Bovine milk basic whey protein isolate

Definition/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.

Specification: https://www.legislation.gov.uk/eur/2017/2470/annex/paragraph/2

Conditions under which the novel food may be used: Food category Maximum levels

Infant formulae as defined in Regulation (EU) No 609/2013; 30 mg/100 g (powder); 3.9 mg/100 mL (reconstituted)

Follow-on formulae as defined in Regulation (EU) No 609/2013; 30 mg/100 g (powder); 4.2 mg/100 mL (reconstituted)

Total diet replacement for weight control not total diet replacement foods for weight control. 300 mg/day;

Foods for special medical purposes as defined in Regulation (EU) No 609/2013; 30 mg/100 g (powder formula for infants (persons under the age of 1 year (12 months)) during the first months of life until the introduction of appropriate complementary feeding); 3.9 mg/100 mL (reconstituted formula for infants during the first months of life until the introduction of appropriate complementary feeding); 30 mg/100 g (powder formula for infants when appropriate complementary feeding is introduced); 4.2 mg/100 mL (reconstituted formula for infants when appropriate complementary feeding is introduced); 58 mg/day for young children; 380 mg/day for children and adolescents from 3 to 18 years of age; 610 mg/day for adults;

Food Supplements as defined in Directive 2002/46/EC

Food category	Maximum levels
Infant formulae as defined in Regulation (EU) No 609/2013;	30 mg/100 g (powder); 3.9 mg/100 mL (reconstituted)
Follow-on formulae as defined in Regulation (EU) No 609/2013;	30 mg/100 g (powder); 4.2 mg/100 mL (reconstituted)
Total diet replacement for weight control not total diet replacement foods for weight control.	300 mg/day;
Foods for special medical purposes as defined in Regulation (EU) No 609/2013;	30 mg/100 g (powder formula for infants (persons under the age of 1 year (12 months)) during the first months of life until the introduction of appropriate complementary feeding); 3.9 mg/100 mL (reconstituted formula for infants during the first months of life until the introduction of appropriate complementary feeding); 30 mg/100 g (powder formula for infants when appropriate complementary feeding is introduced); 4.2 mg/100 mL (reconstituted formula for infants when appropriate complementary feeding is introduced); 58 mg/day for young children; 380 mg/day for children and adolescents from 3 to 18 years of age; 610 mg/day for adults;
Food Supplements as defined in Directive 2002/46/EC

Additional specific labelling requirements: The designation of the novel food on the labelling of food containing it is “Milk whey protein isolate”.

The labelling of food supplements must bear a statement, as appropriate, that they should not be consumed by infants (persons under the age of 1 year)/infants or young children (persons under the age of 3 years)/infants, children or adolescents (persons under the age of 18 years

Data protection: Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en- Coglès, France. During the period of data protection the novel food bovine milk basic whey protein isolate is authorised for placing on the market within the Union only by Armor Protéines S.A.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 Armor Protéines S.A.S. End date of the data protection: 20 November 2023.

Legislation links: England: Assimilated EU Regulations 2017/2470 , Assimilated EU Regulations 2018/1632 , Assimilated EU Regulations 2019/1686 , The Food Additives and Novel Foods (Authorisations and Miscellaneous Amendments) and Food Flavourings (Removal of Authorisations) (England) Regulations 2024 (legislation.gov.uk)

Scotland: Assimilated EU Regulations 2017/2470 , Assimilated EU Regulations 2018/1632 , Assimilated EU Regulations 2019/1686 , The Food Additives and Novel Foods (Authorisations and Miscellaneous Amendments) and Food Flavourings (Removal of Authorisations) (Scotland) Regulations 2024 (legislation.gov.uk)

Wales: Assimilated EU Regulations 2017/2470 , Assimilated EU Regulations 2018/1632 , Assimilated EU Regulations 2019/1686 , legislation.gov.uk/wsi/2024/741/regulation/6/made/welsh , The Food Additives and Novel Foods (Authorisations and Miscellaneous Amendments) and Food Flavourings (Removal of Authorisations) (Wales) Regulations 2024 (legislation.gov.uk)

Last updated: 01 April 2025 The date the item authorisation was last updated.

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