Statement on the Hepatotoxicity of Green Tea Catechins

Abbreviations

COT/2024/08

Last updated: 05 December 2024

ADI

Acceptable daily intake

ALP

Alkaline phosphatase

ALT

Alanine aminotransferase

AST

Aspartate aminotransferase

AUC

Area under the curve

BMDL10

Benchmark dose lower confidence limit for 10% above background

BMDU10

Benchmark dose upper confidence limit for 10% above background

Cmax

Maximum concentration

DILI

Drug-induced liver injury

DSILI

Dietary supplement-induced liver injury

EFSA ANS

Panel on Food Additives and Nutrient Sources Added to Food

EGCG

(-)- Epigallocatechin-3-gallate

EMA

European Medicines Agency

ESCO

EFSA Scientific Cooperation

GTC

Green tea catechin

GTE

Green tea extract

HILI

Herb-induced liver injury

IARC

International Agency for Research on Cancer

IDILI

Idiosyncratic drug-induced liver injury

i.p.

intraperitoneal

LOQ

Limit of quantification

NIH

National Institutes of Health

NOAEL

No-observed-adverse-effect level

PA

Pyrrolizidine alkaloids

US FDA

United States Food and Drug Administration

USP-NF

United States Pharmacopeia National Formulary