COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/1822 
of 2 December 2020 
author ising the placing on the market of chromium-cont aining yeast (Yarrowia lipolytica) biomass 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) Commission Implementing Regulation (EU) 2019/760 (3) author ised, in accordance with Regulation (EU) 2015/ 
2283, the placing on the mark et of Yarrowia lipolytica yeast biomass as a novel food to be used in food supplements 
as defined in Directive 2002/46/EC of the European Parliament and of the Council (4), excl uding food supplements 
for infants and young children. 
(4) On 22 August 2018, the compan y Skotan S.A. (‘the applicant’) introduced an application to the Commission in 
accordance with Article 10(1) of Regulation (EU) 2015/2283 to place chromium-enr iched biomass of the yeast 
Yarrowia lipolytica on the Union market as a novel food. The applicant requested for chromium-enr iched biomass of 
the yeast Yarrowia lipolytica to be used as a novel food in food supplements, excl uding food supplements for infants 
and young children. The maximum use levels proposed by the applicant are 2 g per day for children from 3 to 9 
years of age, and 4 g per day for adolescents and adults. 
(5) In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food 
Safety Author ity (‘Author ity’) on 18 Febr uary 2019, asking it to provide a scientific opinion by carrying out an 
assessment for chromium-containing yeast (Yarrowia lipolytica) biomass as a novel food. 
(6) On 23 Januar y 2020, the Author ity adopt ed its scientific opinion ‘Safe ty of chromium-enr iched biomass of Yarrowia 
lipolytica as a novel food pursuant to Regulation (EU) 2015/2283’ (5). That opinion is in line with the requirements of 
Article 11 of Regulation (EU) 2015/2283. 
(7) In its opinion, the Author ity concluded that chromium-containing yeast (Yarrowia lipolytica) biomass is safe under the 
proposed uses and use levels, when used in food supplements intended for the general population abov e 
3 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)Commission Implementing Regulation (EU) 2019/760 of 13 May 2019 author ising the placing on the market of Yarrowia lipolytica 
yeast biomass 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 (OJ L 125, 14.5.2019, p. 13). 
(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 Journal 2020;18(3):6005. EN Offi cial Jour nal of the European Union 3.12.2020                                                                                                                                         L 406/39   (8) The opinion of the Author ity gives suffi cient grounds to establish that chromium-containing yeast (Yarrowia 
lipolytica) biomass under the proposed conditions of use complies with Article 12(1) of Regulation (EU) 2015/2283. 
(9) Regulation (EU) 2017/2470 should be theref ore amended according ly. 
(10) 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. Chromium-containing yeast (Yarrowia lipolytica) biomass as specifi ed in the Annex to this Regulation shall be included 
in the Union list of author ised novel foods established in Imple menting Regulation (EU) 2017/2470. 
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. 
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, 2 December 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union L 406/40                                                                                                                                         3.12.2020   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: 
Authorised novel food Conditions under whic h the novel food may be used Additional specific labelling requirements Other requirements 
‘Chromium-contain ing yeast 
(Yarrowia lipolytica) biomass Specified food categor y Maximum levels The designation of the novel food on the labelling of 
the foodstuffs containing it shall be “chromium-con­
taining yeast (Yarrowia lipolytica) biomass” 
The labelling of food supplements containing chro­
mium-containing yeast (Yarrowia lipolytica) biomass 
shall bear a state ment that the food supplements 
should not be consumed by infants and young chil­
dren (children under 3 years of age)/chi ldren from 3 
to 9 years of age (*).  Food supplements as defined in Direc­
tive 2002/46/EC, excl uding food sup­
plements for infants and young children 2 g/da y for children from 3 to 9 years of 
age, resulting in 46 μg of chromium per 
day 
4 g/da y for children from 10 years of age, 
adolescents and adults, resulting in 92 
μg of chromium per day 
(*) Depending on the age group the food supplement is intended for.’   
(2) in Table 2 (Specif ications), the followi ng entr y is inser ted: 
Authorised Novel Food Specification 
‘Chromium-contain ing yeast (Yarrowia lipolytica)  
biomass Descr iption/Def inition: 
The novel food is the dried and heat-killed chromium-containing biomass of the yeast Yarrowia lipolytica. 
The novel food is produced by fermentation in the presence of chromium chlor ide followed by a number of purification steps 
and a heat-killing step of the yeast to ensure the absence of viable Yarrowia lipolytica cells in the novel food. 
Character istics/Composition: 
Total chromium: 18–23 μg/g 
Chromium (VI): < 10 μg/kg (i.e. limit of detection) 
Protein: 40–50 g/100 g 
Dietar y fibre: 24–32 g/100 g 
Sugars: < 2 g/100 g EN Offi cial Jour nal of the European Union 3.12.2020                                                                                                                                         L 406/41   Fat: 6–12 g/100 g 
Total ash: ≤ 15 % 
Water: ≤ 5 % 
Dry matt er: ≥ 95 % 
Hea vy metals : 
Lead: ≤ 3,0 mg/kg 
Cadmium: ≤ 1,0 mg/kg 
Mercur y: ≤ 0,1 mg/kg 
Microbiological criter ia: 
Total aerobic microbial count: ≤ 5 × 103 CFU/g 
Total yeast and mould count: ≤ 102 CFU/g 
Viable Yarrowia lipolytica cells (*): < 10 CFU/g (i.e. limit of detection) 
Colif orms: ≤ 10 CFU/g 
Salmonella spp.: Absence in 25 g 
CFU: colony forming units 
(*) Applicable at all stages after the heat-treatment step to guarant ee the absence of viable Yarrowia lipolytica cells and to be first tested immediately after the heat-treatment step. Measures have to be in place to 
prevent cross-contamination with viable Yarrowia lipolytica cells during pack aging and/or storag e of the novel food.’   EN Offi cial Jour nal of the European Union L 406/42                                                                                                                                         3.12.2020