Bovine milk beta-lactoglobulin (β-lactoglobulin): authorised novel food in the EU

Conditions of use and maximum levels

Table 1, column "Conditions under which the novel food may be used", as written:

• 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

Additional specific labelling requirements

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’.

Specification (Table 2)

Table 2 of the Annex, row with the same name, as written:

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 and version

Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods, Table 1. Consolidated text of 10 August 2026. The text above is copied from that document without change except that amendment markers are removed. It is not advice and it does not decide whether a particular product is covered.

• Consolidated text on EUR-Lex

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