
Article 1 

1. The entry in the Union list of authorised novel foods as provided for in Article 8 of Regulation (EU) 2015/2283 referring to the ‘protein extract from pig kidneys’ shall be amended as specified in the Annex to this Regulation.
2. The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in 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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 6 July 2020.
For the Commission
The President
Ursula VON DER LEYEN
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:
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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 3 capsules or 3 tablets/day; equalising 12,6 mg pig kidney extract a day Diamine oxidase (DAO) content: 0,9 mg/day (3 capsules or 3 tablets with a content of DAO of 0,3 mg/capsule or 0,3 mg/tablet)’
Food for special medical purposes as defined in Regulation (EU) No 609/2013'
((2)) in Table 2 (Specifications), the entry for ‘Protein extract from pig kidneys’ is replaced by the following:
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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 excerpt with natural content of Diamine oxidase (DAO):Physical condition: liquidColour: brownishAppearance: slightly turbid solutionpH value: 6,4–6,8Enzymatic 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/gInfluenza A: negative (Reverse Transcription Real Time PCR)Escherichia coli: < 10 CFU/gTotal aerobic microbiological count: < 105 CFU/gYeasts/moulds count: < 105 CFU/gSalmonella: Absence/10gBile salt resistant enterobacteriaceae: < 104 CFU/gFinal product:Specification pig kidney protein excerpt with natural content of DAO (E.C. 1.4.3.22) in an enteric coated formulation:Physical condition: solidColour: yellow greyAppearance: micropellets or tabletsEnzymatic activity: 110-220 kHDU DAO/g pellet or g tablet (DAO REA (DAO Radioextractionassay))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 Radioextractionassay))Humidity: < 10 %Staphylococcus aureus: < 100 CFU/gEscherichia coli: < 10 CFU/gTotal aerobic microbiological count: < 104 CFU/gTotal combined yeasts/moulds count: < 103 CFU/gSalmonella: Absence/10gBile salt resistant enterobacteriaceae: < 102 CFU/g’'
