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Document 02018R1648-20230129
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)Text with EEA relevance
Consolidated text: 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)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)Text with EEA relevance
ELI: http://data.europa.eu/eli/reg_impl/2018/1648/2023-01-29
02018R1648 — EN — 29.01.2023 — 001.001
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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 (OJ L 275 6.11.2018, p. 1) |
Amended by:
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Official Journal |
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No |
page |
date |
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COMMISSION IMPLEMENTING REGULATION (EU) 2023/65 of 6 January 2023 |
L 6 |
1 |
9.1.2023 |
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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:
The following entry is inserted in Table 1 (Authorised novel foods) in alphabetical order:
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Authorised novel food |
Conditions under which the novel food may be used |
Additional specific labelling requirements |
Other requirements |
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‘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”’ |
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White bread |
14 g/kg |
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Whole meal bread |
14 g/kg |
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Breakfast cereals |
14 g/kg |
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Biscuits |
14 g/kg |
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Soy drink |
3,5 g/kg |
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Yoghurt (*) |
3,5 g/kg |
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Fruit spreads |
30 g/kg |
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Chocolate confectionery |
30 g/kg |
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(*) 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. |
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The following entry is inserted in Table 2 (Specifications) in alphabetical order:
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Authorised Novel Food |
Specification |
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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: |
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Parameter |
Powder form 1 |
Powder form 2 |
Syrup form |
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Moisture (%) |
≤ 5,0 |
≤ 5,0 |
- |
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Dry material (%) |
- |
- |
70 -75 |
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Protein (g/100 g) |
< 0,2 |
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Ash (%) |
≤ 0,3 |
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pH |
3,5 -5,0 |
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Total carbohydrate content (g/100 g) |
≥ 97 |
≥ 95 |
≥ 70 |
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XOS content (dry basis) (g/100 g) |
≥ 95 |
≥ 70 |
≥ 70 |
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Other carbohydrates (g/100 g)a |
2,5 -7,5 |
2 -16 |
1,5 -31,5 |
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Monosaccharides total (g/100 g) |
0 -4,5 |
0 -13 |
0 -29 |
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Glucose (g/100 g) |
0 -2 |
0 -5 |
0 -4 |
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Arabinose (g/100 g) |
0 -1,5 |
0 -3 |
0 -10 |
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Xylose (g/100 g) |
0 -1,0 |
0 -5 |
0 -15 |
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Disaccharides total (g/100 g) |
27,5 -48 |
25 -43 |
26,5 -42,5 |
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Xylobiose (XOS DP2) (g/100 g) |
25 -45 |
23 -40 |
25 -40 |
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Cellobiose (g/100 g) |
2,5 -3 |
2 -3 |
1,5 -2,5 |
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Oligosaccharides total (g/100 g) |
41 -77 |
36 -72 |
32 -71 |
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xylotriose (XOS DP3) (g/100 g) |
27 -35 |
18 -30 |
18 -30 |
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xylotetraose (XOS DP4) (g/100 g) |
10 -20 |
10 -20 |
8 -20 |
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xylopentaose (XOS DP5) (g/100 g) |
3 -10 |
5 -10 |
3 -10 |
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xylohexaose (XOS DP6) (g/100 g) |
1 -5 |
1 -5 |
1 -5 |
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Xyloheptaose (XOS DP7) (g/100 g) |
0 -7 |
2 -7 |
2 -6 |
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Maltodextrin (g/100 g)b |
0 |
20 -25 |
0 |
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Copper (mg/kg) |
< 5,0 |
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Lead (mg/kg) |
< 0,5 |
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Arsenic (mg/kg) |
< 0,3 |
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Salmonella (CFUc/25 g) |
Negative |
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E. coli (MPNd/100 g) |
Negative |
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Yeast (CFU/g) |
< 10 |
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Mould (CFU/g) |
< 10 |
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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 |
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