Use of herbal medicinal products containing pulegone and menthofuran - Scientific guideline

This document addresses the safety of herbal medicinal products containing peppermint, mint oil or pennyroyal oil. It recommends future action in relation to those products.

Keywords: Herbal medicinal products containing pulegone and menthofuran; Peppermint oil, pulegone toxicity, menthofuran toxicity

Current version

Public statement on the use of herbal medicinal products containing pulegone and menthofuran - Revision 1

AdoptedReference Number: EMA/HMPC/258725/2015 Rev.1

Document history - Revision 1 (current)

Public statement on the use of herbal medicinal products containing pulegone and menthofuran - Revision 1

AdoptedReference Number: EMA/HMPC/258725/2015 Rev.1

Overview of comments on draft Public statement on the use of herbal medicinal products containing pulegone and menthofuran - Revision 1

Reference Number: EMA/HMPC/258725/2015

Draft public statement on the use of herbal medicinal products containing pulegone and menthofuran - Revision 1

Consultation dates: 22/12/2014 to 31/03/2015Draft: consultation closedReference Number: EMA/HMPC/138386/2005 Rev. 1Summary:

Since 2005, a number of significant publications on pulegone / menthofuran have appeared in the scientific literature. The HMPC has reviewed the assessment taking into account data that were not referred to previously. Based on a ‘weight-of-evidence toxicity risk assessment’ a limit value is determined and toxicological conclusions made. Because of uncertainties about the mode of action regarding carcinogenicity, the limits should be regarded as provisional. It is recommended that exposure to pulegone and menthofuran should be kept as low as practically achievable. In the evaluation of herbal medicinal products containing pulegone / menthofuran Member States should take steps to ensure that the public are protected from exposure applying the proposed thresholds.

Document history - First version

Public Statement on the use of herbal medicinal products containing pulegone and menthofuran - First version

AdoptedReference Number: EMEA/HMPC/138386/2005