ANNEX ISupplementary provisions
ANNEX I Specifications of the enzyme preparation of prolyl oligopeptidase produced with a genetically modified strain of Aspergillus niger Specification of the enzyme Systematic name Prolyl oligopeptidase Synonyms Prolyl endopeptidase, proline-specific endopeptidase, endoprolylpeptidase Molecular weight 66 kDa Enzyme Commission number EC 3.4.21.26 CAS number 72162-84-6 Source A genetically modified strain of Aspergillus niger (GEP-44) Description : Prolyl oligopeptidase is available as an enzyme preparation containing approximately 30 % maltodextrin. Specifications of the enzyme preparation of prolyl oligopeptidase Parameter Specifications Limits Activity > 580 000 PPI ( 1 ) /g (> 34,8 PPU ( 2 ) /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 ≤ 10 3 CFU/g Total yeasts and moulds ≤ 10 2 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) ( 1 ) PPI — Protease Picomole International. ( 2 ) PPU — Prolyl Peptidase Units or Proline Protease Units.