COMMISSION IMPLEMENTING REGUL ATION (EU) 2022/966 
of 21 June 2022
amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use, the specif ic 
labelling requirements and specif ications of the novel food Calanus finmar chicus oil 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng regar d 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 author ised and included in the Union list of novel foods 
may be placed on the mark et within the Union.
(2) Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Imple menting 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 finmarch icus oil as 
an author ised novel food.
(4) Commission Implementing Decision (EU) 2017/2353 (3)author ised, in accordance with Regulation (EC) No 258/97 
of the European Parliament and of the Council (4), the placing on the mark et 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 compan y ‘Calanus A/S’ (‘the applicant’) submitted an application to the Commission in 
accordance with Article 10(1) of Regulation (EU) 2015/2283 for a chang e of the specifi cations, of the conditions of 
use, and of the specific labelling requirements of the novel food ‘Calanus finmarch icus oil’. The applicant proposed to 
change the specifi cations of Calanus finmarchicus oil with regard to astaxanthin esters to the level up to 0,25 %. They 
requeste d an increased maximum level of up to 0,25 % of astaxanthin esters contained in Calanus finmarch icus oil for 
persons older than fourteen years of age, in addition to the currently author ised maximum level of < 0,1 % of 
astaxanthin esters in Calanus finmarchicus oil for the general population. For food supplements containing the 
currently author ised level of < 0,1 % astaxanthin esters that are intended for the general population, the applicant 
proposed reducing the currently author ised use levels of the Calanus finmarch icus oil from 2,3 g/da y to 1,0 g/da y and 
excl uding infants and young children.
(6) As a consequence of the proposed changes in the specifi cations 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.
(1)OJ L 327, 11.12.2015, p. 1.
(2)Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance 
with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).
(3)Commission Implementing Decision (EU) 2017/2353 of 14 December 2017 author ising the placing on the market of oil from Calanus 
finmarchicus as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 336, 
16.12.2017, p. 45).
(4)Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 Januar y 1997 concer ning novel foods and novel food 
ingredients (OJ L 43, 14.2.1997, p. 1).EN Offi cial Jour nal of the European Union 22.6.2022 L 166/125  (7) The Commission considers that the request ed updat e of the Union list concer ning specif ications of Calanus 
finmarch icus oil and the resulting change s 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 safet y evaluation by the European Food Safet y 
Authority (‘the Auth ority’) in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessar y. 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 expect ed 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 Author ity(5).
(8) Further more, the Commission considers that the requeste d updat e of the Union list concer ning the reduction of the 
currently author ised use levels of Calanus finmarch icus oil from 2,3 g/da y to 1,0 g/da y in food supplements intended 
for the general population that contain < 0,1 % astaxanthin esters, and the excl usion of infants and young children 
is also 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 necessar y. The exclusion of infants and young children is justified 
because the anticipated combined intake of astaxanthin esters from food supplements containing Calanus 
finmarch icus oil with levels of < 0,1 % astaxanthin esters and from the normal diet is expect ed to exceed the revised 
Acceptable Daily Intake (‘ADI’) of 0,2 mg astaxanthin/kg of body weight established by the Auth ority for these 
groups of consumers.
(9) The proposed change to the specifi cations and conditions of use of Calanus finmarchicus oil as regards the astaxanthin 
esters values are in line with the conclusions of the safety assessment conduct ed by the Author ity on astaxanthin. 
Theref ore, it is appropr iate to amend the specifications and the conditions of use of the novel food Calanus 
finmarch icus oil at the proposed astaxanthin esters levels.
(10) The proposed changes to the labelling requirements of Calanus finmarch icus oil are in line with the conclusions of the 
safety assessment conduct ed by the Author ity on astaxanthin. In addition, the Commission considers appropr iate to 
lay down additional labelling requirement in order to prevent concomitant consump tion of astaxanthin food 
supplements, which is likely to exceed the ADI established by the Auth ority. Theref ore, it is appropr iate to include 
additional labelling requirements for that novel food.
