{
  "url": "https://openlegislation.uk/eu-decision-2010-30/annex-II",
  "json_url": "https://openlegislation.uk/eu-decision-2010-30/annex-II.json",
  "legislation": "eudn/2010/30",
  "legislation_title": "Commission Decision of 9 December 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2009) 9703) (Text with EEA relevance) (2010/30/EU)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2010-30",
  "path": "annex/II",
  "kind": "annex",
  "number": "II",
  "heading": null,
  "text": "In Annex II to Decision 2008/911/EC, the following is inserted after the entry relating to ‘Calendula officinalis L’:\n‘ COMMUNITY LIST ENTRY ON ECHINACEA PURPUREA (L.) MOENCH, HERBA RECENS\nScientific name of the plant\nEchinacea purpurea (L.) Moench\nBotanical family\nAsteraceae\nHerbal substance\nPurple coneflower herb\nCommon name in all EU official languages of herbal substance\nBG (bălgarski): пурпурна ехинацея, пресен стрък\nCS (čeština): čerstvá nať třapatky nachové\nDA (dansk): Purpursolhat, frisk urt\nDE (Deutsch): Purpursonnenhutkraut, frisch\nEL (elliniká): Πόα Εχινάκεας της πορφυράς\nEN (English): purple coneflower herb\nES (español): Equinácea purpúrea, partes aéreas incluidas sumidades floridas\nET (eesti keel): punane siilkübar\nFI (suomi): kaunopunahattu, tuore verso\nFR (français): parties aériennes fraîches d’échinacée pourpre\nHU (magyar): bíbor kasvirág virágos hajtása\nIT (italiano): Echinacea purpurea, pianta fresca\nLT (lietuvių kalba): rausvažiedžių ežiuolių žolė\nLV (latviešu valoda): purpursarkanās ehinacejas laksti\nMT (malti): Echinacea Vjola\nNL (nederlands): rood zonnehoedkruid\nPL (polski): jeżówka purpurowa, świeże ziele\nPT (português): Equinácea, partes aéreas floridas\nRO (română): iarbã proaspãtã de Echinacea, pãlãria soarelui\nSK (slovenčina): echinacea purpurová, čerstvá vňať\nSL (slovenščina): sveža zel škrlatne ehinaceje\nSV (svenska): röd solhatt, färsk ört\nIS (íslenska): Sólhattur\nNO (norsk): Rød solhatt\nHerbal preparation(s)\nExpressed juice and dried expressed juice from fresh flowering aerial parts.\nEuropean Pharmacopoeia monograph reference\nN/A\nIndication(s)\nTraditional herbal medicinal product for treatment of small superficial wounds.\nThe product is a traditional herbal medicinal product for use in a specified indication exclusively based on long-standing use.\nType of tradition\nEuropean.\nSpecified strength\n10 to 20 g/100 g of expressed juice or equivalent amount of dried expressed juice in liquid or semi-solid dosage forms.\nSpecified posology\nAdolescents over the age of 12 years, adults, elderly\nSmall amount of ointment is applied on the affected area 2-3 times a day.\nThe use in children under 12 years of age is not recommended (see below “Special warnings and precautions for use”).\nRoute of administration\nCutaneous use.\nDuration of use or any restrictions on the duration of use\nDo not use the medicinal product for more than 1 week.\nIf the symptoms persist during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.\nAny other information necessary for the safe use\nContra-indications\nHypersensitivity to the active substance or to plants of the Asteraceae (Compositae) family.\nSpecial warnings and precautions for use\nIf signs of skin infection are observed, medical advice should be sought.\nThe use in children below 12 years of age is not recommended because a safe use has not been sufficiently documented.\nInteractions with other medicinal products and other forms of interaction\nNone reported.\nPregnancy and lactation\nThere are no data on cutaneous use during pregnancy or lactation.\nProducts containing Echinacea should not be applied to the breast of breastfeeding women.\nEffects on ability to drive and use machines\nNo studies on the effects on the ability to drive and use machines have been performed.\nUndesirable effects\nHypersensitive reactions (local rash, contact dermatitis, eczema and angioedema of the lips) may occur.\nThe frequency is not known.