EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10400/2021 
(POOL/E1/2021/10400/10400 -EN.docx)  
[…](2021) XXX  draft 
 
COMMISSION REGULATION (EU) …/…  
of XXX  
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)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
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)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 1925/2006 of the European Parliament an d of the 
Council of 20 December 2006 on the addition of vitamins and minerals and of certain other 
substances to foods1, 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 in itiative 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 substanc es 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 307/20122. The available information , on which the request was based , 
included a scien tific opinion on green tea extracts by the National Food Institute of the 
Technical University of Denmark3, and a safety assessment on levels of ( -)-
epigallocatechin -3-gallate in green tea extracts used in food supplements carried out 
by the Norwegian Inst itute of Public Health4.  
(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 R egulation (EC) No 
1925/2006.  
                                                 
1 OJ L 404, 30.12.2006, p. 26.  
2 Commission Implementing Regulation (EU) No 307/2012 of 11 April 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 foo ds 
(OJ L 102, 12.4.2012, p. 2).  
3 Opinion on green tea extracts and green tea infusion – Danish Technical University (2015) .    
4 Safety  assessment on levels of  (-)-Epigallocatechin -3-gallate (EGCG) in green tea extracts used in food 
supplements , Norwegian  Institute of Public Health (2015) .   
EN 2  EN (5) On 14 March 2018, the Authority adopted a scientific opinion on the safety of green 
tea catechins5. 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 co ntaining 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 te a 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 infusi ons, 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 . 
(8) In th e opinion, the Authority explained that  there were a number of uncertainties 
regarding exposure to green tea catechins , and the biological and toxicological effects . 
Therefore,  it was unable to provide advice on a dietary i ntake of green tea catechins 
that does not give rise to concerns about harmful effects to health, for the general 
population, and as appropriate, for vulnerable subgroups of the population.  The 
chemical composition , including the content of ( -)-epigallocat echin -3-gallate, varies 
widely due to plant variety, growing environment, season, age of leaves and 
manufacturing conditions , and there are  uncertainties on how the composition of 
extracted catechins and other substances used to prepare green tea extracts is 
influenced by manufacturing procedures.  The Authority noted the limited data on 
dose–response relationships between doses of ( -)-epigallocatechin -3-gallate and 
abnormal liver parameters that is needed for the assessment of a dose of ( -)-
epigallocatechin -3-gallate that will not cause an effect on liver parameters. 
Furthermore, uncertainties exist as to whether more serious liver effects may develop 
after long -term use of green tea extracts , as well as un certainties on the mechanisms 
leading to dose -dependent hepatotoxicity of ( -)-epigallocatechin -3-gallate. The 
mechanism  leading to hepatotoxicity in rare cases of liver injury that have been 
reported after consumption of green tea infusions, is not certain , and the Authority 
stated that such cases are probably d ue to an idiosyncratic reaction, therefore there is 
no clear relation to the dose, route or duration of ad ministration of the substance.  
(9) Considering that no daily intake of green tea catechins in foo ds that does not give rise 
to concerns for human health could be set , and considering the significant harmful 
effect on health associated with the intake of (-)-epigallocatechin -3-gallate  at a daily 
intake level equal to or above 800  mg, the use of green t ea extracts containing 800 mg 
or more of (-)-epigallocatechin -3-gallate  in foods including food supplements,  should 
be prohibited. Green tea extract containing ( -)- epigallocatechin -3-gallate should 
                                                 
5 EFSA Journal 2018;16(4):5239 .  
EN 3  EN therefore be placed in Part B of Annex III to Regulation (EC) No 1925/2006 and its 
addition to foods or its use in the manufacture of foods should only be allowed under 
the conditions specified in that Annex.  
(10) As the Authority could not identify , in its 14 March 2018  opinion,  a dietary intake of 
green tea catechi ns that does not give rise to concerns about harmful effects to health, 
for the general population, and as appropriate, for vulnerable subgroups of the 
population , and as, therefore, there remains the possibility of harmful effects on health 
associated wit h the use of green tea extracts containing less than 800 mg of (-)-
epigallocatechin -3-gallate , but scientific uncertainty in this regard persists , the use of 
green tea extracts containing ( )- epigallocatechin -3-gallate  in foods and food 
supplements, should  be placed under Union scrutiny and therefore, should be included 
in Part C of Annex III to Regulation (EC) No 1925/2006. Considering the 
uncertainties outlined by the Authority in its 14 March 2018  opinion and its 
recommendation that studies should be per formed to determine a dose –response of 
hepatotoxicity of green tea catechins and examine inte r and intra species variability, 
interested parties may submit,  under Article 8(4) of Regulation (EC) No 1925/2006 , 
the data necessary to demonstrat e the safety of green tea extracts used in foods 
including food supplements in accordance with Article 5 of Commission 
Implementing Regulation (EU) No 307/2012. In accordance with Article 8(5) , the 
Commission should take a decision , within four years from t he entry into force of this 
Regulation, whether to include green tea extract containing  (-)- epigallocatechin -3-
gallate in Annex III, Part A or Part B, to Regulation (EC) No 1925/2006, as 
appropriate, taking into account the opinion of the Authority on any  submitted data.  
(11) The Authority recommended , in its 14 March 2018  opinion,  that labels of green tea 
products, with particular reference to food supplements, should include the content of 
catechins and the proportion of (-)-epigallocatechin -3-gallate . It is important to ensure 
effectively and verifiably that consumers cannot be exposed to equal or higher levels 
of green tea extract containing ( -)-epigallocatechin -3-gallate that the Authority 
considered harmful for human health . It is therefore necessary to pr ovide for 
appropriate labelling requirements for all foods containing green tea extracts  
containing (-)- epigallocatechin -3-gallate .  
(12) Article 6(3) of Directive 2002/46/EC  of the European Parliament and of the Council6 
requires the labelling of food supplem ents with the portion of the product that is 
recommended for daily consumption together with a warning not to exceed the stated 
recommended daily dose. As different foods or food supplements containing green tea 
extracts may be consumed simultaneously, the re is a risk  of exceeding the  daily dose 
of (-)- epigallocatechin -3-gallate  laid down in the Annex to this Regulation . Therefore, 
it is necessary to provide for appropriate labelling requirement s for all foods 
containing green tea extract containing ( -)-epigallocatechin -3-gallate.  
(13) The Authority also noted , in its 14 March 2018  opinion,  that the administration of 
green tea extract under fasting conditions, and as a bolus, leads to a significant 
increase in the area under the plasma  concentration -time curve  of (-)- epigallocatechin -
3-gallate compared to administration with food and in split doses, and that fasting has 
been demonstrated to increase the toxicity of green tea catechins in experimental 
                                                 
