COMMISSION IMPLEMENTING REGUL ATION (EU) 2021/1326 
of 10 August 2021
author ising the placing on the market of Schizoc hytr ium sp. (FCC-3204) oil as a novel food 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) On 23 Januar y 2019 , the compan y Fermentalg (‘the applicant’) submitted an application to the Commission 
pursuant to Article 10(1) of Regulation (EU) 2015/2283 for an extension of use of the novel food Schizochytr ium sp. 
oil. The applicant requeste d to extend the use of Schizochytr ium sp. oil to infant formula and follow-on formula 
intended for infants and young children as defined in Regulation (EU) No 609/2013 of the European Parliament 
and of the Council (3). The strain of Schizochytr ium sp. used by the applicant and concer ned by that application is 
specifi ed as strain FCC-3204.
(4) On 15 Apr il 2019 , the applicant submitte d another application to the Commission pursuant to Article 10(1) of 
Regulation (EU) 2015/2283 requesting to change the conditions of use of the novel food Schizochytr ium sp. oil. The 
applicant requeste d to increase the maximum level of Schizochytr ium sp. oil in food supplements as defined in 
Directive 2002/46/EC of the European Parliament and of the Council (4)for the adult population, excluding 
pregnant and lactating women. The strain of Schizochytr ium sp. used by the applicant and concer ned by that 
application is the same strain FCC-3204 as above.
(5) In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food 
Safety Author ity (‘the Auth ority’) on 13 May 2019 , requesting it to provide a scientific opinion by carrying out an 
assessment for an extension of the use of Schizochytr ium sp. oil as a novel food in infant formula and follow-on 
formula.
(6) In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consult ed the Auth ority on 10 July 
2019 , requesting it to provi de a scientific opinion by carrying out an assessment for the change of the conditions of 
use of Schizochytr ium sp. oil as a novel food in food supplements.
(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 (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young 
children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, 
Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament 
and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).
(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).EN Offi cial Jour nal of the European Union L 288/24                                                                                                                                         11.8.2021  (7) On 24 November 2020 , the Author ity adopt ed its scientific opinions on the ‘Safety of oil from Schizochytr ium 
limacinum (strain FCC-3204) for use in infant and follow-on formula as a novel food pursuant to Regulation (EU) 
2015/2283’ (5)and ‘Safety of oil from Schizochytr ium limacinum (strain FCC-3204) for use in food supplements as a 
novel food pursuant to Regulation (EU) 2015/2283’ (6). These opinions are in line with the requirements of 
Article 11 of Regulation (EU) 2015/2283.
(8) In these opinions, the Authority conf irmed that the strain FCC-3204 belongs to the species Schizochytr ium limacinum, 
which was attributed the qualif ied presump tion of safety (‘QPS’) status and included in 2020 in the list of QPS- 
recommended biological agents intentionally added to food or feed (7).
(9) The Author ity concluded that Schizochytr ium sp. oil produced from the strain FCC-3204, belonging to the species 
Schizochytr ium limacinum, is safe under the proposed conditions of use in infant formula and in follow-on formula 
and at the maximum level of 1 g/da y in food supplements.
(10) With regar d to the application concer ning the food supplements, the Author ity considered that the data provided by 
the applicant were not suffi cient to conclude on the safet y of the novel food at the proposed uses (3 g DHA/da y in 
food supplements for adults, excl uding pregnant and lactating women). However , the Author ity in its 2012 
scientific opinion on the ‘Tolerable Upper Intake Level of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) 
and docosapentaenoic acid (DPA)’(8)concluded that supplemental intake s of DHA alone up to about 1 g/da y do not 
raise safety concer ns for the general population. In line with the conclusions made by the Author ity, and taking into 
account the Member State s views, the Commission is of the view that this author isation should concer n general 
population abov e 3 years of age.
(11) A labelling requirement should be provi ded in order to properly inform the consumers that the food supplements 
containing Schizochytr ium sp. (FCC-3204) oil should not be consumed by infants and children under 3 years of age.
(12) Data submitte d by the applicant did not allow for a conclusion on the safety of oil produced from other strains of the 
Schizochytr ium microalgae genus. Theref ore, the opinions of the Author ity do not give sufficient grounds to establish 
that oil produced from other strains of Schizochytr ium microalgae genus when used in infant formula and follow-on 
formula and with increased levels in food supplements fulfil the requirements of Article 12(1) of Regulation (EU) 
2015/2283.
(13) Following the Author ity’s opinions and taking into account that author ised Schizochytr ium sp. oil for whic h an 
extensi on of use was requeste d is neither species-specific nor strain-specific, it is theref ore necessar y to author ise the 
placing on the mark et of oil from strain FCC-3204 of Schizochytr ium sp. under the assessed conditions of use, and not 
an extensi on of use of oil from all strains of the Schizochytr ium genus as requeste d by the applicant.
(14) Regulation (EU) 2017/2470 should theref ore be amended according ly.
(15) 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. Schizochytr ium sp. (FCC-3204) oil as specif ied in the Annex to this Regulation shall be included in the Union list of 
author ised novel foods established in Implementing Regulation (EU) 2017/2470.
(5)EFSA Journal 2021;19(1):6344.
(6)EFSA Journal 2021;19(1):6345.
(7)EFSA BIOHAZ Panel, 2020. Statement on the update of the list of QPS-recommended biological agent s intentionally added to food or 
feed as notif ied to EFSA 11: suitability of taxonomic units notifi ed to EFSA until Sept ember 2019. EFSA Journal 2020;18(2):5965, 57 pp.
(8)EFSA Journal 2012;10(7):2815.EN Offi cial Jour nal of the European Union 11.8.2021                                                                                                                                         L 288/25  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.
Article 2
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to 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, 10 August 2021 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 288/26                                                                                                                                         11.8.2021  ANNEX 
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
(1) in Table 1 (Author ised novel foods), the follo wing entr y is inser ted:
‘Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirementsOther 
requirementsData protection
Schizochytr ium sp. (FCC-3204) 
oilSpecif ied food categor y Maximum levels of DHA The designation of the novel food on the 
labelling of the foodstuffs containing it shall be 
“Oil from the microalgae Schizochytr ium sp.”.
The labelling of food supplements containing 
Schizochytr ium sp. (FCC-3204) oil shall bear a 
statement that they should not be consumed by 
infants and children under 3 years of age.’Infant formula and follow-on 
formula as defined in 
Regulation (EU) No 609/2013In accordance with Regulation 
(EU) No 609/2013
Food supplements as defined 
in Directive 2002/46/EC for 
the general population abov e 
3 years of age1 g/da y
(2) in Table 2 (Specif ications), the followi ng entr y is inser ted:
‘Author ised Novel Food Specifications
Schizochytr ium sp. (FCC-3204) oilDescr iption/Def inition:
The novel food is an oil produced from the strain FCC-3204 of the microalg ae Schizochytr ium sp.
Composition:
Acid value: ≤ 0,5 mg KOH/g
Peroxide value (PV): ≤ 5,0 meq/kg oil
Moisture and volatiles: ≤ 0,05 %
Unsaponifi ables: ≤ 4,5 %
Trans-f atty acids: ≤ 1,0 %
Docosahexaenoic acid (DHA): ≥ 32,0 %
p-anisidine value: ≤ 10’EN Offi cial Jour nal of the European Union 11.8.2021                                                                                                                                         L 288/27