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At 2 mg daily, the ingredient can be used for nutrition and coloring in food supplements.
The European Commission ruled on January 22, 2013, that synthetic zeaxanthin is safe for human consumption at 2 mg daily. The Commission's ruling gives synthetic zeaxanthin European "novel food ingredient" status after a lengthy process of back-and-forth with industry. Zeaxanthin is a common carotenoid found alonside lutein (another carotenoid) in numerous plants. Its large concentration in the human eyes has motivated research on its role in eye health.
DSM Nutritional Products (Parsippany, NJ) petitioned for the approval with appropriate officials in New Zealand who ultimately moved the request to the Commission. The company's approval process began in June 2004, when it petitioned for synthetic zeaxanthin's novel ingredient status with a maximum daily human intake of 20 mg daily. After a review of safety data, EFSA officially rejected the proposal in April 2008, stating that the ingredient's safety at this maximum level "has not been established."
In January 2012, DSM offered new safety data and a new proposal of just 2 mg daily. EFSA gave its nod that 2 mg does not appear to raise safety concerns and the European Commission made its approval just days ago. The approval qualifies synthetic zeaxanthin as a novel food ingredient and/or colorant for food supplements.