Decree No. 225 / 2008 Coll.
Decree laying down requirements for food supplements and for the enrichment of foodstuffs
Valid
Order
Effective from 01.07.2008
225
DECLARATION
of 17 June 2008
laying down requirements for food supplements and for the enrichment of foodstuffs
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., Act No. 316 / 2004 Coll. and Act No. 120 / 2008 Coll.:
Subject matter
This decree (1) implements the relevant provisions of the European Community2) and, following the directly applicable regulations of the European Community3), regulates:
(a) requirements for the composition, labelling and use of food supplements;
(b) the conditions for the addition of other substances to food, except food supplements.
Requirements for the composition of food supplements
(1) Vitamins and minerals which may be used for the manufacture of food supplements are set out in Annex 1 to this Decree. These vitamins and minerals may only be used in the form set out in Annex 2 to this Decree. The purity requirements of the substances listed in Annex No 2 to this Decree lay down specific legislation laying down health requirements for the purity and identity of additives (4).
(2) Other substances which may be used for the production of food supplements and the conditions under which they may be used are listed in Annex 3 to this Decree. Food supplements may not be added individually or in a mixture of narcotic or psychotropic substances (5), precursors of category 1 of Annex I directly applicable to the European Communities (6), other substances for which toxic, genotoxic, teratogenic, hallucinogenic, narcotic or other adverse effects on the human organism have been demonstrated. Other substances as provided for in Annex 4 to this Regulation may not be used for the manufacture of food supplements.
Labelling of food supplements
(1) In addition to the labelling requirements for food packaging provided for in the law and in specific legislation7), the consumer packaging shall indicate:
(a) in the name of the food, the word "food supplement,"
(b) the name of vitamins, minerals or other substances characterising the product;
(c) the quantity of vitamins, minerals or other substances related to the recommended daily dose, using the units listed in Annex 1 to this Decree for vitamins and minerals,
(d) data on the vitamin and mineral content as well as the percentage of the recommended daily dose referred to in Annex 5 to this Decree, which may be indicated in graphical form,
(e) the recommended daily dosage and, where appropriate, other conditions of use;
(f) warning against exceeding the recommended daily dosage;
(g) a warning to keep the products out of the reach of children;
(h) a warning that food supplements are not a substitute for a varied diet;
(i) "Not suitable for pregnant women" warnings for food supplements containing more than 800 µg (RE) vitamin A per daily dose;
(2) For food supplements containing the plant Cimicifuga racemosa (grape platter) or its extracts, a warning shall be provided on the consumer packaging of the need for interruption of consumption and search for a physician in any suspected liver disease.
(3) The data referred to in paragraph 1 (c) shall be reported by means of the average values established on the basis of a quantitative analysis of the food supplement by the manufacturer.
(4) An indication of the total quantity shall be given in accordance with the specific legislation (7) or the rules for marking the symbol "e" (8). A positive and negative mass variation of not more than 5% shall not be regarded as misleading to the consumer.
(5) The labelling of food supplements must not
(a) to attribute or refer to properties related to the prevention, treatment or cure of human diseases;
(b) contain no claim indicating or suggesting that a balanced and varied diet in general cannot provide sufficient amounts of vitamins or minerals.
(6) Nutrition and health claims for food supplements may be indicated under the conditions of the directly applicable European Communities legislation on nutrition and health claims on food labelling 9).
Method of use of food supplements
(1) Food supplements are used in the form of capsules or capsules, pastilles, tablets, tablets, tablets, powder bags, ampoules with liquid, drops or other simple forms of liquids and powders intended for consumption in small measured quantities and are thus put into circulation. Food supplements shall only be put into circulation in packs.
(2) Food produced or put into circulation in a Member State of the European Communities or originating in one of the States Parties to the European Economic Area or in Turkey shall not be refused for circulation in the Czech Republic provided that the food corresponds to:
(a) the provisions which are binding on the manufacture or placing on the market of such food in one of those States; or
(b) the production procedures and rules of good manufacturing practice applied in one of those States for which there is sufficient detailed documentation to enable additional investigations to be carried out where necessary.
(3) Paragraph 2 shall not apply where the laws, regulations and procedures referred to in paragraph 2 do not guarantee a level of protection of a legitimate interest corresponding to the level of protection in the Czech Republic.
