Nature-Identical Zeaxanthin Receives Novel Food Approval

Main Category: Regulatory Affairs / Drug Approvals
Article Date: 31 Jan 2013 - 1:00 PST


DSM Nutritional Products is pleased to report that on January 24, 2013 the European Commission approved the use of nature-identical Zeaxanthin in the European Union as an ingredient in food supplements. The decision follows a positive EFSA safety assessment delivered on September 13, 2012, which concluded that the use level for Zeaxanthin does not raise safety concerns. This opens up the 27 EU-member state market to DSM's Zeaxanthin brand OPTISHARP®[1].

Together with Lutein, Zeaxanthin is one of the main components of the macular pigment selectively deposited into the human macula. It is found in a small, highly sensitive area of the retina responsible for central vision where it works as a blue light filter and as an antioxidant.  

Zeaxanthin, and more specifically OPTISHARP® Zeaxanthin, has been subject of numerous publications. Several scientific peer reviewed studies demonstrate the antioxidant role of Zeaxanthin in the retina and the lens, and it is acknowledged by eye health professionals as playing a positive role in eye health. OPTISHARP® is being used at 2mg dose/day, in combination with DSM's FloraGlo® Lutein[2], in the on-going study AREDS 2 (Age Related Eye Disease Study) sponsored by the National Eye Institute of the National Institutes of Health in the United States.

OPTISHARP is widely applied to nutritional supplements in several other regions of the world, and this decision by the European Commission now offers companies in Europe the opportunity to add value to their products with a scientifically relevant and safe new ingredient.

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