Lutein suppliers like Kemin Health, Cognis Nutrition and Omniactive Health Technologies were dealt a blow in 2010 when the European Food Safety Authority issued an article 13 opinion stating there was insufficient evidence linking the carotenoid lutein with eye health benefits.
EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) lutein opinion found that while the carotenoid had the ability to raise macular pigment density, this effect did not necessarily benefit, “maintenance of normal vision”.
The companies have committed to resubmitting, although none of them have done so as yet, but Coppens backed the article 13.5 route they have outlined that lets them submit individually and offers the potential of more intimate dealings with the NDA over study details and overall dossier content including the ever-crucial claim wording.
Article 13.4, which allowed for the submission of additional data to member state-submitted article 13 claims without the company-specific criteria of article 13.5, was also an option.
“The opinion was an insufficient opinion and the [European] Commission has acknowledged that since the data that had been introduced for such applications dated back before 2007 there may have been new data that has become available in the meantime,” Coppens said at a recent lutein congress hosted by Kemin Health and DSM Nutritional Products in Munich, Germany.
“So the Commission will open the possibility for those companies that are interested in those claims to submit that additional data.”
“The advantage of article 13.5 is that you have direct contact,” Coppens suggested.
“On the other hand for substances that have been used for a long time and where there is quite a substantial amount of data available, perhaps there is no need to have a full application and that may also be an element that companies consider when they choose between article 13.4 and 13.5.”
“I am confident that lutein will in the end have a claim.”