Draft Commission Regulation (EU) amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards green tea extract containing (-)-epigallocatechin-3-gallate (Text with EEA relevance). Language(s): English. Number of pages: 6
This draft Commission Regulation concerns the inclusion of green tea catechins in Annex III of Regulation (EC) No 1925/2006 ('the Regulation').
In its opinion, adopted on 14 March 2018, EFSA concluded that while catechins from green tea infusions prepared in a traditional way were considered safe for use, catechins taken as a food supplement, at and above 800mg of (-)-epigallocatechin-3-gallate, had been shown to cause elevated serum transaminases, which is indicative of liver injury. Therefore, pursuant to the procedure of Article 8 of the Regulation, this substance should be included in Annex III (Part B) to the Regulation.
Furthermore, as EFSA could not identify a safe dietary intake of green tea catechins, and therefore, there is still the possibility of harmful effects on health but scientific uncertainty persists in this regard, this substance should be placed under Union scrutiny (Part C of Annex III to the Regulation).