The draft guidance on health claims published by the European Food Safety Authority last week, has drawn mixed reaction from industry, which has a month to respond to the document.
"We welcome this very much as it will be the guideline for companies to develop submission files for claims in future," Patrick Coppens, secretary general of the Belgium-based European Responsible Nutrition Alliance told FF&N. "It is very positive that EFSA has published this guidance so quickly and although the consultation deadline is sharp, we will study the document in detail and submit our comments."
He noted that the guidance only refers to article 14 claims — those that relate to disease reduction — with detail on article 18 claims requiring new scientific data and proprietary protection as well as children's claims yet to be clarified. "It is, however, very positive that EFSA intends this document to be a living document, to be adapted whenever necessary," he said, but warned: "What the document does not do is give insight into the criteria that will ultimately be used to assess the value of the scientific evidence and arrive at a positive or negative opinion. Although there is no legal obligation to do so, we believe that at a given moment EFSA should also make public the criteria it intends to use and submit these to a public consultation."
Coppens criticised the implication in the guidance that article 18 claims would not be assessed until a central registry of claims was published in 2010. "If this interpretation continues to prevail, companies that had intended to use the procedure face losing return on investment because they will not be able to protect their data for the next three years."
In the US, Daniel Fabricant, PhD, vice president of scientific and regulatory affairs at the Washington DC-based Natural Products Association, expressed concern at the direction of the EFSA guidance. "Essentially this will only allow what most would consider an approved health claim on products," he said. "This would deny consumers access to valuable information like structure/function claims, which, without approval from EFSA, is not in the best interest of public health."
He cited folic acid, which took 20 years to be granted a structure/function claim for neural tube defects in the US, despite solid scientific support. "There has to be some mechanism to get information to the consumer on the potential benefits of a product outside of an approved health claim."
Industry members have until June 17 to comment on the draft guidance.