Regulation 33 Amendment of Regulation 2015/2283

For Article 27, substitute—

“Authorisation of a novel food and inclusion in the list based on protected proprietary scientific evidence or scientific data

1.

Where a novel food is authorised and included in the list pursuant to Articles 10 to 12 based on proprietary scientific evidence or scientific data that are granted data protection as provided for in Article 26(1), the entry of that novel food in the list must indicate, in addition to the information referred to in Article 9(3)—

(a)

the date of inclusion of the novel food in the list;

(b)

the fact that that inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26;

(c)

the name and address of the applicant;

(d)

the fact that during the period of data protection the novel food is authorised for placing on the market within the United Kingdom only by the applicant specified in point (c) of this paragraph, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 or with the agreement of the initial applicant;

(e)

the end date of the data protection provided for in Article 26.

2.

Scientific evidence or scientific data protected in accordance with Article 26 or for which the protection period under that Article has expired is not to be granted renewed protection.”.