Regulation 6(2)(c)
SCHEDULE 5Insertion of entry in Table 1 in the Annex to Commission Implementing Regulation (EU) 2017/2470 for Cetylated fatty acids
| “Cetylated fatty acids | Specified food category Food supplements as defined in the Food Supplements (England) Regulations 2003(1) 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 England, 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.” |
EUR 2002/178, amended by S.I. 2019/641; there are other amending instruments but none is relevant.