Monica COTARCĂ, Valeriu TABĂRĂ
Knowing volatile oils is an important issue taking into account the widespread aromatherapy. In 2009, the European Medicine Agency (E.M.A.) published a final monograph replacing the monographs of national authorities of the European Union for the recording of traditional plant medicine containing Common sage as active ingredient. Quality according to the Quality Standards corersponding to the European Pharmacopoiea is a previous condition for recording essential/volatile oils ( e.g., Sage PhEur leaves or Sage PhEur tincture). As far as essential Common sage oil is concerned, E.M.A. concluded that risks do not overrun benefits: therefore, there will not be any monograph on Common sage of the European Community unless they bring up new clinical evidence. In the United States, Salvia Folia is regulated as food ingredient and as a component of food supplements. Common sage leaves is listed as G.R.A.S. (Generally Recognised as Safe) to be sued as a condiment or as natural flavour, while Salvia Aetheroleum is a G.R.A.S. agent used only as aromatic. To use the essential oil as flavour, they published a monograph titled Quality Standards for the Essential common sage oil in the United States in the Pharmacopoeia of the Convention for Food Chemical Products, Codex. For therapeutic use, as part of the U.S. Food and Drug Administration (F.D.A.), there is a revision going on (O.T.C. Over the Counter sub-commission that regulates the possibility of using certain natural-based medicine without a medical prescription), to prove the safety and efficacy of common sage oil combined with mint oil in mouth hygiene and therapeutic products. Common sage oil is characterised by a high level of thujone. Consumption of common sage oil as single ingredient implies a high risk of overdose. In the monograph by the H.M.P.C. (Committee on Herbal Medicinal Products), the presence of thujone (common sage leaves) is allowed in preparations, but it is restricted to a daily intake of 0.5 mg/person for a amximum duration of 2 weeks. According to the regulations applyable to traditional plant medicines stipulated in Chapter 2a of the Directive 2001/83/CE, article 16a paragraph (1) letter (a) concerning their use in minor directions that do not require a doctor’s surveillance, the risk – benefit analysis in commons sage is negative. If new information concerning the clinical safety and efficacy of the common sage oil were available, such documents could be re-evaluated by the H.M.P.C.
Keywords: essential common sage oil, α-thujone, β-thujone, camphor row direction, quality of essential oil
Presentation: oral