(11) The information provid ed in the application gives sufficient grounds to establish that the change s to the conditions 
of use, the specifi c labelling requirements and specifi cations of the novel food Calanus finmarchicus oil are in 
accordance with the conditions of Article 12 of Regulation (EU) 2015/2283 and should be appro ved.
(12) The Annex to Implementing Regulation (EU) 2017/2470 should theref ore be amended according ly.
(13) In order to provid e business operators with suffi cient time to adjust their practices to compl y with the requirements 
of this Regulation, transitional measures should be laid down as regar ds food supplements containing Calanus 
finmarch icus oil, whic h have been lawfully placed on the Union mark et or dispatche d from third countr ies for the 
Union, before the date of entr y into force of this Regulation.
(14) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGUL ATION:
Article 1
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
(5)Safet y of astaxanthin for its use as a novel food in food supplements; EFSA Jour nal 2020;18(2):5993.EN Offi cial Jour nal of the European Union L 166/126 22.6.2022  Article 2
1. Calanus finmarch icus oil food supplements which were lawfully placed on the mark et before the date of entr y into force 
of this Regulation, may be mark eted until their date of minimum durability or use by date.
2. Calanus finmarch icus oil food supplements which were dispatch ed from a third countr y and were on their way to the 
Union before the date of entr y into force of this Regulation and complying with the rules in force before the date of entr y 
into force of this Regulation, may be market ed until their date of minimum durability or use by date.
Article 3
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 21 June 2022 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 22.6.2022 L 166/127  ANNEX 
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
(1) in Table 1 (Author ised novel foods), the entr y for ‘Calanus finmarch icus oil’ is replaced by the follo wing:
Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements
‘Calanus finmar chicus oil Specif ied food categor y Maximum levels 1.The designation of the novel food on 
the labelling of the foodstuffs con­
taining it shall be ‘oil from Calanus 
finmarchicus (crustacean)’ .
2.The labelling of food supplements 
containing Calanus finmarch icus oil 
shall bear a statement that those food 
supplements should not be con­
sumed:
a)if other food supplements containing 
astaxanthin esters are consumed on 
the same day.
b)by infants and children younger than 
3 years.
c)by children younger than 14 years, if 
the ingredient contains ≥ 0,1 % astax ­
anthin.’Food supplements as defined in 
Directive 2002/46/EC, excluding food 
supplements for infants and young 
children1,0 g/da y (< 0,1 % astaxanthin esters, 
resulting in < 1,0 mg astaxanthin per day) 
for the general population, excl uding 
infants and young children
2,3 g/da y (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
(2) in Table 2 (Specif ications), the entr y for ‘Calanus finmarch icus oil’ is replaced by the followi ng:
Authorised Novel Food Specifications
‘Calanus finmar chicus oil Descr iption/Def inition:
The novel food is ruby coloured, slightly viscous oil with a slight shellf ish odour extract ed from the crustacean (mar ine zooplankton) 
Calanus finmarch icus. The ingredient consists primar ily of wax esters (> 85 %) with minor amounts of triglycerides and other neutral 
lipids.
Specif ications:
Water: < 1,0 %
Wax esters: > 85 %
Total fatty acids: > 46 %
Eicosapentaenoic acid (EPA): > 3,0 %EN Offi cial Jour nal of the European Union L 166/128 22.6.2022  Docosahexaenoic acid (DHA): > 4,0 %
Total fatty alcohols: > 28 %
C20:1 n-9 fatty alcohol: > 9,0 %
C22:1 n-11 fatty alcohol: > 12 %
Trans fatty acids: < 1,0 %
Astaxanthin esters: ≤ 0,25 %
Peroxide value (PV): < 3,0 meq. O2/kg’EN Offi cial Jour nal of the European Union 22.6.2022 L 166/129