
Article 1 

1. Dried Euglena gracilis 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. For a period of five years from the date of entry into force of this Regulation only the initial applicant:
— Company: Kemin Foods L.C.,
— Address: 2100 Maury Street Des Moines, IA 50317, USA,is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for the novel food without reference to the data protected pursuant to Article 2 of this Regulation or with the agreement of Kemin Foods L.C.
3. 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 to this Regulation.
Article 2 
The data contained in the application file on the basis of which the novel food referred to in Article 1 has been assessed by the Authority, claimed by the applicant as proprietary and without which the novel food could not have been authorised, shall not be used for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of Kemin Foods L.C.
Article 3 
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Article 4 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 2 December 2020.
For the Commission
The President
Ursula VON DER LEYEN
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 Data protection
‘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.  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
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 children150 mg/day for children from 3 to 9 years of age225 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

((2)) in Table 2 (Specifications), the following entry is inserted:

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/kgCadmium: ≤ 0,5 mg/kgMercury: ≤ 0,05 mg/kgArsenic: ≤ 0,02 mg/kgMicrobiological criteria:Aerobic plate count: ≤ 10 000 CFU/gColiforms: ≤ 100 MPN/gYeast and mould: ≤ 500 CFU/gEscherichia coli: Absence in 10 gStaphylococcus aureus: Absence in 10 gSalmonella: Absence in 25 gListeria monocytogenes: Absence in 25 gCFU: colony forming units.MPN: most probable number’
