Commission Implementing Regulation (EU) 2018/1632 of 30 October 2018 authorising the placing on the market of bovine milk basic whey protein isolate 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 Bovine milk basic whey protein isolate 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: Armor Protéines S.A.S. Address: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France; 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 Armor Protéines S.A.S.

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 to this Regulation.

4 The authorisation provided for in this Article shall be without prejudice to the provisions of Regulation (EU) No 1169/2011, to the provisions of Directive 2002/46/EC, and to the provisions of Regulation (EU) No 609/2013.

The study 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 Armor Protéines S.A.S.

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.