In EU Reg 1169/2011 on the provision of food information to consumers, one can read:
‘The prime consideration for requiring mandatory food information should be to enable consumers to identify and make appropriate use of a food and to make choices that suit their individual dietary needs.’
Indeed, EU consumers should have access to transparent and equitable information regarding food products, along with the latest innovative solutions backed by recent scientific discoveries. This access is crucial for enabling them to make informed decisions that promote their well-being and health.
Yet, in Europe, the probiotics sector is facing a lack of harmonization and a near-total veto on any health claims, despite the dynamism of the field’s research. What happened, where are we now, and what can we hope for in the future?
Historic: 2011, the blackout on probiotic claims
According to the widely recognized FAO/WHO definition (2001), revised by Hill et al. (2014), probiotics are defined as “Live microorganisms that, when administered in adequate amounts, confer a health benefit on the host”.
This definition, although it bears no legal value, is widely recognized and used across the globe, by regulators and industry alike. It is however subject to interpretation and discussion: what can be considered as adequate amounts? With which units of quantification? What outcome would qualify as a benefit? Which population is considered? Which variability is tolerated?
The European Commission, based on this definition and the EC Regulation 1924/2006 for the use of nutrition and health claims in foods, as indicated in the guidance document interprets that “the term ‘probiotic’ is to be considered as implying a health benefit and indications such as ‘contains probiotics’ should therefore be regarded as health claims when considering new applications”.
Are there health claims and “official” probiotics out there?
EFSA has published guidance on how to prepare a health claim application (updated in 2017 – https://www.efsa.europa.eu/en/press/news/170131) and a document aligning the General scientific guidance for stakeholders on health claim applications (General scientific guidance for stakeholders on health claim applications | EFSA (europa.eu)).
EU Commission Guidance on the Regulation N° 1924/2006 clarifies the distinction between nutrition claims and health claims made on foods:
- A claim is a nutrition claim if in the naming of the substance or category of substances, there is only factual information (Nutrition claims examples: Contains lycopene; Contains lutein)
- A claim is a health claim if in the naming of the substance, or category of substances, there is a description or indication of a functionality or an implied effect on health.
According to EFSA a Health claim is any statement used on labels, in marketing, or in advertising that health benefits can result from consuming a given food or from one of its components such as vitamins and minerals, fiber, and ‘probiotic’ bacteria.
Hundreds of health claims dossiers have been submitted to EFSA for probiotics and only one article 13.1 claim was authorized, in 2010, on lactose digestion for yogurt or fermented milk containing at least 100 million cfu/g of live L. bulgaricus and S. thermophilus (https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2010.1763).
Impact on the market
According to this regulatory framework and the virtual absence of authorized health claims, probiotics and prebiotics are the category of foods the most negatively affected by Nutrition and Health Claims Regulation.
Euromonitor graciously shared for the purpose of this article market sales in different regions of the world between 2010 and 2022 (Figure 1). This data reveals that as of 2010, the rise of awareness in the probiotics and microbiome sector led to an important surge in sales in the consumer healthcare category, which retail value grew by 350 % globally between 2010 and 2022. In this same period, the progression in Europe was only 180%, only half of the average global growth. In North America, retail value was multiplied by 4, when in APAC, Latin America and Middle East and Africa regions, the growth was about 5-fold. If we exclude Europe, the average global growth in probiotic supplements would have been by 4,4.
This enables us to make a calculation based on the hypothesis that, if the claims were similar to other regions of the world, the sales progression would also be aligned. Applying the multiplicator of 4,4 between 2010 and 2022 in Western Europe posits that sales could have reached over 3,1 billion USD in 2022 alone just for the dietary supplements category, compared to the effective 1,2 billion.
Overall, across Europe in the span of the past decade, the loss of earnings is immense. It implies less chance for European players to reinvest in production optimization, science & innovation, and to stay competitive, even though all major historic probiotic producers were European.
Impact for consumers
The raison d’être of the regulation on the provision of food information to consumers is to protect them from deceptive claims and to provide them with the appropriate details to enable informed decisions for their diet and health. For Basil Mathioudakis, who worked in the European Commission and was a panelist in this year’s Barcelona Probiota regulatory spotlight: “the history and objective behind the European food law were to protect human health, consumer interests, fair trading and free circulation of goods in the EU”.
However, consumers rely heavily on claims to make such informed decisions, and today, in Europe, they are in the dark. As highlighted by an IPA Europe survey, consumers are feeling uninformed and are asking for more information on the products. Dr. Chyn Boon Wong confirms that in Japan, where regulatory bodies authorize health claims for probiotics on gut health and cognition, the understanding is at a higher level.
