There is strong science showing that probiotics help prevent common health problems, Rosanna Pecere, executive director at the International Probiotics Association (IPA), told the audience in Dublin. However, Europe still does not allow companies to say this clearly to consumers through authorized health claims.
As Pecere highlighted during a panel discussion on how regulatory priorities are evolving, recent economic evidence has highlighted a disconnect between probiotic science and current European regulation.
“We asked an economic expert to analyze how much the healthcare system could save if probiotics were used more for prevention in Europe,” she said. “The research was done across all 27 European countries using data and a method recognized by the European Commission. With just a 1% increase in the use of probiotics, we estimate about €10 billion in healthcare savings per year.”
However, Pecere noted that the regulatory system is lagging behind both science and economic value.
“Despite strong science, we still do not have authorized health claims,” she said.
“There is a regulatory gap, and recognition of probiotics as a category is the minimum change Europe can make. Europe is investing in microbiome research, but regulatory recognition has not kept up with the science.”
Closing the gap between science and regulation
Pecere did, however, note that it is clear Europe is taking steps in the right direction.
“We see a lot of money that the Commission is putting into funding projects on the microbiome—around €100 million for one project,” she said. “This is why we need to recognize probiotics as a category. It is really the minimum Europe can do if it continues to invest in microbiome research.”
Dr. Yolanda Garcia-Cazorla, scientific officer at the European Food Safety Authority (EFSA), told the audience that it is increasingly important to bridge the gap between science and regulatory bodies.
“It is clear that there is a gap between regulation and what industrial science is telling us,” she said. “Our role is to try to reduce this gap and integrate new scientific knowledge into regulation.”
EFSA’s objective is to understand how this knowledge can be introduced into legal frameworks.
“Regulation is slow, but we are clearly moving in the right direction,” Dr. Garcia-Cazorla added.
Laying the groundwork for regulatory change
EFSA has now adopted its first-ever horizontal guidance for microorganism risk assessment, replacing siloed approaches.
“In September 2025, the panel adopted a new guidance for the characterization and risk assessment of microorganisms,” Dr. Garcia-Cazorla said. “This is very important guidance because it is the first time that it is horizontal.”
She explained that different EFSA panels operate under separate rulebooks. As a result, using the same microorganism in animal feed and in food for human consumption requires submitting separate applications and meeting different requirements—even though the microorganism is the same.
Now, EFSA uses one common set of rules, and a microorganism is evaluated the same way no matter how it will be used.
“This creates a more equal and predictable system for everyone,” Dr. Garcia-Cazorla said. “The guidance reflects advances in science.”
She noted that EFSA’s previous rules mainly covered bacteria and fungi, while other types of microorganisms were largely outside the formal assessment framework. However, its new rules cover more types of microorganisms, including bacteriophages, as they are increasingly used in food and food-related applications.
