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

   Xylo-oligosaccharides as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.
   The entry 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.
   The authorisation provided for in this Article shall be without prejudice to the provisions 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 following that of its publication in the Official Journal of the European Union .

ANNEX

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
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
DP: Degree of polymerization
( a )
Other carbohydrates include monosaccharides (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.’

Schedules & Appendices

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