Commission Implementing Regulation (EU) 2023/65 of 6 January 2023 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods, Implementing Regulation (EU) 2018/1648 authorising the placing on the market of xylo-oligosaccharides as a novel food, Implementing Regulation (EU) 2019/1686 authorising the extension of use of bovine milk basic whey protein isolate as a novel food, and Implementing Regulation (EU) 2021/96 authorising the placing on the market of 3'-sialyllactose sodium salt as a novel food (Text with EEA relevance)

Article 1

The Annex to Implementing Regulation (EU) 2017/2470 is corrected in accordance with Annex I to this Regulation.

Article 2

Implementing Regulation (EU) 2018/1648 is corrected in accordance with Annex II to this Regulation.

Article 3

Implementing Regulation (EU) 2019/1686 is corrected in accordance with Annex III to this Regulation.

Article 4

Implementing Regulation (EU) 2021/96 is corrected in accordance with Annex IV to this Regulation.

Article 5

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Correction of Implementing Regulation (EU) 2017/2470

ANNEX ISupplementary provisions

ANNEX I Correction of Implementing Regulation (EU) 2017/2470 The Annex to Implementing Regulation (EU) 2017/2470 is corrected as follows: (1) in Table 1 (Authorised novel foods), the entry for ‘Bovine milk basic whey protein isolate’ is replaced by the following: 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” (*) Depending on the age group the food supplement is intended for.   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 (2) in Table 1 (Authorised novel foods), the entry for ‘3'-Sialyllactose (3'-SL) sodium salt (microbial source)’ is replaced by the following: 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: a) if foods containing added 3'-Sialyllactose sodium salt are consumed on the same day. b) by infants and young children   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 (3) in Table 2 (Specifications), the entry for ‘Galacto-oligosaccharide’ is replaced by the following: ‘ 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’ (4) in Table 2 (Specifications), the entry for ‘Xylo-oligosaccharide’ is replaced by the following: 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’

Correction of Implementing Regulation (EU) 2018/1648

ANNEX IISupplementary provisions

ANNEX II Correction of Implementing Regulation (EU) 2018/1648 In point 2 of the Annex to Implementing Regulation (EU) 2018/1648, in Table 2 (Specifications), the entry for ‘Xylo-oligosaccharide’ is replaced by the following: 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’

Correction of Implementing Regulation (EU) 2019/1686

ANNEX IIISupplementary provisions

ANNEX III Correction of Implementing Regulation (EU) 2019/1686 In point 1 of the Annex to Implementing Regulation (EU) 2019/1686, in Table 1 (Authorised novel foods), the entry for ‘Bovine milk basic whey protein isolate’ is replaced by the following: 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” (*) Depending on the age group the food supplement is intended for.   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

Correction of Implementing Regulation (EU) 2021/96

ANNEX IVSupplementary provisions

ANNEX IV Correction of Implementing Regulation (EU) 2021/96 In point 1 of the Annex to Implementing Regulation (EU) 2021/96, in Table 1 (Authorised novel foods), the entry for ‘3'-Sialyllactose (3'-SL) sodium salt (microbial source)’ is replaced by the following: 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: a) if foods containing added 3'-Sialyllactose sodium salt are consumed the same day. b) by infants and young children   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