Requirements For Dietary Supplements And Fortification

Original Language Title: požadavky na doplňky stravy a na obohacování potravin

Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=67160&nr=225~2F2008~20Sb.&ft=txt

225/2008 Sb.



DECREE



of 17 May. June 2008,



laying down the requirements on food supplements and food fortification



352/2009: Sb.



The Ministry of health shall, pursuant to section 19 para. 1 (b). and) and (j))

Act No. 110/1997 Coll. on foodstuffs and tobacco products and amending

and the addition of some 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.:



§ 1



The subject of the edit



This Decree ^ 1) incorporates the relevant provisions of the European

Community ^ 2), and in the wake of the regulations directly applicable European

^ 3) provides for community



and) requirements for the composition of food supplements, their labeling and method

the use of food supplements,



(b)) the conditions adding other substances to foods, with the exception of add-ins

diet.



§ 2



Requirements for the composition of food supplements



(1) the vitamins and minerals that can be used for the production of accessories

diet, are set out in annex 1 to this notice. These vitamins and

minerals can be used only in the form referred to in annex 2 to this

the Decree. Requirements for the purity of the substances referred to in annex 2 to this

the Decree sets out the special law laying down health

requirements for the purity and identity of the additives ^ 4).



(2) other substances that can be used for the manufacture of food supplements, and

the conditions under which they can be used are listed in Appendix 3 to this

the Decree. To food supplements cannot be added individually or in combination:

narcotic or psychotropic substances ^ 5), precursors of category 1 of annex I to

directly applicable legislation of the European communities ^ 6), other substances

which was proven toxic, genotoxic, teratogenic, hallucinogenic,

intoxicating or other adverse effects on the human body. For the production of accessories

the diet cannot be used for more substances in Appendix 4 to this

the Decree.



§ 3



The labelling of food supplements



(1) in addition to the labelling requirements of the packaging of the food prepared in the law and

in a separate legal regulation) ^ 7 for the consumer on the packaging shall indicate:



and food) in the title, the word "Supplement",



(b)) name of vitamins, minerals, or other substances

characterizing the product,



(c) the quantity of the number) of vitamins, minerals, or other

substances related to the recommended daily dose, for vitamins and

mineral substances shall apply to those listed in annex 1 to this

the Decree,



d) data on the content of vitamins and minerals and as a percentage

the recommended daily allowance specified in the annex 5 to this Decree, and

This information can also be specified in a graphical format,



(e) the recommended daily dosage) and, where appropriate, other terms of use



f) warning before crossing the recommended daily dosage,



g) warning that the products were stored out of the reach of children,



h) warning that dietary supplements are not a substitute for a varied diet;



I) warning "not suitable for pregnant women" in the case of food supplements containing

more than 800 µ g vitamin A (RE) in the daily ration,



(2) in the case of a food supplement containing plant Cimicifuga racemosa

(ploštičník grapy) or its extracts are also on the packaging for

the consumer shall indicate the need to interrupt notification the consumption and

find a doctor at any suspected liver disease.



(3) the information referred to in paragraph 1 (b). (c)), are average values

established on the basis of quantitative analysis of a food supplement made by

by the manufacturer.



(4) an indication of the total amount stated under a special legal

prescription ^ 7) or under the rules for the marking of the "e" symbol ^ 8). By volume

or weight deviation of the positive and negative up to minus 5%

not considered to be misleading consumers.



(5) the labelling of food supplements must not



and add-ins) diet to arrogate properties relating to the prevention, treatment,

or cure of human disease or reference to such properties,



(b)) contain no claim stating or implying that a balanced and

varied diet generally cannot provide sufficient amounts of vitamins

or minerals.



(6) the nutrition and health claims for dietary supplements may be

conditions directly applicable legislation of the European communities on

requirements for nutrition and health claims in the labelling,

food ^ 9).



§ 4



How to use food supplements



(1) food supplements are used in forms of capsules or capsules,

pastilles, tablets, coated tablets, sachets of powder, ampoules of liquids, drops

or other simple forms of liquids and powders designed for the income in

small measured amounts, and this is how the circulation. ::

the diet is in circulation given only bottled.



(2) Food produced or put into circulation in a member country of the European

the community or resulting in one of the States which are Contracting

a party to the European economic area, or in Turkey must not be

refused to be put into circulation in the Czech Republic, provided that this

Food matches



and) regulations for the production of this food or putting

on the market in one of these States, or be binding upon



(b)) the manufacturing procedures and rules of good manufacturing practices used in the

one of those States for which there exists a sufficiently detailed

documentation, based on which, if necessary, can be done

additional investigation.



