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)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
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.
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.
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.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
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’
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.