COMMISSION IMPLEMENTING REGULATION (EU) 2020/973
of 6 July 2020
authorising a change of the conditions of use of the novel food ‘protein extract from pig kidneys’ and amending Implementing Regulation (EU) 2017/2470
(Text with EEA relevance)
Article 1
Article 2
ANNEX
Authorised novel food |
Conditions under which the novel food may be used |
Additional specific labelling requirements |
Other requirements |
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‘Protein extract from pig kidneys |
Specified food category |
Maximum levels |
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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)’ |
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Food for special medical purposes as defined in Regulation (EU) No 609/2013 |
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: 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: < 105 CFU/g Yeasts/moulds count: < 105 CFU/g Salmonella: Absence/10g Bile salt resistant enterobacteriaceae: < 104 CFU/g Final product: Specification pig kidney protein excerpt 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 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/g Escherichia 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 enterobacteriaceae: < 102 CFU/g’ |