COMMI SSION REGUL ATION (EU) 2022/2340 
of 30 November 2022
amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council 
as regards green tea extracts containing (-)-epigallocatechin-3-gallate 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng 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 (1), 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 
provid ed by Member State s, the Commission may initiat e 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, restr icted or under Union scrutiny , if that substance is associated with a potential 
risk to consumers as provid ed for in Article 8(1) of Regulation (EC) No 1925/2006.
(2) On 12 October 2015 , Nor way, 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 
catec hins, and in particular of (-)-epig allocatec hin-3-gallat e in green tea extracts used in the manuf acture of food.
(3) The request of Nor way, Sweden and Denmark fulfilled the necessar y conditions and requirements laid down in 
Articles 3 and 4 of Commission Implementing Regulation (EU) No 307/2012 (2). The available information, on 
which the request was based, included a scientifi c opinion on green tea extracts by the National Food Institute of the 
Techn ical University of Denmark (3), and a safety assessment on levels of (-)-epiga llocatec hin-3-gallat e in green tea 
extracts used in food supplements carried out by the Nor wegian Institute of Public Health (4).
(4) The Commission theref ore request ed the European Food Safety Auth ority (‘the Author ity’) to deliver a scientific 
opinion on the evaluation of the safety of green tea cate chins from all food sources in accordance with Article 8 of 
Regulation (EC) No 1925/2006.
(5) Green tea is produced from the leaves of Camellia sinensis (L.) Kuntze, without fermentation, whic h results in the 
presence of flavanols, commonly known as catec hins, the most relevant of whic h is (-)-epigallocat echi n-3-gallat e. 
Green tea cate chins can be consumed as traditional green tea infusions, reconstituted tea drinks or as a food 
supplement containing concentrated green tea extracts with widely diffe ring levels of (-)-epig allocatec hin-3-g allate.
(1)OJ L 404, 30.12.2006, p. 26.
(2)Commission Implementing Regulation (EU) No 307/2012 of 11 Apr il 2012 establishing implementing rules for the application of 
Article 8 of Regulation (EC) No 1925/2006 of the European Parliament and of the Council on the addition of vitamins and minerals 
and of certain other substances to foods (OJ L 102, 12.4.2012, p. 2).
(3)Opinion on green tea extracts and green tea infusion – Danish Technical University (2015).
(4)Safet y assessment on levels of (-)-Epig allocatec hin-3-gallat e (EGCG) in green tea extracts used in food supplements, Nor wegian Institute 
of Public Health (2015).EN Offi cial Jour nal of the European Union 1.12.2022 L 310/7  (6) On 10 Apr il 2017 , the Author ity launch ed a public ‘Call for data’ on new scientific information as regar ds the use of 
green tea catec hins to retrieve from inter ested parties documented information relevant to the evaluation of those 
substances from all sources in foods, including preparations such as food supplements and infusions. However , no 
data were received from interested parties on the levels of catec hins in green tea extracts used for the manufact uring 
of food supplements.
(7) On 14 March 2018 , the Author ity adopt ed a scientifi c opinion on the safety of green tea catec hins (5). The Authority 
concluded in that opinion that catec hins from green tea infusions prepared in a traditional way, and reconstituted 
drinks with an equivalent compo sition to traditional green tea infusions, are in general considered to be safe 
according to the presump tion of safety approach, provided the intake corresponds to repor ted intakes in Member 
State s. The mean daily intak e of (-)-epigallocat echi n-3-gallat e resulting from the consump tion of green tea infusions 
range s from 90 to 300 mg/da y.
(8) The Auth ority also concluded that, based on the available data on the potential adverse effects of green tea catec hins 
on the liver , there is evidence from inter ventional clinical trials that intak e of doses equal to or above 800 mg of 
(-)-epiga llocatec hin-3-gallat e per day in the form of a food supplement, has been shown to induce a statistically 
signif icant increase of serum transaminases in treated subjects compar ed to control subjects, which is indicative of 
liver injur y.
