EHPM Workshop on the Future of Monacolin K from Red Yeast Rice


EHPM's workshop on Monacolin K, held on Thursday the 28th of November in Brussels, saw a great participation from National Associations and companies and from several EU countries.

The first session of the workshop offered an extensive description of the current state of the art for the Monacolin K dossier.

Michel Horn, Chair of EHPM, gave a welcome speech and briefly introduced the use (and misuse) of Article 8 of Regulation 1925/2006.

Following, Livia Menichetti, Head of Policy and Administration of EHPM gave a presentation detailing the steps of the Article 8 procedure for Monacolin K, the most recent developments in the process and laid out the possible next steps and actions.

Joris Geelen, Partner at the consultancy Food Compliance International, gave an explanation of the implementing regulation relative to the above-mentioned Article 8 and an in-depth description of the scrutiny procedure.

The second session allowed for companies and national associations to showcase their experience and best practices and to exchange views on the next steps for Monacolin K.

The session started with a presentation by Andrea Zanardi, Managing Director at Meda Pharma (a Mylan company) and Vice President of the Italian association FEDERSALUS. Mr. Zanardi summarised the results of the main studies supporting the safety of Monacolin K, published after EFSA’s opinion of August 2018. He reiterated the safety of the ingredient also on the basis of the vigilance data collected by Mylan.

Antonino Santoro, representing FEDERSALUS in the EHPM Board, presented the regulatory history and situation of Monacolin K in Italy and proposed a two-fold action, working both on the political level, with lobbying actions, and on the technical level, with collection of safety data and clinical studies, with dosages of Monacolin K lower than 3 mg.

Delphine Dupont, Executive Director at SYNADIET, assisted by Antoine Noel, CEO of Dielen Laboratoire presented SYNADIET’s proposal for a European clinical study.

The final part of the event saw the participants engaging in a fruitful debate involving companies and associations. Ms. Geurts, Director of NPN, Dutch Member of EHPM, highlighted that NPN is working with a Lawyer to point out possible procedural flaws and misuse of the precautionary principle by the EC.

Valerie Vercammen, Secretary General of EHPM’s Belgian Member NAREDI, stressed that it will be crucial to communicate with EFSA, to have clear guidelines on the kind of data that the industry needs to provide during the scrutiny, before engaging in any study that might end up being considered ineligible by the Authority.

The EHPM is proud of having facilitated this productive exchange between companies that are keen to support the safety of monacolin K. The high number of participants confirmed the interest of the sector in going forward on this dossier.

The main point shared by all the speakers and participants alike is the importance of joining our efforts and unite our strengths to reach the best results.

To quote the EHPM chair, Michel Horn in his closing remarks, “alone we go faster, together we go farther”.

If you missed our workshop, you can find the LIVE-tweeting highlights here.

Photos of the event are available here.

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