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Green tea extract and EGCG: the EU limit and label warnings for food supplements

If you make, import or sell foods or food supplements containing green tea extract in the EU, one rule applies directly to you. Since December 2022, green tea extracts containing (−)-epigallocatechin-3-gallate (EGCG) have been a restricted substance under Annex III of Regulation (EC) No 1925/2006 [1, 2]. This article summarises what the rule says, why it was introduced and what to check on a product. It quotes the legal text wherever wording matters.

Why the rule exists

In 2015, Norway, Sweden and Denmark asked the European Commission to look at the risks of catechins, and EGCG in particular, in green tea extracts [1]. In its 2018 opinion, the European Food Safety Authority (EFSA) considered catechins from traditionally prepared green tea infusions to be generally safe at reported intakes. The mean daily EGCG intake from infusions is 90–300 mg [1, 3]. However, clinical trials showed that 800 mg of EGCG or more per day, taken as a food supplement, caused a statistically significant increase in serum transaminases, which indicates liver injury [1, 3]. EFSA could not identify an intake of green tea catechins that raises no concern [1].

What Regulation (EU) 2022/2340 requires

Commission Regulation (EU) 2022/2340 of 30 November 2022 was published in the Official Journal on 1 December 2022 (L 310, p. 7) and entered into force on the twentieth day after publication [1]. Non-compliant products lawfully placed on the market before then could remain on the market until 21 June 2023 [1].

Scope. The entry covers "green tea extracts containing (-)-epigallocatechin-3-gallate". It excludes aqueous green tea extracts which, after reconstitution in beverages, have a composition comparable to traditional green tea infusions [1]. Highly purified EGCG (at least 90%), authorised as a novel food, is not affected by this Regulation and has its own conditions of use [1].

Condition of use (Annex III, Part B): "Daily portion of food shall contain less than 800 mg of (-)-epigallocatechin-3-gallate" [1]. Note the wording "less than": a daily portion of exactly 800 mg does not comply.

Labelling. The label shall [1]:

The empty-stomach warning has a clear basis. EFSA noted that taking green tea extract while fasting, and as a single large dose, significantly increases EGCG exposure compared with taking it with food and in split doses [1]. These labelling rules apply on top of the general food supplement rules in Directive 2002/46/EC, which already require the recommended daily portion and a warning not to exceed it [1, 4].

Still under Union scrutiny

The same Regulation also placed these extracts in Part C of Annex III ("under Union scrutiny"). Harmful effects below 800 mg a day cannot be ruled out, and scientific uncertainty remains [1]. Interested parties may submit safety data. Within four years of the Regulation's entry into force, the Commission is to decide whether to move the extracts to Part A (prohibited) or Part B (restricted) [1]. At the time of writing (September 2026), the consolidated text of Regulation (EC) No 1925/2006 on EUR-Lex (version of 26 November 2025) still shows the Part B conditions and the Part C listing [2]. Watch for changes.

A practical checklist

When to talk to your doctor or pharmacist

For consumers: talk to your doctor or pharmacist before using a green tea extract product if you take medicines, have a liver condition, or are pregnant or breastfeeding (the label warning applies to you). Talk to them too if you feel unwell while using one, or if a blood test has shown raised liver values. Tell them about every supplement you take, including any that contain green tea.

This article is general information, not legal advice, and not medical advice, diagnosis or treatment. Always check the current legal text and your national requirements.

References

  1. Commission Regulation (EU) 2022/2340 of 30 November 2022 amending Annex III to Regulation (EC) No 1925/2006 as regards green tea extracts containing (-)-epigallocatechin-3-gallate. OJ L 310, 1.12.2022, p. 7. EUR-Lex. https://eur-lex.europa.eu/eli/reg/2022/2340/oj/eng
  2. Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods, consolidated text 02006R1925-20251126, Annex III. EUR-Lex. https://eur-lex.europa.eu/eli/reg/2006/1925/2025-11-26/eng
  3. EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS). Scientific opinion on the safety of green tea catechins. EFSA Journal. 2018;16(4):5239. doi:10.2903/j.efsa.2018.5239. https://doi.org/10.2903/j.efsa.2018.5239
  4. Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements, Article 6(3). EUR-Lex. https://eur-lex.europa.eu/eli/dir/2002/46/oj/eng

About the author: Milen Cholakov is a Master of Pharmacy (MPharm, Medical University of Varna), licensed in Bulgaria, with clinical-trial experience.