Commission Implementing Regulation (EU) 2023/972 of 10 May 2023 authorising the placing on the market of aqueous ethanolic extract of Labisia pumila as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

1 Aqueous ethanolic extract of Labisia pumila is authorised to be placed on the market within the Union. Aqueous ethanolic extract of Labisia pumila shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.

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

Only the company Medika Natura Sdn. Bhd. is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of five years from 6 June 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 Medika Natura Sdn. Bhd.

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 Medika Natura Sdn. Bhd.

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