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GMP Compliance of Essential Oils as Atypical Actives by Risk Assessment

Michael Hubbert¹, Sigrid Drewes², Robert Hahn³, Andrea Lutz-Röder⁴, Iris Müller⁵, Claudia Valder⁶, Ehrhard Anhalt⁷, Barbara Steinhoff⁷

MADAUS GmbH¹, Troisdorf (Germany), Merz Consumer Care GmbH², Frankfurt/Main (Germany), IMG – Institut für
Marktzugangsrechte im Gesundheitswesen GmbH & Co. KG³, Ascheberg (Germany), Kneipp-Werke, Kneipp-Mittel-Zentrale
GmbH & Co. KG⁴, Würzburg (Germany), SALUS Haus GmbH & Co. KG⁵, Bruckmühl (Germany), Frey & Lau GmbH⁶, Henstedt-
Ulzburg (Germany), Bundesverband der Arzneimittel-Hersteller e. V.⁷, Bonn (Germany)

For many essential oils imported from outside Europe full GMP requirements can hardly be fulfilled. Therefore they require a specific approach suitable for Atypical Actives. Such a risk-based approach is proposed using the established model of the Failure Mode and Effective Analysis (FMEA). It consists in the quantification of the risk by numbers and its expression by multiplication of the severity by the probability and by the detectability of the occurence of the failure/risk. A specific template is presented which can be used for a risk assessment of essential oils in order to guarantee their quality and safety.