Dried Euglena gracilis: 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:

• Breakfast cereal bars, granola bars and protein bars: 630 mg/100 g
• Yoghurt: 150 mg/100 g
• Yoghurt Beverages: 95 mg/100 g
• Fruit and vegetable juices, nectars, fruit/vegetable blend beverages: 120 mg/100 g
• Fruit-Flavoured Drinks: 40 mg/100 g
• Meal replacement beverages: 75 mg/100 g
• Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants: 100 mg/day for young children 150 mg/day for children from 3 to 9 years of age 225 mg/day for children from 10 years of age and adolescents (to 17 years of age) 375 mg/day for adults
• Total diet replacement for weight control as defined by Regulation (EU) No 609/2013: 190 mg/meal

Additional specific labelling requirements

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘dried biomass of Euglena gracilis algae’. The labelling of food supplements containing dried Euglena gracilis shall bear a statement that those food supplements should not be consumed by infants/children under 3 years of age/children under 10 years of age/children and adolescents under 18 years of age (12).

Specification (Table 2)

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

Description/Definition:

The novel food is dried whole cell Euglena, which is the dried biomass of the microalga Euglena gracilis.

The novel food is produced by fermentation followed by filtration and a heat-killing step of the microalga to ensure the absence of viable Euglena gracilis cells in the novel food.

Characteristics/Composition:

Total carbohydrates: ≤ 75 %

β-glucan: > 50 %

Protein: ≥ 15 %

Fat: ≤ 15 %

Ash: ≤ 10 %

Moisture: ≤ 6 %

Heavy metals:

Lead: ≤ 0,5 mg/kg

Cadmium: ≤ 0,5 mg/kg

Mercury: ≤ 0,05 mg/kg

Arsenic: ≤ 0,02 mg/kg

Microbiological criteria:

Aerobic plate count: ≤ 10 000 CFU/g

Coliforms: ≤ 100 MPN/g

Yeast and mould: ≤ 500 CFU/g

Escherichia coli: Absence in 10 g

Staphylococcus aureus: Absence in 10 g

Salmonella: Absence in 25 g

Listeria monocytogenes: Absence in 25 g

CFU: colony forming units.

MPN: most probable number

Notes

(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

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