Decree No. 446 / 2004 Coll.
Decree laying down requirements for food supplements and food enrichment
Valid
Order
Effective from 01.08.2004
Text versions:
01.08.2004
30.07.2004
446
DECLARATION
of 16 July 2004
laying down requirements for food supplements and for the enrichment of food supplements
According to Article 19 (1) (a) and (j) of Act No. 110 / 1997 Coll., on Food and Tobacco Products, and amending and supplementing certain related laws, as amended by Act No. 306 / 2000 Coll., Act No. 146 / 2002 Coll. and Act No. 316 / 2004 Coll., (hereinafter "the Act '):
Subject matter
(1) This decree, in accordance with the law of the European Communities (1), lays down requirements for dietary supplements (2) and forthe enrichment of food supplements (2).
(2) This decree does not apply to medication3).
Basic concepts
(1) Enrichment or fortification of foodstuffs means the addition of food supplements to foods to increase their nutritional value.
(2) The reference dose is the quantity of food supplement which is the basis for calculating the allowed enrichment limit.
Conditions of use of food supplements
(1) Food supplements are only put into circulation in packs. They are usually prepared in the form of capsules or capsules, pastilles, tablets, expensive, powder bags, liquid ampoules, drops or other simple forms of liquids and powders intended for intake in small measured quantities.
(2) Vitamins and minerals which can be used for the production of food supplements are listed in Annex 1 to this Decree. The authorised forms of vitamins and minerals are listed in Annex 2 to this Decree.
(3) The maximum levels of vitamins, minerals and certain other food supplements are set out in Annex 3 to this Decree.
(4) The purity requirements of the substances listed in Annex No 2 to this Decree are set out in specific legislation4), 5). For substances listed in Annex 2 to this Decree for which purity criteria are not laid down in specific legislation, the purity criteria recommended by international regulations shall apply until such specifications are adopted.
(5) Food supplements must not contain plants, or parts thereof, containing very potent active substances used for pharmaceutical and therapeutic purposes as specified in the specific legislation6) and plants or parts thereof listed in Annex 4 to this Decree.
Labelling of food supplements
(1) In addition to the particulars provided for in the Food Act and in the Specific Legislation (7), the packaging shall also include:
(a) as part of the designation "food supplement,"
(b) the name of the category (vitamins, minerals) or the name of the substances characterising the product or the type of such substances;
(c) the quantity of vitamins, minerals or other food supplements per unit quantity (tablet, capsule or capsule, dose, etc.). For vitamins and minerals, the units listed in Annex 1 to this Decree shall be used,
(d) the content of added vitamins and minerals shall be reported by means of the average values determined on the basis of the manufacturer's analysis of the product;
(e) the content of added vitamins and minerals shall be expressed as a percentage of the recommended daily dose referred to in Annex 5 to this Decree. The percentages may also be expressed in graphical form,
(f) indication of the number of units (tablets, capsules, capsules, etc.) in the consumer package,
(g) recommended dosage and other conditions of use,
(h) warning against exceeding the recommended daily dosage;
(i) the warning "Save out of reach of children!"
(j) indication that the products are not intended for use as a substitute for a varied diet,
(k) "Not suitable for pregnant women" warnings for products containing more than 800 μg (RE) vitamin A per daily dose.
(2) Labelling of food supplements and the ways in which they are presented and advertised,
(a) must not attribute or refer to the characteristics of the prevention, treatment or cure of human diseases to food supplements;
(b) it must not contain any claim claiming or suggesting that a balanced and varied diet cannot provide sufficient nutrients.
Enrichment of food supplements
Enrichment of food supplements does not apply to the use of these substances as additives (8), to foods for particular nutrition9) and to food supplements.
Conditions of use of food supplements
(1) The food supplements authorised and their reference doses are listed in Annex 6 to this Decree.
(2) Individual food supplements intended for the enrichment of foodstuffs may be added to foods only in the forms set out in Annex 2 to this Decree.