(3) the provisions of paragraph 2 shall not apply in the case of legislation,

codes of good practice or procedures referred to in paragraph 2 do not guarantee

the degree of protection of the legitimate interest of the appropriate extent of this protection in the Czech

Republic.



§ 5



Terms of adding other substances to foods



(1) the conditions for the addition of vitamins, minerals, or other substances

to food regulates the directly applicable European Community regulation on the

addition of vitamins and minerals and of certain other substances to

food ^ 10). The food cannot be added individually or their mixtures

narcotic or psychotropic substances ^ 5), category I precursors directly

of the applicable legislation of the European communities ^ 6), other substances for which

was proven toxic, genotoxic, teratogenic, hallucinogenic, intoxicating

or any other adverse effect on the human body.



(2) other substances that cannot be used in food production, are listed in the

Annex No. 4.



§ 6



Regulation (EEC)



Repeals the Decree 446/2004 Coll. laying down the requirements for the

supplements and fortification of the food supplements.



§ 7



Transitional provisions



The production of food supplements and food production enriched food supplements

shall be assessed in accordance with the existing legislation until 1. 7.2009.

Thus produced supplements and foods fortified with food supplements

shall be assessed when put into circulation, according to the existing legislation

until 1 April. 8.2010; Similarly, when assessing accessories

diet foods enriched food supplements put into circulation before the

the effective date of this Ordinance.



§ 8



The effectiveness of the



This Decree shall enter into force on 1 January 2000. July 1, 2008.



Minister:



Mudr. Julínek, MBA in r.



Annex 1



Vitamins and minerals that can be used for the manufacture of food supplements



1. vitamins



Vitamin A (RE mikrog) *



Vitamin D (mikrog)



Vitamin E (mg Alpha-TE) **



Vitamin K (mikrog)



Vitamin B1 (thiamin) (mg)



Vitamin B2 (riboflavin) (mg)



Niacin (mg NE) ***



Pantothenic acid (mg)



Vitamin B6 (pyridoxine) (mg)



Folic acid (mikrog)



Vitamin B12 (cyanocobalamin) (mikrog)



Biotin (mikrog)



Vitamin C (mg)



2. Mineral substances



Calcium (mg)



Magnesium (mg)



Iron (mg)



Copper (mikrog)



Iodine (mikrog)



Zinc (mg)



Manganese (mg)



Sodium (mg)



Potassium (mg)



Selenium (mikrog)



Chromium (mikrog)



Molybdenum (mikrog)



Fluorine (mg)



Chlorine (mg)



Phosphorus (mg)



Note:



* RE = trans-retinolekvivalent



** Alpha-TE = Alpha-tokoferolekvivalent



No = niacinekvivalent



Annex 2



Forms of vitamins and minerals that can be used for the production of accessories

