Commission Implementing Regulation (EU) 2020/1822 of 2 December 2020 authorising the placing on the market of chromium-containing 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)

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 .

ANNEX

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  ( *1 ) .
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 day
4 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/kg
Microbiological criteria:
Total aerobic microbial count: ≤ 5 × 10 3 CFU/g
Total yeast and mould count: ≤ 10 2 CFU/g
Viable Yarrowia lipolytica cells  ( *2 ) : < 10 CFU/g (i.e. limit of detection)
Coliforms: ≤ 10 CFU/g
Salmonella spp.: Absence in 25 g
CFU: colony forming units
( *1 )   Depending on the age group the food supplement is intended for.’
( *2 )   Applicable at all stages after the heat-treatment step to guarantee 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 storage of the novel food.’

Schedules & Appendices

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