Amendment to specifications for the novel food protein extract from pig kidneys
European Union
Jul 31, 2024
With implementing Regulation (EU) 2024/2048 of 29 July 2024, the Commission amended Implementing Regulation (EU) 2017/2470 as regards the specifications and the conditions of use of the novel food protein extract from pig kidneys.
Evidence provided by the applicant and by previous applicants in support of the previous amendments in the specifications and conditions of use of the novel food indicates that the form of the novel food has no impact on its safety, provided that the maximum authorised levels of 12,6 mg pig kidney extract per day resulting in a maximum intake of 0,9 mg DAO per day and delivered in 3 doses with each dose containing a maximum of 0,3 mg of DAO are not exceeded in any of those forms.
The information provided in the application and the available scientific evidence underpinning the authorisation of this novel food and previous authorisations of changes in the specifications to authorise the different forms of the novel food (enteric coated pellets, enteric coated capsules, and enteric coated tablets), gives sufficient grounds to establish that the above-described changes to the specifications and the conditions of use of the novel food protein extract from pig kidneys are in accordance with the conditions laid down in Article 12 of Regulation (EU) 2015/2283 and should be approved.
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