Danone’s vice president of external affairs and head of EU regulatory affairs, Patrick O’Quin, told NutraIngredients.com recently that the positive opinion issued by the European Food Safety Authority (EFSA) linking tomato extract consumption and reduced blood platelet aggregation had informed its recent diarrhoea submission.
That positive opinion, for which NutraIngredients.com coverage can be viewed here, was also influencing the tweaking of the three article 13.5 gut health and immunity claims it pulled from the process back in April, before any positive article 13.5 opinion had been delivered.
“When we withdraw our claims in April, there was much more uncertainty about what was required in the dossiers,” O’Quin said. “But we closely studied the positive tomato extract opinion that came in at the end of May and it has been very instructive for our ongoing dossier preparations.”
EFSA’s very tight wording in that opinion was validation of its position that claim wording must succinctly represent the science and do nothing more, with any consumer-friendly claim wording adjustment coming, if at all, coming from the European Commission and member states at committee level.
“So we have taken all this in and feel very confident about the diarrhoea claim and the Activia and Actimel claims we will resubmit soon once EFSA produces its final guidance from the industry meeting in June [expected next month],” O’Quin said.
More succinct, more comprehensible
While the tomato extract opinion handed to UK start-up, Provexis, had been instructive, O’Quin added that EFSA’s raft of article 14 opinions had also been helpful, and had become more succinct and comprehensible as the process had moved along.
Professor Albert Flynn, the head of EFSA’s health claims assessment panel, acknowledged greater transparency and clarity was a goal of the agency at its stakeholders meeting in June.
O’Quin pointed out that regardless of how the EU health claims process pans out, health claims provided only one part of a product’s communication arsenal, and he ranked them behind the taste of a product.
“Health claims are not the cornerstone of the product,” he observed. “In some countries our products make no claims whatsoever. The most important thing is that the consumers like the product and they feel a benefit from consuming it.”
He said studies were ongoing utilising a range of strains, some sponsored by Danone, some not, and that although there was a lot of attention paid to the process at the moment due to the publication of the first EFSA opinions, a broader view should be taken because the process remained open for health claim submissions as more data came to hand.