Conditions for adding other substances to food
(1) The conditions for the addition of vitamins, minerals or other substances to food are laid down in the directly applicable European Community Regulation on the addition of vitamins, minerals and certain other substances to food 10). Food may not be individually added or mixed with narcotic or psychotropic substances (5), category I precursors directly applicable to the European Communities (6), other substances for which toxic, genotoxic, teratogenic, hallucinogenic, narcotic or other adverse effects on the human organism have been demonstrated.
(2) Other substances which cannot be used in the manufacture of foodstuffs are listed in Annex 4.
Repeal
Decree No. 446 / 2004 Coll., laying down requirements for food supplements and for enrichment of food supplements, is hereby repealed.
Transitional provisions
The production of food supplements and the production of food enriched with food supplements shall be assessed in accordance with the existing legislation no later than 1 July 2009. Food supplements and food supplements thus produced shall be assessed when put into circulation in accordance with the existing legislation no later than 1.8.2010; Similarly, the assessment of food supplements fortified with food supplements put into circulation before the date of application of this Decree shall be carried out.
Efficacy
This Decree shall take effect on 1 July 2008.
Minister:
Dr. Julinek, MBA v. r.
Příloha č. 1
Annex No 1 to Decree No 225 / 2008 Coll.
Vitamins and minerals that can be used for 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)
Biotin (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)
Note:
* RE = trans- retinolekvivalent
* * α-TE = alpha-tocopherolecvivalent
* * * NE = niacinequivalent
Příloha č. 2
Annex No 2 to Decree No 225 / 2008 Coll.
Forms of vitamins and minerals that can be used to produce food supplements
1. Vitamin Forms
| vitamin | forma |
|---|---|
| Vitamin A | retinol |
| retinyl-acetát | |
| retinyl –palmitát | |
| β-karoten | |
| Vitamin D | cholekalciferol |
| ergokalciferol | |
| Vitamin E | D-α-tokoferol |
| DL-α-tokoferol | |
| D-α-tokoferyl-acetát | |
| DL-α-tokoferyl-acetát | |
| D-α-tokoferyl-sukcinát | |
| Vitamin K | fylochinon (fytomenadion) |
| Vitamin B1 | thiamin-hydrochlorid |
| thiamin-mononitrát | |
| Vitamin B2 | riboflavin |
| riboflavin-5- fosfát, sodná sůl | |
| Niacin | kyselina nikotinová |
| nikotinamid | |
| Kyselina pantothenová | D-pantothenan vápenatý |
| D-pantothenan sodný | |
| dexpanthenol | |
| Vitamin B6 | pyridoxin-hydrochlorid |
| pyridoxin-5-fosfát | |
| Foláty | kyselina pteroylmonoglutamová |
| kalcium-L-methylfolát | |
| Vitamin B12 | kyanokobalamin |
| hydroxokobalamin | |
| Biotin | D-biotin |
| Vitamin C | kyselina L-askorbová |
| L-askorban vápenatý | |
| L-askorban draselný | |
| L-askorban sodný | |
| L-askorbyl-6-palmitát |
2. Mineral Forms
| Minerální látka | Forma 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 | |
| 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) | |
| sacharát železitý | |
| oxid železitý se sacharosou | |
| bisglycinát železitý | |
| Měď | uhličitan měďnatý |
| citronan měďnatý | |
| glukonan měďnatý | |
| síran měďnatý | |
| komplex mědi a lysinu | |
| Jód | jodičnan sodný |
| jodid sodný | |
| jodičnan draselný | |
| jodid draselný | |
| Zinek | octan zinečnatý |
| chlorid zinečnatý | |
| citronan zinečnatý | |
| glukonan zinečnatý | |
| mléčnan zinečnatý | |
| oxid zinečnatý | |
| uhličitan zinečnatý | |
| síran zinečnatý | |
| 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 | |
| Selen | selenan sodný |
| hydrogenseleničitan sodný | |
| seleničitan sodný | |
| Chrom | chlorid chromitý |
| síran chromitý | |
| Molybden | molybdenan amonný |
| molybdenan sodný | |
| Fluor | fluorid draselný |
| fluorid sodný |
Příloha č. 3
Annex No. 3 to Decree No. 225 / 2008 Coll.
