This is an application for the change in the conditions of use of the currently authorised novel food ‘pig kidney protein extract which contains 7% of the diamine oxidase (DAO) enzyme. The proposed change in the conditions of use concerns the use of pellets, in addition to the currently authorised encapsulated pellets with enteric coating, as a form of the novel food. The protein extract is manufactured according to the authorised specifications for this novel food included in the Union list of novel foods and is obtained from homogenized pig kidneys through a combination of salt precipitation and high-speed centrifugation. The obtained precipitate containing essentially proteins, of which 7% is the enzyme DAO, is re-suspended in a physiologic buffer system. The pig kidney extract obtained is formulated as encapsulated granules or pellets with enteric coating, according to the applicant DR Healthcare España, S.L.
Cf. 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.
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