(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union.

(2)

Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) has established a Union list of novel foods.

(3)

The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 includes Calanus finmarchicus oil as an authorised novel food.

(4)

Commission Implementing Regulation (EU) 2022/966 (3) authorised the placing on the market of Calanus finmarchicus oil for use in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (4), up to a maximum level of 1,0 g/day (< 0,1 % astaxanthin esters resulting in < 1,0 mg astaxanthin per day) for the general population, excluding infants and young children, and up to a maximum level of 2,3 g/day (from 0,1 % to ≤ 0,25 % astaxanthin esters resulting in ≤ 5,75 mg astaxanthin per day) for the general population older than 14 years of age.

(5)

On 16 December 2024, the company Calanus A/S (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 for a change of the conditions of use of the novel food ‘Calanus finmarchicus oil’. The applicant proposed to change the conditions of use with regard to astaxanthin esters to the level up to 0,25 % for all population groups. They requested an increased maximum level of up to 0,25 % of astaxanthin esters contained in Calanus finmarchicus oil for children 3 to less than 14 years of age. For food supplements containing the currently authorised level of < 0,1 % astaxanthin esters that are intended for the general population, the applicant proposed reducing the currently authorised use levels of the Calanus finmarchicus oil from 1,0 g/day to 0,9 g/day (≤ 0,25 % astaxanthin esters resulting in ≤ 2,25 mg astaxanthin per day) and excluding infants and young children. For food supplements that are intended for the general population older than 10 years of age the applicant proposed a maximum use level of 2,2 g/day (≤ 0,25 % astaxanthin esters, resulting in ≤ 5,5 mg astaxanthin per day). For food supplements containing the currently authorised level of ≤ 0,25 % astaxanthin esters that are intended for the general population older than 14 years of age, the applicant also proposed increasing the currently authorised use levels of the Calanus finmarchicus oil from 2,3 g/day to 3,1 g/day (≤ 0,25 % astaxanthin esters resulting in ≤ 7,75 mg astaxanthin per day). Finally, the applicant requested to amend the additional labelling requirements, as the statement indicating that food supplements containing Calanus finmarchicus oil should not be consumed by children younger than 14 years if the ingredient contains ≥ 0,1 % astaxanthin is no longer appropriate as the astaxanthin content of Calanus finmarchicus oil will be harmonised across all population groups.

(6)

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, and that a safety evaluation by the European Food Safety Authority (‘the Authority’) in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary. The proposed increase in the astaxanthin esters in oil from Calanus finmarchicus is expected to result in intakes of astaxanthin which, in combination with the intake of astaxanthin from the normal diet, are not expected to exceed, in any population group, the acceptable daily intake of 0,2 mg of astaxanthin/kg body weight established by the Authority (5).

(7)

It is therefore appropriate to amend the conditions of use of the novel food Calanus finmarchicus oil, as proposed by the applicant.

(8)

It is also appropriate to amend the labelling requirements of Calanus finmarchicus oil, in line with the proposed conditions of use, as the statement that food supplements containing Calanus finmarchicus oil should not be consumed by children younger than 14 years if the ingredient contains ≥ 0,1 % astaxanthin does no longer apply.

(9)

The information provided in the application gives sufficient grounds to establish that the changes to the conditions of use and to the specific labelling requirements of the novel food Calanus finmarchicus oil are in accordance with the conditions of Article 12 of Regulation (EU) 2015/2283 and should be approved.

(10)

The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

(11)

In order to provide business operators with sufficient time to adjust their practices to comply with the requirements of this Regulation, transitional measures should be laid down as regards food supplements containing Calanus finmarchicus oil which have been lawfully placed on the Union market or dispatched from third countries for the Union before the date of entry into force of this Regulation.

(12)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,