Commission Implementing Regulation (EU) 2024/1046 of 9 April 2024 authorising the placing on the market of beta-glucan from Euglena gracilis microalgae as a novel food and amending Implementing Regulation (EU) 2017/2470

• CELEX: Implementing Regulation (EU) 2024/1046
• Articles: 5

Article 1

1.   Beta-glucan from Euglena gracilis microalgae is authorised to be placed on the market within the Union.

Beta-glucan from Euglena gracilis microalgae shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.

2.   The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 2

Only the company Kemin Foods L.C.  ( 19 ) is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of 5 years from 30 April 2024, unless a subsequent applicant obtains an authorisation for that novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of Kemin Foods L.C.

Article 3

The scientific data contained in the application file and fulfilling the conditions laid down in Article 26(2) of Regulation (EU) 2015/2283 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 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

‘ Beta-glucan from Euglena gracilis microalgae

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be “beta-glucan from Euglena gracilis microalgae”.

Authorised on 30 April 2024. 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., 1900 Scott Avenue Des Moines, IA 50317, United States. During the period of data protection, the novel food beta-glucan from Euglena gracilis microalgae is authorised for placing on the market within the Union only by Kemin Foods L.C., unless a subsequent applicant obtains authorisation for the 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 date protection 30 April 2029.’

Cereal bars

670 mg/100 g

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013

600 mg/day

Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children

100 mg/day for children from 3 to 9 years of age

150 mg/day for children from 10 to 17 years of age

200 mg/day for adults

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be “beta-glucan from Euglena gracilis microalgae”.

2.

The labelling of food supplements containing the novel food shall bear a statement that they should only be consumed by persons above 3 years of age/above 9 years of age/adults, depending on the age group the product is intended for

(2)

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

Authorised Novel Food

Specification

‘ Beta-glucan from Euglena gracilis microalgae

Description/Definition:

The novel food, beta-glucan from Euglena gracilis microalgae (paramylon), is a linear, unbranched beta-1,3-D-glucan polymer derived from the non-GM microalga Euglena gracilis .

The novel food is produced by fermentation, followed by pH adjustment and homogenization to release the beta-glucan granules. The granules are isolated by decanting and washing, and subsequently, acidified and filtered. After drying, the product is milled. The process includes conditions such as an alkaline pH and heat-killing step of the microalga to ensure the absence of viable Euglena gracilis cells in the novel food.

Characteristics/composition:

Appearance: cream white powder

Beta-glucan  ( *1 ) : (%) ≥ 95

Moisture (%): ≤ 6

Ash (%): ≤ 1

Heavy metals:

Lead (mg/kg): ≤ 0,5

Cadmium (mg/kg): ≤ 0,5

Mercury (mg/kg): ≤ 0,05

Arsenic (mg/kg): ≤ 0,02

Microbiological criteria:

Total aerobic microbial count (CFU/g): ≤ 3 000

Total yeast and mould count (CFU/g): ≤ 100

Coliforms (MPN/g): ≤ 30

Escherichia coli : Not detected in 10 g

Staphylococcus aureus : Not detected in 10 g

Salmonella spp.: Not detected in 25 g

Listeria monocytogenes : Not detected in 25 g

CFU: colony forming units, MPN: most probable number.

( *1 )   Expressed as total dietary fibre.’