Decree No. 58 / 2018 Coll.
Decree on food supplements and food composition
Valid
Effective from 01.11.2018
58
DECLARATION
of 29 March 2018
on food supplements and food composition
According to Article 18 (1) (a) and (t) 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., Act No. 120 / 2008 Coll. and Act No. 139 / 2014 Coll., ("the Act '):
Subject matter
This decree implements the relevant European UnionRegulation (1) and, following the directly applicable European UnionRegulations (2)
(a) requirements for the composition, labelling and use of food supplements;
(b) food composition requirements.
Requirements for the composition of food supplements
(1) Vitamins and minerals and their forms, which may be used for the manufacture of food supplements, are set out in Annexes I and II to Directive 2002 / 46 / EC on the approximation of the laws of the Member States relating to food supplements, as directly applicable European Union3).
(2) Certain plants and certain 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 1 to this Decree.
Labelling of food supplements
(1) In addition to the labelling requirements for packaged foodstuffs laid down in the directly applicable European Union4) governing the labelling of foodstuffs and the requirements laid down in the law, the packaging for consumers shall be indicated:
(a) in the name of the food, the words "food supplement,"
(b) the name of vitamins, minerals or other substances characterising the product;
(c) the quantity of vitamins, minerals or other substances having a nutritional or physiological effect related to the recommended daily dose, using the units listed in Annex I to Directive 2002 / 46 / EC on the approximation of the laws of the Member States relating to food supplements, as directly applicable to European Union5, for vitamins and minerals;
(d) data on the vitamin and mineral content as well as the percentage of the intake reference value as set out in Annex XIII to Regulation (EU) No 1169 / 2011 of the European Parliament and of the Council, which may be indicated in graphical form,
(e) recommended daily dosing,
(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;
(j) the warning "May reduce blood clotting" in food supplements containing Ginkgo biloba (jinn);
(k) an indication of the need for interruption of consumption and search for a physician in any suspected liver disease in food supplements containing the plant Cimicifuga racemosa (grape platter) or extracts thereof.
(2) The data referred to in paragraph 1 (c) shall be reported by means of the average values established on the basis of the quantitative analysis of the food supplement by the manufacturer.
(3) An indication of the total quantity shall be given in accordance with another legislation (6) or the rules for marking the symbol "e" (7).
(4) Labelling must not:
(a) to attribute or refer to properties related to the prevention, treatment or cure of human diseases; and
(b) contain no claim indicating or suggesting that a balanced and varied diet in general cannot provide sufficient nutrients.
(5) Nutrition and health claims for food supplements may be indicated under the conditions of the directly applicable European Union Regulation on the requirements for the labelling of nutrition and health claims for food 8).
(6) Substances the placing on the market of which is subject to the directly applicable European Union Regulation on novel foods (9) may only be present in food supplements in accordance with this Regulation.
Method of use of food supplements
Food supplements are used in the form of capsules, pastilles, tablets, pills and other similar forms, as well as in the form of spreads, such as liquid in ampoules, dropper bottles and other similar forms of liquid or bulk products intended for consumption in small measured quantities, and are thus placed on the market.
Food composition requirements
(1) The conditions for the addition of vitamins, minerals or other substances to food are laid down in the directly applicable European Union Regulation on the addition of vitamins, minerals and other substances to food 10).
(2) A food containing narcotic or psychotropic substances (11), substances listed in Category I of the directly applicable European Union drug precursor regulation (12), anabolic and other hormonal agents (13), substances of a hormonal nature or other substances that have been shown to be toxic, genotoxic, teratogenic, hallucinogenic, narcotic or other adverse effects on the human organism cannot be placed on the market.
(3) Certain plants and certain other substances which cannot be used in the manufacture of foodstuffs are listed in Annex 2 to this Decree.
Transitional provision
Food placed on the market or labelled before the date of entry into force of this Order may be sold until stocks are exhausted.
Final provision
This Decree was notified in accordance with Directive (EU) 2015 / 1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical and information society services.