Indeed, requiring the highest scientific standards, when these are out of reach for even the best strains and best players in the industry, implies that the most scientifically-backed products stand on the same shelves with the same absence of claims as the “cowboy products” – but the latter are cheaper.
For the exceptionally informed consumer who reads scientific publications and knows what strain and concentration they want, there is no connection to finding the products and brands on the market. So, there is no access to the information starting from the product, and no access to the product starting from the science. This disconnect is a major hurdle for consumers, healthcare professionals, and industry alike.
FMCG Gurus 2022 reports show that consumers, overwhelmingly, don’t understand what probiotics are and what is the difference between the different biotic categories (probiotics, prebiotics, synbiotics, postbiotics). They are 77% not to check the bacteria strains on a probiotic before buying it, while about 70% say clinical evidence on probiotic packaging to support health claims is important.
“Consumers are left in the dark. If you can’t say something on the label that is informative then how does the consumer know what to expect from taking something?” – Dr. Gregory Reid, professor of microbiology, immunology and surgery at the University of Western Ontario, and one of the leading global researchers in probiotics. (Source: Nutraingredients.com) (Source: NutraIngredients).
Some key opinion leaders, doctors and writers try to bridge the gap with books and recommendations of products they checked and tried, but their vision of the market can’t be exhaustive and objective, and although this is useful guidance for consumers, this can’t be expected to solve the problem. We need a process of independent reviewers who assess the science for each product and submitted claim, with a reasonable set of expectations, approving claims based on real data. As already exists in Canada and Japan for example.
Where are we now with declaring probiotics on the pack in Europe?
There is variation in how different member countries have opted to implement the existing European regulations. Bulgaria, Czech Republic, Denmark, Greece, Italy, Malta, the Netherlands, Poland, Spain, and France now accept the labeling of the term probiotic on supplements (NutraIngredients Europe), as a reference to nutritional/physiological effects and/or as category name. It is important to note that while the conditions of use for the term ‘probiotic’ are generally similar, they are not identical across EU jurisdictions. The IPA Europe provides a legal framework detailing the situation per country here.
In January 2023, the French authorities DGCCRF part of the Ministry of Economy published an official letter authorizing the use of the term “probiotic” on food supplement packages, provided they meet the definition and conditions of use.
The definition they rely on is “Living microorganisms, which, when consumed in adequate quantities, have a beneficial effect on the health of the host by contributing to the balance of the intestinal flora”.
Conditions of use:
- a probiotic dosage of at least 10^7- 10^9 live cells of a strain per day
- only a claim referring to the balance of the intestinal flora is authorized
- the strains should have a history of safe consumption (not novel food)
- strains must be well characterized and not bear antibiotic resistance
Limits: this new opportunity to claim “probiotic” relies on the concept of “contributing to the balance of the intestinal flora” which beyond using outdated terminology, does not consider the scientific community’s difficulty in defining a healthy microbiota, and thus what modulations of the microbiota could be considered as positive. It also fails to recognize that probiotics benefits can be mediated by many other mechanisms than an impact on the microbiota. For example, direct modulation of the immune system, metabolism of short chain fatty acids, production of metabolites of interest, as the example of Hafnia alvei HA4597 producing ClpB acting as a mimetic of a satiety hormone…
In addition, the currently used definition reinforces the limiting belief that probiotics can only play a role in digestive health, restraining the ability of companies to communicate the potential benefits of probiotics beyond the gastrointestinal tract, in areas such as metabolism, cognition, bone density, skin health, and more. Other limitations are the fact that the term “probiotic” is approved for use in supplements but not in food applications, and that the clarification left out “prebiotics” in the status quo.
Italy was one of the first European countries to make its own interpretation to allow the labeling of the probiotic term. The guidelines were published by the Ministry of Health in 2013 and revised in March 2018 (C_17_pubblicazioni_1016_ulterioriallegati_ulterioreallegato_0_alleg.pdf (salute.gov.it).
In Italy, probiotics can be labeled as such, and accompanied by the claim “promotes the intestinal flora” if:
- they have long been used to supplement the human intestinal microflora (microbiota)
- they are considered safe for use in humans (QPS benchmark, absence of transmissible antibiotic resistance)
- they are active in the intestines in such a quantity as to be able to multiply there (minimum of 10^9 live cells per day, until the end of shelf life)
- the microorganism is characterized down to the strain level
The Spanish Q&A document refers to the only authorized health claim and their position is based on the ‘principle of mutual recognition’ laid down in the Treaty on European Union: Probióticos en los alimentos (aesan.gob.es).
