Executive Order on food supplements 1)

Pursuant to Sections 13, 24, 58 subsections 1, 61, 74 and 78, subsection 3 in Act no. 471 of 1 July 1998 on food products etc. (the Foodstuffs Act), the following shall be laid down:

Chapter 1 Area of application

Section 1. This Executive Order concerns food supplements. Food supplements shall be sold or delivered to the ultimate consumer only in a pre-packaged form. Subsection 2. The order does not apply to medicinal products, cf. Section 1 of the Medicines Act.

Chapter 2 Definitions Section 2. For the purposes of this Executive Order "food supplements" means foodstuffs

1) the purpose of which is to supplement the normal diet

2) which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination; and 3) 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.

Chapter 3 Composition

Section 3. Only the and minerals listed in Annex 1 can be used for the production of food supplements and only in the amounts that fall within the limit values. Subsection 2. Products with added vitamins and/or minerals, if the content exceeds the limits established in Annex 1 (the medical threshold), are covered by the Medicines Act.

Section 4. Only the sources of vitamins and minerals listed in Annex 2 may be used for the manufacture of food supplements. Subsection 2. For the substances that are covered by this order, and for which purity criteria have been established according to the Positive list 2), the purity criteria set out in the Positive list shall apply.

Chapter 4 Reporting

Section 5. Products intended to be marketed as food supplements must be reported to the local foods inspectorate. Reporting is carried out in that the party responsible for initial sales in Denmark submits a model of the labelling used for the product no later than the time when marketing begins. Subsection 2. For food supplements with ingredients other than vitamins and minerals, information on the product's purpose and composition, including concentration and production methods, must also be submitted. For vegetable and animal sources, there must also be an indication of what part of the plant or animal was used, along with extraction methods. Subsection 3. Supplement substances used in food supplements must be approved according to the rules in the order on additives for food products. Subsection 4. All changes in the reported information as well as recalls of the product from the market must be reported to the local food inspectorate.

Chapter 5 Labelling and marketing

Section 6. Food supplements must have the following information affixed: 1) the product name “food supplement”, 2) the names of the categories of nutrients or substances that characterise the product or an indication of the nature of those nutrients or substances, 3) both the Danish and Latin names, including author name, of ingredients consisting of drugs, 4) the recommended daily dose, 5) a warning not to exceed the stated recommended daily dose, 6) a statement to the effect that food supplements should not be used as a substitute for a varied diet, 7) a statement to the effect that the products should be stored out of the reach of young children, and 8) The words ”Should not be used in pregnant women or children under 1 year of age unless directed by a doctor or nurse”, unless otherwise permitted by The Danish Veterinary and Food Administration, e.g. in the form of an exemption. Subsection 2. Food supplements should also meet the general labelling provisions.

Section 7. 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 Annex I. Subsection 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. Subsection 3. The declared values mentioned in subsections 1 and 2 shall be average values based on the manufacturer's analysis of the product. Subsection 4. Information on vitamins and minerals should also be indicated in percentages of the reference values for recommended daily allowance (RDA) indicated in Annex 3. This percentage may also be given in graphical form. Subsection 5. For the vitamins and minerals indicated in Annex 3, where a recommended daily allowance has not been set, the percentage of the RDA should be replaced by with the words “not established”.

Section 8. 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.

Chapter 6 Complaints

Section 9. Complaints concerning the decisions of the local food inspectorates in relation to this order can be presented to The Danish Veterinary and Food Administration.

Chapter 7 Penalty provisions

Section 10. Violation of Section 1 and sections 3-8 of this Executive Order is punishable by fine. Subsection 2. The penalty can increase to up to 2 years' imprisonment if the violation was deliberate or due to gross negligence, and if the violation has 1) caused health-related damage or presented risk of such damage, or 2) achieved or was intended to achieve financial gain for the offender or others, including savings. Subsection 3. Companies etc. (legal persons) may be subject to legal penalty under the rules in chapter 5 of the Penal Code.

Chapter 8 Entry into force and transitional provisions

Section 11. The order shall enter into force on 31 July 2003. However, Section 5, subsections 1, 2 and 4 only enter into force on 31 October 2003. Subsection 2. Executive Order no. 860 of 25 September 1996 on food supplements will be concurrently repealed, aside from Section 5, subsections 1-3 and 5-7, which are repealed on 31 October 2003. Subsection 3. Products which comply with the regulations in force may be sold until 31 July 2005.

Ministry of Food, Agriculture and Fisheries, 21 July 2003 Henrik G. Jensen /Sanne Witt

Annex 1

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

Minimum content per Maximum content per Nutrient recommended daily dose recommended daily dose A 250 µg 1500 µg

Vitamin B1 0.5 mg 2.25 mg

Vitamin B2 0.5 mg 2.6 mg

Vitamin B6 0.5 mg 3 mg

Vitamin B12 0.5 µg 9 µg Folic acid 60 µg 400 µg Niacin 5 mg 30 mg 2 mg 15 mg Biotin 45 µg 225 µg 20 mg 90 mg 1.5 µg 10 µg 3 mg 41 mg 20 µg 150 µg 250 mg 1.5 g 250 mg 1.5 g 90 mg 600 mg 4 mg 27 mg 4 mg 22.5 mg 0.5 mg 3 mg 45 µg 225 µg 1 mg 5 mg 15 µg 125 µg 15 µg 125 µg Molybendum 45 µg 250 µg Fluoride Chloride

