Cabinet of Ministers Regulations No. 441 in 2004 (April 27. No 25, § 28) mandatory safety requirements for dietary supplements and their labelling requirements Issued under the food surveillance law article 4 of part two and 10.1 and 13. the third paragraph of article i. General questions 1. lays down minimum safety requirements for food products, which are used in limited quantities to enrich normal diet with vitamins, minerals, or other substances having a nutritional or physiological effect, alone or in combination (food supplement) as well as dietary supplements registration procedures and requirements for marking.
2. a product containing a single vitamin or mineral, are considered dietary supplements, if the mass of the active substance that allows the product to be considered as a food supplement, not less than 15% of the maximum daily dose.
3. the provisions shall not apply to medicinal products.
II. Minimum safety requirements 4. Dietary supplements manufactured in capsules, gel, liquid, powder, pills, tablets, shelf or in another form, and they are intended for use in measurement quantities. Dietary supplements distributed in bulk.
5. In the manufacture of food supplements allowed to use this provision in annex vitamins and minerals there specified connections that comply with food regulations governing food ingredients set out purity criteria.
III. Registration procedure 6. European Union Member States produced and recorded for dietary supplements, which include vitamins and minerals, according to the annex to these provisions, Latvia is authorised, subject to the Latvian food centre and the food and veterinary service and sending the product labelling.
7. Dietary supplements, which are not subject to the provisions of paragraph 6, authorised to import and distribute only after registration of the Latvian food centre in accordance with the procedure laid down in these provisions. The Latvian food centre will review the documents submitted and take a decision. If the decision is positive, the Latvian food centre will issue a decision on registration and register the appropriate nutritional supplements. If the product does not meet the food regulatory, regulatory requirements, the Latvian food centre shall issue a reasoned decision on refusal of registration.
8. If you have submitted for the registration of food supplements, which are referred to in the annex to these provisions, without vitamins and minerals contain other substances and compounds, the Latvian food centre may require the applicant to submit to the national medicines agency finding that nutritional supplements are not concerned as medicinal products to be registered.
9. The Latvian food centre will create and maintain a register of registered food supplements. The register shall contain the following information: manufacturer or retailer 9.1 legal address, actual address, contact name and phone number;
9.2. list of ingredients of food supplements, including the quantity of plants and their parts used names and Latvian Latin;
9.3. dietary supplements recommended daily allowance (RDA);
9.4. nutritional supplements products, packaging and packing unit size;
9.5. labels, instructions (if needed).
10. To register dietary supplements, the applicant (manufacturer or distributor) submitted to the Latvian food centre: 10.1. application that contains the following information: manufacturer or distributor 10.1.1. name and business address;
10.1.2. the name of the product;
10.2. technical documents or regulations in the product description, which specifies the characteristics of the product, composition, specific ingredients and their quantity;
10.3 information about the composition of the product to existing plants, including their scientific botanical name of Latvian and Latin, each plant part used (such as flowers, root) and products (e.g., extract, powder), relevant biological active substance group names, the use of certain plant types, the permissible dose limits and warnings about possible risks of use, and special storage;
10.4. the labelling of the model;
10.5. the instructions for use, if necessary;
10.6. the manufacturer of the product issued a declaration of conformity, approvals or regulations established in Latvia officially recognised abroad issued product, process or service conformity assessment or certification;
10.7. The food and veterinary service food company issued a recognition or a copy of the registration certificate or the operation of the pharmaceutical regulatory laws duly received a special permit (license) the pharmaceutical activity.
11. If you changed the registered product labelling, production or conditions of use, the applicant within 30 days, inform the Latvian food centre.
12. Expenses associated with the provision of paragraph 10 of that document expertise-70.98 lats (VAT Excl.)-borne by the applicant.
13. The Latvian food centre on nutritional supplements the registration or refusal of registration may be challenged in the Ministry of health.
IV. labelling 14. Dietary supplements labelled legislation on food labelling. The label shall include the following additional indications: 14.1. "food supplement";
14.2. the daily intake;
14.3. the ingredients and their quantities in units of mass or volume daily intake;
14.4. vitamins and minerals daily percentage;
14.5. the recommendation not to use the dietary supplements as a complete and balanced diet substitutes;
14.6. a warning that the product must be stored out of the reach of children;
9.1. a warning not to exceed the recommended daily dose.
15. the dietary supplements regulations technical documents, in the labelling, in the instructions for use, promotional material and other information should not contain indications or references that nutritional supplements, treating the condition prevents or cures disease, and must not contain any direct or indirect reference to the fact that a balanced and varied diet cannot provide sufficient nutrients. The label must contain an indication of nutritional supplements the nutrients or substances.
16. Compliance monitoring and controls are carried out by the food and veterinary service.
V. concluding questions
17. in Latvia until 31 December permitted to distribute dietary supplements if their composition used in other vitamins and minerals and their connection in accordance with the annex to these provisions, if these nutritional supplements are distributed to the Member States of the European Union before the July 12, 2002.