(9) In that opinion, the Authority explained that there were a number of uncer tainties regarding exposure to green tea 
catec hins and their biological and toxicological effects. Theref ore, it was unable to provid e advice on a dietar y intak e 
of green tea catec hins that does not give rise to concer ns about harmful effects to health for the general population 
and, as appropr iate, for vulnerable subgroups of the population. The chemical composition, including the conte nt 
of (-)-epigallocat echi n-3-gallat e, varies widely depending on the plant variety, the growing environment, the season, 
the age of leav es and the manuf actur ing conditions, and there are uncer tainties on how the composition of 
extract ed catec hins and other substances used to prepare green tea extracts is influenced by manuf actur ing 
procedures. The Auth ority noted the limited data on dose–response relationships between doses of 
(-)-epiga llocatec hin-3-gallat e and abnor mal liver parameter s, which is needed for the assessment of a dose of 
(-)-epiga llocatec hin-3-gallat e that would not cause an effect on liver paramet ers. Further more, there are 
uncer tainties as to whether more serious liver effects may develop after long-ter m use of green tea extracts, as well 
as regarding the mech anisms leading to dose-dependent hepat otoxicity of (-)-epig allocatec hin-3-gallat e. The 
mechani sm leading to hepatot oxicity in the rare cases of liver injur y that have been repor ted after consump tion of 
green tea infusions is not certain, and the Auth ority stated that such cases are probably due to an idiosyncratic 
reaction, theref ore there is no clear relation to the dose, route or duration of administration of the substance.
(10) Consider ing that the Auth ority could not deter mine a daily intake of green tea catec hins in foods that does not give 
rise to concer ns for human health, and consider ing the signif icant harmful effect on health associated with a daily 
intake level of (-)-epig allocatec hin-3-gallat e equal to or above 800 mg, the addition to foods or use in the 
manufact ure of foods of (-)-epigallocat echin-3-g allate from green tea extracts at levels of 800 mg or more per daily 
portion of food should be prohibit ed. Green tea extracts containing (-)- epigalloc atec hin-3-gallat e should theref ore 
be included in Part B of Annex III to Regulation (EC) No 1925/2006 and its addition to foods or its use in the 
manufact ure of foods should only be allowed under the conditions specif ied in that Annex.
(11) The Author ity in its opinion of 14 March 2018 could not identify a dietar y intake of green tea catec hins that does 
not give rise to concer ns about harmful effects to health for the general population and, as appropr iate, for 
vulnerable subgroups of the population. As there is still a possibility of harmful effects on health associated with a 
daily intake level of less than 800 mg of (-)-epig allocatec hin-3-gallat e from green tea extracts, but scientifi c 
uncer tainty in this regard persists, green tea extracts containing (-)- epigalloc atec hin-3-gallat e should be placed 
under Union scrutiny and included in Part C of Annex III to Regulation (EC) No 1925/2006. Consider ing the 
(5)EFSA Jour nal 2018;16(4):5239.EN Offi cial Jour nal of the European Union L 310/8 1.12.2022  uncer tainties outlined by the Author ity in its 14 March 2018 opinion and its recommendation that studies should be 
performe d to deter mine a dose–response of hepat otoxicity of green tea catec hins and examine inter and intra species 
variability , inter ested parties may submit, under Article 8(4) of Regulation (EC) No 1925/2006, the data necessar y to 
demonstrate the safety of green tea extracts in accordance with Article 5 of Imple menting Regulation (EU) 
No 307/2012.
(12) In accordance with Article 8(5), the Commission should take a decision, within four years from the entr y into force 
of this Regulation, whether to include green tea extracts containing (-)- epiga llocatec hin-3-gallat e in Annex III, Part A 
or Part B, to Regulation (EC) No 1925/2006, as appropr iate, taking into account the opinion of the Auth ority on any 
submitted data.
(13) Article 6(3) of Directive 2002/46/EC of the European Parliament and of the Council (6)requires the labelling of food 
supplements with the portion of the product that is recommended for daily consump tion together with a warning 
not to excee d the stated recommended daily dose. As different foods or food supplements containing green tea 
extracts may be consumed over one day, there is a risk that the consumer ’s intake exceed s the maximum daily dose 
of (-)- epigallocat echin-3-gallat e. Theref ore, it is necessar y to provide for appropr iate labelling requirements for all 
foods containing green tea extracts containing (-)-epiga llocatec hin-3-gallat e.
