CPHI Milan 2026: ProBiotix Health to present probiotics ahead of EU Monacolin K ban

ProBiotix Health will bring the gut-heart axis to center stage at the upcoming CPHI Milan tradeshow in Italy next month. Amid evolving EU regulations on Monacolin K, a natural compound found in red yeast rice that is used to lower cholesterol, the probiotic formulator will pitch its patented strain, Lactiplantibacillus plantarum (LPLDL), as an alternative for supporting cardiometabolic health. 

Nutrition Insight speaks with Cellan Davies, head of Marketing at ProBiotix Health, to learn more. “At CPHI, we’re focusing on formulating for the future of cholesterol and cardiometabolic health, particularly the opportunity created by the changing regulatory landscape of Monacolin K.”

The EU is expected to ban monacolins from red yeast rice in foods and dietary supplements. Authorities have found that it acts as an unapproved prescription drug, having the same chemical structure as the cholesterol-lowering prescription medicine lovastatin.

The EU Food Safety Authority has also noted serious side effects of Monacolin K, such as muscle and liver damage.

Probiotics for heart health

Davies shares that ProBiotix Health is positioning itself with a greater emphasis on the connection between the gut microbiome and cardiometabolic health. 

Cellan Davies, head of Marketing at ProBiotix Health.“Our patented strain LPLDL is central to this, with multiple independent human intervention studies demonstrating its positive impact on multiple key cardiometabolic biomarkers,” he notes.

ProBiotix Health originally isolated the strain from tomatoes. It highlights that Lactobacilli are commonly found in the human gut microbiome and have been used as probiotics. 

The company details that LPLDL has been found to positively impact total, LDL, and HDL cholesterol, alongside apolipoprotein B, triglycerides, and blood pressure in human intervention studies.

“This reflects the evolution of ProBiotix Health beyond traditional digestive health positioning toward scientifically validated solutions that support a broader range of cardiometabolic health needs,” says Davies.

“ProBiotix Health recognizes that cardiometabolic health is complex and that there is still more to understand about the relationship between the gut microbiome and cardiovascular health.”

“Our ongoing research aims to explore where the microbiome and LPLDL could play a role beyond established cardiovascular benefits, opening new opportunities across the wider cardiometabolic health landscape.”

What are customers seeking

According to Davies, one of the biggest questions ProBiotix Health expects to hear from most customers at the show is, “What comes after Monacolin K?”

ProBiotix Health expects most customers at the show to ask, “What comes after Monacolin K?”“With regulations around Monacolin K changing, reformulation is likely to be a major topic of conversation as brands consider the future of existing cholesterol products. However, the conversation with us will go beyond simply finding a replacement ingredient.”

“Brands will continue to look at how they can develop more differentiated, future-ready cardiovascular and cardiometabolic products,” he continues. “This creates an opportunity to rethink the selection criteria for the next generation of cholesterol ingredients, prioritizing regulatory confidence, robust clinical proof, true differentiation, and a clearly understood mechanism of action.”

He stresses that instead of replacing one established ingredient with another, reformulation is an opportunity to raise the bar on cholesterol products.

Market opportunities and challenges

ProBiotix Health is seeing opportunities in Europe, the US, and other international markets for cholesterol, cardiovascular, and broader cardiometabolic health.

Companies are reformulating cholesterol-supporting products in response to regulatory changes, and brands are developing new concepts around heart health.“Demand from brands spans clinically validated ingredients and commercially ready finished formulations,” says Davies. “This includes companies reformulating existing cholesterol-supporting products in response to changes in the regulatory environment and brands developing entirely new concepts around cardiovascular and cardiometabolic health.” 

“Flexibility is important as new product development opportunities are not limited to a single format. LPLDL can be incorporated into finished dosages, which offers brands the opportunity to fit different consumer and market requirements.”

However, the biggest constraint on the cholesterol health category now is regulatory uncertainty, he notes.

“With regulatory changes to Monacolin K, we expect even greater scrutiny to be applied to other established ingredients. In the future, expect more formulators and new product developers to look for solutions that combine demonstrated efficacy and safety. This will assist in establishing their product positioning coupled with long-term regulatory confidence.”

Davies sees significant opportunities to do more than simply reformulate using the same “next ingredient” as other brands are using in their finished products. “This is a point of change for brands to differentiate with clinically validated, innovative solutions such as LPLDL — designing products that fit not only emerging market trends but consumer requirements for efficacy too,” he concludes.