As we commented in one of our news in September 2020, green tea (Camelia sinensis L. Kuntze) has been on EFSA spotlight due to the risk of liver damage associated with the consumption of green tea extract that contains epigallocatechin gallate (EGCG) For this reason, it has been studied to establish a dose-response of hepatotoxicity in order to confirm a safe consumption dose.
Last June, the proposal to restrict the use of green tea extract with EGCG was approved by vote with favourable result of the Member States of EU, presenting a proposal for the final version of the Regulation during past July. This Regulation proposal would amend Annex III of Regulation (EC) 1925/2006.
Currently, the proposal is on the table of the European Parliament for the scrutiny procedure, which is expected to end during the first week of October 2022.
In the meantime, the affected products must be adapted to the prosperous new regulation, which establishes a maximum daily dose of 800 mg of EGCG and requires that the labels must to include the indication of warnings.
It is important to note that the proposal mentions the possibility of having a transitional period of 6 months to exhaust the stocks of those units already placed on the market before the date of entry into force of new Regulation, and it will be 20 days after its publication.
Presently, we will wait for the final publication of the new Regulation to know its details and to be able to establish a deadline for the total adaptation of the affected products.
Cía de Productos Naturales Lleó recommends anticipating changes, whether in formulation or labelling, in order to adapt the affected products in advance. At the same time, we will keep you informed of any developments in this regard.
