Cetylated fatty acids: authorised novel food in the EU

Conditions of use and maximum levels

Table 1, column "Conditions under which the novel food may be used", as written:

• Food supplements as defined in Directive 2002/46/EC for the adult population: 1,6 g/day

Additional specific labelling requirements

1. The designation of the novel food on the labelling of the food supplements containing it shall be ‘cetylated fatty acids preparation’. 2. The labelling of food supplements containing the novel food shall bear a statement that those food supplements should not be consumed by persons under 18 years of age.

Specification (Table 2)

Table 2 of the Annex, row with the same name, as written:

Description/Definition:

The novel food concerns primarily a mixture of cetylated myristic acid and cetylated oleic acid synthesised from cetyl alcohol, myristic acid and oleic acid, and to a lesser degree, other cetylated fatty acids and other compounds from olive oil.

Characteristics/composition:

Ester content: 70-80 %, of which: Cetyl oleate: 22-30 %, Cetyl myristate: 41-56 %

Triglycerides: 22-25 %

Acid value (mg KOH/g): ≤ 5

Saponification value (mg KOH/g): 130-150

Microbiological criteria:

Total aerobic microbial count: ≤ 1 000 CFU/g

Yeasts and moulds: ≤ 100 CFU/g

KOH: potassium hydroxide

CFU: colony forming units

Source and version

Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods, Table 1. Consolidated text of 10 August 2026. The text above is copied from that document without change except that amendment markers are removed. It is not advice and it does not decide whether a particular product is covered.

• Consolidated text on EUR-Lex

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