‘Probiotics’ as a health claim? This is the decision of the European Ombudsman

The European Ombudsman

In this matter, the complainant filed a complaint with the European Ombudsman, asserting that the European Commission wrongly regards the term "probiotics" as a "health claim" when used on food labeling and in other communications (such as advertising) about food products. The complaint also covered related terms such as "prebiotics." After multiple discussions with the European Commission failed to change its interpretation, the complainant turned to the European Ombudsman, who examines complaints from EU citizens or natural or legal persons residing or established in the EU. These complaints must relate to cases of maladministration by EU institutions, bodies, or agencies. Upon receiving a complaint, the European Ombudsman investigates and issues a report.

Complainant’s Arguments

The complainant argued that the European Commission incorrectly assumes that the use of the term "probiotics" on food labeling and in communications implies a positive health effect resulting from the consumption of the product. According to the complainant, the term objectively informs consumers about the ingredients in food products. For these reasons, the complainant believes that phrases such as "contains probiotics" should be permitted as nutrition claims under Regulation (EC) No. 1924/2006 on nutrition and health claims (‘Claims Regulation’). Furthermore, the complainant contended that the European Commission’s position creates legal uncertainty.

This legal uncertainty, according to the complainant, stems from food businesses being unsure whether, and under what conditions, they may use the term "probiotics" on their products. This also leads to confusion among consumers. Additionally, the complainant argued that the European Commission’s stance is inconsistent with EFSA guidelines, as the term "probiotics" itself does not refer to any specific health benefits. Lastly, the complainant pointed out inconsistencies in the application of regulations within the EU, as certain Member States allegedly allow the use of the term "probiotics" to some extent under their national guidelines.

European Commission’s Position

The European Commission reaffirmed its position that the term "probiotics" should be classified as a health claim because it implies a positive health effect. Since no approved health claims exist for probiotics due to a lack of scientific evidence, the use of the term is not permitted. The European Commission emphasized that there is no legal uncertainty, as its interpretation was established in its guidelines in 2007, agreed upon by Member States, acknowledged by the practices of food business operators and consistently used.

The European Commission further argued that any alternative interpretation would contradict the objectives of the Claims Regulation and Regulation (EU) No. 1169/2011 on the provision of food information to consumers,  which is to protect consumers from potentially misleading information about the food they purchase. Regarding the complainant’s proposal to classify "probiotics" as a "nutrition claim," the European Commission stated that there is no link between probiotics and the nutritional qualities of food, making such a classification impossible. The same reasoning applied to the complainant’s proposal to consider probiotics as a neutral descriptor.

European Ombudsman’s Considerations

The European Ombudsman first addressed the underlying factual question: whether the term "probiotics" creates the expectation among consumers that its intake has a positive health effect, and if so, to what extent its use on food labeling and in communications influences consumer purchasing decisions. The Ombudsman emphasized that the complainant did not dispute the lack of scientific evidence demonstrating health benefits from probiotics.

The Ombudsman also outlined her role in cases involving divergent interpretations of legal frameworks. This role is to assess whether the EU administration’s interpretation of the relevant legal framework is reasonable and consistent with its underlying objectives and principles. The Ombudsman can only question the position of the EU administration on complex factual questions only if she finds manifest errors in the administration’s assessment.

European Ombudsman’s Decision

The Ombudsman found no manifest error in the European Commission’s approach. She reiterated the general objective of the Claims Regulation: to protect consumers from potentially misleading information about food products. In light of this objective, consumer protection against misleading information should take precedence over other interests. Furthermore, there was no indication that the European Commission’s guidelines were outdated. The Ombudsman also noted that such claims could be approved in the future if supported by scientific evidence demonstrating health benefits.

Additionally, the Ombudsman disagreed with the complainant’s claim that the European Commission’s interpretation creates legal uncertainty. Legal uncertainty would arise if applicable rules were unclear, preventing stakeholders from determining what behaviors are prohibited, required, or permitted. On the contrary, the European Commission’s position has contributed to clarifying the legal framework.

Finally, regarding the differences in the application or interpretation of regulations among Member States, the Ombudsman noted that it is beyond her mandate to determine whether specific Member States act in violation of Claims Regulation. Furthermore, such a finding would not invalidate the European Commission’s position but would instead indicate non-compliance with EU law by certain Member States.

Accordingly, the Ombudsman did not support the complainant’s arguments and concluded that there was no manifest error or maladministration by the European Commission.

Implications for Food Businesses

With this decision, the European Ombudsman confirms that, for now, there is no approved health claim for the use of the term "probiotics," and it is considered an unauthorized health claim. Food businesses should therefore review their product labels and other advertising statements for compliance with applicable regulations to avoid enforcement actions by regulatory authorities such as the Dutch Advertising Code Committee (Keuringsraad KOAG) or the Netherlands Food and Consumer Product Safety Authority (NVWA). However, in the Netherlands, the term "probiotics" may still be used as a category designation for food supplements.

About Ploum’s International Trade, Customs, and Food Law Team

Do you have questions about foodstuffs? Our specialists in the International Trade, Customs, and Food Law team are ready to assist you. With years of experience in food law, we can provide you with swift and effective support. If you have any questions regarding this topic or other matters related to International Trade, Customs, or Food Safety and Legislation, please contact one of our team members or reach out directly to Marijn van Tuijl (m.vantuijl@ploum.nl).