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Europe delays decision on rejected 13.1 health claims

Article 13.1 health claims rejected by the European Food Safety Authority (EFSA) have been given a stay of execution after the European Commission's Standing Committee on Food Chain and Animal Health decided against voting to make them illegal.

The committee, which is made up of representatives of the European Union's 27 member states, met on July 12 to consider the fate of the first batch of Article 13.1 general function health claims that were subject to opinions issued by EFSA in October 2009. Of the 523 claims assessed by the agency's NDA Panel, around two thirds were rejected.

Committee members were set to vote on whether to adopt EFSA's opinions into law — which would have meant those subject to negative judgments becoming prohibited from being used. But a myriad of concerns surrounding the way the claims were assessed led to the committee asking its Working Group — which meets monthly — to consider a number of issues before the committee meets again on 11 October.

A spokesperson for EAS, the Brussels-based regulatory consultancy, said: "Those outstanding issues relate to the wording and conditions of use of claims as well as the fundamental question as to whether the Community List of Article 13 claims should be adopted in a piecemeal fashion as EFSA delivers its opinions in batches, which is opposed by some Member States."

Christiane Alexander, biologist and project manager at Germany-based consultancy Analyze & Realize, said the committee was also worried that some of the evidence used by EFSA to assess the 13.1 health claims might be too old — having been submitted as long ago 2006, when the Article 13.1 health claims application process began. "The procedure has taken so long that the data submitted is outdated," she said. "It was submitted to EFSA three to four years ago and since then science has moved forward."

Alexander said it was unclear what would happen next. "The Commission definitely wants a decision on the claims by the end of the year. But there are so many open questions."

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