The Food Additives and Novel Foods (Authorisations and Miscellaneous Amendments) and Food Flavourings (Removal of Authorisations) (England) Regulations 2024

Regulation 6(2)(c)

SCHEDULE 5 Insertion 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.”

(1)

EUR 2002/178, amended by S.I. 2019/641; there are other amending instruments but none is relevant.