DSM has reported that it has received a positive opinion from the European Food Safety Authority (EFSA) on the safety of nature-identical zeaxanthin as an ingredient in food supplements.
This decision, said the company, opens the way for DSM’s zeaxanthin brand OPTISHARP to obtain a market authorisation in the EU and underpins its importance as a nutritional ingredient.
The panel concluded that, based on the available data, intakes of up to 0.75 mg/kg body weight per day for zeaxanthin, corresponding to a daily intake of 53 mg for a person with a body weight of 70 kg, do not raise safety concerns.
The EFSA opinion is in response to a comprehensive dossier which includes a two-generation reproductive toxicity study and twenty-two additional references, prepared and submitted by DSM to the European Commission in January 2012.
Together with lutein, zeaxanthin is one of the main components of the macular pigment. It is deposited into the human macula, the 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 the 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 Lutein2, 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.