COMMISSION IMPLEMENTING REGUL ATION (EU) 2023/951 
of 12 May 2023
amending Implementing Regulation (EU) 2017/2470 as regards the specif ications of the novel food 
protein extract from pig kidne ys 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng regar d to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on 
novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing 
Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) 
No 1852/2001 (1), and in particular Article 12 thereof,
Whereas:
(1) Regulation (EU) 2015/2283 provides that only novel foods author ised and included in the Union list of novel foods 
may be placed on the mark et within the Union.
(2) Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Imple menting Regulation (EU) 2017/2470 (2)has 
established a Union list of novel foods.
(3) The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 includes prot ein extract from pig 
kidne ys as an author ised novel food.
(4) Pursuant to Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council (3), on 
29 Febr uary 2012 , the compan y Sciot ec Diagnostic Techn ologies, GmbH notified the Commission of its intention 
to place on the mark et prote in extract from pig kidneys as a novel food ingredient to be used in foods for special 
medical purposes as defined in Article 2 of Regulation (EU) No 609/2013 of the European Parliament and of the 
Council (4), and in food supplements as defined in Article 2 of Directive 2002/46/EC of the European Parliament 
and of the Council (5). On the basis of that notification, the prot ein extract from pig kidne ys was included in the 
Union list of novel foods, when that list was established.
(5) Commission Implementing Regulation (EU) 2020/973 (6)amended the specifi cations of the novel food protein 
extract from pig kidneys to include enteric coated tablets as an allowed form of prote in extract from pig kidne ys to 
be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council and 
in foods for special medical purposes as defined in Regulation (EU) No 609/2013, in addition to the author ised 
enteric coated encapsulated pellets.
(1)OJ L 327, 11.12.2015, p. 1.
(2)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 (OJ L 351, 30.12.2017, p. 72).
(3)Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 Januar y 1997 concer ning novel foods and novel 
foods ingredients (OJ L 43, 14.2.1997, p. 1).
(4)Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young 
children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, 
Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament 
and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).
(5)Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the appro ximation of the laws of the 
Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).
(6)Commission Implementing Regulation (EU) 2020/973 of 6 July 2020 author ising a chang e of the conditions of use of the novel food 
‘prot ein extract from pig kidneys’ and amending Implementing Regulation (EU) 2017/2470 (OJ L 215, 7.7.2020, p. 7).EN Offi cial Jour nal of the European Union 15.5.2023 L 128/73  (6) On 11 July 2022 , the compan y Bioiber ica, S.A.U (‘the applicant’) submitted an application to the Commission in 
accordance with Article 10(1) of Regulation (EU) 2015/2283 for a chang e of the specifications of the novel food 
prote in extract from pig kidneys to include a production process involving the use of a series of aceton e wash steps 
of the pig kidne ys, followed by heat-dr ying steps, milling and sieving, to result in a pale brown powder final form of 
the novel food whic h is formulated either in enteric coated capsules or as encapsulated enteric coated pellets or 
enteric coated tablets to reach the active sites of digestion. The applicant also requested the use of Ultra High 
Performan ce Liquid Chromat ography linked with Fluorescent Detection (‘UHPLC-FLD’) as an additional method to 
the currently author ised one for the determination of the enzymatic activity of Diamine Oxidase (‘DAO’) contained 
in the prot ein extract ed from the pig kidneys. This method results in the activity of DAO being expressed in 
measurement units (‘MU’) that are different from the currently author ised ones. The applicant justif ied their request 
for the addition of a new production process on the fact that their production process besides being robust and 
consistent in producing the novel food in line with the author ised specifications, it is not protect ed by third party 
patents as the currently author ised novel food production process is thereby preventing the applicant and other 
food business operators from making use of it. The applicant justif ied their request for the use UHPL C-FLD method 
to measure the DAO activity as being a well-known method that is easy to validate and imple ment while being 
equally reliable to the currently author ised Radio Extraction Assa y (‘REA ’) method.
