1. The entry in the Union list of authorised novel foods, established under Implementing Regulation (EU) 2017/2470, referring to the substance bovine milk basic whey protein isolate shall be amended as specified in the Annex to this Regulation.
2. The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.
3. The authorisation provided for in this Article shall be without prejudice to the provisions of Regulation (EU) No 609/2013 and of Directive 2002/46/EC.
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
ANNEXSupplementary provisions
ANNEX
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
(1)
In Table 1 (Authorised novel foods), the entry on ‘Bovine milk basic whey protein isolate’ is replaced by the following:
‘ Authorised novel food
Conditions under which the novel food may be used
Additional specific labelling requirements
Other requirements
Data Protection
Bovine milk basic whey protein isolate
Specified food category
Maximum levels
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.
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.’
Infant formulae as defined in Regulation (EU) No 609/2013
Follow-on formulae as defined in Regulation (EU) No 609/2013
Total diet replacement foods for weight control as defined by Regulation (EU) No 609/2013
Foods for special medical purposes as defined in Regulation (EU) No 609/2013
Food Supplements as defined in Directive 2002/46/EC
30 mg/100 g (powder)
3,9 mg/100 mL (reconstituted)
30 mg/100 g (powder)
4,2 mg/100 mL (reconstituted)
300 mg/day
30 mg/100 g (powder formula for infants 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
25 mg/day for infants
58 mg/day for young children
250 mg/day for children and adolescents from 3 to 18 years of age
610 mg/day for adults
(2)
in Table 2 (Specifications), the entry on ‘Bovine milk basic whey protein isolate’ is replaced by the following:
‘ Authorised Novel Food
Specification
Bovine milk basic whey protein isolate
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’
