Concerns Heighten for Botanicals in EFSA Claims Assessment Process

Botanical food supplements rely on information on the intended use and health effects, which are covered by the EU claims legislation and are currently on EFSA’s table for assessment.

15/06/09 The European Botanical Forum (EBF) this month expressed concern over the future of botanical products in light of the European Food Safety Authority’s (EFSA) method for assessing botanical claims.

The EBF, which represents the main botanical ingredients and food supplements manufacturers in the European Union (EU), voiced fears that if EFSA refuses to accept criteria that are sufficient for pharmaceutical herbal products, based on traditional knowledge, it could lead to the eradication of their products.

Botanical food supplements rely on information on the intended use and health effects, which are covered by the EU claims legislation and are currently on EFSA’s table for assessment.

“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 European Commission and EFSA have so far given no indication as to how such assessment will be done differently,” said Manfred Ruthsatz, chairman of the EBF. 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”.

EFSA recently sent back to the Commission more than half of the approximately 4000 claims received for further clarification, including many botanical claims, which according to the EBF “shows that something is fundamentally wrong with the process.”

Patrick Coppens, EBF Secretary-General, 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. 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 the EFSA technical meeting on 15 June in Brussels, where it aims to get final clarification on how EFSA intends to assess the article 13 claims, particularly claims relating to botanicals.