This week, the EU accepted EFSA’s risk assessment on the fermented rice ingredient to the World Trade Organization (WTO), signaling a likely full ban on monacolins from red yeast rice in EU food and dietary supplements.
In March 2025, EFSA’s Panel on Nutrition, Novel Foods and Food Allergens reviewed data on the safety of monacolins, 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 there is insufficient evidence to establish a safe daily intake level.
Now, the European Commission is likely to move monacolins from red yeast rice into Part A (prohibited substances) of Annex III of Regulation (EC) No 1925/2006. The draft is currently open for comments through the WTO notification process, with the final regulation expected around the middle of this year.
EU to ban monacolins in Red Yeast Rice
Dr. Jerome Le Bloch, head of scientific affairs at Foodchain ID, told NutraIngredients it was ‘almost certain’ monacolins from red yeast rice will be added to the list of substances that are prohibited from being added to foods in the European Union, meaning companies cannot add it to foods or food supplements in the EU and products containing it cannot legally be sold as foods or supplements in the EU market.
“I don’t see how this consultation at the WTO level will change the draft regulation,” Le Bloch said.
He did however, note that publication of the regulation may spur legal action, much as has been done on hydroxyanthracene derivatives, where, following several companies and trade groups filing actions for annulment, the EU General Court annulled parts of the ruling in 2024.
Despite this possibility, any legal action does not block the entry into force of the regulation, and monacolin-containing red yeast rice preparations will not be usable in Europe by the end of the transitional period.
Are there nutraceutical alternatives to monacolins from red yeast rice?
The ban applies only to monacolins from red yeast rice, not to red yeast rice itself, Le Bloch explained, meaning that red yeast rice products without monacolins could still be authorised, with some brands already developing monacolin-free red yeast rice products.
“There is a risk of novel food classification if the process to eliminate monacolins is new, but this may be a solution,” he said.
Dr Miguel Florido, a nutraceutical formulation consultant with a focus on cardiometabolic health, said monacolins will leave a large therapeutic gap, as they have been one of the most effective lipid-lowering nutraceuticals because it functioned similarly to a statin.
Current alternatives are bergamot polyphenols and berberine, although the botanical derivative is also under safety review by the EFSA, he explained.
Bergamot acts through several pathways linked to cholesterol metabolism and oxidative stress, while berberine works through AMPK and improves lipid metabolism and insulin sensitivity. Both lower LDL levels less than monacolin K but provide broader metabolic benefits, he explained.
Furthermore, phytosterols offer a supportive option, but their effect is moderate and requires high doses. Some botanicals, such as artichoke extracts and citrus flavonoids, show potential but still lack strong evidence, he noted.
“In the short term, I believe the category will rely much more on rational multi-ingredient formulations than on the discovery of a single compound capable of replacing monacolin K,” Dr. Florido said. “At the moment, there is simply no standalone ingredient that combines the same level of potency, clinical familiarity, and market maturity.”
Monacolin K’s market success also exposed some structural weaknesses of the supplement market, he said.
“The ingredient spread across a very heterogeneous landscape, with wide variability in raw material quality, monacolin standardisation and product purity,” he told NI. “That flexibility helped the category grow, but it also made safety signals and attribution of adverse effects more difficult to interpret.”
While the ingredient is widely used to manage mild hypercholesterolaemia, solutions are shifting away from a purely cholesterol-focused model toward a broader view of cardiometabolic risk that emphasises obesity, dysfunctional adiposity, insulin resistance and inflammation, he said.
“That is why we are already seeing the industry move toward combinations built around bergamot, berberine and phytosterols, often supported by fibre, artichoke extracts, or microbiome-oriented strategies,” Dr. Florido said. “From a formulation standpoint, this is logical as instead of relying on one dominant mechanism, these combinations try to accumulate complementary effects across cholesterol metabolism, bile acid turnover, insulin sensitivity, postprandial lipaemia and low-grade inflammation.”
The next generation of heart health support
The next generation of heart health support will shift from chasing a ‘single miracle’ ingredient to creating systemic solutions, Dr. Florido said.
“I think the sector should be careful not to frame this transition as a search for ‘the next monacolin’,” he said. “That would be too narrow and probably the wrong objective. The real opportunity lies in developing more comprehensive cardiometabolic solutions.”
In the immediate term, many companies are already reformulating products by removing monacolin K and replacing it with familiar ingredient combinations, Dr. Florido noted. But while he says this response is understandable, it risks creating many similar, repetitive formulations.
He believes real innovation will require new scientifically supported ingredients and a shift from focusing only on cholesterol reduction to broader metabolic health.
“The strategic future lies in repositioning the category toward broader metabolic health,” he said.
“For nutraceuticals, the post-monacolin era represents an opportunity to rethink priorities,” he said. “Instead of focusing exclusively on cholesterol numbers, the field could aim at outcomes that are far more relevant to long-term cardiometabolic prevention.
“In that sense, the future may be less about replacing one LDL-lowering molecule with another, and more about redefining what success actually means in cardiometabolic nutraceuticals.”
Attention on GLP-1 agonists has highlighted that reducing body weight and visceral fat while improving metabolic regulation also lowers cholesterol, LDL, triglycerides, and blood pressure, reducing overall cardiometabolic risk. Therefore, focusing on these interconnected pathways could create a more effective and coherent therapeutic model than trying to lower LDL in isolation, he suggested.
“One area that I find genuinely promising is microbiome-targeted strategies, not because they replicate the direct lipid-lowering mechanism of monacolin K, but because they may fit much better into the future of cardiometabolic nutraceuticals: more systemic, more integrative, and less narrowly focused on LDL alone,” he said.
