Document ID: 32023R1583
Language: ENG

<table><col/><col/><col/><col/><tbody><tr><td><p>2.8.2023&#160;&#160;&#160;</p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 194/13</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2023/1583
of 1 August 2023
amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food Lacto- N -neotetraose (microbial source)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard 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:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Regulation (EU)&#160;2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Pursuant to Article&#160;8 of Regulation (EU)&#160;2015/2283, Commission Implementing Regulation (EU)&#160;2017/2470&#160;<a>(<span>2</span>)</a> has established a Union list of authorised novel foods.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Commission Implementing Decision (EU)&#160;2016/375&#160;<a>(<span>3</span>)</a> authorised, in accordance with Regulation (EC) No&#160;258/97 of the European Parliament and of the Council&#160;<a>(<span>4</span>)</a>, the placing on the market of chemically synthesized Lacto-<span>N</span>-neotetraose as a novel food ingredient.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Pursuant to Article&#160;5 of Regulation (EC) No&#160;258/97, on 1&#160;September 2016, the company Glycom&#160;A/S informed the Commission of its intention to place on the market Lacto-<span>N</span>-neotetraose of microbial source produced with genetically modified<span>Escherichia coli</span> strain K-12 as a novel food ingredient. Lacto-<span>N</span>-neotetraose of microbial origin produced with genetically modified<span>Escherichia coli</span> strain K-12 was included in the Union list of novel foods on the basis of that notification when the Union list was established.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Commission Implementing Regulation (EU)&#160;2019/1314&#160;<a>(<span>5</span>)</a> amended the specifications of the novel food Lacto-<span>N</span>-neotetraose (microbial source) produced with genetically modified<span>Escherichia coli</span> strain K-12.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Commission Implementing Regulation (EU)&#160;2021/912&#160;<a>(<span>6</span>)</a> amended the specifications of the novel food Lacto-<span>N</span>-neotetraose (microbial source) to allow Lacto-<span>N</span>-neotetraose produced by the combined activity of the genetically modified strains PS-LNnT-JBT and DS-LNnT-JBT derived from<span>Escherichia coli</span> strain BL21(DE3) to be placed on the market under the same conditions of use as the ones previously authorised for Lacto-<span>N</span>-neotetraose.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>On 15&#160;November 2022, the company Chr. Hansen&#160;A/S (&#8216;the applicant&#8217;) submitted an application to the Commission in accordance with Article&#160;10(1) of Regulation (EU)&#160;2015/2283 for a change of the specifications of Lacto-<span>N</span>-neotetraose (microbial source) produced by the combined activity of the derivative strains PS-LNnT-JBT and DS-LNnT-JBT of<span>Escherichia coli</span> strain BL21(DE3). The applicant requested for the reference to the specific genetically modified derivative strains PS-LNnT-JBT and DS-LNnT-JBT of<span>Escherichia coli</span> BL21(DE3) used to produce Lacto-<span>N</span>-neotetraose (microbial source) to be replaced by the generic mention of both strains. In addition the applicant requested a change in the specifications of Lacto-<span>N</span>-neotetraose (microbial source) so that it can be produced using authorised derivative strains of<span>Escherichia coli</span> K-12&#160;and/or of<span>Escherichia coli</span> BL21(DE3) rather than the current limitation of using either the authorised derivative strain of<span>Escherichia coli</span> K-12 or the authorised derivative strains of<span>Escherichia coli</span> BL21(DE3).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>The applicant justified the request for the proposed changes in the specifications of Lacto-<span>N</span>-neotetraose (microbial source) to replace the specific mention of PS-LNnT-JBT and DS-LNnT-JBT of<span>Escherichia coli</span> strain BL21(DE3) by a more generic mention of production and optional degradation strains as being a more accurate way to describe the respective functions of the two strains in the production process as assessed&#160;<a>(<span>7</span>)</a> by the European Food Safety Authority (&#8216;the Authority&#8217;), and as a means to allow for more flexibility to the applicant and other food business operators to use authorised derivatives of<span>Escherichia coli</span> strain BL21(DE3) in line with their respective functions rather than limiting their production to the specific derivative strains PS-LNnT-JBT and DS-LNnT-JBT. In addition, in the applicant&#8217;s view this modification would also align the authorised specifications of Lacto-<span>N</span>-neotetraose produced with derivative strains of<span>Escherichia coli</span> strain BL21(DE3) to the authorised specifications of other novel foods produced with production and optional degradation derivative strains of<span>Escherichia coli</span> BL21(D3) in which specific derivative strains are not mentioned. The applicant also justified the request to allow use of combinations of authorised derivative strains of the<span>Escherichia coli</span> strains, namely<span>Escherichia coli</span> K-12&#160;and/or<span>Escherichia coli</span> BL21(DE3) as an additional means to allow for flexibility to the applicant and other food business operators to use authorised derivative strains of<span>Escherichia coli</span> in the production of Lacto-<span>N</span>-neotetraose.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>The Commission considers that the requested update of the Union list concerning the change of the specifications of Lacto-<span>N</span>-neotetraose proposed by the applicant, is not liable to have an effect on human health and that a safety evaluation by the Authority in accordance with Article&#160;10(3) of Regulation (EU)&#160;2015/2283 is not necessary. The parent<span>Escherichia coli</span> strains BL21(DE3) and K-12 and their genetically modified derivative strains used in the production of Lacto-<span>N</span>-neotetraose have been positively assessed by the Authority&#160;<a>(<span>8</span>)</a> and in the context of a notification pursuant to Article&#160;5 of Regulation (EC) No&#160;258/97, respectively. Their use in the production of Lacto-<span>N</span>-neotetraose with or without the additional use of the optional degradation derivative strain of<span>Escherichia coli</span> strain BL21(DE3) will produce Lacto-<span>N</span>-neotetraose in line with the authorised specifications, and consequently will not affect the safety profile of the authorised novel food.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>The information provided in the application and the above Opinion of the Authority give sufficient grounds to establish that the changes to the specifications of Lacto-<span>N</span>-neotetraose (microbial source), are in accordance with the conditions of Article&#160;12 of Regulation (EU)&#160;2015/2283 and should be approved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>The Annex to Implementing Regulation (EU)&#160;2017/2470 should therefore be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
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 following 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, 1 August 2023.