Repeal
They shall be deleted:
1. Decree No. 225 / 2008 Coll., laying down requirements for food supplements and enrichment.
2. Decree No. 352 / 2009 Coll., amending Decree No. 225 / 2008 Coll., laying down requirements for food supplements and enrichment.
Efficacy
This Decision shall enter into force on 1 November 2018.
Minister:
Ing. Milek v. r.
Příloha č. 1
Annex No 1
Conditions of use of certain plants and certain other substances in food supplements
1. Conditions of use of certain plants
| Název rostliny | Část rostliny | Nejvyšší přípustné množství v denní dávce | |
|---|---|---|---|
| 1. | Cimicifuga racemosa (ploštičník hroznovitý) | sušený kořen a oddenek | 40 mg |
| 2. | Citrus aurantium (hořký pomeranč) | extrakt (přepočteno na množství synefrinu) | 20 mg synefrinu |
| 3. | Crataegus spp. (hloh) | sušený list, květ, plod | 1000 mg |
| 4. | Echinacea spp. (třapatka) | sušený kořen, nať | 500 mg |
| 5. | Garcinia cambogia (garcinie kambodžská) | slupka (přepočteno na množství kyseliny hydroxycitronové) | 2000 mg |
| 6. | Ginkgo biloba (jinan dvoulaločný) | standardizovaný extrakt 24/6 z listů | 60 mg |
| 7. | Ginkgo biloba (jinan dvoulaločný) | sušený list | 4000 mg |
| 8. | Hypericum perforatum (třezalka tečkovaná) | sušená nať | 900 mg |
| 9. | Panax ginseng (všehoj ženšenový) | sušený kořen | 2000 mg |
| 10. | Ptychopetalum olacoides (muira puama) | sušené dřevo | 500 mg |
| 11. | Rhodiola rosea (rozchodnice růžová) | standardizovaný extrakt z kořene (4 % rosavinu) | 100 mg |
| 12. | Tribulus terrestris (kotvičník zemní) | sušená nať, plody | 2000 mg |
| 13. | Turnera diffusa (pantala rozkladitá) | sušené listy | 1000 mg |
| 14. | Uncaria tomentosa (vilcacora, kočičí dráp) | sušený kořen | 1000 mg |
| 15. | Valeriana officinalis (kozlík lékařský) | sušený kořen | 1000 mg |
2. Conditions of use of certain other substances other than plants
| Další látky | Nejvyšší přípustné množství v denní dávce | |
|---|---|---|
| 1. | Acetylkarnitin | 500 mg |
| 2. | Koenzym Q10 (ubichinon a ubichinol) | 200 mg |
| 3. | Kyselina orotová | 50 mg |
| 4. | Pycnogenol | 100 mg |
| 5. | Taurin | 2000 mg |
Příloha č. 2
Annex No 2
List of certain plants and certain other substances prohibited in the manufacture of foodstuffs
1. Certain plants prohibited in food production
| Latinský název | Český název | Rostlinná část | |
|---|---|---|---|
| 1. | Aconitum spp. | oměj | kořen |
| 2. | Adonanthe spp. (Adonis spp.) | hlaváček | nať |
| 3. | Alkanna spp. | kamejník | |
| 4. | Alstonia spp. | alstonie | kůra |
| 5. | Ammi visnaga (L.) LAM. | moráč zákrovnatý | plod |
| 6. | Andira spp. | andira | |
| 7. | Anchusa spp. | pilát | |
| 8. | Apocynum spp. | toješť | kořen |
| 9. | Areca catechu L. | areka obecná (betelový oříšek) | semeno |
| 10. | Aristolochiaceae | čeleď podražcovité | |
| 11. | Artemisia cina | pelyněk cicvárový | |
| 12. | Asarum spp. | kopytník | nať |
| 13. | Aspidosperma quebracho-blanco Schlecht. | štítosemenka kebračo | kůra |
| 14. | Atropa spp. | rulík | |
| 15. | Azadirachta indica | zederach indický | |
