EFSA Board: No resources for pre-submission claim meetings

20-Dec-2010 - Last updated on 20-Dec-2010 at 12:08 GMT

EFSA gives thumbs down to pre-submision meetings

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The European Food Safety Authority (EFSA) confirmed at its Board Management meeting last week that the resources do not exist to accommodate meetings between its health claims panel and parties before claim submissions are formally made.

EFSA executive director Catherine Geslain-Lanéelle reiterated that the agency’s annual budget of €77.3m was not sufficient to cover pre-submission meetings.

But the meeting did confirm EFSA’s ongoing commitment to greater communication between applicants and its health claims panel.

A Management Plan was accepted by EFSA’s Management Board which included the statement: “Dialogue with applicants is a crucial aspect of EFSA’s work, particularly in the evaluation of regulated products and health claims. Therefore, technical meetings and similar events that aim to ensure that all parties share a common understanding of the requirements will be prioritised while in parallel EFSA will introduce streamlined, centralised services for applicants.”

EFSA has already demonstrated its commitment in this direction by hosting its second general stakeholders meeting on health claims at its EFSA’s Parma, Italy, headquarters in the summer. It followed that with this month’s gut-immunity meeting in Amsterdam and other subject-specific meetings are planned throughout 2011 and into 2012.

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At these meetings, the likes of Danone, Danisco and European trade groups have been calling for pre-submission dialogue with EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) to better guide the building of expensive health claim dossiers.

The confirmed rejection of the idea last week will come as another blow to the European Union functional foods and food supplements industry that has largely been reeling since the 2006 nutrition and health claims regulation kicked into life in August 2008, when the NDA published its first health claim opinions.

The desire for pre-submission meetings comes from the position held by many sectors of industry that despite the meetings EFSA has convened, along with increased dialogue with applicants and use of stop-the-clock procedures, that claims criteria remains ambiguous.

The pre- and probiotics industries just last Friday raised the issue in a formal letter signed by four major sector groups and addressed to both EFSA and the European Commission.

In reference to pre-submission they wrote: “Such consultations would not only benefit the quality of future applications but may also improve the efficiency of the process. Moreover, these consultations could – in the long run – lower the cost to EFSA, as the majority of the applications would improve and be properly presented and structured.”

Speaking to NutraIngredients, Yoghurt and Live Fermented Milk Association (YLFA) spokesperson, Carine Lambert, said there were member state examples where industry even paid fees to have consultations, although this had not been raised by the four groups.

EFSA’s management plan can be found here.