ELI: http://data.europa.eu/eli/reg_impl/2024/1027/oj 1/3COMMISSION IMPLEMENTING REGUL ATION (EU) 2024/1027 
of 8 Apr il 2024
amending Implementing Regulation (EU) 2017/2470 as regards the specif ications of the novel food 
galact o-oligosacchar ide 
(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 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 galact o-oligosacch aride as 
an author ised novel food.
(4) Pursuant to Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council (3), galacto- 
oligosacc haride has been author ised to be placed on the market as a novel food to be used in a number of foods, 
including infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 of the European 
Parliament and of the Council (4).
(5) On 28 July 2023 , the compan y FrieslandCampina Ingredients (‘the applicant’) submitted an application to the 
Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 for a change of the specifications of 
the novel food galact o-oligosaccha ride. The applicant requeste d the remo val of galact ose from the specifi cations of 
the novel food whic h currently include galact ose at levels greater than 0.8% of the dry matt er.
(6) The applicant justified their request for the proposed chang e in the specifications of galacto-oligosacc haride by the 
introduction of additional purification steps in its production. That additional purification aims to remove 
monosacch arides like galactose to produce a higher purity galact o-oligosacch aride.
(7) The Commission considers that the request ed change in the specifications of galacto-oligosacc haride is not liable to 
have an effect on human health and that a safety evaluation by the European Food Safety Auth ority in accordance 
with Article 10(3) of Regulation (EU) 2015/2283 is not necessar y. Galactose has a histo ry of safe use as a 
constituent of the normal diet when dair y products are consumed. As a result, it is author ised to be present in the 
(1)OJ L 327, 11.12.2015, p. 1, ELI: http://data.europa.eu/eli/reg/2015/2283/oj .
(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, 
ELI: http://data.europa.eu/eli/reg_impl/2017/2470/oj ).
(3)Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 Januar y 1997 concer ning novel foods and novel 
foods ingredients (OJ L 43, 14.2.1997, p. 1, ELI: http://data.europa.eu/eli/reg/1997/258/oj ).
(4)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, ELI: http:// 
data.europa.eu/eli/reg/2013/609/oj ).
Offi cial Jour nal  
of the European Union EN 
L series    
2024/1027  9.4.2024ELI: http://data.europa.eu/eli/reg_impl/2024/1027/oj 2/3novel food at minimal levels of 0,8% or more and without a maximum author ised level as it does not raise safety 
concer ns. Thus, irrespective of the purification steps during the production, the specifications do not need to 
require a certain level of galactose in the novel food.
(8) The information provided in the application gives suffi cient grounds to establish that the changes to the 
specifi cations of the novel food are in accordance with the conditions laid down in Article 12 of Regulation 
(EU) 2015/2283 and should be appro ved.
(9) The Annex to Implementing Regulation (EU) 2017/2470 should theref ore be amended according ly.
(10) 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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 Apr il 2024 .
For the Commission
The President
Ursula VON DER LEYENOJ L, 9.4.2024 EN  ELI: http://data.europa.eu/eli/reg_impl/2024/1027/oj 3/3ANNEX 
In Table 2 (‘Specif ications ’) of the Annex to Imp lementing Regulation (EU) 2017/2470, the entr y for ‘Galacto-oligosacc haride’ is replaced by the followi ng:
Authorised Novel Food Specificatio ns
‘Galacto -oligosacchar ide Descr iption/Def inition:
Galact o-oligosacchar ide is produced from milk lacto se by an enzymatic process using β-galact osidases from Aspergillus oryzae, Bifidobacter ium 
bifidum, Pichia pastor is, Sporo bolomyces singular is, Kluyv eromy ces lactis and Papiliotrema terrestris.
GOS: min. 46 % Dry Matt er (DM)
Lact ose: max. 40 % DM
Glucose: max. 22 % DM
Ash: max. 4,0 % DM
Prot ein: max. 4,5 % DM
Nitr ite: max. 2 mg/kg’OJ L, 9.4.2024 EN