Commission Implementing Regulation (EU) 2024/1048 of 9 April 2024 authorising the placing on the market of protein concentrate from Lemna gibba and Lemna minor as a novel food and amending Implementing Regulation (EU) 2017/2470

• CELEX: Implementing Regulation (EU) 2024/1048
• Articles: 5

Article 1

1.   Protein concentrate from Lemna gibba and Lemna minor is authorised to be placed on the market within the Union.

Protein concentrate from Lemna gibba and Lemna minor 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 ABC Kroos BV  ( 13 ) 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 ABC Kroos BV.

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 5 years from the date of entry into force of this Regulation without the agreement of ABC Kroos BV.

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

‘ Protein concentrate from Lemna gibba and Lemna minor

Specified food category

Maximum levels

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be “protein concentrate from the Lemna gibba and Lemna minor plants” or “protein concentrate from the Lemna gibba plant” depending on the presence of Lemna minor .

2.

Where foods containing the novel food include an amount of vitamin K that is considered significant in accordance with point 2 of Part A of Annex XIII to Regulation (EU) No 1169/2011, the nutrition declaration shall indicate the amount of vitamin K.

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: ABC Kroos BV, Drosteweg 8, 8101 NB Raalte, NETHERLANDS. During the period of data protection, the novel food protein concentrate from Lemna gibba and Lemna minor is authorised for placing on the market within the Union only by ABC Kroos BV, 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 ABC Kroos BV.

End date of the date protection: 30 April 2029.’

Cereal bars

10 g/100 g

Prepacked bread and rolls

1,7 g/100 g

Powdered drink mixes

20 g/100 g

Noodles

6 g/100 g

Food supplements as defined in Directive 2002/46/EC for the adult population

1 g/day

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be “protein concentrate from the Lemna gibba and Lemna minor plants” or “protein concentrate from Lemna gibba plant” depending on the presence of Lemna minor .

2.

The labelling of food supplements containing the novel food shall bear a statement that they should only be consumed by adults.

3.

Where food supplements containing the novel food include an amount of vitamin K that is considered significant in accordance with point 2 of Part A of Annex XIII to Regulation (EU) No 1169/2011 and Article 8 of Directive 2002/46/EC, the labelling of food supplements containing novel food shall indicate the amount of vitamin K.

(2)

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

Authorised Novel Food

Specification

‘ Protein concentrate from Lemna gibba and Lemna minor

Description/Definition:

The novel food is a protein concentrate produced from the Lemna gibba (70–100 %) and Lemna minor (0–30 %) plant species. The manufacturing process of the protein concentrate involves mechanical separation of the protein fraction from insoluble fibres, followed by precipitation under acidic conditions, pasteurisation and spray drying.

The cultivation is carried out in basins in greenhouses under controlled conditions. The water used for the cultivation is filtered and UV-treated. The cultivation conditions are monitored to control the growth of algae, yeast and fungi. The pH is maintained between 5,5 and 6,5.

Characteristics/composition:

Appearance: green powder

Moisture: 1,5-8 %

Protein (Nx6,25): 60-75 %

Ash: 4-12 %

Fat: 2-11 %

Fibre: 6-17 %

Ash: 4-12 %

Vitamins:

β-Carotene: < 755 mg/kg

Vitamin K 1 (Phylloquinone): < 16 mg/100 g

Minerals:

Boron: < 10 mg/kg

Copper: < 12 mg/kg

Molybdenum: < 40 mg/kg

Iron: < 670 mg/kg

Zinc: < 50 mg/kg

Manganese: < 100 mg/kg

Antinutritional factors:

Oxalic acid: < 1 900 mg/kg

Heavy metals:

Lead (mg/kg): ≤ 0,3

Cadmium (mg/kg): ≤ 0,2

Mercury (mg/kg): ≤ 0,1

Arsenic (mg/kg): ≤ 0,2

Cyanotoxins:

Microcystins-/Nodularin: < 0,19 mg/kg

Other contaminants:

Lysino-alanine (bound): < 500 mg/kg

Lysino-alanine (free): < 10 mg/kg

Nitrate: < 3 000 mg/kg

Pesticides:

Pesticide levels in accordance with Code number 0254000 (“Subgroup (d) watercresses” in the group of Leaf vegetables, herbs and edible flowers) set out in Regulation (EC) No 396/2005.

Microbiological criteria:

Total colony count: < 10 4 CFU/g

Bacillus cereus : < 100 CFU/g

Clostridium perfringens : < 100 CFU/g

Coagulase-positive Staphylococci: < 100 CFU/g

Escherichia coli : < 10 CFU/g

Enterobacteriaceae : < 10 CFU/g

Listeria monocytogenes : Not detected in 25 g

Salmonella spp.: Not detected in 25 g

Yeasts and moulds: < 10 CFU/g

CFU: colony forming units.’.