Requirements For Dietary Foods For Special Medical Purposes And Its Additional Marking

Original Language Title: Prasības diētiskajai pārtikai cilvēkiem ar veselības traucējumiem un tās papildu marķējumam

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Read the untranslated law here: https://www.vestnesis.lv/op/2015/128.9


Cabinet of Ministers Regulations No. 360 in 2015 (30 June. No 30 39) requirements for dietary foods for special medical purposes and its additional markings Issued under the food surveillance law in the third paragraph of article 4 and article 13 paragraph 3 of part 1 of the regulations sets out the requirements for dietary foods for special medical purposes (hereinafter referred to as the dietary food), and the additional marking. 2. Dietary Foods may be marketed in the European Union if it meets the requirements of this regulation. 3. Dietary Foods are suitable for people with disabilities, and is distributed to the appropriate indication. Dietetic food is used for medical surveillance. 4. Dietary foods intended as sole or supplementary nutrition for people: 4.1 with limited, weakened or interfere with the body's metabolism or absorb, Digest, absorb or excrete ordinary foodstuffs or certain of its component nutrients; 4.2. other specific medical dietary requirements, if their diet is not possible to draw up, transforming the ordinary food, using another specific use for food or a combination of the food. 5. Dietary Foods are classified into three groups: 5.1 with nutrients completely delivered food, which using according to the manufacturer's instructions, may constitute the sole source of nourishment for people for whom it is intended; 5.2. in nutrients completely delivered food, the composition of which is intended for people with a specific disease or health problems, and that by using the according to the manufacturer's instructions, may constitute the sole source of nourishment; 5.3. with nutrients not completely delivered food, the composition of which is intended for people with a specific disease or health problems, but which may not be used as the sole source of nourishment. 6. These regulations 5.2 and 5.3 referred to dietary foods may also be used as a partial replacement or supplement to the diet. 7. Dietetic food manufacturers or assemblers (hospital and medical treatment) are responsible for the following requirements: 7.1 dietary food is manufactured or assembled according to medical and nutrition knowledge; 7.2. use of dietary food according to the instructions of the manufacturer or packagers are safe, effective and efficiently ensure the nutritional requirements of people, for which it is intended; 7.3. If the rules referred to in point 5.1. food intended for infants (children under the age of 12 months) feeding, vitamin and mineral content it complies with the rules referred to in annex 1; 7.4. If the rules referred to in point 5.2 of the food for baby feeding, vitamin and mineral content it complies with the provisions of annex 1, as well as the requirements may be allowed in one or more of the specified component, if it is required according to the intended use; 7.5. If the rules referred to in paragraph 5.3 food intended for feeding infants, the maximum vitamin and mineral content must not exceed the provisions mentioned in annex 1 as well as a tolerance of one or more constituents, if this is necessary according to the intended use; 7.6. baby feeding dietary foods intended for other nutrients, other than vitamins and minerals, comply with the laws and requirements of the formulae for infants and makslīg to follow-on formulae, provided this is not contrary to the expected usage; 7.7. the provisions referred to in subparagraph 5.1 food vitamin and mineral content is relevant to this provision in annex 2 of these requirements, if the food is not for infant feeding; 7.8. this rule 5.2. consumption referred to in subparagraph vitamin and mineral content is relevant to this provision in annex 2, as well as the requirements may be allowed in one or more of the specified component, if it is required according to the expected usage and food is not designed for infant feeding; 7.9. the maximum vitamin and mineral content of this rule 5.3. food referred to in subparagraph may not exceed this provision 2. the quantities referred to in the annex, as well as a tolerance of one or more constituents, if this is necessary according to the expected usage and food is not designed for infant feeding; 7.10. the manufacture of dietetic food, uses substances referred to in the Commission of 13 October 2009 Regulation (EC) no 953/2009 on substances that dietary considerations can be added to foodstuffs intended for particular nutritional uses, in the annex. 