Commission Implementing Regulation (EU) 2022/966 of 21 June 2022 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use, the specific labelling requirements and specifications of the novel food Calanus finmarchicus oil (Text with EEA relevance)

• Published date: 22 June 2022
• Subject Matter: Protocol on Ireland/Northern Ireland,Foodstuffs,Internal market - Principles
• Official Gazette Publication: Official Journal of the European Union, L 166, 22 June 2022

22.6.2022 EN Official Journal of the European Union L 166/125

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COMMISSION IMPLEMENTING REGULATION (EU) 2022/966

of 21 June 2022

amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use, the specific labelling requirements and specifications of the novel food Calanus finmarchicus oil

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,

Whereas:

(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 Decision (EU) 2017/2353 (3) authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council (4), the placing on the market of Calanus finmarchicus oil as a novel food ingredient to be used in food supplements intended for the general population.

(5) On 30 November 2021, 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 specifications, of the conditions of use, and of the specific labelling requirements of the novel food ‘Calanus finmarchicus oil’. The applicant proposed to change the specifications of Calanus finmarchicus oil with regard to astaxanthin esters to the level up to 0,25 %. They requested an increased maximum level of up to 0,25 % of astaxanthin esters contained in Calanus finmarchicus oil for persons older than fourteen years of age, in addition to the currently authorised maximum level of < 0,1 % of astaxanthin esters in Calanus finmarchicus oil for the general population. 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 2,3 g/day to 1,0 g/day and excluding infants and young children.

(6) As a consequence of the proposed changes in the specifications Calanus finmarchicus oil and the conditions of use of this novel food, the applicant proposed an amendment in its labelling to ensure that consumers only use the food supplements intended for their age group. In addition, in light of the current use of food supplements containing astaxanthin esters in the Union market, the applicant also proposed additional specific labelling to warn consumers not to use Calanus finmarchicus oil food supplements, when other food supplements containing astaxanthin esters are consumed on the same day.

(7) The Commission considers that the requested update of the Union list concerning specifications of Calanus finmarchicus oil and the resulting changes in its conditions of use for the population groups older than 14 years of age is 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 increase in the astaxanthin esters in oil from Calanus finmarchicus from < 0,1 % to ≤ 0,25 % in food supplements intended for population groups older than 14 years is expected to result in intakes of astaxanthin esters which, in combination with the intake of astaxanthin from the normal diet, are not expected to exceed the revised Acceptable Daily Intake (‘ADI’) of 0,2 mg astaxanthin/kg bw, established by the Authority (5).

(8) Furthermore, the Commission considers that the requested update of the Union list concerning the reduction of the currently authorised use levels of Calanus finmarchicus oil from 2,3 g/day to 1,0 g/day in food supplements intended for the general population that contain < 0,1 % astaxanthin esters, and the exclusion of infants and young children is also not liable to have an effect on human health and that

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