
Article 1 

1. Yarrowia lipolytica yeast biomass as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.
2. The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.
3. The authorisation 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 following 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, 13 May 2019.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

((1)) The following entry is inserted in Table 1 (Authorised novel foods) in alphabetical order:
'
Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements
Yarrowia lipolytica yeast biomass Specified food category Maximum levels The designation of the novel food on the labelling of the foodstuffs containing it shall be “Yarrowia lipolytica yeast heat-killed biomass” 
Food Supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children 6 g/day for children from 10 years of age, adolescents and general adult population3 g/day for children from 3 to 9 years of age'
((2)) The following entry is inserted in Table 2 (Specifications) in alphabetical order:

‘Authorised Novel Food Specification
Yarrowia lipolytica yeast biomass 
The novel food is the dried and heat-killed biomass of the yeast Yarrowia lipolytica.

Protein : 45-55 g/100 g

Dietary 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 content: ≥ 95 %

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)

Coliforms: ≤ 10 CFU/g

Salmonella spp.: Absence in 25 g


