L 6/4
ANNEX I
Correction of Implementing Regulation (EU) 2017/2470 EN
The Annex to Implementing Regulation (EU) 2017/2470 is corrected as follows:
(1) in Table 1 (Authorised novel foods), the entry for ‘Bovine milk basic whey protein isolate’ is replaced by the following: Conditions under which the novel food may be used
‘Bovine milk basic Specified food category Maximum levels whey protein isolate Infant formulae as defined in 30 mg/100 g (powder) Regulation (EU) No 609/2013 3,9 mg/100 mL (reconstituted) Follow-on formulae as defined 30 mg/100 g (powder) in Regulation (EU) 4,2 mg/100 mL (reconstituted) No 609/2013 Total diet replacement foods 300 mg/day for weight control as defined in Regulation (EU) No 609/2013 Foods for special medical 30 mg/100 g (powder formula for purposes as defined in infants during the first months of life Regulation (EU) No 609/2013 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)
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.
Other requirements
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.’
9.1.2023
30 mg/100 g (powder formula for infants when appropriate complementary feeding is introduced)
Additional specific labelling requirements
Official Journal of the European Union
Authorised novel food