On 6 October 2021, the European Commission launched a consultation (until 3 November 2021) on adraft regulation as regards green tea extract containing epigallocatechin-3-gallate, according to article 8 of Regulation (EC) 1925/2006 and following the opinion of EFSA published in 2018.
This draft regulation would add Green tea extracts containing epigallocatechin-3-gallate used in foods including beverages (excluding green tea infusions prepared in a traditional way and reconstituted drinks (containing at least 0.12 g dry mass of extracts from tea in 100 mL) with an equivalent composition to traditional green tea infusions), and food supplements:
– in Part B of Annex III to Regulation (EC) 1925/2006 (under restrictions):
Dose of EGCG < 800 mg / day (to be indicated on the label: content of catechins and the proportion EGCG per portion of the product and maximum number of portions of the product for daily consumption).
Mandatory warnings: Warning not to consume a daily amount of 800 mg of EGCG or more. “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”.
– and in Part C of Annex III to Regulation (EC) 1925/2006, i.e. under Union scrutiny (under scrutiny because of scientific uncertainty: the industry will have 18 months to submit additional scientific data demonstrating the safety of the substances for a possible new assessment by EFSA; and the Commission should take a decision within four years).
Concretely, it corresponds to:
– a ban of green tea extracts containing a daily dose of EGCG greater than or equal to 800 mg/day
– and for lower doses: placing under restrictions (warnings) and under Union scrutiny.
The European Commission received 11 feedbacks on this consultation. Following these feedbacks, additional discussions would take place between European authorities and interesting parties on this draft text.
The final text may be published in the Official Journal of the European Union mid 2022.