnerable groups This level is applicable to the

Additional Notes

only.

(f)

-

-

-

there is a possibility that a very

Individuals unable to regulate

the clinical trials indicate that

small number of people may

vulnerable to the enhanced

iron absorption caused by

be particularly sensitive

iron absorption due to

haemochromatosis or

thalassaemia may be

Vulnerable Groups

(allergic) to thiamin.

vitamin C.

(e)

-

-

on the basis of a 60

Guidance Level

(per day)

kg adult

1000 mg

100 mg

1 mg

(d)

-

on the basis of a 60

Maximum Upper

(per day)

kg adult

10 mg

Level

(c)

-

-

-

(Vitamin B 1 )

(Pyridoxine)

(Cobalamin)

Vitamin B 12

Vitamin B 6

Vitamin C

Nutrient

Thiamin

(b)

e Number

Referenc

(a)

1µg Retinol Equivalent = 1µg

palmitate = 6 µg β-carotene =

12 µg other carotenoids with

provitamin A activity = 3.33

IU vitamin A activity from

retinol = 1.78 µg retinyl

Additional Notes

retinol

(f)

vitamin A intolerance has been

individuals with compromised

renal failure, diabetes mellitus

who wish to become pregnant

vitamin A except on medical

older people; those suffering

Women who are pregnant or

teratogenic risk, particularly

observed on some children.

liver function. An apparent

within the first trimester of

haemodialysis patients and

toxicity include the young;

from osteoporosis, chronic

Other groups potentially

Retinol may represent a

vulnerable to vitamin A

supplements containing

should not take dietary

Vulnerable Groups

or under-nutrition;

pregnancy.

advice.

(e)

on the basis of a 60

Guidance Level

(per day)

kg adult

1500 µg

(d)

on the basis of a 60

Maximum Upper

(per day)

kg adult

Level

(c)

-

Vitamin A

Nutrient

(Retinol)

(b)

e Number

Referenc

10a

(a)

Additional Notes

(f)

-

-

-

Adults with disease states such

as sarcoidosis, Mycobacterium

and/or a history of myocardial

vulnerable to hypercalcaemia

reported at vitamin D intakes

current smokers, individuals

(>0.025mg/day). Infants are

of 0.050 mg/day and above.

exposure to asbestos, those

most at risk of developing

with high alcohol intakes,

hypercalcaemia are more

hypercalcaemia has been

carotene toxicity include

infections and idiopathic

with previous high-level

resulting from moderate

Groups vulnerable to β-

Vulnerable Groups

hypervitaminosis D;

hypercalciuria and

vitamin D intakes

infarction.

(e)

-

on the basis of a 60

Guidance Level

(per day)

0.025 mg

kg adult

(d)

-

-

on the basis of a 60

Maximum Upper

(per day)

(727 mg)

kg adult

800 IU

Level

7 mg

(c)

-

β-carotene

Vitamin D

Vitamin E

Nutrient

(b)

e Number

Referenc

10b

(a)

Additional Notes

(f)

-

-

-

susceptible to the development

of methaemoglobanaemia, and

risk of copper toxicity due to a

damage caused by menadione

Children may be at increased

this would include oxidative

uptake and immature biliary

Individuals with glucose-6-

Haemodialysis patients and

sensitive to copper excess.

subjects with chronic liver

phosphate dehydrogenase

Infants are vulnerable to

combination of efficient

disease are potentially

Vulnerable Groups

vitamin K3 toxicity.

deficiency are more

(vitamin K3).

excretion.

(e)

-

on the basis of a 60

Guidance Level

(per day)

kg adult

1 mg

9 mg

2 mg

(d)

on the basis of a 60

Maximum Upper

(per day)

kg adult

Level

(c)

-

-

-

(phylloquinone)

Vitamin K 1

Chromium

Vitamin K

(trivalent)

Nutrient

Copper

(b)

MINERALS

e Number

Referenc

(a)

Additional Notes

(f)

-

Pregnant and lactating women,

and goitre and hypothyroidism

and neonates are considered to

be vulnerable groups as iodine

freely crosses the placenta and

have been reported to occur in

exposed to pharmacological

is expressed in breast milk,

doses of iodine and iodide.

