Iron milk caseinate: 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:

• 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)

Additional specific labelling requirements

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.

Specification (Table 2)

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

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 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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