Project for a European Commission Regulation: monacolins towards a definitive ban
The regulatory framework for monacolins from red yeast fermented rice is approaching its final definition. On March 4, 2026, the European Commission notified the World Trade Organization (WTO) of a Project for a Regulation (code G/SPS/N/EU/923).
This proposal mandates the shift of monacolins from Part B (restricted substances) to Part A of Annex III of Regulation (EC) No 1925/2006, thereby prohibiting their use in foods, including dietary supplements.
Although the public consultation remains open until May 3, 2026, the probability of avoiding the ban is limited. However, for products already on the market at the time of entry into force, a 12-month transitional period is expected.
Scientific background and evolution
In 2018, EFSA conducted a scientific opinion which highlighted the impossibility of establishing a daily intake level of monacolins from red yeast rice considered safe for human health. Based on that opinion, Regulation (EU) 2022/860 was issued to place monacolins in Annex III, Part B (restricted substances), introducing the following requirements:
- Maximum limit: a dosage of less than 3 mg of monacolins per daily dose.
- Labeling: specific mandatory warnings to be included on the label.
Simultaneously, monacolins were included in Part C for “Community surveillance“.
The limitations imposed by Regulation (EU) 2022/860 inevitably affected the requirements underlying the authorization of the health claim on Monacolin K: “Red rice Monacolin K contributes to the maintenance of normal blood cholesterol levels”. As this claim is supported by a daily dose of 10 mg of Monacolin K, it can no longer be reported on the label under the current 3 mg/day safety restriction.
The surveillance phase (from 2022 to the end of 2025) represented the final window for the industry to provide new safety data. However, as confirmed by the EFSA review in January 2025, the scientific evidence provided was not sufficiently robust to establish a safe level of consumption, leading the Commission to propose the transfer to Part A.
Procedural timeline (Regulatory Procedure with Scrutiny)
The WTO-notified draft measure (G/SPS/N/EU/923) follows the Regulatory Procedure with Scrutiny, involving several institutional steps. Subject to final confirmation, the expected timeline is as follows:
- May 3, 2026: deadline for the WTO public consultation.
- Third Quarter 2026 (likely not before September 2026): following the SCoPAFF vote and the subsequent scrutiny period by the European Parliament and the Council, the regulation may be published. It will enter into force on the 20th day after publication. From that moment, the ban on placing new products on the market will apply.
- Transitional period: a 12-month period for the disposal of existing stocks (legally marketed before entry into force) will start from the entry into force of the regulation.
- Final Deadline (indicatively Q3 2027): from this point, the commercialization of products containing monacolins will be prohibited.
Update of May 13, 2026 – Ban on Monacolin K from Red Yeast Rice
On May 13, 2026, the Member States’ Standing Committee voted and approved the proposal to ban the use of Monacolin K derived from Red Yeast Rice in food supplements.
During the vote, Italy voted against the ban, while Portugal and the Czech Republic abstained, highlighting the need for a longer transitional period and to allow the industry to submit further scientific data.
What are the next steps?
Following the scrutiny period by the European Parliament and the Council, the Regulation will be published in the Official Journal of the European Union. It will enter into force twenty days after its publication, with a projected one-year transitional period for application.
It is estimated that, barring any changes, the new provisions will become fully applicable between late 2027 and early 2028.
>>> Complife is ready to provide full support for the regulatory and testing activities required for product reformulations.
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