MEPs Question EFSA’s Approach to Evaluating Article 13.1 Claims
Titled “Botanicals & Food supplements in the EU: Impacts, weaknesses and limitations of Article 13.1 of the EU’s claims regulation”, the MEPs called for further dialogue with the European Commission on the current direction of the Nutrition and Health Claims Regulation and its potential impact on the industry and consumers.

4/22/2011 --- Members of the European Parliament (MEPs) have gathered to discuss mounting concerns about the European Food Safety Authority’s (EFSA) approach towards the evaluation of Article 13.1 claims.
The workshop was led by MEPs Boguslaw Sonik (EPP), Marian Harkin (ALDE) and Michèle Rivasi (Greens / EFA), who could not be there. The MEPs debated the impact of what they said was a disproportionate EFSA approach to the evaluation of Article 13.1 claims, which is inconsistent with other EU legislation.
Titled “Botanicals & Food supplements in the EU: Impacts, weaknesses and limitations of Article 13.1 of the EU’s claims regulation”, the MEPs called for further dialogue with the European Commission on the current direction of the Nutrition and Health Claims Regulation and its potential impact on the industry and consumers.
“EFSA’s evaluations on health claims for dietary supplements poses serious problem” said Michele Rivasi, during the preparation of the workshop. “How is it that over 95% of cases of health claims filed for natural or herbal substances received a negative opinion of the EFSA?”
“EFSA’s approach is too stringent and based on procedures derived from the drug industry,” Rivasi continued.. “It takes into account very little scientific evidence and dismisses claims that have been approved in several European countries. In doing so, EFSA assessments are also in contradiction to the European Medicines Agency, which, through the directive on traditional herbal remedies, recognises the healing properties of dozens of plants.”
Article 13.1 of the Nutrition and Health Claims Regulation aims to harmonise the use of claims across the European Union following an assessment of their scientific substantiation by EFSA.
“It is vital that the Commission takes into consideration the economic impact that this approach will have on small and medium sized enterprises (SMEs),” said Sonik. “SMEs are the backbone of our economy and it is important that their rights are not unnecessarily infringed upon.”
”We also need to remember that the main objective of this legislation is to systematise the knowledge of consumers about the actual value of health related products,” he added. “This goal can be achieved by providing more clarity and transparency on EFSA’s criteria for the approval and rejection of claims.”
“The claims Regulation aims to prevent misleading claims with a view of facilitating consumer choice among “safe and adequately labeled” food products (Recital 1)” Marian Harkin remarked. “However, the effect of banning all claims other than those few that are allowed risks putting consumers into an information void which will make it difficult for them to understand what the product was intended for. This situation works to contravene consumer choice".
Rivasi said: “It is imperative that EFSA reviews its assessment methodology given the likely impact that this will have for the industry and consumers”.