COMMISSION IMPLEMENTING REGULATION (EU) 2020/1820
of 2 December 2020
authorising the placing on the market of dried
Euglena gracilis
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
Article 4
ANNEX
Authorised novel food |
Conditions under which the novel food may be used |
Additional specific labelling requirements |
Other requirements |
Data protection |
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‘Dried Euglena gracilis |
Specified food category |
Maximum levels |
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 (*1). |
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Authorised on 23 December 2020. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Kemin Foods L.C., 2100 Maury Street Des Moines, IA 50317, USA. During the period of data protection, the novel food is authorised for placing on the market within the Union only by Kemin Foods L.C. unless a subsequent applicant obtains authorisation for that novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Kemin Foods L.C. End date of the data protection: 23 December 2025.’ |
Breakfast cereal bars, granola bars and protein bars |
630 mg/100 g |
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Yoghurt |
150 mg/100 g |
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Yoghurt Beverages |
95 mg/100 g |
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Fruit and vegetable juices, nectars, fruit/vegetable blend beverages |
120 mg/100 g |
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Fruit-Flavoured Drinks |
40 mg/100 g |
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Meal replacement beverages |
75 mg/100 g |
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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 |
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Total diet replacement for weight control as defined by Regulation (EU) No 609/2013 |
190 mg/meal |
Authorised Novel Food |
Specification |
‘Dried Euglena gracilis |
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’ |