Article 1
Open ↗The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Source
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)
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)
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 ↗
Article 2
Open ↗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
Open ↗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.’
Other acts of the same type
Commission Implementing Regulation (EU) 2017/2468 of 20 December 2017 laying down administrative and scientific requirements concerning traditional foods from third countries in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (Text with EEA relevance. )Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (Text with EEA relevance. )Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (Text with EEA relevance. )Commission Delegated Regulation (EU) 2018/236 of 20 December 2017 correcting the Estonian language version of Delegated Regulation (EU) 2017/654 supplementing Regulation (EU) 2016/1628 of the European Parliament and of the Council with regard to technical and general requirements relating to emission limits and type-approval for internal combustion engines for non-road mobile machineryCommission Delegated Regulation (EU) 2018/541 of 20 December 2017 amending Delegated Regulation (EU) 2017/2358 and Delegated Regulation (EU) 2017/2359 as regards their dates of application (Text with EEA relevance. )Commission Implementing Regulation (EU) 2017/2384 of 19 December 2017 specifying the technical characteristics of the 2019 ad hoc module on work organisation and working time arrangements as regards the labour force sample survey pursuant to Council Regulation (EC) No 577/98 (Text with EEA relevance. )Commission Implementing Regulation (EU) 2017/2418 of 19 December 2017 approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications (‘Nürnberger Bratwürste’/‘Nürnberger Rostbratwürste’ (PGI))Commission Implementing Regulation (EU) 2017/2446 of 19 December 2017 amending Implementing Regulation (EU) 2016/1368 establishing a list of critical benchmarks used in financial markets pursuant to Regulation (EU) 2016/1011 of the European Parliament and of the Council (Text with EEA relevance. )Commission Delegated Regulation (EU) 2017/2364 of 18 December 2017 amending Directive 2014/25/EU of the European Parliament and of the Council in respect of the application thresholds for the procedures for the award of contracts (Text with EEA relevance. )Commission Delegated Regulation (EU) 2017/2365 of 18 December 2017 amending Directive 2014/24/EU of the European Parliament and of the Council in respect of the application thresholds for the procedures for the award of contracts (Text with EEA relevance. )Commission Delegated Regulation (EU) 2017/2366 of 18 December 2017 amending Directive 2014/23/EU of the European Parliament and of the Council in respect of the application thresholds for the procedures for the award of contracts (Text with EEA relevance. )Commission Regulation (EU) 2017/2367 of 18 December 2017 amending Directive 2009/81/EC of the European Parliament and of the Council in respect of the application thresholds for the procedures for the award of contracts (Text with EEA relevance. )
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
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