(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 authorised novel foods.

(3)

The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 includes astaxanthin-rich oleoresin from Haematococcus pluvialis algae as an authorised novel food.

(4)

The novel food ‘astaxanthin-rich oleoresin from Haematococcus pluvialis algae’ has been authorised in accordance with Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council (3) for use in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (4) intended for the general population. The maximum authorised levels of the novel food is 40–80 mg/day of oleoresin, resulting in ≤ 8 mg astaxanthin per day.

(5)

Commission Implementing Regulation (EU) 2021/1377 (5) amended the conditions of use of the novel food astaxanthin-rich oleoresin from Haematococcus pluvialis algae. In particular, the use of the novel food in food supplements containing 40–80 mg of astaxanthin-rich oleoresin from Haematococcus pluvialis algae corresponding to levels of astaxanthin up to 8 mg has been limited to adults and adolescents above 14 years of age. The amendment was based on an opinion of the European Food Safety Authority (‘the Authority’) ‘Safety of astaxanthin for its use as a novel food in food supplements’ (6), which concluded on the safety of the levels up to 8 mg of astaxanthin only for the population above 14 years of age.

(6)

On 15 December 2022, the company Natural Algae Astaxanthin Association (‘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, astaxanthin-rich oleoresin from Haematococcus pluvialis algae. The applicant requested to extend the use of the novel food in food supplements intended for children 3 to less than 10 years of age at levels of 23 mg/day of oleoresin (corresponding to up to 2,3 mg/day of astaxanthin), and to food supplements intended for adolescents aged 10 to less than 14 years of age containing 57 mg/day oleoresin (corresponding to up to 5,6 mg/day of astaxanthin).

(7)

The Commission considers that the requested change in the conditions of use of astaxanthin-rich oleoresin from Haematococcus pluvialis algae is not liable to have an effect on human health and that a safety evaluation by the Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary. Taking into account the Acceptable Daily Intake (‘ADI’) of astaxanthin of 0,2 mg/kg body weight per day and the intakes of astaxanthin from the background diet as set out in the opinion of the authority published in 2020, the intake of astaxanthin from food supplements as proposed by the applicant would result in overall intakes of astaxanthin that do not exceed the ADI.

(8)

The information provided in the application gives sufficient grounds to establish that the changes in the conditions of use of astaxanthin-rich oleoresin from Haematococcus pluvialis algae, are in accordance with the conditions of Article 12 of Regulation (EU) 2015/2283 and should be approved.

(9)

In line with the change in the conditions of use of food supplements containing various levels of astaxanthin-rich oleoresin from Haematococcus pluvialis algae depending on the targeted age groups of the population, it is necessary to inform consumers by appropriate labelling that food supplements containing the novel food are not to be consumed by the groups of the population they are not intended for, and are not to be consumed by infants and young children. In addition, the Commission considers appropriate to lay down additional labelling requirement in order to prevent concomitant consumption of astaxanthin food supplements, which is likely to exceed the ADI established by the Authority.

(10)

In order to limit the administrative burden and to provide business operators with sufficient time to comply with the requirements of this Regulation, transitional periods should be laid down to cover food supplements containing ≤ 8,0 mg astaxanthin which have been placed on the market or dispatched from third countries for the Union and are intended for the general population older than 14 years of age, before the date of entry into force of this Regulation. Those transitional measures should take into account the safety of consumers by providing them the information about the appropriate use in line with the requirements of this Regulation.

(11)

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

(12)

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