Commission Implementing Regulation (EU) 2023/951 of 12 May 2023 amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food protein extract from pig kidneys (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/951
• Articles: 3

Article 1

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

ANNEX

In Table 2 (Specifications) of the Annex to Implementing Regulation (EU) 2017/2470, the entry for ‘Protein extract from pig kidneys’ is replaced by the following:

Authorised Novel Food

Specification

‘ Protein extract from pig kidneys

Description/Definition:

The protein extract is obtained from homogenised pig kidneys through a combination of salt precipitation and high speed centrifugation. The obtained precipitate contains essentially proteins with 7 % of the enzyme diamine oxidase (enzyme nomenclature E.C. 1.4.3.22) and is resuspended in a physiologic buffer system. The obtained pig kidney extract is formulated as encapsulated enteric coated pellets or enteric coated tablets to reach the active sites of digestion.

Basic Product:

Specification: pig kidney protein extract with natural content of Diamine oxidase (DAO):

Physical condition: liquid

Colour: brownish

Appearance: slightly turbid solution

pH value: 6,4–6,8

Enzymatic activity: > 2 677 kHDU DAO/ml (DAO REA (DAO Radioextractionassay))

Microbiological criteria:

Brachyspira spp.: negative (Real Time PCR)

Listeria monocytogenes: negative (Real Time PCR)

Staphylococcus aureus: < 100 CFU/g

Influenza A: negative (Reverse Transcription Real Time PCR)

Escherichia coli: < 10 CFU/g

Total aerobic microbiological count: < 10 5 CFU/g

Yeasts/moulds count: < 10 5 CFU/g

Salmonella: Absence/10g

Bile salt resistant enterobacteriaceae: < 10 4 CFU/g

Final product:

Specification pig kidney protein extract with natural content of DAO (E.C. 1.4.3.22) in an enteric coated formulation:

Physical condition: solid

Colour: yellow grey

Appearance: micropellets or tablets

Enzymatic activity: 110-220 kHDU DAO/g pellet or g tablet (DAO REA (DAO Radio Extraction Assay))

Acid stability 15 min 0,1M HCl followed by 60 min Borat pH = 9,0: > 68 kHDU DAO/g pellet or g tablet (DAO REA (DAO Radio Extraction Assay))

Humidity: < 10 %

Microbiological criteria:

Staphylococcus aureus : < 100 CFU/g

Escherichia coli : < 10 CFU/g

Total aerobic microbiological count: < 10 4 CFU/g

Total combined yeasts/moulds count: < 10 3 CFU/g

Salmonella : Absence/10g

Bile salt resistant enterobacteriaceae: < 10 2 CFU/g

PCR: Polymerase Chain Reaction; HDU (Histamine Degrading Units);

Description/Definition:

The protein extract is obtained from homogenised pig kidneys through a series of steps involving a number of acetone washes to defat and dehydrate the homogenized pig kidneys, followed by draining, drying, milling, and sieving to produce a powder containing essentially proteins with a 7-9 % (on average) content of the enzyme diamine oxidase (enzyme nomenclature E.C. 1.4.3.22). The pig kidney extract powder is formulated either in enteric coated capsules or as encapsulated enteric coated pellets or enteric coated tablets to reach the active sites of digestion.

Basic Product:

Specification: pig kidney protein extract with natural content of Diamine oxidase (DAO):

Physical condition: powder

Colour: pale brown

Enzymatic activity: ≥ 0,10 mU/mg (UHPLC-FLD (Ultra High Performance Liquid Chromatography linked with Fluorescent Detection)).

Humidity: < 10 %

Residual Solvents:

Acetone: < 5 000  mg/kg

Microbiological criteria:

Staphylococcus aureus : < 100 CFU/g

Escherichia coli : < 10 CFU/g

Total aerobic microbiological count: < 10 4 CFU/g

Total combined yeasts/moulds count: < 10 3 CFU/g

Salmonella : Absence/10g

Bile salt resistant enterobacteriaceae: < 10 2 CFU/g

Listeria monocytogenes : absence in 25 g

Final product:

Specification pig kidney protein extract with natural content of DAO (E.C. 1.4.3.22) in an enteric coated formulation:

Physical condition: solid

Colour: pale brown

Appearance: micropellets, capsules, or tablets

Enzymatic activity (micropellets, capsules or tablets): 2,29 – 4,6 mU/g pellet or g tablet or g capsule (UHPLC-FLD (Ultra High Performance Liquid Chromatography linked with Fluorescent Detection)).

Acid stability 15 min 0,1M HCl followed by 60 min Borat pH = 9,0: > 1,4 mU DAO/g pellet or g tablet or g capsule (UHPLC-FLD (Ultra High Performance Liquid Chromatography linked with Fluorescent Detection))

Humidity: < 10 %

Microbiological criteria:

Staphylococcus aureus : < 100 CFU/g

Escherichia coli : < 10 CFU/g

Total aerobic microbiological count: < 10 4 CFU/g

Total combined yeasts/moulds count: < 10 3 CFU/g

Salmonella : Absence/10g

Bile salt resistant enterobacteriaceae: < 10 2 CFU/g

Listeria monocytogenes : absence in 25 g

mU: milliUnit (expressed in mU/mg) measures nanomols (nmol) of histamine degraded by the DAO per minute using Ultra High Performance Liquid Chromatography linked with Fluorescent Detection (UHPLC-FLD) (O. Comas-Basté et al. Analytical and Bioanalytical Chemistry 411:7595-7602 (2019)). 1 mU corresponds to 48 000 HDU of the DAO Radio Extraction Assay (REA) method.’