There are just a few days to go before EFSA stages a landmark meeting to discuss the claims approval process it is applying under the European Nutrition & Health Claims Regulation. The event, to be held in Brussels on 15 June, will be the first real opportunity food and beverage companies and experts have had to quiz EFSA's assessors about the tough levels of proof they are seeking when evaluating claims dossiers.
Ahead of the meeting, towards the end of May, EFSA published a draft document containing 'Frequently Asked Questions' in relation to the health claims approval process. The FAQ document covers a variety of issues, including how a food or constituent should be characterised; how a claimed effect should be shown to be beneficial to human health; and how the NDA Panel (which assesses claims) decides whether a claim is substantiated.
The FAQ can be viewed in full here.
But will the document make any difference to the many food companies alarmed by how tough it has proved to get claims approved? Nigel Baldwin, senior scientific and regulatory consultant at Cantox Health Sciences International, and a leading expert on the health claims regulation, told Functional Ingredients the FAQ document was welcome, but warned that the fundamental problems facing manufacturers remained.
"My view overall is to minimise the legislation and maximise the guidance, so all dialogue is helpful. The main point is, though, that you cannot hide from the fact that you have to do good science. If you do that the guidance will sort itself out.
"We need more flexibility around the term 'cause-effect' In assessing each specific food-health relationship that forms the basis of a claim, the NDA Panel makes a scientific judgement on the extent to which a cause and effect relationship is established between consumption of the food or constituent and the claimed effect.
"This is a sound principle. But EFSA to date has simply reported whether a cause effect actually exists without any reflection of the strength of the evidence. Critical to the industry is the ability to make claims that may not be cast iron but may still be potentially beneficial to the consumer. The use of the terms 'may' or 'might' or similar terms which reflect the strength of evidence is vital to encourage more research and justify expenditure on more clinical research that would increase, or indeed weaken in some cases, the strength of the cause-effect relationship."
Baldwin also said more time was required to enable manufacturers and EFSA to interact in relation to claims assessments. "We need to allow more time for 'stop clocks', so that getting the final wording right and the data required is a more interactive process between EFSA and the applicant," he said. "Currently the regulation stipulates such short maximum discussion times that this just does not occur."
But he added: "Don't expect EFSA to be able to change their approach because they exist for good science and not politics."
On a political note, separately, there have been calls for EFSA to take a "time-out" on implementation of the regulation. At a conference in Brussels Jules Maaten, a Dutch MEP, told delegates: "The lack of an impact assessment for this piece of legislation, particularly with regard to R&D, technology and innovation, the confirmation of the European Commission that the January 2010 deadline will not be met, and the postponement of the nutrient profiling and food labelling debates, raise the need for a time-out to reflect on the implementation of the health claims legislation."
He added there should be "no staggering of the publication of the EFSA health claim opinions as this would lead to a market distortion and was not in the interest of society or industry."
Elsewhere, and on a more positive note, UK-based nutritional science business Provexis said it had become the first company to earn a positive verdict from EFSA in relation to an Article 13(5) claim, which is a claim supported by either proprietary data or new science.
The successful claim was for the company's Fruitflow ingredient, extracted from tomatoes, which has a beneficial impact on blood circulation. EFSA panel judged that a cause and effect relationship had been established between consumption of Fruitflow and the reduction of platelet aggregation in humans. EFSA has now adopted the scientific opinion substantiating the health claim and this will go through the final authorisation procedure in the coming weeks.
Stephen Moon, chief executive of Provexis, said: "We understand that Fruitflow is the first technology to have a health claim adopted by EFSA under Article 13(5) of the new legislation. While the process has required intensive resource allocation over the last few months, we are supportive of the new framework, given it clears the way for scientifically-substantiated products to prevail in the market."