(3) The purity requirements of the substances listed in Annex 2 to this Decree are set out in the Specific Legislation (4), (5).
(4) In order to achieve an easy and accurate dosage of food supplements in food production, these substances may also be used individually or in a mixture of food supplements.
(1) Foodstuffs listed in Annex 7 to this Decree may be enriched with food supplements up to a maximum quantity corresponding to the percentage of the reference levy indicated in this table. Iodine can also be enriched with edible salt.
(2) Vitamins A and D may be enriched with edible fats and oils up to a maximum of 10 mg. Kg1 vitamin A and 0,1 mg. Kg1 vitamin D. Furthermore, vitamins A and D dairy products may be enriched with a maximum of 1,6 mg. Kg1 vitamin A and 0,01 mg. Kg1 vitamin D may be enriched.
(3) Foodstuffs which need to be adapted to be used according to the manufacturer's instructions before consumption and which after preparation belong to the foodstuffs listed in Annex 7 to this Decree may be enriched in such a way that the percentage of the reference dose is not exceeded in the food intended for consumption.
(4) According to the estimated daily average consumption, foodstuffs are to be classified in categories A, B, C and D as set out in Annex 7 to this Decree.
(5) Enrichment of the iodine edible salt shall be done in such a way that the iodine content expressed as an element is not less than 20 mg. Kg-1 and at the same time not more than 34 mg. Kg-1 and Edible salts.
Labelling of food supplements
(1) Specific legislation on the labelling of food supplements in fortified foods (10) applies. Their content shall be given as part of the nutrition (nutritional) marking.
(2) The content of food supplements at the end of the minimum durability period or the shelf life period of the fortified food shall be as indicated on the packaging of the product.
Repeal
The following shall be deleted:
1. Decree No. 53 / 2002 Coll., laying down chemical health requirements for individual food and food ingredients, conditions of use of additives, auxiliary and food supplements.
2. Decree No. 233 / 2002 Coll., amending Decree No. 53 / 2002 Coll., laying down chemical requirements for the health of individual food and food ingredients, conditions of use of additives, aids and food supplements.
3. Decree No. 306 / 2004 Coll., amending Decree No. 53 / 2002 Coll., laying down chemical health requirements for each type of food and food raw material, conditions of use of additives, auxiliary and food supplements, as amended by Decree No. 233 / 2002 Coll.
This Decree shall take effect on 1 August 2004.
Minister:
Dr. Kubinyi, Ph.D. v. r.
Příloha č. 1
Annex No 1 to Decree No 446 / 2004 Coll.
Vitamins and minerals which may be used in the manufacture of food supplements
1. Vitamines
Vitamin A (µg RE)
Vitamin D (µg)
Vitamin E (mg α-TE)
Vitamin K (µg)
Vitamin B1 (thiamine) (mg)
Vitamin B2 (riboflavin) (mg)
Niacin (mg NO)
Pantothenic acid (mg)
Vitamin B6 (pyridoxine) (mg)
Folic acid (µg)
Vitamin B12 (cyanocobalamin) (µg)
Biotine (µg)
Vitamin C (mg)
2. Mineral substances
Calcium (mg)
Magnesium (mg)
Iron (mg)
Copper (μg)
Iodine (μg)
Zinc (mg)
Manganese (mg)
Sodium (mg)
Potassium (mg)
Selenium (µg)
Chromium (µg)
Molybdenum (µg)
Fluorine (mg)
Chlorine (mg)
Phosphorus (mg)
Příloha č. 2
Annex No 2 to Decree No 446 / 2004 Coll.
