Selenium-containing yeast (Yarrowia lipolytica) biomass: authorised novel food in the EU

Conditions of use and maximum levels

Table 1, column "Conditions under which the novel food may be used", as written:

• Food supplements as defined in Directive 2002/46/EC (12), 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

Additional specific labelling requirements

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 (3).

Specification (Table 2)

Table 2 of the Annex, row with the same name, as written:

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 (14): 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 (13): < 10 CFU/g (i.e. limit of detection)

Coliforms: ≤ 10 CFU/g

Salmonella spp.: Absence in 25 g

CFU: colony forming units

Notes

(3) 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).

(12) Depending on the age group the food supplement is intended for.

Source and version

Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods, Table 1. Consolidated text of 10 August 2026. The text above is copied from that document without change except that amendment markers are removed. It is not advice and it does not decide whether a particular product is covered.

• Consolidated text on EUR-Lex

Want the whole list as one table?

If we publish the Union list as one table (name, food category, maximum level), we write to you once. We use the email for nothing else.