Commission Implementing Regulation (EU) 2023/6 of 3 January 2023 authorising the placing on the market of pea and rice protein fermented by Lentinula edodes (Shiitake mushroom) mycelia as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/6
• Articles: 5

Article 1

(1)   Pea and rice protein fermented by Lentinula edodes (Shiitake mushroom) mycelia is authorised to be placed on the market within the Union.

Pea and rice protein fermented by Lentinula edodes (Shiitake mushroom) mycelia 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 MycoTechnology, Inc.  ( 6 ) is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of five years from 24 January 2023, 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 MycoTechnology, Inc.

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 MycoTechnology, Inc..

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

‘ Pea and rice protein fermented by Lentinula edodes (Shiitake mushroom) mycelia

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be “Pea and rice protein fermented by Shiitake mushroom mycelia”.

Authorised on 24.1.2023. This inclusion is based on proprietary scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: MycoTechnology, Inc., 18250 E. 40th Avenue, Suite 50, Aurora, 80011 Colorado, United States. During the period of data protection, the novel food pea and rice protein fermented by Lentinula edodes (Shiitake mushroom) mycelia is authorised for placing on the market within the Union only by MycoTechnology, Inc. unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of MycoTechnology, Inc.

End date of the data protection: 24.1.2028.’

Bakery wares, breads, rolls, croutons, pizza

5 g/100 g

Breakfast cereals and cereal bars

33 g/100 g

Fruit- and vegetable-based drinks

20 g/100 ml

Ready-to-mix beverage powders

93 g/100 g

Cocoa and chocolate confectionary

7 g/100 g

Dairy analogues and non-dairy meal replacements for weight control

11 g/100 g

Fermented milk-based products

5 g/100 g

Pasta-based products

15 g/100 g

Meat preparations and meat products

14 g/100 g

Soups (ready-to-eat) and soup concentrates or powders

3 g/100 g

Salads

26 g/100 g

Meat analogues

40 g/100 g

Milk-based drinks

1 g/100 g

Single meal replacements for weight control

1 g/100 g

(2)

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

Authorised Novel Food

Specification

‘ Pea and rice protein fermented by Lentinula edodes (Shiitake mushroom) mycelia

Description:

The novel food is produced from the fermentation of a mixture of 65 % pea and 35 % rice protein concentrates by the mycelia of the Shiitake mushroom ( Lentinula edodes ) followed by heat treatment to terminate the fermentation and a series of drying steps to form a powder.

Characteristics/Composition:

Protein (% dry weight, N x 6,25): ≥ 75,0

Moisture: ≤ 7,0

Total fat (% dry weight): ≤ 10,0

Ash (% dry weight): ≤ 10,0

Carbohydrates (% by calculation): ≤ 15,0

Mycotoxins :

Aflatoxin B1 (μg/kg): < 1,0

Aflatoxin B2 (μg/kg): < 1,0

Aflatoxin G1 (μg/kg): < 1,0

Aflatoxin G2 (μg/kg): < 1,0

Aflatoxin total (B1+B2+G1+G2) (μg/kg): < 3,0

Heavy metals:

Arsenic (μg/g): < 0,1

Cadmium (μg/g): < 0,1

Lead (μg/g): < 0,3

Mercury (μg/g): < 0,1

Microbiological criteria:

Total aerobic microbial count: < 1 000 CFU/g

Total yeast/moulds count: < 100 CFU/g

Coliforms: ≤ 10 CFU/g

Salmonella spp.: Absent in 25 g

Escherichia coli : < 10 CFU/g

Listeria monocytogenes : Absent in 25 g

*CFU: Colony Forming Units’