Annex 2

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

Nutrient Source

VITAMINS Retinol Retinyl Acetate Retinol Palmitate Retinyl Propionate* Beta-carotene

Vitamin B1 (Thiamine) Thiamin hydrochloride Thiamin mononitrate

Vitamin B2 (Riboflavin) Riboflavin Riboflavin-5’-phosphate

Vitamin B6 Pyridoxine Hydrochloride

Vitamin B12 Hydroxycobalamin Hydroxocobalamin acetate * Hydroxocobalamin chloride * Hydroxocobalamin sulfate * Folic Acid Pteroylmonoglutaminic acid (Folic acid) Niacin Nicotinamide Nicotinic acid Pantothenic acid Calcium-D-pantothenate Dexpantothenol Sodium-D-pantothenate Biotin D-Biotin Vitamin C L-Ascorbic acid Calcium-L-ascorbate Potassium-L-ascorbate Sodium-L-ascorbate L-Ascorbyl-6-palmitate Vitamin D Colecalciferol Ergocalciferol Vitamin E D- -Tocopherol DL- -Tocopherol D- -Tocopherol acetate DL- -Tocopherol acetate D- -Tocopheryl succinate DL- -Tocopheryl succinate * Vitamin K Phytomenadione (Phylloquinone)

MINERALS Calcium Calcium acetate * Calcium salts of citric acid - Monocalcium citrate - Dicalcium citrate - Tricalcium citrate Calcium citramalate * Calcium glycerophosphate Calcium hydroxide Calcium oxide Calcium salts of phosphoric acid - Monocalcium phosphate - Dicalcium phosphate - Tricalcium phosphate Phosphorous Potassium of phosphoric acid - Monopotassium phosphate - Dipotassium phosphate - Tripotassium phosphate Magnesium Magnesium acetate Magnesium carbonate Magnesium hydroxide carbonate * Magnesium salts of citric acid - Dimagnesium citrate - Trimagnesium citrate Magnesium glycerophosphate Magnesium hydroxide Magnesium salts of phosphoric acid - Dimagnesium phosphate - Trimagnesium phosphate Iron Ferric ammonium citrate Ferric diphosphate (Ferric pyrophosphate) Ferric saccharate Ferrous carbonate Ferrous citrate Ferrous fumarate Ferrous gluconate Ferrous lactate Ferrous phosphate * Ferrous sulfate Sodium ferrous phosphate Iron, carbonyl Iron, electrolytic Iron, hydrogen reduced Zinc Zinc carbonate Zinc chloride Zinc citrate Zinc lactate Copper Cupric carbonate Cupric hydroxide carbonate * Cupric citrate Cupric gluconate Cupric oxide * Cupric sulfate Copper-lysine-complex Iodine Potassium iodate Sodium iodate Manganese Manganese carbonate Manganese chloride Mangan citrate Mangan gluconate Mangan glycerophosphate Mangan citrate Chromium Chromium chloride Chromium sulfate Chromium dinicotinate * Chromium trinicotinate * Selenium Sodium hydrogen selenite L-Selenmethionine * Ammonium molybdenate Sodium molybdenate Potassium Potassium carbonate Potassium hydrogen carbonate Potassium citrates -Monopotassium citrate -Tripotassium citrate Potassium glycerophosphate Potassium hydroxide Potassium lactate Potassium salts of phosphoric acid - Monopotassium phosphate - Dipotassium phosphate - Tripotassium phosphate Sodium Sodium carbonate Sodium hydrogen carbonate Sodium citrates - Monosodium citrate - Disodium citrate - Trisodium citrate Sodium gluconate Sodium lactate Sodium salts of phosphoric acid - - Disodium phosphate - Trisodium phosphate Fluoride Potassium Fluoride * Substances for which Denmark shall make a statement to the European Commission no later than 12 July 2005. These substances can be used if the European Food Safety Authority has not made a negative statement.

Annex 3

Vitamins and minerals that can be declared and recommended daily allowance

Children 1-10 years old Adults and children over the age of 11 Vitamins Vitamin A a) 400 µg 800 µg

Vitamin B1 0.7 mg 1.4 mg Vitamin B2 0.8 mg 1.6 mg

Vitamin B6 0.8 mg 2 mg

Vitamin B12 1 µg 1 µg Folic Acid 75 µg 200 µg Niacin b) 9 mg 18 mg Pantothenic acid 2 mg 6 mg Biotin 8 µg 150 µg Vitamin C 40 mg 60 mg Vitamin D 10 µg 5 µg Vitamin E c) 5 mg 10 mg Vitamin K 30 µg 90 µg Minerals Calcium 600 mg 800 mg Phosphorus 470 mg 800 mg Magnesium 85 mg 300 mg Iron 8 mg 14 mg Zinc 5 mg 15 mg Copper 0.34 mg 0.9 mg Iodine 70 µg 150 µg Manganese 1.2 mg 1.8 mg Chromium 11 µg 25 µg Selenium 20 µg 40 µg Molybdenum 17 µg 45 µg Potassium Sodium Fluoride Chloride

a) 1 retinol equivalent (RE) = 1 g retinol or 2 g -carotene from food supplements or 12 g - carotene from food. b) 1 niacin equivalent (NE) = 1 mg niacin or 60 mg tryptophan. c) 1 alpha-tocopherol equivalent (alpha-TE) = 1 mg D-alpha-tocopherol.

Official notes 1) The Executive Order contains provisions that implement European Parliament/Council Directive 2002/46/EC of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements. 2) Positive list. List of additives for food products, Danish Veterinary and Food Administration.