diet



1. Forms of vitamins



+---------------------------+--------------------------------------+

| Vitamin | form |

+---------------------------+--------------------------------------+

| Vitamin A | retinol |

| | retinyl acetate |

| | retinyl palmitate |

| | beta-carotene |

+---------------------------+--------------------------------------+

| Vitamin D | cholecalciferol |

| | ergocalciferol |

+---------------------------+--------------------------------------+

| Vitamin E | D-alpha tocopherol |

| | DL-alpha-tocopherol |

| | D-alpha-tocopheryl acetate |

| | DL-alpha-tocopheryl acetate |

| | D-alpha-tocopheryl succinate |

+---------------------------+--------------------------------------+

| Vitamin K | fylochinon (fytomenadion) |

+---------------------------+--------------------------------------+

| Vitamin B1 | thiamin hydrochloride |

| | thiamin-mononitrate |

+---------------------------+--------------------------------------+

| Vitamin B2 | riboflavin |


| | Riboflavin-5-phosphate, sodium salt |

+---------------------------+--------------------------------------+

| Nicotinic Acid | Nicotinic Acid |

| | NICOTINAMIDE |

+---------------------------+--------------------------------------+

| Pantothenic acid | D-CALCIUM PANTOTHENATE |

| | D-PANTOTHENATE, sodium |

| | dexpanthenol |

+---------------------------+--------------------------------------+

| Vitamin B6 | pyridoxine hydrochloride |

| | pyridoxine-5-phosphate |

+---------------------------+--------------------------------------+

| Folate | pteroylmonoglutamová acid |

| | calcium-L-methylfolát |

+---------------------------+--------------------------------------+

| Vitamin B12 | vitamin B12 |

| | hydroxokobalamin |

+---------------------------+--------------------------------------+

| Biotin | D-biotin |

+---------------------------+--------------------------------------+

| Vitamin C | L-Ascorbic acid |

| | L-ascorbate |

| | L-ascorbate |

| | L-ascorbate |

| | L-askorbyl-6-palmitate |

+---------------------------+--------------------------------------+



2. Forms of minerals



+---------------------------+--------------------------------------+

| A mineral substance | The form of the mineral substances |

+---------------------------+--------------------------------------+

| Calcium | calcium carbonate |

| | calcium salts of citric acid |

| | calcium chloride |

| | Calcium Gluconate |

| | calcium glycerophosphate |

| | calcium lactate |

| | calcium salts of orthophosphoric acid |

| | calcium hydroxide |

| | calcium oxide |

+---------------------------+--------------------------------------+

| Magnesium | magnesium acetate |

| | magnesium carbonate |

| | magnesium chloride |

| | magnesium salts of citric acid |

| | magnesium gluconate |

| | magnesium glycerophosphate |

| | magnesium salts of orthophosphoric acid |

| | magnesium lactate |

| | magnesium hydroxide |

| | magnesium oxide |

| | magnesium sulphate |

+---------------------------+--------------------------------------+

| Iron | ferrous carbonate |

| | ferrous citrate |

| | ferric ammonium citrate-ammonium |

| | ferrous gluconate |

| | ferrous fumarate |

| | ferric sodium diphosphate |

| | ferrous lactate |

| | ferrous sulfate |

| | dicalcium diphosphate |

| | Elemental iron |

| | (obtained by reduction with hydrogen or |

| | electrolytically) |

| | ferric saccharate |

| | iron oxide is sucrose |

| | bisglycinát yellow |

+---------------------------+--------------------------------------+

| Měď | cupric carbonate |

| | cupric citrate |

| | cupric gluconate |

| | copper sulphate |

| | copper-lysine complex |

+---------------------------+--------------------------------------+

| Jód | sodium iodate |

| | sodium iodide |

| | potassium iodate |

| | potassium iodide |

+---------------------------+--------------------------------------+

| Zinc | Zinc acetate |

| | Zinc chloride |

| | Zinc citrate |

| | zinc gluconate |

| | Zinc lactate |

| | zinc oxide |

| | Zinc carbonate |

| | zinc sulphate |

+---------------------------+--------------------------------------+

| Mangan | manganese carbonate |

| | manganese chloride |

| | manganese citrate |

| | manganese gluconate |

| | manganese glycerophosphate |

| | manganese sulphate |

+---------------------------+--------------------------------------+

| Sodium | sodium bicarbonate |

| | sodium carbonate |

| | sodium chloride |

| | sodium citrate |

| | sodium gluconate |

| | sodium lactate |

| | sodium hydroxide |

| | sodium salts of orthophosphoric acid |

+---------------------------+--------------------------------------+

| Potassium | potassium bicarbonate |

| | potassium carbonate |

| | potassium chloride |

| | potassium citrate |

| | potassium gluconate |

| | potassium glycerophosphate |

| | potassium lactate |

| | potassium hydroxide |

| | potassium salts of orthophosphoric acid |

+---------------------------+--------------------------------------+

| Selenium | SODIUM SELENATE |

| | sodium hydrogen selenite |

| | sodium selenite |

+---------------------------+--------------------------------------+

| Chrome | chromium(iii) chloride |

| | chromium(iii) sulfate |

+---------------------------+--------------------------------------+

| Molybdenum | ammonium molybdate |

| | sodium molybdate |

+---------------------------+--------------------------------------+

| Fluorine | potassium fluoride |

| | sodium fluoride |

+---------------------------+--------------------------------------+



Annex 3



Conditions of use of certain other substances in food supplements



1. conditions for the use of certain plants

+-------------------------------- +--------------------------------------------------------- +---------------------+

| Plant name | part | The maximum permitted |

| | | the quantity in the daily |

| | | dose |

+-------------------------------- +--------------------------------------------------------- +---------------------+

| Cimicifuga racemosa (ploštiční | dried root and Rhizome | 20 mg |

| grapy) | | |

+-------------------------------- +--------------------------------------------------------- +---------------------+

| Citrus aurantium | extract (calculated on the amount of Synephrine) | 10 mg of Synephrine |

| (bitter orange) | | |

+-------------------------------- +--------------------------------------------------------- +---------------------+

