COMMI SSION REGUL ATION (EU) 2020/279 
of 27 Febr uary 2020 
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council 
as regards the use of soybean hemicellulose (E 426) 
(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, soybean hemicellulose (E 426) is currently author ised for 
use as a food additive in a wide variety of foods at maximum levels ranging between 1 500 and 30 000 mg/kg. 
(4) On 16 August 2017, an application was submitted for the extension of use of soybean hemicellulose (E 426) as a 
stabiliser in flavoured fermented milk products and flavoured drinks. The application was subsequently made 
available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008. 
(5) Soybean hemicellulose (E 426), when used as a stabiliser in flavour ed fermented milk products and flavoured drinks, 
prevents an agglomeration and precipitation of proteins and phase separation under acidic conditions. 
(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) On 14 Marc h 2017, the Author ity published a scientific opinion re-evaluating the safety of soybean hemicellulose (E 
426) as a food additive (3). The Author ity concluded that it is very unlikely that there is a safet y concer n from the 
current use of soybean hemicellulose (E 426) as a food additive, and that there is no need for a numer ical acceptable 
daily intake (ADI). Such conclusion is used for substances of a very low safety concer n and only if there is reliable 
information for both exposure and toxicity and there is a low probability of adverse health effects in humans at 
doses that do not induce nutr itional imbalance in animals (4). 
(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 Journal 2017;15(3):4721. 
(4)EFSA Journal 2014;12(6):3697, Statement on a concept ual framework for the risk assessment of certain food additives re-evaluated 
under Commission Regulation (EU) No 257/2010. EN Offi cial Jour nal of the European Union L 59/6                                                                                                                                            28.2.2020   (8) Part C of Annex II to Regulation (EC) No 1333/2008 defines all groups of additives. In general, Group I of Part C lists 
food additives, excep t for colours and sweet eners, for which there is no need for a numer ical acceptable daily intake 
and which are author ised for use in many foods in accordance with quantum satis principle as defined in Article 3(2) 
(h) of that Regulation. 
(9) The outcome of the safety assessment of soybean hemicellulose (E 426) allows its inclusion in Group I of Part C of 
Annex II to Regulation (EC) No 1333/2008. Since in accordance with Part E of Annex II to Regulation (EC) 
No 1333/2008 the use of Group I additives is already permitted in flavoured fermented milk products and 
flavour ed drinks, the inclusion of soybean hemicellulose (E 426) in Group I would address the request ed extensi on 
of use. The inclusion of soybean hemicellulose (E 426) in Group I would also mak e redundant the existing entr ies 
for soybean hemicellulose (E 426) in Part E of Annex II to Regulation (EC) No 1333/2008 since the use of Group I 
additives is permitted in all the concer ned food categor ies, and they should be theref ore delet ed. Similarly , the 
existing reference to the maximum level of soybean hemicellulose (E 426) in the introduction part for food categor y 
17 (Food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (5)) in Part 
E of Annex II to Regulation (EC) No 1333/2008 should be delet ed, since within Group I soybean hemicellulose (E 
426) is to be author ised in accordance with the quantum satis principle. 
(10) Annex II to Regulation (EC) No 1333/2008 should theref ore be amended according ly. 
(11) 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, 27 Febr uary 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     
(5)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). EN Offi cial Jour nal of the European Union 28.2.2020                                                                                                                                            L 59/7   ANNEX 
Annex II to Regulation (EC) No 1333/2008 is amended as follows : 
(1) in Part C, Group I, the entr y for E 426 is inser ted after the entr y for E 425: 
‘E 426 Soybean hemicellulose quantum satis ’   
(2) part E is amended as follows: 
(a) The entr ies for E 426 (Soybean hemicellulose) in cate gories 04.2.6 (Processed potato products), 05.2 (Other confect ioner y including breath freshening microsweets), 05.4 
(Decorations, coatings and fillings, excep t fruit-based fillings covered by catego ry 4.2.4), 06.5 (Noodles), 06.7 (Pre-cooked or processed cereals), 07.2 (Fine baker y wares), 10.2 
(Processed eggs and egg products), 12.6 (Sauces), 14.1.4 (Flav oured drinks), 17.1 (Food supplements supplied in a solid form, excluding food supplements for infants and young 
children) and 17.2 (Food supplements supplied in a liquid form, excl uding food supplements for infants and young children) are delet ed. 
(b) The introductor y part of entr y for food catego ry 17. ‘Food supplements as defined in Directive 2002/46/EC’ is replaced as follows: 
‘17. Food supplements as defined in Directiv e 2002/46/EC  
INTR ODUCTION PART , APPLIES TO ALL SUBCA TEGORIES  
The maximum levels of use indicated for colours, poly ols, sweetene rs, and E 200-213, E 338-452, E 405, E 416, E 432-436, E 459, E 468, E 473-475, E 491-495, E 
551-553, E 901-904, E 961, E 1201-1204, E 1505 and E 1521 refer to the food supplements ready for consum ption prepared followi ng the instr uctions of use 
provid ed by the manufacturer . 
The dilution factor for those food supplements that have to be dilut ed or dissolved has to be communicated together with the instr uctions of use.’   EN Offi cial Jour nal of the European Union L 59/8                                                                                                                                            28.2.2020