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European Commission restricts the use of green tea extracts

In November 2022, Regulation (EU) 2022/2340 amending Annex III to Regulation (EC) no. 1925/2006 as regards green tea extracts containing (-)-epigallocatechin-3-gallate (EGCG) was published.

Green tea obtained from the leaves of Camellia sinensis (L.) Kuntze contains flavanols commonly known as catechins, the most important of which is (-)-epigallocatechin-3-gallate (EGCG). Green tea catechins can be taken in the form of traditional infusions, reconstituted drinks, or dietary supplements containing concentrated extracts.

Following some reports of harmful effects, and upon request of the European Commission, EFSA issued a scientific opinion in 2018 according to which catechins in green tea extracts taken as a dietary supplement could pose risks of liver damage.

The safety assessment
October 2015
Norway, Sweden and Denmark submitted some information to the Commission about the potential risk to consumers associated with the intake of catechins, particularly EGCG in green tea extracts used in food:

  • scientific opinion on green tea extracts formulated by the National Food Institute of the Technical University of Denmark
  • safety assessment of EGCG levels in green tea extracts used in dietary supplements prepared by the Norwegian Institute of Public Health

The European Union then initiated the monitoring procedure (art. 8, Regulation (EC) no. 1925/2006) and requested EFSA a scientific opinion on the safety.

The restriction proposal
Based on available data regarding the catechins potential adverse effects on liver, clinical trials have shown that doses of 800 mg or more of EGCG per day in dietary supplement form causes a statistically significant increase in serum transaminases in treated subjects compared with control subjects, consistent with the presence of liver injury. In addition, EFSA points out that it is not possible to determine the exact levels of catechins green tea consumer exposure, and thus their biological and toxicological effects. In fact, the chemical composition of extracts varies considerably depending on several factors, including plant variety, growing environment, season, leaf age, and manufacturing conditions; furthermore, there are uncertainties about how manufacturing procedures affect the composition of extracted catechins and other substances used to prepare tea extracts.

Based on this scientific opinion, the European Commission proposed to restrict the use of green tea extracts in order to ensure foods safety for human consumption. Green tea extracts containing EGCG used in foods, beverages and supplements were included in Annex III Part B of EC Reg. 1925/2006 – restricted substances. In addition, EGCG as a highly purified extract from green tea leaves (min. purity 90%) is authorized for use as a Novel food and listed in Regulation no. 2470/2017 with specific conditions of use, including a maximum level of 150 mg of extract in one serving of food or dietary supplements.

Mérieux NutriSciences ensures product compliance with all requirements

ANALYTICAL SERVICES
According to the conditions of use, the daily dose should contain less than 800 mg of EGCG. Dietary supplements, herbal products and extracts (including green tea dry extract) can be analyzed in our labs by chromatographic methods to quantify:

  • (-)-EPIGALLOCATECHIN-3-GALLATE (EGCG)
  • CATECHINS and GALLOCATECHINS

The quantification of these substances –particularly EGCG– is fundamental for monitoring and verifying compliance with the maximum daily intake limits specified by (EC) Regulation no. 1925/2006 and (EU) Regulation no. 2470/2017 in case of highly purified extracts.

REGULATORY SERVICES
The following additional requirements should be stated on the label:

  • The label shall provide the maximum number of portions for daily consumption and a warning not to consume a daily amount of 800 mg of (-)-epigallocatechin-3-gallate or more.
  • The label shall indicate the content of (-)-epigallocatechin-3-gallate per portion.
  • The label shall include the following warnings:
    • “Should not be consumed if you are consuming other products containing green tea on the same day”;
    • “Should not be consumed by pregnant or lactating women and children below 18 years old”;
    • “Should not be consumed on an empty stomach”.

Article 6 of Directive 2002/46/EC requires that supplements be labeled with mandatory elements including the recommended quantity of product for daily consumption together with a warning not to exceed the stated recommended daily dose. Mérieux NutriSciences Expert Services Unit offers a range of services to support companies in labeling new or existing food supplements to conform to continuously changing legal requirements.

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