Conditions of use of certain other substances in food supplements
1. Conditions of use of certain plants
| Název rostliny | Část rostliny | Nejvyšší přípustné množství v denní dávce |
|---|---|---|
| Cimicifuga racemosa (ploštičník hroznovitý) | sušený kořen a oddenek | 20 mg |
| Citrus aurantium (hořký pomeranč) | extrakt (přepočteno na množství synefrinu) | 10 mg synefrinu |
| Crataegus spp. (hloh) | sušený list, květ, plod | 200 mg |
| Dioscorea sp. (rod Jam) | sušená hlíza | 100 mg |
| Echinacea spp. (třapatka) | sušený kořen, nať | 500 mg |
| Garcinia cambogia (garcinie kambodžská) | slupka (přepočteno na množství kyseliny hydroxycitronové) | 2000 mg |
| Ginkgo biloba (jinan dvoulaločný) | standardizovaný extrakt 24/6 z listů | 40 mg |
| Ginkgo biloba (jinan dvoulaločný) | sušený list | 2500 mg |
| Hypericum perforatum (třezalka tečkovaná) | sušená nať | 300 mg |
| Panax ginseng (všehoj ženšenový) | sušený kořen | 1000 mg |
| Ptychopetalum olacoides (muira puama) | sušené dřevo | 500 mg |
| Rhodiola rosea (rozchodnice růžová) | standardizovaný extrakt z kořene (4% rosavinu) | 100 mg |
| Schisandra chinensis (klanopraška čínská) | sušené plody | 600 mg |
| Tabebuia impetiginosa (lapačo červené) | sušená kůra | 3000 mg |
| Tribulus terrestris (kotvičník zemní) | sušená nať, plody | 2000 mg |
| Turnera diffusa (pantala rozkladitá) | sušené listy | 1000 mg |
| Uncaria tomentosa (vilcacora, kočičí dráp) | sušený kořen | 1000 mg |
| Valeriana officinalis (kozlík lékařský) | sušený kořen | 500 mg |
2. Conditions of use of certain other substances other than plants
| Další látky | Nejvyšší přípustné množství v denní dávce |
|---|---|
| acetylkarnitin | 500 mg |
| DMAE (dimethylaminoethanol) | 20 mg |
| Kyselina orotová | 50 mg |
| Pycnogenol | 100 mg |
| Taurin | 2000 mg |
Příloha č. 4
Annex No. 4 to Decree No. 225 / 2008 Coll.
List of other substances prohibited in food production
Table 1 List of plants prohibited in food production
| Latinský název | Český název | Rostlinná část |
|---|---|---|
| Aconitum spp. | oměj | kořen |
| Adonanthe spp. (Adonis spp.) | hlaváček | nať |
| Alkanna spp. | kamejník | |
| Alstonia spp. | alstonie | kůra |
| Ammi visnaga (L.) LAM. | moráč zákrovnatý | plod |
| Andira spp. | andira | |
| Anchusa spp. | pilát | |
| Apocynum spp. | toješť | kořen |
| Areca catechu L. | areka obecná (betelový oříšek) | semeno |
| Aristolochiaceae | čeleď podražcovité | |
| Artemisia cina | pelyněk cicvárový | |
| Asarum spp. | kopytník | nať |
| Aspidosperma quebracho-blanco SCHLECHT. | štítosemenka kebračo | kůra |
| Atropa spp. | rulík | list, nať, kořen |
| Azadirachta indica | zederach indický | |
| Baccharis coridifolia | pomíšenka srdcolistá | |
| Baccharis megapotamica | pomíšenka poříční | |
| Borago officinalis | brutnák lékařský | nať, květ |
| Bragantia wallichii | bragantie Wallichova | |
| Brachyglottis spp. | jazýčkovec | |
| Caltha palustris | blatouch bahenní | |
| Cassia acutifolia (Cassia senna) | kassie ostrolistá | list, plod |
| Cassia angustifolia VAHL | kassie úzkolistá | list, plod |
| Catharanthus roseus (L). G.DON | katarant růžový | nať |
| Cephaelis spp. | hlavěnka (uragoga) | kořen |
| Cineraria spp. | ||
| Cinchona spp. | chinovník | kůra |
| Citrullus colocynthis | kolokvinta obecná | plod |
| Clematis spp. | plamínek | |
| Cocculus spp. (Anamirta cocculus) | chebule (latnatá) | |
| Coleus forskohlii | koleus (kopřivěnka) Forskohlův | |
| Colchicum spp. | ocún | semeno |
| Conium maculatum | bolehlav plamatý | |
| Convallaria majalis L. | konvalinka vonná | list, nať |
