Ad hoc stakeholder meeting with interested food business representatives of EFSA’s Article 8(4) Opinion related to monacolins from red yeast rice

Background

On 23 May 2025, EFSA held an online ad-hoc meeting with interested food business representatives on “EFSA’s Scientific Opinion on additional scientific data related to the safety of monacolins from red yeast rice submitted pursuant to Article 8(4) of Regulation (EC) No 1925/2006” (hereafter Article 8(4) opinion related to monacolins from RYR). The opinion was published in February 2025.

In line with its commitment to engaging with stakeholders, EFSA invited both the organisations that submitted data during the scrutiny period and the umbrella organisations that are part of EFSA's registered stakeholder scheme operating in relevant sectors to attend the meeting. The meeting was attended by 16 participants, representing 12 organisations of interested food business operators.

During the meeting, EFSA scientific officers delivered a presentation that explained and clarified the NDA panel mandate, the data considered and the methodological approach applied in EFSA’s Article 8(4) opinion related to monacolins from RYR. The presentation content included clarification needs and questions submitted by interested participants ahead of the meeting. Additional follow-up clarifications were provided to participants during the Q&A discussions.