Regulatory update on red yeast rice monacolins in food supplements. The European Commission is evaluating a possible total ban, with transitional periods of 6 or 12 months. Analysis of timelines, regulatory implications, EFSA’s role and impact on nutraceutical companies. Red yeast rice monacolins are once again at the center of the European regulatory debate. In…
In this article we are going to analyze the questions and answers regarding the new European Regulation 2017/745 or MDR (Medical Device Regulation). Recall that we are among the first Italian companies to have obtained MDR certifications for some of our medical devices. How are economic operators regulated in the new MDR regulation? In…
Extension of the transition period: the proposal to amend the European regulation 2017/745 MDR The proposal to amend the European Regulation 2017/745 MDR and the European Regulation 2017/746 IVDR, announced on December 9 during the EPSCO meeting came earlier than expected and was already published on the European Commission’s Medical Device website on January 6.…
Red yeast rice, LDL cholesterol, dietary supplements, statins, European regulation For years, monacolin K has symbolized the meeting point between nutraceuticals and cholesterol management. Authorized with an official claim by EFSA, it has become firmly established in the dietary supplement market aimed at maintaining normal LDL cholesterol levels. Today, however, the scenario has changed. The…