Address https://gelex.eu/eli/EU/regulation/2023/65@2023-01-06/en

Contents

1. Preamble
2. 1. Article 1
   2. Article 2
   3. Article 3
   4. Article 4
   5. Article 5
3. ANNEX
4. ANNEX I Correction of Implementing Regulation (EU) 2017/2470
5. (2) a)
6. ANNEX II abDP:cd Correction of Implementing Regulation (EU) 2018/1648
7. ANNEX III (*) Correction of Implementing Regulation (EU) 2019/1686
8. ANNEX IV Correction of Implementing Regulation (EU) 2021/96
9. a)
10. b)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001, and in particular Articles 8 and 12 thereof,

Whereas:

(1) Pursuant to Article 8 of Regulation (EU) 2015/2283, the Commission was to establish, by 1 January 2018, the Union list of novel foods authorised or notified under Regulation (EC) No 258/97 of the European Parliament and of the Council.

(2) The Union list of novel foods authorised or notified under Regulation (EC) No 258/97 was established by Commission Implementing Regulation (EU) 2017/2470.

(3) The Commission has identified errors in the Annex to Implementing Regulation (EU) 2017/2470. Corrections are needed in order to provide clarity and legal certainty to food business operators and to the Member States’ competent authorities, thus ensuring the proper implementation and use of the Union list of novel foods.

(4) The conditions of use of the novel food bovine milk basic whey protein isolate, authorised by Commission Implementing Regulation (EU) 2018/1632, were subsequently extended by Commission Implementing Regulation (EU) 2019/1686. In Table 1 of the Annex to Implementing Regulation (EU) 2019/1686, the lines separating the specified food categories and the maximum authorised levels were erroneously omitted, thereby making unclear what food category corresponds to what authorised use. That might create confusion for enforcement authorities and the food business operators. Therefore, a correction of the Annex to Implementing Regulation (EU) 2019/1686 and Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

(5) The novel food 3'-Sialyllactose sodium salt (microbial source) was authorised by Commission Implementing Regulation (EU) 2021/96. The maximum levels indicated for the food category Flavoured fermented milk-based products including heat-treated products were erroneously added to the food category Unflavoured fermented milk-based products, and vice versa. Therefore, a correction of Table 1 of Annex to Implementing Regulation (EU) 2021/96 and Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

(6) The novel food Galacto-oligosaccharide was authorised under certain conditions of use pursuant to Article 5 of Regulation (EC) No 258/97. The microbial source Bacillus circulans of the enzyme β-galactosidase used for the production of the Galacto-oligosaccharide was erroneously added to the specifications. Therefore, this source of β-galactosidase should be removed from the entry Galacto-oligosaccharide in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470.

(7) The novel food Xylo-oligosaccharide was authorised under certain conditions of use by Commission Implementing Regulation (EU) 2018/1648, based on a favourable opinion on the safety of the novel food by the European Food Safety Authority (the Authority). The specifications of the syrup form of Xylo-oligosaccharide erroneously did not contain the parameter dry material in the corresponding column. This error has been corrected in the revised scientific opinion of the Authority. Therefore, the specifications concerning Xylo-oligosaccharide in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 and in the Annex to Implementing Regulation (EU) 2018/1648 should be corrected accordingly.

(8) Implementing Regulation (EU) 2017/2470, Implementing Regulation (EU) 2018/1648, Implementing Regulation (EU) 2019/1686 and Implementing Regulation (EU) 2021/96 should therefore be corrected accordingly.

(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

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.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 6 January 2023. For the Commission The President Ursula von der Leyen

ANNEX

(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 (a) if foods containing added 3'-Sialyllactose sodium salt are consumed on the same day. (b) by infants and young children (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: 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 (4abdpcd) 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 (CFUc/25 g) Negative E. coli (MPNd/100 g) Negative Yeast (CFU/g) < 10 Mould (CFU/g) < 10 Other carbohydrates include monosaccharides (glucose, xylose and arabinose) and cellobiose. Maltodextrin content is calculated according to the amount added in the process. Degree of polymerization CFU: Colony Forming Units MPN: Most Probable Number Anx. i. The Annex to Implementing Regulation (EU) 2017/2470 is corrected as follows:

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 (a) if foods containing added 3'-Sialyllactose sodium salt are consumed on the same day. (b) by infants and young children (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: 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 (4abdpcd) 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 (CFUc/25 g) Negative E. coli (MPNd/100 g) Negative Yeast (CFU/g) < 10 Mould (CFU/g) < 10 Other carbohydrates include monosaccharides (glucose, xylose and arabinose) and cellobiose. Maltodextrin content is calculated according to the amount added in the process. Degree of polymerization CFU: Colony Forming Units MPN: Most Probable Number

(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: 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 (a) if foods containing added 3'-Sialyllactose sodium salt are consumed on the same day. (b) by infants and young children

(2) a)

if foods containing added 3'-Sialyllactose sodium salt are consumed on the same day.

b)

by infants and young children

(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)abDP:cd 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 (CFUc/25 g) Negative E. coli (MPNd/100 g) Negative Yeast (CFU/g) < 10 Mould (CFU/g) < 10 Other carbohydrates include monosaccharides (glucose, xylose and arabinose) and cellobiose. Maltodextrin content is calculated according to the amount added in the process. Degree of polymerization CFU: Colony Forming Units MPN: Most Probable Number

Anx_ii. abdpcd. 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 (CFUc/25 g) Negative E. coli (MPNd/100 g) Negative Yeast (CFU/g) < 10 Mould (CFU/g) < 10 Other carbohydrates include monosaccharides (glucose, xylose and arabinose) and cellobiose. Maltodextrin content is calculated according to the amount added in the process. Degree of polymerization CFU: Colony Forming Units MPN: Most Probable Number

ANNEX II abDP:cd 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 (CFUc/25 g) Negative E. coli (MPNd/100 g) Negative Yeast (CFU/g) < 10 Mould (CFU/g) < 10 Other carbohydrates include monosaccharides (glucose, xylose and arabinose) and cellobiose. Maltodextrin content is calculated according to the amount added in the process. Degree of polymerization CFU: Colony Forming Units MPN: Most Probable Number

Anx. iii. 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

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

(a) if foods containing added 3'-Sialyllactose sodium salt are consumed the same day. (b) by infants and young children Anx. iv. 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: 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

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: 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 (a) if foods containing added 3'-Sialyllactose sodium salt are consumed the same day. (b) by infants and young children

a)

if foods containing added 3'-Sialyllactose sodium salt are consumed the same day.

b)

by infants and young children

Versions

1. 2023-01-06