European harmonization probiotic claims possible? Here’s the latest.

The International Probiotics Association Europe (IPA Europe) is calling for harmonized use of the claim ‘probiotics’ in the EU. Aforementioned term is generally considered an unauthorized health claim under the EU Claims Regulation. Nevertheless, an increasing number of EU member states allows the use of this claim under certain conditions. This blogpost dives into the regulatory status of probiotic claims in different EU member states and the latest developments in this area.

When entering the keyword ‘probiotic’ in the EU Health Claims Register, one is confronted with over 100 rejected health claims. Over the past years, this has led to the question whether the term ‘probiotic’ should be allowed under certain conditions, and has resulted into divergent policies in different EU member states. To protect both the food industry (against unfair competition) and the consumer (against misleading information), these divergent policies are reason for IPA Europe to call for a harmonized framework.

Czech Republic, Northern Ireland and France
Although EU member states generally consider ‘probiotics’ to be an unauthorized health claim under the EU Claims Regulation, some EU member states take a different approach. ‘Probiotics’ is for example considered a nutrition claim in the Czech Republic. Such claim is allowed if the conditions set forth in the EU Claims Regulation are met. This means, amongst others, that the good bacteria in question are present in the food in an amount that, according to generally accepted scientific evidence, causes the claimed beneficial effect. By contrast, in France and Northern Ireland, the term ‘probiotics’ can be used as a general, non-specific health claim that is allowed in combination with the authorized health claim “live cultures in yoghurt or fermented milk improve lactose digestion of the product in individuals who have difficulty digesting lactose”.

Italy
Italy takes the view that the term ‘probiotics’ does not meet the definition of a health claim and therefore falls outside the scope of the EU Claims Regulation. Italy supports this view by EFSA’s conclusion that probiotic colonization in the intestinal flora (without further specification of bacterial species or strains) is insufficient evidence to substantiate a beneficial effect on human health. In other words, no link between probiotics and health can be demonstrated, for which reason ‘probiotics’ cannot be considered a health claim. Aforementioned reasoning is however not a free pass to unconditionally use the term ‘probiotics’ in Italy. Instead, the following conditions must be met if and when using this term: (i) safety for human consumption, (ii) a history of use for the benefit of the intestinal flora, and (iii) presence of the relevant bacteria in the food in live form and in an adequate quantity until end of shelf life.

Denmark and Spain
In Denmark, the term ‘probiotics’ can be used based on a different legal ground, namely as a mandatory category designation under the EU Food Supplements Directive. In France, such is also possible. Indeed, Article 6(3)(a) of the EU Food Supplements Directive requires that the labeling of the food supplement shall bear “the names of the categories of nutrients or substances that characterize the product or an indication of the nature of those nutrients or substances”. In Spain, the claim ‘probiotics’ is allowed thanks to the principle of mutual recognition. Based on this principle, a product lawfully marketed in one EU member state must also be accepted on the market of another EU member state. Since probiotic claims are therefore allowed on the Spanish market for products from other EU member states, banning the term ‘probiotics’ at national level would discriminate against national producers. Therefore, both food products produced within Spain and those produced outside of the country can bear the claim ‘probiotics’.

Netherlands
In the Netherlands – just like in Denmark and France – the term ‘probiotics’ can be used as a category designation for food supplements. This Dutch practice is laid down in the Guideline Document on the EU Claims Regulation by the Dutch Health Advertising Knowledge and Advice Council (in Dutch: Keuringsraad). An earlier version of the Nutrition and Health Claims Manual by the Dutch Food Safety Authority (in Dutch: NVWA Handboek Voedings- en Gezondheidsclaims) also explicitly mentioned this possibility. Such is now longer mentioned in the latest version of the Nutrition and Health Claims Manual, which can be explained by the fact that ‘probiotics’ as a category designation for food supplements is not a nutrition or health claim.

Although claims that further elaborate on the health effect of probiotics (sporadically) occur on the Dutch (online) market, these are not allowed. Whether the expression “increases the good bacteria in the intestinal flora” (without using the term ‘probiotics’) is acceptable in the Netherlands, is yet unclear. Yakult uses this expression to advertise its fermented milk drink. The Dutch Health Advertising Knowledge and Advice Council would not allow this expression in the context of its preventive supervision in the context of food supplements, because this expression in effect creates a link between the food product and health. If the NVWA has however a different opinion on this and does consider aforementioned expression possible, then other food businesses can take advantage of this too. The call for harmonized uses of the term ‘probiotics’ by IPA Europe, about which more below, can possibly contribute to the acceptance of such expression at national level.

”Probiotics’ not a health claim”
As demonstrated above, various EU member states have introduced national rules on the use of the term ‘probiotics’. As a result, IPA Europe believes that the European Commission’s position that ‘probiotics’ implies a health benefit and is therefore a(n unauthorized) health claim no longer holds water. Instead, IPA Europe advocates qualifying the claim ‘contains probiotics’ as a nutrition claim, just like ‘contains vitamins and minerals’ and ‘contains fiber’. Aforementioned substances may have beneficial nutritional properties, but no specific health benefit is claimed. To strengthen its argument that ‘probiotics’ is not a health claim, IPA Europe explains that the term is not sufficiently precise to substantiate the claimed health benefit under reference to an EFSA guidance document published in 2016.

Call for harmonized use of the term ‘probiotics’
According to IPA Europe, ‘probiotics’ is therefore not a health claim and does not require authorization under the EU Claims Regulation. At the same time, it emphasizes the need for clear rules on the use of the claim as this contributes to a fair competitive environment for food businesses and helps consumers to make informed choices. In December 2023, IPA Europe therefore called for a clearly defined framework for the use of the term ‘probiotics’ in the EU. IPA Europe recommends the following four criteria for consistent use thereof:

1. characterization of the species level and identification of at strain level;
2. the probiotic strain must be safe for the intended use, e.g. based on the QPS list;
3. the probiotic status should be scientifically documented; and
4. the probiotic strains must be alive in the product and in a sufficient amount up to the end of shelf-life.

Final comment
The EU knows a fragmented regulatory landscape when it comes to the use of the term ‘probiotics’. Despite IPA Europe’s efforts for a harmonized approach throughout the EU, we will need European legislation or a ruling from the European Court of Justice to have the same rules in all EU member states. For now, the term ‘probiotics’ is (fortunately) not completely banned in the Netherlands and neither in quite a few other EU Member States.

This blogpost has also been published in Dutch at VMT.nl.