II
(Non-legislative acts)
REGUL ATIONS
COMMISSION IMPLEMENTING REGUL ATION (EU) 2023/65 
of 6 Januar y 2023
correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods, 
Implementing Regulation (EU) 2018/1648 author ising the placing on the market of xylo- 
oligosacchar ides as a novel food, Implementing Regulation (EU) 2019/1686 author ising the 
extension of use of bovine milk basic whey protein isolate as a novel food, and Implementing 
Regulation (EU) 2021/96 author ising the placing on the market of 3'-sialyllactose sodium salt as a 
novel food 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng regar d 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 (1), 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 Januar y 2018 , the 
Union list of novel foods author ised or notified under Regulation (EC) No 258/97 of the European Parliament and 
of the Council (2).
(2) The Union list of novel foods author ised or notified under Regulation (EC) No 258/97 was established by 
Commission Implementing Regulation (EU) 2017/2470 (3).
(3) The Commission has identif ied errors in the Annex to Implementing Regulation (EU) 2017/2470. Corrections are 
needed in order to provide clarity and legal certainty to food business operat ors and to the Member States’ 
compet ent author ities, thus ensur ing the proper implementation and use of the Union list of novel foods.
(1)OJ L 327, 11.12.2015, p. 1.
(2)Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 Januar y 1997 concer ning novel foods and novel food 
ingredients (OJ L 43, 14.2.1997, p. 1).
(3)Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance 
with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).EN Offi cial Jour nal of the European Union 9.1.2023 L 6/1  (4) The conditions of use of the novel food ‘bovine milk basic whe y protein isolat e’, author ised by Commission 
Implementing Regulation (EU) 2018/1632 (4), were subsequently extende d by Commission Implementing 
Regulation (EU) 2019/1686 (5). In Table 1 of the Annex to Implementing Regulation (EU) 2019/1686, the lines 
separating the specifi ed food catego ries and the maximum author ised levels were erroneously omitted, thereby 
making unclear what food categor y corresponds to what author ised use. That might create confusion for 
enforcement author ities and the food business operat ors. Theref ore, a correction of the Annex to Imp lementing 
Regulation (EU) 2019/1686 and Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is necessar y.
(5) The novel food ‘3'-Sialyllact ose sodium salt (microbial source)’ was author ised by Commission Implemen ting 
Regulation (EU) 2021/96 (6). The maximum levels indicate d for the food cate gory ‘Flav oured fermented milk -based 
products including heat-treate d products’ were erroneously added to the food catego ry ‘Unf lavoured fermented 
milk -based products’, and vice versa. Theref ore, 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 necessar y.
(6) The novel food ‘Galacto- oligosacchari de’ was author ised under certain conditions of use pursuant to Article 5 of 
Regulation (EC) No 258/97. The microbial source ‘Bacillus circulans ’ of the enzyme ‘β-galactosi dase’ used for the 
production of the Galacto-oligosacc haride was erroneously added to the specific ations. Theref ore, this source of 
β-galact osidase should be removed from the entr y ‘Galacto- oligosacchari de’ in Table 2 of the Annex to 
Implementing Regulation (EU) 2017/2470.
(7) The novel food ‘Xylo-oligosacchari de’ was author ised under certain conditions of use by Commission Implementing 
Regulation (EU) 2018/1648 (7), based on a favourable opinion on the safety of the novel food by the European Food 
Safety Auth ority (‘the Author ity’). The specifi cations of the syrup form of ‘Xylo-oligosacchari de’ erroneously did not 
contain the parameter ‘dry mater ial’ in the corresponding column. This error has been corrected in the revised 
scientific opinion of the Author ity(8). Theref ore, the specifi cations concer ning ‘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 correcte d according ly.
(8) Implementing Regulation (EU) 2017/2470, Implementing Regulation (EU) 2018/1648, Implementing Regulation 
(EU) 2019/1686 and Implemen ting Regulation (EU) 2021/96 should theref ore be corrected according ly.
