Enrichment regulation: Green tea extract with (-)-epigallocatechin-3-gallate.
With Regulation (EU)2022/2340 green tea extracts are included in Annex III Part B of Regulation (EC) No. 1925/2006 (Enrichment Regulation). been added. When used in foods, they are subject to the condition that the (-)-epigallocatechin-3-gallate content in a daily daily portion of food is below 800 mg
Regulatory News
New enrichment regulation:
Green tea-extract with (-)-epigallocatechin-3-gallat
With Commission Regulation (EU)2022/2340 green tea extracts have been included in Annex III Part B of Regulation (EC) No 1925/2006 (Fortification Regulation).
- When used in foods, they are subject to the condition that the content of (-)-epigallocatechin-3-gallate in a daily portion of food is below 800 mg.
- Therefore, the maximum daily consumption amount in servings of the food must be indicated.
- In addition, a warning is required that the daily intake of 800 mg of (-)-epigallocatechin-3-gallate should not be exceeded.
- The amending regulation came into force on December 21, 2022; products containing green tea extract that have been lawfully marketed to date can still be marketed until June 21, 2023.
Water based green tea extracts containing (-)-epigallocatechin-3-gallate, which have a composition comparable to traditional green tea infusions after reconstitution in beverages, are exempt from the new regulation.
Official Journal of the European Union 01.12.2022
The product Teavigo® is unaffected by the Regulation, as recital 17 of Regulation (EU)2022/2340 states that the use of (-)-epigallocatechin-3-gallate as a highly purified extract from green tea (Camellia sinensis (L.) Kuntze) leaves containing at least 90% (-)-epigallocatechin-3-gallate in fortified foods and food supplements is unaffected. This substance is safe and approved for use as a novel food under the NovelFoodVO of the European Parliament and of the Council and is subject to the conditions of use and specifications laid down in Commission Implementing Regulation (EU) 2017/2470.
From the specification according to DVO 2017/2470 Table 1, the following conditions of use can be found:
In the EFSA ANS Panel's scientific opinion on the safety of green tea catechins from dietary sources, including preparations such as dietary supplements and infusions, it exclusively addresses the association between consumption of (-) - epigogallocatechin-3-gallate (EGCG) and hepatoxicity. Based on the available data on the potential adverse effects of green tea catechins on the liver, the panel concluded that there is evidence from clinical intervention studies that intake of doses equal to or greater than 800 mg EGCG/day results in a significant increase in serum transaminases. An evaluation of epigallocatechin (EGC) is not available. However, the Panel concludes that "catechins" from traditionally prepared green tea infusions are generally considered safe.
Regulation DVO 2017/2470 Table 1 refers only to the derivative (-) - epigogallocatechin-3-gallate (EGCG), therefore this regulation does not apply.
The XLB stands for EXtreme Low Bitterness, because Sunphenon® XLB-100 is the green tea extract with the lowest bitterness content.
Sunphenon® XLB-100 is a decaffeinated and polyphenol-rich green tea extract.
Since gallates are mainly responsible for bitterness, Sunphenon® XLB-100 is debittered by an enzymatic treatment that hydrolyzes the bitter-tasting gallates. Accordingly,
Sunphenon® XLB-100 contains only gallate-free catechins. In addition, it also has excellent stability and very low astringency.
Perfect for taste sensitive beverages, chewing gum, chewable tablets, toothpaste, peppermint candies, sweets.
Do you need more information? We are looking forward to provide you with more study details and answer your questions
Therefore please contac us at ne@vivatis.de.