1. Refined shrimp peptide concentrate 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: Marealis AS;
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Address: Stortorget 1, Kystens Hus, 2nd floor, N-9008 Tromsø Postal address: P.O. Box 1065, 9261 Tromsø, Norway;
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 Marealis AS.
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 Directive 2002/46/EC and to the provisions of Regulation (EU) No 1169/2011.
The studies 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 (EC) No 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 Marealis AS.
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)
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
‘Refined shrimp peptide concentrate
Specified food category
Maximum levels
The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘refined shrimp peptide concentrate’.
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: Marealis AS., Stortorget 1, Kystens Hus, 2nd floor, N-9008 Tromsø Postal address: P.O. Box 1065, 9261 Tromsø, Norway. During the period of data protection the novel food refined shrimp peptide concentrate is authorised for placing on the market within the Union only by Marealis AS 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 Marealis AS.
End date of the data protection: 20 November 2023.’
Food Supplements as defined in Directive 2002/46/EC for the adult population
1 200 mg/day
(3)
The following entry is inserted in Table 2 (Specifications) in alphabetical order:
Authorised Novel Food
Specification
‘Refined shrimp peptide concentrate
Description
Refined shrimp peptide concentrate is a peptide mixture obtained from northern shrimp ( Pandalus borealis ) shells and heads via a series of purification steps following enzymatic proteolysis using a protease from Bacillus licheniformis and/or Bacillus amyloliquefaciens .
Characteristics/Composition
Total Dry matter (%): ≥ 95,0 %
Peptides (w/weight dry matter): ≥ 87,0 % of which peptides with molecular weight < 2 kDa: ≥ 99,9 %
Fat (w/w): ≤ 1,0 %
Carbohydrates (w/w): ≤ 1,0 %
Ash (w/w): ≤ 15,0 %
Calcium: ≤ 2,0 %
Potassium: ≤ 0,15 %
Sodium: ≤ 3,5 %
Heavy Metals
Arsenic (inorganic): ≤ 0,22 mg/kg
Arsenic (organic): ≤ 51,0 mg/kg
Cadmium: ≤ 0,09 mg/kg
Lead: ≤ 0,18 mg/kg
Total mercury: ≤ 0,03 mg/kg
Microbiological criteria:
Total viable cell count: ≤ 20 000 CFU/g
Salmonella : ND/25g
Listeria monocytogenes : ND/25g
Escherichia coli : ≤ 20 CFU/g
Coagulase positive Staphylococcus aureus: ≤ 200 CFU/g
Pseudomonas aeruginosa : ND/25g
Mould/yeast: ≤ 20 CFU/g
CFU: Colony Forming Units
ND:
Not Detectable’