| 16. | Baccharis coridifolia | pomíšenka srdcolistá | |
| 17. | Baccharis megapotamica | pomíšenka poříční | |
| 18. | Borago officinalis | brutnák lékařský | nať, květ |
| 19. | Bragantia wallichii | bragantie Wallichova | |
| 20. | Brachyglottis spp. | jazýčkovec | |
| 21. | Caltha palustris | blatouch bahenní | |
| 22. | Cassia acutifolia (Cassia senna) | kasie ostrolistá | list, plod |
| 23. | Cassia angustifolia VAHL | kasie úzkolistá | list, plod |
| 24. | Catharanthus roseus (L). G.DON | katarant růžový | nať |
| 25. | Cephaelis spp. | hlavěnka (uragoga) | kořen |
| 26. | Cinenaria spp. | cinenárie | |
| 27. | Citrullus colocynthis | kolokvinta obecná | plod |
| 28. | Clematis spp. | plamínek | kořen*) |
| 29. | Cocculus spp. (Anamirta cocculus) | chebule (latnatá) | |
| 30. | Colchicum spp. | ocún | semeno |
| 31. | Conium maculatum | bolehlav plamatý | |
| 32. | Convallaria majalis L. | konvalinka vonná | list, nať |
| 33. | Corydalis spp. | dymnivka | kořen |
| 34. | Croton tiglium | ladel počistivý | |
| 35. | Cynoglossum spp. | užanka | |
| 36. | Datura spp. | durman | list, nať, semeno |
| 37. | Digitalis spp. | náprstník | list |
| 38. | Diploclisia affinis, Diploclisia chinensis | diklopsie příbuzná diklopsie čínská | |
| 39. | Dryopteris filix-mas | kapraď samec | oddenek |
| 40. | Duboisia spp. | jedovatice | list |
| 41. | Ecballium elaterium A. RICH. | tykvice pukavá | plod |
| 42. | Ephedra spp. | chvojník | nať |
| 43. | Erechthites spp. | starčkovec | |
| 44. | Erythroxylon sp. | rudodřev | |
| 45. | Eschscholtzia californica CHAM. | sluncovka kalifornská | nať |
| 46. | Eupatorium spp. (kromě Eupatorium perfoliatum) | konopáč | |
| 47. | Euphorbia spp. | pryšec | nať, šťáva |
| 48. | Exogonium purga | jalapa počistivá | |
| 49. | Frangula alnus MILL. | krušina olšová | kůra |
| 50. | Gelsemium sempervirens (L.) AIT. | jasmínovec vždyzelený | kořen |
| 51. | Genista tinctoria | kručinka barvířská | |
| 52. | Gossypium spp. | bavlník | semeno |
| 53. | Heliotropium spp. | otočník | |
| 54. | Helleborus spp. | čemeřice | kořen |
| 55. | Hydrastis canadensis L. | vodilka kanadská | kořen |
| 56. | Hyoscyamus spp. | blín | list, nať |
| 57. | Chelidonium majus L. | vlaštovičník větší | kořen, list, nať |
| 58. | Chenopodium ambrosioides | merlík vonný | |
| 59. | Ipomoea spp. **) | povijnice | |
| 60. | Ledum palustre | rojovník bahenní | |
| 61. | Lithospermum officinale | kamejka | |
| 62. | Lobelia spp. | lobelka | nať |
| 63. | Mallotus philippinensis | kamala | |
| 64. | Mandragora officinarum L. | mandragora lékařská | kořen |
| 65. | Menispermum canadense, Menispermum dahuricum | lunoplod (chebule) kanadský lunoplod dahurský | |
| 66. | Mucuna pruriens | mukuna | |
| 67. | Nerium oleander L. | oleandr obecný | list, nať |
| 68. | Nicotiana spp. | list | |
| 69. | Papaver somniferum L. | mák setý | plod s výjimkou zralých semen, šťáva |
| 70. | Pausinystalia yohimbe (K.SCHUM.) PIERRE | bujarník johimbe | kůra |
| 71. | Petasites spp. | devětsil | |
