COMMISSION IMPLEMENTING REGULATION (EU) 2020/1993
of 4 December 2020
authorising the placing on the market of selenium-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
Article 2
Article 3
ANNEX
Authorised novel food |
Conditions under which the novel food may be used |
Additional specific labelling requirements |
Other requirements |
|
‘Selenium-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 “selenium-containing yeast (Yarrowia lipolytica) biomass”. The labelling of food supplements containing selenium-containing yeast (Yarrowia lipolytica) biomass shall bear a statement that the food supplements should not be consumed by infants and children under 4 years of age/children under 7 years of age/children under 11 years of age/children and adolescents under 18 years of age (*1). |
|
Food supplements as defined in Directive 2002/46/EC(1), excluding food supplements for infants and children under 4 years of age |
50 mg/day for children from 4 to 6 years of age, resulting in 10 μg of selenium per day 100 mg/day for children from 7 to 10 years of age, resulting in 20 μg of selenium per day 500 mg/day for adolescents from 11 to 17 years of age, resulting in 100 μg of selenium per day 800 mg/day for adults, resulting in 160 μg of selenium per day |
Authorised Novel Food |
Specification |
‘Selenium-containing yeast (Yarrowia lipolytica) biomass |
Description/Definition: The novel food is the dried and heat-killed selenium-containing biomass of the yeast Yarrowia lipolytica. The novel food is produced by fermentation in the presence of sodium selenite followed by a number of purification steps including a heat-killing step of the yeast to ensure the absence of viable Yarrowia lipolytica cells in the novel food. Characteristics/Composition: Total selenium: 165–200 μg/g Se-methionine(2): 100–140 μg/g Protein: 40–50 g/100 g Dietary fibre: 24–32 g/100 g Sugars: < 1 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 × 103 CFU/g Total yeast and mould count: ≤ 102 CFU/g Viable Yarrowia lipolytica cells(3): < 10 CFU/g (i.e. limit of detection) Coliforms: ≤ 10 CFU/g Salmonella spp.: Absence in 25 g CFU: colony forming units |