Since the late 2000s, more than 400 health claim applications for probiotics have been submitted to the European Commission, but none have been authorized for dietary supplements. In fact, the term ‘probiotic’ itself is treated as an unauthorized health claim within the European Union.
This is because the World Health Organization’s definition of probiotics—“live microorganisms which when administered in adequate amounts confer a health benefit on the host”—implies that probiotics have inherent health-promoting effects, something which the European Commission says could be misleading to consumers unless it can be scientifically substantiated.
The same is true for prebiotics, which are defined as “a non-viable food component that confers a health benefit on the host associated with modulation of the microbiota” by the Food and Agriculture Organization (FAO).
“Considering the broad definitions of FAO and WHO on probiotics and prebiotics, the European Commission considers that in the naming of probiotics and prebiotics, there is a description or indication of a functionality or an implied effect on health,” explained David Pineda Ereño, managing director of regulatory firm DPE International Consulting.
“In the EU, health claims must be authorized for their use in food and food supplements […] Therefore, the European Commission considers the terms probiotics and prebiotics to be non-authorized health claims.”
The terms ‘probiotics’ and ‘prebiotics’ are therefore heavily regulated and restricted within the European Union. Meanwhile, postbiotics face their own set of unique challenges given the lack of an agreed definition. What’s more, a number of Member States have developed and implemented their own laws, creating a nuanced and inconsistent legal landscape.
How is the safety of biotic products assessed in the European Union?
In the European Union, the regulation of biotic products (including pre, pro and postbiotics) is characterized by a non-harmonized framework. There is no dedicated law governing biotic products, and they are instead regulated under general food law and the Food and Supplements Directive (2002/46/EC).
While there is no regulatory list of probiotic microorganisms that are permitted in the European Union, the European Food Safety Authority (EFSA) has drawn up a positive list of microorganisms which EFSA has evaluated for safety, known as the qualified presumption of safety (QPS).
Companies do not directly apply for QPS status, but EFSA evaluates their safety following a technical dossier application from companies seeking market authorization to use a microorganism in food or feed.
“QPS means that EFSA, under certain conditions, considers a microorganism safe,” explained Luca Bucchini, managing director at Hylobates Consulting. “In practice, many consider QPS as a reference point for safety. So, even internationally, in the context of submissions in the U.S. or elsewhere, QPS status is a positive factor for applications.”
If a microbe has not been granted QPS status, it does not necessarily mean it is unsafe but rather that there is insufficient data to clarify its safety. For microorganisms which do not appear on the list, companies submitting applications will be subjected to a more rigorous safety assessment to determine whether it can be used in food or feed in Europe.
Postbiotics generally do not appear on the QPS list given that they are not living microorganisms, and the same is true for prebiotic ingredients. In both cases, ingredients which have a history of consumption before 1997 are automatically deemed safe, while newer ones must undergo a novel food safety evaluation.
What is the definition of a probiotic?
In 2001, the United Nations World Health Organization and the Food and Agriculture Organization defined probiotics as “live microorganisms which when administered in adequate amounts confer a health benefit on the host”. This definition is widely accepted as the standard, international scientific definition.
How are probiotics regulated within the European Union?
Health claims represent one of the biggest regulatory hurdles for probiotics in the EU. The only approved claim related to bacterial strains is for yogurt cultures improving lactose digestion. This claim specifically applies to L. delbrueckii subsp. bulgaricus and Streptococcus thermophilus (minimum 100 million CFU/g) and is only permitted on yogurt containing at least colony-forming units (CFU) of live starter microorganisms per gram.
This means many dietary supplement companies operating in the European Union are prevented from using any health claims on their probiotic products, as well as using the term ‘probiotic’ itself. However, the European Commission’s stance on the term probiotic was published in the form of guidance only and is therefore not legally binding. A number of member states have therefore developed and implemented their own guidance to allow the term ‘probiotic’ to be used on food and feed products.