| Crataegus spp. | dried leaf, flower, fruit | 200 mg |

| (hloh ) | | |

+-------------------------------- +--------------------------------------------------------- +---------------------+

| Dioscorea sp. | dried tuber | 100 mg |

| (genus) | | |

+-------------------------------- +--------------------------------------------------------- +---------------------+

| Echinacea spp. | dried root, stem | 500 mg |

| (Echinacea purpurea) | | |

+-------------------------------- +--------------------------------------------------------- +---------------------+

| Garcinia cambogia | Peel (calculated on the amount of acid hydroxycitronové) | 2000 mg |

| (Garcinia Cambodia) | | |

+-------------------------------- +--------------------------------------------------------- +---------------------+

| Ginkgo biloba | standardized extract 24/6 from the leaves of | 40 mg |

| (jinan) | | |

+-------------------------------- +--------------------------------------------------------- +---------------------+

| Ginkgo biloba | the dried sheet | 2500 mg |

| (jinan) | | |

+-------------------------------- +--------------------------------------------------------- +---------------------+

| Hypericum perforatum | dried grass | 300 mg |

| (St. John's wort) | | |

+-------------------------------- +--------------------------------------------------------- +---------------------+

| Panax ginseng | dried root | 1000 mg |

| (všehoj ženšenový) | | |

+-------------------------------- +--------------------------------------------------------- +---------------------+

| Ptychopetalum olacoides | dried wood | 500 mg |


| (muira puama) | | |

+-------------------------------- +--------------------------------------------------------- +---------------------+

| Rhodiola rosea | standardized root extract (4% rosavinu) | 100 mg |

| (rhodiola rosea) | | |

+-------------------------------- +--------------------------------------------------------- +---------------------+

| Schisandra chinensis | dried fruits | 600 mg |

| (schisandra Chinese) | | |

+-------------------------------- +--------------------------------------------------------- +---------------------+

| Tabebuia impetiginosa | the dried bark | 3000 mg |

| (red Lapacho) | | |

+-------------------------------- +--------------------------------------------------------- +---------------------+

| Tribulus terrestris | dried leaves, fruits | 2000 mg |

| (Tribulus terrestris) | | |

+-------------------------------- +--------------------------------------------------------- +---------------------+

| Turnera diffusa | dried leaves | 1000 mg |

| (pantala patula) | | |

+-------------------------------- +--------------------------------------------------------- +---------------------+

| Uncaria tomentosa | dried root | 1000 mg |

| (vilcacora, cat's claw) | | |

+-------------------------------- +--------------------------------------------------------- +---------------------+

| Valeriana officinalis | dried root | 500 mg |

| (Valerian) | | |

+-------------------------------- +--------------------------------------------------------- +---------------------+



2. Conditions of use of certain other substances other than plants



+-------------------------------+-------------------------------------+

| Other substances | The maximum permitted quantity |

| | in a daily dose |

+-------------------------------+-------------------------------------+

| acetylkarnitin | 500 mg |

+-------------------------------+-------------------------------------+

| DMAE (dimethylaminoethanol) | 20 mg |

+-------------------------------+-------------------------------------+

| Orotová acid | 50 mg |

+-------------------------------+-------------------------------------+

| Pycnogenol | 100 mg |

+-------------------------------+-------------------------------------+

| Taurine | 2000 mg |

+-------------------------------+-------------------------------------+



Annex 4



A list of other substances banned in food production



Table 1 list of plants banned in food production

+--------------------------------------------- +---------------------------- +----------------------+

| Latin name | Czech name | Plant part |

+--------------------------------------------- +---------------------------- +----------------------+

| Aconitum spp. | aconite | root |

+--------------------------------------------- +---------------------------- +----------------------+

| Adonanthe spp. (Adonis spp.) | hlavacek | the stem |

+--------------------------------------------- +---------------------------- +----------------------+

| Alkanna spp. | kamejník | |

+--------------------------------------------- +---------------------------- +----------------------+

| Alstonia spp. alstonia | | bark |

+--------------------------------------------- +---------------------------- +----------------------+

| Ammi visnaga (l.) LAM. | moráč zákrovnatý | product |

+--------------------------------------------- +---------------------------- +----------------------+

| Andira spp. | andira | |

+--------------------------------------------- +---------------------------- +----------------------+

| Anchusa spp. | Pilate | |

+--------------------------------------------- +---------------------------- +----------------------+

| Apocynum spp. | toješť | root |

+--------------------------------------------- +---------------------------- +----------------------+