| 72. | Physostigma venenosum BALF. | puchýřnatec jedovatý | semeno |
| 73. | Pilocarpus spp. | mrštnoplod, jaborand | list |
| 74. | Pinellia ternata | pinelie trojčetná | |
| 75. | Piper methysticum FORSTER | pepřovník opojný (kava-kava) | |
| 76. | Podophyllum peltatum L. | noholist štítnatý | kořen |
| 77. | Polygonum sachalinensis | křídlatka sachalinská | |
| 78. | Polygonum cuspidatum | křídlatka japonská | |
| 79. | Pulsatilla vulgaris | koniklec | |
| 80. | Rauwolfia serpentina (L.) BENTH. | rauwolfie plazivá | kořen |
| 81. | Rhamnus cathartica L. | řešetlák počistivý | kůra, plod |
| 82. | Rhamnus purshiana DC. | řešetlák Purshův | kůra |
| 83. | Rheum officinale | reveň lékařská | kořen |
| 84. | Rheum palmatum | reveň dlanitá | kořen |
| 85. | Rhododendron ferrugineum L. | pěnišník rezavý | list |
| 86. | Ricinus communis L. | skočec obecný | semeno |
| 87. | Ruta graveolens | routa vonná | nať |
| 88. | Sarothamnus scoparius (L.) WIMM.ex KOCH | janovec metlatý | květ, nať |
| 89. | Sassafras albidum | sasafras | |
| 90. | Scopolia carniolica JACQ. | pablen kraňský | kořen |
| 91. | Senecio spp. | starček | |
| 92. | Schoenocaulon officinale (SCHLECHT.et CHAM.) GRAY | sabadila lékařská | semeno |
| 93. | Sida cordifolia | sida srdcolistá | |
| 94. | Sinomenium acutum | sinomenium prudké | |
| 95. | Spartium junceum L. | vítečník sítinovitý | květ, nať |
| 96. | Spigelia spp. | spigelie | kořen, nať |
| 97. | Stephania spp. | stefánie | |
| 98. | Strophanthus spp. | krutikvět | semeno |
| 99. | Strychnos spp. | kulčiba | semeno |
| 100. | Symphytum spp. | kostival | kořen |
| 101. | Tabebuia impetiginosa syn. Handroanthus impetiginosus (Mart. Ex DC.) Matto | lapačo červené | kůra |
| 102. | Taxus spp. | tis | |
| 103. | Thevetia peruviana (PERS.) SCHUMANN | tevetie | nať |
| 104. | Tussilago farfara | podběl obecný | list, květ |
| 105. | Urginea maritima (L.) J.B.BAK. | urginea přímořská | cibule |
| 106. | Veratrum spp. | kýchavice | kořen |
| 107. | Vladimiria souliei | vladimira Souliejova | |
| 108. | Xysmalobium undulatum R. BROWN | xysmalobium kadeřavé | kořen |
*) The prohibition applies when aristoloch acid is present. The aristoloch acid free root and other parts of the plant body are allowed.
* *) Except for species Ipomoea batatas (L.) Lam. and Ipomoea aquatica Forssk.
2. Some other substances prohibited in food production
| 1. | Claviceps spp. (paličkovice – sklerocium) |
| 2. | Acetyltryptofan |
| 3. | Koloidní stříbro |
| 4. | Laktulóza |
| 5. | N-acetylcystein |
1) 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, as amended by Commission Directive 2006 / 37 / EC, Commission Regulation (EC) No 1170 / 2009, Commission Regulation (EU) No 1161 / 2011, Commission Regulation (EU) No 119 / 2014, Commission Regulation (EU) 2015 / 414, Commission Regulation (EU) 2017 / 1203, Commission Regulation (EU) 2021 / 418 and Commission Regulation (EU) 2024 / 248.
2) 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, as amended. Regulation (EC) No 1925 / 2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods, as amended.
