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Probiotics in the EU: Regulation challenges and opportunities

Article-Probiotics in the EU: Regulation challenges and opportunities

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There is growing understanding of the role the gut plays in overall physical and mental health – but the lack of a harmonised regulatory approach has hindered uptake of probiotics in the EU, say experts.

The global probiotics market was valued at $58.17 billion last year, and is expected to expand at a compound annual growth rate of 7.5% from 2021 to 2030, according to market analysis by Grand View Research.

However, a survey of 8,000 consumers conducted earlier this year on behalf of the International Probiotics Association (IPA) Europe found that while respondents generally had a positive outlook on probiotics, they lacked awareness on their correct usage and usefulness.

The organisation has since called for a coherent regulatory approach across the EU, along with greater consumer education.

Going beyond the gut: Microbiome linked to multiple health areas

IPA Europe’s executive director, Rosanna Pecere, told Vitafoods Insights:

“We function as a complex system, for which the host-microbiota relationship is central. It is a fascinating area that is retaining the great attention of experts and a strong science innovation.

“Recent studies support the concept that diet should be viewed as a means to prevent potentially durable alterations of symbiosis, as observed in immune-mediated metabolic and inflammatory diseases.”

These will be among the topics addressed during next week’s NutrEvent conference in Nantes, where Pecere is taking part in a panel discussion regarding regulatory opportunities and constraints for pre-, pro-, and postbiotics.

She added: “Probiotic modulation of the microbiota-gut-brain axis is an area of great interest. Emerging research suggests that the gut may be more involved in decision-making than previously thought. The proper ecological balance of the gut microbiota is known to affect cognitive function and fundamental behaviour patterns, such as social interaction and stress management.”

With a host of potential applications, it is hardly surprising that innovators are looking to take advantage of opportunities in the digestive health sector.

Health claims and the problem of labelling

However, while interest is high, regulation is complex – particularly within the EU, where guidance is inconsistent between different countries.

Pecere told Vitafoods Insights: “In many member states, the term ‘probiotic’ is widely understood as indicating a category of products. This is particularly true of Italy, one of the largest markets in Europe. Some European countries issued national guidance which allow the use of the term in labelling and communications.

“De facto, today the interpretation of the European Commission of the term ‘probiotic’ … is obsolete and is overcome by national practices. It is important to notice that the term ‘probiotic’ is not mentioned in Regulation 1924/2006 on nutrition and health claim (NHCR), which is the legal reference for the voluntary information (claims) on food and food supplements.”

Regulation 1924/2006 states that the phrase “contains probiotics/prebiotics” should be considered a health claim, meaning that the term “probiotic” cannot be used in labels and communication – even though the European Commission guidance is non-binding.

Pecere said: “For a claim related to a strain that ha[s] specific characteristics and, therefore, specific effects on health, the submission of a dossier to EFSA [the European Food Safety Authority] for a health claim authorisation is required, but we do know that application for probiotics – and for food in general – are encountering the difficulties of providing evidence of the mechanism of action in healthy people and on the measurable relationship of cause-effect.”

She added: “More generally, the word ‘probiotic’ should be recognised in the EU as information to the consumer, ie. the descriptive name of the food, in the list of ingredients, under Regulation 1169/2011 (consumer information), and as a specific category of ingredients with condition of use.”

So, what does this mean for the future of probiotics?

Pecere said: “The microbiome is an unbelievable genetic machinery, which can be modified by diet and with the use of probiotics. Clinical research into the role of (gut) microbiota in a wide variety of diseases and conditions is booming. Ultimately, this may offer new indications for gut microbiota management by probiotic food and food supplements.”