The European Commission culled the list from more than 43,000 submissions it had received from companies and organisations within the European Union’s 27 member states.
Many of these submissions were duplicates or deemed inappropriate due to a lack of scientific backing, hence the drastic reduction in number.
EFSA, which recently launched a drive to draft in scientists on an ad hoc basis to help it cope with its increasing workload in health claims and other areas, is due to publicly release the list by tomorrow.
Call for data
The Palma, Italy-based agency has called on companies to submit scientific data referenced in original submissions and issued guidance on what is required and how it should be presented.
Lorène Courrège, director of regulatory affairs at the European Federation of Associations of Health Product Manufacturers (EHPM), said EFSA’s latest request for data, while not unexpected, had not been written into the original health and nutrition claims regulation that was passed in October 2006 and entered the EU legislature in January 2007.
“This latest request is not a legal requirement as it is not stated in the regulation,” Courrege told NutraIngredients.com. “But companies risk having their claims submissions jeopardised if they do not present the data so it becomes a time-consuming and financial burden upon them.”
She said a typical dossier might contain 10-20 references that needed to be tracked, copyrighted, and collated, at a cost of up to €800.
“For big companies that have submitted dossiers this is not so much of a problem,” she said. “But for a small to medium sized company that has submitted multiple claims, and many have, it can become a significant cost.”
EFSA had also failed to clarify the criteria it would use to assess the dossiers it received, a situation that may see uniform requirements applied to article 14 children’s and disease reduction claims as well as generic article 13 claims when separate criteria was required.
Moving forward
One company that is glad to see the process moving forward is National Starch Food Innovation, which submitted two claims in relation to its Hi-Maize phase two resistant starch ingredient.
Its prebiotic and blood sugar article 13 generic claims are on the list and it is gathering the required data to send to EFSA.
Its European regulatory compliance manager, Julie Scott, welcomed the advance and looked forward to 2010 when the published list would finally deliver the EU-wide harmonisation promised by the legislation.
“If all or most of the claims are approved Europe will have the most progressive, liberated health claims system in the world,” Scott said. “The potential benefits for trade are enormous as well as consumer education.”
She added: “With potential product repositioning and reformulation on the horizon, suppliers offering functional ingredients with proven, recognised health benefits will be invaluable allies for manufacturers. Hi-maize is an example of an ingredient we have already substantiated. In this way, we can help manufacturers make the new legislation work to their advantage.”