
Article 1 
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.
Article 2 
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’.
Article 3 
This Decision is addressed to DSM Nutritional Products Ltd, Wurmisweg 576, 4303 Kaiseraugst, Switzerland.
Done at Brussels, 24 July 2017.
For the Commission
Vytenis ANDRIUKAITIS
Member of the Commission
ANNEX I

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.


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)



ANNEX II

Food category Maximum dose
Food supplements as defined in Directive 2002/46/EC 120 PPU/day (2,7 g of enzyme preparation/day) (2 × 106 PPI/day) for general adult population