(9) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGUL ATION:
Article 1
The Annex to Implementing Regulation (EU) 2017/2470 is corrected in accordance with Annex I to this Regulation.
(4)Commission Implementing Regulation (EU) 2018/1632 of 30 October 2018 author ising the placing on the market of bovine milk 
basic whey prot ein isolate 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 (OJ L 272, 31.10.2018, p. 23).
(5)Commission Implementing Regulation (EU) 2019/1686 of 8 Octo ber 2019 author ising the extension of use of bovin e milk basic whey 
prot ein isolate 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 (OJ L 258, 9.10.2019, p. 13).
(6)Commission Implementing Regulation (EU) 2021/96 of 28 Januar y 2021 author ising the placing on the market of 3'-sialyllactose 
sodium salt 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 (OJ L 31, 29.1.2021, p. 201).
(7)Commission Implementing Regulation (EU) 2018/1648 of 29 October 2018 author ising the placing on the market of xylo- 
oligosaccha rides 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 (OJ L 275, 6.11.2018, p. 1).
(8)EFSA Jour nal 2018;16(7):5361.EN Offi cial Jour nal of the European Union L 6/2 9.1.2023  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 correcte d in accordance with Annex IV to this Regulation.
Article 5
This Regulation shall enter into force on the twentieth day followi ng 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 Januar y 2023 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 9.1.2023 L 6/3  ANNEX I 
Cor rection of Implementing Regulation (EU) 2017/2470 
The Annex to Implementing Regulation (EU) 2017/2470 is corrected as follows:
(1) in Table 1 (Author ised novel foods), the entr y for ‘Bovine milk basic whey prot ein isolat e’ is replaced by the followi ng:
Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirementsOther 
requirementsData Prot ection
‘Bovine milk basic 
whe y protein isolateSpecified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be “Milk whey prote in isolat e”.
Food supplements containing bovine 
milk basic whey protein isolate shall bear 
the followi ng statement :
“This food supplement should not be 
consumed by infants/chi ldren/ 
adolescents under the age of one/three/ 
eighte en (*) years”
(*)Depending on the age group the food 
supplement is intended for.Auth orised on 20 November 
2018 . This inclusion is based on 
propr ietar y scientific evidence 
and scientific data prot ected in 
accordance with Article 26 of 
Regulation (EU) 2015/2283. 
Applicant: Armor Protéine s S.A. 
S., 19 bis, rue de la Libération 
35460 Saint-Br ice-en-Cog lès, 
France . Dur ing the period of data 
protection the novel food bovine 
milk basic whey prot ein isolat e is 
author ised for placing on the 
market within the Union only by 
Armor Proté ines S.A.S. unless a 
subsequent applicant obtains 
author isation for the novel food 
without reference to the 
propr ietar y scientific evidence or 
scientifi c data protect ed in 
accordance with Article 26 of 
Regulation (EU) 2015/2283 or 
with the agreement of Armor 
Protéine s S.A.S. End date of the 
data protect ion: 20 November 
2023 .’Infant formulae as defined in 
Regulation (EU) No 609/201330 mg/100 g (powder)
3,9 mg/100 mL (reconstitut ed)
Follo w-on formulae as defined 
in Regulation (EU)  
No 609/201330 mg/100 g (powder)
4,2 mg/100 mL (reconstitut ed)
Total diet replacement foods 
for weight control as defined 
in Regulation (EU)  
No 609/2013300 mg/da y
Foods for special medical 
purposes as defined in 
Regulation (EU) No 609/201330 mg/100 g (powder formula for 
infants during the first months of life 
until the introduction of appropr iate 
compl ementar y feeding)
3,9 mg/100 mL (reconstitut ed 
formula for infants during the first 
months of life until the introduction 
of appropr iate compl ementar y 
feeding)
30 mg/100 g (powder formula for 
infants when appropr iate 
compl ementar y feeding is 
introduced)EN Offi cial Jour nal of the European Union L 6/4 9.1.2023  4,2 mg/100 mL (reconstitut ed 
formula for infants when appropr iate 
compl ementar y feeding is 
introduced)
58 mg/da y for young children
380 mg/da y for children and 
adolescents from 3 to 18 years of age
610 mg/da y for adults
Food supplements as defined 
in Directive 2002/46/EC25 mg/da y for infants
58 mg/da y for young children
250 mg/da y for children and 
adolescents from 3 to 18 years of age
610 mg/da y for adultsEN Offi cial Jour nal of the European Union 9.1.2023 L 6/5  (2) in Table 1 (Author ised novel foods), the entr y for ‘3'-Sialyllact ose (3'-SL) sodium salt (microbial source)’ is replaced by the follo wing:
Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirementsOther 
requirementsData Prot ection
‘3'-Sialyllacto se 
(3'-SL) sodium salt
(microbial source)Specified food categor y Maximum levels (expressed as 3'- 
Sialyl lactose)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'-Sialyllac ­
tose sodium salt are consumed on the 
same day.
