Bovine milk osteopontin: 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:

• Infant formula as defined in Regulation (EU) No 609/2013 (13): 151 mg/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
• Follow-on formula as defined in Regulation (EU) No 609/2013 (13): 151 mg/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
• Milk-based drinks intended for young children: 151 mg/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

Additional specific labelling requirements

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Bovine milk Osteopontin’.

Specification (Table 2)

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

Description

Bovine milk osteopontin is isolated from pasteurised or microfiltered bovine whey or milk by ion exchange chromatography, ultrafiltration to remove low molecular weight components and spray drying. During this filtration steps lactose and whey proteins predominantly alpha-lactalbumin and beta lactoglobulin are removed.

Characteristics/Composition

Protein % as is (N × 6,38): 76,5-80,5

Bovine milk osteopontin (bmOPN) (% of protein): ≥ 84,5

Full-length bmOPN (MW 33,9 kDa) (% of bmOPN): ≥ 15

N-terminal fragment bmOPN (MW 19,8 kDa) (% of bmOPN): ≥ 70

Other milk protein (% of protein): ≤ 14,5

Moisture: < 9,5 %

Lactose: ≤ 1,0 %

Fat: ≤ 1,0 %

Ash: ≤ 11 %

Insolubility index (mL) ≤ 1,0

Heavy metals

Lead: < 0,05 mg/kg

Cadmium: < 0,05 mg/kg

Mercury: < 0,05 mg/kg

Arsenic: < 0,5 mg/kg

Aflatoxin M1 < 0,1 μg/kg

Microbiological criteria

Total plate count (30 °C) (CFU/g): ≤ 5 000

Mould/yeast (CFU/g): ≤ 100

Bacillus cereus (CFU/g): < 50

Sulfur-reducing Clostridia (CFU/g): < 10

Staphylococcus aureus: Not detected in 1 g

Enterobacteriaceae (CFU/g): < 10

Salmonella spp.: Not detected in 25 g

CFU: Colony Forming Units

Notes

(13) Without prejudice to the requirements of Regulation (EU) No 609/2013 and Regulation (EU) 2016/127.

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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