Decree No. 368 / 2024 Coll.
Decree amending Decree No. 58 / 2018 Coll., on food supplements and food composition
Valid
Order
Effective from 01.07.2025
368
DECLARATION
of 4 December 2024
amending Decree No 58 / 2018 Coll., on food supplements and food composition
The Ministry of Agriculture provides pursuant to Article 18 (1) (a) and (s) of Act No. 110 / 1997 Coll., on Food and Tobacco Products and on the amendment and addition of certain related laws, as amended by Act No. 316 / 2004 Coll., Act No. 139 / 2014 Coll., Act No. 180 / 2016 Coll. and Act No. 174 / 2021 Coll.:
Decree No. 58 / 2018 Coll., on food supplements and food composition, is amended as follows:
1. footnote 1 shall read:
"(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. At the end of footnote 3, the sentence "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 food and used in the manufacture of food supplements. '," Commission Regulation (EU) 2021 / 418 of 9 March 2021 amending Directive 2002 / 46 / EC of the European Parliament and of the Council as regards nicotinamide riboside chloride and citrate malate of magnesium used in the manufacture of food supplements and as regards the measurement units used for copper' and "Commission Regulation (EU) No 2024 / 248 of 16 January 2024 amending Annex II to Directive 2002 / 46 / EC of the European Parliament and Council as regards hydroxide / 46 / EC.
3. In Articles 2 (2) and 5 (2), the words "plants and certain 'shall be inserted after the words" some'.
4. At the end of footnote 4 and footnote 12, the words "as amended 'shall be added.
5. In Paragraph 3 (1) (c), the words "applicable regulation 'are replaced by the words" applicable rules'.
6. At the end of footnote 5, the words "and Commission Regulation (EU) 2021 / 418 'are added.
7. in Article 3 (1) (d), the words "directly applicable European Union5" are replaced by the words "Regulation (EU) No 1169 / 2011 of the European Parliament and of the Council."
8. In Paragraph 3 (1), at the end of point (k), the word "a 'is replaced by a dot and point (l) is deleted.
9. In Article 5 (1), the second sentence is deleted.
10. In Article 5, the following paragraph 2 is inserted after paragraph 1, including footnote 13:
"(2) A food containing narcotic or psychotropic substances (11), substances listed in Category I of the directly applicable European Union drug precursor regulation (12), substances with anabolic and other hormonal effect13), 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.
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 greater quantity 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. "
Paragraph 2 shall become paragraph 3.
11. At the end of the text of footnote 11, the sentence "Government Regulation No. 463 / 2013 Coll., on substance lists, as amended, is added to the separate line. '
12. Annexes 1 and 2 shall read as follows:
"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. | tabák | 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 |
Technical Regulation
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.
Efficacy
This Decree shall take effect on 1 July 2025.
Minister for Agriculture:
Mgr. Excellent v. r.
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Regulation Information
| Citation | Decree No. 368 / 2024 Coll., amending Decree No. 58 / 2018 Coll., on Food Supplements and Food Composition |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 09.12.2024 |
|---|---|
| Effective from | 01.07.2025 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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