COMMISSION IMPLEMENTING REGUL ATION (EU) 2023/1581 
of 1 August 2023
amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel 
food ‘astaxanthin-r ich oleoresin from Haematococcus pluvialis algae ’ 
(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 author ised novel foods.
(3) The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 includes astaxanthin-r ich oleoresin 
from Haematococcus pluvialis alga e as an author ised novel food.
(4) The novel food ‘astaxanthin-r ich oleoresin from Haematococcus pluvialis algae’ has been author ised 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 author ised levels of the novel food is 40–80 mg/da y 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-r ich oleoresin from Haematococcus pluvialis algae. In particular , the use of the novel food in food 
supplements containing 40–80 mg of astaxanthin-r ich oleoresin from Haematococcus pluvialis algae corresponding 
to levels of astaxanthin up to 8 mg has been limite d to adults and adolescents above 14 years of age. The 
amendment was based on an opinion of the European Food Safety Author ity (‘the Authority’) ‘Safety of astaxanthin 
for its use as a novel food in food supplements’ (6), whic h concluded on the safety of the levels up to 8 mg of 
astaxanthin only for the population abov e 14 years of age.
(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)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).
(4)Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the appro ximation of the laws of the 
Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).
(5)Commission Implementing Regulation (EU) 2021/1377 of 19 August 2021 author ising the chang e of the conditions of use of the 
novel food astaxanthin-r ich oleoresin from Haematococcus pluvialis algae under Regulation (EU) 2015/2283 of the European Parliament 
and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (OJ L 297, 20.8.2021, p. 20).
(6)EFSA Panel on Nutr ition, Novel Foods and Food Allergens, Scientific Opinion on the safety of astaxanthin as a novel food in food 
supplements. EFSA Journal 2020;18(2):5993.EN Offi cial Jour nal of the European Union L 194/4 2.8.2023  (6) On 15 December 2022 , the compan y Natural Algae Astaxanthin Association (‘the applicant’) submitte d an 
application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 for a chang e of the 
conditions of use of, astaxanthin-r ich oleoresin from Haematococcus pluvialis algae. The applicant requeste d 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/da y of oleoresin (cor responding to up to 2,3 mg/da y of astaxanthin), and to food supplements intended for 
adolescents aged 10 to less than 14 years of age containing 57 mg/da y oleoresin (cor responding to up to 
5,6 mg/da y of astaxanthin).
(7) The Commission considers that the requested change in the conditions of use of astaxanthin-r ich 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 necessar y. Taking into account the 
Acceptable Daily Intak e (‘ADI’) of astaxanthin of 0,2 mg/kg body weight per day and the intakes of astaxanthin from 
the backg round diet as set out in the opinion of the author ity published in 2020, the intak e of astaxanthin from food 
supplements as proposed by the applicant would result in overall intakes of astaxanthin that do not excee d the ADI.
(8) The information provi ded in the application gives suffi cient grounds to establish that the chang es in the conditions 
of use of astaxanthin-r ich oleoresin from Haematococcus pluvialis algae, are in accordance with the conditions of 
Article 12 of Regulation (EU) 2015/2283 and should be appro ved.
(9) In line with the change in the conditions of use of food supplements containing various levels of astaxanthin-r ich 
oleoresin from Haematococcus pluvialis algae depending on the target ed age groups of the population, it is necessar y 
to inform consumers by appropr iate 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 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 Author ity.
(10) In order to limit the administrative burden and to provi de business operat ors with suffi cient time to compl y with the 
requirements of this Regulation, transitional periods should be laid down to cover food supplements containing 
≤ 8,0 mg astaxanthin whic h have been placed on the market or dispatche d from third countr ies for the Union and 
are intended for the general population older than 14 years of age, before the date of entr y into force of this 
Regulation. Those transitional measures should take into account the safety of consumers by provid ing them the 
information about the appropr iate use in line with the requirements of this Regulation.
(11) The Annex to Implementing Regulation (EU) 2017/2470 should theref ore be amended according ly.
(12) 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.
Article 2
1. Food supplements containing ≤ 8,0 mg astaxanthin intended for the general population older than 14 years of age, 
which were lawfully placed on the mark et 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 .EN Offi cial Jour nal of the European Union 2.8.2023 L 194/5  2. Food supplements containing ≤ 8,0 mg astaxanthin intended for the general population older than 14 years of age, 
imp orted into the Union may be market ed until their date of minimum durability or use by date where the importer of 
such food can demonstrate that they were dispatche d from the third countr y concer ned and were on their way to the 
Union before the date of entr y into force of this Regulation.
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, 1 August 2023 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 194/6 2.8.2023  ANNEX 
In the Annex to Implementing Regulation (EU) 2017/2470, the entr y for ‘Astaxanthin-r ich oleoresin from Haematococcus pluvialis algae’ in Table 1 (Auth orised novel foods) is replaced by 
the follo wing:
Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements
‘Astaxanthin-r ich oleoresin from 
Haematococcus pluvialis algaeSpecif ied food categor y Maximum levels of astaxanthin The designation of the novel food on the 
labelling of the foodstuffs containing it shall be 
‘Astaxanthin rich oleoresin from Haematococcus 
pluvialis algae’
The labelling of food supplements containing 
Astaxanthin rich oleoresin from Haematococcus 
pluvialis algae shall bear a statement that they 
should not be consumed:
(a) if other food supplements containing astax ­
anthin esters are consumed on the same day
(b) by infants and young children under 3 years 
of age
(c) by infants and children under 10 years of 
age (*)
(d) by infants, children and adolescents under 
14 years of age (*).Food supplements as defined in 
Directive 2002/46/EC excluding 
infants and young children2,3 mg astaxanthin per day for 
children 3 to less than 10 years of age
5,7 mg astaxanthin per day for 
adolescents 10 to less than 14 years 
of age
8 mg astaxanthin per day for general 
population older than 14 years of age
(*)Depending on the age group the food supplement is intended for.’EN Offi cial Jour nal of the European Union 2.8.2023 L 194/7