Commission Implementing Regulation (EU) 2021/2079 of 26 November 2021 authorising the placing on the market of vitamin D2 mushroom powder 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)
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Article 1
1 The vitamin D2 mushroom powder as specified in the Annex shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.
2 For a period of 5 years from 19 December 2021 only the initial applicant: Company: MBio, Monaghan Mushrooms, Address: Tullygony, Tyholland, Co. Monaghan, Ireland, 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 novel food without reference to the data protected pursuant to Article 2 or with the agreement of MBio, Monaghan Mushrooms.
3 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.
Article 2
The data contained in the application file on the basis of which the novel food referred to in Article 1 have been assessed by the Authority, claimed by the applicant as proprietary and without which the novel food could not have been authorised, shall not be used for the benefit of a subsequent applicant for a period of 5 years from 19 December 2021 without the agreement of MBio, Monaghan Mushrooms.
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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