| Corydalis spp. | dymnivka | kořen |
| Croton tiglium | ladel počistivý | |
| Cynoglossum spp. | užanka | |
| Datura spp. | durman | list, nať, semeno |
| Digitalis spp. | náprstník | list |
| Diploclisia affinis, Diploclisia chinensis | diklopsie příbuzná diklopsie čínská | |
| Dryopteris filix-mas | kapraď samec | oddenek |
| Duboisia spp. | jedovatice | list |
| Ecballium elaterium A. RICH. | tykvice pukavá | plod |
| Ephedra spp. | chvojník | nať |
| Erechthites spp. | starčkovec | |
| Erythroxylon sp. | rudodřev | |
| Eschscholtzia californica CHAM. | sluncovka kalifornská | nať |
| Eupatorium spp. (kromě Eupatorium perfoliatum) | konopáč | |
| Euphorbia spp. | pryšec | nať, zaschlá šťáva |
| Exogonium purga | jalapa počistivá | |
| Frangula alnus MILL. | krušina olšová | kůra |
| Gelsemium sempervirens (L.) AIT. | jasmínovec vždyzelený | kořen |
| Genista tinctoria | kručinka barvířská | |
| Gossypium spp. | bavlník | semeno |
| Hedera helix L. | břečťan popínavý | list |
| Heliotropium spp. | otočník | |
| Helleborus spp. | čemeřice | kořen |
| Hydrastis canadensis L. | vodilka kanadská | kořen |
| Hyoscyamus spp. | blín | list, nať |
| Chelidonium majus L. | vlaštovičník větší | kořen, list, nať |
| Chenopodium ambrosioides | merlík vonný | |
| Ipomoea spp. | povíjnice | |
| Ledum palustre | rojovník bahenní | |
| Lithospermum officinale | kamejka | |
| Lobelia spp. | lobelka | nať |
| Mallotus philippinensis | kamala | |
| Mandragora officinarum L. | mandragora lékařská | kořen |
| Menispermum canadense, Menispermum dahuricum | lunoplod (chebule) kanadský lunoplod dahurský | |
| Mucuna pruriens | mukuna | |
| Nerium oleander L. | oleandr obecný | list, nať |
| Nicotiana spp. | tabák | list |
| Papaver somniferum L. | mák setý | plod s výjimkou zralých semen, zaschlá šťáva |
| Pausinystalia yohimbe (K.SCHUM.) PIERRE | bujarník johimbe | kůra |
| Petasites spp. | devětsil | |
| Physostigma venenosum BALF. | puchýřnatec jedovatý | semeno |
| Pilocarpus spp. | mrštnoplod, jaborand | list |
| Pinellia ternata | pinelie trojčetná | |
| Piper methysticum FORSTER | pepřovník opojný (kava-kava) | |
| Podophyllum peltatum L. | noholist štítnatý | kořen |
| Polygonum sachalinensis | křídlatka sachalinská | |
| Polygonum cuspidatum | křídlatka japonská | |
| Pulsatilla vulgaris | koniklec | |
| Rauwolfia serpentina (L.) BENTH. | rauwolfie plazivá | kořen |
| Rhamnus cathartica L. | řešetlák počistivý | kůra, plod |
| Rhamnus purshiana DC. | řešetlák Purshův | kůra |
| Rheum officinale, palmatum | reveň | kořen |
| Rhododendron ferrugineum L. | pěnišník rezavý | list |
| Ricinus communis L. | skočec obecný | semeno |
| Ruta graveolens | routa vonná | nať |
| Sarothamnus scoparius (L.) WIMM.ex KOCH | janovec metlatý | květ, nať |
| Sassafras albidum | sasafras | |
| Scopolia carniolica JACQ. | pablen kraňský | kořen |
| Senecio spp. | starček | |
| Schoenocaulon officinale (SCHLECHT.et CHAM.) GRAY | sabadila lékařská | semeno |
| Sida cordifolia | sida srdcolistá | |
| Sinomenium acutum | sinomenium prudké | |
| Spartium junceum L. | vítečník sítinovitý | květ, nať |
| Spigelia spp. | spigelie | kořen, nať |
| Stephania spp. | ||
| Strophanthus spp. | krutikvět | semeno |
| Strychnos spp. | kulčiba | semeno |
| Symphytum spp. | kostival | kořen |
| Taxus spp. | tis | |
| Thevetia peruviana (PERS.) SCHUMANN | tevetie | nať |
| Tussilago farfara | podběl obecný | list, květ |
| Urginea maritima (L.) J.B.BAK. | urginea přímořská | cibule |
| Veratrum spp. | kýchavice | kořen |
