The fact so many claims were being passed back to the risk manager (the EC and member states) from the risk assessor (EFSA), was indicative of a process that was malfunctioning, EBF said.
“We support the claims regulation and have tried to address the request for clarification the best way we could, but we have found so many inconsistencies in this request that we have grave doubts about the coherency of the process and have even more unanswered questions,” Patrick Coppens, EBF Secretary-General, said.
“We strongly believe this process cannot credibly proceed and have requested to the Commission that it enables such reassessment with all parties involved around the table before the first opinions are published.”
The EBF will attend EFSA’s stakeholder meeting in Brussels next Monday, where it was hoped clarification about how generic article 13.1 claims will be treated by EFSA would be forthcoming.
Inappropriate scientific criteria
EBF, which represents major European botanicals suppliers, said EFSA was applying inappropriate criteria to herbal products and extracts and other health claims.
Data based on traditional usage that on occasion was acceptable for some pharmaceutical herbal products, was in danger of failing to be recognised by EFSA.
“Despite the fact that the claims regulation calls for a different type of assessment between article 13 claims and applications for authorisation under article 14, the EC and EFSA have so far given no indication as to how such assessment will be done differently,” said EBF chairman, Manfred Ruthsatz.
“On the contrary, many believe that the same ‘gold standard’ approach taken for disease risk reduction claims will be applied to evaluate functional health claims. Beyond a breach with the meaning of the text, we consider the sole reliance on clinical trials as disproportionate. The regulation particularly foresees using the totality of supportive evidence and this includes respecting traditional usage”.