COMMI SSION IMPLEMENTING REGUL ATION (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 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having 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 and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof, 
Whereas: 
(1)  Regulation (EU) 2015/2283 provi des that only novel foods author ised and included in the Union list may be 
placed on the market within the Union. 
(2)  Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing 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 submit a draf t implementing act 
author ising placing on the Union market of a novel food and on the updating of the Union list. 
(4)  On 10 Apr il 2017, the compan y Skotan S.A. (‘the Applicant’ ) made a request in accordance with Article 4 of 
Regulation (EC) No 258/97 of the European Parliament and of the Council (3) to the compet ent author ity of 
Poland to place Yarrowia lipolytica yeast biomass on the Union mark et as a novel food within the meaning of 
point (d) of Article 1(2) of that Regulation. The application request ed for Yarrowia lipolytica yeast biomass to be 
used in food supplements. The maximum use levels proposed by the applicant are 3 g per day for children from 
3 to 9 years of age, and 6 g per day thereaf ter. 
(5)  On 15 Novem ber 2017, the compet ent author ity of Poland issued its initial assessment repor t. In that repor t, it 
came to the conclusion that Yarrowia lipolytica yeast biomass meets the criteria for novel foods set out in 
Article 3(1) of Regulation (EC) No 258/97. 
(6)  Pursuant to Article 35(1) of Regulation (EU) 2015/2283, any request for placing a novel food on the mark et 
within the Union submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97 and 
for which the final decision has not been taken before 1 Januar y 2018 shall be treated as an application 
submitte d under Regulation (EU) 2015/2283. 
(7)  While the request for placing Yarrowia lipolytica yeast biomass on the Union mark et as a novel food was 
submitte d to a Member State in accordance with Article 4 of Regulation (EC) No 258/97, the application also 
meets the requirements laid down in Regulation (EU) 2015/2283. 
(8)  In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food 
Safety Author ity (‘Author ity’) on 22 June 2018, asking it to provide a scientific opinion by carrying out an 
assessment for Yarrowia lipolytica yeast biomass as a novel food. 
(9)  On 17 Januar y 2019, the Author ity adopt ed the ‘Scientific Opinion on the safety of Yarrowi a lipolytica yeast 
biomass as a novel food pursuant to Regulation (EU) 2015/2283’ (4). That opinion is in line with the 
requirements of Article 11 of Regulation (EU) 2015/2283. 14.5.2019 L 125/13 Official Jour nal of the European Union EN     
(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 27 Januar y 1997 of the European Parliament and of the Council concer ning novel foods and novel foods 
ingredients (OJ L 43, 14.2.1997, p. 1). 
(4)EFSA Jour nal 2019;17(2):5594. (10)  The opinion of the Authority gives sufficient grounds to establish that Yarrowia lipolytica yeast biomass in the 
proposed use and use levels, when used in food supplements, complies with Article 12(1) of Regulation (EU) 
2015/2283. 
(11)  Directive 2002/46/EC of the European Parliament and of the Council (5) lays down requirements on food 
supplements. The use of Yarrowia lipolytica yeast biomass should be author ised without prejudice to the 
requirements of that Directive. 
(12)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
1. Yarrowia lipolytica yeast biomass 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. 
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. 
3. The author isation provided for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC. 
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 State s. 
Done at Brussels, 13 May 2019. 
For the Commission 
The President 
Jean-Claude JUNCK ER  14.5.2019 L 125/14 Official Jour nal of the European Union EN     
(5)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). ANNEX 
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:  
(1) The followi ng entr y is inser ted in Table 1 (Author ised novel foods) in alphabetical order: 
‘Authorised novel food Conditions under whic h the novel food may be used Additional specific labelling requirements Other requirements 
Yarrowia lipolytica 
yeast biomass Specified food categ ory Maximum levels The designation of the novel food on the la­
belling of the foodstuffs containing it shall 
be “Yarrowia lipolytica yeast heat-killed bio­
mass”’  Food Supplements as defined in Directive 
2002/46/EC, excl uding food supplements 
for infants and young children 6 g/da y for children from 10 years of age, 
adolescents and general adult population 
3 g/da y for children from 3 to 9 years of 
age   
(2) The followi ng entr y is inser ted in Table 2 (Specifi cations) in alphabetical order: 
‘Authorised Novel Food Specification 
Yarrowia lipolytica 
yeast biomass Descr iption/Def inition: 
The novel food is the dried and heat-killed biomass of the yeast Yarrowia lipolytica. 
Character istics/Composition: 
Protein : 45-55 g/100 g 
Dietar y fibre: 24-30 g/100 g 
Sugars: < 1,0 g/100 g 
Fat: 7-10 g/100 g 
Total ash: ≤ 12 % 
Water content: ≤ 5 % 
Dry matter conte nt: ≥ 95 % 
Microbiological criter ia: 
Total Aerobic Microbial Count : ≤ 5 × 103 CFU/g 
Total Yeast and Mould Count: ≤ 102 CFU/g 
Viable Yarrowia lipolytica cells (1): < 10 CFU/g (i.e. limit of detection) 
Colif orms: ≤ 10 CFU/g 
Salmonella spp.: Absence in 25 g 
(1)  To be 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 NF’   14.5.2019 L 125/15 Official Jour nal of the European Union EN     