THE MINISTRY OF HEALTH AND SOCIAL WELFARE

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1 THE MINISTRY OF HEALTH AND SOCIAL WELFARE 4080 Pursuant to Article 15, paragraph 2, subparagraph 15 of the Food Act (Official Gazette 46/07), the Minister of Health and Social Welfare, with the approval of with the Minister of Agriculture, Fisheries and Rural Development, hereby issues the ORDINANCE ON NUTRIENT-ENRICHED FOODS (ADDITION OF VITAMINS, MINERALS AND OF CERTAIN OTHER SUBSTANCES TO FOODS)[1] I. SUBJECT MATTER, SCOPE AND DEFINITIONS Subject matter and scope Article 1 This Ordinance lays down the conditions to be fulfilled by nutrient-enriched foods when placed on the market whilst providing a high level of consumer protection. The provisions of this Ordinance that concern vitamins and minerals shall not apply to food supplements covered by the Ordinance on food supplements [2]. The provisions of this Ordinance shall also apply to: a) foods for particular nutritional uses and, in the absence of specific provisions, compositional requirements of such foods [3], b) novel foods and novel food ingredients, c) genetically modified foods, d) food additives and flavourings, e) authorised oenological practices and processes. Definitions Article 2 For the purposes of this Ordinance, the following definitions shall apply:»agency«means the Croatian Food Agency.

2 »Nutrient-enriched foods«means the foods to which vitamins, minerals and other substances are added.»other substance«means a substance other than a vitamin or a mineral that has a specific nutritional or physiological effect. II. ADDITION OF VITAMINS AND MINERALS Requirements for the addition of vitamins and minerals Article 3 Only vitamins and/or minerals listed in Annex I, in chemical forms listed in Annex II may be added to foods. The Annexes are printed along with this Ordinance and form its integral parts. Vitamins and minerals in a form that is bio-available to human body may be added to foods, whether or not they are usually contained therein, with the possibility of taking into account the following: a) a deficiency of one or more vitamins and/or minerals in the population or specific population groups that can be demonstrated by clinical or sub-clinical evidence of deficiency or indicated by estimated low levels of intake of nutrients; or b) the potential to improve the nutritional status of the population or specific population groups and/or correct possible deficiencies in dietary intakes of vitamins or minerals due to changes in dietary habits; or c) evolving generally acceptable scientific knowledge on the role of vitamins and minerals in nutrition and consequent effects on health. Restrictions on the addition of vitamins and minerals Vitamins and minerals may not be added to: Article 4 a) unprocessed foodstuffs, including unprocessed fruit, vegetables, meat, poultry, fish, and other; b) beverages containing more than 1.2 % by volume of alcohol. By way of derogation from paragraph 1, item b) of this Article, notwithstanding the provisions of Article 3, paragraph 2 of this Ordinance and provided that no nutrition or health claims are made, vitamins and minerals may be added to products: 1.) which bear the tariff item [4] 2.) which were placed of the markets of the EU Member States before 1 July 2007.

3 Purity criteria Article 5 The purity criteria specified in special purity criteria rules shall be applicable to the vitamin formulations and mineral substances listed in Annex II [5]. For those vitamin formulations and mineral substances for which purity criteria have not yet been specified, generally acceptable criteria recommended by international bodies shall be applicable until such specifications are adopted. Conditions for the addition of vitamins and minerals Article 6 When a vitamin or mineral is added to foods, the total amount of the vitamin or mineral present, for whatever purpose, in the foods as sold on the market shall not exceed recommended daily allowance set in Annex III which is printed along with this Ordinance and forms an integral part thereof. For concentrated and dehydrated products, the recommended daily amounts shall be those present in the foods when prepared for consumption according to the manufacturer's instructions. Added vitamins and minerals shall be present in foods in significant amounts, in accordance with Annex I to the Ordinance on nutrition labelling of foodstuffs (Official Gazette 60/2008, 74/08)[6] III. ADDITION OF CERTAIN OTHER SUBSTANCES Article 7 A substance other than vitamins or minerals, or an ingredient containing a substance other than vitamins and minerals, may be added to foods or used in the manufacture of foods. IV LABELLING, ADVERTISING AND PRESENTATION Article 8 The labelling, advertising and presentation of foods to which vitamins and minerals have been added shall not include any stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients.

