L 310/8
EN
Official Journal of the European Union
1.12.2022
(6)
On 10 April 2017, the Authority launched a public ‘Call for data’ on new scientific information as regards the use of green tea catechins to retrieve from interested parties documented information relevant to the evaluation of those substances from all sources in foods, including preparations such as food supplements and infusions.
However, no data were received from interested parties on the levels of catechins in green tea extracts used for the manufacturing of food supplements.
(7)
On 14 March 2018, the Authority adopted a scientific opinion on the safety of green tea catechins (5).
The Authority concluded in that opinion that catechins from green tea infusions prepared in a traditional way, and reconstituted drinks with an equivalent composition to traditional green tea infusions, are in general considered to be safe according to the presumption of safety approach, provided the intake corresponds to reported intakes in Member States.
The mean daily intake of (-)-epigallocatechin-3-gallate resulting from the consumption of green tea infusions ranges from 90 to 300 mg/day.
(8)
The Authority also concluded that, based on the available data on the potential adverse effects of green tea catechins on the liver, there is evidence from interventional clinical trials that intake of doses equal to or above 800 mg of (-)-epigallocatechin-3-gallate per day in the form of a food supplement, has been shown to induce a statistically significant increase of serum transaminases in treated subjects compared to control subjects, which is indicative of liver injury.
(9)
In that opinion, the Authority explained that there were a number of uncertainties regarding exposure to green tea catechins and their biological and toxicological effects.
Therefore, it was unable to provide advice on a dietary intake of green tea catechins that does not give rise to concerns about harmful effects to health for the general population and, as appropriate, for vulnerable subgroups of the population.
The chemical composition, including the content of (-)-epigallocatechin-3-gallate, varies widely depending on the plant variety, the growing environment, the season, the age of leaves and the manufacturing conditions, and there are uncertainties on how the composition of extracted catechins and other substances used to prepare green tea extracts is influenced by manufacturing procedures.
The Authority noted the limited data on dose–response relationships between doses of (-)-epigallocatechin-3-gallate and abnormal liver parameters, which is needed for the assessment of a dose of (-)-epigallocatechin-3-gallate that would not cause an effect on liver parameters.
Furthermore, there are uncertainties as to whether more serious liver effects may develop after long-term use of green tea extracts, as well as regarding the mechanisms leading to dose-dependent hepatotoxicity of (-)-epigallocatechin-3-gallate.
The mechanism leading to hepatotoxicity in the rare cases of liver injury that have been reported after consumption of green tea infusions is not certain, and the Authority stated that such cases are probably due to an idiosyncratic reaction, therefore there is no clear relation to the dose, route or duration of administration of the substance.
(10)
Considering that the Authority could not determine a daily intake of green tea catechins in foods that does not give rise to concerns for human health, and considering the significant harmful effect on health associated with a daily intake level of (-)-epigallocatechin-3-gallate equal to or above 800 mg, the addition to foods or use in the manufacture of foods of (-)-epigallocatechin-3-gallate from green tea extracts at levels of 800 mg or more per daily portion of food should be prohibited.
Green tea extracts containing (-)- epigallocatechin-3-gallate should therefore be included in Part B of Annex III to Regulation (EC) No 1925/2006 and its addition to foods or its use in the manufacture of foods should only be allowed under the conditions specified in that Annex.
(11)
The Authority in its opinion of 14 March 2018 could not identify a dietary intake of green tea catechins that does not give rise to concerns about harmful effects to health for the general population and, as appropriate, for vulnerable subgroups of the population.
As there is still a possibility of harmful effects on health associated with a daily intake level of less than 800 mg of (-)-epigallocatechin-3-gallate from green tea extracts, but scientific uncertainty in this regard persists, green tea extracts containing (-)- epigallocatechin-3-gallate should be placed under Union scrutiny and included in Part C of Annex III to Regulation (EC) No 1925/2006.
Considering the
(5) EFSA Journal 2018;16(4):5239.