II 
(Non-legislative acts) 
REGUL ATIONS 
COMMI SSION IMPLEMENTING REGUL ATION (EU) 2018/1648 
of 29 Oct ober 2018 
author ising the placing on the marke t 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, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having 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 of the European Parliament and of the Council and Commission Regulation (EC) 
No 1852/2001 (1), and in particular Article 12 thereof, 
Whereas: 
(1)  Regulation (EU) 2015/2283 provi des that only novel foods author ised and included in the Union list may be 
placed on the market within the Union. 
(2)  Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing 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 decide on the author isation and on 
the placing on the Union market of a novel food and on the updating of the Union list. 
(4)  On 4 May 2016, the compan y Long live Europe Food Division Ltd (‘the Applicant’ ) submitte d a request to the 
compet ent author ity of Hungar y to place xylo-oligosacchar ides on the Union market as a novel food ingredient 
within the meaning of point (e) of Article 1(2) of Regulation (EC) No 258/97 of the European Parliament and of 
the Council (3). The application requests for xylo-oligosacchari des to be used in a number of food cate gories, 
namely , baker y and dair y products, fruit spreads, chocolate confecti oner y and soy-dr inks for the general 
population. 
(5)  Pursuant to Article 35(1) of Regulation (EU) 2015/2283, any request for placing a novel food on the mark et 
within the Union submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97, and 
for which the final decision has not been taken before 1 Januar y 2018, shall be treated as an application 
submitte d under Regulation (EU) 2015/2283. 
(6)  While the request for placing xylo-oligosacchari des on the mark et as a novel food within the Union was 
submitte d to a Member State in accordance with Article 4 of Regulation (EC) No 258/97, the application also 
meets the requirements laid down in Regulation (EU) 2015/2283. 6.11.2018 L 275/1 Official Jour nal of the European Union EN     
(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)Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 Januar y 1997 concer ning novel foods and novel food 
ingredients (OJ L 43, 14.2.1997, p. 1). (7)  On 18 July 2016, the compet ent author ity of Hung ary issued its initial assessment repor t. In that repor t, it 
concluded that xylo-oligosacc harides meets the criteria for a novel food ingredient set out in Article 3(1) of 
Regulation (EC) No 258/97. 
(8)  On 12 June 2017, the Commission forwarded the initial assessment repor t to the other Member States. Reasoned 
objections were raised by other Member State s within the 60-da y period laid down in the first subparagraph of 
Article 6(4) of Regulation (EC) No 258/97 with rega rd to the specif ications, stability , anticipated daily intake and 
toxicological studies. 
(9)  In view of the objections raised by the other Member States, the Commission consult ed the European Food Safety 
Author ity (‘the Auth ority’) on 6 September 2017, asking it to carry out an additional assessment for xylo- 
oligosacc harides as a novel food ingredient in accordance with Regulation (EC) No 258/97. 
(10)  On 27 June 2018, the Auth ority adop ted the ‘Scientif ic Opinion on the safety of xylo-oligosacc harides as a novel 
food pursuant to Regulation (EU) 2015/2283’ (1). This opinion is in line with the requirements of Article 11 of 
Regulation (EU) 2015/2283. 
(11)  That opinion gives sufficient grounds to establish that xylo-oligosacchari des in the proposed uses and use levels 
when used as an ingredient in baker y and dair y products, fruit spreads, chocolat es and soy-dr inks, complies with 
Article 12(1) of Regulation (EU) 2015/2283. 
(12)  Regulation (EU) No 1308/2013 of the European Parliament and of the Council (2) lays down requirements for 
milk and milk products which apply to xylo-oligosacc harides when used as an ingredient in 
milk products. Pursuant to point 2 of Part III of Annex VII to that Regulation, xylo-oligosacchari des cannot be 
used in milk products to replace, in whole or in part, any milk constituent. The use of xylo-oligosacc harides as 
a novel food in milk products should theref ore be limite d according ly. 
(13)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
1. Xylo-oligosaccharides as specified in the Annex to this Regulation shall be included in the Union list of author ised 
novel foods established in Imple menting Regulation (EU) 2017/2470. 
2. The entr y in the Union list referred to in the first paragraph shall include the conditions of use and labelling 
requirements laid down in the Annex to this Regulation. 
