
Article 1 

1. Chromium-containing yeast (Yarrowia lipolytica) 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.
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, 2 December 2020.
For the Commission
The President
Ursula VON DER LEYEN
ANNEX

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

((1)) in Table 1 (Authorised novel foods), the following entry is inserted:

Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements
‘Chromium-containing yeast (Yarrowia lipolytica) biomass Specified food category Maximum levels The designation of the novel food on the labelling of the foodstuffs containing it shall be “chromium-containing yeast (Yarrowia lipolytica) biomass”The labelling of food supplements containing chromium-containing yeast (Yarrowia lipolytica) biomass shall bear a statement that the food supplements should not be consumed by infants and young children (children under 3 years of age)/children from 3 to 9 years of age. 
Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children 2 g/day for children from 3 to 9 years of age, resulting in 46 μg of chromium per day4 g/day for children from 10 years of age, adolescents and adults, resulting in 92 μg of chromium per day

((2)) in Table 2 (Specifications), the following entry is inserted:

Authorised Novel Food Specification
‘Chromium-containing yeast (Yarrowia lipolytica) biomass Description/Definition: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 chloride 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.Characteristics/Composition:
 Total chromium: 18–23 μg/g
 Chromium (VI): < 10 μg/kg (i.e. limit of detection)
 Protein: 40–50 g/100 g
 Dietary fibre: 24–32 g/100 g
 Sugars: < 2 g/100 g
 Fat: 6–12 g/100 g
 Total ash: ≤ 15 %
 Water: ≤ 5 %
 Dry matter: ≥ 95 %Heavy metals:
 Lead: ≤ 3,0 mg/kg
 Cadmium: ≤ 1,0 mg/kg
 Mercury: ≤ 0,1 mg/kgMicrobiological criteria:
 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
 CFU: colony forming units

