Epigallocatechin gallate as a purified extract from green tea leaves (Camellia sinensis): 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:

• Foods including food supplements as defined in Directive 2002/46/EC: 150 mg of extract in one portion of food or food supplement

Additional specific labelling requirements

The labelling shall bear a statement that consumers should not consume more than 300 mg of extract per day

Specification (Table 2)

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

Description/Definition:

A highly purified extract from the leaves of green tea (Camellia sinensis (L.) Kuntze) in the form of a fine, off-white to pale pink powder. It is composed of a minimum of 90 % epigallo-catechin gallate (EGCG), and has a melting point between approx. 210 and 215 °C

Appearance: off-white to pale pink powder

Chemical name: polyphenol (-) epigallocatechin-3-gallate

Synonyms: epigallocatechin gallate (EGCG)

CAS No.: 989-51-5

INCI name: epigallocatechin gallate

Molecular mass: 458,4 g/mol

Loss on drying: max 5,0 %

Heavy metals:

Arsenic: max 3,0 ppm

Lead: max 5,0 ppm

Assay:

Min. 94 % EGCG (on dry material)

max. 0,1 % caffeine

Solubility: EGCG is fairly soluble in water, ethanol, methanol and acetone

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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