INFORMATION NOTE ON THE NEW PUBLISHED NOVEL FOOD REGULATION: ASTAXANTHIN

On 2 August 2023, the Commission published Regulation (EU) 2023/1581 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food 'astaxanthin-rich oleoresin from the algae Haematococcus pluvialis'.

Its use in food supplements was already authorised, with a maximum content of 8 mg astaxanthin per day. The new Regulation limits the use of food supplements containing 8 mg astaxanthin to adults and adolescents over 14 years of age, and classifies the maximum content of astaxanthin in different population groups:

-          Children aged 3 to 10 years: up to 2.3 mg/day of astaxanthin.

-          Adolescents aged 10-14 years: up to 5.7 mg/day of astaxanthin.

-          General population over 14 years of age: up to 8 mg/day of astaxanthin.

In addition to the conditions of use, specific labelling requirements have also been added:

-          The designation of the novel food on the labelling of products containing it shall be 'astaxanthin rich oleoresin from Haematococcus pluvialis algae '.

-          The following additional warning: “Do not consume the product if other food supplements containing astaxanthin esters are consumed on the same day.”

The changes of this Regulation entered into force on 22 August without a fixed transition period, therefore, food supplements may be placed on the market until their date of minimum durability or use-by date if they:

-          Contain ≤8 mg of astaxanthin per daily dose, intended for the general population over 14 years of age and were legally on the market before the date of entry into force of the Regulation or they contain or;

-          Contain ≤8 mg of astaxanthin per daily dose, are intended for the general population over 14 years of age and have been imported into the Union, provided that the importer of the food can demonstrate that they were dispatched from the third country concerned and were en route to the Union before the date of entry into force of that Regulation.

From Cía de Productos Naturales Lleó we will contact all our customers affected by the new regulation.