The European Commission has recently approved the extension of use of bovine milk basic whey protein isolate in food supplements and foods for special medicinal purposes for infants.
Following Armor ProtÃ©ines S.A.S.â 2016 request, the ingredient was originally approved as a novel food in 2018 for the use in infant and follow-on formulae, total diet replacement foods for weight control, foods for special medical purposes and food supplements for children and adolescents from 1 to 18 years and adults.
In 2018 the firm requested the Commission for the extension within the meaning of Article 10 (1) of Regulation (EU) 2015/2283 on Novel Foods. The requested changes concern the use of the bovine milk basic whey protein isolate in foods for special medical purposes as defined in Regulation (EU) 609/2013 and in food supplements as defined in Directive 2002/46/EC for infants up to 12 months of age.
Following a positive safety assessment by the European Food Safety Authority (EFSA), this ingredient can now also be used for infants at 25 mg/day in food supplements and food for special medical purposes, as specified in the Union list:
in infant formula (30 mg/100 g powder and 3.9 mg/100 ml reconstituted); and
in follow-on formulae (30 mg/100 g powder and 4.2 mg/100 ml reconstituted).
The authorization was obtained based on proprietary scientific evidence and data protection which ends on 20 November 2023. Until then only Armor ProtÃ©ines S.A.S. can market it unless a subsequent applicant obtains authorization for the novel food without reference to the same proprietary data or with the agreement of the firm.
Commission Implementing Regulation (EU) 2019/1686 of 8 October 2019 authorising the extension of use of bovine milk basic whey protein isolate as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470