3. The author isation provid ed for in this Article shall be without prejudice to the provi sions of Regulation (EU) 
No 1308/2013. 
Article 2 
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation. 
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. 6.11.2018 L 275/2 Official Jour nal of the European Union EN     
(1)EFSA Jour nal 2018;16(7): 5361 
(2)Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common 
organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) 
No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, p. 671). This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 29 October 2018. 
For the Commission 
The President 
Jean-Claude JUNCK ER  6.11.2018 L 275/3 Official Jour nal of the European Union EN     ANNEX 
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:  
(1) The followi ng entr y is inser ted in Table 1 (Author ised novel foods) in alphabetical order: 
Author ised novel food Conditions under whic h the novel food may be used Additional specific labelling requirements Other requirements 
‘Xylo-oligosacchari des Specified food categor y Maximum levels (**) The designation of the novel food on the la­
belling of the foodstuffs containing it shall 
be “Xylo-oligosaccharides”’  Whit e bread 14 g/kg 
Whole meal 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 
Chocolat e confe ctioner y 30 g/kg  
(*) When used in milk products xylo-oligosacc harides shall not replace, in whole or 
in part, any milk constituent  
(**) Maximum levels calculated on the basis of the specific ations of Powder form 1.   
(2) The followi ng entr y is inser ted in Table 2 (Specifi cations) in alphabetical order: 
Author ised Novel Food Specification 
‘Xylo-oligosacchari des Descr iption: 
The novel food is a mixture of xylo-oligosacchar ides (XOS) which are obtained from corncobs (Zea mays subsp. mays) via hydrolysis by a xylanase 
from Trichoder ma reesei follo wed by a purification process. 
Character istics/Composition 
Paramet er Powder form 1 Powder form 2 Syrup form 
Moisture (%) ≤ 5,0 ≤ 5,0 70-75 
Prot ein (g/100 g) < 0,2 6.11.2018 L 275/4 Official Jour nal of the European Union EN     Author ised Novel Food Specification  
Ash (%) ≤ 0,3 
pH 3,5-5,0 
Total carbohydrat e conte nt (g/100 g) ≥ 97 ≥ 95 ≥ 70 
XOS cont ent (dry basis) (g/100 g) ≥ 95 ≥ 70 ≥ 70 
Other carbohydrat es (g/100 g) (a) 2,5-7,5 2-16 1,5-31,5 
Monosacc harides tota l (g/100 g) 0-4,5 0-13 0-29 
Glucose (g/100 g) 0-2 0-5 0-4 
Arabinose (g/100 g) 0-1,5 0-3 0-10 
Xylose (g/100 g) 0-1,0 0-5 0-15 
Disacch arides total (g/100 g) 27,5-48 25-43 26,5-42,5 
Xylobiose (XOS DP2) (g/100 g) 25-45 23-40 25-40 
Cellobiose (g/100 g) 2,5-3 2-3 1,5-2,5 
Oligosacc harides total (g/100 g) 41-77 36-72 32-71 
xylotr iose (XOS DP3) (g/100 g) 27-35 18-30 18-30 
xylotet raose (XOS DP4) (g/100 g) 10-20 10-20 8-20 
xylopentaose (XOS DP5) (g/100 g) 3-10 5-10 3-10 
xylohexaose (XOS DP6) (g/100 g) 1-5 1-5 1-5 
Xyloheptaose (XOS DP7) (g/100 g) 0-7 2-7 2-6 
Maltod extr in (g/100 g) (b) 0 20-25 0 
Copper (mg/kg) < 5,0 
Lead (mg/kg) < 0,5 
Arsenic (mg/kg) < 0,3 6.11.2018 L 275/5 Official Jour nal of the European Union EN     Author ised Novel Food Specification  
Salmonella (CFU (c)/25 g) Neg ative 
E, coli (MPN (d)/100 g) Neg ative 
Yeast (CFU/g) < 10 
Mould (CFU/g) < 10 
DP: Degree of polymer ization 
(a)  Other carbohydrat es include monosacchar ides (glucose, xylose and arabinose) and cellobiose. 
(b)  Maltodextrin content is calculated according to the amount added in the process. 
(c)  CFU: Colony Forming Units. 
(d)  MPN: Most Probable Number .’   6.11.2018 L 275/6 Official Jour nal of the European Union EN