(7) The Commission considers that the requeste d updat e of the Union list is not liable to have an effect on human 
health, and that a safet y evaluation by the European Food Safet y Author ity (‘the Author ity’) in accordance with 
Article 10(3) of Regulation (EU) 2015/2283 is not necessar y. The production process using the aceton e wash 
method followe d by heat-dr ying steps, milling and sieving results in the production of a novel food that compl ies 
with all the author ised specifications and only differs in its form (powder) and colour (pale brown ). The chang es in 
the physical form and appearance of the novel food obtained by the acet one wash method are not expected to 
imp act the safety of the novel food if the author ised conditions of use and specif ications are respected. The use of 
capsules is currently author ised for the enteri c coated pellet form of the novel food and their use for the powder 
form of the novel food is also not liable to change the safety prof ile of this author ised novel food.
(8) Aceton e as a solvent used in the preparation of foods is author ised by Directive 2009/32/EC of the European 
Parliament and of the Council (7), and levels up to 5 000 mg/kg of acet one have been assessed by the Author ity in 
the context of the safety assessment of the application for the author isation of nicotinamide riboside chlor ide as a 
novel food (8)that involved identical proposed uses and resulting anticipate d intake s to the uses and intak es of the 
prote in extract from pig kidne ys. The Commission however considers that, as an additional safety reassurance 
element, acetone should be added as a parameter in the specifications of the protein extract from pig kidne ys 
produced by the acetone wash production process, at the same levels (≤ 5 000 mg/kg) that have been assessed by 
the Authority and are included in the specifi cations of the novel food nicotinamide riboside chlor ide author ised by 
Commission Implementing Regulation (EU) 2020/16 (9).
(9) The Commission also considers that the inclusion in the Union list of the UHPL C-FLD method for the deter mination 
of the enzymatic activity of DAO, and the expression of its resulting activity in differ ent measurement units in 
addition to the currently author ised method and measurement units, will offer food business operators and Member 
State enforcement author ities another method to verify the performa nce and quality of the novel food placed on the 
mark et.
(7)Directive 2009/32/EC of the European Parliament and of the Council of 23 Apr il 2009 on the appro ximation of the laws of the 
Member States on extraction solvents used in the production of foodstuffs and food ingredients (OJ L 141, 6.6.2009, p. 3).
(8)EFSA Jour nal 2019; 17(8):5775.
(9)Commission Implementing Regulation (EU) 2020/16 of 10 Januar y 2020 author ising the placing on the market of nicotinamide 
riboside chlor ide as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending 
Commission Implementing Regulation (EU) 2017/2470 (OJ L 7, 13.1.2020, p. 6).EN Offi cial Jour nal of the European Union L 128/74 15.5.2023  (10) The information provided in the application gives suffi cient grounds to establish that the changes to the 
specifi cations of the novel food prote in extract from pig kidneys are in accordance with the conditions of Article 12 
of Regulation (EU) 2015/2283 and should be approved.
(11) The Annex to Implementing Regulation (EU) 2017/2470 should theref ore be amended according ly.
(12) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGUL ATION:
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 followi ng that of its publication in the Official Journal of the 
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 12 May 2023 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 15.5.2023 L 128/75  ANNEX 
In Table 2 (Specifications) of the Annex to Implementing Regulation (EU) 2017/2470, the entr y for ‘Prot ein extract from pig kidneys’ is replaced by the followi ng:
Authorised Novel Food Specification
‘Protein extract from pig kidne ys Descr iption/Def inition:
The protein extract is obtained from homogenised pig kidne ys 
through a combination of salt precipitation and high speed 
centr ifugation. The obtained precipitate contains essentially protein s 
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 kidne y extract is formulated as encapsulate d enteric 
coated pellets or enteric coated tablets to reac h the active sites of 
diges tion.
