Navigating EU regulations: Probiotics, health claims and consumer awareness

There is a growing amount of evidence on the beneficial effects of probiotics on human health that go beyond their well-known role balancing gut flora, including those on immunity, urinary tract infections, metabolism and mood. ​

However, the European Union's stringent criteria for evaluating health claims have created a challenging landscape for probiotic labelling. This leads to a paradoxical situation where neither the widely known core benefits of most microbial species traditionally used in foods nor other strain-specific benefits have been acknowledged.

The European Food Safety Authority (EFSA) has rejected all health claims submitted for probiotics, except for the standard yoghurt cultures and lactose digestion. This regulatory stance prevents companies from communicating any benefits associated with probiotics in foods. This contradicts the EU's principle of promoting ‘informed choices’ to consumers.

Although devoid of any legal value, the 2007 European Commission (EC) guidelines define the term ‘probiotic’ as a health claim.¹​ However, since it is non-specific and cannot be assessed as such, its use is bound to the presence of specific authorised health claims. Refusing such claims has made the term ‘probiotic’ potentially unlawful, further limiting the consumer’s ability to identify foods containing probiotics on the shelf.

Although some EU member states have gradually permitted the use of the term ‘probiotic’, the varying conditions and standards for its use have led to a diverse range of products on the EU market, differing significantly in content and overall quality. Probiotic supplements' overall quality is intrinsically linked to clear and uniform regulations, which are currently dependent on the attention and expertise of individual member states.

In this fragmented situation, Italy exemplifies how the early identification of national provisions can effectively support market development and consumer awareness. The use of probiotics in Italian food supplements dates back to the 1980s, when they were classified as dietary products under the legislation on Food for Particular Nutritional Uses (PARNUTS). At that time, market placement was subject to prior authorisation.

Balancing nutritional standards and consumer trust​

These supplements, originally called ‘integratori biologico-vitaminici’ (biological-vitamin supplements), had to comply with a ministerial product specification. This outlined the minimum number of live cells and the recommended daily dose required to state their effect on the intestinal flora balance on the label. The inclusion of vitamins, particularly B vitamins, was necessary to meet the nutritional standards for dietary products. This was because an imbalance in the intestinal flora likely led to a reduced bacterial synthesis of these vitamins.

Later, the term ‘biologico’, which in Italian means both ‘biological’ and ‘organic’, was changed to ‘probiotic’. This change was made to avoid confusion with organic products and align with the WHO/FAO definition of probiotics from 2001, as revised by Hill et al. (2014).²​

Directive 2002/46/CE acknowledged that food supplements have a 'physiological' role separate from their nutritional function. As a result, products containing only probiotics were accepted as food supplements and named ‘food supplements of probiotics’ because of their role in restoring gut flora balance. Meanwhile, the ministerial product specification was replaced by more complex guidelines relating to probiotic characterisation, safety, and labelling criteria.

Even after the ban of probiotic claims, Italy allowed the use of the word ‘probiotic’ on labels. They allowed references to balancing intestinal flora, assuming that probiotics could colonise the colon, even if the EFSA did not think this was beneficial. This position helped to prevent Italian consumers from losing trust in these products.

Italian pharmacies, the main sales channel for probiotics, have played a key role in raising consumer awareness. Pharmacists often recommend probiotics for gut discomfort or alongside antibiotic therapy to prevent dysbiosis. This clearly shows widespread agreement among healthcare professionals on the general benefits of probiotics, even though European legislation does not recognise them for labelling, presentation, and advertising purposes.

The prompt implementation of clear and balanced regulations in Italy underscores the commitment of Italian companies to product quality, which is essential for market stability and consumer protection. Establishing clear and harmonised regulations across the EU would ensure a higher and uniform standard of probiotic product quality, foster fair competition, and improve consumer protection.

Establishing consistent quality across the EU​

Fine Foods & Pharmaceuticals N.T.M. S.p.A. is a long-experienced Italian Contract Development and Manufacturing Organisation (CDMO), working in the nutraceutical, pharmaceutical and cosmetics industries, committed to innovation and development of the highest quality products. The Group emphasises that establishing clear and harmonised rules is essential to ensure a higher and consistent quality of probiotic products across the EU.

This would promote fair competition among companies and protect consumers. Fine Foods and its probiotic suppliers, who are continually researching, need to communicate their products' benefits. This enables consumers to make informed decisions to promote their wellbeing.

Revising the criteria for evaluating probiotics in relation to health claims to include widely accepted fundamental benefits and other scientifically proven strain-specific effects could better serve consumer interests, improve public health, and ultimately save on healthcare costs.

A harmonised regulatory framework for probiotics in the EU could lay the groundwork for regulating other categories within the 'biotics' sector. This is important given the potential of gut microbiome modulation to contribute to achieving the United Nations' SDG#3 (good health and wellbeing for all at all ages).

References​

1.​ Europa.eu. Guidance on the implementation of regulation N° 1924/2006 on nutrition and health claims made on foods conclusions of the standing committee on the food chain and animal health.​
2.​ Hill, C.; Guarner, F.; Reid, G.; et al. (2014). Expert consensus document. The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic.​ Nature reviews. Gastroenterology & hepatology, 11(8), 506–514.