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Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (Text with EEA relevance)
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1.On request by the applicant, and where supported by appropriate and verifiable information included in the application provided for in Article 10(1), newly developed scientific evidence or scientific data supporting the application shall not be used for the benefit of a subsequent application during a period of five years from the date of the authorisation of the novel food without the agreement of the initial applicant.
2.The data protection shall be granted by the [F1appropriate authority] under Article 27(1) where the following conditions are met:
(a)the newly developed scientific evidence or scientific data was designated as proprietary by the initial applicant at the time the first application was made;
(b)the initial applicant had exclusive right of reference to the proprietary scientific evidence or scientific data at the time the first application was made; and
(c)the novel food could not have been assessed by the Authority and authorised without the submission of the proprietary scientific evidence or scientific data by the initial applicant.
However, the initial applicant may agree with a subsequent applicant that such scientific evidence and scientific data may be used.
3.Paragraphs 1 and 2 shall not apply to notifications and applications concerning the placing on the market within [F2Great Britain] of traditional foods from third countries.
Textual Amendments
F1Words in Art. 26(2) substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 32(a); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in Art. 26(3) substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 32(b) (as substituted by S.I. 2020/1504, regs. 1(2), 15(9)); 2020 c. 1, Sch. 5 para. 1(1)
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