Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data Protection

‘Bovine milk basic whey protein isolate

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be “Milk whey protein isolate”.

Food supplements containing bovine milk basic whey protein isolate shall bear the following statement:

“This food supplement should not be consumed by infants/children/adolescents under the age of one/three/eighteen (*) years”

Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France. During the period of data protection the novel food bovine milk basic whey protein isolate is authorised for placing on the market within the Union only by Armor Protéines S.A.S. unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Armor Protéines S.A.S. End date of the data protection: 20 November 2023.’

Infant formulae as defined in Regulation (EU) No 609/2013

30 mg/100 g (powder)

3,9 mg/100 mL (reconstituted)

Follow-on formulae as defined in Regulation (EU) No 609/2013

30 mg/100 g (powder)

4,2 mg/100 mL (reconstituted)

Total diet replacement foods for weight control as defined in Regulation (EU) No 609/2013

300 mg/day

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

30 mg/100 g (powder formula for infants during the first months of life until the introduction of appropriate complementary feeding)

3,9 mg/100 mL (reconstituted formula for infants during the first months of life until the introduction of appropriate complementary feeding)

30 mg/100 g (powder formula for infants when appropriate complementary feeding is introduced)

4,2 mg/100 mL (reconstituted formula for infants when appropriate complementary feeding is introduced)

58 mg/day for young children

380 mg/day for children and adolescents from 3 to 18 years of age

610 mg/day for adults

Food supplements as defined in Directive 2002/46/EC

25 mg/day for infants

58 mg/day for young children

250 mg/day for children and adolescents from 3 to 18 years of age

610 mg/day for adults

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data Protection

‘3'-Sialyllactose (3'-SL) sodium salt

(microbial source)

Specified food category

Maximum levels (expressed as 3'-Sialyllactose)

The designation of the novel food on the labelling of the foodstuffs containing it shall be “3'-Sialyllactose sodium salt”.

The labelling of food supplements containing 3'-Sialyllactose sodium salt shall bear a statement that they should not be consumed:

Authorised on 18 February 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 3'-sialyllactose sodium salt is authorised for placing on the market within the Union only by Glycom A/S, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Glycom A/S.

End date of the data protection: 18 February 2026.’

Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products

0,25 g/L

Unflavoured fermented milk-based products

0,25 g/L (beverages)

0,5 g/kg (products other than beverages)

Flavoured fermented milk-based products including heat-treated products

0,25 g/L (beverages)

2,5 g/kg (products other than beverages)

Beverages (flavoured drinks, excluding drinks with a pH less than 5)

0,25 g/L

Cereal bars

2,5 g/kg

Infant formula as defined in Regulation (EU) No 609/2013

0,2 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

Follow-on formula as defined in Regulation (EU) No 609/2013

0,15 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

Processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013

0,15 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

1,25 g/kg for products other than beverages

Milk-based drinks and similar products intended for young children

0,15 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

Total diet replacement foods for weight control as defined in Regulation (EU) No 609/2013

0,5 g/L (beverages)

5 g/kg (products other than beverages)

Food for special medical purposes as defined in Regulation (EU) No 609/2013

In accordance with the particular nutritional requirements of the persons for whom the products are intended

Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children

0,5 g/day

‘Galacto-oligosaccharide

Description/Definition:

Galacto-oligosaccharide is produced from milk lactose by an enzymatic process using β-galactosidases from Aspergillus oryzae, Bifidobacterium bifidum, Pichia pastoris, Sporobolomyces singularis, Kluyveromyces lactis and Papiliotrema terrestris.

GOS: min. 46 % Dry Matter (DM)

Lactose: max. 40 % DM

Glucose: max. 22 % DM

Galactose: min. 0,8 % DM

Ash: max. 4,0 % DM

Protein: max. 4,5 % DM

Nitrite: max. 2 mg/kg’

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 (CFUc/25 g)

Negative

E. coli (MPNd/100 g)

Negative

Yeast (CFU/g)

< 10

Mould (CFU/g)

< 10