Commission Implementing Regulation (EU) 2023/949 of 12 May 2023 authorising the placing on the market of iron milk caseinate 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) Iron milk caseinate is authorised to be placed on the market within the Union. Iron milk caseinate 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 ‘Société des Produits Nestlé S.A.’ ( 15 ) 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 4 June 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 ‘Société des Produits Nestlé S.A.’.
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 ‘Société des Produits Nestlé S.A.’.
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 ‘Iron milk caseinate Specified food category Maximum levels The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘iron milk caseinate’. The labelling of food supplements containing iron milk caseinate shall bear a statement that (a) they should not be consumed by children under 3 years of age; (b) they should not be consumed if other foods containing iron milk caseinate and/or if other foods with added iron are consumed the same day. Authorised on 4 June 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: “Société des Produits Nestlé S.A.”, Avenue Nestlé 55, 1800 Vevey, Switzerland. During the period of data protection, the iron milk caseinate is authorised for placing on the market within the Union only by “Société des Produits Nestlé S.A.” 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 “Société des Produits Nestlé S.A.”. End date of the data protection: 4 June 2028.’ Milk and dairy powder products 500 mg/100 g (≤ 10 mg Fe/100 g) Soft-drinks marketed in relation to physical exercise 85 mg/100 g (≤ 1,7 mg Fe/100 g) Powder cocoa beverage preparations 400 mg/100 g (≤ 8 mg Fe/100 g) Powder or liquid malt-based coffee substitutes 1 050 mg/100 g (≤ 21 mg Fe/100 g) Cereal bars 350 mg/100 g (≤ 7 mg Fe/100 g) Noodles other than glass noodles 75 mg/100 g (≤ 1,5 mg Fe/100 g) Stock cubes or granulates (bouillon base) 4 750 mg/100 g (≤ 95 mg Fe/100 g) Single meal replacements for weight control 120 mg/100 g (≤ 2,4 mg Fe/100 g) Total diet replacement for weight control as defined under Regulation (EU) No 609/2013 235 mg/meal (≤ 4,7 mg Fe/meal) or 700 mg/day (≤ 14,0 mg/Fe/day) Foods for special medical purposes as defined under Regulation (EU) No 609/2013 excluding foods for infants and young children In accordance with the particular nutritional requirements of the persons for whom the products are intended Food supplements as defined in Directive 2002/46/EC, for the adult population 700 mg/day (≤ 14 mg Fe/day) Food supplements as defined in Directive 2002/46/EC, for children and adolescents under 18 years of age, excluding infants and young children 350 mg/day (≤ 7 mg Fe/day) (2) in Table 2 (Specifications), the following entry is inserted: Authorised novel food Specification ‘ Iron milk caseinate Description: Iron milk caseinate is an iron-casein-phosphate complex in the form of a creamy or beige powder produced by the dissolution of ferric iron salts (ferric sulfate or ferric chloride) in a casein solution obtained from bovine milk in the presence of potassium orthophosphate following a series of steps involving pasteurisation, concentration, and drying. Characteristics/Composition: Protein (%): 50,0 – 65,0 Ash (%): 20,0 – 40,0 Moisture (%): < 8,0 Fat (%): < 1,0 Iron (%): 2,0 – 4,0 Potassium (%): 5,0 – 15,0 Phosphorus (%): 2,0 – 6,0 Sodium (%): < 4,0 Heavy metals: Lead: < 0,5 mg/kg Arsenic: ≤ 1,0 mg/kg Cadmium: < 0,5 mg/kg Mercury: < 0,1 mg/kg Mycotoxins: Aflatoxin M1: ≤ 0,02 mg/kg Microbiological criteria: Aerobic plate count: ≤ 1 000 CFU/g Coliforms: ≤ 10 CFU/g Salmonella spp.: Absence in 25 g Yeast and mould: ≤ 10 CFU/g Escherichia coli: ≤ 10 CFU/g Staphylococcus aureus : Absence in 1 g CFU: Colony Forming Units’
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.