Basic Product :
Specifi cation: 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 
Radioextractionassa y))
Microbiological criter ia:
Brach yspira spp.: negative (Real Time PCR)
Lister ia monocytog enes: negative (Real Time PCR)
Staph ylococcus aureus: < 100 CFU/gDescr iption/Def inition:
The protein extract is obtained from homog enised pig kidneys 
through a series of steps involving a number of acet one washes to 
defat and dehydrate the homogenized pig kidne ys, followed by 
draining, drying, milling, and sieving to produce a powder 
containing essentially protein s with a 7-9 % (on averag e) conte nt 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 enteri c coated 
tablets to reac h the active sites of diges tion.
Basic Product :
Specifi cation: pig kidne y prote in extract with natural content of 
Diamine oxidase (DAO):
Physical condition: powder
Colour: pale brown
Enzymatic activity: ≥ 0,10 mU/mg (UHPLC-FLD (Ultra High 
Performan ce Liquid Chromatograph y linked with Fluorescent 
Detection)).
Humidity: < 10 %
Residual Solv ents:
Aceton e: < 5 000 mg/kg
Microbiological criter ia:
Staphylococc us aureus: < 100 CFU/gEN Offi cial Jour nal of the European Union L 128/76 15.5.2023  Influenza A: negative (Reverse Transcr iption Real Time PCR)
Escherichia coli: < 10 CFU/g
Total aerobic microbiological count : < 105 CFU/g
Yeasts/moulds count: < 105 CFU/g
Salmonella: Absence/10g
Bile salt resistant enterobact eriaceae: < 104 CFU/g
Final product :
Specifi cation pig kidne y protein extract with natural cont ent of DAO 
(E.C. 1.4.3.22) in an enteric coate d formulation:
Physical condition: solid
Colour: yello w grey
Appearance: micropellets or tablets
Enzymatic activity: 110-220 kHDU DAO/g pellet or g tablet (DAO 
REA (DAO Radio Extraction Assa y))
Acid stability 15 min 0,1M HCl follo wed by 60 min Borat pH = 9,0: 
> 68 kHDU DAO/g pellet or g tablet (DAO REA (DAO Radio 
Extraction Assa y))
Humidity: < 10 %
Microbiological criter ia:
Staphylococc us aureus: < 100 CFU/g
Escher ichia coli: < 10 CFU/gEscher ichia coli: < 10 CFU/g
Total aerobic microbiological count : < 104 CFU/g
Total combined yeasts/moulds count: < 103 CFU/g
Salmonella: Absence/10g
Bile salt resistant enterobact eriaceae: < 102 CFU/g
Lister ia monocytogenes: absence in 25 g
Final product :
Specifi cation pig kidne y prote in extract with natural cont ent of DAO 
(E.C. 1.4.3.22) in an enteric coate d 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-FL D (Ultra High Performance 
Liquid Chromatograph y linked with Fluorescent Detection)).
Acid stability 15 min 0,1M HCl follo wed 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 Chromatograph y linked with Fluorescent 
Detection))
Humidity: < 10 %
Microbiological criter ia:
Staphylococc us aureus: < 100 CFU/gEN Offi cial Jour nal of the European Union 15.5.2023 L 128/77  Total aerobic microbiological count : < 104 CFU/g
Total combined yeasts/moulds count: < 103 CFU/g
Salmonella: Absence/10g
Bile salt resistant enterobact eriaceae: < 102 CFU/g
PCR: Polymerase Chain Reaction; HDU (Histamine Degrading Units);Escher ichia coli: < 10 CFU/g
Total aerobic microbiological count : < 104 CFU/g
Total combined yeasts/moulds count: < 103 CFU/g
Salmonella: Absence/10g
Bile salt resistant enterobact eriaceae: < 102 CFU/g
Lister ia 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 
Performan ce Liquid Chromatograph y linked with Fluorescent 
Detection (UHPLC-FLD) (O. Comas-Bast é et al. Analytical and 
Bioanalytical Chemistr y 411:7595-7602 (2019)). 1 mU corresponds 
to 48 000 HDU of the DAO Radio Extraction Assa y (REA) method.’EN Offi cial Jour nal of the European Union L 128/78 15.5.2023