Fielding questions at the NutraIngredients Health Claims 2010 conference in Brussels last week, the EC’s Lars Korsholm said article 13.4 may offer hope to rejected claims as a means of submitting additional data.
This facility has drawn little attention to date because its function only becomes live once article 13.1 general health associations are validated by the European Commission, something that is expected to occur for the first time in January, 2010.
But submissions under article 13.4 could only be made by member states or on recommendation of the EC, Korsholm said, and not by individual companies.
“We will provide as much guidance as possible to facilitate the use of article 13.4,” Korsholm said. “Indications are that the article will be operational in early 2010 when we are likely to receive request to initiate the 13.4 process.”
The full text of the 2006 nutrition and health claims regulation can be found here.
Distortion of competition
Food law specialist, Nicole Coutrelis, of the French and Belgian-based legal firm, Coutrelis & Associates, agreed the article could be utilised to submit reworked claims, but questioned the staggered publication of opinions.
“There are issues around distortion of competition that raise a lot of problems that are likely to surface next year,” she said. “The balance of interest is not being represented.”
She also wondered about the legality of the regulation not meeting the deadline written into the regulation to have all claims processed by January, 2010. There are obligations and consequences if these obligations are not met,” Coutrelis said.
It is expected the process will not be completed now until 2011.
Patrick Coppens, the secretary general of Belgian trade group, the European Responsible Nutrition Alliance (ERNA), said he expected that there was a lot data that had not been submitted due to the vagaries of the process, and which could be added to adjusted claims now that certain aspects of the regulation’s requirements had become clearer.