The most affected groups by this will be companies producing supplements containing monacolin, consumers who depend on monacolins to manage their cholesterol levels and the physicians who guide them in its use.
This decision delivers a significant setback to parts of the supplement sector, Luca Bucchini, food risk scientist and expert in food regulation, told NutraIngredients.
The EFSA opinion on RYR Supplements
The scientific opinion published by EFSA’s Panel on Nutrition, Novel Foods and Food Allergens reviewed data on the safety of monacolins, with the panel concluding that consuming monacolin K, the active compound in RYR, at doses as low as 3 mg per day could lead to severe adverse effects, including rhabdomyolysis (a serious muscle condition) and liver damage.
Despite submissions from industry stakeholders during the EU’s scrutiny period, EFSA concluded that there is insufficient evidence to establish a safe daily intake level for monacolins. The findings align with previous EFSA assessments, which flagged safety concerns due to monacolin K’s chemical similarity to lovastatin, a prescription statin drug.
The report also highlighted inconsistencies in the composition of RYR supplements, with variations in monacolin content and potential contaminants, and advised consumers to exercise caution when using these supplements, particularly those with existing health conditions.
Are monacolins banned in the EU?
If monacolins from RYR are deemed unsafe at any level, the EU is likely to impose a ban, Bucchini noted.
“A ban, with no threshold, is the most likely scenario despite the long tradition of use of RYR in traditional cuisine, an aspect that EFSA has ignored,” he said.
The EU’s regulatory stance on RYR differs from other markets. The United States allows RYR with low monacolin concentrations, and Canada, with no reported adverse events, permits up to 1 mg of monacolins per day. The UK’s position remains uncertain.
Bucchini explained that since many countries allow RYR in dietary supplements and health products, a zero-tolerance ban would be hard to justify scientifically and culturally, however, “the EFSA opinion gives the Commission and the Member States little room for alternatives.”
Bucchini also noted that monacolins occur in other fungi, but EFSA has “refused to analyze data in this regard.”
The ban would mean that companies could face legal action, such as product liability lawsuits, if they continue selling RYR supplements after relevant regulations come into effect, triggering widespread enforcement. And while some manufacturers outside the EU may still try to sell RYR supplements with monacolins to EU consumers online, it would be illegal.
Advice to brands and formulators
The EFSA opinion itself has no direct legal impact. However, Bucchini noted that within the next year, the European Commission will draft a regulation based on this opinion, likely leading to a full ban on monacolins from red yeast rice by listing them under part A (of the Annex to Regulation (EU) 2015/2283), meaning it is not allowed in food supplements or other food products within the EU.
Bucchini explained that by mid-2026, RYR supplements will probably be prohibited in the EU, potentially with a transitional period—though past actions suggest the Commission may take a strict approach.
“In the past, the Commission has been very aggressive against RYR,” Bucchini said.
The ruling will significantly affect the marketing of RYR supplements, particularly regarding health claims and consumer warnings. While RYR has traditionally been an effective cholesterol management option, adverse events have been reported, although “clearly above the current maximum level” of 3 mg per day, Bucchini said.
As a result, alternatives like Danacol, the dairy product made by Danone which is designed to help reduce cholesterol levels, will gain a market advantage, he continued.
Businesses will need to prepare for the likely ban throughout 2025, which is most likely going to require reformulation, replacing RYR with other ingredients.
In countries like Italy and Spain, many patients with borderline hypercholesterolemia have embraced monacolins in supplements while rejecting statins— the specific class of drugs that inhibit HMG-CoA reductase, an enzyme involved in cholesterol production in the liver.
Therefore, medical professionals are concerned that this ruling could negatively impact public health, Bucchini noted.
Some typical alternatives for heart health and cholesterol management include: plant sterols that may block cholesterol absorption in the gut; berberine, a natural compound from the Berberis plant, which has been found to help lower low-density lipoprotein (LDL) cholesterol and regulate blood sugar; niacin (vitamin B3), which may boost high-density lipoprotein (HDL) cholesterol while lowering LDL; and omega-3 fatty acids which may reduce triglycerides and inflammation.
EFSA opinion raises further concerns
As Bucchini noted, while there is widespread awareness of some of the issues related to monacolins at 10 mg, the real concern across the broader industry is that another effective substance is removed from those permitted for use in the EU.
“The industry is—I believe—even more worried that EFSA makes no attempt to establish safe levels on so-called ‘Article 8′ substances or look at intake of the substances in the diet despite being very clearly reprimanded by the General Court of the EU for failing to do so in the aloe-related rulings,” Bucchini said.
Article 8 (of the EU Regulation (EC) No 1925/2006) allows the European Commission to restrict or prohibit the use of certain substances in food if they pose a risk to public health. Under this regulation, EFSA is responsible for evaluating the risks of these substances.
However, as Bucchini explained, EFSA has been previously reprimanded by the EU’s General Court, following the ban of several hydroxyanthracene derivatives (HADs)—compounds found in aloe extracts.
In this instance, industry groups challenged the ban, arguing that EFSA failed to assess safe intake levels and overgeneralized risks without proving harm at real-world consumption levels, and the General Court of the EU agreed, annulling parts of the regulation.
Bucchini reported that some in the industry feel that EFSA and the European Commission are not considering scientific evaluations or regulatory decisions made by other jurisdictions (like the U.S. or other countries) when assessing substances.
“There is a lack of regard for what other jurisdictions have done,” he said. “As some in the sector have put it, ‘we can’t trust EFSA to use the best science and the Commission to be fair and proportionate’.”