Yakult fights EFSA’s doubt on probiotic health claims

Posted by Nicole Eckersley on 21st October 2010

Japanese dairy firm Yakult has said it will continue to conduct human studies to back-up the health benefits of its probiotic products, after the European Food Safety Authority (EFSA) cast doubt on health claims for probiotics.

In a series of opinions published on Tuesday, EFSA assessed more than 800 health claims from food companies. The claims included assertions that probiotic bacteria strains boost the immune system and reduce gut problems.

However, EFSA’s independent panel of scientists found no “cause and effect relationship” had been established between the consumption of the strains Lactobacillus fermentum and Lactobacillus plantarum in maintaining immune defences.

In particular, the panel examined a dossier of 12 studies submitted by Yakult for its own strain of probiotic bacteria, Lactobacillus casei shirota. The panel found that all were “inadequate” to support the company’s claim that its products maintained immune defences against the common cold.

In a statement today, Yakult said that the health claim submitted by Yakult to EFSA was a “specific health claim within a limited area”, relating to maintenance of upper respiratory tract health.

“This is just one aspect of research and claim evidence that we have been working on,” a spokesperson for Yakult said. “The claim was supported by well-designed double-blind placebo-controlled human studies.

“As pioneer in probiotics…Yakult will continue to conduct human studies, exploring and confirming the health benefits of its probiotic products,” it added.

The firm said it wished to discuss the evaluation process, scientific criteria and the published outcome with EFSA.

“Taking into consideration the outcome of this assessment by EFSA, we will focus all our efforts on the preparation and submission of new health claim dossiers,” Yakult said. “We also expect that the guidelines currently being drafted by EFSA that will be discussed at the stakeholder meeting on 2 December will further clarify the scientific requirements for dossiers. With the benefit of this further guidance, the company anticipates a positive EFSA opinion in due course.”

The opinions are the latest in a series of rulings by EFSA, which has already published five opinions on claims relating to probiotics. In October last year, a number of health claims for ‘probiotic’ drinks and yoghurts were rejected by Europe’s food safety watchdog in its first assessment.

Since then, the EU has rejected Danone’s claim that immunofortis, an ingredient added to its baby formula products, strengthens babies’ immune systems. Danone also withdrew two scientific health benefit claims for its Activia and Actimel products months later.

In a statement today, Danone said that none of its products were included in the EFSA opinions released yesterday.

“Danone has always supported the principal of European regulations, however the process is complex,” a spokesperson for the firm said. “EFSA is offering more dialogue to dossier applicants to clarify requirements with a ‘gut and immune health workshop’ planned for 2 December, that Danone will attend.

“In light of this, Danone temporarily withdrew applications concerning Actimel and Activia earlier in the year, pending clarification of rules for assessment which it hopes will be made at the workshop,” the firm added. “A third Danone application is still in the process.  EFSA has not yet completed its review of all probiotic products and Danone remains fully confident of the science backing its products.”

EFSA is expected to finalise the evaluations of all ‘general function’ health claims by the end of June 2011.

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