{
  "url": "https://openlegislation.uk/eu-decision-2018-133/annex",
  "json_url": "https://openlegislation.uk/eu-decision-2018-133/annex.json",
  "legislation": "eudn/2018/133",
  "legislation_title": "Commission Implementing Decision (EU) 2018/133 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) 213) (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2018-133",
  "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 Thymus vulgaris L., Thymus zygis Loefl. ex L., aetheroleum:\n‘ Valeriana officinalis L.’;\n(2) in Annex II, the following is inserted after the COMMUNITY LIST ENTRY on Thymus vulgaris L., Thymus zygis Loefl. ex L., aetheroleum:\n‘ UNION LIST ENTRY ON VALERIANA OFFICINALIS L.\nScientific name of the plant\nValeriana officinalis L.\nBotanical family\nValerianaceae\nCommon name in all EU official languages of herbal preparation\nBG (bălgarski): Валериана, корен\nCS (čeština): kozlíkový kořen\nDA (dansk): Baldrianrod\nDE (Deutsch): Baldrianwurzel\nEL (elliniká): Ρίζα βαλεριανής\nEN (English): Valerian root\nES (español): Valeriana, raíz de\nET (eesti keel): palderjanijuur\nFI (suomi): rohtovirmajuuri, juuri\nFR (français): Valériane (racine de)\nHR (hrvatska): odoljenov korijen\nHU (magyar): Macskagyökér\nIT (italiano): Valeriana radice\nLT (lietuvių kalba): Valerijonų šaknys\nLV (latviešu valoda): Baldriāna saknes\nMT (Malti): Għerq tal-Valerjana\nNL (Nederlands): Valeriaanwortel\nPL (polski): Korzeń kozłka\nPT (português): Valeriana, raiz\nRO (română): rădăcină de valeriană\nSK (slovenčina): Koreň valeriány\nSL (slovenščina): korenina zdravilne špajke\nSV (svenska): Vänderot, rot\nIS (íslenska):\nNO (norsk): Valerianarot\nHerbal preparation(s)\n(a) Comminuted herbal substance\n(b) Powdered herbal substance\n(c) Expressed juice from fresh root (1:0,60-0,85)\n(d) Dry extract (DER 4-6:1), extraction solvent: water\n(e) Liquid extract (DER 1:4-6), extraction solvent: water\n(f) Dry extract (DER 4-7:1), extraction solvent: methanol 45 % (V/V)\n(g) Dry extract (DER 5,3-6,6:1), extraction solvent: methanol 45 % (m/m)\n(h) Liquid extract (DER 1:7-9), extraction solvent: sweet wine\n(i) Liquid extract (DER 1:1), extraction solvent: ethanol 60 % (V/V)\n(j) Tincture (ratio of herbal substance to extraction solvent 1:8), extraction solvent: ethanol 60 % (V/V)\n(k) Tincture (ratio of herbal substance to extraction solvent 1:10), extraction solvent: ethanol 56 %\n(l) Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent: ethanol 70 % (V/V)\n(m) Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent: ethanol 60-80 % (V/V)\n(n) Dry extract (DER 5,5-7,4:1), extraction solvent: ethanol 85 % (m/m)\nEuropean Pharmacopoeia monograph reference\n04:2017:0453\nIndications\nTraditional herbal medicinal product for relief of mild symptoms of mental stress and to aid sleep.\nThe product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use.\nType of tradition\nEuropean.\nSpecified strength\nPlease see ‘Specified posology’.\nSpecified posology\nAdolescents, adults and elderly\nOral use\n(a) single dose: 0,3-3 g\nFor relief of mild symptoms of mental stress up to 3 times daily.\nTo aid sleep, a single dose half to one hour before bedtime with an earlier dose during the evening if necessary.\nHerbal tea: 0,3-3 g of the comminuted herbal substance in 150 ml of boiling water as a herbal infusion\n(b) single dose: 0,3-2,0 g\nFor relief of mild symptoms of mental stress up to 3 times daily.\nTo aid sleep, a single dose half to one hour before bedtime with an earlier dose during the evening if necessary.\n(c) single dose: 10 ml\nFor relief of mild symptoms of mental stress up to 3 times daily.\nTo aid sleep, a single dose half to one hour before bedtime with an earlier dose during the evening if necessary.\n(d) single dose: 420 mg\nFor relief of mild symptoms of mental stress up to 3 times daily.\nTo aid sleep, a single dose half to one hour before bedtime with an earlier dose during the evening if necessary.\n(e) single dose: 20 ml\nFor relief of mild symptoms of mental stress up to 3 times daily.\nTo aid sleep, a single dose half to one hour before bedtime.\n(f) single dose: 144-288 mg\nFor relief of mild symptoms of mental stress up to 4 times daily.\nTo aid sleep, a single dose half to one hour before bedtime with an earlier dose during the evening if necessary.\n(g) single dose: 450 mg\nFor relief of mild symptoms of mental stress up to 3 times daily.\nTo aid sleep, a single dose half to one hour before bedtime with an earlier dose during the evening if necessary.\n(h) single dose: 10 ml, up to 3 times daily\n(i) single dose: 0,3-1,0 ml, up to 3 times daily\n(j) single dose: 4-8 ml, up to 3 times daily\n(k) single dose: 0,84 ml\nFor relief of mild symptoms of mental stress 3-5 times daily.\nTo aid sleep, a single dose half an hour before bedtime.\n(l) single dose: 1,5 ml (mental stress), 3 ml (to aid sleep)\nFor relief of mild symptoms of mental stress up to 3 times daily.\nTo aid sleep, a single dose half an hour before bedtime.\n(m) single dose: 10 ml, up to 3 times daily\n(n) single dose: 322 mg, up to 3 times daily\nUse as bath additive\nsingle dose: 100 g for a full bath, up to 1 bath daily\nRoute of administration\nOral use\nUse as bath additive. Temperature: 34-37 °C, duration of bath 10-20 minutes.\nDuration of use or any restrictions on the duration of use\nIf symptoms persist 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.\nUse as bath additive\nFull baths are contraindicated in cases of open wounds, large skin injuries, acute skin diseases, high fever, severe infections, severe circulatory disturbances and cardiac insufficiency.\nSpecial warnings and precautions for use\nThe use in children under 12 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.\nFor tinctures and extracts containing ethanol, the appropriate labelling for ethanol, taken from the ‘Guideline on excipients in the label and package leaflet of medicinal products for human use’, must be included.\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\nMay impair ability to drive and use machines. Affected patients should not drive or operate machinery.\nUndesirable effects\nOral use\nGastrointestinal symptoms (e.g. nausea, abdominal cramps) may occur after ingestion of valerian root preparations. The frequency is not known.\nIf other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.\nUse as bath additive\nNone known\nIf adverse reactions occur, a doctor or a qualified health care practitioner should be consulted.\nOverdose\nOral use\nValerian root at a dose of approximately 20 g caused symptoms, such as fatigue, abdominal cramp, chest tightness, light-headedness, hand tremor and mydriasis, which disappeared within 24 hours. If symptoms arise, treatment should be supportive.\nUse as bath additive\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/2018/133/annex",
    "retrieved_at": "2026-11-01T15:13:12.726016+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."
}