Dispatches from Probiota 2016

Recent risk-reduction claims ‘have not been positive,’ say EFSA.

Earlier this month at Probiota, Yolanda Sanz stated that microbiota changes should be linked to physiological or clinical outcomes of which a direct effect on human health can be attributed to a specific mechanism of action.

Earlier this month at Probiota in Amsterdam, the European Food Safety Authority (EFSA) stated that microbiota changes should be linked to physiological or clinical outcomes of which a direct effect on human health can be attributed to a specific mechanism of action.

In the context of disease risk reduction, Dr Yolanda Sanz, member of the Dietetic Products, Nutrition and Allergies (NDA) Panel at EFSA, told us why claims needed to establish an independent association between the risk factor and an increased risk of infection.

“Regarding the risk reduction claims, what I can tell you is the applications we have received so far refer to the reduced incidences of infection,” she said.

“None of them have been positive and this may be due to the difficulties you find in identifying and assessing risk factors.”

Dr Sanz discussed the scientific evidence submitted to EFSA during her presentation arguing that there needed to be clear evidence of a biological basis through which the risk factor contributed to the infection. Submitted evidence would need to show modification of this risk factor.

As an example, Dr Sanz pointed towards the health claims made to satisfy article 13.5 – newly developed scientific data/proprietary data, and article 14 – reduction of disease risk and children’s development and health.

Out of the 155 applications related to this area for July 2015, 58 applications went on to be published or adopted. The rest were rejected or withdrawn.

She pointed towards recent efforts made by EFSA to improve the dialogue between the different stakeholders and guidance on gut immune pathogen claims.

The ‘probiotic’ question

With the industry heavily represented at the event the lack of clarity in the approvals process, became a major sticking point with many believing that changes to the assessment process were a prerequisite to gain a clear understanding of the scientific requirements needed to obtain approval.

When questioned on the potential ‘billion dollar’ negative impact of not allowing the use of the term ‘probiotic,’ to describe foods, Dr Sanz said: “From the industry point of view, I understand the position. But this is an issue that EFSA plays no part of.”

“From a scientific point of view, I think we should be able to have claims in the field and we should in the future be able to generate evidence that support claims.” 

Probiotic category creation

On the back of a large number of rejected health claims, food and drink manufacturers are now looking to seek a nutrition claim where, for example, the probiotic bacterial strain could be used as a generic descriptor.

This led to the question of whether probiotics should have their own form of regulation where a proven effect in treating diseases was demonstrated but was not used as a medicine.

“In this case you could take another route and instead of applying for health claims, you could also try to apply for uses in the medical area,” said Dr Sanz.  

“With medical foods the context is completely different because you have to submit a notification demonstrating that there is an advantage from a nutritional point of view for this disease or disorder.

“I can’t see how probiotics can go down this route, but the pharmacological route is a possibility.”

Dr Sanz concluded by commenting on EFSA’s position on the ongoing dialogue that occurred with pre-submissions and discussions of health claims. She was also asked whether the updates would make it easier for EFSA to decrease the failure rate of applications in the future.

“The process will be easier for both sides. But the point is that the resources EFSA has at its disposal to carry out these tests. We have to take into account the number of countries within the European Union and the number of pre-submissions we receive.”

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