Amendments to the Terms of Use for Astaxanthin-Rich Oleoresin: Analysis of European Commission Regulation (EU) 2023/2852
On December 21, 2023, the Official Journal of the European Union published Commission Implementing Regulation (EU) 2023/2852, dated December 20, 2023, which corrects Commission Implementing Regulation (EU) 2023/1581. The latter regulation amends Implementing Regulation (EU) 2017/2470 regarding the conditions of use of the new foodstuff named “astaxanthin-rich oleoresin derived from the Haematococcus pluvialis algae.”
Previously, with Implementing Regulation (EU) 2021/13771, the European Commission had already modified the conditions of use for this foodstuff, restricting its use in food supplements intended for adults and adolescents aged 14 and above. The new permitted maximum levels ranged from 40 to 80 mg/day of oleoresin, equivalent to ≤ 8 mg of astaxanthin per day.
Subsequently, the European Commission further adjusted the permitted maximum levels for the use of astaxanthin-rich oleoresin in food supplements. This modification expanded the product’s use to children aged 3 to under 10 years, also differentiating the maximum doses for adolescents aged 10 to under 14 years and adults above 14 years. Implementing Regulation (EU) 2023/15812 established the following doses.
• 2.3 mg of astaxanthin per day (23 mg/day of oleoresin) for children aged 3 to under 10 years;
• 5.7 mg of astaxanthin per day (57 mg/day of oleoresin) for adolescents aged 10 to under 14 years;
• 8 mg of astaxanthin per day for the general population aged 14 and above.
It set the new conditions of use for this ingredient, specifying specific daily doses of astaxanthin based on age. However, they identified an error regarding transitional measures for food supplements containing ≤ 8.0 mg of astaxanthin intended for the population above 14 years.
The Commission then issued Implementing Regulation (EU) 2023/2852 to rectify this aspect, clearly stating the timeframes for marketing such food supplements compliant with the provisions of Implementing Regulation (EU) 2021/1377.
The correction states that companies can place these supplements on the market until February 1, 2024, and can market them until the minimum storage period or the expiration date. The correction came into effect on December 22, 2023, with retroactive effect from August 21, 2023, the effective date of Regulation (EU) 2023/1581.
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