Experts fear EFSA requests are unattainable as Danone pulls claim dossiers

Functional dairy company Danone has withdrawn three dossiers from the European Union's health claims approval process until after a meeting with the European Food Safety Authority later this year.

The France-based business said it had taken the decision to pull the applications, which relate to its Actimel probiotic shots and Activia probiotic yoghurts, because it believed the meeting would reduce levels of uncertainty surrounding how EFSA is assessing claims.

In a statement, Danone said: "EFSA is organising a meeting with all concerned parties (businesses, EFSA experts, consultants and representatives of the European Commission) on June 15 to clarify its requirements and make additional recommendations. The conclusions of this consultation will be published in the weeks following the meeting.

"In view of this, Danone decided that the logical thing to do was to withdraw its three applications concerning fresh dairy products currently under consideration (one relating to Actimel and two to Activia) to be in a position to review them in the light of these new recommendations and make any appropriate changes.

"Danone will re-submit its applications once EFSA has clarified its requirements. Several other companies have already taken similar action."

The meeting will be the first opportunity for companies involved in the health claims process to quiz EFSA scientists about how they are assessing claims. In particular, there is growing concern about the stringent requirements EFSA's assessors appear to be applying to applications, which has resulted in most of those evaluated so far being rejected.

In the March issue of Functional Ingredients magazine Nigel Baldwin, senior scientific and regulatory consultant at Cantox Health Sciences International, warned that this could have catastrophic consequences for the functional food sector.

"There has to be a discussion at some point on the levels of evidence required, because if there isn't, the realistic outcome is that a high percentage of the industry will fail in the next year," he said.

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