{
  "url": "https://openlegislation.uk/eu-decision-2011-785/annex",
  "json_url": "https://openlegislation.uk/eu-decision-2011-785/annex.json",
  "legislation": "eudn/2011/785",
  "legislation_title": "Commission Implementing Decision of 28 November 2011 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(2011) 7382) (Text with EEA relevance) (2011/785/EU)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2011-785",
  "path": "annex",
  "kind": "annex",
  "number": null,
  "heading": null,
  "text": "Annexes I and II to Decision 2008/911/EC are amended as follows:\n1.. in Annex I, the following substance is inserted after Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung (sweet fennel fruit):\n‘ Hamamelis virginiana L., folium et cortex aut ramunculus destillatum ’;\n2.. in Annex II, the following is inserted after the entry relating to Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung, fructus:\n‘ COMMUNITY LIST ENTRY ON HAMAMELIS VIRGINIANA L., FOLIUM ET CORTEX AUT RAMUNCULUS DESTILLATUM\nScientific name of the plant\nHamamelis virginiana L.\nBotanical family\nHamamelidaceae\nHerbal preparation(s)\n1.. Distillate prepared from fresh leaves and bark (1:1.12 – 2.08; extraction solvent ethanol 6 % m/m)\n2.. Distillate prepared from dried twigs (1:2; extraction solvent ethanol 14-15 %)\nEuropean pharmacopoeia monograph reference\nNot applicable\nIndication(s)\nIndication (a)\nTraditional herbal medicinal product for relief of minor skin inflammation and dryness of the skin.\nIndication (b)\nTraditional herbal medicinal product to be used for the temporary relief of eye discomfort due to dryness of the eye or to exposure to wind or sun.\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\nChildren over six years of age, adolescents, adults and elderly\nIndication (a)\nDistillate in a strength corresponding to 5-30 % in semi-solid preparations, several times daily.\nThe use in children under six years of age is not recommended (see section ‘Special warnings and precautions for use’).\nAdolescents, adults and elderly\nIndication (b)\nEye drops Distillate (2) diluted (1:10), 2 drops/each eye, 3-6 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\nCutaneous use.\nOcular use.\nDuration of use or any restrictions on the duration of use\nChildren over six years of age, adolescents, adults and elderly\nIndication (a)\nIf the symptoms persist longer than two weeks during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.\nAdolescents, adults and elderly\nIndication (b)\nThe recommended duration of use is four days. If the symptoms persist longer than two days 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\nContraindications\nHypersensitivity to the active substance.\nSpecial warnings and precautions for use\nIndication (a)\nThe use in children under six years of age has not been established due to lack of adequate data.\nIndication (b)\nIf eye pain, changes in vision, continued redness, or irritation of the eye is experienced, or if the condition worsens or persists for more than 48 hours during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.\nThe use in children under 12 years of age has not been established due to lack of adequate data.\nFor 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.\nPregnancy 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.\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\nIndication (a)\nAllergic contact dermatitis may occur in sensitive patients. The frequency is not known.\nIndication (b)\nConjunctivitis cases have been reported. The 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.\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": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "According to USP (USP-31- NF 26, 2008 Vol 3:3526)."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "The medicinal product complies with the Ph. Eur. monograph on eye preparations (01/2008:1163).’."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2011/785/annex",
    "retrieved_at": "2026-11-01T15:15:37.554801+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."
}