Dec 6 2011 --- Article 13.1 health claims that have been given an unfavourable EFSA opinion should be carefully reassessed by applying a different type of assessment to that required for Article 13.5 and 14 claims, European trade association EHPM has said.

Commenting on the vote yesterday in favour of a list of permitted Article 13.1 claims for use in the European Union (EU), EHPM said that huge issues exist for claims that have not made it onto the permitted list.

The Standing Committee on the Food Chain and Animal Health yesterday adopted the regulation establishing the permitted list of Article 13.1 claims.

Claims that will be considered rejected will be included as such in the Union Register and forbidden from use after a six-month transition period.

“Our problem is not with the permitted list of claims, but we remain concerned about claims that have not made it onto this list,” said EHPM Chairman Peter van Doorn. “In addition, some claims have received unfavourable opinions because they were not within the scope of the Nutrition and Health Claims Regulation. However, these should be authorised under the provision of article 10.3 of the regulation allowing reference to general and non specific benefits provided they are accompanied by a specific authorised health claim.”

“Claims that have received negative EFSA opinions should not automatically be considered as rejected,” he continued. “Many of the unfavourable opinions are the result of failures in the procedures, namely a lack of clarity in a number of important issues. We continue to call for further evaluation regarding EFSA’s assessment criteria, which we believe are not appropriate.”

EHPM has consistently called to grade evidence relating to Article 13.1 health claims rather than give yes/no opinions, arguing that both the Nutrition and Health Claims Regulation and the Terms of Reference that EFSA should be following require an assessment of the extent to which cause and effect can be shown.

“The ‘extent’ is determined by the strength, consistency and biological plausibility of the totality of the available data in support of a beneficial nutritional and/or physiological effect,” said Mr van Doorn. “The EFSA pharmaceutical approach does not recognise the complexities of nutrition research and instead opts for the easier route of requiring conclusive cause and effect evidence. EFSA’s only attempt at grading the evidence has been in under one percent of all evaluations, where it stated that there was insufficient evidence to assess the claim.”

The statement came after a meeting of the Standing Committee on the Food Chain and Animal Health, Member States supported the European Commission's draft Regulation to adopt a list of permitted health claims for use on food.

Health and Consumer Policy Commissioner John Dalli, made the following statement: "I welcome today's important decision. Consumers have the right to accurate and reliable information on food labels to help them make healthier choices. When it comes to health claims, ensuring that they are truthful and accurate is of particular importance. This measure, once endorsed by the European Parliament and the Council, will help national authorities to ensure a high level of consumer protection."

Commissioner Dalli concluded: "I would like to recall that consumer protection is the main objective of the nutrition and health claims Regulation. Consumers tend to over-estimate the value of food products on which claims are made. We now have the tools to clean up the market from those health claims attributing unsubstantiated and misleading health benefits to products. Misleading claims are also unfair competition, disadvantaging the majority of food business operators who try to ensure consumers have the correct information on which to make informed choice. This measure will make for better clarity, with harmonised rules throughout the EU".

The Commission note that 44,000 health claims had been submitted from Member States. It required a consolidation of this large number of claims to over 4,600 entries in a list for assessment by EFSA and consideration by the Commission and Member States as risk managers.

The health claims now included on the permitted list are representative of some 500 entries from the consolidated list for which the process of authorisation required is completed. The process of authorisation is also completed for another 2000 entries from the consolidated list. The remainder of the claims (some 2000) are still awaiting completion of the authorisation process.

In September 2010 the Commission decided that it was not possible to continue with the assessment of health claims for plant and herbal substances, the so-called "botanical" substances. EFSA was asked to discontinue its assessment on claims for botanicals and these, together with a number on botanicals already assessed, have been put on hold. Also consideration of some claims for micro-organisms was suspended. EFSA concluded that they were insufficiently characterised. Silimilarly for claims for which the evidence was insufficient for EFSA to reach a conclusion about the cause and effect relationship were put on hold. These claims are therefore also on hold pending a reassessment of the additional data where this has been submitted.