Advanced Search

Amendments To The Cabinet Of Ministers Of 20 September 2005, The Regulation No 725 "rules On Minimum Safety And Labelling Requirements For Dietary Supplements And Dietary Supplements Registration Order"

Original Language Title: Grozījumi Ministru kabineta 2005.gada 20.septembra noteikumos Nr.725 "Noteikumi par obligātajām nekaitīguma un marķējuma prasībām uztura bagātinātājiem un uztura bagātinātāju reģistrācijas kārtību"

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$40 per month.
Cabinet of Ministers Regulations No. 440 Riga 2014 (august 5. No 42) 17 amendments to the Cabinet of Ministers of 20 September 2005, the Regulation No 725 "rules on minimum safety and labelling requirements for dietary supplements and dietary supplements registration order" Issued under the food surveillance law article 4 of part two and 10.1 and the third subparagraph of article 13 and article 7 of the law on Advertising, the second part to make the Cabinet of 20 September 2005, the Regulation No 725 "rules on minimum safety and labelling requirements for dietary supplements and dietary supplements registration order" (Latvian journal , 2005, 152, no. 210; 2007.112 no; 2008, 18, 83. no; 2010, nr. 196.) the following amendments: 1. provisions of title be expressed by the following: "the rules on food supplements". 2. Supplement, on the basis of the provisions of the Act, issued after the words ' third ' by the words ' and article 7 of the law on Advertising, the second part ". 3. Replace paragraph 1, the words "safety and labelling" with the words "safety, labelling, advertising and presentation of the contents". 4. To supplement the provisions under point 2.2 the following: "2.2 nutritional supplements manufacturer (dealer) the marketing of food supplements site provides information about the products that it distributes to the seller to provide adequate information to consumers." 5. Make paragraph 5 by the following: "5. Vitamins and minerals comply with the safety requirements of the food control law and regulations on dietary supplements. In the manufacture of food supplements only allowed to use the vitamins and minerals and in ways as: 5.1 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; 5.2. 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; 5.3. 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. " 6. Express 6.1. subparagraph by the following: "6.1. notice for registration of food supplements, the importation and placing on the market (annex 2);". 7. Express 6.4. subparagraph by the following: "6.4. sample text label and instructions for use of the sample (if such will be added to the packaging) in the national language. If the notice for registration of food supplements, the importation and placing on the market (annex 2) shall be submitted in paper form, the applicant in the food and veterinary service in addition to submit the text of the label in the national language, using the available electronic media. " 8. Make paragraph 9 by the following: "9. in the event log in the product documentation, technical regulations, oriģinālmarķējum, instructions, certificates or for distributing the product in Latvia submitted a sample of the label, the information shows that the product could be drugs, the food and veterinary service requires the State Agency of medicines of the opinion, if it is not submitted to the food and veterinary service." 9. Express 10.1. and 10.2. subparagraph by the following: "10.1. manufacturer's name and address; 10.2. the dealer's name and address; ". 10. Express 10.7. subparagraph by the following: "10.7. instructions for use of the sample, if any, will be added to the package." 11. Express 11.1. subparagraph as follows: "notice 11.1 nutritional supplements for registration, for the importation and placing on the market (annex 2);". 12. Replace paragraph 11.4., the word "application" with the words "dietary supplements registration, import and placing on the market (annex 2). 13. Express 11.5. subparagraph by the following: "11.5. usage instructions, if any, of the samples will be added to the package, by sending by electronic means, to the food and veterinary service official e-mail address;". 14. Make the following paragraph 13: "13. If you change the registered food supplements, the applicant shall notify the food and veterinary service statement dietary supplements registration, import and placing on the market (annex 2) as a new submit dietary supplements. If the labelling of food supplements, the changes do not apply to components of food supplements, the applicant the food and veterinary service immediately shall provide notice of changes to registered food supplements (annex 3). " 15. Replace paragraph 15 in the numbers and the words "in paragraph 6 and 11" with numbers and the words "6, 11 and 13. 16. Make 16 the following: "4. The food and veterinary service in the month following that rule 6, 11 and 13 of the receipt of the documents referred to in the decision of: 16.1. dietary supplements registration of veterinary services in food and dietary supplements for the refusal of registration in the register or, if the product does not meet the food laws and regulatory requirements; 16.2. the modification of dietary supplements in the register or a refusal to make changes if the product does not conform to the regulations of food regulatory requirements. " 17. Delete paragraph 17. 18. Express 18 as follows: "6. The provisions referred to in paragraph 16 of the decision may be challenged in the food chain monitoring law and administrative procedure law." 19. the title of chapter IV, Expressed as follows: "IV. labelling and advertising". 20. Express 20.4. subparagraph by the following: "the quantity of ingredients 20.4. (nutrients or substances with a nutritional or physiological effect) in units of mass or volume daily. Vitamins and minerals provide specific units according to the rules referred to in paragraph 5 of the European Union regulation on the addition of vitamins and minerals supplements; ". 21. the supplement to chapter IV and 21.3 21.2 point as follows: "the advertising of food supplements in 21.2 include" food supplements "and" dietary supplement does not substitute for a complete and balanced diet ". 21.3 "food supplement does not replace a full and balanced diet" takes no less than five percent of the ads. Letter size to indicate busy for most of the technical part of the text area provided for. " 22. Make annex 2 as follows: "2. the annex to Cabinet of Ministers of 20 September 2005, the Regulation No 725 statement dietary supplements registration, import and placing on the market for 1. Food supplement nutritional supplements manufacturer name of company name of veids1 public address Products of lielums2 unit of presentation packing unit lielums3 the recommended 24-hour (day) deva4 notes. 1 such as tablets, capsules, powder. 2 for example, pills by 0.5 g. 3 for example, 420 ml bottle of 30 tablets. 4 for example, 2 pills a day.
2. Ingredients no PO box Sastāvdaļa5 quantity and mērvienība6 notes. 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 (for example, extract, extract, powder). Plant extract in addition to indicate the relationship of the plant extract. 6 nutrients or substances with a nutritional or physiological effect is given daily (daily) dose of units of mass or volume.
3. Applicant Firm (name) address (legal and actual) Bank details contact Telephone number and electronic mail address of the Notes 4. Izplatītājs7 Firm (name) address (legal and actual) note note. fill in Section 7 if the applicant and the dealer has a variety of legal persons.
5. the documents annexed to the statement 1. Sample text for the label in the national language to p. 2. Instructions for use specimen (if such will be added to the packaging) to p. 3. the labelling of food supplements or packaging the original EC. 4. other documents, p. "
23. To supplement the provisions of annex 3 with the following: "3. the Cabinet of Ministers of 20 September 2005, the Regulation No 725 registered for change notification 1. food supplements food supplements food supplement name dietary supplements registration number changes 2.

Nr.  p. k. The changes mark the desired described more precisely 1. Nutritional supplements name 2. Name of manufacturer 3. Manufacturer address 4. Dealer name 5. Distributor address 6. Product type 7. Package unit size 8. Packing unit size 9. The recommended daily dose (days) 10. Labelling 11. Instructions for use 3. Applicant Firm (name) address (legal and actual) Bank details contact Telephone number and electronic mail address of the indication of the period required for the disposal of stocks of food supplements after making changes to the registry 4. the documents annexed to the statement 1. Sample text for the label in the national language to p. 2. Instructions for use specimen (if such will be added to the packaging) to p. 3. the labelling of food supplements or packaging the original EC. 4. other documents, p. "
Prime Minister-Minister of traffic Anrij of the Minister of Agriculture John Dreyer Dūklav a