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EU Imposes Restrictions on Probiotic Claims

EU Imposes Restrictions on Probiotic Claims Food and Beverage Business

According to EU regulations, a health claim can only be made if supported by scientific evidence that verifies its benefits to health. This evaluation relies heavily on findings from the European Food Safety Authority (EFSA).

The EU classifies the term ‘probiotic’ as a health claim. This classification stems from a guidance document concerning health claims regulation. However, EFSA deems it insufficiently evidenced to substantiate health benefits, thus prohibiting its inclusion on product packaging.

Recently, the International Probiotics Association (IPA) Europe lodged a complaint with the European Commission, arguing that ‘probiotic’ should be classified as a ‘nutrition claim’ rather than a health claim.

IPA Europe contended that the term merely describes a product and does not imply unproven health benefits.

By classifying it as a health claim and imposing usage restrictions, IPA Europe argued that this has essentially created a ban on the industry’s ability to use the term.

Moreover, since EFSA requires health claims to refer to specific bodily functions, the term ‘probiotic’ lacks such specificity. Therefore, IPA believes it will be challenging to obtain a favorable evaluation for probiotics.

Additionally, the organization highlighted that the restrictions surrounding ‘probiotic’ contribute to legal ambiguities, leaving producers uncertain about its permissible use.

Interestingly, 10 EU member states have already implemented guidelines permitting the term’s use on products. This inconsistency raises questions regarding the validity of the restrictions and fosters confusion.

After the Commission initially rejected the complaint, the matter was escalated to the EU Ombudsman.

The Ombudsman’s position

The Ombudsman sided with the Commission, agreeing that the term ‘probiotic’ implies a health claim lacking sufficient evidence. However, future applications backed by scientific data remain a possibility.

Furthermore, the Ombudsman stated that there is no ambiguity, confirming that the Commission clarified the legal framework in its response.

Regarding the reference to member states where the term is allowed, the Ombudsman suggested that these members might not be in compliance with EU regulations.

Ultimately, the Ombudsman upheld the Commission’s ruling.

How has IPA Europe responded to the decision?

In reaction, Rosanna Pecere, executive director of IPA Europe, expressed that the Ombudsman’s ruling does not clearly explain why EFSA considers ‘probiotic’ a health claim in the first place.

“The use of the term should not require a health claim assessment by EFSA, as long as no reference to a specific health effect is made,” notes Pecere.

Katia Merten-Lentz, a partner at Food Law Science and Partners, added, “In its decision, the Ombudsman fails to explain why he deemed ‘reasonable’ for the Commission to consider that the mere word ‘probiotics’ implies that a health relationship exists between a food category and health.”

She asserts that this omission hinders opportunities to improve legal clarity and consumer protection while also stifling innovation within the EU food sector.

The current status of the term ‘probiotic’ is rooted in a guideline, which Pecere argues holds no legal authority.

Moreover, she suggests that this guidance “does not reflect the reality anymore” and should be retracted, given its “no legal status,” making this withdrawal feasible.

To address this legal gap, IPA Europe proposed that probiotics be classified as a ‘nutrition claim.’ However, the Commission dismissed this suggestion, stating there is no connection between the term and food’s nutritional qualities.

As a result, according to IPA Europe’s Pecere, industry stakeholders have expressed ongoing confusion about the decision, potentially leading to more complaints.

Defining the term ‘probiotic’

The term ‘probiotic’ pertains to microorganisms typically found in food and beverages that are claimed to enhance gut health.

While regulations surrounding its use are comparatively relaxed in other regions like the US and Canada, the EU maintains strict regulations based on its classification as a health claim, for which adequate evidence is reportedly lacking.

Although the EU does not provide its own definition of ‘probiotic,’ it relies on the World Health Organisation’s (WHO) definition: “live microorganisms which when administered in adequate amounts confer a health benefit on the host.”

Notably, Pecere emphasizes that this definition, endorsed by a joint FAO/WHO inquiry conducted back in 2001, underscores the benefits of probiotics.

This investigation includes findings suggesting a reduction in infectious diarrhea and the prevention of urogenital tract disorders. Nevertheless, much of the evidence remains deemed ‘preliminary’ regarding cardiovascular treatment and cancer, while the effectiveness for treating constipation is considered ‘debatable’.

The investigation concludes by stating, “the experts agreed that adequate scientific evidence exists to indicate that there is potential for the derivation of health benefits from consuming food containing probiotics.”

“However, it was felt that additional research data are needed to confirm a number of these health benefits in humans, applying a systematic approach and following the guidelines for the assessment of probiotics suggested in this report.”

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