b)by infants and young childrenAuth orised on 18 Febr uary 2021 . 
This inclusion is based on 
propr ietar y scientific evidence 
and scientific data prot ected in 
accordance with Article 26 of 
Regulation (EU) 2015/2283.
Applicant: Glycom A/S, Kogle 
Allé 4, DK-2970 Hørsholm, 
Denmark . Dur ing the period of 
data protection, the novel food 3'- 
sialyllactose sodium salt is 
author ised for placing on the 
market within the Union only by 
Glycom A/S, unless a subsequent 
applicant obtains author isation 
for the novel food without 
reference to the propr ietar y 
scientifi c evidence or scientifi c 
data protect ed 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 Febr uary 2026 .’Unflavoured pasteur ised and 
unflavoured sterilised 
(including UHT) milk 
products0,25 g/L
Unflavoured fermented milk - 
based products0,25 g/L (beverages)
0,5 g/kg (products other than 
beverages)
Flavour ed fermente d milk - 
based products including 
heat-treat ed products0,25 g/L (beverages)
2,5 g/kg (products other than 
beverages)
Beverage s (flavour ed drinks, 
excl uding 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 609/20130,2 g/L in the final product ready for 
use, mark eted as such or 
reconstituted as instr ucted by the 
manufacturer
Follo w-on formula as defined 
in Regulation (EU)  
No 609/20130,15 g/L in the final product ready for 
use, mark eted as such or 
reconstituted as instr ucted by the 
manufacturer
Processed cereal-based food 
and baby food for infants and 
young children as defined in 
Regulation (EU) No 609/20130,15 g/L (beverages) in the final 
product ready for use, market ed as 
such or reconstitute d as instr ucted by 
the manufacturerEN Offi cial Jour nal of the European Union L 6/6 9.1.2023  1,25 g/kg for products other than 
beverages
Milk -based drinks and similar 
products intended for young 
children0,15 g/L in the final product ready for 
use, mark eted as such or 
reconstituted as instr ucted by the 
manufacturer
Total diet replacement foods 
for weight control as defined 
in Regulation (EU)  
No 609/20130,5 g/L (beverages)
5 g/kg (products other than 
beverages)
Food for special medical 
purposes as defined in 
Regulation (EU) No 609/2013In accordance with the particular 
nutr itional requirements of the 
persons for whom the products are 
intended
Food supplements as defined 
in Directive 2002/46/EC, 
excl uding food supplements 
for infants and young children0,5 g/da y
(3) in Table 2 (Specif ications), the entr y for ‘Galacto-oligosacc haride’ is replaced by the followi ng:
‘Galact o-oligosacchar ide Descr iption/Def inition:
Galact o-oligosacchar ide is produced from milk lactose by an enzymatic process using β-galacto sidases from Aspergillus oryzae, 
Bifidobacter ium bifidum, Pichia pastor is, Sporobol omy ces singular is, Kluyv eromy ces lactis and Papiliotr ema terrestr is.