| Areca catechu l. areca catechu (betel | nut | seed |

+--------------------------------------------- +---------------------------- +----------------------+

| Aristolochiaceae | family Aristolochiaceae | |

+--------------------------------------------- +---------------------------- +----------------------+

| Artemisia cina | wormwood cicvárový | |

+--------------------------------------------- +---------------------------- +----------------------+

| Asarum spp. | Wild ginger | the stem |

+--------------------------------------------- +---------------------------- +----------------------+

| Aspidosperma quebracho-blanco SCHLECHT. | štítosemenka kebračo | bark |

+--------------------------------------------- +---------------------------- +----------------------+

| Atropa spp. | Belladonna | leaf, stem, root |

+--------------------------------------------- +---------------------------- +----------------------+

| Azadirachta indica | zederach Indian | |

+--------------------------------------------- +---------------------------- +----------------------+

| Baccharis coridifolia | srdcolistá | pomíšenka |

+--------------------------------------------- +---------------------------- +----------------------+

| Baccharis megapotamica | pomíšenka fluviatile | |

+--------------------------------------------- +---------------------------- +----------------------+

| Borage borago officinalis | | the stem, flower |

+--------------------------------------------- +---------------------------- +----------------------+

| Bragantia wallichii | bragantie Wallichova | |

+--------------------------------------------- +---------------------------- +----------------------+

| Brachyglottis spp. | Orchid | |

+--------------------------------------------- +---------------------------- +----------------------+

| Caltha palustris | caltha palustris | |

+--------------------------------------------- +---------------------------- +----------------------+

| Cassia acutifolia (Cassia senna) kassie ostrolistá | sheet, product |

+--------------------------------------------- +---------------------------- +----------------------+

| Cassia angustifolia VAHL | kassie blue Lupin | sheet, product |

+--------------------------------------------- +---------------------------- +----------------------+

| Catharanthus roseus (l.). URG.DON | katarant pink | the stem |

+--------------------------------------------- +---------------------------- +----------------------+

| Cephaelis spp. | hlavěnka (uragoga) | root |

+--------------------------------------------- +---------------------------- +----------------------+

| Cineraria spp. | | |

+--------------------------------------------- +---------------------------- +----------------------+

| Cinchona spp. | Cinchona | bark |

+--------------------------------------------- +---------------------------- +----------------------+

| Citrullus colocynthis | kolokvinta General | product |

+--------------------------------------------- +---------------------------- +----------------------+

| Clematis spp. |-flame | |

+--------------------------------------------- +---------------------------- +----------------------+

| Cocculus spp. (Anamirta cocculus) | chebule (latnatá) | |

+--------------------------------------------- +---------------------------- +----------------------+

| Coleus forskohlii | koleus (kopřivěnka) Forskohlů | |

+--------------------------------------------- +---------------------------- +----------------------+

| Colchicum spp. | Colchicum | seed |

+--------------------------------------------- +---------------------------- +----------------------+

| Conium maculatum | conium | |

+--------------------------------------------- +---------------------------- +----------------------+

| Convallaria majalis l. | Lily of the Valley | leaf, stem |

+--------------------------------------------- +---------------------------- +----------------------+

| Corydalis spp. | dymnivka | root |

+--------------------------------------------- +---------------------------- +----------------------+

| Croton tiglium | ladel počistivý | |

+--------------------------------------------- +---------------------------- +----------------------+

| Cynoglossum spp. | užanka | |

+--------------------------------------------- +---------------------------- +----------------------+


| Datura spp. | durman | leaf, stem, seed |

+--------------------------------------------- +---------------------------- +----------------------+

| Digitalis spp. | Foxglove | sheet |

+--------------------------------------------- +---------------------------- +----------------------+

| Diploclisia affinis, | diklopsie related | |

+--------------------------------------------- +---------------------------- +----------------------+

| Diploclisia chinensis | diklopsie || |

+--------------------------------------------- +---------------------------- +----------------------+

| Dryopteris filix-mas | Dryopteris male | Rhizome |

+--------------------------------------------- +---------------------------- +----------------------+

| Duboisia spp. | jedovatice | sheet |

+--------------------------------------------- +---------------------------- +----------------------+

| Ecballium elaterium a. RICH. | pukavá | || product |

+--------------------------------------------- +---------------------------- +----------------------+

| Ephedra spp. | ephedra | the stem |

+--------------------------------------------- +---------------------------- +----------------------+