Denmark and France, for example, allow the use of the term probiotics in food supplements to characterize the nature of the product, and Italy permits the term providing that specific conditions are fulfilled. Other EU Member States which allow the term include Bulgaria, Cyprus, Czechia, Greece, Malta, The Netherlands, Poland and Spain.
Member states following EC guidelines often use the term ‘live bacteria’ on products instead to communicate to consumers that their product contains probiotic strains. Many of these countries follow the European Federation of Associations of Health Product Manufacturers’ (EHPM) Probiotics Guidelines which stipulate that probiotic strains must be characterized by genus, species and strain designation.
Even so, the International Probiotic Association (IPA) says the EC’s guidance is hindering the potential of the sector, and the industry body has long called for a more cohesive approach to probiotic regulation.
In 2023, the IPA commissioned a consumer survey in eight European countries to gather opinions, trends and behaviors surrounding probiotics. The research, which collected feedback from 8,000 participants, revealed that consumers are better informed about probiotics in countries where the term is allowed (or partially allowed) by national guidance, suggesting that restrictive regulations are likely to be impacting consumer awareness of probiotics and therefore the European probiotic market.
According to the IPA’s executive director Rosanna Pecere, part of the issue stems from the European Commission’s resistance to formally incorporate the WHO and FAO definition of probiotics into its regulatory system—something which is surprising, she noted, given that the European Commission recently recognized microbiome research as a key driver of innovation in health and prevention in its Life Science Strategy.
“This recognition must be matched by efforts to fill the existing regulatory gap to enable the quality and effective development of microbiome-based products,” she said. “We continue to advocate for the ultimate goal of recognition of the probiotic category and distinction between general descriptive uses of the term ‘probiotic’ and specific claims, as recognized in other jurisdictions (e.g., Canada and Thailand).
“This would allow for appropriate consumer information while maintaining the scientific standards required for health claims under the nutrition and health claim regulation. It should also include provisions for regular updates based on scientific advances, especially as innovation in probiotic strains continues to evolve.”
Prebiotics and synbiotics: Claims and terminology
As with probiotics, the European Commission has not integrated a formal definition of prebiotics into its regulatory framework. And while the term ‘prebiotic’ is not authorized for dietary supplements, there are a number of health claims which can be used alongside prebiotic ingredients.
For example, “barley grain fiber contributes to an increase in fecal bulk” and “beta-glucans contribute to the maintenance of normal blood cholesterol levels” are both approved health claims.
Some nutrition claims can also be made for prebiotic ingredients. For example, prebiotic ingredients that qualify as sources of dietary fiber may carry authorized claims such as “source of fiber” and “high in fiber”, provided they meet the conditions set out under the relevant regulations.
Given the lack of harmonized criteria for using ‘prebiotic’ as a term in the EU, several EU member states have chosen to provide national guidance on the use of ‘prebiotic’ in the marketing of foods and dietary supplements.
“As in the case of probiotics, member states are taking national positions on the use of this term,” Pecere said. “By way of example, in Italy, prebiotics that meet the definition of fibers can use the wording ‘promotes intestinal flora balance’ on the label. In Spain, the use of the term prebiotic is authorized only for products containing FOS or inulin.”
For synbiotics, which provide both prebiotic and probiotics in a singular product, the law is hazy, and national positions are very limited on the use of this term. Only Italy regulates the use of the word ‘synbiotic’.
What is the definition of a prebiotic?
In 2007, the FAO defined prebiotics as "a non-viable food component that confers a health benefit on the host associated with modulation of the microbiota”. More recently, in 2017, ISAPP suggested that a prebiotic is “a substrate that is selectively utilized by host microorganisms conferring a health benefit." In 2025, the IPA officially adopted ISAPP's definition of a prebiotic, showcasing their alignment.
Postbiotics: A gray regulatory area
Postbiotics are relatively new to the commercial biotic market. The first postbiotic to receive novel food approval was pasteurized Akkermansia muciniphila, which was authorized in 2021.
