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)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
1. Selenium-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 .
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 ‘ 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 (2) in Table 2 (Specifications), the following entry is inserted: 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 × 10 3 CFU/g Total yeast and mould count: ≤ 10 2 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 ( 1 ) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements ( OJ L 183, 12.7.2002, p. 51 ). ( *1 ) Depending on the age group the food supplement is intended for.’ ( 2 ) Expressed as selenium. ( 3 ) 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.’
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.