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

Regulation 6

SCHEDULE 5 Amendments to the list of novel foods in the Annex to Commission Implementing Regulation (EU) 2017/2470 for the authorisation of cetylated fatty acids as a novel food

1.  In Commission Implementing Regulation (EU) 2017/2470, the Annex (list of novel foods) is amended as follows.

2.  In Table 1 (authorised novel foods), after the entry for “Calanus finmarchicus oil” insert the following entry—

“Cetylated fatty acids	Specified food category Food supplements as defined in the Food Supplements (Wales) 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 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.”

3.  In Table 2, (specifications), after the entry for “Calanus finmarchicus oil” insert the following entry—

“Cetylated Fatty Acids

Description/Definition The novel food is a mixture of 70 – 80% cetylated fatty acids which are produced from the reaction of cetyl alcohol with myristic acid and oleic acid. Characteristics/Composition Physical status at 25°C: Solid Colour (APHA Colour): ≤ 600 Acid value (mg KOH/g): ≤ 5 Iodine value (I2g/100g): 30 – 50 Saponification value (mg KOH/g): 130 – 150 Hydroxyl value (mg KOH/g): ≤ 20 Ester content (%): 70 – 80 Cetyl oleate (%): 22 – 30 Cetyl myristate (%): 41 – 56 Triglycerides (%): 22 – 25 Microbiological criteria Total aerobic microbial count (CFU/g): ≤ 1000 Yeasts and moulds (CFU/g): ≤ 100 APHA: American Public Health Association KOH: potassium hydroxide CFU: Colony Forming Units”.

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S.I. 2003/1719 (W. 186), to which there are amendments not relevant to these Regulations.