| Erechthites spp. | starčkovec | |

+--------------------------------------------- +---------------------------- +----------------------+

| Erythroxylon sp. | rudodřev | |

+--------------------------------------------- +---------------------------- +----------------------+

| Eschscholtzia californica CHAM. | sluncovka California | the stem |

+--------------------------------------------- +---------------------------- +----------------------+

| Eupatorium spp. | konopáč | |

| (in addition to Eupatorium perfoliatum) | | |

+--------------------------------------------- +---------------------------- +----------------------+

| Euphorbia spp. | Euphorbia | the stem, the dried juice |

+--------------------------------------------- +---------------------------- +----------------------+

| Exogonium purga | jalapa počistivá | |

+--------------------------------------------- +---------------------------- +----------------------+

| Frangula alnus MILL. | Rhamnus frangula | bark |

+--------------------------------------------- +---------------------------- +----------------------+

| Gelsemium sempervirens (l.) AIT. | jasmínovec natural | root |

+--------------------------------------------- +---------------------------- +----------------------+

| Genista tinctoria | kručinka barvířská | |

+--------------------------------------------- +---------------------------- +----------------------+

| Gossypium spp. | cotton | seed |

+--------------------------------------------- +---------------------------- +----------------------+

| Hedera helix l. | Hedera Helix | sheet |

+--------------------------------------------- +---------------------------- +----------------------+

| Heliotropium spp. | otočník | |

+--------------------------------------------- +---------------------------- +----------------------+

| Helleborus spp. | Hellebore | root |

+--------------------------------------------- +---------------------------- +----------------------+

| Hydrastis canadensis L. | goldenseal | root |

+--------------------------------------------- +---------------------------- +----------------------+

| Hyoscyamus spp. | henbane | leaf, stem |

+--------------------------------------------- +---------------------------- +----------------------+

| Chelidonium majus l. | chelidonium | root, leaf, stem |

+--------------------------------------------- +---------------------------- +----------------------+

| Chenopodium ambrosioides | goosefoot scented | |

+--------------------------------------------- +---------------------------- +----------------------+

| Ipomoea spp. | povíjnice | |

+--------------------------------------------- +---------------------------- +----------------------+

| Ledum palustre | Ledum mud | |

+--------------------------------------------- +---------------------------- +----------------------+

| Lithospermum officinale | || | |

+--------------------------------------------- +---------------------------- +----------------------+

| Lobelia spp. | lobelka | the stem |

+--------------------------------------------- +---------------------------- +----------------------+

| Mallotus philippinensis kamala | | |

+--------------------------------------------- +---------------------------- +----------------------+

| Mandragora officinarum l. | mandragora officinarum | root |

+--------------------------------------------- +---------------------------- +----------------------+

| Menispermum canadense, | lunoplod (chebule) Canadian | |

+--------------------------------------------- +---------------------------- +----------------------+

| Menispermum dahuricum | lunoplod dahurský | |

+--------------------------------------------- +---------------------------- +----------------------+

| Mucuna pruriens | mukuna | |

+--------------------------------------------- +---------------------------- +----------------------+

| Nerium oleander l. Oleander General | | leaf, stem |

+--------------------------------------------- +---------------------------- +----------------------+

| Nicotiana spp. | | sheet |

+--------------------------------------------- +---------------------------- +----------------------+

| Papaver somniferum L. | opium poppy | product with the exception of |

| | | mature seeds |

| | | dried juice |

+--------------------------------------------- +---------------------------- +----------------------+

| Pausinystalia yohimbe (k. SCHUM.) PIERRE | bujarník johimbe | bark |

+--------------------------------------------- +---------------------------- +----------------------+

| Petasites spp. | butterbur | |

+--------------------------------------------- +---------------------------- +----------------------+

| Physostigma venenosum BALF. | puchýřnatec toxic | seed |

+--------------------------------------------- +---------------------------- +----------------------+

| Pilocarpus spp. | mrštnoplod, jaborand | sheet |

+--------------------------------------------- +---------------------------- +----------------------+

| Pinellia ternata | pinelie trojčetná | |

+--------------------------------------------- +---------------------------- +----------------------+

| Piper methysticum FORSTER | black heady | |

| | (kava-kava) | |

+--------------------------------------------- +---------------------------- +----------------------+

| Podophyllum peltatum l. | noholist African slender-snouted | root |

+--------------------------------------------- +---------------------------- +----------------------+

| Sakhalin knotweed polygonum sachalinensis | | |

+--------------------------------------------- +---------------------------- +----------------------+

