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Commission Implementing Regulation (EU) 2023/859 of 25 April 2023 amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food 2’-Fucosyllactose (microbial source) to authorise its production by a derivative strain of Corynebacterium glutamicum ATCC 13032 (Text with EEA relevance)

CELEX
32023R0859
Document type
REG_IMPL
Sector
Legislation
Date of document
2023-04-25
In force since
2023-05-16
Status
In force

Text

Article-level text, parsed from the formex manifestation.

Article 1

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 2

Only the company ‘Advanced Protein Technologies Corporation’ is authorised to place on the market within the Union the novel food 2′-Fucosyllactose (microbial source) produced with a derivative strain of Corynebacterium glutamicum ATCC 13032, for a period of five years from 16 May 2023, unless a subsequent applicant obtains an authorisation for that novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of ‘Advanced Protein Technologies Corporation’.

Article 3

The scientific data contained in the application file and fulfilling the conditions laid down in Article 26(2) of Regulation (EU) 2015/2283 shall not be used for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of ‘Advanced Protein Technologies Corporation’.

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

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