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)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Without prejudice to Directive 2002/46/EC, the enzyme preparation of prolyl oligopeptidase produced with a genetically modified strain of Aspergillus niger as specified in Annex I to this Decision may be placed on the Union market as a novel food ingredient to be used in food supplements intended for the general adult population with a maximum dose established in Annex II to this Decision.
The designation of the enzyme preparation of prolyl oligopeptidase produced with a genetically modified strain of Aspergillus niger authorised by this Decision on the labelling of the foodstuffs shall be ‘prolyl oligopeptidase’.
This Decision is addressed to DSM Nutritional Products Ltd, Wurmisweg 576, 4303 Kaiseraugst, Switzerland.
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.
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 × 10 6 PPI ( 2 ) /day) for general adult population ( 1 ) PPU — Prolyl Peptidase Units or Proline Protease Units. ( 2 ) PPI — Protease Picomole International.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.