GOS: min. 46 % Dry Matte r (DM)
Lact ose: max. 40 % DM
Glucose: max. 22 % DM
Galact ose: min. 0,8 % DM
Ash: max. 4,0 % DM
Prote in: max. 4,5 % DM
Nitr ite: max. 2 mg/kg’EN Offi cial Jour nal of the European Union 9.1.2023 L 6/7  (4) in Table 2 (Specif ications), the entr y for ‘Xylo-oligosacchari de’ is replaced by the followi ng:
Authorised novel food Specification
‘Xylo- 
oligosacchar idesDescr iption:
The novel food is a mixture of xylo-oligosacc harides (XOS) whic h are obtained from corncobs (Zea mays subsp. mays ) via hydrolysis by a xylanase from 
Trichoder ma reesei followe d by a purification process.
Character istics/Composition:
Parameter Powder form 1 Powder form 2 Syr up form
Moisture (%) ≤ 5,0 ≤ 5,0 -
Dry mater ial (%) - - 70-75
Prote in (g/100 g) < 0,2
Ash (%) ≤ 0,3
pH 3,5-5,0
Total carbohydrat e cont ent (g/100 g) ≥ 97 ≥ 95 ≥ 70
XOS cont ent (dry basis) (g/100 g) ≥ 95 ≥ 70 ≥ 70
Other carbohydrat es (g/100 g)a2,5-7,5 2-16 1,5-31,5
Monosacc harides tota l (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
Disaccha rides 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
Oligosacc harides total (g/100 g) 41-77 36-72 32-71
xylotr iose (XOS DP3) (g/100 g) 27-35 18-30 18-30
xylot etraose (XOS DP4) (g/100 g) 10-20 10-20 8-20
xylopentaose (XOS DP5) (g/100 g) 3-10 5-10 3-10EN Offi cial Jour nal of the European Union L 6/8 9.1.2023  xylohexaose (XOS DP6) (g/100 g) 1-5 1-5 1-5
Xylohep taose (XOS DP7) (g/100 g) 0-7 2-7 2-6
Maltode xtrin (g/100 g)b0 20-25 0
Copper (mg/kg) < 5,0
Lead (mg/kg) < 0,5
Arsenic (mg/kg) < 0,3
Salmonella (CFUc/25 g) Neg ative
E. coli (MPNd/100 g) Neg ative
Yeast (CFU/g) < 10
Mould (CFU/g) < 10
aOther carbohydrat es include monosacc harides (glucose, xylose and arabinose) and cellobiose.
bMaltod extr in cont ent is calculat ed according to the amount added in the process.
DP: Degree of polymer ization
cCFU: Colon y Forming Units
dMPN: Most Probable Number ’EN Offi cial Jour nal of the European Union 9.1.2023 L 6/9  ANNEX II 
Cor rection of Implementing Regulation (EU) 2018/1648 
In point 2 of the Annex to Implementing Regulation (EU) 2018/1648, in Table 2 (Specifications), the entr y for ‘Xylo-oligosacch aride’ is replaced by the following:
Author ised novel food Specification
‘Xylo- 
oligosacchar idesDescr iption:
The novel food is a mixture of xylo-oligosacc harides (XOS) whic h are obtained from corncobs (Zea mays subsp. mays) via hydrolysis by a xylanase from Trichoder ma 
reese i followed by a purification process.