Forms of vitamins and minerals which may be used in the manufacture of food supplements and food supplements
| Vitaminy | |||
|---|---|---|---|
| Vitamin A | (a) retinol (b) retinol-acetát (c) retinol-palmitát (d) beta-karoten | Niacin | (a) kyselina nikotinová (b) nikotinamid |
| Kyselina pantothenová | (a) D-pantothenan vápenatý (b) D-pantothenan sodný (c) dexpanthenol | ||
| Vitamin D | (a) cholekalciferol (b) ergokalciferol | ||
| Vitamin B6 | (a) pyridoxin-hydrochlorid (b) pyridoxin-5‘-fosfát | ||
| Vitamin E | (a) D-alfa-tokoferol (b) DL-alfa-tokoferol (c) D-alfa-tokoferol-acetát (d) DL-alfa-tokoferol-acetát (e) D-alfa-sukcinát kyseliny tokoferolové | ||
| Kyselina listová | (a) kyselina pteroylmonoglutamová | ||
| Vitamin B12 | (a) kyanokobalamin (b) hydroxokobalamin | ||
| Biotin | (a) D-biotin | ||
| Vitamin K | (a) fylochinon (fytomenadion) | Vitamin C | (a) kyselina-L-askorbová (b) L-askorban sodný (c) L-askorban vápenatý (d) L-askorban draselný (e) L-askorbyl-6-palmitát |
| Vitamin B1 | (a) thiamin hydrochlorid (b) thiamin mononitrát | ||
| Vitamin B2 | (a) riboflavin (b) riboflavin-5-fosfát, sodná sůl | ||
| Minerální látky | |||
|---|---|---|---|
| Vápník | uhličitan vápenatý vápenaté soli kyseliny citrónové chlorid vápenatý glukonan vápenatý glycerofosforečnan vápenatý mléčnan vápenatý vápenaté soli kyseliny fosforečné hydroxid vápenatý oxid vápenatý | Hořčík | octan hořečnatý uhličitan hořečnatý chlorid hořečnatý hořečnaté soli kyseliny citrónové glukonan hořečnatý glycerofosforečnan hořečnatý hořečnaté soli kyseliny fosforečné mléčnan hořečnatý hydroxid hořečnatý oxid hořečnatý síran hořečnatý |
| Minerální látky | |||
|---|---|---|---|
| Železo | uhličitan železnatý citronan železnatý citronan železito-amonný glukonan železnatý fumaran železnatý difosforečnan sodno-železitý mléčnan železnatý síran železnatý difosforečnan železitý elementární železo (získané redukcí vodíkem nebo elektrolyticky) oxid železitý se sacharosou | Mangan | uhličitan manganatý chlorid manganatý citronan manganatý glukonan manganatý glycerofosforečnan manganatý síran manganatý |
| Sodík | hydrogenuhličitan sodný uhličitan sodný chlorid sodný citronan sodný glukonan sodný mléčnan sodný hydroxid sodný sodné soli kyseliny fosforečné | ||
| Draslík | hydrogenuhličitan draselný uhličitan draselný chlorid draselný citronan draselný glukonan draselný glycerofosforečnan draselný mléčnan draselný hydroxid draselný draselné soli kyseliny fosforečné | ||
| Měď | uhličitan měďnatý citronan měďnatý glukonan měďnatý síran měďnatý | ||
| Jód | jodičnan sodný jodid sodný jodičnan draselný jodid draselný | ||
| Selen | selenan sodný hydrogenseleničitan sodný seleničitan sodný | ||
| Zinek | octan zinečnatý chlorid zinečnatý citronan zinečnatý glukonan zinečnatý mléčnan zinečnatý oxid zinečnatý uhličitan zinečnatý síran zinečnatý | ||
| Chrom | chlorid chromitý síran chromitý | ||
| Molybden | molybdenan amonný molybdenan sodný | ||
| Fluor | fluorid draselný fluorid sodný | ||
Příloha č. 3
Annex No 3 to Decree No 446 / 2004 Coll.
