Bovine milk basic whey protein isolate: authorised novel food in the EU
Bovine milk basic whey protein isolate is on the Union list of authorised novel foods (Implementing Regulation (EU) 2017/2470). Conditions of use and maximum levels by food category: 16 entries, quoted below.
- Regulation
- Implementing Regulation (EU) 2017/2470, Annex, Table 1
- Listed as
- Bovine milk basic whey protein isolate
- Text version
- Consolidated text of 10 August 2026
- Version
- Consolidated text of 10 August 2026
- Official source
- Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods
Conditions of use and maximum levels
Table 1, column "Conditions under which the novel food may be used", as written:
- Infant formulae as defined in Regulation (EU) No 609/2013: 30 mg/100 g (powder)
- Infant formulae as defined in Regulation (EU) No 609/2013: 3,9 mg/100 mL (reconstituted)
- Follow-on formulae as defined in Regulation (EU) No 609/2013: 30 mg/100 g (powder)
- Follow-on formulae as defined in Regulation (EU) No 609/2013: 4,2 mg/100 mL (reconstituted)
- Total diet replacement foods for weight control as defined in Regulation (EU) No 609/2013: 300 mg/day
- Foods for special medical purposes as defined in Regulation (EU) No 609/2013: 30 mg/100 g (powder formula for infants during the first months of life until the introduction of appropriate complementary feeding)
- Foods for special medical purposes as defined in Regulation (EU) No 609/2013: 3,9 mg/100 mL (reconstituted formula for infants during the first months of life until the introduction of appropriate complementary feeding)
- Foods for special medical purposes as defined in Regulation (EU) No 609/2013: 30 mg/100 g (powder formula for infants when appropriate complementary feeding is introduced)
- Foods for special medical purposes as defined in Regulation (EU) No 609/2013: 4,2 mg/100 mL (reconstituted formula for infants when appropriate complementary feeding is introduced)
- Foods for special medical purposes as defined in Regulation (EU) No 609/2013: 58 mg/day for young children
- Foods for special medical purposes as defined in Regulation (EU) No 609/2013: 380 mg/day for children and adolescents from 3 to 18 years of age
- Foods for special medical purposes as defined in Regulation (EU) No 609/2013: 610 mg/day for adults
- Food supplements as defined in Directive 2002/46/EC: 25 mg/day for infants
- Food supplements as defined in Directive 2002/46/EC: 58 mg/day for young children
- Food supplements as defined in Directive 2002/46/EC: 250 mg/day for children and adolescents from 3 to 18 years of age
- Food supplements as defined in Directive 2002/46/EC: 610 mg/day for adults
Additional specific labelling requirements
The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Milk whey protein isolate’. Food supplements containing bovine milk basic whey protein isolate shall bear the following statement: ‘This food supplement should not be consumed by infants/children/adolescents under the age of one/three/eighteen (*) years’ (*) Depending on the age group the food supplement is intended for.
Specification (Table 2)
Table 2 of the Annex, row with the same name, as written:
Description
Bovine milk basic whey protein isolate is a yellowish grey powder obtained from bovine skimmed milk via a series of isolation and purification steps.
Characteristics/Composition
Total protein (w/weight of product): ≥ 90 %
Lactoferrin (w/weight of product): 25-75 %
Lactoperoxidase (w/weight of product): 10-40 %
Other proteins (w/weight of product): ≤ 30 %
TGF-β2: 12-18 mg/100 g
Moisture: ≤ 6,0 %
pH (5 % solution w/v): 5,5 - 7,6
Lactose: ≤ 3,0 %
Fat: ≤ 4,5 %
Ash: ≤ 3,5 %
Iron: ≤ 25 mg/100 g
Heavy Metals
Lead: < 0,1 mg/kg
Cadmium: < 0,2 mg/kg
Mercury: < 0,6 mg/kg
Arsenic: < 0,1 mg/kg
Microbiological criteria:
Aerobic mesophilic count: ≤ 10 000 CFU/g
Enterobacteriaceae: ≤ 10 CFU/g
Escherichia coli: Negative/g
Coagulase positive Staphylococci: Negative/g
Salmonella: Negative/25 g
Listeria: Negative/25 g
Cronobacter spp.: Negative/25 g
Moulds: ≤ 50 CFU/g
Yeasts: ≤ 50 CFU/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.
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