Commission Implementing Regulation (EU) 2022/2534 of 21 December 2022 authorising the placing on the market of bovine milk beta-lactoglobulin (β-lactoglobulin) as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2022/2534
• Articles: 5

Article 1

1.   Bovine milk beta-lactoglobulin ( β -lactoglobulin) is authorised to be placed on the market within the Union.

Bovine milk beta-lactoglobulin ( β -lactoglobulin) 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 Arla Foods Ingredients Group P/S  ( 12 ) 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 11 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 Arla Foods Ingredients Group P/S.

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 Arla Foods Ingredients Group P/S.

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

‘ Bovine milk beta-lactoglobulin ( β -lactoglobulin)

Specified food category

Maximum levels (g NF/100 ml)

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘bovine milk beta-lactoglobulin’ or ‘bovine milk β -lactoglobulin’.

Authorised on 11 January 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Arla Foods Ingredients Group P/S, Sønderhøj 10-12, 8260 Viby J, Denmark. During the period of data protection, the novel food beta-lactoglobulin ( β -lactoglobulin) is authorised for placing on the market within the Union only by Arla Foods Ingredients Group P/S 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 Arla Foods Ingredients Group P/S.

End date of the data protection: 11 January 2028.’

Soft drinks marketed in relation to physical exercise

25

Whey powder (reconstituted)

8

Milk based drinks and similar products

12

Foods for special medical purposes as defined in Regulation (EU) No 609/2013 intended for the general population older than 3 years of age, excluding pregnant and lactating women

In accordance with the particular nutritional requirements of the persons for whom the products are intended

(2)

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

Authorised novel food

Specification

‘ Bovine milk beta-lactoglobulin ( β -lactoglobulin)

Description:

Beta-lactoglobulin ( β -lactoglobulin) protein is a white to cream powder produced from bovine whey by a series of steps involving filtration, concentration, crystallisation, re-dissolution (in water), pH adjustment to acidic or neutral pH, re-concentration and drying.

CAS number: 9045-23-2

Molecular weight: 36,7 kDa (dimer); 18,3 kDa (monomer)

Characteristics/Composition:

pH (10 % solution): 3,5-8,0

Protein (N x 6,38) (%): ≥ 86,0

Beta-lactoglobulin (% of protein): ≥ 90,0

Lactose (%): ≤ 1,0

Fat (%): ≤ 1,0

Ash (%): ≤ 5,0

Moisture (%): ≤ 5,5

Heavy Metals :

Cadmium (mg/kg): < 0,2

Lead (mg/kg): < 0,1

Mercury (mg/kg): < 0,01

Contaminants:

Aflatoxin M1 (μg/kg): < 0,01

Microbiological criteria:

Total plate count: ≤ 5 000 CFU/g

Total yeast/moulds count: ≤ 10 CFU/g

Enterobacteriaceae: ≤ 10 CFU/g

Salmonella spp.: Absent in 25 g

Bacillus cereus : < 100 CFU/g

Listeria monocytogenes : Absent in 25 g

Staphylococcus aureus : < 10 CFU/g

Sulfite-reducing clostridia: < 10 CFU/g

CFU: Colony Forming Units; kDa: kiloDaltons’