COMMISSION IMPLEMENTING REGUL ATION (EU) 2023/950 
of 12 May 2023
amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel 
food 2’-F ucosyllact ose 
(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 2’-Fucosyllact ose of 
synthetic and microbial source as an author ised novel food.
(4) Commission Implementing Decision (EU) 2016/376 (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 synthetic 2’-Fucosyllactose as a 
novel food ingredient.
(5) On 23 June 2016 , the compan y Glycom A/S (‘the applicant ’), notified the Commission, pursuant to Article 5 of 
Regulation (EC) No 258/97, of its intenti on to place on the mark et 2’-Fucosyllactose produced by bacteri al 
fermentation with Escher ichia coli strain K-12. 2’-Fucosyllact ose of microbial origin produced with Escher ichia coli 
strain K-12 was included in the Union list of novel foods on the basis of that notifi cation when the Union list was 
established.
(6) Commission Implementing Decision (EU) 2017/2201 (5)author ised, in accordance with Regulation (EC) No 258/97, 
the placing on the mark et of 2’-Fucosyllact ose produced with Escher ichia coli strain BL21 as a novel food ingredient.
(1)OJ L 327, 11.12.2015, p. 1.
(2)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).
(3)Commission Implementing Decision (EU) 2016/376 of 11 March 2016 author ising the placing on the market of 2′-O-fucosyllact ose 
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. 27).
(4)Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 Januar y 1997 concer ning novel food and novel food 
ingredients (OJ L 43, 14.2.1997, p. 1).
(5)Commission Implementing Decision (EU) 2017/2201 of 27 Novem ber 2017 author ising the placing on the market of 2′- 
fucosyllacto se produced with Escherichia coli strain BL21 as a novel food ingredient under Regulation (EC) No 258/97 of the 
European Parliament and of the Council (OJ L 313, 29.11.2017, p. 5).EN Offi cial Jour nal of the European Union L 128/68 15.5.2023  (7) On 13 October 2022 , the applicant submitted an application to the Commission in accordance with Article 10(1) of 
Regulation (EU) 2015/2283 for a change in the conditions of use of 2’-Fucosyllact ose. The applicant requeste d the 
remo val of the oblig ator y condition that, when 2’-Fucosyllactose is used in combination with Lact o-N-neotetraose 
in infant formula and follow-on formula as defined in Article 2 of Regulation (EU) No 609/2013 of the European 
Parliament and of the Council (6), and in milk -based drinks and similar products intended for young children, at the 
currently author ised levels of up to 1,2 g/l, they should be used only at a 2:1 ratio (two parts 2’-Fucosyllactose to one 
part Lacto-N-neot etraose).
(8) In the application for the proposed modifi cation in the conditions of use of 2’-Fucosyllactose , the applicant 
considered that the 2:1 oblig atory ratio of 2’-Fucosyllactose to Lacto-N-neot etraose when they are used together in 
infant formula and follow on formula as defined in Article 2 of Regulation (EU) No 609/2013, and 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
(9) The Commission considers that the request ed update of the Union list of novel foods is not liable to have an effect on 
human health and that a safety evaluation by the European Food Safety Author ity (‘the Author ity’) in accordance 
with Article 10(3) of Regulation (EU) 2015/2283 is not necessar y. In this regard the Author ity in the recent 
opinion (7), concluded that the use of 2’-Fucosyllact ose alone or Lact o-N-neotetraose alone in food supplements as 
defined in Article 2 of Directive 2002/46/EC of the European Parliament and of the Council (8)at the currently 
maximum author ised levels of up to 1,2 g/da y or up to 0,6 mg/da y respectively , is safe and the resulting intakes of 
each of these oligosacc harides from these uses would be lower than the intak es of Lact o-N-neotetraose or 2’- 
Fucosyllactose from human milk whic h naturally contains them.
(10) The information provid ed in the application and the Auth ority’s opinion give suffi cient grounds to establish that the 
changes in the conditions of use of the novel food 2’-Fucosyllact ose are in accordance with the conditions of 
Article 12 of Regulation (EU) 2015/2283 and should be appro ved.
(11) The Annex to Implementing Regulation (EU) 2017/2470 should theref ore be amended according ly.
(12) 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.
(6)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).
(7)EFSA Journal 2022;20(5):7257.
(8)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 15.5.2023 L 128/69  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 L 128/70 15.5.2023  ANNEX 
In Table 1 (Author ised novel foods) of the Annex to Implementing Regulation (EU) 2017/2470, the entr y for 2’-Fucosyllact ose is replaced by the followi ng:
Autho rised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements
‘2’-F ucosyllact ose Specif ied food categor y Maximum levels 1. The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be “2′-fucosyllactose”.
2. The labelling of food supplements con­
taining 2′-fucosyllact ose shall bear a 
statement that the supplements should 
not be used if other foods with added 2′- 
fucosyllactose are consumed the same 
day.
3. The labelling of food supplements con­
taining 2′-fucosyllactose intende d for 
young children shall bear a statement 
that the supplements should not be used 
if breast milk or other foods with added 
2′-fucosyllactose are consumed the 
same day.’Unflavoured paste urised and steri lised 
(including UHT) milk -based products1,2 g/l
Unflavoured fermented milk -based products 1,2 g/l for beverages
19,2 g/kg for products other than beverages
Flavoured fermented milk -based products 
including heat-treated products1,2 g/l for beverages
19,2 g/kg for products other than beverages
Dair y analogues, including beverage 
whit eners1,2 g/l for beverages
12 g/kg for products other than beverages
400 g/kg for whit ener
Cereal bars 12 g/kg
Table-top sweet eners 200 g/kg
Infant formula as defined under Regulation 
(EU) No 609/20131,2 g/l in the final product ready for use, 
mark eted as such or reconstituted as 
instr ucted by the manufact urer
Follo w-on formula as defined under 
Regulation (EU) No 609/20131,2 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 609/201312 g/kg for products other than beverages
1,2 g/l for liquid food ready for use, mark eted 
as such or reconstituted as instr ucted by the 
manufact urerEN Offi cial Jour nal of the European Union 15.5.2023 L 128/71  Autho rised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements
Milk based drinks and similar products 
intended for young children1,2 g/l for milk -based drinks and similar 
products in the final product ready for use, 
mark eted as such or reconstituted as 
instr ucted 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 609/20134,8 g/l for drinks
40 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 
Implementing Regulation (EU) No 828/201460 g/kg
Flavoured drinks 1,2 g/l
Coffe e, tea (excluding blac k tea), herbal and 
fruit infusions, chicor y; 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 products9,6 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, excl uding infants3,0 g/da y for general population
1,2 g/da y for young childrenEN Offi cial Jour nal of the European Union L 128/72 15.5.2023