6 Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the 
approximation of the laws of the Member States relating to food supplements  (OJ L 183 12.7.2002, p. 
51).  
EN 4  EN animals. Therefore, it is necessary to warn consumers not to  consume green tea extract 
preparations in foods , including food supplements, under fasting conditions.  
(14) The Authority further noted , in its 14 March 2018  opinion,  that none of the 
intervention studies addressed pregnant and lactating  women, breast -fed inf ants and 
children  below 18 years old , and thus there remains the  possibility  of harmful effects 
on health associated with  the use of green tea catechins. I t is therefore appropriate to 
include a warning  as regards  the use of foods and food supplements containing green 
tea extracts in certain vulnerable groups of consumers . Furthermore, considering the 
uncertainties outlined by the Authority in that opinion , it is appropriate to warn 
persons to seek medical advice i f they experience any health problems.  
(15) (-)-Epigallocatechin -3-gallate  as a highly purified extract from the leaves of green tea 
(Camellia sinensis  (L.) Kuntze ) containing a minimum of  90% (-) -epigallocatechin -3-
gallate  has a defined CAS registry number an d manufacturing process and  is 
authorised for use as a novel food  under the Regulation (EU) 2015/2283 of the 
European Parliament and of the Council on novel foods,7 and in accord ance with the 
conditions of use and specifications laid down by Commission Implementing 
Regulation (EU) 2017/2470 establishing the Union list of novel foods8. The use of 
highly purified extracts of (-)-epigallocatechin -3- gallate in fortified foods and food 
supplem ents that fall within the conditions of use and specifications of the novel food 
in Regulation (EU) 2017/2470 should continue to be used in accordance with that 
regulation.   
(16) Regulation (EC) No 1925/2006 should therefore be amended accordingly.  
(17) The measures  provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex III to Regulation (EC) No 1925/2006 is amended as follows:  
 
1. The following ent ry is inserted in the table in P art B , in alphabetical order : 
 
‘ 
Restricted substance  Conditions of use  Additional requirements  
Green tea extract 
containing ( -)- 
epigallocatechin -3-gallate 
used in foods including Individual p ortion of food 
or food supplement for 
daily consumption shall 
contain less than 800  mg of The label shall provide the 
maximum number of 
portion s of the product for 
daily consumption a nd a 
                                                 
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 Regula tion (EU) 2015/2283 of the European Parliament and of 
the Council on novel foods (OJ L 351, 30.12.2017, p. 72) . 
  
EN 5  EN beverages *, and food 
supplements as defined by 
Directive 2002/46/EC  
 
 
 
* excluding green tea 
infusions prepared in a 
traditional way and 
reconstituted drinks 
(containing at least 0.12  g 
dry mass of extracts from 
tea in 100  mL) with an 
equivalent composition to 
traditional green tea 
infusions.   (-)-epigallocatechin -3-
gallate  warning not to consume  a 
daily amount of  800 mg of 
(-)-epigallocatechin -3-
gallate  or more .  
The label shall indicate the 
content of catechins and 
the proportion of ( -)- 
epigallocatechin -3-gallate 
per portion of the product .  
 
The label shall include t he 
following warnings : 
 
“Should not be consumed 
if you are already 
consuming  other products 
containing green tea”.    
 
“Should not be consumed 
by pregnant  or lactating 
women , children below 18 
years old .”  
 
“Seek advice from a 
doctor on consumption of 
this product if you 
experience health 
problems” . 
 
“Should not be consumed 
under fasting conditions”.  
’ 
2. The following entry is inserted in Part C , in alphabetical order : 
 
 ‘Green tea extracts containing ( -)- epiga llocatechin -3-gallate  used in food s including 
beverages*, and in food supplements as defined by Directive 2002/46/EC  
*excluding green tea infusions prepared in a traditional way and reconstituted drinks  
(containing at least 0.12  g dry mass of extracts from  tea in 100  mL) with an 
equivalent composition to traditional green tea infusions. ’ 
Article 2  
This Regulation shall enter into force on the twentieth day following 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.   
EN 6  EN Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN