Commission Implementing Regulation (EU) 2024/2048 of 29 July 2024 amending Implementing Regulation (EU) 2017/2470 as regards the specifications and the conditions of use of the novel food protein extract from pig kidneys — Full Text

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 .

Supplementary provisions

ANNEXSupplementary provisions

ANNEX The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows: (1) in Table 1 (Authorised novel foods), the entry for ‘Protein extract from pig kidneys’ is replaced by the following: Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements ‘ Protein extract from pig kidneys Specified food category Maximum levels Food supplements as defined in Directive 2002/46/EC 12,6 mg protein extract from pig kidney/day containing 0,9 mg/day diamine oxidase (DAO) taken in 3 doses per day, each dose containing a maximum of 0,3 mg DAO Food for special medical purposes as defined in Regulation (EU) No 609/2013 In accordance with the particular nutritional requirements of the persons for whom the products are intended, but not higher than 12,6 mg protein extract from pig kidney/day containing 0,9 mg/day DAO’ (2) in Table 2 (Specifications), 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 protein extract from pig kidney is formulated in appropriate forms and dosage to reach the active sites of digestion. Basic product: Specification: Protein extract from pig kidney 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 Radio Extraction Assay)) 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/10 g Bile salt resistant enterobacteriaceae: < 10 4 CFU/g Final product: Specification protein extract from pig kidney with natural content of DAO (E.C. 1.4.3.22) in appropriate forms and dosage to reach the active sites of digestion: Physical condition: solid Colour: yellow grey Enzymatic activity: 110-220 kHDU DAO/g (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 (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/10 g 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 protein extract from pig kidney is formulated in appropriate forms and dosage to reach the active sites of digestion. Basic product: Specification: Protein extract from pig kidney with natural content of diamine oxidase (DAO): Physical condition: powder Colour: pale brown Enzymatic activity: ≥ 0,10 mU/mg (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/10 g Bile salt resistant enterobacteriaceae: < 10 2 CFU/g Listeria monocytogenes : absence in 25 g Final product: Specification protein extract from pig kidney with natural content of DAO (E.C. 1.4.3.22) in appropriate forms and dosage to reach the active sites of digestion: Physical condition: solid Colour: pale brown Enzymatic activity: 2,29-4,6 mU/g (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 (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/10 g 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 fetection (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.’

Article 1

Article 2

Supplementary provisions

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