Commission Implementing Regulation (EU) 2023/463 of 3 March 2023 authorising the placing on the market of bovine milk osteopontin 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 osteopontin is authorised to be placed on the market within the Union. Bovine milk osteopontin 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 ( 8 ) is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of five years from 26 March 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 five 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 entry on ‘Bovine milk Osteopontin’ is inserted: Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements Data Protection ‘Bovine milk osteopontin Specified food category Maximum levels The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Bovine milk Osteopontin’. Authorised on 26 March 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 Bovine milk osteopontin 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: 26 March 2028. Infant formula as defined in Regulation (EU) No 609/2013 ( *1 ) 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 ( *1 ) 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 (2) in Table 2 (Specifications), the following entry ‘Bovine milk osteopontin’ is inserted: Authorised Novel Food Specification ‘ Bovine milk osteopontin 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’ ( *1 ) Without prejudice to the requirements of Regulation (EU) No 609/2013 and Regulation (EU) 2016/127.’
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.