COMMISSION IMPLEMENTING REGUL ATION (EU) 2021/1377 
of 19 August 2021
author ising the change 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 
(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 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)
establishing a Union list of author ised novel foods was adopt ed.
(3) Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the author isation and on the 
placing on the Union mark et of a novel food and on the updating of the Union list.
(4) The novel food ‘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 intended for the general population, as defined in Directive 2002/46/EC of the European Parliament 
and of the Council (4). The maximum author ised levels of the astaxanthin-r ich oleoresin from Haematococcus 
pluvialis algae for the general population is currently 40-80 mg per day of oleoresin, resulting in ≤ 8,0 mg 
astaxanthin per day.
(5) At the time of the establishment of the Union list of author ised novel foods in 2017, the Commission considered 
that, based on previous two opinions (5),(6)of 2014 of the European Food Safety Author ity (‘the Auth ority’), one on 
the use of astaxanthin in feed additives as defined in Regulation (EC) No 1831/2003 of the European Parliament and 
the Council (7)on feed additives for animal nutr ition, that established an Acceptable Daily Intake (‘ADI’) of 
0,034 mg/kg body weight per day for astaxanthin, and one on the safety of astaxanthin as a novel food ingredient, 
the intake of astaxanthin from food supplements containing the maximum author ised use levels of up to 8,0 mg 
per day, may exce ed the ADI and may not be in accordance with the conditions set out in Article 7 of Regulation 
(EU) 2015/2283. The Commission considered that the Union list should be amended to adjust the author ised levels 
of astaxanthin in light of the 2014 Author ity opinions.
(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)EFSA Jour nal 2014;12(6):3724.
(6)EFSA Jour nal 2014; 12(7):3757.
(7)Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal 
nutr ition (OJ L 268, 18.10.2003, p. 29).EN Offi cial Jour nal of the European Union L 297/20                                                                                                                                         20.8.2021  (6) The Commission also became aware of new scientific evidence in 2017, submitte d by business operators during the 
public consultation of the draf t Implementing Regulation establishing the Union list of author ised novel foods, 
pointing to a considerably higher ADI for astaxanthin than the one previously established by the Author ity. In 
addition, evidence submitted during the same public consultation demonstrated that there already existed a 
considerable intake of astaxanthin from the normal diet as it is naturally present in some fish and crustaceans.
(7) On 27 Febr uary 2018 , the Commission, in accordance with Article 29(1) of Regulation (EC) No 178/2002 of the 
European Parliament and of the Council (8)requeste d the Auth ority to deliver an opinion on the safety of 
astaxanthin when used as a novel food in food supplements at levels of up to 8,0 mg/da y, taking into account the 
overall cumulative intake of astaxanthin from all food sources.
(8) On 18 December 2019 , the Author ity adop ted its scientific opinion ‛Safe ty of astaxanthin for its use as a novel food 
in food supplements’ (9).
(9) In its scientifi c opinion, the Author ity concluded that on the basis of the new evidence, the ADI for astaxanthin is 
0,2 mg/kg body weight per day. Taking into account the astaxanthin ADI and the intake of astaxanthin from the 
normal diet, the Auth ority concluded that the intake of the maximum currently author ised levels of up to 
8,0 mg/da y astaxanthin from food supplements containing astaxanthin-r ich oleoresin from Haematococcus pluvialis 
algae is safe for adults and adolescents above 14 years old.
(10) A clear designation of the novel food and a labelling requirement should be laid down for food supplements 
containing astaxanthin-r ich oleoresin from Haematococcus pluvialis algae in order ensure that those food 
supplements are not consumed by children and adolescents aged less than 14 years of age.
(11) The Annex to Implementing Regulation (EU) 2017/2470 should theref ore be amended according ly.
(12) Evidence form the mark et place seems to indicate that although food supplements containing ≤ 8,0 mg astaxanthin 
are currently author ised for the general population, in practice they are not used by children and adolsescents but are 
almost excl usively used by the adult population. In order to limit the administrative burden and to provi de business 
operat ors with sufficient time to adjust their practices 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 dispatc hed from third countr ies for the Union and are intended for the general 
population, before the date of entr y into force of this Regulation. Those transitional measures should take into 
account the safety of consumers by providing them the information about the appropr iate use in line with the 
requirements of this Regulation.
(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
1. The entr y in the Union list of author ised novel foods, as provided for in Article 6 of Regulation (EU) 2015/2283 and 
included in Implementing Regulation (EU) 2017/2470, referring to the novel food astaxanthin-r ich oleoresin from 
Haematococcus pluvialis algae, is amended as specifi ed in the Annex to this Regulation.
2. The entr y in the Union list refer red to in paragraph 1 shall include the conditions of use and labelling requirements 
laid down in the Annex to this Regulation.
(8)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down the general principles 
and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety 
(OJ L 31, 1.2.2002, p. 1).
(9)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 Jour nal 2020;18(2):5993.EN Offi cial Jour nal of the European Union 20.8.2021                                                                                                                                         L 297/21  Article 2
1. Food supplements containing ≤ 8,0 mg astaxanthin intende d for the general population whic h 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.
2. Foods supplements containing ≤ 8,0 mg astaxanthin intended for the general population impor ted into the Union 
may be mark eted until their date of minimum durability or use by date where the imp orter of such food can demonstrate 
that they were dispatched 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.
3. The food business operat ors should provi de a notice for the food supplements referred to in paragraph 1 to be 
displa yed at the place of sale informing them that those food supplements should not be consumed by infants, children 
and adolescents below the age of 14 years.
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, 19 August 2021 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 297/22                                                                                                                                         20.8.2021  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 (Author ised novel foods) is replaced by 
the follo wing:
‘Author ised novel food Conditions under which the novel food may be used Additio nal specif ic labelling requirements Other requirements
‘Astaxanthin-r ich oleoresin from 
Haematococcus pluvialis algae’Specified food categor y Maximum levels 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-r ich oleoresin from Haematococcus 
pluvialis algae shall bear a statement that they 
should not be consumed by infants, children, and 
adolescents younger than 14 years.’Food Supplements as defined in 
Directive 2002/46/EC, excl uding 
infants, young children, children, 
and adolescents younger than14 
years40-80 mg/da y of oleoresin, resulting 
in ≤ 8 mg astaxanthin per dayEN Offi cial Jour nal of the European Union 20.8.2021                                                                                                                                         L 297/23