COMMISSION IMPLEMENTING REGULATION (EU) 2018/1633
of 30 October 2018
authorising the placing on the market of refined shrimp peptide concentrate 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 |
|
‘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’. |
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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: 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 |
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’ |