(14) The Auth ority recommended, in its 14 March 2018 opinion, that labelling of green tea products, with particular 
referen ce to food supplements, should include the conte nt of (-)-epig allocatec hin-3-gallat e. It is impor tant to ensure 
effectively and verifiably that consumers cannot be exposed to levels of (-)-epigallocat echin-3-g allate from green tea 
extracts that the Auth ority considers harmful for human health. It is theref ore necessar y to provid e for appropr iate 
labelling requirement indicating the conte nt of (-)-epigallocat echin-3-g allate per portion of the food.
(15) The Author ity also noted, in its 14 March 2018 opinion, that the administration of green tea extracts under fasting 
conditions, and as a bolus, leads to a significant increase in the area under the plasma concentration-time curve of 
(-)- epigalloc atec hin-3-gallat e compar ed to administration with food and in split doses, and that fasting has been 
demonstrated to increase the toxicity of green tea catec hins in exper imental animals. Theref ore, it is necessar y to 
warn consumers not to consume green tea extract preparations in foods on an emp ty stomach.
(16) The Auth ority further noted, in its 14 March 2018 opinion, that none of the inter vention studies addressed pregnant 
and lactating women, breast-fed infants and children below 18 years old, and thus there remains the possibility of 
harmful effects on health associate d with the use of green tea catec hins in those vulnerable groups of consumers. It 
is theref ore appropr iate to include a warning as regards the use of foods containing green tea extracts in those 
vulnerable groups of consumers.
(17) This Regulation should not affect the use in fortified foods and food supplements of (-)-epigallocat echi n-3-gallat e as a 
highly purified extract from the leav es of green tea (Camellia sinensis (L.) Kuntze) containing a minimum of 90 % (-) 
-epigallo catec hin-3-gallat e. That substance is safe and author ised for use as a novel food under Regulation (EU) 
2015/2283 of the European Parliament and of the Council (7), and is subject to the conditions of use and 
specifi cations laid down by Commission Implementing Regulation (EU) 2017/2470 (8).
(6)Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the appro ximation of the laws of the 
Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).
(7)Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending 
Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the 
European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, p. 1).
(8)Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance 
with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).EN Offi cial Jour nal of the European Union 1.12.2022 L 310/9  (18) A reasonable period should be provid ed to allow food business operat ors to adapt to the new requirements set out in 
this Regulation. Consider ing the safety concer ns such period should concer n only products already lawfully placed 
on the mark et before the entr y into force of this Regulation.
(19) Regulation (EC) No 1925/2006 should theref ore be amended according ly.
(20) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGUL ATION:
Article 1
Annex III to Regulation (EC) No 1925/2006 is amended as follows:
(1) in Part B, the follo wing entr y is inser ted in the table, in alphabetical order :
Restr icted substance Conditions of use Additional requirements
‘Green tea extracts containing (-)- 
epiga llocatec hin-3-gallat e(*)Daily portion of food shall 
contain less than 800 mg of 
(-)-epig allocatec hin-3-gallat eThe label shall provid e the maximum number of 
portions of the food for daily consump tion and a 
warning not to consume a daily amount of 800 mg 
of (-)-epig allocatec hin-3-gallat e or more.
The label shall indicate the content of (-)- 
epiga llocatec hin-3-gallat e per portion of the food.
The label shall include the followi ng warnings:
“Should not be consumed if you are consuming 
other products containing green tea on the same 
day”.
“Should not be consumed by pregnant or lactating 
women and children below 18 years old”.
“Should not be consumed on an emp ty stomach”.’
(*)excluding aqueous green tea extracts containing (-)- epigallocat echin-3-gallat e whic h after reconstitution in beverages have a 
compo sition com parable to traditional green tea infusions.
(2) in Part C, the followi ng entr y is inser ted, in alphabetical order :
‘Green tea extracts containing (-)- epigallocat echin-3-g allate (*)
_____________
(*) excl uding aqueous green tea extracts containing (-)- epiga llocatec hin-3-gallat e which after reconstitution in 
beverage s have a compo sition comparab le to traditional green tea infusions.’ .EN Offi cial Jour nal of the European Union L 310/10 1.12.2022  Article 2
Foodstuffs containing green tea extracts containing (-)- epigalloc atec hin-3-gallat e, whic h do not comply with the 
requirements of this Regulation and were lawfully placed on the mark et before the entr y into force of this Regulation may 
remain on the mark et until 21 June 2023 .
Article 3
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 30 November 2022 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 1.12.2022 L 310/11