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)
Article 1
Article 2
Article 3
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) |
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 |
≤ 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) |
ANNEX II
Authorised uses of the enzyme preparation of prolyl oligopeptidase produced with a genetically modified strain of
Aspergillus niger
Food category |
Maximum dose |
Food supplements as defined in Directive 2002/46/EC |
120 PPU(1)/day (2,7 g of enzyme preparation/day) (2 × 106 PPI(2)/day) for general adult population |