4 The labelling, advertising and presentation of foods to which vitamins and minerals have been added shall not in any way mislead or deceive the consumer as to the nutritional merit of a food that may result from the addition of these nutrients. The labelling of food to which vitamins and minerals and certain other substances have been added as defined in provisions of this Ordinance, shall include the following information: the nutritive value, data provided in Article 4, paragraph 1, group 2 of the Ordinance on nutrition labelling of foodstuffs (Official Gazette 60/2008, 74/08)[7] as well as data on the total amounts present of the vitamins, minerals and other substances when added to the food; the nutrition claim indicating such addition in accordance with the Ordinance on nutrition and health claims which are specified in the food declaration.[8] This Article shall apply without prejudice to other provisions of the Food Act which are applicable to specific food categories. V. SAFEGUARD MEASURES Article 9 Where as a result of a new information or reassessment of existing information on nutrientenriched food it becomes either suspected or established that the food endangers human health despite complying with the relevant special rules, the Minister of Health may temporarily suspend or restrict trading in such food on the territory of the Republic of Croatia. The Minister competent for health (hereinafter: Minister) shall inform the head of the competent authority on implemented measures referred to in paragraph 1 of this Article and shall give reasons for adopting the measures. Where special rules [9] applicable to certain foods lay down restrictions on or suspension of certain substances, these shall also apply to nutrient-enriched foods covered by the provisions of this Ordinance. Placing on the market Article 10 The nutrient-enriched foods which comply with this Ordinance and special food rules concerning their composition, manufacturing specification, labelling, advertising and presentation, as well as placing on the market, may be freely sold on the market of the Republic of Croatia. Placing on the market of nutrient-enriched foods that fail to comply with the requirements referred to in paragraph 1 of this Article shall be prohibited.

5 Article 11 When a food enriched with vitamins and/or minerals is placed on the Croatian market for the first time, the food business operator shall accordingly inform the Ministry of Health and Social Welfare (hereinafter: Ministry). The information shall include the name and address of the manufacturer or the person in charge of packaging or market placement who is registered in the Republic of Croatia, as well as other product labelling data as defined in special rules. The information shall be submitted in writing in accordance with the instructions provided on the web-site of the Ministry ( Article 12 When a food enriched with other substances, as referred to in Article 7 of this Ordinance, is placed on the Croatian market for the first time, the food business operator shall submit an application for the assignment of the notification number. The application for the assignment of the notification number referred to in paragraph 1 shall be submitted to the Ministry in writing. The application shall be accompanied with the following documentation: 1. food labelling data in Croatian language, 2. the original packaging or packaging design, 3. the evidence on the amount of vitamins, minerals and/or other substances added to foods, 4. the evidence that the same product is sold on the manufacturer's home market, for foods imported into the Republic of Croatia, 5. where foods which are already on the EU market are imported into the Republic of Croatia, the evidence proving that the foods are marketed in at least two EU Member States, 6. for foods manufactured in the Republic of Croatia, the excerpt from the Register of Approved Establishments, 7. the evidence that the applicant is registered in the Republic of Croatia, 8. any other documentation required by the Commission referred to in Article 12, 9. a copy of the payment slip as evidence of settlement of the costs of the approval procedure. Article 13 By way of derogation from Article 12 of this Ordinance, the food business operator shall have to obtain the opinion of the Ministry for placing on the Croatian market the enriched food referred to in Article 7 of this Ordinance, which is manufactured in and imported from an EU Member State.

6 The application requesting the opinion referred to in paragraph 1 of this Article shall be submitted to the Ministry in writing. The application shall be accompanied by: 1. the evidence that the applicant is registered in the Republic of Croatia, 2. the official document obtained from the competent authority of the EU Member State where the food is manufactured or placed on the market, as an evidence that such food is legally manufactured, authorised and placed on the market of the EU Member State. 3. food labelling data in Croatian language. Article 14 Food business operators shall, once a year, before February 1 of the current year, supply the Agency with the preceding year's data on sales of nutrient-enriched food in the Republic of Croatia. The data shall be submitted in writing in accordance with instructions provided on the Agency's web-site ( Article 15 The Minister shall appoint the Commission for enriched foods and for nutrition and health claims (herein: the Commission). The notification number required for the placing on the market of nutrient-enriched foods referred to in Article 12 of this Ordinance shall be granted or refused by the Minister's decision which shall be based on the Commission's opinion. The Minister shall give the opinion on the placement of nutrient-enriched foods referred to in Article 13 based on the opinion of the Commission. The Commission shall adopt its Rules of Procedure. The costs of issuing the notification number referred to in paragraph 2 of this Article shall be covered by the applicant and their amount shall be determined by the Minister's decision. Article 16 The Ministry shall keep stored on magnetic medium the Register of nutrient-enriched foods which have been placed on the market of the Republic of Croatia. The Register is accessible on the web-site of the Ministry (

7 TRANSITIONAL AND FINAL PROVISIONS Article 17 Food business operators shall harmonise their operations with the provisions laid down in this Ordinance before 30 July Article 18 On the date of entry into force of this Ordinance, Article 46 of the Ordinance on foodstuffs for particular dietary uses (Official Gazette 81/04) shall cease to apply. Article 19 This Ordinance shall enter into force on the eighth day after the day of its publication in the Official Gazette, with the exclusion of Article 16 which shall enter into force on 30 July Class: /08-04/62 Reg. No.: Zagreb on 12 December 2008 The Minister Darko Milinović, m. p. ANNEX I VITAMINS AND MINERALS WHICH MAY BE ADDED TO FOODS 1. Vitamins Vitamin A Vitamin D Vitamin E Vitamin K Vitamin B1 Vitamin B2 Niacin Pantothenic acid