Maximum levels of vitamins, minerals and certain other food supplements in food supplements
Vitamins
| Vitaminy/jednotky | Nejvyšší přípustné množství v denní dávce |
|---|---|
| Vitamin A (μg) RE* | 2000 |
| Vitamin D (μg) | 10 |
| Vitamin K (μg) | 60 |
| Thiamin (vitamin B1) (mg) | 10 |
| Riboflavin (vitamin B2) (mg) | 10 |
| Niacin (mg) NE** | 500 |
| Kyselina pantothenová (mg) | 40 |
| Vitamin B6 (pyridoxin) (mg) | 10 |
| Kyselina listová (μg) | 1000 |
| Vitamin B12 (kyanokobalamin) (μg) | 50 |
| Biotin (μg) | 500 |
| Vitamin C (mg) | 2000 |
| Vitamin E (mg) α-TE*** | 100 |
* RE = trans- retinolekvivalent
* * NE = niacinequivalent
* * * α-TE = alpha-tocopherolecvivalent
Mineral substances
| Minerální látky/jednotky | Nejvyšší přípustné množství v denní dávce |
|---|---|
| Draslík (mg) | 1000 |
| Vápník (mg) | 2500 |
| Hořčík (mg) | 400 |
| Železo (mg) | 20 |
| Zinek (mg) | 25 |
| Měď (μg) | 3000 |
| Jód (μg) | 200 |
| Selen (μg) | 200 |
| Mangan (mg) | 5 |
| Chrom (μg) | 200 |
| Molybden (μg) | 100 |
| Fluor (mg) | 1 |
Some other food supplements
| Potravní doplňky | Nejvyšší přípustné množství v denní dávce |
|---|---|
| Koenzym Q 10 | 60 mg |
| Karoteny | 20 mg |
| Karnitin | 1000 mg |
| Kreatin | 2,5 g |
| Mateří kasička nativní | 200 mg |
| Propolis | 50 mg |
| Lecitin | Není omezeno |
| Inositol | Není omezeno |
| Mlezivo (colostrum) | Není omezeno |
| Sušená biomasa zelených řas rodů Chlorella, Scenedesmus, sinic rodu Spirulina. Sušená biomasa nebo extrakty z biomasy hnědých a červených jedlých řas z čeledí Fucaceae, Phaeophyceae a Rhodophyceae (tzv. kelp) | Není omezeno |
| Vitální kultury mikroorganizmů | Není omezeno |
| Bifidobacterium spp. | |
| Candida valida | |
| Kluyveromyces marxianus, | |
| Lactobacillus acidophilus | |
| Lactobacillus bulgaricus | |
| Lactobacillus delbrueckii subsp. bulgaricus | |
| Lactococcus | |
| Leuconostoc | |
| Streptococcus lactis, | |
| Streptococcus salivarius subsp. thermophilus | |
| Saccharomyces cerevisiae | |
| Saccharomyces exignus | |
| Saccharomyces unisporus | |
| Torulopsis | |
| Včelí pyl | Není omezeno |
Příloha č. 4
Annex No. 4 to Decree No. 446 / 2004 Coll.
