COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/916 
of 1 July 2020 
author ising the extension of use of xylo-oligosacchar ides as a novel food under Regulation (EU) 
2015/2283 of the European Parliament and of the Council and amending Commission Implementing 
Regulation (EU) 2017/2470 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Havi ng regar d to the Treaty on the Functioning of the European Union, 
Havi ng regar d to 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 and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof, 
Whereas: 
(1) Regulation (EU) 2015/2283 provides that only novel foods author ised and included in the Union list may be placed 
on the mark et within the Union. 
(2) Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Imple menting Regulation (EU) 2017/2470 (2) 
establishing a Union list of author ised novel foods was adopt ed. 
(3) Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to submit a draf t implementing act 
author ising placing on the Union mark et of a novel food and on the updating of the Union list. 
(4) Commission Implementing Regulation (EU) 2018/1648 (3) author ised the placing on the Union mark et of xylo- 
oligosacc harides as a novel food under Regulation (EU) 2015/2283, to be used in a number of food categor ies, 
namely , bread, breakfast cereals, biscuits, soy-dr inks, yoghur t, fruit spreads and chocolat e confecti oner y for the 
general population. 
(5) On 25 November 2019, the compan y Shandong Long live Biot echn ology Co. Ltd submitted an application to the 
Commission to change the conditions of use of the novel xylo-oligosacc harides pursuant to Article 10(1) of 
Regulation (EU) 2015/2283. The application request ed to extend the use of xylo-oligosacc harides in food 
supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (4) intended for the 
general adult population at the maximum use levels of 2 g per day. 
(1)OJ L 327, 11.12.2015, p. 1. 
(2)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). 
(3)Commission Implementing Regulation (EU) 2018/1648 of 29 October 2018 author ising the placing on the market of xylo- 
oligosaccha rides as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending 
Commission Implementing Regulation (EU) 2017/2470 (OJ L 275, 6.11.2018, p. 1). 
(4)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 L 209/6                                                                                                                                             2.7.2020   (6) The Commission considers that a safet y evaluation of the current application by the European Food Safet y Author ity 
(‘the Author ity’) in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessar y, as the proposed 
extensi on of use of xylo-oligosacc harides is covered by the safety assessment conduct ed by the Auth ority(5) 
underlying the author isation of xylo-oligosacchari des by Implementing Regulation (EU) 2018/1648. 
(7) In that opinion, the Authority conduct ed a conser vative exposure assessment, using the highest anticipate d daily 
intake based on the assump tion that a person would consume all proposed food products containing the maximum 
added amount of the xylo-oligosacchar ides. On the basis of this exposure assessment, the Author ity concluded that 
the resulting highest anticipated daily intake of 7,7 g of xylo-oligosacc harides per day still remains way below both, 
the daily intake levels of 10–12 g of xylo-oligosacc harides that were associated with acute and transient gastro- 
intest inal effects in human clinical inter vention studies, and below the Dietar y Reference Value (‘DR V’) of 25 g of 
dietar y fibre per day for the general adult population previously established by the Auth ority(6). 
(8) The intak e from the proposed extension of use of xylo-oligosacc harides in food supplements at levels of 2 g per day, 
combined with the highest intake of 7,7 g xylo-oligosacchari des from its currently author ised uses as a novel food, 
could result in an overall maximum intak e of 9,7 g xylo-oligosacchari des per day. This overall intake level will also 
be below both the intake levels of 10–12 g of xylo-oligosacc harides that were associated with acute and transient 
gastro-intestinal effects in human clinical inter vention studies, and below the Dietar y Reference Value (‘DR V’) of 25 
g dietar y fibre per day for the general adult population established by the Author ity. 
(9) The information provided in the application and the scientifi c opinion of the Author ity combined with the abov e 
considerations give suffi cient grounds to establish that the proposed extensi on of use of the novel food ‘xylo- 
oligosacc harides ’ compl ies with Article 12 of Regulation (EU) 2015/2283. 
(10) It is theref ore appropr iate to amend the conditions of use of xylo-oligosacchari des in the Union list of author ised 
novel foods by including the use of xylo-oligosacc harides in food supplements intended for the adult population. 
(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 
The Union list of author ised novel foods, established under Implemen ting Regulation (EU) 2017/2470, referring to the 
novel food xylo-oligosacc harides, is amended as specified in the Annex to this Regulation. 
Article 2 
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation. 
(5)Scientific Opinion on the safety of xylo-oligosaccharides as a novel food pursuant to Regulation (EU) 2015/2283 (EFSA Journal 
2018;16(7): 5361). 
(6)Scientific Opinion on Dietar y Reference Values for carboh ydrates and dietar y fibre (EFSA Journal 2010;8(3):1462). EN Offi cial Jour nal of the European Union 2.7.2020                                                                                                                                            L 209/7   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, 1 July 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union L 209/8                                                                                                                                             2.7.2020   ANNEX 
In the Annex to Implementing Regulation (EU) 2017/2470, the entr y for ‘xylo-oligosacchar ides’ in Table 1 (Auth orised novel foods) is replaced by the followi ng:                                                                 
Autho rised novel food Conditions under whic h the novel food may be used Additional specific labelling 
requirements Other requirements 
‘Xylo-oligosaccharides Specified food categor y Maximum levels (**) The designation of the novel food on 
the labelling of the foodstuffs con­
taining it shall be “Xylo-oligosac­
charides”  White bread 14 g/kg 
Wholemeal bread 14 g/kg 
Breakf ast cereals 14 g/kg 
Biscuits 14 g/kg 
Soy drink 3,5 g/kg 
Yoghur t (*) 3,5 g/kg 
Fruit spreads 30 g/kg 
Chocolate confecti oner y 30 g/kg 
Food supplements as defined in Di­
rective 2002/46/EC for the general 
adult population 2 g/da y 
(*) When used in milk products xylo-oligosaccha rides shall not replace, in whole or in part, any milk constituent. 
(**) Maximum levels calculated on the basis of the specificatio ns of Powder form 1.’   EN Offi cial Jour nal of the European Union 2.7.2020                                                                                                                                            L 209/9