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)

• CELEX: Implementing Regulation (EU) 2020/973
• Articles: 3

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 .

Schedules & Appendices

ANNEX

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

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

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(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 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: < 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 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: < 10 4 CFU/g

Total combined yeasts/moulds count: < 10 3 CFU/g

Salmonella : Absence/10g

Bile salt resistant enterobacteriaceae: < 10 2 CFU/g’

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