18. Dietary supplements, which do not comply with the requirements of these provisions, but the Latvian food centre up to the date of entry into force of the provisions has issued a positive opinion, can be distributed even after the entry into force of these regulations to the opinion had expired, but no longer than up to July 31, 2005.
Informative reference to European Union Directive provisions included in the law arising from the European Parliament and of the Council of 10 June 2002 Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements (text with EEA relevance).
Prime Minister i. Emsis Health Minister r. Muciņš annex to the Cabinet of Ministers of 27 April 2004 the Regulation No. 441 vitamins and minerals which may be used in the manufacture of food supplements no PO box
Vitamins and minerals vitamins and minerals use connections 1 2 3 1.
Vitamin a 1.1.
Vitamin a (µ g RE) retinol, retinyl acetate, retinilpalmitāt, beta-carotene 1.2.
(Μ g) vitamin d cholecalciferol, ergocalciferol 1.3.
Vitamin e (mg α-TE) D-alpha-tocopherol, DL-alpha-tocopherol, D-alpha-tocopheryl acetate, DL-alpha-tocopheryl acetate, D-acid Alpha-tokoferilsukcināt 1.4.
(Μ g) vitamin k PHYLLOQUINONE (phytomenadione) 1.5.
Vitamin B1 (mg) thiamin chloride, thiamin mononitrate 1.6.
Vitamin B2 (mg) riboflavin, riboflavin sodium phosphate 1.1.
Niacin (mg NE) Nicotinic Acid, NICOTINAMIDE 1.8.
Pantothenic acid (mg) of calcium D-PANTOTHENATE, sodium dexpanthenol D-PANTOTHENATE, 1.9.
Vitamin B6 (mg) pyridoxine chloride, Pyridoxine phosphate 1.10.
Folic acid (µ g) pteroilmonoglutamīnskāb-1.11.
Vitamin B12 (µ g), hidroksokobalamīn of cyanocobalamin 1.12.
Biotin (µ g) D-biotin 1.13.
Vitamin c (mg), L-Ascorbic acid sodium L-ascorbate calcium L-ascorbate, potassium L-ascorbate, L-ASCORBYL 6-palmitate 2.
Minerals 2.1.
Calcium (mg), calcium carbonate, calcium chloride, calcium salts of citric acid, Calcium Gluconate, calcium glycerophosphate, calcium lactate, calcium salts of orthophosphoric acid, calcium hydroxide, calcium oxide 2.2.
Magnesium (mg) magnesium acetate, magnesium carbonate, magnesium chloride, magnesium salts of citric acid, magnesium gluconate, magnesium glycerophosphate, magnesium salts of orthophosphoric acid, magnesium lactate, magnesium hydroxide, magnesium oxide, magnesium sulphate 2.3.
Iron (mg) iron (II) carbonate, ferrous citrate, ferric ammonium citrate, ferrous gluconate, iron (II) fumarāt, iron (iii) sodium diphosphate, ferrous lactate, ferrous sulphate, iron (iii) diphosphate (ferric pyrophosphate), iron (iii) saharāt, elemental iron (Carbonyl + electrolytic +-hydrogen reduced) 2.4.
Copper (µ g) copper (II) carbonate, copper citrate, copper gluconate, copper sulphate, copper-lysine complex 2.5.
Iodine (µ g), sodium iodide, potassium iodate, potassium iodide, potassium iodate 2.6.
Zinc (mg) zinc acetate, zinc chloride, zinc citrate, zinc gluconate, zinc lactate, zinc oxide, zinc carbonate, zinc sulphate 2.7.
Manganese (mg), manganese carbonate, manganese chloride, manganese citrate, manganese gluconate, manganese glycerophosphate, manganese sulphate 2.8.
Sodium (mg) of sodium bicarbonate, sodium carbonate, sodium chloride, sodium citrate, sodium gluconate, sodium lactate, sodium hydroxide, sodium salts of orthophosphoric acid 2.9.
Potassium (mg), potassium bicarbonate, potassium carbonate, potassium chloride, potassium citrate, potassium gluconate, potassium glycerophosphate, potassium lactate, potassium hydroxide, potassium salts of orthophosphoric acid 2.10.
Selenium (µ g) sodium selenate, sodium selenite, SODIUM SELENATE 2.11.
Chromium (µ g) chromium (iii) chloride, chromium (iii) sulphate 2.12.
Molybdenum (µ g) ammonium molybdate (molybdenum (VI)), sodium molybdate (molybdenum (VI)) 2.13.
Fluoride (mg) potassium fluoride, sodium fluoride 2.14.
Chloride (mg) 2.15.
Phosphorus (mg) Health Minister r. Muciņš
