Cognis to submit article 13.5 lutein claim ‘within months’
The company’s US-based senior marketing manager, Sharrann Simmons, told NutraIngredients-USA.com the company was working on a proprietary and emerging science article 13.5 eye health dossier that could be ready in months for its XanGold-branded lutein esters.
If approved the claims would likely match the eye health claims being made in various EU countries, the structure/function claims made in the US and those made in other parts of the world.
The dossier will contain new science including a new review of the lutein body of science and “one major study” that had been completed but not yet published since the initial submission was made under the generic article 13.1 section of the regulation in 2008. That dossier drew a negative opinion from EFSA last week. It can be found here.
Eyes on 13.5
It was contributed to by all lutein suppliers and Cognis, like Kemin, believes it has a better chance of winning a positive opinion from the European Food Safety Authority (EFSA) health claims panel by going it alone and focusing purely on XanGold.
Kemin and its lutein partner DSM Nutritional Products this week committed to submitting a dossier via the same 13.5 route for Kemin’s lutein product, FloraGLO.
“Like many others we were willing to contribute to the article 13.1 submission but now it is important we submit an article 13.5 dossier,” Simmons said.
“We have learnt that it is not just the science you present to EFSA but the way it is presented that can make a difference in terms of explaining the significance of various studies. So we are strengthening the dossier with these learnings in mind.”
She said some Cognis clients had been concerned about the claims they were making on their products since the ruling came through, to which Cognis replied it, “business as usual” until the EFSA opinion had been discussed by the European Commission and passed into law.
It is possible the opinion can be amended at this stage of the process.
The article 13.1 submission contained two claims approved by the French Food Safety Agency (AFSSA) in 2004. They stated:
- “Lutein helps protect the retina and the lens from oxidation”
- “Lutein is one (of the) constituent(s) of the retina and the lens.”
It contained 232 references including 86 human studies, 42 of which were human intervention studies investigating either vision endpoints lutein bioavailability.
“While we were initially disappointed in the EFSA ruling, in reviewing the opinion, we have identified areas that can be more clearly supported with strong scientific evidence that has evolved since the original submission was completed over three years ago,” said Holger Becker, PhD, Xangoldglobal product manager, Cognis Nutrition & Health, in a statement.
Lutein is most commonly linked to reducing the risk of age related macular degeneration (ADM) and is often used in combination with zeaxanthin.
The global lutein market is set to hit $124.5 million (€93 million) in 2013, according to a 2007 report from Frost & Sullivan.
