# Commission Implementing Decision (EU) 2017/1387 of 24 July 2017 authorising the placing on the market of an enzyme preparation of prolyl oligopeptidase produced with a genetically modified strain of Aspergillus niger as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2017) 4975) (Only the English text is authentic), Division: Specifications of the enzyme preparation of prolyl oligopeptidase

Extent: E+W+S+N.I.

PPI — Protease Picomole International.
PPU — Prolyl Peptidase Units or Proline Protease Units.
Parameter
Specifications Limits
Activity
> 580 000 PPI/g (> 34,8 PPU/g)
Appearance
Microgranulate
Colour
Off-white to orange yellowish. The colour may change from batch to batch
Dry Matter
> 94 %
Gluten
< 20 ppm
Heavy metals
Total heavy metals (as lead)
≤ 10 mg/kg
Lead
≤ 1,0 mg/kg
Arsenic
≤ 1,0 mg/kg
Cadmium
≤ 0,5 mg/kg
Mercury
≤ 0,1 mg/kg
Microbiological specifications
Total aerobic plate count
≤ 103 CFU/g
Total yeasts and moulds
≤ 102 CFU/g
Sulphite reducing anaerobes
≤ 30 CFU/g
Enterobacteriaceae
< 10 CFU/g
Salmonella
Absent in 25 g
Escherichia coli
Absent in 25 g
Staphylococcus aureus
Absent in 10 g
Pseudomonas aeruginosa
Absent in 10 g
Listeria monocytogenes
Absent in 25 g
Antimicrobial activity
Absent
Mycotoxins
Below limits of detection: Aflatoxin B1, B2, G1, G2 (< 0,25 μg/kg), total Aflatoxins (< 2,0 μg/kg), Ochratoxin A (< 0,20 μg/kg), T-2 Toxin (< 5 μg/kg), Zearalenone (< 2,5 μg/kg), Fumonisin B1 and B2 (< 2,5 μg/kg)

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Source: https://www.legislation.gov.uk/eudn/2017/1387/annex/I/division/2 (the official version)
Page: https://openlegislation.uk/eu-decision-2017-1387/annex-I/division-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.