COMMI SSION IMPLEMENTING REGUL ATION (EU) 2019/1314 
of 2 August 2019 
author ising the change of the specif ications of the novel food Lacto -N-neotetraose produced with 
Escher ichia coli K-12 under Regulation (EU) 2015/2283 of the European Parliament and of the 
Council and amending Commission Implementing Regulation (EU) 2017/2470 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having 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 provi des that only novel foods author ised and included in the Union list may be 
placed on the market within the Union. 
(2)  Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) 
was adopt ed, which establishes a Union list of author ised novel foods. 
(3)  Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to submit a draf t implementing act 
author ising the placing on the Union market of a novel food and updating the Union list. 
(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 
synthesized Lacto-N-n eotetraose 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 (‘the 
Applicant’), informed the Commission of its intention to place on the market Lact o-N-neotet raose of microbial 
source produced with Escheri chia coli strain K-12 as a novel food ingredient. 
(6)  In the notification to the Commission, the Applicant also submitted a repor t issued by the compe tent author ity 
of Ireland pursuant to Article 3(4) of Regulation (EC) No 258/97, whic h, on the basis of the scientific evidence 
submitte d by the Applicant, had concluded that Lacto-N-neot etraose produced with Escher ichia coli strain K-12 is 
substantially equivalent to the synthetic Lacto-N-n eotetraose author ised by Commission Implementing Decision 
(EU) 2016/375. Theref ore, Lact o-N-neotetraose of microbial origin was included in the Union list of novel foods. 
(7)  On 18 December 2018, the Applicant pursuant to Article 10(1) of Regulation (EU) 2015/2283, requeste d 
a change in the specif ications of the Lact o-N-neotet raose with Escher ichia coli strain K-12 in order to reduce the 
energy and environmental load of the Lacto-N-neot etraose manufactur ing process and reduce the cost per unit 
produced. The change s concer n a decrease in the levels of the Lacto-N-neot etraose from equal or greater than 
92 % to equal or greate r than 80 %, and increases in the levels of the minor sacchari des present in the novel 
food, namely an increase in the levels of D-Lactose from up to 3,0 % to up to 10,0 %, and an increase in the 
levels of para-Lacto-N-neohexaose from up to 3,0 % to up to 5,0 %. 
(8)  To ensure that the overall purity of the novel food after the request ed changes are introduced in its specifications 
remains as high as the currently author ised Lacto-N-n eotetraose, the Applicant also proposes that the sum of the 
levels of Lact o-N-neotetraose and of the minor sacchari des (D-Lactose, Lacto-N-tri ose II, para-Lact o-N- 
neohexaose, and Lacto-N-neot etraose fructo se isomer) in the novel food is equal or greater than 92,0 %. 5.8.2019 L 205/4 Official Jour nal of the European Union EN     
(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) 2016/375 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 of 27 Januar y 1997 concer ning novel food and novel food 
ingredients (OJ L 43, 14.2.1997, p. 1). (9)  The requeste d changes in the specifi cations of the novel food are due to the modifications in its manufa ctur ing 
process that entail the replacement of the crystallisation purification step with a spra y drying step which is 
currently used in the production of Lacto-N-neot etraose by Escher ichia coli strain K-12. The applicant theref ore 
request ed to amend the entr y of Lact o-N-neotet raose of microbial origin in the Union list of author ised novel 
foods in order to reflect that chang e in the purification step of the manuf actur ing process. 
(10)  The Commission considered that the request ed modifi cations involving sacchari des of the author ised novel food 
whic h are also components of the human milk while maintaining an overall high sum of those and the other 
minor saccharides present in the novel food, do not alter the safety considerations that suppor ted the author is­
ation of the synthetic Lacto-N-neot etraose and the Lact o-N-neotetraose produced with Escher ichia coli strain K-12, 
and theref ore do not necessitate a consultation of the European Food Safety Author ity. 
(11)  Taking into account the above considerations, the requested changes comply with Article 12(1) of Regulation 
(EU) 2015/2283. Theref ore, it is appropr iate to amend the specifications of the novel food Lact o-N-neotet raose 
of microbial origin produced with Escher ichia coli strain K-12 at the proposed levels of Lact o-N-neotetraose, of D- 
Lact ose, and of para-Lact o-N-neohexaose, and of the overall levels of Lact o-N-neotetraose together with minor 
saccharides (D-Lact ose, Lact o-N-tr iose II, para-Lact o-N-neohexaose, and Lacto-N-neot etraose fructose isomer). 
(12)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
The entr y in the Union list of author ised novel foods as provided for in Article 6 of Regulation (EU) 2015/2283 
referring to the substance Lacto-N-neot etraose produced with Escher ichia coli strain K-12 shall be amended as specifi ed in 
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 State s. 
Done at Brussels, 2 August 2019. 
For the Commission 
The President 
Jean-Claude JUNCK ER  5.8.2019 L 205/5 Official Jour nal of the European Union EN     ANNEX 
In Table 2 (Specifi cations) of Implementing Regulation (EU) 2017/2470, the entr y for ‘Lacto-N- neotetraose (microbial 
source)’ is replaced by the following: 
‘Lacto-N-ne otetraose 
(microbial source) Def inition: 
Chemical name: β-D-Galactop yranosyl-(1→4)-2-acetamido-2-deo xy-β-D-g lucop yranosyl- 
(1→3)-β-D-galact opyranosyl-(1→4)-D-g lucop yranose 
Chemical formula: C26H45NO21 
CAS No: 13007-32-4 
Molecular weight: 707,63 g/mol 
Source: 
Genetically modified strain of Escher ichia coli K-12 
Descr iption: 
Lacto-N-neot etraose is a white to off-white powder that is produced by a microbiological 
process. 
Purity: 
Assa y (water free): ≥ 80 % 
D-Lactose: ≤ 10,0 % 
Lacto-N-tri ose II: ≤ 3,0 % 
para-Lacto-N-neohexaose: ≤ 5,0 % 
Lacto-N-neot etraose fructo se isomer : ≤ 1,0 % 
Sum of saccha rides (Lacto-N-neot etraose, D-Lactose, Lacto-N-triose II, para-Lact o-N-neohex ­
aose, Lact o-N-neotet raose fructo se isomer): ≥ 92 % 
pH (20 C, 5 % solution): 4,0-7,0 
Water: ≤ 9,0 % 
Ash, sulphate d: ≤ 0,4 % 
Residual solvents (methanol): ≤ 100 mg/kg 
Residual protein s: ≤ 0,01 % 
Microbiological criter ia: 
Aerobic mesophilic bacteria total count: ≤ 500 CFU/g 
Yeasts: ≤ 10 CFU/g 
Moulds: ≤ 10 CFU/g 
Residual endoto xins: ≤ 10 EU/mg 
CFU: Colon y Forming Units; EU: Endoto xin Units’   5.8.2019 L 205/6 Official Jour nal of the European Union EN