The document answers questions such as: What are probiotics? What is microbiota? Are probiotics authorized in food? What information may appear on the labeling of food?
In the area of food supplements, many food supplements on the market label “probiotic/s”. These products arrive from different EU countries, where they are allowed to be marketed under this name, and therefore cannot be prevented from being marketed in Spain under the ‘principle of mutual recognition’ laid down in the Treaty on European Union.
Therefore, until there is a uniform approach within the Member States of the European Union, the term ‘probiotic/s’ can be accepted on the label of foodstuffs, both domestically manufactured and in other countries of the EU. However, the use of this term cannot be accompanied by any health claims unless expressly authorized under the European Union Regulation.
The Guidance of the self-regulatory body KOAG/KAG on NHCR, published in 2018, indicates that: ‘For probiotics, you can indicate on the label the obligatory category of the micronutrients or substances that are characteristic of the food supplement. When used in any other way, for promotional purposes, it is a health claim in itself’. Currently, there are no approved health claims for probiotics.
The Nutrition and Health Claims Handbook of NVWA from March 2021 indicated clearly that the term “probiotics” was allowed on food and on food supplements, but this provision was removed after a few months and since then the use of the term probiotics is applicable only to food supplements (Titel: (keuringsraad.nl)).
Danish authorities have published in May 2021 a national rule indicating that the term probiotic can be used on the label of the product as a term for the mandatory category for food supplements.
Where next: can Europe be inspired by successful examples like Canada?
Other countries outside the EU, such as Canada, have established frameworks where the term ‘probiotic’ is not classified as a health claim. These frameworks could serve as an inspirational model for the EU while shaping a harmonized proper regulation.
In 2009, Health Canada introduced its monograph for probiotics to be used in the Natural Health Product (NHP) category, which outlined a well-defined safety standard and a commitment to updates based on the latest scientific advancements and knowledge (Canada Probiotics Monograph). This dedicated framework for probiotics has been influential in several countries, serving as a model to establish safety protocols and defining characterization including the process for update and safety standards that a product must meet to reach the market. Efficacy expectations are also defined. The adoption of Health Canada’s approach in other jurisdictions could help shape the regulatory landscape for probiotics.
A recent development that highlights the necessity for harmonization not only in the EU but also beyond, is the establishment in March 2023 of a working group of Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU), with the following terms:
a. Further refine proposal 2.1 discussion Paper on Harmonized Probiotic Guidelines for Use in Foods and Food Supplements in document CX/NFSDU 23/43/7, especially with regards to the scope, impact on food safety and need for scientific advice; and
b. Develop a revised discussion paper and project document, taking into account comments at CCNFSDU43 for its consideration at the 44th session of the CCNFSDU.
This proposal has been supported by countries all over the world. The industry sees the benefits of this initiative which would offer a consistent interpretation globally, and consumers would obtain more information to make knowledgeable choices. This work underscores the importance of international collaboration in addressing regulatory matters in a standardized way.
Conclusion and recommendation
The European regulatory framework for probiotics so far has failed consumers and industry alike, restraining key information on scientifically backed products, impeding higher-quality products from differentiating from the rest, generating distrust in the category, curbing market growth, and thus holding back investments in the probiotics cradle continent.
The problem is double: we observe a lack of harmonization in the interpretation of the probiotic definition and implied restrictions of the term in most of the EU, and an alignment on the absence of health claims despite some strains being backed by multiple high-quality clinical studies, and medical associations recommendation such as ESPGHAN’s in pediatric gastrointestinal disorders, or even drug status.
As a way forward, it should be promoted to EU Member States to clarify a harmonized definition and criteria to qualify as a probiotic, and authorize health claims based on sound and independent scientific evaluation of safety and efficacy in the process of notifying new products and their claims.
This would be crucial in fostering consumers’ informed choices, equity, and innovation and in producing a more solid ground from which to regulate a tide of new terms completing the probiotics category: microbiota-based therapy, prebiotics, synbiotics, postbiotics, psychiobiotics, and more. This harmonization and opening are needed on a note of urgency as the rest of the world keeps investing and progressing in these categories, with the risk of leaving the EU behind despite its head start.
With gratitude and appreciation to Duresa FRITZ, Global Regulatory Manager, for our rich discussions on regulatory aspects and for contributing her insights that both motivated and enabled this article.