ATODLEN 5Diwygio’r rhestr o fwydydd newydd yn yr Atodiad i Reoliad Gweithredu’r Comisiwn (EU) 2017/2470 ar gyfer awdurdodi asidau brasterog wedi eu setyleiddio fel bwyd newydd

2

Yn Nhabl 1 (bwydydd newydd awdurdodedig), ar ôl y cofnod ar gyfer “Calanus finmarchicus oil” mewnosoder y cofnod a ganlyn—

Cetylated fatty acids

Specified food category

Food supplements as defined in the Food Supplements (Wales) Regulations 200312 for persons aged 18 years or above

Maximum levels

2.1 g/day

The designation of the novel food on the labelling of food containing it is “cetylated fatty acids preparation”.

The labelling of food supplements must bear a statement that they should not be consumed by persons under 18 years of age.

Included in the list on 28 June 2024.

This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Pharmanutra S.p.A, Via Delle Lenze 216/b, 56122 Pisa, Italy.

During the period of data protection, cetylated fatty acids is authorised for placing on the market, within Wales, only by Pharmanutra S.p.A 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 of Regulation (EU) 2015/2283 or with the agreement of Pharmanutra S.p.A.

The data protection will expire at the end of 27 June 2029.