COMMISSION IMPLEMENTING REGUL ATION (EU) 2023/961 
of 12 May 2023
amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel 
food Lacto-N-neo tetraose 
(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 and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
Whereas:
(1) Regulation (EU) 2015/2283 provides that only novel foods author ised and included in the Union list of novel foods 
may be placed on the mark et within the Union.
(2) Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Imple menting Regulation (EU) 2017/2470 (2)has 
established a Union list of novel foods.
(3) The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 includes Lact o-N-neotetraose of 
synthetic and microbial source as author ised novel food.
(4) Commission Implementing Decision (EU) 2016/375 (3)author ised, in accordance with Regulation (EC) No 258/97 
of the European Parliament and of the Council (4), the placing on the mark et of chemically synthesised Lact o-N- 
neot etraose as a novel food ingredient.
(5) Pursuant to Article 5 of Regulation (EC) No 258/97, on 1 Sept ember 2016 , the compan y Glycom A/S, notifi ed the 
Commission of its intention to place on the market Lact o-N-neotet raose of microbial source produced with 
genetically modified Escher ichia coli strain K-12 as a novel food ingredient. Lact o-N-neotetraose of microbial origin 
produced with genetically modified Escher ichia coli strain K-12 was included in the Union list of novel foods on the 
basis of that notificati on when the Union list was established.
(6) Commission Implementing Regulation (EU) 2019/1314 (5)amended the specifi cations of the novel food Lact o-N- 
neot etraose (microbial source) produced with genetically modified Escher ichia coli strain K-12.
(7) Commission Implemen ting Regulation (EU) 2021/912 (6)amended the specifications of the novel food Lact o-N- 
neot etraose (microbial source) to allow the novel food Lacto-N-neot etraose produced by the combined activity of 
the genetically modifi ed strains PS-LNn T-JBT and DS-LNn T-JBT derived from Escher ichia coli strain BL21(DE3) to be 
placed on the market and be used in the previously author ised uses and at the previously author ised use levels.
(1)OJ L 327, 11.12.2015, p. 1.
(2)Commission Implementing Regulation (EU) No 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).
(3)Commission Implementing Decision (EU) 2016/375 of 11 March 2016 author ising the placing on the market of Lacto -N-neotetraose 
as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 70, 16.3.2016, 
p. 22).
(4)Regulation (EC) No 258/97 of the European Parliament and of the Council concer ning novel food and novel food ingredients (OJ L 43, 
14.2.1997, p. 1).
(5)Commission Implementing Regulation (EU) 2019/1314 of 2 August 2019 author ising the chang e of the specificatio ns of the novel 
food Lacto-N- neotetraose produced with Escherichia coli K-12 under Regulation (EU) 2015/2283 of the European Parliament and of 
the Council and amending Commission Implementing Regulation (EU) 2017/2470 (OJ L 205 5.8.2019, p. 4).
(6)Commission Implementing Regulation (EU) 2021/912 of 4 June 2021 author ising chang es in the specificatio ns of the novel food 
Lacto -N-neotetraose (microbial source) and amending Implementing Regulation (EU) 2017/2470 (OJ L 199, 7.6.2021, p.10).EN Offi cial Jour nal of the European Union 16.5.2023 L 129/3  (8) On 3 October 2022 , the compan y Glycom A/S (‘the applicant’) submitted an application to the Commission in 
accordance with Article 10(1) of Regulation (EU) 2015/2283 for a chang e in the conditions of use of Lact o-N- 
neot etraose. The application requested for Lact o-N-neotet raose to be used in infant formula, follo w-on formula as 
defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (7), at the currently 
author ised levels of up to 0,6 g/l, without the obligat ory use in combination with 2′-Fucosyllactos e at a 1:2 use 
ratio (one part Lacto-N-neot etraose with two parts 2′-Fucosyllactose), and in milk -based drinks and similar 
products intended for young children without the oblig atory use in combination with 2′-Fucosyllactose at a 1:2 use 
ratio when the two novel foods are added separately .
(9) In the application for the proposed modif ication in the conditions of use of Lacto-N-neot etraose, the applicant 
considered that oblig atory use of a combination of Lacto-N-neot etraose with 2′-Fucosyllactos e at a 1:2 ratio when 
they are used together in infant formula and follow-on formula as defined in Article 2 of Regulation (EU) 
No 609/2013, or at differ ent ratios with 2′-Fucosyllact ose when the two are used in combination in milk -based 
drinks and similar products intende d for young children, unnecessar ily limits the ability of food business operat ors 
to place on the market these foods with differ ent ratios of those two oligosacc harides.
