ELI: http://data.europa.eu/eli/reg_impl/2024/1026/oj 1/4COMMISSION IMPLEMENTING REGUL ATION (EU) 2024/1026 
of 8 Apr il 2024
amending Implementing Regulation (EU) 2017/2470 as regards the specif ications 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 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) Astaxanthin-r ich oleoresin from Haematococcus pluvialis algae has been author ised pursuant to 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), intende d for the general 
population.
(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 level of astaxanthin-r ich 
oleoresin from Haematococcus pluvialis algae in food supplements at levels of up to 8,0 mg/da y astaxanthin has been 
restr icted to adults and adolescents above 14 years old.
(1)OJ L 327, 11.12.2015, p. 1, ELI: http://data.europa.eu/eli/reg/2015/2283/oj .
(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, ELI: 
http://data.europa.eu/eli/reg_impl /2017/2470/oj ).
(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, ELI: http://data.europa.eu/eli/reg/1997/258/oj ).
(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, ELI: http://data.europa.eu/eli/dir/2002/46/oj ).
(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, ELI: http:// 
data.europa.eu/eli/reg_impl /2021/1377/oj ).
Offi cial Jour nal  
of the European Union EN 
L series    
2024/1026  9.4.2024ELI: http://data.europa.eu/eli/reg_impl/2024/1026/oj 2/4(6) Commission Implementing Regulation (EU) 2023/1581 (6)further amended the conditions of use of the novel food 
astaxanthin-r ich oleoresin from Haematococcus pluvialis algae . In particular , it extended the use of the novel food in 
food supplements intende d for children aged 3 to less than 10 years of age to levels of 23 mg/da y of oleoresin 
(cor responding to up to 2,3 mg/da y of astaxanthin), and in food supplements intended for adolescents of 10 to less 
than 14 years of age to 57 mg/da y oleoresin (cor responding to up to 5,7 mg/da y of astaxanthin).
(7) On 20 June 2022 , the compan y Astareal AB (‘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 specifications of the novel food 
astaxanthin-r ich oleoresin from Haematococcus pluvialis algae. The applicant requeste d to modify the conte nt levels 
for several parameters in the specific ations. This concer ns the modification of range for astaxanthin monoesters in 
oleoresin from 79,8-91,5 % w/w of (total) carotenoids to 66,7-91,5 % w/w of (total) carotenoids, the modifi cation 
of the range of astaxanthin diesters from 0,16-19,0 % w/w of (total) carotenoids to 0,16 to 32,5 % w/w of (total) 
carotenoids, the modifi cation of range for astaxanthin 9-cis stereoisomer from 0,3-17,3 % w/w of (total) 
carotenoids to 0,3-30,0 % w/w of (total) carotenoids, and the modifi cation of the range of the prot ein cont ent from 
0,3-4,4 % to 0,0-4,4 %.
(8) In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food 
Safety Author ity (‘the Author ity’) on 26 Sept ember 2022 , requesting it to provid e a scientifi c opinion on the change 
of the specif ications of the novel food astaxanthin-r ich oleoresin from Haematococcus pluvialis algae.
(9) On 26 Sept ember 2023 , the Author ity adopt ed its scientific opinion on the ‘Safety of a change in specific ations of 
the novel food oleoresin from Haematococcus pluvialis containing astaxanthin pursuant to Regulation 
(EU) 2015/2283’ (7)in accordance with Article 11 of Regulation (EU) 2015/2283.
(10) In its scientifi c opinion, the Authority concluded that the novel food astaxanthin-r ich oleoresin from Haematococcus 
pluvialis algae is safe under the proposed changes in the specifications, and theref ore it is appropr iate to amend those.
(11) The information provid ed in the application and the Auth ority’s opinion give suffi cient grounds to establish that the 
changes to the specifi cations of the novel food 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) 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
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union.
(6)Commission Implementing Regulation (EU) 2023/1581 of 1 August 2023 amending Implementing Regulation (EU) 2017/2470 as 
regar ds the conditions of use of the novel food ‘astaxanthin-r ich oleoresin from Haematococcus pluvialis algae’ (OJ L 194, 2.8.2023, 
p. 4, ELI: http://data.europa.eu/eli/reg_impl/20 23/1581/oj ).
(7)EFSA Journal 2023;21(11):8338; doi: 10.2903/j.efsa.2023.8338.OJ L, 9.4.2024 EN  ELI: http://data.europa.eu/eli/reg_impl/2024/1026/oj 3/4This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 Apr il 2024 .
For the Commission
The President
Ursula VON DER LEYENOJ L, 9.4.2024 EN  ELI: http://data.europa.eu/eli/reg_impl/2024/1026/oj 4/4ANNEX 
In Table 2 (‘Specif ications ’) of the Annex to Implementing Regulation (EU) 2017/2470, the entr y for ‘Astaxanthin-r ich oleoresin from Haematococcus pluvialis algae’ is replaced by the 
follo wing:
Autho rised Novel Food Specification
‘Astaxanthin-r ich oleoresin from 
Haematococcus pluvialis algaeDescr iption:
Astaxanthin is a carot enoid produced by Haematococcus pluvialis alga e. Production methods for the growth of the algae are variable; using “closed” 
systems exposed to sunlight or strictly controlled illuminat ed light alternatively open ponds may be used. The algal cells are harveste d and dried; 
the oleoresin is extract ed using either super critical CO 2 or a solvent (ethyl acetate ). The Astaxanthin is dilut ed and standardized to 2,5 %, 5,0 %, 
7,0 %, 10 %, 15 % or 20 % using olive oil, safflower oil, Sunf lowe r oil or MCT (Medium Chain Triglycerides).
Character istics/Composition:
Fat: 42,2-99 %
Protein: ≤ 4,4 %
Carbohydr ate: ≤ 52,8 %
Fibre: < 1,0 %
Ash: ≤ 4,2 %
Specifi cation of Caroteno ids % w/w
Total Astaxanthins: 2,9-11,1 %
9-cis-astaxanthin: 0,3-30,0 %
13-cis-astaxanthin: 0,2-7,0 %
Astaxanthin monoeste rs: 66,7-91,5 %
Astaxanthin diest ers: 0,16-32,5 %
Beta-Carot ene: 0,01-0,3 %
Lutein: ≤ 1,8 %
Canthaxanthin: ≤ 1,30 %
Microbiological criter ia:
Total aerobic bacteria: < 3 000 CFU/g
Yeast and Moulds: < 100 CFU/g
Colif orms: < 10 CFU/g
E. coli: Negative
Salmonella: Negative
Staph ylococcus: Neg ative’OJ L, 9.4.2024 EN