New regulation on green tea extracts containing EGCG

A new European Union regulation limits the amount of green tea extract containing epigallocatechin gallate (EGCG) that can be present in food and sets new labeling requirements. 

Underlying this decision are health concerns related to EGCG, a catechin responsible for potential liver damage. Continue reading to find out the consequences of the regulation that went into effect on December 22, 2022, and the measures we are implementing for our green tea extracts. 

Green tea and safety: the liver risks associated with EGCG

Catechins are substances naturally found in the leaves of Camellia sinensis (L.) Kuntze, the tea plant, but they are also present in cocoa and red wine. Green tea is obtained by simple drying of the leaves, which do not have to undergo oxidative processes or fermentation (like black tea), hence why this type of tea is particularly rich in catechins. The most abundant of these catechins is epigallocatechin gallate (EGCG), which has been under observation by EFSA for several years. 

As early as 2018, the European Food Safety Authority reported that consumption of EGCG equal to or greater than 800 milligrams per day (mg/day) may increase the risk of liver damage when taken as a dietary supplement (EFSA ANS Panel. Scientific Opinion on the safety of green tea catechins. EFSA Journal 2018;16(4):5239 https://doi.org/10.2903/j.efsa.2018.5239). 

Indeed, the analyzed studies revealed a significant increase in serum transaminases, an indicator of liver injury, in subjects who had taken EGCG supplements in dosages of 800 mg/day or more. 

This would appear to contradict traditional uses of green tea, which has always been associated with health benefits. According to legend, the first green tea drinker was the Chinese emperor Shen Nung, and to this day this beverage enjoys wide popularity in Asian countries, marking the rhythms of the day. 

Green tea extract promotes diuresis, weight balance, and normal bowel function. It is also known for its tonic properties, against physical and mental fatigue, and antioxidant properties. For external use, green tea extract is highly valued in cosmetics for its astringent, emollient, and humectant properties, as well as a skin conditioner, tonic, and UV filter. 

Despite these recognized benefits, reports of possible harmful effects related to catechins and EGCG in particular have also surfaced in recent years. Several cases of liver damage associated with the use of green tea products have been reported in Nordic countries, leading EFSA to assess the safety of this extract. 

After its evaluations, EFSA concluded that catechins in green tea infusions and beverages are generally risk-free, although rare cases of idiosyncratic reactions have also been reported for infusions, in contrast to dietary supplements containing EGCG for doses of 800 mg/day or more, which may pose a health risk. According to EFSA, dietary supplements containing green tea catechins provide a daily dose of EGCG of between 5 and 1,000 mg per day.

The new regulation for dietary supplements containing EGCG

Based on EFSA’s opinion, the European Commission has amended Annex III of Regulation (EC) No. 1925/2006 to set limits for EGCG content. The new regulation establishes that a daily portion of food shall contain less than 800 mg of (-)-epigallocatechin-3-gallateintake (EGCG) from green tea extracts.

According to the regulation, labels should indicate not to exceed the total daily amount of 800 mg, with warnings for children and adolescents under 18 years of age and pregnant or lactating women. Finally, the label should discourage people from consuming other products containing green tea on the same day, as well as on an empty stomach.

However, there is a six-month transition period for manufacturers: foodstuffs that do not comply with the new requirements but were legally placed on the market before the regulation came into force can remain on the market until June 21, 2023.

The new regulation also inserted green tea extracts containing EGCG among the substances under surveillance by the European Union (i.e., in Part C of Annex III of Reg. (EC) No. 1925/2006). This means that affected companies will have 24 months from December 22, 2022, to provide data supporting the safety of such preparations.

What changes for green tea infusions

No concerns, however, with respect to infusions. EFSA experts concluded that green tea infusions, instant beverages, and ready-to-drink green tea beverages are reasonably safe. 

Among the adult population in the European Union, the average daily intake of EGCG from the consumption of green tea infusions ranges from 90 to 300 milligrams per day, which is generally lower than the intake from food supplements. In addition, traditional infusions and drinks are usually consumed together with other foods and in a fractionated manner throughout the day.

Therefore, the regulations do not apply to aqueous green tea extracts containing EGCG which after reconstitution in beverages have a composition comparable to traditional green tea infusions.

EPO actions in light of the EU regulation

Following the new regulation, we are taking all necessary measures to monitor EGCG in our green tea extracts. For dry extracts of green tea produced entirely by EPO (CODE 3131105), since they are aqueous extracts, their exclusion from the new regulation must be evaluated according to their intended use. EPO has revised the technical specifications with the inclusion of ECGC maximum limits (based on historical data), to support our customers in the correct application of the new rules, according to the dosage and the percentage of the extract in the final formulation.

For selected extracts (CODE 3531195 and 3131150), EPO issues a statement in which the % range related to EGCG is given. The information is based on data obtained from our suppliers. 

We are also available to implement monitoring of additional codes and support our clients in cases of doubt or more information about the new regulation (qualityassurance@eposrl.com). 

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