Prolyl oligopeptidase (enzyme preparation): authorised novel food in the EU

Conditions of use and maximum levels

Table 1, column "Conditions under which the novel food may be used", as written:

• Food Supplements as defined in Directive 2002/46/EC for general adult population: 120 PPU/day (2,7 g of enzyme preparation/day) (2 × 106 PPI/day) PPU - Prolyl Peptidase Units or Proline Protease Units PPI - Protease Picomole International

Additional specific labelling requirements

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Prolyl oligopeptidase’

Specification (Table 2)

Table 2 of the Annex, row with the same name, as written:

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:

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:

Lead: ≤ 1,0 mg/kg

Arsenic: ≤ 1,0 mg/kg

Cadmium: ≤ 0,5 mg/kg

Mercury: ≤ 0,1 mg/kg

Microbiological criteria:

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: Absence in 25 g

Escherichia coli: Absence in 25 g

Staphylococcus aureus: Absence in 10 g

Pseudomonas aeruginosa: Absence in 10 g

Listeria monocytogenes: Absence in 25 g

Antimicrobial activity: AbsentMycotoxins: 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

Source and version

Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods, Table 1. Consolidated text of 10 August 2026. The text above is copied from that document without change except that amendment markers are removed. It is not advice and it does not decide whether a particular product is covered.

• Consolidated text on EUR-Lex

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