Commission Implementing Regulation (EU) 2018/1648 of 29 October 2018 authorising the placing on the market of xylo-oligosaccharides 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.)

COMMISSION IMPLEMENTING REGULATION (EU) 2018/1648

of 29 October 2018

authorising the placing on the market of xylo-oligosaccharides 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)

Article 1

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 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.

ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

• (1) The following entry is inserted in Table 1 (Authorised novel foods) in alphabetical order: Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements ‘Xylo-oligosaccharides Specified food category Maximum levels () The designation of the novel food on the labelling of the foodstuffs containing it shall be “Xylo-oligosaccharides”’ White bread 14 g/kg Whole meal bread 14 g/kg Breakfast cereals 14 g/kg Biscuits 14 g/kg Soy drink 3,5 g/kg Yoghurt () 3,5 g/kg Fruit spreads 30 g/kg Chocolate confectionery 30 g/kg ()  When used in milk products xylo-oligosaccharides shall not replace, in whole or in part, any milk constituent ()  Maximum levels calculated on the basis of the specifications of Powder form 1.

• (2) The following entry is inserted in Table 2 (Specifications) in alphabetical order: Authorised Novel Food Specification

Xylo-oligosaccharides Description: The novel food is a mixture of xylo-oligosaccharides (XOS) which are obtained from corncobs (Zea mays subsp. mays) via hydrolysis by a xylanase from Trichoderma reesei followed by a purification process. Characteristics/Composition: Parameter Powder form 1 Powder form 2 Syrup form Moisture (%) ≤ 5,0 ≤ 5,0 - Dry material (%) - - 70 -75 Protein (g/100 g) < 0,2 Ash (%) ≤ 0,3 pH 3,5 -5,0 Total carbohydrate content (g/100 g) ≥ 97 ≥ 95 ≥ 70 XOS content (dry basis) (g/100 g) ≥ 95 ≥ 70 ≥ 70 Other carbohydrates (g/100 g)^a 2,5 -7,5 2 -16 1,5 -31,5 Monosaccharides total (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 Disaccharides 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 Oligosaccharides total (g/100 g) 41 -77 36 -72 32 -71 xylotriose (XOS DP3) (g/100 g) 27 -35 18 -30 18 -30 xylotetraose (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 Maltodextrin (g/100 g)^b 0 20 -25 0 Copper (mg/kg) < 5,0 Lead (mg/kg) < 0,5 Arsenic (mg/kg) < 0,3 Salmonella (CFU^c/25 g) Negative E. coli (MPN^d/100 g) Negative Yeast (CFU/g) < 10 Mould (CFU/g) < 10 ^a  Other carbohydrates include monosaccharides (glucose, xylose and arabinose) and cellobiose. ^b  Maltodextrin content is calculated according to the amount added in the process. DP:  Degree of polymerization ^c  CFU: Colony Forming Units ^d  MPN: Most Probable Number