the offspring of mothers

Vulnerable Groups

(e)

on the basis of a 60

Guidance Level

(per day)

kg adult

0.2 mg

(d)

on the basis of a 60

Maximum Upper

(per day)

kg adult

Level

(c)

-

Nutrient

Iodine

(b)

e Number

Referenc

(a)

Additional Notes

(f)

-

-

-

the susceptibility of humans to

anti-psychotic drugs increases

vulnerable to the toxic effects

Groups with impaired biliary

It has also been reported that

ethanol and long-term use of

Anaemic individuals may be

accumulation and toxicity.

clearance, such as patients

with liver disease or older

susceptible to manganese

increased absorption that

of manganese due to the

occurs in states of iron

Vulnerable Groups

manganese toxicity.

people, may also be

deficiency.

(e)

-

-

(for products intended

on the basis of a 60

Guidance Level

(for the general

for the older

population)

population)

(per day)

kg adult

0.5 mg

0.2 mg

25 µg

4 mg

(d)

on the basis of a 60

Maximum Upper

(per day)

kg adult

Level

(c)

-

-

-

Molybdenum

Manganese

Selenium

Nutrient

(b)

e Number

Referenc

(a)

Additional Notes

(f)

-

-

-

sarcoidosis may have a higher

Patients with renal failure are

glycosylated haemoglobin in

risk of renal stone formation

younger have a much higher

increased risk. Patients with

developing hypercalcaemia

without renal failure taking

Zinc supplementation may

particularly susceptible to

supplements. Individuals

diuretics may also be at

8 year old children and

hypercalcuria, primary

susceptibility to dental

increase the levels of

when taking calcium

hyperthyroidism and

Vulnerable Groups

absorptive or renal

following calcium

supplementation.

diabetics.

fluorosis.

(e)

on the basis of a 60

Guidance Level

(per day)

kg adult

1500 mg

0.01 mg

25 mg

(d)

on the basis of a 60

Maximum Upper

(per day)

kg adult

Level

(c)

-

-

-

Nutrient

Calcium

Fluoride

Zinc

(b)

e Number

Referenc

(a)

Additional Notes

(f)

-

-

-

gastrointestinal tract disease or

shown to be vulnerable to the

Individuals with pre-existing

chronic hepatitis, have been

Vulnerable Groups

toxic effects of iron.

(e)

-

-

on the basis of a 60

Guidance Level

(per day)

kg adult

400 mg

250 mg

17 mg

(d)

on the basis of a 60

Maximum Upper

(per day)

kg adult

Level

(c)

-

-

-

Magnesium

Phosphorus

Nutrient

Iron

(b)

e Number

Referenc

(a)

Additional Notes

(f)

-

potassium-sparing diuretics, β-

adrenal insufficiency, acidosis

vulnerable, as are those using

renal disease, hyperkalaemia,

Individuals with pre-existing

or insulin deficiency are also

inflammatorydrugs, arginine

Infants may be vulnerable to

physiological resrve in renal

enzyme inhibitors, digitalis,

excessive potassium due to

limited renal reserve and

vulnerable to potassium

angiotensin-converting

toxicity due to reduced

certain drugs, such as

Older people may be

Vulnerable Groups

adrenergic blockers,

immature function.

non-steroidal anti-

hydrochloride and

succinylcholine.

function.

(e)

on the basis of a 60

Guidance Level

(per day)

kg adult

3700 mg

(d)

on the basis of a 60

Maximum Upper

(per day)

kg adult

Level

(c)

-

Potassium

Nutrient

(b)

e Number

Referenc

(a)

supplements. Levels of sodium

Because sodium chloride may

have effects at normal dietary

demonstrate a clear benefit to

the consumer from a higher

recommended for use in

manufacturer is able to

shall be kept as low as

intakes in suceptible

individuals, it is not

possible unless the

Additional Notes

level.

(f)

Salt-sensitive persons

Vulnerable Groups

(e)

on the basis of a 60

Guidance Level

(per day)

kg adult

(d)

-

on the basis of a 60

Maximum Upper

(per day)

kg adult

Level

(c)

-

Sodium chloride

Nutrient

(b)

e Number

Referenc

(a)