List of certain prohibited plants for the production of food supplements
| Latinský název | |
|---|---|
| Rostliny čeledi Aristolochiaceae (podražcovité) | Gossypium sp. div. (semeno) |
| Alkanna spp. | Genista tictoria |
| Alstonia sp. div. (kůra) | Hedera helix L. (list) |
| Ammi visnaga (L.) LAM. (plod) | Heliotropium spp. |
| Andira spp. | Chenopodium ambrosioides |
| Anchusa spp. | Ipomoea sp. div. (kořen) |
| Apocynum sp. div. (kořen) | Krameria triandra RUIZ et PAV. (kořen) |
| Areca catechu L. (semeno) | Ledum palustre |
| Artemisia cina | Lithospermum officinale |
| Asarum spp. (nať) | Mallotus philipinensis (kamala) |
| Borago officinalis (nať, květ) | Menispermum canadense, dauricum |
| Bragantia wallichii | Mucuna pruriens |
| Brachyglotis spp. | Petasites spp. |
| Caltha palustris | Piper methysticum FORSTER (kava-kava) |
| Cassia angustifolia, senna L (list, plod) | Podophyllum peltatum L. (kořen) |
| Cassia angustifolia VAHL (list, plod) | Pulsatilla vulgaris |
| Cineraria spp. | Rhamnus catharthica L. (kůra, plod) |
| Citrullus colocynthis (plod) | Rhamnus purshiana DC. (kůra) |
| Clematis spp. | Rheum officinalis, palmatum (kořen) |
| Cocculus spp | Rhododendron ferrugineum L. (list) |
| Conium maculatum | Ruta graveolens (nať) |
| Croton tiglium | Sarothamnus scoparius (L.) WIMM.ex KOCH (květ, nať) |
| Cynoglossum spp. | Sassafras albidum |
| Diploclisia affinis, chinensis | Senecio spp. |
| Dryopteris filix-mas (oddenek) | Sinomenium acutum |
| Ecballium elaterium A. RICH, (plod) | Spartium junceum L. (květ, nať) |
| Erechthites spp. | Spigelia sp. div. (kořen, nať) |
| Eschscholtzia California CHAM, (nať) | Stephania spp. |
| Eupatorium spp. (kromě E. perfoliatum) | Symphytum sp.div. (kořen) |
| Exogonium purga | Tussilago farfara L. (list, květ) |
| Frangula alnus MILL, (kůra) | Vladimiria souliei |
| Gelsemium sempervirens (L.) AIT. (kořen) | Xysmalobium undulatum R. BROWN (kořen) |
Příloha č. 5
Annex No 5 to Decree No 446 / 2004 Coll.
Vitamins and minerals and their recommended daily doses used for labelling food supplements
| Vitamin A | μg | 800 |
| Vitamin D | μg | 5 |
| Vitamin E | mg | 10 |
| Thiamin (vitamin B1) | mg | 1,4 |
| Riboflavin (vitamin B2) | mg | 1,6 |
| Niacin | mg | 18 |
| Kyselina pantothenová | mg | 6 |
| Vitamin B6 (pyridoxin) | mg | 2 |
| Kyselina listová | μg | 200 |
| Vitamin B12 (kyanokobalamin) | μg | 1 |
| Biotin | μg | 150 |
| Vitamin C | mg | 60 |
| Fosfor | mg | 800 |
| Hořčík | mg | 300 |
| Jód | μg | 150 |
| Vápník | mg | 800 |
| Zinek | mg | 15 |
| Železo | mg | 14 |
Příloha č. 6
Annex No 6 to Decree No 446 / 2004 Coll.
Food supplements authorised to enrich food and their reference doses
| Potravní doplněk | Referenční dávka |
|---|---|
| Vitamin B1 | 1,4 mg |
| Vitamin B2 | 1,6 mg |
| Vitamin B6 | 2,0 mg |
| Vitamin B12 | 1,0 μg |
| Vitamin C | 60,0 mg |
| Vitamin E | 10,0 mg |
| Karoten | 16,0 mg |
| Niacin | 18 mg |
| Biotin | 0,15 mg |
| Kyselina listová | 200 μg |
| Kyselina pantothenová | 6 mg |
| Draslík | 1000,0 mg |
| Hořčík | 300,0 mg |
| Vápník | 800,0 mg |
| Zinek | 15,0 mg |
| Měď | 2,0 mg |
| Jód | 150,0 μg |
Příloha č. 7
Annex No 7 to Decree No 446 / 2004 Coll.
