The green light comes four years after the European regulator initially said there was ‘insufficient science at this point in time’ to back a DSM claim that 20mg per day per person was safe in dietary supplements.
However the European Commission asked EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA panel) to update its opinion on the safety of synthetic zeaxanthin as a novel food ingredient in supplements after DSM provided a second dossier including new data – including a two generation study – earlier this year.
Specifically DSM’s dossier asked for an assessment of whether a proposed use level of up to 2 mg per person per day would be safe.
The new opinion states that the nature-identical zeaxanthin is safe an ingredient in food supplements
EFSA said: “Based on the available data, intakes of 0.75 mg/kg bw per day for synthetic zeaxanthin, corresponding to a daily intake of 53 mg for a person with a body weight of 70 kg, do not raise safety concerns,”
“Therefore, the use levels proposed by the applicant do not raise safety concerns.”
The regulatory panel explained that a no observed adverse effect level (NOAEL) of 150 mg per kg per day was identified in the two-generation reproduction toxicity study provided by DSM. However it said that given an absence of a chronic toxicity and carcinogenicity studies “the Panel applies an uncertainty factor of 200 on the NOAEL in the two-generation study.” This uncertainty factor results in the 0.75 mg/kg per day safe level approved by EFSA.