Foodlaw-Reading
Dr David Jukes, The University of Reading, UK
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Commission consultation, 6 October 2021
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Commission consultation: Draft Commisssion Regulation 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 A copy of the draft Regulation is available on this site (click on image). The consultation is available on the Commission site - see: Restricting the use of green-tea catechins in foods. The consultation closes on 3 November 2021. |
Catechins are a type of compound found in green tea. In 2018, the European Food Safety Authority issued a scientific opinion that catechins in green tea extracts taken as a food supplement could risk liver injury.
This opinion was issued following reports of adverse impacts from consuming green-tea extracts.
On the basis of this scientific opinion, the European Commission proposes to restrict the use of green-tea extracts, to ensure that foods containing this substance are safe for human consumption.
The following are the initial recitals from the draft regulation (see the pdf file for the full draft):
Having regard to Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods, and in particular Article 8(2)(a)(ii) and (b) thereof,
Whereas:
(1) Pursuant to Article 8(2) of Regulation (EC) No 1925/2006, on its own initiative or on the basis of information provided by Member States, the Commission may initiate a procedure to include a substance or an ingredient containing a substance other than a vitamin or a mineral in Annex III to that Regulation listing the substances whose use in foods is prohibited, restricted or under Union scrutiny, if that substance is associated with a potential risk to consumers as provided for in Article 8(1) of Regulation (EC) No 1925/2006.
(2) On 12 October 2015, Norway, Sweden and Denmark sent a request to the Commission to initiate the procedure under Article 8 of Regulation (EC) No 1925/2006 as a potential risk to consumers was associated with the intake of green tea extracts found in food.
(3) The request by Norway, Sweden and Denmark fulfilled the necessary conditions and requirements laid down in Articles 3 and 4 of Commission Implementing Regulation (EU) No 307/2012. The available information, on which the request was based,included a scientific opinion on green tea extracts by the National Food Institute of the Technical University of Denmark, and a safety assessment on levels of (-)-epigallocatechin-3-gallate in green tea extracts used in food supplements carried out by the Norwegian Institute of Public Health.
(4) The Commission therefore requested the European Food Safety Authority (‘the Authority’) to deliver a scientific opinion on the evaluation of the safety of green tea catechins from all food sources in accordance with Article 8 of Regulation (EC) No 1925/2006.
(5) On 14 March 2018, the Authority adopted a scientific opinion on the safety of green tea catechins. Green tea is produced from the leaves of Camellia sinensis (L.) Kuntze, without fermentation, which results in the presence of flavanols commonly known as catechins, the most relevant of which is (-)-epigallocatechin-3-gallate. Green tea catechins can be consumed as traditional green tea infusion, reconstituted tea drinks or as food supplements containing concentrated green tea extracts with widely differing levels of (-)-epigallocatechin-3-gallate. In response to a public ‘Call for data’ launched by the Authority, no data were received from interested parties on the levels of catechins in green tea extracts used for the manufacturing of food supplement.
(6) 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.
(7) The Authority concluded in that opinion 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 taken as 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.