8. Dietary Foods allowed to be marketed only in retail pre-packaged. 9. Dietary food trade name is "dietary foods for special medical purposes". 10. Dietary food trade name language of European Union Member States comply with the provisions of this annex. 11. Dietary foods labelled in accordance with the requirements of the legislation on the labelling of prepackaged food. In addition to the particulars on the label, the following information: 11.1 energy kilojoules (kJ) and kilocalories (kcal) and numerically expressed protein, carbohydrate and fat content in 100 grams or 100 millilitres of the product as well as bulk, if necessary, 100 g or per 100 ml according to the manufacturer's instructions for use in the product. In addition, the following information may be specified per meal, which gave the label, or specified per serving, if the label indicates the number of servings in the package; 11.2. each of these rules 1 and 2 in the annex to the ingredients in the numerical quantity of 100 g or 100 ml of the product as well as bulk, if necessary, 100 g or per 100 ml according to the manufacturer's instructions for use in the product. In addition, the following information may be specified per meal, which gave the label, or specified per serving, if the label indicates the number of servings in the package; 11.3. the protein, carbohydrate and fat, as well as other nutrients and their components the Declaration of content, if it is necessary for the future use of the product, expressed in number 100 grams or 100 millilitres of the product as well as bulk, if necessary, 100 g or per 100 ml according to the manufacturer's instructions for use for the product. In addition, the following information may be specified per meal, which gave the label, or specified per serving, if the label indicates the number of servings in the package; 11.4. If necessary, the osmolality of the product, or osmolaritāt; 11.5. the product contains the protein or protein hydrolysates contained origins and characteristics; 11.6. "relevant information" (or similar indication) with very highlight information about: 11.6.1. that the product is to the medical surveillance; 11.6.2. or the product may be used as the sole source of nourishment; 11.6.3. that the product is intended to be a certain age people (if necessary); 11.6.4. that the product is hazardous to health if used people who this product is not intended (if necessary); 11.7. claim "Dietary use", including the mention of the illness or disorders, in which case intended for this product; 11.8. If necessary, precautions and contraindications; 7.4. product characteristics or traits, which certifies compliance with the use of the product. This also applies to nutrients been increased, reduced, or which are not included in or are otherwise changed, as well as the grounds for the use of the product; 11.10. If necessary, warning that the product is not for parenteral use; 11.11. If necessary, an indication of the preparation, the use and the storage of the product after the opening of the container. 12. Import distribution and distribute in Latvia only allowed the dietary food which is notified in accordance with the laws of the special dietary food requirements and its additional markings, registration, and payment of State fee. 13. Be declared unenforceable in the Cabinet of 3 April 2001, Regulation No 155 "minimum safety requirements for dietary foods for special medical purposes and requirements marking" (Latvian journal, 2001; 2003, 56. No 25. No; 2006, nr. 185.161. No; 2007, 2008, nr. 201.;; 2010, 57. No; 148. no 2013).
Informative reference to directives of the European Union

The rules included provisions resulting from: 1) of the Commission of 25 March 1999, Directive 1999/21/EC on dietary foods for special medical purposes; 2) Commission of 23 October 2006, Directive 2006/82/EC adapting Directive 91/321/EEC on infant formulae and follow-on formulae and Directive 1999/21/EC on dietary foods for special medical purposes, by reason of the accession of Bulgaria and Romania; 3) Commission 22 December 2006 of Directive 2006/141/EC on artificial of infant formulae and follow-on formulae for infants and amending Directive 1999/21/EC; 4) of the European Parliament and of the Council of 6 May 2009 directive 2009/39/EC on foodstuffs intended for particular nutritional uses; 5) Commission 2013 8 February 13/26/EU directive adapting certain directives in the food safety, veterinary and phytosanitary policy in relation to the accession of Croatia. The Prime Minister is the Rapidity of the farming Minister Newsletters John Dūklav annex 1 Cabinet 30 June 2015 by Regulation No 360 requirements with nutrients for the fully completed dietary