| Polygonum cuspidatum | Japanese knotweed | |

+--------------------------------------------- +---------------------------- +----------------------+

| Pulsatilla vulgaris | pasque flower | |

+--------------------------------------------- +---------------------------- +----------------------+

| Rauwolfia serpentina (l.) BENTH. | rauwolfie trailer | root |

+--------------------------------------------- +---------------------------- +----------------------+

| Rhamnus cathartica l. Rhamnus počistivý | | the bark, fruit |

+--------------------------------------------- +---------------------------- +----------------------+

| Rhamnus purshiana DC. Rhamnus Purshův | | bark |

+--------------------------------------------- +---------------------------- +----------------------+

| Rheum officinale, palmatum | rhubarb | root |

+--------------------------------------------- +---------------------------- +----------------------+

| Rhododendron ferrugineum l. | rhododendron Rusty | sheet |

+--------------------------------------------- +---------------------------- +----------------------+

| Ricinus communis L. | castor bean | seed |

+--------------------------------------------- +---------------------------- +----------------------+

| Rue ruta graveolens | scented | the stem |


+--------------------------------------------- +---------------------------- +----------------------+

| Sarothamnus scoparius (l.) WIMM. ex KOCH | cytisus scoparius | flower stem |

+--------------------------------------------- +---------------------------- +----------------------+

| Sassafras Sassafras albidum | | |

+--------------------------------------------- +---------------------------- +----------------------+

| Scopolia carniolica JACQ. | pablen kraňský | root |

+--------------------------------------------- +---------------------------- +----------------------+

| Senecio spp. | ragwort | |

+--------------------------------------------- +---------------------------- +----------------------+

| Schoenocaulon officinale (SCHLECHT.et CHAM.) | sabadila medical | seed |

| GRAY | | |

+--------------------------------------------- +---------------------------- +----------------------+

| SIDA cordifolia |» sida srdcolistá | |

+--------------------------------------------- +---------------------------- +----------------------+

| Sinomenium acutum | sinomenium sharp | |

+--------------------------------------------- +---------------------------- +----------------------+

| Spartium junceum l. | spartium | flower stem |

+--------------------------------------------- +---------------------------- +----------------------+

| Spigelia spp. | spigelie | root, stem |

+--------------------------------------------- +---------------------------- +----------------------+

| Stephania spp. | | |

+--------------------------------------------- +---------------------------- +----------------------+

| Strophanthus spp. | krutikvět | seed |

+--------------------------------------------- +---------------------------- +----------------------+

| Strychnos spp. | kulčiba | seed |

+--------------------------------------------- +---------------------------- +----------------------+

| Symphytum spp. | Comfrey | root |

+--------------------------------------------- +---------------------------- +----------------------+

| Taxus spp. |tis | |

+--------------------------------------------- +---------------------------- +----------------------+

| Thevetia peruviana (pers.) SCHUMANN | tevetie | the stem |

+--------------------------------------------- +---------------------------- +----------------------+

| Tussilago farfara coltsfoot | generic | leaf, flower |

+--------------------------------------------- +---------------------------- +----------------------+

| Urginea maritima (l.) URJ.B.BAK. urginea seaside | | Onion |

+--------------------------------------------- +---------------------------- +----------------------+

| Veratrum spp. | Veratrum | root |

+--------------------------------------------- +---------------------------- +----------------------+

| Vitex agnus-castus | vitex General | |

+--------------------------------------------- +---------------------------- +----------------------+

| Vladimiria souliei | Vladimir Souliejova | |

+--------------------------------------------- +---------------------------- +----------------------+

| Xysmalobium undulatum r. BROWN | xysmalobium curly | root |

+--------------------------------------------- +---------------------------- +----------------------+



