Maize-germ oil high in unsaponifiable matter: 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: 2 g/day
• Chewing gum: 2 %

Additional specific labelling requirements

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Maize-germ oil extract’

Specification (Table 2)

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

Description/Definition:

Maize-germ oil high in unsaponifiable matter is produced by vacuum distillation and it is different from refined maize-germ oil in the concentration of the unsaponifiable fraction (1,2 g in refined maize-germ oil and 10 g in ‘maize-germ oil high in unsaponifiable matter’).

Purity:

Unsaponifiable matter: > 9,0 g/100 g

Tocopherols: ≥ 1,3 g/100 g

α-tocopherol (%): 10-25 %

β-tocopherol (%): < 3,0 %

γ-tocopherol (%): 68-89 %

δ-tocopherol (%): < 7,0 %

Sterols, triterpenic alcohols, methylsterols: > 6,5 g/100 g

Fatty acids in triglycerides:

palmitic acid: 10,0-20,0 %

stearic acid: < 3,3 %

oleic acid: 20,0-42,2 %

linoleic acid: 34,0-65,6 %

linolenic acid: < 2,0 %

Acid value: ≤ 6,0 mg KOH/g

Peroxide value (PV): ≤ 10 mEq O2/kg

Heavy metals:

Iron (Fe): < 1 500 μg/kg

Copper (Cu): < 100 μg/kg

Impurities:

Polycyclic aromatic hydrocarbons (PAH) Benzo(a)pyrene: < 2 μg/kg

Treatment with active carbon is required to ensure that polycyclic aromatic hydrocarbons (PAH) are not enriched in the production of ‘maize-germ oil high in unsaponifiable matter’

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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