3) Commission Regulation (EC) No 1170 / 2009 of 30 November 2009 amending Directive 2002 / 46 / EC of the European Parliament and of the Council and Regulation (EC) No 1925 / 2006 of the European Parliament and of the Council as regards lists of vitamins and minerals and their forms which may be added to foods, including food supplements. Commission Regulation (EU) No 1161 / 2011 of 14 November 2011 amending Directive 2002 / 46 / EC of the European Parliament and of the Council, Regulation (EC) No 1925 / 2006 of the European Parliament and of the Council and Commission Regulation (EC) No 953 / 2009 as regards lists of mineral substances that may be added to foodstuffs. Commission Regulation (EU) No 119 / 2014 of 7 February 2014 amending Directive 2002 / 46 / EC of the European Parliament and of the Council and Regulation (EC) No 1925 / 2006 of the European Parliament and of the Council as regards chromium-enriched yeast used for the manufacture of food supplements and chromate lactate added to foods. Commission Regulation (EU) 2015 / 414 of 12 March 2015 amending Directive 2002 / 46 / EC of the European Parliament and of the Council as regards glucosamine salt of (6 S) -5-methyltetrahydrofolic acid used in the manufacture of food supplements. Commission Regulation (EU) 2017 / 1203 of 5 July 2017 amending Directive 2002 / 46 / EC of the European Parliament and of the Council and Regulation (EC) No 1925 / 2006 of the European Parliament and of the Council as regards organic silicon (monomethylsilanetriol) and calcium salt of phosphorylated oligosaccharides (Pos-Ca ®) added to foods and used in the manufacture of food supplements. Commission Regulation (EU) 2016 / 418 of 9 March 2021 amending Directive 2002 / 46 / EC of the European Parliament and of the Council as regards nicotinamide riboside chloride and magnesium citrate used in the manufacture of food supplements and as regards measurement units used for copper. Commission Regulation (EU) No 2024 / 248 of 16 January 2024 amending Annex II to Directive 2002 / 46 / EC of the European Parliament and of the Council as regards hydroxide-adipate-ferric tartrate used in the manufacture of food supplements.
(4) Regulation (EU) No 1169 / 2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924 / 2006 and (EC) No 1925 / 2006 of the European Parliament and of the Council and repealing Commission Directive 87 / 250 / EEC, Council Directive 90 / 496 / EEC, Commission Directive 1999 / 10 / EC, Directive 2000 / 13 / EC of the European Parliament and of the Council, Commission Directives 2002 / 67 / EC and 2008 / 5 / EC and Commission Regulation (EC) No 608 / 2004, as amended.
5) Commission Regulation (EC) No 1170 / 2009 and Commission Regulation (EU) 2021 / 418.
6) Decree No. 417 / 2016 Coll., on certain methods of labelling foodstuffs, as amended.
7) Act No. 505 / 1990 Coll., on Metrology, as amended. Decree No 328 / 2000 Coll., on the method of making certain types of pre-packaged goods, the quantity of which is expressed in units of mass or volume, as amended.
8) Regulation (EC) No 1924 / 2006 of the European Parliament and of the Council.
(9) Regulation (EU) 2015 / 2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169 / 2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258 / 97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852 / 2001, as amended.
10) Regulation (EC) No 1925 / 2006 of the European Parliament and of the Council.
11) Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended. Government Regulation No. 463 / 2013 Coll., on substance lists, as amended.
12) Regulation (EC) No 273 / 2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors, as amended.
13) Government Decree No. 454 / 2009 Coll., establishing, for the purposes of the Criminal Code, what is considered to be substances with anabolic and other hormonal effects and what is the larger amount of them and what is considered to be a method for the purposes of the Criminal Code to increase oxygen transmission in the human organism and other methods with doping effect, as amended.
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Regulation Information
| Citation | Decree No. 58 / 2018 Coll., on food supplements and food composition |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 12.04.2018 |
|---|---|
| Effective from | 01.11.2018 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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