(10) The Commission considers that the request ed update of the Union list concer ning the change in the conditions of 
use of Lact o-N-neotetraose proposed by the applicant is not liable to have an effect on human health and that a 
safety evaluation by the European Food Safety Auth ority (‘the Auth ority’) in accordance with Article 10(3) of 
Regulation (EU) 2015/2283 is not necessar y. In this regard, the Authority in a recent opinion (8)concluded that the 
use of Lacto-N-neot etraose alone or 2′-Fucosyllact ose alone in food supplements as defined in Article 2 of 
Directive 2002/46/EC of the European Parliament and of the Council (9)at the currently maximum author ised 
levels of up to 0,6 mg/da y or up to 1,2 g/da y respectively , is safe and the resulting intakes of each of these 
oligosacc harides from these uses would be lower than the intakes of Lacto-N-neot etraose or 2′-Fucosyllact ose from 
human milk which naturally contains them.
(11) The information provi ded in the application and existing Author ity’s opinions gives suffic ient grounds to establish 
that the changes in the conditions of use of the novel food Lacto-N-neot etraose should be approved.
(12) The Annex to Implementing Regulation (EU) 2017/2470 should theref ore be amended according ly.
(13) 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 amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union.
(7)Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young 
children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, 
Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament 
and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).
(8)EFSA Jour nal 2022; 207(5):7257.
(9)Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the appro ximation of the laws of the 
Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).EN Offi cial Jour nal of the European Union L 129/4 16.5.2023  This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 12 May 2023 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 16.5.2023 L 129/5  ANNEX 
In Table 1 (Author ised novel foods) of the Annex to Implementing Regulation (EU) 2017/2470, the entr y for lacto -N-neotet raose is replaced by the following:
Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements
‘Lacto-N- neotetraose Specif ied food categor y Maximum levels 1.The designation of the novel food on 
the labelling of the foodstuffs con­
taining it shall be ‘lacto-N-ne ote­
traose’.
2.The labelling of food supplements 
containing lacto -N-neote traose shall 
bear a statement that the supplements 
should not be used if other foods with 
added lacto -N-neote traose are con­
sumed the same day.
3.The labelling of food supplements 
containing lacto-N-neot etraose in­
tended for young children shall bear 
a state ment that the supplements 
should not be used if breast milk or 
other foods with added lacto -N-neo ­
tetraose are consumed the same day.’Unflavour ed pasteur ised and sterilised (including 
UHT) milk -based products0,6 g/l
Unflavour ed fermented milk -based products 0,6 g/l for beverages
9,6 g/kg for products other than beverage s
Flavoured fermented milk -based products 
including heat-treat ed products0,6 g/l for beverages
9,6 g/kg for products other than beverage s
Dair y analogues, including beverag e whit eners 0,6 g/l for beverages
6 g/kg for products other than beverage s
200 g/kg for whit ener
Cereal bars 6 g/kg
Table-top sweeteners 100 g/kg
Infant formula as defined under Regulation (EU) 
No 609/20130,6 g/l in the final product ready for use, mark eted 
as such or reconstituted as instr ucted by the 
manufact urer
Follow-on formula as defined under Regulation 
(EU) No 609/20130,6 g/l in the final product ready for use, mark eted 
as such or reconstituted as instr ucted by the 
manufact urer
Processed cereal-based foods and baby foods for 
infants and young children as defined under 
Regulation (EU) No 609/20136 g/kg for products other than beverage s
0,6 g/l for liquid food ready for use, market ed as 
such or reconstituted as instr ucte d by the 
manufact urerEN Offi cial Jour nal of the European Union L 129/6 16.5.2023  Milk based drinks and similar products intended 
for young children0,6 g/l for milk -based drinks and similar products 
in the final product ready for use, market ed as 
such or reconstituted as instr ucte d by the 
manufact urer
Foods for special medical purposes as defined 
under Regulation (EU) No 609/2013In accordance with the particular nutr itional 
requirements of the persons for whom the 
products are intended
Total diet replacement for weight control as 
defined in Regulation (EU) No 609/20132,4 g/l for drinks
20 g/kg for bars
Bread and pasta products bear ing statements on 
the absence or reduced presence of gluten in 
accordance with the requirements of 
Commission Implementing Regulation (EU) 
No 828/201430 g/kg
Flavoured drinks 0,6 g/l
Coffee, tea (excluding blac k tea), herbal and fruit 
infusions, chicory ; tea, herbal and fruit infusions 
and chicor y extracts; tea, plant, fruit and cereal 
preparations for infusions, as well as mixe s and 
instant mixes of these products4,8 g/l – the maximum level refers to the products 
ready to use
Food Supplements as defined in 
Directive 2002/46/EC, for the general 
population, excluding infants1,5 g/da y for general population
0,6 g/da y for young childrenEN Offi cial Jour nal of the European Union 16.5.2023 L 129/7