8 Vitamin B6 Folic acid Vitamin B12 Biotin Vitamin C 2. Minerals Calcium Magnesium Iron Copper Iodine Zink Manganese Sodium Potassium Selenium Chromium Molybdenumum Fluoride Chloride Phosphorus

9 ANNEX II VITAMIN FORMULATIONS AND MINERAL SUBSTANCES WHICH MAY BE ADDED TO FOODS 1. Vitamin formulations 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

10 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 pyridoxine dipalmitate FOLIC ACID pteroylmonoglutamic acid VITAMIN B12 cyanocobalamin hydroxycobalamin BIOTIN D-biotin VITAMIN C L-ascorbic acid sodium-l-ascorbate calcium-l-ascorbate potassium-l-ascorbate

11 L-ascorbyl 6-palmitate 2. Mineral substances calcium carbonate calcium chloride calcium salts of citric acid calcium gluconate calcium glycerophosphate calcium lactate calcium salts of orthophosphoric acid calcium hydroxide calcium oxide calcium sulphate magnesium acetate magnesium carbonate magnesium chloride magnesium salts of citric acid magnesium gluconate magnesium glycerophosphate magnesium salts orthophosphoric acid magnesium lactate magnesium hydroxide magnesium oxide magnesium sulphate ferrous carbonate

12 ferrous citrate ferric ammonium citrate ferrous gluconate ferrous fumarate ferric sodium diphosphate ferrous lactate ferrous sulphate ferric diphosphate (ferric pyrophosphate) ferric saccharate elemental iron (carbonyl + electrolytic + hydrogen reduced) cupric carbonate cupric citrate cupric gluconate cupric sulphate copper lysine complex sodium iodide sodium iodate potassium iodide potassium iodate zinc acetate zinc chloride zinc citrate zinc gluconate zinc lactate zinc oxide

13 zinc carbonate zinc sulphate manganese carbonate manganese chloride manganese citrate manganese gluconate manganese glycerophosphate manganese sulphate sodium bicarbonate sodium carbonate sodium citrate sodium gluconate sodium lactate sodium hydroxide sodium salts of orthophosphoric acid sodium selenate sodium hydrogen selenite sodium selenite sodium fluoride potassium fluoride potassium bicarbonate potassium carbonate potassium chloride potassium citrate potassium gluconate

14 potassium glycerophosphate potassium lactate potassium hydroxide potassium salts of orthophosphoric acid chromium (III) chloride and its hexahydrate chromium (III) sulphate and its hexahydrate ammonium molybdate (molybdenum (VI)) sodium molybdate (molybdenum (VI)) ANNEX III Table 1 DAILY ALLOWANCE OF VITAMINS AND MINERALS FOR ADULT PERSONS Vitamin A (retinol) (a) μg Provitamin A (β-carotene) mg Vitamin D (cholecalciferol) (b) μg Vitamin E (tocopherol) (e) mg Vitamin C (ascorbic acid) mg Vitamin K (phylloquinone) μg Minimum daily allowance 120 Maximum daily allowance , Recommended daily allowance 800 1, Vitamin B1 (thiamin) mg Vitamin B2 (riboflavin) mg Vitamin B3 (niacin) (d) mg Vitamin B6 (pyridoxine) mg Folic acid (e) μg Vitamin B (cyanocobalamin) (f) μg Pantothenic acid mg

15 Biotin μg Choline mg Calcium (Ca) mg Phosphorus (P) mg Magnesium (Mg) mg Iron (Fe) mg Zinc (Zn) mg Fluorine (F) mg Iodine (J) μg Selenium (Se) μg Chromium (Cr) μg Copper (Cu) μg 173 3,000 1,150 Manganese (Mn) mg Molybdenum (Mo) μg [1] Ordinance transposes the provisions of the Directive 1925/2006/EC of 20 December 2006 on the addition of vitamins, minerals and of certain other substances to foods. [2] Ordinance will transpose the provisions of the Directive 2002/46EC of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements [3] National legislation transposing the legislation of the European Union and the legislation of the European Union which will directly apply upon accession to the EU. [4] Provisions of the Regulation 479/2008/EC of 29 April 2008 on common organisation of the market in wine shall be transposed by a special rule, and the full implementation shall begin on the day of accession to the EU. [5] National legislation transposing the legislation of the European Union and the legislation of the European Union which will directly apply upon EU accession. [6] Ordinance transposes the provisions of the Council Directive 90/496/EC of 24 September 1990 on nutrition labelling of foodstuffs, amended by the Commission Directive 2003/120/EC of 5 December 2003 [7] Ordinance transposes the provisions of the Council Directive 90/496/EC of 24 September 1990 on nutrition labelling of foodstuffs, amended by the Commission Directive 2003/120/EC of 5 December 2003 [8] Ordinance shall transpose the provisions of the Regulation 1924/2006 of the European Parliament and of the of 20 December 2006 on nutrition and health claims made on foods [9] National legislation transposing the legislation of the European Union and the legislation of the European Union which will directly apply upon accession to the EU.