Table 2 list of some other substances banned in the manufacture

food

+-----------------------------------------------+

| Název |

+-----------------------------------------------+

| Claviceps spp. (paličkovice-sklerocium) |

+-----------------------------------------------+

| Acetyltryptofan |

+-----------------------------------------------+

| Dehydroepiandrosterone (DHEA) |

+-----------------------------------------------+

| Gamma-aminobutyric acid (GABA) |

+-----------------------------------------------+

| 5-hydroxytryptofan (5-HTP) |

+-----------------------------------------------+

| Colloidal silver |

+-----------------------------------------------+

| Lactulose |

+-----------------------------------------------+

| Melatonin |

+-----------------------------------------------+

| N-acetylcystein |

+-----------------------------------------------+



Annex 5



The recommended daily allowance (RDA) for vitamins and minerals



+-------------------------------+------------+--------------------------+

| When a vitamin or a mineral substance | Unit | The recommended daily dose |

+-------------------------------+------------+--------------------------+

| Vitamin A | mikrog | 800 |

+-------------------------------+------------+--------------------------+

| Thiamin (vitamin B1) | mg | 1,1 |

+-------------------------------+------------+--------------------------+

| Riboflavin (vitamin B2) | mg | 1,4 |

+-------------------------------+------------+--------------------------+

| Vitamin B6 | mg | 1,4 |

+-------------------------------+------------+--------------------------+

| Vitamin B12 | mikrog | 2,5 |

+-------------------------------+------------+--------------------------+

| Pantothenic acid | mg | 6 |

+-------------------------------+------------+--------------------------+

| Vitamin C | mg | 80 |

+-------------------------------+------------+--------------------------+

| Vitamin D | mikrog | 5 |

+-------------------------------+------------+--------------------------+

| Vitamin E | mg | 12 |

+-------------------------------+------------+--------------------------+

| Vitamin K | mikrog | 75 |

+-------------------------------+------------+--------------------------+

| Biotin | mikrog | 50 |

+-------------------------------+------------+--------------------------+

| Folic acid | mikrog | 200 |

+-------------------------------+------------+--------------------------+

| Nicotinic Acid | mg | 16 |

+-------------------------------+------------+--------------------------+

| Potassium | mg | 2000 |

+-------------------------------+------------+--------------------------+

| Phosphorus | mg | 700 |

+-------------------------------+------------+--------------------------+

| Fluoride | mg | 3.5 |

+-------------------------------+------------+--------------------------+

| Magnesium | mg | 375 |

+-------------------------------+------------+--------------------------+

| Chloride | mg | 800 |

+-------------------------------+------------+--------------------------+

| Chrome | mikrog | 40 |

+-------------------------------+------------+--------------------------+

| Jód | mikrog | 150 |

+-------------------------------+------------+--------------------------+

| Mangan | mg | 2 |

+-------------------------------+------------+--------------------------+

| Měď | mg | 1 |

+-------------------------------+------------+--------------------------+

| Molybdenum | mikrog | 50 |

+-------------------------------+------------+--------------------------+

| Selenium | mikrog | 55 |

+-------------------------------+------------+--------------------------+

| Calcium | mg | 800 |

+-------------------------------+------------+--------------------------+

| Zinc | mg | 10 |

+-------------------------------+------------+--------------------------+

| Iron | mg | 14 |

+-------------------------------+------------+--------------------------+



Note:



The recommended daily allowance of vitamins and minerals are subject to

the total daily intake of vitamins and minerals. As a source of vitamins and

minerals can be considered dietary supplements containing at least

significant amounts of vitamins and minerals, which is considered to be

at least 15% of the recommended daily doses of values listed in the table,

that is contained in 100 g or 100 ml or per package if

This pack contains one serving.



Selected provisions of the novel



Article. (II) Act No. 352/2009 Coll.



Transitional provisions



Dietary supplements, which are not marked in accordance with this Decree, the

until 31 December 2006. October 2012, be judged according to the existing legislation.



1) is released on the basis and within the limits of the law, which has already been the appropriate

Directive of the European communities reflected.



2) directive of the European Parliament and of the Council 2002/46/EC of 10 June 1999. June

2002 on the approximation of the laws of the Member States relating to the

food supplements.



Commission Directive 2006/37/EC of 30 March 2004. March 2006 amending

Annex II to the directive of the European Parliament and of the Council 2002/46/EC as regards the

the inclusion of certain substances.




3) European Parliament and Council Regulation (EC) No 1924/2006 of 20 October.

December 2006 on nutrition and health claims in the labelling,

food.



European Parliament and Council Regulation (EC) No 1925/2006 on adding

vitamins and minerals and of 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 167/1998 Coll., on addictive substances and amending certain

other acts, as amended.



6) European Parliament and Council Regulation (EC) No 273/2004 of 11 March.

February 2004 on drug precursors.



7) Decree No. 113/2005 Coll., about how the labelling of foodstuffs and tobacco

products, as amended.



8) Act 505/1990 Coll., on weights and measures, as amended.



Decree 328/2000 Coll. on the method of making certain types of cash

packaged goods, the quantity of which is expressed in units of weight or

volume.



9) European Parliament and Council Regulation (EC) No 1924/2006.



10) European Parliament and Council Regulation (EC) No 1925/2006.