Commission Implementing Regulation (EU) 2023/2851 of 20 December 2023 authorising the placing on the market of partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa) as a novel food and amending Implementing Regulation (EU) 2017/2470

• CELEX: Implementing Regulation (EU) 2023/2851
• Articles: 5

Article 1

1.   Partially hydrolysed protein from spent barley ( Hordeum vulgare ) and rice ( Oryza sativa ) is authorised to be placed on the market within the Union.

Partially hydrolysed protein from spent barley ( Hordeum vulgare ) and rice ( Oryza sativa ) 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 Evergrain LLC  ( 11 ) 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 10 January 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 Evergrain LLC.

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 Evergrain LLC.

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

“ Partially hydrolysed protein from spent barley ( Hordeum vulgare ) and rice ( Oryza sativa )

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Partially hydrolysed protein from spent barley and rice’.

In accordance with Article 21 to Regulation (EU) No 1169/2011.

Authorised on 10 January 2024. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Evergrain LLC, 3205 S. 9th St, St. Louis, Missouri, 63118 USA. During the period of data protection, the novel food partially hydrolysed protein from spent barley ( Hordeum vulgare ) and rice ( Oryza sativa ) is authorised for placing on the market within the Union only by Evergrain LLC, 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 Evergrain LLC.

End date of the date protection: 10 January 2029.”

Fried or extruded cereal, seed or root-based products

5 g/100 g

Confectionery including chocolate

5 g/100 g

Breakfast cereals

5 g/100 g

Pastas and rice (or other cereal)-based dishes

8 g/100 g

Soups (dry mixture)

50 g/100 g

Soups (ready-to-eat)

5 g/100 g

Sauces

10 g/100 g

Dried sauce preparation

50 g/100 g

Meat analogues

15 g/100 g

Cereal bars

30 g/100 g

Butter and margarine/oil blends

10 g/100 g

Milk analogues based ice creams

10 g/100 g

Milk analogues

5 g/100 ml

Nut/seeds paste/emulsion

15 g/100 g

Energy drinks

8 g/100 ml

Soft drinks marketed in relation to physical exercise

5 g/100 ml

Cola type drinks

5 g/100 g

Powdered drink bases

90 g/100 g

Beverages based on fruit and/or vegetable juices

5 g/100 ml

Cream, cheese and yoghurt (non-soy) analogues

10 g/100 g

Hummus

10 g/100 g

Alcohol-free beer

5 g/100 ml

Meal replacement for weight control

30 g/100 g

(2)

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

Authorised Novel Food

Specification

“ Partially hydrolysed protein from spent barley ( Hordeum vulgare ) and rice ( Oryza sativa )

Description/Definition:

The novel food is partially hydrolysed protein from spent barley ( Hordeum vulgare ) and rice ( Oryza sativa ), residues obtained from the solid by-product of beer production that contains 45-70 % spent barley and 30-55 % spent rice.

The novel food is produced by enzymatically treating the pasteurised spent barley and rice residues of the mash step of beer production. Several mechanical treatment steps of the partial hydrolysate are employed to obtain the final product.

Characteristics/composition:

Appearance: powder

Degree of hydrolysis: 1-7 %

Proteins (N x 6,25): 78-90 %

Moisture: 2-8 %

Carbohydrates: 2-10 %

Fat: 0-2 %

Ash: 1-8 %

Heavy metals:

Arsenic (mg/kg): ≤ 0,2

Cadmium (mg/kg): ≤ 0,1

Lead (mg/kg): ≤ 0,2

Mercury (mg/kg): ≤ 0,01

Mycotoxins:

Aflatoxin B1: ≤ 2 μg/kg

Sum of aflatoxins (B1, B2, G1, G2): ≤ 4 μg/kg

Deoxynivalenol: < 200 μg/kg

Fumonisins (sum of B1, B2): ≤ 200 μg/kg

Ochratoxin A: ≤ 3 μg/kg

Zearalenone: ≤ 20 μg/kg

Patulin: ≤ 50 μg/kg

Antinutritional factors:

Phytic acid: < 0,25 %

Microbiological criteria:

Total aerobic microbial count (CFU/g): < 10 4

Coliforms (CFU/g): < 100

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

Salmonella spp.: Not detected in 25 g

Escherichia coli (CFU/g): < 10

Staphylococcus aureus (CFU/g): < 10

Listeria monocytogenes : Not detected in 25 g

Bacillus cereus (CFU/g): < 100

CFU: colony forming units”