S.L. 449.36 Art. 1Citation. Scope and applicability. Cap. 458. Definitions. General provisions. Manufacture of food supplements.

The title of these regulations is the Food Supplements Regulations.

2.1. 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. 3.1. 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 paragraph (a), shall mean any substances falling within one of the categories listed in the Fourth Schedule. 4.1 Food supplements may only be marketed if they comply with 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 twelve 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 twelve months may be dispensed to that category of persons.

5.1. Only vitamins and minerals listed in the First Schedule, in the forms listed in the Second Schedule, may be used for the manufacture 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, food supplements providing 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 may only be sold in Malta subject to a prior approval by the Food Safety Commission.

The Food Safety Commission shall take into account, in particular, the product’s presentation, its labelling, any instructions for its use, as well as any other indication or information provided by the manufacturer. The Food Safety Commission may also make the marketing of such food supplements subject to any conditions it deems appropriate for the purposes of safeguarding public health.

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, 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.

5.8 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 eighteen years of age, the guidance body weights for each age group shall be those indicated in the Fifth Schedule, and the values in columns (c) and (d) of the Third Schedule shall be reduced proportionately.

6.1. For the purposes of regulation 5.1 of the Labelling, Presentation and Advertising of Foodstuffs Regulations, 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 regulation 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, 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. 7.1. The amount of the nutrients or substances with a nutritional 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 for Foodstuffs Regulations. 7.4 The declared values mentioned in regulations 7.1 and 7.2 shall be average values based on the manufacturer’s 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. 8.1. 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 st prescribed by regulation 8.1 shall take place by not later than 31 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 product’s 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. 9.1. 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. FIRST SCHEDULE Vitamins and minerals which may be used in the manufacture of food

Vitamins Vitamin A (µg RE) Vitamin D (µg)

Vitamin E (mg α-TE) Vitamin K (µg) Vitamin B1 (mg)

Vitamin B2 (mg) Niacin (mg NE) Pantothenic acid (mg)

Vitamin B6 (mg) Folic acid (µg) Vitamin B12 (µg)

Biotin (µg) Vitamin C (mg)

Minerals Calcium (mg) Magnesium (mg)

Iron (mg) Copper (µg) Iodine (µg)

Zinc (mg) Manganese (mg) Sodium (mg)

Potassium (mg) Selenium (µg) Chromium (µg)

Molybdenum (µg) Fluoride (mg) Chloride (mg)

Phosphorus (mg) SECOND SCHEDULE

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

Vitamins VITAMIN A retinol retinyl acetate retinyl palmitate beta-carotene

VITAMIN D cholecalciferol ergocalciferol VITAMIN E

D-alpha-tocopherol DL-alpha-tocopherol D-alpha-tocopheryl acetate DL-alpha-tocopheryl acetate D-alpha-tocopheryl acid succinate VITAMIN K phylloquinone (phytomenadione)

VITAMIN B1 thiamin hydrochloride thiamin mononitrate VITAMIN B2

riboflavin riboflavin 5’-phosphate, sodium NIACIN nicotinic acid nicotinamide

PANTOTHENIC ACID D-pantothenate, calcium D-pantothenate, sodium dexpanthenol VITAMIN B6

pyridoxine hydrochloride pyridoxine 5’-phosphate FOLATE

(a) pteroylmonoglutamic acid

(b) calcium-L-methylfolate