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.
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
ANNEXSupplementary provisions
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.’