| Vitex agnus-castus | drmek obecný | |
| Vladimiria souliei | vladimira Souliejova | |
| Xysmalobium undulatum R. BROWN | xysmalobium kadeřavé | kořen |
Table 2 List of certain other substances prohibited in food production
| Název |
|---|
| Claviceps spp. (paličkovice – sklerocium) |
| Acetyltryptofan |
| Dehydroepiandrosteron (DHEA) |
| Kyselina gama-aminomáselná (GABA) |
| 5-hydroxytryptofan (5-HTP) |
| Koloidní stříbro |
| Laktulóza |
| Melatonin |
| N-acetylcystein |
Příloha č. 5
Annex No 5 to Decree No 225 / 2008 Coll.
Recommended daily doses (PPAs) of vitamins and minerals
| Vitamin nebo minerální látka | jednotka | Doporučená denní dávka |
|---|---|---|
| Vitamin A | μg | 800 |
| Thiamin (vitamin B1) | mg | 1,1 |
| Riboflavin (vitamin B2) | mg | 1,4 |
| Vitamin B6 | mg | 1,4 |
| Vitamin B12 | μg | 2,5 |
| Kyselina pantothenová | mg | 6 |
| Vitamín C | mg | 80 |
| Vitamín D | μg | 5 |
| Vitamín E | mg | 12 |
| Vitamin K | μg | 75 |
| Biotin | μg | 50 |
| Kyselina listová | μg | 200 |
| Niacin | mg | 16 |
| Draslík | mg | 2000 |
| Fosfor | mg | 700 |
| Fluoridy | mg | 3,5 |
| Hořčík | mg | 375 |
| Chloridy | mg | 800 |
| Chrom | μg | 40 |
| Jód | μg | 150 |
| Mangan | mg | 2 |
| Měď | mg | 1 |
| Molybden | μg | 50 |
| Selen | μg | 55 |
| Vápník | mg | 800 |
| Zinek | mg | 10 |
| Železo | mg | 14 |
Note:
Recommended daily doses of vitamins and minerals refer to total daily intake of vitamins and minerals. Food supplements containing at least a significant amount of vitamins and minerals may be considered as a source of vitamins and minerals, which are considered to be at least 15% of the recommended daily doses listed in the table, contained in 100 g or 100 ml or in a single package, provided that the package contains one portion.
1) It is issued on the basis and within the limits of the law to which the relevant directive of the European Communities has already been reflected.
2) Directive 2002 / 46 / EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements. Commission Directive 2006 / 37 / EC of 30 March 2006 amending Annex II to Directive 2002 / 46 / EC of the European Parliament and of the Council as regards the classification of certain substances.
3) Regulation (EC) No 1924 / 2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. Regulation (EC) No 1925 / 2006 of the European Parliament and of the Council on the addition of vitamins, minerals and certain other substances to foods.
4) Decree No. 54 / 2002 Coll., laying down health requirements for the identity and purity of additives, as amended.
5) Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended.
6) Regulation (EC) No 273 / 2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors.
7) Decree No. 113 / 2005 Coll., on the labelling of foodstuffs and tobacco products, as amended.
8) Act No. 505 / 1990 Coll., on Metrology, as amended. Decree No 328 / 2000 Coll., on the method of making certain types of prepackaged goods, the quantity of which is expressed in units of weight or volume.
9) Regulation (EC) No 1924 / 2006 of the European Parliament and of the Council.
10) Regulation (EC) No 1925 / 2006 of the European Parliament and of the Council.
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Regulation Information
| Citation | Decree No. 225 / 2008 Coll., laying down requirements for food supplements and enrichment |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 30.06.2008 |
|---|---|
| Effective from | 01.07.2008 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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