Requirements For Dietary Supplements

Original Language Title: Prasības uztura bagātinātājiem

Read the untranslated law here: https://www.vestnesis.lv/op/2015/242.4


Cabinet of Ministers Regulations No. 685 in 2015 (on 1 December. No 64 34) requirements for dietary supplements are Issued under the food surveillance law article 4, second subparagraph, and paragraph 2 of part 10.1, article 13, paragraph 3, third paragraph, and article 7 of the law on Advertising, the second part i. General questions 1. determines: 1.1. minimum safety requirements for food supplements; 1.2. the order in which records the dietary supplements, suspend or restrict their movement and withdrawing registration; 1.3. requirements for additional labelling of food supplements; 1.4. dietary supplements advertising content and design requirements. 2. These provisions shall not apply to medicinal products. 3. In Latvia, authorised for the placing on the market for dietary supplements if they: are 3.1 announced food and veterinary service (hereinafter service) and included in the register of food supplements; 3.2. designed as a food and are delivered to the final consumer only prepackaged. 4. Food Company (hereinafter-the company) ensures that the appropriate nutritional supplements instead of trade is the information about the products that it distributes. 5. Service does not restrict or prohibit the marketing of food supplements to their composition, manufacturing specifications, presentation or labelling, if they comply with the rules and regulations of food regulatory requirements. II. Minimum safety requirements 6. Nutritional supplements are foods to supplement a normal diet of concentrated nutrients (vitamins and minerals) or other substances having a nutritional or physiological effect, alone or in combination. Dietary supplements marketed in certain doses, capsules, lozenges, tablets, pills and other similar forms, powder bags, ampoules, phials and dropping other similar liquid and powder designed for use in small and measured quantity. 7. The manufacturer is the maximum quantity of vitamins and minerals recommended dietary supplements a day (24-hour) dose is determined, subject to the following observations: 7.1 the most safe levels established by scientific risk assessment based on generally accepted scientific data; 7.2. the various consumer groups in different degrees of sensitivity; 7.3. vitamins and minerals from other dietary sources; 7.4. the addition of vitamins and minerals recommended dose for consumers. 8. In the manufacture of food supplements only allowed to use the vitamins and minerals and in ways as defined by: 8.1. Commission of 30 November 2009. in Regulation (EC) no 1170/2009 amending European Parliament and Council Directive 2002/46/EC of the European Parliament and of the Council and Regulation (EC) No 1925/2006 as regards the lists of vitamins and minerals, as well as their types, which may be added to foods including food supplements; 8.2. the Commission of 14 November 2011 in Regulation (EU) no 1161/2011, amending European Parliament and Council Directive 2002/46/EC of the European Parliament and Council Regulation (EC) No 1925/2006 and Commission Regulation (EC) no 479/2009 as regards the lists of the minerals which may be added to foods; 8.3. Commission 2014 7 February Regulation (EU) No 119/2014, amending European Parliament and Council Directive 2002/46/EC of the European Parliament and of the Council and Regulation (EC) No 1925/2006 as regards the yeast that enriched with chromium and is used in the manufacture of food supplements, as well as for chromium (iii) lactate trihydrate, which are added to food products; 8.4. the Commission's 2015 March 12 in Regulation (EU) No 2015/414, amending European Parliament and Council Directive 2002/46/EC in relation to the (6S)-6-metiltetrahidrofolijskāb glikozamīn of the salt used in the manufacture of food supplements. III. Registration, suspension or restriction of movement and the arrangements for cancellation of the registration 9. to register the nutritional supplements, the company shall submit the service: 9.1. statement dietary supplements registration (annex 1) (hereinafter referred to as the notice); 9.2. the labelling of food supplements in the original language of the sample (for example, a box, a label, or a clear photocopy of the original packaging with legible text or scanned form layout); 9.3. the marking sample text and other information in the Latvian language, which will be added to dietary supplements. 10. Where a notification is submitted in paper form, the company this rule 9.3. sample referred to in addition to the services and the information submitted by the available electronic media. 11. the service may require the State Agency of medicines of the opinion: 11.1. If information specified in the notice suggests that nutritional supplements are medications; 11.2. If the Department finds that the notified or included in nutritional supplements in the other Member State of the European Union is distributed as a medicinal product; 11.3. in the light of the other Member States of the European Union, the competent authorities of the information received. 12. Service, if necessary, can request from the company for any other information about dietary supplements, in order to assess compliance with the food laws and regulatory requirements. 13. If you make changes to the registered food supplements, the company submitted a notification service for registered food supplement changes (annex 2). 