Under EU law, a health claim cannot be made unless scientific evidence exists to suggest that what is being claimed is actually beneficial for health. The decision is based on evidence from the European Food Safety Authority (EFSA).
In the view of the EU, the term ‘probiotic’ is a health claim, according to a guidance document on the regulation of health claims. However, it is not considered a valid health claim as, according to EFSA, it does not have enough evidence linking it to health and thus should not be allowed to appear on packaging.
A recent complaint to the European Commission by the organisation International Probiotics Association (IPA) Europe suggested that ‘probiotic’ should not be considered a health claim at all, but a ‘nutrition claim.’
‘Probiotic,’ IPA Europe suggested, simply describes a product and should not be considered as implying any health benefits that can’t be proved.
The designation of it as a ‘health claim’ and subsequent restriction on its use, the organisation argued, has led to a de-facto ban on industry using the term.
Furthermore, as a ‘health claim,’ by EU regulation, must refer to a health benefit to a specific body function, and the term ‘probiotic’ does not contain such a reference, the complainant believes they will never deliver a positive assessment on probiotics.
The complainant also suggested that the restrictions on the term ‘probiotic’ create legal uncertainty, as producers are not sure whether they can use the term.
The complaint pointed out that 10 EU member states have already adopted their own guidelines which allow the use of the term on products. It questioned how this could be if the term is restricted, suggesting this creates confusion.
After the complainant had its case rejected by the Commission, it was taken to the EU Ombudsman.
The Ombudsman’s position
The Ombudsman agreed with the assessment of the Commission that the term ‘probiotic’ implies a health claim, one which was not backed up by evidence. It does not rule out future applications for the use of the term, backed by scientific evidence.
It also suggested that there is no lack of clarity, and that the commission, in its response to the complainant, clarified the legal framework.
In response to the complainant’s reference to EU member states, in which the term is allowed, the Ombudsman suggested that these member states may not be compliant with EU regulation.
In the end, the Ombudsman upheld the Commission’s decision.
How has IPA Europe responded to the decision?
Rosanna Pecere, executive director of IPA Europe, has suggested that the Ombudsman’s decision does not address why EFSA considers the term ‘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,” says Pecere.
“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,” adds Katia Merten-Lentz, partner at Food Law Science and Partners.
“It results in a missed opportunity to enhance legal clarity and consumer protection, and to support innovation within the EU food sector.”
The status of the term ‘probiotic’ is based on a guideline, which, she says, is not legally binding.
She goes on to say that the this guidance “does not reflect the reality anymore,” and should be withdrawn. As it has “no legal status,” she says, this should be easy.
To fill this void, IPA Europe had suggested to the commission that probiotics should be considered a ‘nutrition claim,’ but this was rejected, as the Commission argued that there was no link between the term and the nutritional qualities of food.
According to IPA Europe’s Pecere, industry stakeholders have since voiced their confusion about the decision which, she predicts, has the potential to lead to more complaints.
Defining the term ‘probiotic’
The term ‘probiotic’ refers to microorganisms, often contained in food and drink, which enter into the gut and are said to improve gut health.
In other territories, including the US and Canada, regulations around its use are more relaxed, but in Europe, the term is restricted. This is mainly because, as previously mentioned, the EU considers it a health claim, of which, it suggests, there isn’t enough evidence to support.
While ‘probiotic’ is not defined by the EU itself, it uses the World Health Organisation’s (WHO) definition: “live microorganisms which when administered in adequate amounts confer a health benefit on the host.”
The WHO’s definition, points out Pecere, was backed by a joint FAO/WHO investigation into the health benefits of probiotics back in 2001. “As such, the European Commission refers to the WHO/FAO definition but does not recognise the scientific data supporting the definition.”
Such scientific evidence, which is included in the investigation, includes reducing the affects of infectious diarrhoea and preventing urogenital tract disorders.
However, much of the evidence is considered ‘preliminary’, such as the benefits of the use of probiotics in treating cardiovascular disease and some cancers, and ‘debatable’, in regards to its ability to treat constipation.
A spokesperson of the EFSA explains that while the WHO/FAO document provides a definition of probiotics and guidelines for the assessment of their health benefits, the document “does not establish a positive list of microorganisms in food that qualify for the term ‘probiotics’ as defined.”
The regulation on health claims “requires clear evidence demonstrating the specific health effects of each product or microorganism strain in humans.” This means that “each proposed claim must be backed by specific scientific studies showing a direct and causal relationship between the probiotic strain and the claimed health benefit.”
No such claims, according to the EFSA spokesperson, have so far been substantiated.
The WHO/FAO document concludes by saying “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.”
