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.