COMMISSION IMPLEMENTING REGULATION (EU) 2018/1632
of 30 October 2018
authorising the placing on the market 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
(Text with EEA relevance)
Article 1
Article 2
Article 3
Article 4
ANNEX
Authorised novel food |
Conditions under which the novel food may be used |
Additional specific labelling requirements |
Other requirements |
Data Protection |
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‘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 children/adolescents under the age of three/eighteen (*) years”
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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.’ |
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Infant formulae as defined in Regulation (EU) No 609/2013 |
30 mg/100 g (powder) 3,9 mg/100 mL (reconstituted) |
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Follow-on formulae as defined in Regulation (EU) No 609/2013 |
30 mg/100 g (powder) 4,2 mg/100 mL (reconstituted) |
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Total diet replacement foods for weight control as defined by Regulation (EU) No 609/2013 |
300 mg/day |
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Foods for special medical purposes as defined in Regulation (EU) No 609/2013 |
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 |
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Food Supplements as defined in Directive 2002/46/EC |
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 |
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’ |