14. before this rule 9 and paragraph 13 of the submission of the notification referred to in the company shall pay the State fee pursuant to the regulations on dietary supplements in the country of registration fee. 15. the service during the month following that rule 9 and 13 of the document referred to in paragraph shall take appropriate decisions receipt on: 15.1. dietary supplements registration services of nutritional supplements on refusal of registration in the register or, if the product does not comply with food legislation in the area of regulatory requirements; 15.2. changes in dietary supplements in the register or a refusal to make changes, if the product does not comply with food legislation in the area of regulatory requirements. 16. If the Department receives new information, or make existing information, check, on the basis of which it can be concluded that a registered nutritional supplements can cause or pose a threat to human health, the Department adopts the decision on limiting the marketing of food supplements or suspension or removal from the market. Service in accordance with the laws and regulations on the operation of the rapid alert system for food and feed chain without delay on the decision taken shall inform the Member States and the European Commission. 17. If the register included dietary supplements poses a risk to human health, the Department adopts a decision to revoke the registration of food supplements and deleted it from the registry of food supplements. 18. If the registry included in nutritional supplements does not pose a risk to human health, but does not meet the food area of regulatory legislation, the service can take a decision on the suspension of food supplements to prevent non-compliance. If the discrepancy is not resolved, the Department may decide to revoke the registration of food supplements. 19. the service creates a registry of food supplements and maintain it. The register shall be published in the official tīmekļvietn. The register shall contain the following information: 19.1. manufacturer's name and address; 19.2. for nutritional supplements to food business operators (for example, the importer, the Distributor's) name and address; 19.3. the list of ingredients of food supplements and nutrients or substances with a nutritional or physiological effect the quantity of days (24-hour) dose (also used in Latvian, and the plant names in Latin); 19.4. the recommended food supplements (daily) dose; 19.5. the products in the form of food supplements, the packaging and the packing unit size; 12.2. the label text, and other information, if any, will be added to dietary supplements, for example, instructions for use. 20. If the register of food supplements food supplements included more are not placed on the market, the company will inform the service and service of food supplements shall be deleted from the register of food supplements. IV. additional requirements for the labelling and advertising of dietary supplements 21 marked in the order set out in the Act, regulations on the requirements for the labelling of prepackaged food, and of the European Parliament and of the Council of 25 October 2011 in Regulation (EU) no 1169/2011 on the provision of food information to consumers and on the amendment of the European Parliament and Council Regulation (EC) No 1924/2006 and (EC) No 1925/2006 and Commission Directive 87/250/EEC , Council Directive 90/496/EEC, Commission Directive 1999/10/EC of the European Parliament and Council Directive 2000/13/EC, Commission Directive 2002/67/EC and 2008/5/EC and Regulation (EC) no 608/2004 (hereinafter Regulation No 1169/2011). The labelling shall include the following additional information: 21.1. trade name "food supplement"; 21.2. the nutrient or substance category names that describe nutritional supplements, or indication of those nutrients or substances; 21.3. the recommended food supplements (daily) dose; 21.4. warning do not exceed the recommended daily dose (24-hour); 21.5. the recommendation not to use the dietary supplements full and balanced diet substitutions; 21.6. warning that the food supplement should be stored out of the reach of children; 21.7. with numbers – the quantity of nutrients or substances with a nutritional or physiological effect in units of mass or volume in the day (24-hour) dose. Vitamins and minerals provide specific units according to the rules referred to in point 8 the regulatory enactments; 21.8. vitamins and minerals as percentage of the nutrient reference values specified in Regulation No 1169/2011 in part A of annex XIII. Vitamins and minerals can also be indicated as a percentage of the graphic. 22. The minimum amounts of vitamins and minerals for the day (24-hour) dose recommended by the manufacturer, is not significantly smaller than Regulation No 1169/2011 XIII of part A of annex 2 contains the vitamins and minerals. 23. the labelling specified nutrient or other substance in such a quantity that has a nutritional or physiological effect: 23.1. corresponds to the quantity of food supplements, which suggested as day (24-hour) dose; 23.2. the average quantity is based on the nutritional supplements producer testing results. 24. the nutritional supplements in the labelling, presentation and advertising must not include: 24.1. a claim that a food supplement, treats or cures disease, or mention of this possibility; 24.2. any direct or indirectly that a balanced and varied diet cannot provide sufficient nutrients. 25. To advertise only allowed dietary supplements dietary supplements included in the register. 26. the advertising of food supplements contain the indication "dietary supplements" and "dietary supplement does not substitute for a complete and balanced diet". 