Foods which may be enriched with food supplements up to a maximum quantity corresponding to the percentage of the reference dose
| Skupina | Potravina | Procentuální podíl referenční dávky ve 100 g resp. ve 100 ml potraviny | |||
|---|---|---|---|---|---|
| Vitamin C % | Ostatní vitaminy a karoten* % | Jód % | Ostatní minerální látky* % | ||
| A | mléko | 100 | 30 | 20 | 30 |
| chléb, běžné a jemné pečivo | 100 | 50 | 20 | 30 | |
| nealkoholické nápoje, koncentráty k přípravě nealkoholických nápojů | 100 | 30 | 20 | 30 | |
| pivo | 100 | 30 | 20 | 30 | |
| ovocné a bylinné čaje, instantní čaje a čajové extrakty | 100 | 50 | 20 | 30 | |
| dehydratované výrobky | 100 | 50 | 20 | 30 | |
| B | masné a rybí výrobky | 200 | 100 | 30 | 50 |
| výrobky z brambor | 200 | 100 | 30 | 50 | |
| těstoviny | 200 | 100 | 30 | 50 | |
| směsi z obilovin, mušli | 200 | 100 | 30 | 50 | |
| mléčné výrobky | 200 | 100 | 30 | 50 | |
| C | mražené krémy | 200 | 200 | - | 100 |
| jedlé ruky a oleje | 200 | 200 | - | 100 | |
| zpracované ovoce a zelenina | 200 | 200 | 50 | 100 | |
| trvanlivé pečivo, cukrářské výrobky | 200 | 200 | 50 | 100 | |
| D | cukrovinky (kromě žvýkaček), čokoláda a čokoládové bonbóny | 300 | 200 | 100 | 200 |
| žvýkačky a podobné výrobky | 500 | 300 | 200 | 300 | |
| kořenící přípravky | 500 | 300 | 200 | 300 | |
* listed in Annex No 6
1) Directive 2002 / 46 / EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to food supplements.
2) Act No. 110 / 1997 Coll., on Food and Tobacco Products and amending and supplementing certain related laws, as amended by Act No. 166 / 1999 Coll., Act No. 119 / 2000 Coll., Act No. 306 / 2000 Coll., Act No. 146 / 2002 Coll., Act No. 274 / 2003 Coll., Act No. 94 / 2004 Coll. and Act No. 316 / 2004 Coll.
3) Act No. 79 / 1997 Coll., on medicinal products and on amendments and additions to certain related laws, as amended by Act No. 102 / 2001 Coll., Act No. 309 / 2002 Coll., Act No. 320 / 2002 Coll., Act No. 129 / 2003 Coll. and Act No. 274 / 2003 Coll.
4) Decree No. 54 / 2002 Coll., laying down health requirements for the identity and purity of additives, as amended by Decree No. 318 / 2003 Coll.
5) § 7 (d) and (e) of Act No. 79 / 1997 Coll., on Medicines and on the amendment and addition of certain related laws, as amended by Act No. 129 / 2003 Coll.
6) Annex (a) to Decree No 343 / 2003 Coll., which issues a list of plants used for pharmaceutical and therapeutic purposes.
7) Decree No. 324 / 1997 Coll., on the method of labelling of foodstuffs and tobacco products, on the tolerance from the quantity of product indicated by the symbol "e," as amended by Decree No. 24 / 2001 Coll. and Decree No. 259 / 2003 Coll.
8) Decree No. 304 / 2004 Coll., establishing the types of additives and extraction solvents and their conditions of use in the manufacture of foodstuffs.
9) Decree No. 54 / 2004 Coll., on foodstuffs intended for particular nutritional uses and their method of use.
10) Article 6 (1) (m) of Act No. 110 / 1997 Coll., on Food and Tobacco Products, and amending and supplementing certain related laws, as amended by Act No. 306 / 2000 Coll. § 6 of Decree No. 293 / 1997 Coll., on the method of calculation and presentation of nutritional (nutritional) value of foodstuffs and on labelling data on possible adverse health effects.
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Regulation Information
| Citation | Decree No. 446 / 2004 Coll., laying down requirements for food supplements and for the enrichment of food supplements |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 30.07.2004 |
|---|---|
| Effective from | 01.08.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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