Commission Implementing Regulation (EU) 2018/1123 of 10 August 2018 authorising the placing on the market of 1-methylnicotinamide chloride 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.)

1 1-methylnicotinamide chloride 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: Pharmena SA Address: ul. Wolczanska 178, 90 530 Lodz, Poland 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 of this Regulation or with the agreement of Pharmena SA.

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.

4 The authorisation provided for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC.

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 proprietary and without which the data protection could not have been authorised, 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 Pharmena SA.

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

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