For the Commission
The President
Ursula VON DER LEYEN
( 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 authorising 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 January 1997 concerning novel foods and novel food ingredients ( OJ L 43, 14.2.1997, p. 1 ).
( 5 ) Commission Implementing Regulation (EU) 2019/1314 of 2 August 2019 authorising the change of the specifications 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 authorising changes in the specifications of the novel food Lacto- N -neotetraose (microbial source) and amending Implementing Regulation (EU) 2017/2470 ( OJ L 199, 7.6.2021, p. 10 ).
( 7 ) EFSA Journal 2020;18(11):6305.
( 8 ) EFSA Journal 2020;18(11):6305.
ANNEX
In the Annex to Implementing Regulation (EU) 2017/2470, in Table 2 (Specifications), the entry for Lacto- N -neotetraose (microbial source) is replaced by the following:
<table><col/><col/><tbody><tr><td><p>&#8216;<span>Lacto-<span>N</span>-neotetraose</span></p><p><span>(microbial source)</span></p></td><td><p><span>Definition</span></p><p>Chemical name: &#946;-D-Galactopyranosyl-(1&#8594;4)-2-acetamido-2-deoxy-&#946;-D-glucopyranosyl-(1&#8594;3)-&#946;-D-galactopyranosyl-(1&#8594;4)-D-glucopyranose</p><p>Chemical formula: C<span>26</span>H<span>45</span>NO<span>21</span></p><p>CAS No: 13007-32-4</p><p>Molecular weight: 707,63&#160;g/mol</p><p><span>Description/Source</span></p><p>Lacto-<span>N</span>-neotetraose is a white to off-white powder that is produced by a microbiological process using genetically modified strain of<span>Escherichia coli</span> K-12, and/or of<span>Escherichia coli</span> BL21(DE3). An additional optional genetically modified degradation strain of<span>Escherichia coli</span> BL21(DE3) may be used in the production process to degrade intermediate carbohydrate by-products and remaining starting carbohydrate substrates.</p><p><span>Purity</span></p><p>Assay (water free): &#8805;&#160;80&#160;%</p><p>D-Lactose: &#8804;&#160;10,0&#160;%</p><p>Lacto-<span>N</span>-triose II: &#8804;&#160;3,0&#160;%</p><p><span>para</span>-Lacto-<span>N</span>-neohexaose: &#8804;&#160;5,0&#160;%</p><p>Lacto-<span>N</span>-neotetraose fructose isomer: &#8804;&#160;1,0&#160;%</p><p>Sum of saccharides (Lacto-<span>N</span>-neotetraose, D-Lactose, Lacto-<span>N</span>-triose II,<span>para</span>-Lacto-<span>N</span>-neohexaose, Lacto-<span>N</span>-neotetraose fructose isomer): &#8805;&#160;92&#160;% (% w/w dry matter)</p><p>pH (20&#160;&#176;C, 5&#160;% solution): 4,0-7,0</p><p>Water: &#8804;&#160;9,0&#160;%</p><p>Ash, sulphated: &#8804;&#160;1,0&#160;%</p><p>Residual solvents (methanol): &#8804;&#160;100 mg/kg</p><p>Residual proteins: &#8804;&#160;0,01&#160;%</p><p><span>Microbiological criteria</span></p><p>Aerobic mesophilic bacteria total count: &#8804;&#160;500 CFU/g</p><p>Yeasts and moulds: &#8804;&#160;50 CFU/g</p><p>Residual endotoxins: &#8804;&#160;10 EU/mg</p><p>CFU: Colony Forming Units; EU: Endotoxin Units&#8217;</p></td></tr></tbody></table>