The EU health claims regulation is expected to go through a second reading in parliament in early 2006 and could be adopted in March.
Yet many of the details of the law remain unclear. While applications for health claims must provide evidence of 'generally accepted scientific data', there are no guidelines yet as to how this term will be defined.
Professor David Richardson, former chief scientist at Nestle and member of numerous scientific advisory boards, has taken a proactive approach to the gap in information by publishing proposed guidelines in two different journals this summer. He is hoping to shape the way Europe's scientific committees assess claims in the future.
"Article 12 states that member states will have to draw up their lists of health claims within 12 months of the law going through. This doesn't leave us much time if the law is adopted in early 2006," explained Professor Richardson.
Discussing his guidelines at a conference in Berlin last month, Professor Richardson said European firms should be able to work with grades of evidence, similar to the laws for qualified health claims already in place in the US.
"We're talking about emerging and evolving science," he told NutraIngredients.com.
"Take folate and folic acid. It is well-established that they reduce the risk of anaemia. Now they are also associated with reduced risk of neural tube defects. But if you asked, ten years ago this link was only at a possible level, whereas now it is probable.
Then there is the emerging evidence for its benefit to the heart through its association with homocysteine levels."
Few nutrients will have enough conclusive evidence to support a reduced risk of disease claim under the new law, believes Professor Richardson.But even if such science is not yet convincing, it still needs to be communicated to the consumer, he said. Graphics could be used to convey the levels of evidence.
"Our main objective is to make sure that when the science is assessed, full account is taken of the emerging science as well as the consensus science."
Professor Richardson points out that a number of international organizations already use different levels of claims. For the WHO, these are classed as 'convincing, probable, possible and insufficient'.
He suggests that allowing insufficient claims with a disclaimer, as under the US system, is likely to be misleading for consumers, but that the other three levels can reasonably be made.
There is also an element of harmonization in Professor Richardson's proposals, which "take the best of what is in the US system without going quite so far".
Graded health claims are also being considered in Asia, and are expected to come under discussion at the next Codex meeting in Bonn in November.
"In Korea they are already using grades of evidence and China is looking at this too. The EU could take a lead in showing what can be done in this whole area of substantiation by looking at the grading and weight of evidence," he said.
EFSA will be charged with developing rules and guidance on how to present health claims but it is unclear whether it has started this process.In a bid to shape the way they are developed, Professor Richardson has published his proposed guidelines as a letter to the editor in the August issue of the European Journal of Nutrition as well as the 1 September issue of the Food Science and Technical Bulletin.
He further elaborated on the guidelines in a paper drawn up for the International Alliance of Dietary Supplement Associations (IADSA) at its meeting in Berlin. The final paper will be distributed by IADSA to its members.
It goes further than the journal publications in that it examines the process for the scientific substantiation of health claims. It is designed to underpin new laws around the world.