{
  "url": "https://openlegislation.uk/eu-decision-2018-134/annex",
  "json_url": "https://openlegislation.uk/eu-decision-2018-134/annex.json",
  "legislation": "eudn/2018/134",
  "legislation_title": "Commission Implementing Decision (EU) 2018/134 of 24 January 2018 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2018) 218) (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2018-134",
  "path": "annex",
  "kind": "annex",
  "number": null,
  "heading": null,
  "text": "Decision 2008/911/EC is amended as follows:\n(1) In Annex I, the following substance is inserted after Pimpinella anisum L:\n‘ Sideritis scardica Griseb., herba.’;\n(2) In Annex II, the following is inserted after the COMMUNITY LIST ENTRY on Pimpinella anisum L:\n‘UNION LIST ENTRY ON SIDERITIS SCARDIA GRISEB., HERBA\nScientific name of the plant\nSideritis scardica Griseb.\nBotanical family\nLamiaceae (Labiatae)\nHerbal substance\nIronwort (Sideritis herba)\nCommon name in all EU official languages of herbal preparation\nBG (bălgarski): Мурсалски чай, стрък\nCS (čeština): nať hojníku\nDA (dansk): Kortkroneurt\nDE (Deutsch): Balkan-Gliedkraut\nEL (elliniká): Πόα σιδηρίτου\nEN (English): Ironwort\nES (español): Siderita, partes aéreas de\nET (eesti keel): haavarohuürt\nFI (suomi): raudakki, verso\nFR (français): Crapaudine (parties aériennes de)\nHR (hrvatska): očistova zelen\nHU (magyar): sármányvirág virágos hajtása\nIT (italiano): Stregonia parti aeree fiorite\nLT (lietuvių kalba): Timsrų žolė\nLV (latviešu valoda): Siderītu laksts\nMT (Malti): ħaxixa tas-Sideritis\nNL (Nederlands): (Griekse) bergthee, kruid\nPL (polski): Ziele gojnika\nPT (português): Siderite, partes aéreas\nRO (română): iarba de ceaiul muntelui cretan\nSK (slovenčina): Vňať ránhoja\nSL (slovenščina): zel sklepnjaka\nSV (svenska): Sårmynta, ört\nIS (íslenska):\nNO (norsk): Gresk fjellte\nHerbal preparations\nComminuted herbal substance\nEuropean Pharmacopoeia monograph reference\nNot applicable\nIndications\nIndication (1)\nTraditional herbal medicinal product used for the relief of cough associated with cold.\nIndication (2)\nTraditional herbal medicinal product used for the relief of mild gastrointestinal discomfort.\nThe product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.\nType of tradition\nEuropean\nSpecified strength\nPlease see “Specified posology”.\nSpecified posology\nAdults and elderly\nIndication (1) and (2)\nSingle dose: Herbal tea: 2-4 g of the comminuted herbal substance in 150-200 ml of water as a herbal infusion 2-3 times daily\nDaily dose: up to 12 g\nThe use in children and adolescents under 18 years of age is not recommended (see section “Special warnings and precautions for use”)\nRoute of administration\nOral use\nDuration of use or any restrictions on the duration of use\nIndication (1)\nIf symptoms persist longer than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.\nIndication (2)\nIf symptoms persist longer than 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.\nAny other information necessary for the safe use\nContraindications\nHypersensitivity to the active substance and to other plants of the Lamiaceae (Labiatae) family.\nSpecial warnings and precautions for use\nThe use in children and adolescents under 18 years of age has not been established due to lack of adequate data.\nIf the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.\nInteractions with other medicinal products and other forms of interaction\nNone reported\nFertility, pregnancy and lactation\nSafety during pregnancy and lactation has not been established. In the absence of sufficient data, use during pregnancy and lactation is not recommended.\nNo fertility data available.\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\nNone known\nIf adverse reactions occur, a doctor or qualified health care practitioner should be consulted.\nOverdose\nNo case of overdose has been reported.\nPharmaceutical particulars (if necessary)\nNot applicable\nPharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)\nNot applicable.\n’",
  "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/2018/134/annex",
    "retrieved_at": "2026-11-01T15:13:12.705613+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."
}