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Regulation 6
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.” |
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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.
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