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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.)

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.)

Implementing Regulation (EU) 2018/1648 Β· Regulation Β· 4 articles

Data as of 2026-07-04 Β· Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. Β· Read the official text β†—

Article 1

1.Β Β Β 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. 2.Β Β Β 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. 3.Β Β Β 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 .

Supplementary provisions

ANNEXSupplementary provisions

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 β€˜Xylo-oligosaccharides Specified food category Maximum levels (**) The designation of the novel food on the labelling of the foodstuffs containing it shall be β€œXylo-oligosaccharides”’ Β  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 β€˜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) β‰₯ 97 β‰₯ 95 β‰₯ 70 XOS content (dry basis) (g/100 g) β‰₯ 95 β‰₯ 70 β‰₯ 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.’

Source: EUR-Lex (Publications Office of the EU), Β© European Union, reuse permitted under Commission Decision 2011/833/EU.

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