This decision 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 53mg for a person with a body weight of 70kg, 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.
Source: DSM
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