\nIf other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.\nOverdose\nNo case of overdose has been reported.\nCOMMUNITY LIST ENTRY ON ELEUTHEROCOCCUS SENTICOSUS (RUPR. ET MAXIM.) MAXIM., RADIX\nScientific name of the plant\nEleutherococcus senticosus (Rupr. et Maxim.) Maxim.\nBotanical family\nAraliaceae\nHerbal substance\nEleutherococcus root\nCommon name in all EU official languages of herbal substance\nBG (bălgarski): елеутерокок, корен\nCS (čeština): eleuterokokový kořen\nDA (dansk): Russisk rod\nDE (Deutsch): Taigawurzel\nEL (elliniká): Pίζα Eλευθεροκόκκου\nEN (English): Eleutherococcus root\nES (español): Eleuterococo, raíz de\nET (eesti keel): eleuterokokijuur\nFI (suomi): venäjänjuuren juuri\nFR (français): racine d’éleuthérocoque (racine de ginseng sibérien)\nHU (magyar): Szibériai ginszeng gyökér (tajga gyökér)\nIT (italiano): Eleuterococco radice\nLT (lietuvių kalba): Eleuterokokų šaknys\nLV (latviešu valoda): Eleiterokoka sakne\nMT (malti): Għerq ta’ l-elewterokokku\nNL (nederlands): Russische ginsengwortel\nPL (polski): korzeń eleuterokoka\nPT (português): Raiz de Ginseng Siberiano\nRO (română): Rădăcină de ginseng siberian\nSK (slovenčina): Všehojovcový koreň\nSL (slovenščina): korenina elevterokoka\nSV (svenska): Rysk rot\nIS (íslenska): Síberíu ginseng, rót\nNO (norsk): Russisk rot\nHerbal preparation(s)\nComminuted herbal substance for preparation of a herbal tea\nLiquid extract (1:1, ethanol 30-40 % v/v)\nDry extract (13-25: 1, ethanol 28-40 % v/v)\nDry extract (17-30: 1, ethanol 70 % v/v)\nDry aqueous extract (15-17:1)\nTincture (1:5, ethanol 40 % v/v)\nEuropean Pharmacopoeia monograph reference\nEleutherococcus — Eleutherococci radix (ref.: 01/2008: 1419 corrected 6.0)\nIndication(s)\nTraditional herbal medicinal product for symptoms of asthenia such as fatigue and weakness.\nThe product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.\nType of tradition\nChinese, European.\nSpecified strength\nNot applicable.\nSpecified posology\nAdolescents over 12 years of age, adults, elderly\nHerbal preparations.\nDaily dose.\nComminuted herbal substance as herbal tea: 0,5-4 g.\nTea preparation: 0,5 to 4 g of comminuted herbal substance for infusion in 150 ml of boiling water.\nDosage frequency: 150 ml of tea infusion should be divided in one to three doses taken during the day.\nLiquid extract: 2-3 ml.\nDry extracts (ethanol 28-70 % v/v) corresponding to 0,5-4 g dried root.\nDry aqueous extract (15-17:1): 90-180 mg.\nTincture: 10-15 ml.\nThe daily dose can be taken in one to three doses.\nThe use is not recommended in children under 12 years of age (see below “Special warnings and precautions for use”).\nRoute of administration\nOral use.\nDuration of use or any restrictions on the duration of use\nNot to be taken for more than 2 months.\nIf the symptoms persist for more than 2 weeks during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.\nAny other information necessary for the safe use\nContra-indications\nHypersensitivity to the active substance.\nArterial hypertension.\nSpecial warnings and precautions for use\nThe use in children under 12 years of age is not recommended because sufficient experience is not available.\nIf the symptoms worsen during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.\nInteractions with other medicinal products and other forms of interaction\nNone reported.\nPregnancy and lactation\nSafety during pregnancy and lactation has not been established.\nIn the absence of sufficient data, the use during pregnancy and lactation is not recommended.\nEffects on ability to drive and use machines\nNo studies on the effect on the ability to drive and use machines have been performed.\nUndesirable effects\nInsomnia, irritability, tachycardia and headaches may occur. The frequency is not known.\nOverdose\nNo case of overdose has been reported.’",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2010/30/annex/II",
    "retrieved_at": "2026-11-01T15:16:15.194989+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}