{
  "url": "https://openlegislation.uk/eu-decision-2012-67/annex",
  "json_url": "https://openlegislation.uk/eu-decision-2012-67/annex.json",
  "legislation": "eudn/2012/67",
  "legislation_title": "Commission Implementing Decision of 3 February 2012 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(2012) 514) (Text with EEA relevance) (2012/67/EU)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2012-67",
  "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‘ Thymus vulgaris L., Thymus zygis Loefl. ex L., aetheroleum’;\n(2) in Annex II, the following is inserted after the entry on Pimpinella anisum L.:\n‘ COMMUNITY LIST ENTRY ON THYMUS VULGARIS L., THYMUS ZYGIS LOEFL. EX L., AETHEROLEUM\nScientific name of the plant\nThymus vulgaris L., Thymus zygis Loefl. ex L.\nBotanical family\nLamiaceae\nHerbal preparation(s)\nEssential oil obtained by steam distillation from the fresh flowering aerial parts of Thymus vulgaris L., Thymus zygis Loefl. ex L. or a mixture of both species\nEuropean Pharmacopoeia monograph reference\n01/2008:1374\nIndication(s)\nTraditional herbal medicinal product for the relief of symptoms in coughs and colds.\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\nAdults and elderly\nCutaneous use: in liquid and semi-solid dosage forms in concentrations up to 10 %; apply up to 3 times daily.\nUse as bath additive: 0,007-0,025 g per litre.\nAdolescents\nUse as bath additive: 0,007-0,025 g per litre\nChildren 6-12 years\nUse as bath additive: 0,0035-0,017 g per litre\nChildren 3-6 years\nUse as bath additive: 0,0017-0,0082 g per litre\nOne bath every day or every second day.\nThe cutaneous use in children and adolescents under 18 years of age is not recommended (see section “Special warnings and precaution for use”).\nThe use as bath additive in children under 3 years of age is not recommended (see section “Special warnings and precaution for use”).\nRoute of administration\nCutaneous use: apply to the chest and the back.\nUse as a bath additive: recommended temperature of bath: 35-38 °C.\nDuration of use or any restrictions on the duration of use\nDuration of a bath: 10-20 minutes.\nIf the symptoms persist longer than 1 week, 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\nCutaneous use:\nLike other essential oils Thyme oil should not be applied to the face particularly in the nasal area of babies and infants under the age of 2 years because of the risk of a laryngospasm.\nWhen dyspnoea, fever or purulent sputum occurs, a doctor or a qualified health care practitioner should be consulted.\nThe use in children and adolescents under 18 years of age is not recommended due to lack of adequate data.\nUse as bath additive:\nWhen dyspnoea, fever or purulent sputum occurs, a doctor or a qualified health care practitioner should be consulted.\nThe use in children under 3 years of age is not recommended because medical advice should be sought and due to lack of adequate data.\nIn cases of hypertension, a full bath should be used with caution.\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\nHypersensitivity reactions and skin irritation have been observed. The frequency is not known.\nIf other adverse reactions not mentioned above occur, a doctor or a 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.’",
  "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/2012/67/annex",
    "retrieved_at": "2026-11-01T15:15:32.958924+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."
}