COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/1993 
of 4 December 2020 
author ising the placing on the market of selenium-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 21 Sept ember 2018, the compan y Skotan S.A. (‘the applicant’) introduced an application to the Commission 
pursuant to Article 10(1) of Regulation (EU) 2015/2283 to place selenium-enr iche d biomass of the yeast Yarrowia 
lipolytica on the Union market as a novel food. The applicant request ed for selenium-enr iche d biomass of the yeast 
Yarrowia lipolytica to be used in food supplements as defined in Directive 2002/46/EC, excl uding food supplements 
for infants and young children as defined in Regulation (EU) No 609/2013 of the European Parliament and of the 
Council (5). The maximum use levels proposed by the applicant are 0,2 g per day for children from 3 to 9 years of 
age, and 1 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 selenium-containing yeast (Yarrowia lipolytica) biomass as a novel food. 
(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)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). EN Offi cial Jour nal of the European Union L 410/62                                                                                                                                         7.12.2020   (6) On 18 December 2019, the Author ity adopt ed the scientifi c opinion ‘Safety of selenium-enr iched biomass of 
Yarrowia lipolytica as a novel food pursuant to Regulation (EU) 2015/2283’ (6). That opinion is in line with the 
requirements of Article 11 of Regulation (EU) 2015/2283. 
(7) In that opinion, the Authority concluded that selenium-containing yeast (Yarrowia lipolytica) biomass is not of safet y 
concer n at the proposed use levels. The Author ity also considered that the selenium provid ed by selenium- 
containing yeast (Yarrowia lipolytica) biomass is as safe as selenium from other dietar y sources. 
(8) The Auth ority also noted that, at the use levels proposed by the applicant, the intake of the novel food in 
combination with a backg round diet high in selenium could lead to total selenium intake s exce eding the Tolerable 
Upper Intake Level (‘UL’) for selenium established by the Scientific Committ ee on Food (7), in all targe t population 
groups, excep t for children from 7 to 9 years of age. 
(9) In light of the obser vation made by the Author ity relating to the combined intake of selenium, the applicant 
submitted a modifi ed request to the Commission with regard to the conditions of use of selenium-containing yeast 
(Yarrowia lipolytica) biomass, in particular concer ning the maximum levels of the novel food in food supplements 
and the population groups for whic h food supplements are intended. The applicant proposed the novel food to be 
used in food supplements intended for the general population from 4 years of age, at levels ranging from 50 mg/da y 
to 800 mg/da y, that would result in selenium intakes which , combined with the selenium intakes from a backg round 
diet high in selenium, would not exceed the UL for selenium. 
(10) The Commission considers that the Authority’s opinion and the modified conditions of use request ed by the 
applicant give sufficient grounds to establish that selenium-containing yeast (Yarrowia lipolytica) biomass at the 
proposed uses and use levels when used in food supplements, compl ies with Article 12(1) of Regulation (EU) 2015/ 
2283. 
(11) Regulation (EU) 2017/2470 should be theref ore 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 
1. Selenium-containing yeast (Yarrowia lipolytica) biomass as specified 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. 
(6)EFSA Journal 2020;18(1):5992. 
(7)SCF (Scientifi c Committee on Food), 2000. Opinion of the Scientific Committee on Food on the Tolerable Upper Intake Level of 
selenium. SCF/CS/NUT/UPPLEV/25 Final, 18 pp. EN Offi cial Jour nal of the European Union 7.12.2020                                                                                                                                         L 410/63   This Regulation shall be binding in its entirety and directly applicable in all Member States. 
Done at Brussels, 4 December 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union L 410/64                                                                                                                                         7.12.2020   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: 
Autho rised novel food Conditions under whic h the novel food may be used Additional specific labelling requirements Other requirements 
‘Selenium-containing 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 “selenium-containing yeast (Yarro­
wia lipolytica) biomass”. 
The labelling of food supplements con­
taining selenium-containing yeast (Yarro­
wia lipolytica) biomass shall bear a state­
ment that the food supplements should 
not be consumed by infants and children 
under 4 years of age/c hildren under 7 years 
of age/c hildren under 11 years of age/c hil­
dren and adolescents under 18 years of 
age (*).  Food supplements as defined in 
Directive 2002/46/EC (1), excl uding 
food supplements for infants and 
children under 4 years of age 50 mg/da y for children from 4 to 6 years of 
age, resulting in 10 μg of selenium per day 
100 mg/da y for children from 7 to 10 years 
of age, resulting in 20 μg of selenium per 
day 
500 mg/da y for adolescents from 11 to 17 
years of age, resulting in 100 μg of sele­
nium per day 
800 mg/da y for adults, resulting in 160 μg 
of selenium per day 
(1) 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). 
(*) 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: 
Autho rised Novel Food Specification 
‘Selenium-containing yeast (Yarrowia lipolytica) biomass Descr iption/Def inition: 
The novel food is the dried and heat-killed selenium-containing biomass of the yeast Yarrowia lipolytica. 
The novel food is produced by fermentation in the presence of sodium selenit e followed by a number of purifi­
cation steps including a heat-killing step of the yeast to ensure the absence of viable Yarrowia lipolytica cells in the 
novel food. 
Character istics/Composition: 
Total selenium: 165–200 μg/g 
Se-methionine (1): 100–140 μg/g 
Prote in: 40–50 g/100 g 
Dietar y fibre: 24–32 g/100 g 
Sugars: < 1 g/100 g 
Fat: 6–12 g/100 g 
Total ash: ≤ 15 % 
Water: ≤ 5 % 
Dry matter: ≥ 95 % 
Hea vy metals: 
Lead: ≤ 3,0 mg/kg EN Offi cial Jour nal of the European Union 7.12.2020                                                                                                                                         L 410/65   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 (2): < 10 CFU/g (i.e. limit of detection) 
Colif orms: ≤ 10 CFU/g 
Salmonella spp.: Absence in 25 g 
CFU: colony forming units 
(1) Expressed as selenium. 
(2) 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 packaging and/or storag e of the novel food.’   EN Offi cial Jour nal of the European Union L 410/66                                                                                                                                         7.12.2020