IPA Europe made an official request to the EU Ombudsman in December 2023 to examine how the European Commission addressed concerns about its stance on probiotic foods and supplements being systematically classified as health claims, which is based on a non-binding 2007 guidance.
The association sought clarification on the rationale behind this position and more specifically what factors support it beyond the 2001 Joint FAO/WHO Expert Consultation’s definition of probiotics. It should be stressed that 10 Member States already allow the use of the term “probiotics” on product labels.
The Ombudsman’s role in cases of divergent legal interpretations is to assess whether the EU administration’s interpretation of the relevant legal framework is reasonable and aligns with its guiding administrative principles, explained IPA Europe in a release.
“The association was pleased and welcomed the Ombudsman’s acknowledgement of our request for further clarification from the EU commission on this matter” said Rosanna Pecere, executive director for IPA Europe.
However, the Ombudsman recently published its decision to close the case, reportedly finding no maladministration by the European Commission.
“While we respect the Ombudsman’s role, its conclusions fail to address the main critical concerns raised by stakeholders,” stated IPA Europe.
The need for harmonization
The result has created disappointment as the conclusion failed to address the longstanding need for clearer guidance and formal recognition of probiotics as a distinct category of products and ingredients.
“This was a big, missed opportunity to reset the clocks in Europe,” said George Paraskevakos, executive director of IPA Global. “Establishing a more consistent and unified regulatory framework across Europe is essential in providing legal clarity, strengthening consumer protection and allowing for continued innovation in the food sector.
“Products with probiotics are widely used by consumers globally, and the timing for this would have served as a great occasion to lay some foundation towards regulatory harmonization to industry, regulators and consumers.“
Prior to 2009, Europe was the number one market for probiotics, but now ranks third, after China and United States. In Europe, the retail value of probiotics, (sour milk products, yogurts and dairy-based drinking products, food supplements), was around €10 Billion in 2023, said IPA Europe in a release.
The association noted that the Commission’s decision to adopt a “restrictive” and “overly cautious” interpretation of “probiotics” carries broader implications:
1. Chilling effect on innovation: “Overcaution can discourage innovation and the development of products or marketing strategies, particularly in industries like food and supplements,” said IPA Europe. “This goes in the opposite direction of the establishing a harmonized regulatory framework that supports innovation, reduces administrative burdens, and strengthens the position of the European industry in global markets.”
2. Neglect of evidence-based argumentation: “A cautious stance might ignore robust evidence and consumer data that provide a better understanding of how terms are perceived by consumers. This could result in a one-sided regulatory framework that focuses on hypothetical risks rather than real-world data.”
3. Impact on consumer education: “Maintaining a restrictive interpretation may limit consumers' access to valuable information about probiotics and their scientifically validated effects, hindering informed decision-making. Clear and balanced communication is essential for fostering a transparent and consumer-oriented market for probiotics, which supports both public health and economic growth.”
4. Legal uncertainty: IPA Europe said that the current interpretation has undoubtedly created legal uncertainty within the European market, with 10 Member States already allowing the use of the term “probiotics” on products, and undermines the Ombudsman’s statement that “there is no legal uncertainty on this matter”. IPA Europe said there is a clear need to revise the European Commission interpretation.
