European Commission Amends Regulation on Calanus Finmarchicus Oil

The European Commission has recently issued a regulation that amends the conditions of use and labelling requirements of Calanus finmarchicus oil, a novel food authorized in the European Union. The regulation was issued on July 28, 2025, and aims to update the Union list of Calanus finmarchicus oil to reflect changes in its conditions of use for children and adolescents. The Commission has also made transitional measures to allow food supplements containing Calanus finmarchicus oil to remain on the market until their minimum durability or use-by date.

Key Takeaways:

• The European Commission has issued a regulation amending the conditions of use and labelling requirements of Calanus finmarchicus oil, a novel food authorized in the European Union.
• The regulation updates the Union list of Calanus finmarchicus oil to reflect changes in its conditions of use for children and adolescents, including an increase in the maximum level of astaxanthin esters contained in the oil.
• The Commission has determined that the changes to the conditions of use and labelling requirements are in accordance with Article 12 of Regulation (EU) 2015/2283 and should be approved.
• Transitional measures were implemented to allow food supplements containing Calanus finmarchicus oil to remain on the market until their minimum durability or use-by date.
• The regulation entered into force on July 28, 2025.
• The changes to the conditions of use and labelling requirements are expected to result in intakes of astaxanthin that do not exceed the acceptable daily intake established by the European Food Safety Authority.
• Calanus A/S, the company that submitted the application for the change in conditions of use, proposed to increase the maximum level of astaxanthin esters in the oil for children and adolescents.
• The changes to the conditions of use of Calanus finmarchicus oil are expected to result in intakes of astaxanthin that do not exceed the acceptable daily intake established by the European Food Safety Authority.

Statistics:

• The Commission considers that the requested update of the Union list of Calanus finmarchicus oil concerning the changes in its conditions of use for children from 3 to less than 10 years of age, for adolescents from 10 to less than 14 years of age, and for the general population older than 14 years of age are not liable to have an effect on human health.
• A safety evaluation by the European Food Safety Authority is not necessary due to the expected effects of the changes to the conditions of use on human health.
• The proposed increase in the astaxanthin esters in oil from Calanus finmarchicus is expected to result in intakes of astaxanthin that do not exceed the acceptable daily intake of 0.2 mg of astaxanthin/kg body weight established by the European Food Safety Authority.
• The regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union.

Sources:

• COMMISSION IMPLEMENTING REGULATION (EU) 2025/1513 of 28 July 2025 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use and the additional labelling requirements of the novel food Calanus finmarchicus oil.
• Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods.
• Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283.
• Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements.
• EFSA Journal 2020;18(2):5993, https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2020.5993.