EU Proposes Restrictions On Green Tea Extracts In Supplements

The European Commission is planning to restrict the use of green tea extracts containing a potentially harmful catechin in supplements and other foods over fears of liver injury.

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The European Commission is seeking to restrict the use of green tea extracts in food supplements and certain beverages due to a risk of liver injury.

A scientific opinion issued by the European Food Safety Authority in 2018 concluded that catechins in green tea extracts taken as supplements were associated with significant harmful effect on health at certain levels. EFSA said evidence from clinical trials indicated that intake of doses equal to or above 800mg per day of a particular green tea catechin, (-)-epigallocatechin-3-gallate (EGCG), as a food supplement, had been shown to induce a statistically significant increase of serum transaminases in treated subjects compared to control subjects, which was indicative of liver injury.

Open for feedback until 3 November 2021, a draft act drawn up by the Commission proposes adding green tea extracts containing EGCG used in foods to Annex III, Part B of Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods.

The listing in Part B of the Annex – which concerns restrictions on substances added to foods – would require individual portions of food or food supplements for daily consumption to contain less than 800 mg of EGCG.

Infusions And Drinks Exempt

The proposed restriction would not apply to green tea infusions prepared in a traditional way and reconstituted drinks (containing at least 0.12g dry mass of extracts from tea in 100 mL) with an equivalent composition to traditional green tea infusions. In its opinion, EFSA concluded that such products were generally considered to be safe as the mean daily intake of EGCG resulting from the consumption of green tea infusions ranged from 90 to 300 mg/day.

Under the proposal, the labels of foods containing green tea extracts must list the maximum number of portions of the product for daily consumption and a warning not to consume a daily amount of 800 mg of EGCG or more. The label shall also indicate the content of catechins and the proportion of EGCG per portion of the product.

Certain warnings must also be displayed on product labels:

• “Should not be consumed if you are already consuming other products containing green tea”;

• “Should not be consumed by pregnant or lactating women, children below 18 years old”;

• “Seek advice from a doctor on consumption of this product if you experience health problems”;

• “Should not be consumed under fasting conditions.”

Outright Ban Under Consideration

In addition to its listing in Part B of the Annex, “Green tea extracts containing EGCG used in foods including beverages, and in food supplements” will also be added to Part C, under the Commission’s proposal.

Part C of the Annex lists those substances for which the possibility of harmful effects on health has been identified but scientific uncertainty persists.

In its 2018 opinion, EFSA said it was unable to identify a dietary intake of green tea catechins that did not give rise to concerns about harmful effects to health, for the general population, and vulnerable subgroups.

Considering these uncertainties, plus EFSA’s recommendation that studies should be performed to determine a dose–response of hepatotoxicity of green tea catechins and examine inter and intra species variability, the Commission said it was inviting interested parties to submit the data necessary to demonstrate the safety of green tea extracts used in foods.

From the date the proposed regulation comes into force, the Commission has four years to determine whether to include green tea extract containing EGCG in Annex III, Part B, or place it in Part A, which would prohibit its use in foods altogether.

Concerns in Europe around catechins in green tea extracts date back to 2015, when Norway, Sweden and Denmark sent a request to the Commission to investigate after they had identified a potential risk to consumers following consumption of foods containing EGCG. The available information, on which the request was based, included a scientific opinion on green tea extracts by the National Food Institute of the Technical University of Denmark, and a safety assessment on levels of EGCG in green tea extracts used in food supplements carried out by the Norwegian Institute of Public Health.