As far as the companies were concerned, they had submitted a comprehensive dossier, which they firmly believed substantiated a health claim in relation to lutein's antioxidant benefits for eye health. They were particularly upset by EFSA's second consecutive rejection of their submissions for 'insufficient' evidence.
They were surprised that the EFSA opinion related to 'maintenance of normal vision', which was different from the requested claim. This sought authorisation for 'lutein, a constituent of the retina and the lens, contributes to protecting these tissues from oxidative damage'.
DSM and Kemin argued that there was a consistent body of evidence demonstrating lutein's antioxidant effect in in-vitro and animal eye models. They added that studies on humans further reported that lutein could protect the retina from additional oxidative damage caused by blue light something which they argued EFSA had already accepted.
They said the EFSA opinion was also inconsistent with an earlier opinion from the French Food Safety Agency and was inconsistent with determinations of the Brazilian Health Surveillance Agency and the Natural Health Products Division of Health Canada, which have authorised antioxidant claims for lutein.
On EFSA's recommendations, the European Commission only approved 222 general article 13.1 health claims in May from the 44,000 originally submitted five years ago (including the rejection of all probiotic health claim submissions). Given this fact, the battle between companies seeking to take commercial advantage of health claims and those trying to regulate the sector, in what they claim to be the interest of European consumers, will inevitably continue.
The only glint of light-hearted relief from the health claims misery to emerge last month arose from Leatherhead Food Research's launch of an airline meal that satisfied all 222 of the approved health claims.