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Commission Implementing Regulation (EU) 2019/506 of 26 March 2019 authorising the placing on the market of D-ribose as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance.)

CELEX
32019R0506
Document type
REG_IMPL
Sector
Legislation
Date of document
2019-03-26
In force since
2019-04-16
Status
In force

Text

Article-level text, parsed from the formex manifestation.

Article 1

1 D-ribose as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.

2 For a period of five years from the date of entry into force of this Regulation only the initial Applicant: Company: Bioenergy Life Science, Inc. Address: 13840 Johnson St. NE, Minneapolis, Minnesota, 55304, USA; is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for the same novel food without reference to the data protected pursuant to Article 2 of this Regulation or with the agreement of Bioenergy Life Science, Inc.

3 The entry in the Union list referred to in the first paragraph shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.

Article 2

The studies contained in the application file on the basis of which the novel food referred to in Article 1 has been assessed by the Authority, claimed by the applicant as fulfilling the requirements 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 Bioenergy Life Science, Inc.

Article 3

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

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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