EU: New limitation of ingredients in food supplements

In connection with Article 8(2) of Regulation (EC) no. 1925/2006, the Commission adopted Regulation no. 2022/2340, which restricts the use of EGCG, i.e. (-)-epigallocatechin-3-gallate in green tea extracts, as it represents a potential risk for consumers, which in daily doses above than 800 mg can cause a statistically significant increase of serum transaminases for in treated subjects compared to control subjects, which is indicative of liver injury.

Green tea is produced from the leaves of Camellia sinensis (L.) Kuntze, without fermentation, which results in the presence of flavanols, commonly known as catechins, the most relevant of which is (-)-epigallocatechin-3-gallate. Green tea catechins can be consumed as traditional green tea infusions, reconstituted tea drinks or as a food supplement containing concentrated green tea extracts with widely varying levels of (-)-epigallocatechin-3-gallate.

EGCG is limited to 800 mg per day, the label shall include an additional warning.

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