Given their novel nature and recency to the market, there is no specific regulatory classification for postbiotics, a situation which is further complicated by a lack of consensus on a definition and other considerations such as differences in manufacturing techniques, safety, storage and stability.
More than 20 definitions of a postbiotic have been published across peer-reviewed literature, and both the IPA and the International Scientific Association for Probiotics and Prebiotics (ISAPP) have proposed differing definitions.
While ISAPP defines postbiotics as a “preparation of inanimate microorganisms and/or their components that confers a health benefit on the host”, the IPA defines them as “non-viable microbial ingredients conferring a beneficial physiological effect.”
In the absence of a universally accepted definition, no formal positions have yet been issued by regulatory authorities on the use of the term postbiotics, and the European Commission has yet to provide comment. There have also been no approved health claims related to postbiotic ingredients.
“There is no real postbiotic regulations to speak of—no accepted definition, or regulations/frameworks,” said George Paraskevakos, executive director of the IPA. “That being said, the IPA postbiotics paper offers a practical, industry-focused view on how postbiotics can be clearly understood and applied across global markets.
“It highlights the current lack of alignment in definitions and calls for science-based frameworks to bring greater clarity and consistency to the category. The paper also outlines key considerations around manufacturing, safety and regulatory pathways, with a strong emphasis on consumer protection. Overall, it aims to help industry and regulators navigate this evolving space while supporting responsible innovation and market growth.”
The IPA has also recently established a Postbiotic Definition Alignment Task Force to help support the development of a clear, consensus-based definition and coordinated a new framework for postbiotic classification: a ‘decision tree’ which determines what constitutes a postbiotic and what does not, and differentiates postbiotics into four categories.
The decision tree is designed to be applied to all ingredients marketed as postbiotics to assess their safety, quality and efficacy and better inform regulatory guidelines and industry standards.
ISAPP has also published several documents alongside its consensus definition, addressing frequently asked questions and providing guidance on the quantification of postbiotics.
What is the definition of a postbiotic?
There is no single, agreed upon definition of a postbiotic. While more than 20 definitions have been published across peer-reviewed literature, ISAPP defines postbiotics as a “preparation of inanimate microorganisms and/or their components that confers a health benefit on the host”, and the IPA defines them as “non-viable microbial ingredients that confer beneficial physiological effects when administered through food and dietary supplements."
Looking ahead
Considering that both ISAPP’s and the IPA’s definition of a postbiotic infers a health benefit, it is likely that the European Commission will, at some point, update its guidance to stipulate that the term ‘postbiotic’ is a health claim that requires approval from EFSA. However, this is yet to be established.
The EC was also expected to present a legislative proposal to revise the EU food labeling legislation in 2023, but it never materialized due to divergent positions among EU Member States in a number of topics, according to Pineda Ereño.
“A future legislative proposal to revise these regulations could provide an opportunity to introduce elements that would further harmonize probiotic labeling,” he said. “However, there appear to be no plans in this regard at the moment.”
Even so, work by industry bodies such as the IPA and ISAPP have led to meaningful progress, with more than 12 countries now allowing probiotic labeling. Building on this momentum, the IPA says it will continue to advocate for the ultimate goal of securing an approved health claim for probiotics in Europe, something which could bridge the gap between scientific advancement and regulatory practice.
To support this objective, the IPA has conducted a socio-economic impact assessment (SEA) on probiotics in Europe to quantify the potential economic and societal benefits of increased probiotic use. By evaluating the potential benefits of harmonizing probiotic standards and analyzing the socio-economic impacts of a greater uptake in probiotics, the research predicts that the quantified economic benefits could exceed €10 billion annually. Pecere said this paper provides solid evidence of the benefits of harmonized legislation.
“Overall, a harmonized EU framework would support the functioning of the internal market, reduce regulatory complexity, contribute to a consistent level of consumer protection across Member States and facilitate greater use of probiotics, likely realizing significant socio-economic benefits,” she said.