Character istics/Composition:
Parameter Powder form 1 Powder form 2 Syr up form
Moisture (%) ≤ 5,0 ≤ 5,0 -
Dry mat erial (%) - - 70-75
Protein (g/100 g) < 0,2
Ash (%) ≤ 0,3
pH 3,5-5,0
Total carboh ydrate content (g/100 g) ≥ 97 ≥ 95 ≥ 70
XOS content (dry basis) (g/100 g) ≥ 95 ≥ 70 ≥ 70
Other carboh ydrate s (g/100 g)a2,5-7,5 2-16 1,5-31,5
Monosaccha rides 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
Disaccharide s 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
Oligosacc harides total (g/100 g) 41-77 36-72 32-71
xylotr iose (XOS DP3) (g/100 g) 27-35 18-30 18-30
xylotet raose (XOS DP4) (g/100 g) 10-20 10-20 8-20EN Offi cial Jour nal of the European Union L 6/10 9.1.2023  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
Maltodextr in (g/100 g)b0 20-25 0
Copper (mg/kg) < 5,0
Lead (mg/kg) < 0,5
Arsenic (mg/kg) < 0,3
Salmonella (CFUc/25 g) Neg ative
E. coli (MPNd/100 g) Neg ative
Yeast (CFU/g) < 10
Mould (CFU/g) < 10
aOther carbohydrat es include monosacch arides (glucose, xylose and arabinose) and cellobiose.
bMaltode xtrin content is calculated according to the amount added in the process.
DP: Degree of polymer ization
cCFU: Colon y Forming Units
dMPN: Most Probable Number ’EN Offi cial Jour nal of the European Union 9.1.2023 L 6/11  ANNEX III 
Cor rection of Implementing Regulation (EU) 2019/1686 
In point 1 of the Annex to Imple menting Regulation (EU) 2019/1686, in Table 1 (Author ised novel foods), the entr y for ‘Bovine milk basic whey protein isolate’ is replaced by the following:
Author ised novel food Conditions under which the novel food may be usedAdditional specific labelling 
requirementsOther 
requirementsData Prot ection
‘Bovine milk basic whey 
protein isolateSpecif ied food categor y Maximum levels The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be “Milk whey 
prote in isolate ”.
Food supplements containing bovine 
milk basic whe y protein isolate shall 
bear the followi ng statement:
“This food supplement should not be 
consumed by infants/c hildren/ 
adolescents under the age of one/ 
three/eightee n (*) years”
(*)Depending on the age group the 
food supplement is intended for.Auth orised on 20 November 2018 . 
This inclusion is based on propr ietar y 
scientific evidence and scientific data 
prote cted in accordance with 
Article 26 of Regulation (EU)  
2015/2283. Applicant: Armor 
Protéine s S.A.S., 19 bis, rue de la 
Libération 35460 Saint-Br ice-en- 
Cog lès, France. Dur ing the period of 
data protect ion the novel food bovine 
milk basic whe y protein isolate is 
author ised for placing on the mark et 
within the Union only by Armor 
Protéine s S.A.S. unless a subsequent 
applicant obtains author isation for 
the novel food without reference to 
the propr ietar y scientific evidence or 
scientific data prot ected 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 609/201330 mg/100 g (powder)
3,9 mg/100 mL (reconstitut ed)
Follow-on formulae as defined 
in Regulation (EU)  
No 609/201330 mg/100 g (powder)
4,2 mg/100 mL (reconstitut ed)
Total diet replacement foods 
for weight control as defined in 
Regulation (EU) No 609/2013300 mg/da y
Foods for special medical 
purposes as defined in 
Regulation (EU) No 609/201330 mg/100 g (powder formula 
for infants during the first 
months of life until the 
introduction of appropr iate 
compl ementar y feeding)
3,9 mg/100 mL (reconstitut ed 
formula for infants during the 
first months of life until the 
introduction of appropr iate 
compl ementar y feeding)
30 mg/100 g (powder formula 
for infants when appropr iate 
compl ementar y feeding is 
introduced)EN Offi cial Jour nal of the European Union L 6/12 9.1.2023  4,2 mg/100 mL (reconstitut ed 
formula for infants when 
appropr iate complementary 
feeding is introduced)