27. "the food supplement is not a substitute for effective and balanced diet" takes no less than five percent of the ads. Letter size is such as to indicate busy for most of the technical part of the text area provided. V. closing question 28 dietary supplements that are marketed and labelled by 2016-December 13, you can use the abbreviation DHS (recommended daily intake) to express the reference value on the addition of vitamins and minerals as a percentage of the recommended daily allowance specified in Regulation No 1169/2011 in part A of annex XIII. Informative reference to European Union directives, the regulations include provisions resulting from: 1) of 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; 2) Commission of 30 March 2006, Directive 2006/37/EC amending Annex II of the European Parliament and of the Council of 10 June 2002 Directive 2002/46/EC as regards the inclusion of certain substances. The Prime Minister is the Rapidity of the farming Minister Newsletters John Dūklav annex 1 Cabinet 2015 December 1 Regulation No 685 statement dietary supplements registration 1. Food supplement nutritional supplements manufacturer name company name, registration number, contact telephone number, public address and electronic mail address of the veids1 unit of the prepackage Products lielums2 packing unit lielums3 recommended daily deva4 2. ingredients (the ingredients) No. PO box 3. Sastāvdaļa5 quantity and mērvienība6 company (on food information responsible food business operator, the importer or the Distributor) 7 Companies (name, registration number) public address (legal and actual) contact telephone number and electronic mail address of the notes. the company submitting the 4 paziņojumu8 company (name, registration number) public address (legal and actual) contact telephone number and electronic mail address of the notes 5. the documents annexed to the statement 1. Sample text for the label in a language to Latvian ... p. 2. Add the label information (sample instructions or other information, if any, will be added to the packaging). p. 3. Highlight the sample in the original language (for example, a box, a label, or a clear photocopy of the original packaging with legible text, or the layout the scanned form) 9. EC. 4. other documents, to the p. ..
6. information on the State duty samaksu10 State duty payer (company name, registration number) date of payment 7. receipt of the decision of the service type 1. The decision to send to the specified e-mail address 2. The decision to send to the specified mail address: legal actual 3. The decision to receive onsite notes. 1 such as tablets, capsules, powder. 2 for example, pills by 0.5 g. 3 for example, 420 ml bottle of 30 tablets. If nutritional supplements will be offered with different types of taste, please specify them in this section. 4 for example, two pills a day. 5 If the ingredients of food supplements vitamins or minerals that indicate the types of chemical compounds. Plants indicates their scientific botanical name of Latvian and Latin, used part of the plant (such as flowers, root) and products (e.g., tablet, capsule, powder, extract, excerpt). Plant extract in addition to indicate the relationship of the plant extract. 6 nutrients or substances with a nutritional or physiological effect of the dose given to the numbers of units of mass or volume. 7 section filled in if this annex referred to in paragraph 1, the name of the company. fill out Section 8, if the applicant is not one of this annex 1 or 3 the undertakings referred to in paragraph. 9 If the original Latvian language will be prepared after the registration of food supplements, additional means to provide proof that the original will be filed after the preparatory service. fill in Section 10, if the payment is made to the credit institution. Agriculture Minister John Dūklav annex 2 Cabinet 2015 December 1 Regulation No 685 registered notice changes in food supplements food supplements 1 food supplement name dietary supplements registration number on izmaiņas1 No 2. PO box The changes mark the desired described more precisely 1. Nutritional supplements name 2. Name of manufacturer 3. Manufacturer address 4. The name of the company 5. Business address 6. Product type 7. Package unit size 8. Packing unit size 9. Recommended daily (daily) dose of 10. Ingredients 11. The quantity of components 12. Labels or other information accompanying the company 3 Companies (name, registration number) public address (legal and actual) contact Telephone number and electronic mail address 4. the documents annexed to the statement 1. Sample text for the label in a language to Latvian ... p. 2. Add the label information (instructions or other information, if any, will be added to the packaging). p. 3. Highlight the sample in the original language (for example, a box, a label, or a clear photocopy of the original packaging with legible text, or the layout the scanned form) 2. EC. 4. other documents, to the p. ..
5. information about state dues paying State fees provisions (company name, registration number) date of payment 6. receipt of the decision of the service type 1. The decision to send to the specified e-mail address 2. The decision to send to the specified mail address: legal actual 3. The decision to receive onsite notes. 1 dietary supplements with the marking on the register may be placed on the market until the expiration date, if this food supplement and its labelling complies with the requirements of the law. 2 If the original Latvian language will be drawn up after the registration of food supplements, in addition to indicate that the original will be filed after the preparatory service. 3 fill out the section, if payment is made to the credit institution. Minister of agriculture John Dūklav