{
  "url": "https://openlegislation.uk/eu-decision-2016-1659/annex",
  "json_url": "https://openlegislation.uk/eu-decision-2016-1659/annex.json",
  "legislation": "eudn/2016/1659",
  "legislation_title": "Commission Implementing Decision (EU) 2016/1659 of 13 September 2016 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(2016) 5748) (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2016-1659",
  "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 Hamamelis virginiana L.:\n‘ Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum’;\n(2) In Annex II, the following is inserted after the entry Hamamelis virginiana L.:\n‘ UNION LIST ENTRY ON MELALEUCA ALTERNIFOLIA (MAIDEN AND BETCH) CHEEL, M. LINARIIFOLIA SMITH, M. DISSITIFLORA F. MUELLER AND/OR OTHER SPECIES OF MELALEUCA, AETHEROLEUM\nScientific name of the plant\nMelaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and other species of Melaleuca\nBotanical family\nMyrtaceae\nCommon name in all EU official languages of herbal preparation\nBG (bălgarski): Чаено дърво, масло\nCS (čeština): silice kajeputu střídavolistého\nDA (dansk): Tetræolie\nDE (Deutsch): Teebaumöl\nEL (elliniká): Μελαλεύκης αιθέριο έλαιο\nEN (English): Tea tree oil\nES (español): Melaleuca alternifolia, aceite esencial de\nET (eesti keel): teepuuõli\nFI (suomi): teepuuöljy\nFR (français): Mélaleuca (arbre à thé) (huile essentielle de)\nHR (hrvatska): eteričnog ulje australijskog čajevca\nHU (magyar): Teafa-olaj\nIT (italiano): Melaleuca essenza\nLT (lietuvių kalba): Arbatmedžių eterinis aliejus\nLV (latviešu valoda): Tējaskoka ēteriskā eļļa\nMT (Malti): Żejt tal-Melaleucae\nNL (Nederlands): Theeboomolie\nPL (polski): Olejek eteryczny drzewa herbacianego\nPT (português): Óleo esencial de melaleuca\nRO (română): Melaleuca (arbore de ceai) (ulei esențial)\nSK (slovenčina): Silica melaleuky\nSL (slovenščina): eterično olje melalevke\nSV (svenska): Teträdsolja\nNO (norsk): Tetreolje\nHerbal preparation\nEssential oil\nEuropean Pharmacopoeia monograph reference\n01/2008:1837\nIndications\nIndication (a)\nTraditional herbal medicinal product for treatment of small superficial wounds and insect bites.\nIndication (b)\nTraditional herbal medicinal product for treatment of small boils (furuncles and mild acne).\nIndication (c)\nTraditional herbal medicinal product for the relief of itching and irritation in cases of mild athlete's foot.\nIndication (d)\nTraditional herbal medicinal product for symptomatic treatment of minor inflammation of the oral mucosa.\nThe product is a traditional herbal medicinal product for use in specified indication exclusively based upon long-standing use.\nType of tradition\nEuropean.\nSpecified strength\nPlease see ‘Specified posology’.\nSpecified posology\nIndication (a)\nAdolescents, adults and elderly\nSingle dose\n0,03-0,07 ml of undiluted essential oil to be applied to the affected area using a cotton bud 1-3 times daily.\nLiquid preparations containing 0,5 % to 10 % of essential oil to be applied to the affected area 1-3 times daily.\nIndication (b)\nAdolescents, adults and elderly\nSingle dose\nOily liquid or semi-solid preparations containing 10 % of essential oil to be applied to the affected area 1-3 times daily, or\n0,7-1 ml of essential oil stirred into 100 ml of lukewarm water to be applied as an impregnated dressing to the affected areas of skin. Undiluted essential oil to be applied to the boil using a cotton bud 2-3 times daily.\nIndication (c)\nAdolescents, adults and elderly\nSingle dose\nOily liquid or semi-solid preparations containing 10 % of essential oil to be applied on the affected area 1-3 times daily. 0,17-0,33 ml of essential oil in an appropriate volume of warm water to cover the feet. Soak feet for 5-10 minutes daily.\nUndiluted essential oil to be applied to the affected area using a cotton bud 2-3 times daily.\nIndication (d)\nAdolescents, adults and elderly\n0,17-0,33 ml of essential oil to be mixed in 100 ml of water for rinse or gargle several times daily.\nThe use in children under 12 years of age is not recommended (see section ‘Special warnings and precautions for use’).\nRoute of administration\nIndications (a), (b) and (c)\nCutaneous use\nIndication (d)\nOromucosal use.\nDuration of use or any restrictions on the duration of use\nIndication (a)\nIf the symptoms persist longer than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.\nIndications (b) and (c)\nNot to be used for more than 1 month.\nIf the symptoms persist during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.\nIndication (d)\nIf the symptoms persist longer than 5 days 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 or to colophony.\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 a rash develops, discontinue use.\nNot to be used orally or as inhalation.\nNot to be used in eyes or ears.\nIf the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.\nIndication (a)\nIf fever or signs of exacerbating skin infection are observed, a doctor or a qualified health care practitioner should be consulted.\nIndication (b)\nIn cases of severe acne a doctor or a qualified health care practitioner shall be consulted.\nIndication (c)\nFor the eradication of fungal infection a doctor or a qualified health care practitioner shall be consulted.\nIndication (d)\nNot to be swallowed.\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, the 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\nAdverse skin reactions including smarting pain, mild pruritus, burning sensation, irritation, itching, stinging, erythema, oedema (contact dermatitis) or other allergic reactions have been reported. The frequency is not known.\nBurn-like skin reactions have been reported. The frequency is rare (< 1/1 000).\nIf other adverse reactions not mentioned occur, a doctor or a qualified health care practitioner should be consulted.\nOverdose\nCutaneous use:\nNone reported.\nOromucosal use:\nAccidental overdose may cause central nervous system depression and muscle weakness. However, in adults these symptoms generally resolve within 36 hours.\nIf ingestion occurs, the patient should be monitored and standard supportive treatment applied as required.\nIn children, ingestion of tea tree oil is a medical emergency requiring immediate hospital treatment and respiratory support.\nPharmaceutical particulars (if necessary)\nStore in air-tight containers, protected from light and heat.\nProper storage and handling are needed to avoid the formation of oxidation products which have greater potential for skin sensitisation.\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.’",
  "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/2016/1659/annex",
    "retrieved_at": "2026-11-01T15:13:50.687521+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."
}