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)

• CELEX: Implementing Regulation (EU) 2020/1820
• Articles: 5

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 .

Schedules & Appendices

ANNEX

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  ( *1 ) .

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 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

(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/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’

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