58 mg/da y for young children
380 mg/da y for children and 
adolescents from 3 to 18 years of 
age
610 mg/da y for adults
Food supplements as defined 
in Directive 2002/46/EC25 mg/da y for infants
58 mg/da y for young children
250 mg/da y for children and 
adolescents from 3 to 18 years of 
age
610 mg/da y for adultsEN Offi cial Jour nal of the European Union 9.1.2023 L 6/13  ANNEX IV 
Cor rection of Implementing Regulation (EU) 2021/96 
In point 1 of the Annex to Implementing Regulation (EU) 2021/96, in Table 1 (Author ised novel foods), the entr y for ‘3'-Sialyllact ose (3'-SL) sodium salt (microbial source)’ is replaced by 
the follo wing:
Autho rised novel food Conditions under which the novel food may be usedAdditio nal specific labelling 
requirementsOther requirements Data Protection
‘3'-Sialyllactose (3'-SL) 
sodium salt
(microbial source)Specified food categor y Maximum levels (expressed as 3'- 
Sialyl lactose)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'- 
Sialyllactos e sodium salt shall 
bear a statement that they 
should not be consumed:
a)if foods containing added 
3'-Sialyllact ose sodium 
salt are consumed the 
same day.
b)by infants and young chil­
drenAuthor ised on 18 Febr uary 
2021 . This inclusion is based 
on propr ietar y scientific 
evidence and scientific data 
prot ected in accordance with 
Article 26 of Regulation (EU)  
2015/2283.
Applicant: Glycom A/S, Kogle 
Allé 4, DK-2970 Hørsholm, 
Denmark . Dur ing the period of 
data protection, the novel food 
3'-sialyllact ose sodium salt is 
author ised for placing on the 
mark et within the Union only 
by Glycom A/S, unless a 
subsequent applicant obtains 
author isation for the novel 
food without reference to the 
propr ietar y scientifi c evidence 
or scientific data prote cted in 
accordance with Article 26 of 
Regulation (EU) 2015/2283 or 
with the agreement of Glycom  
A/S.
End date of the data prote ction: 
18 Febr uary 2026 .’Unflavoured paste urised and 
unflavour ed steri lised 
(including UHT) milk 
products0,25 g/L
Unflavoured fermented milk - 
based products0,25 g/L (beverages)
0,5 g/kg (products other than 
beverages )
Flavoured fermented milk - 
based products including 
heat-treat ed products0,25 g/L (beverages)
2,5 g/kg (products other than 
beverages )
Beverag es (flavoured drinks, 
excl uding 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 609/20130,2 g/L in the final product 
ready for use, market ed as 
such or reconstituted as 
instr ucted by the 
manufact urerEN Offi cial Jour nal of the European Union L 6/14 9.1.2023  Follo w-on formula as defined 
in Regulation (EU)  
No 609/20130,15 g/L in the final product 
ready for use, market ed as 
such or reconstituted as 
instr ucted by the 
manufact urer
Processed cereal-based food 
and baby food for infants and 
young children as defined in 
Regulation (EU) No 609/20130,15 g/L (beverages) in the 
final product ready for use, 
mark eted as such or 
reconstituted as instr ucted by 
the manufact urer
1,25 g/kg for products other 
than beverag es
Milk -based drinks and similar 
products intended for young 
children0,15 g/L in the final product 
ready for use, market ed as 
such or reconstituted as 
instr ucted by the 
manufact urer
Total diet replacement foods 
for weight control as defined 
in Regulation (EU)  
No 609/20130,5 g/L (beverages)
5 g/kg (products other than 
beverages )
Food for special medical 
purposes as defined in 
Regulation (EU) No 609/2013In accordance with the 
particular nutr itional 
requirements of the persons 
for whom the products are 
intended
Food Supplements as defined 
in Directive 2002/46/EC, 
excl uding food supplements 
for infants and young children0,5 g/da yEN Offi cial Jour nal of the European Union 9.1.2023 L 6/15