COMMI SSION REGUL ATION (EU) 2020/356 
of 4 March 2020 
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council 
as regards the use of polysorbates (E 432-436) in carbonated bev erages 
(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 1333/2008 of the European Parliament and of the Council of 16 December 2008 on 
food additives (1), and in particular Article 10(3) thereof, 
Whereas: 
(1) Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives appro ved for use in food and 
their conditions of use. 
(2) That list may be updated in accordance with the common procedure refer red to in Article 3(1) of Regulation (EC) 
No 1331/2008 of the European Parliament and of the Council (2), either on the initiative of the Commission or 
follo wing an application. 
(3) Pursuant to Annex II to Regulation (EC) No 1333/2008, poly oxyet hylene sorbitan tristearate (polysorbate 65) 
(E 436) is currently author ised for use as a food additive in the group ‘polysorbat es’ (E 432-436) in a wide variety of 
foods at maximum levels ranging between 500 and 10 000 mg/kg and quantum satis in food supplements. 
(4) On 4 July 2018, an application was submitt ed for the author isation of the use of polysorbate 65 (E 436) as an anti- 
foaming agent in several types of beverages. The application was subsequently made available to the Member States 
pursuant to Article 4 of Regulation (EC) No 1331/2008. 
(5) It results from the application that, the proposed use of polysorbate 65 (E 436) is required at the maximum level of 
10 mg/kg for containment and inhibition of foam during the manuf acture of carbonate d beverages by forming a 
layer around bubbles and stabilising larger bubbles preventing them to coalesce and break . The application shows 
that, the inhibition of foam is needed to efficiently operat e the production equipment, to reduce product waste, to 
maintain a safe workplace, and to keep facilities clean and in a hygienic state. 
(6) Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission has to seek the opinion of the European 
Food Safety Author ity (‘the Auth ority’) in order to update the Union list of food additives set out in Annex II to 
Regulation (EC) No 1333/2008, excep t where the update in question is not liable to have an effect on human health. 
(7) The safety of polysorbat es (E 432-436) used as food additives was re-evaluated by the Auth ority in 2015 (3). The 
Authority concluded that the exposure estimates did not exceed the acceptable daily intake (ADI) of 25 mg/kg body 
weight/da y in the refined non-brand-lo yal scenar io for all age groups at both the mean exposure level and the high 
level; although for todd lers at the highest level they were very close to the ADI. The Author ity noted that more data 
were needed to decrease uncer tainties in the refined exposure assessment scenar io used since no repor ted uses had 
been obtained for three food cate gories and that other dietar y sources of exposure to polysorbates could not be 
considered in the opinion. 
(1)OJ L 354, 31.12.2008, p. 16. 
(2)Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common 
author isation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1). 
(3)EFSA Jour nal 2015;13(7):4152. EN Offi cial Jour nal of the European Union 5.3.2020                                                                                                                                            L 67/31   (8) In the application the applicant estimate d the exposure by using the Food Additives Intake Model (4) developed by 
the Author ity. The estimates provi ded indicate that the additional exposure due to the requeste d extension of use is 
negligible (belo w 1 % of the ADI). 
(9) The extended use of polysorbate 65 (E 436) at the maximum level of 10 mg/kg in the food categor ies 14.1.4 
‘Flav oured drinks ’, 14.2.3 ‘Cider and perry’, 14.2.4 ‘Fruit wine and made wine ’ and 14.2.8 ‘Other alcoholic drinks 
including mixtures of alcoholic drinks with non-alcoholic drinks and spirits with less than 15 % of alcohol’ in Part E 
of Annex II to Regulation (EC) No 1333/2008 requires an update of the Union list whic h is not liable to have an 
effect on human health, since its impact on the overall exposure to polysorbate s (E 432-436) is negligible. 
Consequently , it is not necessar y to seek the opinion of the Auth ority. 
(10) For the sake of consistency , it is appropr iate to address the request ed use of (polysorbate 65) (E 436) by author ising 
the group polysorbate s (E 432-436) in the respective food catego ries. 
(11) Theref ore, it is appropr iate to author ise the use of polysorbat es (E 432-436) at the maximum level of 10 mg/kg in 
the food catego ries 14.1.4 ‘Flav oured drinks’, 14.2.3 ‘Cider and perry’, 14.2.4 ‘Fruit wine and made wine’ 
and 14.2.8 ‘Other alcoholic drinks including mixtures of alcoholic drinks with non-alcoholic drinks and spirits with 
less than 15 % of alcohol’. 
(12) Annex II to Regulation (EC) No 1333/2008 should theref ore be amended according ly. 
(13) 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 II to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this Regulation. 
Article 2 
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, 4 March 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     
(4)http://www .efsa.europa.eu/en/applications/f oodingredients/tools EN Offi cial Jour nal of the European Union L 67/32                                                                                                                                             5.3.2020   ANNEX 
Part E of Annex II to Regulation (EC) No 1333/2008 is amended as follows: 
(1) in food categor y 14.1.4 ‘Flav oured drinks ’, the following new entr y for polysorbate s (E 432-436) is inser ted after the entr y for soybean hemicellulose (E 426):  
‘E 432-436 Polysorbates 10 (1) only carbonate d drinks’   
(2) in food categor y 14.2.3 ‘Cider and perry’, the following new entr y for polysorbat es (E 432-436) is inser ted after the entr y for propane-1, 2-diol alginat e (E 405):  
‘E 432-436 Polysorbates 10 (1) only carbonate d drinks’   
(3) in food categor y 14.2.4 ‘Fruit wine and made wine’, the followi ng new entr y for polysorbates (E 432-436) is inser ted after the entr y for metatar taric acid (E 353):  
‘E 432-436 Polysorbates 10 (1) only carbonate d drinks’   
(4) in food catego ry 14.2.8 ‘Other alcoholic drinks including mixtures of alcoholic drinks with non-alcoholic drinks and spirits with less than 15 % of alcohol’, the followi ng new entr y for 
polysorbate s (E 432-436) is inser ted after the entr y for propane-1, 2-diol alginat e (E 405):  
‘E 432-436 Polysorbates 10 (1) only carbonate d drinks’   EN Offi cial Jour nal of the European Union 5.3.2020                                                                                                                                            L 67/33   