food zīdaiņiem1 no p. k. Vitamins and minerals (units) 100 kJ 100 kcal minimum maximum minimum quantity quantity maximum quantity 1. Vitamins: 1.1. Vitamin a (µ g-RE) 14 43 60 180 1.2. Vitamin d (µ g) 0.25 0.75 1 3 1.3. Vitamin k (µ g) 1.4 1 5 4 20. Vitamin c (mg) 1.5 6 8 25 1.9. thiamin (mg) 0.01 0.075 0.04 0.3 1.6. riboflavin (mg) 0.014 0.1 0.06 0.45 1.7. Vitamin B6 (mg) 0.009 0.075 0.035 0.3 1.8. NICOTINAMIDE (mg-NE) 0.2 0.75 0.8 3 1.9. folic acid (µ g) 1 6 4 25 1.10. Vitamin B12 (µ g) 0.025 0.12 0.1 0.5 1.11. Pantothenic acid (mg) 0.07 0.5 0.3 2 1.12. biotin (µ g) 0.4 5 1.5 20 1.13. Vitamin e (mg-TE a/g polyunsaturated fatty acids by linolenic acid) 0.5 (but not less than 0.1 mg/100 kJ) 0,5/0.75 g (but not less than 0.5 mg/100 kcal) 3 2. Minerals: 2.1. sodium (mg) 5 14 20 60 2. chloride (mg) 12 29 50 125 2.3. potassium (mg) 15 35 60 145 2.4. calcium (mg) 12 60 50 250 2.5. phosphorus (mg) 6 22 25 90 2 2.6. magnesium (mg) 1.2 3.6 5 15 2.7. iron (mg) 0.12 0.5 0.5 2.2.8 zinc (mg) 0.12 0.6 0.5 2.4 2.9. copper (µ g) 29 20 120 4.8 2.10. iodine (µ g) 1.2 8.4 5 35 2.11. Selenium (µ g) 1 3 0.25 0.7 2.12. manganese (µ g) 0.25 25 1 100 2. chromium (µ g) – 2.5 – 10 2.14. molybdenum (µ g) – 2.5 – 10 2.15. fluoride (mg)-0.05-0.2 notes. 1, the composition is indicated for use in the finished product, prepared according to the manufacturer's instructions. 2 calcium/phosphorus ratio shall not be less than 1.2 nor greater than 2.0. Minister of Agriculture John Dūklav annex 2 Cabinet 30 June 2015 by Regulation No 360 requirements with nutrients for the fully completed dietary foods, not zīdaiņiem1 no p. k. Vitamins and minerals (units) 100 kJ 100 kcal minimum maximum minimum quantity quantity maximum quantity 1. Vitamins: 1.1. Vitamin a (µ g-RE) 43 35 180 8.4 1.2. Vitamin d (µ g) 0,752 0.5 to 2,5/0,65/0.12 32 1.3. Vitamin k (g µ) 0.85 5 3.5 20 1.4. Vitamin c (mg) 22 0.54 5.25 2.25 1.5. thiamin (mg) 0.015 0.12 0.06 0.5 1.6. riboflavin (mg) 0.02 0.12 0.08 0.5 1.7. Vitamin B6 (mg) 0.02 0.12 0.08 0.5 1.8. NICOTINAMIDE (mg-EN) 0.22 0.75 0.9 3 1.9. folic acid (µ g) 2.5 12.5 10 50 1.10. Vitamin B12 (µ g) 0.017 0.17 0.07 0.7 1.11. Pantothenic acid (mg) 0.035 0.35 0.15 1.5 1.12. biotin (mg) 0.18 1.8 0.75 7.5 1.13. Vitamin e (mg-TE a/g polyunsaturated fatty acids by linolenic acid) 0.5 (but not less than 0.1 mg/100 kJ) 0.75 0.5 (but not less than 0.5 mg/100 kcal) 3 2. Minerals: 2.1. sodium (mg) 7.2 42 30 175 2.2. chloride (mg) 7.2 42 30 175 2.3. potassium (mg) 19 70 80 295 2.4. calcium (mg) 8.4/122 42/602/502/2502 2.5 35 175. phosphorus (mg) 19 30 80 7.2 2.6. magnesium (mg) 1.8 6 7.5 25 2.7. iron (mg) 0.12 0.5 0.5 2.0 2.8. zinc (mg) 0.12 0.36 0.5 1.5 2.9. copper (µ g) 2.10 15 125 60 500. iodine (µ g) 35 1.55 8.4 6.5 2.11. Selenium (µ g) 0.6 2.5 2.5 10 2.12. manganese (µ g) 0.012 0.12 0.05 0.5 2.13. chromium (µ g) 0.3 3.6 1.25 15 2.14. molybdenum (µ g) 0.72 4.3 3.5 18 2.15. fluoride (µ g)-0.05-0.2 notes. 1, the composition is indicated for use in the finished product, prepared according to the manufacturer's instructions. 2 in products intended for children aged from one to ten years. Agriculture Minister John Dūklav annex 3 Cabinet 30 June 2015 by Regulation No 360 dietary food trade name no. p. k. Language trade name 1. Latvian dietary foods for special medical purposes 2. Specialio medicininė of paskirt of the Lithuanian is a product of 3 maisto. Estonian meditsiinilisel näidustusel kasutamisek toit 4. English Food (s) for special medical purpose 5. Диетични храни за медицински Bulgarian специални цели 6. Czech Dietní-lékařské určená Pro zvláštní potravin účely 7. The Danish Levnedsmiddel/Levnedsmidler til formål særlig is the medicinsk 8. French aliment (s) diététiqu (s) destiné (s) à des fins médical spéciales 9. Διαιτητικά τρόφιμα για ειδικούς ιατρικούς Greek σκοπούς 10. Dieetvoeding voor medisch gebruik Dutch 11. Italian alimento dietetic-a Fini Medici destinat special 12. Maltese dijetetik the skopij the mediċ ghal Ikel, speċifiċ 13. Polish-Dietetyczn in the specjalneg spożywcz the przeznaczeni środk-medyczneg 14. Portuguese dietétic de Produto USO the clínic 15. Romanian-pentr of scopur of child support, medical dietetic Speciale 16. Slovak-lekársk Dietetická na účely potravin osobitné 17. Slovenian (dietetičn) Dietn of posebn of zdravstven of živilė za namen 18. Kliininen ravintovalmist/Finnish kliinisiä ravintovalmisteit 19. Spanish alimento para uso to of dietétic is especial 20 médico. Hungarian-gyógyászat, célr Speciál-szán-tápszer 21. German Diätetisch/Diätetisch für medizinisch-Lebensmittel in besonder is Zweck (Bilanziert Diäten-) 22. Swedish is the ändamål Livsmedel för medicinsk speciell 23. Croatian is the medicinsk Hran za posebn potreb in farming Minister John Dūklav to