Updated recommendations for safety limits for menthofuran and pulegone

The Committee on Herbal Medicinal Products (HMPC) has reassessed the toxicity of pulegone and menthofuran to humans based on scientific literature and publications.

Pulegone and menthofuran are present in e.g. peppermint oil (Mentha x piperita L.) and other essential oils isolated from plants belonging to Lamiaceae family, such as corn mint (Mentha arvensis L.) and pennyroyal (Mentha pulegium L.). These essential oils are used in medicinal products both as active substances and excipients.

Committee for Medicinal Products for Human Use (CHMP) has adopted the limit values recommended by the Committee on Herbal Medicinal Products (HMPC). These limit values are applicable to all medicinal products.

All marketing authorisation and registration holders responsible for medicinal products which may contain pulegone or menthofuran either in the active substance or in any excipient must control the safety of these products regarding the aforementioned substances.

Necessary changes to the medicinal products containing pulegone or menthofuran must be implemented with variation procedure within 2 years of the publication of the HMPC statement, i.e. by the end of July 2018.

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Public statement on the use of herbal medicinal products containing pulegone and menthofuran 12 July 2016 (Final, EMA/HMPC/138386/2005 Rev. 1)

Report from the CMDh meeting held on 18-20 July 2016