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.)
1. Bovine milk basic whey protein isolate as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.
2. For a period of five years from the date of entry into force of this Regulation only the initial Applicant:
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Company: Armor Protéines S.A.S.
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Address: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France;
is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for the novel food without reference to the data protected pursuant to Article 2 of this Regulation or with the agreement of Armor Protéines S.A.S.
3. 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.
4. The authorisation provided for in this Article shall be without prejudice to the provisions of Regulation (EU) No 1169/2011, to the provisions of Directive 2002/46/EC, and to the provisions of Regulation (EU) No 609/2013.
The study contained in the application file on the basis of which the novel food referred to in Article 1 has been assessed by the Authority, claimed by the Applicant as fulfilling the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283, shall not be used for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of Armor Protéines S.A.S.
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 .
Supplementary provisions
ANNEXSupplementary provisions
ANNEX
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
(1)
the following last column is added in Table 1 (Authorised novel foods):
‘Data Protection’
(2)
the following entry is inserted in Table 1 (Authorised novel foods) in alphabetical order:
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 children/adolescents under the age of 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
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 foods for weight control as defined by Regulation (EU) No 609/2013
300 mg/day
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
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
(3)
the following entry is inserted in Table 2 (Specifications) in alphabetical order:
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’
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
