{
  "url": "https://openlegislation.uk/eu-decision-2010-28/annex-II",
  "json_url": "https://openlegislation.uk/eu-decision-2010-28/annex-II.json",
  "legislation": "eudn/2010/28",
  "legislation_title": "Commission Decision of 28 July 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2009) 5804) (Text with EEA relevance) (2010/28/EC)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2010-28",
  "path": "annex/II",
  "kind": "annex",
  "number": "II",
  "heading": null,
  "text": "In Annex II to Decision 2008/911/EC, the following is inserted:\n‘Calendula officinalis L’ is inserted before Foeniculum vulgare Miller subsp. vulgare var. vulgare (Bitter fennel, fruit)\n‘ COMMUNITY LIST ENTRY ON CALENDULA OFFICINALIS L\nScientific name of the plant\nCalendula officinalis L.\nBotanical family\nAsteraceae\nHerbal substance\nCalendula flower\nCommon name in all EU official languages of herbal substance\nBG (bălgarski): Невен, цвят\nCS (čeština): Měsíčkový květ\nDA (dansk): Morgenfrueblomst\nDE (Deutsch): Ringelblumenblüten\nEL (elliniká): Άνθος καλέντουλας\nEN (English): Calendula flower\nES (español): Flor de caléndula\nET (eesti keel): Saialilleõisik\nFI (suomi): Tarhakehäkukan kukka\nFR (français): Souci\nHU (magyar): A körömvirág virága\nIT (italiano): Calendula fiore\nLT (lietuvių kalba): Medetkų žiedai\nLV (latviešu valoda): Kliņģerītes ziedi\nMT (malti): Fjura calendula\nNL (nederlands): Goudsbloem\nPL (polski): Kwiat nagietka\nPT (português): Flor de calêndula\nRO (română): Floare de gălbenele (calendula)\nSK (slovenčina): Nechtíkový kvet\nSL (slovenščina): Cvet vrtnega ognjiča\nSV (svenska): Ringblomma, blomma\nIS (íslenska): Morgunfrú, blóm\nNO (norsk): Ringblomst\nHerbal preparation(s)\nA.\nLiquid extract (DER 1:1), extraction solvent ethanol 40-50 % (v/v).\nB.\nLiquid extract (DER 1:1,8-2,2), extraction solvent ethanol 40-50 % (v/v).\nC.\nTincture (DER 1:5), extraction solvent ethanol 70-90 % (v/v).\nEuropean Pharmacopoeia monograph reference\nCalendula flower – Calendulae flos (01/2005:1297)\nIndication(s)\n(a)\nTraditional herbal medicinal product for the symptomatic treatment of minor inflammations of the skin (such as sunburn) and as an aid in healing of minor wounds.\n(b)\nTraditional herbal medicinal product for the symptomatic treatment of minor inflammations in the mouth or the throat.\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\nHerbal preparations:\nA.. Liquid extract (DER 1:1)\nIn semi-solid dosage forms: amount equivalent to 2-10 % herbal substance.\nB.. Liquid extract (DER 1:1,8-2,2)\nIn semi-solid dosage forms: amount equivalent to 2-5 % herbal substance.\nC.. Tincture (DER 1:5)\nIn compresses diluted at least 1:3 with freshly boiled water.\nIn semi-solid dosage forms: amount equivalent to 2-10 % herbal substance.\nAs a gargle or mouth rinse in a 2 % solution.\n2 to 4 times daily\nIndication (a)\nThe use is not recommended in children under 6 years of age (see below “Special warnings and precautions for use”).\nIndication (b)\nThe use in children under 12 years of age is not recommended because there is no experience available (see below “Special warnings and precautions for use”).\nRoute of administration\nCutaneous and oromucosal use.\nDuration of use or any restrictions on the duration of use\nCompresses: remove after 30-60 minutes\nAll herbal preparations: If the symptoms persist after 1 week 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 members of the Asteraceae (Compositae) family.\nSpecial warnings and precautions for use\nIndication (a)\nThe use in children under 6 years of age is not recommended because there is no experience available.\nIndication (b)\nThe use in children under 12 years of age is not recommended because there is no experience available.\nIf signs of skin infection are observed, a doctor or a qualified health care practitioner should be consulted.\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\nNot relevant.\nUndesirable effects\nSkin sensitisation. 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\nNone reported.’\n‘Pimpinella anisum L’ is inserted after Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung (Sweet fennel, fruit)\n‘ COMMUNITY LIST ENTRY ON PIMPINELLA ANISUM L\nScientific name of the plant\nPimpinella anisum L.\nBotanical family\nApiaceae\nHerbal substance\nAniseed\nCommon name in all EU official languages of herbal substance\nBG (bălgarski): Анасон, плод\nCS (čeština): Anýzový plod\nDA (dansk): Anisfrø\nDE (Deutsch): Anis\nEL (elliniká): Γλυκάνισο\nEN (English): Aniseed\nES (español): Fruto de anís\nET (eesti keel): Aniis\nFI (suomi): Anis\nFR (français): Anis (fruit d)\nHU (magyar): Ánizsmag\nIT (italiano): Anice (Anice verde), frutto\nLT (lietuvių kalba): Anyžių sėklos\nLV (latviešu valoda): Anīsa sēklas\nMT (malti): Frotta tal-Anisi\nNL (nederlands): Anijsvrucht\nPL (polski): Owoc anyżu\nPT (português): Anis\nRO (română): Fruct de anason\nSK (slovenčina): Anízový plod\nSL (slovenščina): Plod vrtnega janeža\nSV (svenska): Anis\nIS (íslenska): Anís\nNO (norsk): Anis\nHerbal preparation(s)\nDried aniseed, comminuted or crushed\nEuropean Pharmacopoeia monograph reference\nAnisi fructus (01/2005:0262)\nIndication(s)\n(a)\nTraditional herbal medicinal product for symptomatic treatment of mild, spasmodic gastro-intestinal complaints including bloating and flatulence.\n(b)\nTraditional herbal medicinal product used as an expectorant in cough associated with cold.\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\nAdolescents over 12 years of age, adults, elderly:\nIndications (a) and (b)\n1 to 3,5 g of whole or (freshly) comminuted or crushed aniseed in 150 ml of boiling water as a herbal tea\n3 times daily\nThe use in children under 12 years is not recommended of age (see below “Special warnings and precautions for use”).\nRoute of administration\nOral use\nDuration of use or any restrictions on the duration of use\nNot to be taken for more than 2 weeks.\nIf the 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 or to Apiaceae (Umbelliferae) (caraway, celery, coriander, dill and fennel) or to anethole.\nSpecial warnings and precautions for use\nThe use is not recommended in children under 12 years of age due to the lack of adequate data for safety assessment.\nInteractions with other medicinal products and other forms of interaction\nNone reported.\nPregnancy and lactation\nThere are no data from the use of aniseed in pregnant patients.\nIt is unknown if aniseed constituents are excreted in human breast milk.\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\nAllergic reactions to aniseed affecting the skin or the respiratory system may occur. 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.’",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "For commercial preparations of comminuted or crushed aniseed the applicant must carry out appropriate stability testing related to the content of essential oil components.’"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2010/28/annex/II",
    "retrieved_at": "2026-11-01T15:16:15.237078+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."
}