Document ID: 32021R0912
Language: ENG

<table><col/><col/><col/><col/><tbody><tr><td><p>7.6.2021&#160;&#160;&#160;</p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 199/10</p></td></tr></tbody></table>
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
(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) 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) 2015/2283, Commission Implementing Regulation (EU) 2017/2470&#160;<a>(<span>2</span>)</a> establishing the Union list of authorised novel foods, was adopted.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Pursuant to Article&#160;12 of Regulation (EU) 2015/2283, the Commission is to submit a draft implementing act authorising the placing on the Union market of a novel food and updating the Union list.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Commission Implementing Decision (EU) 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>(5)</p></td><td><p>Pursuant to Article&#160;5 of Regulation (EC) No&#160;258/97, on 1&#160;September 2016, the company Glycom A/S informed the Commission of its intention to place on the market Lacto-<span>N</span>-neotetraose of microbial source produced with<span>Escherichia coli</span> strain K-12 as a novel food ingredient.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>In the notification to the Commission, Glycom A/S also submitted a report issued by the competent authority of Ireland pursuant to Article&#160;3(4) of Regulation (EC) No&#160;258/97, which, on the basis of the scientific evidence submitted by that company, had concluded that Lacto-<span>N-</span>neotetraose produced with<span>Escherichia coli</span> strain K-12 is substantially equivalent to the synthetic Lacto-<span>N</span>-neotetraose authorised by Implementing Decision (EU) 2016/375. Therefore, Lacto-<span>N</span>-neotetraose of microbial source was included in the Union list of novel foods.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>On 23&#160;June 2019, the company Chr. Hansen A/S (&#8216;the applicant&#8217;) submitted an application to the Commission in accordance with Article&#160;10(1) of Regulation (EU) 2015/2283 for the authorisation of Lacto-<span>N</span>-neotetraose (microbial source) produced by the combined activity of the derivative strains PS-L<span>N</span>nT-JBT and DS-L<span>N</span>nT-JBT of<span>Escherichia coli</span> strain BL21(DE3) as a novel food under the same conditions of use as the ones currently authorised for synthetic and microbial sourced Lacto-<span>N</span>-neotetraose. The applicant requested an update of the union list with regard to the new source of that novel food.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>In addition, the applicant proposed updating some of the specifications of Lacto-<span>N</span>-neotetraose (microbial source) produced by that new source, as they differ from the specifications of the authorised microbiologically sourced Lacto-<span>N</span>-neotetraose produced with<span>Escherichia coli</span> strain K-12, as far as they concern an increase in the levels of ash from &#8804;&#160;0,4&#160;% to &#8804;&#160;1,0&#160;%; a higher level for the presence of yeasts and moulds from the current &#8804;&#160;10 Colony Forming Units (&#8216;CFU&#8217;)/g of novel food for each type of microorganism to &#8804;&#160;50 CFU/g for the combination of the two; and the absence of methanol (from the current &#8804;&#160;100 mg/kg), and of Lacto-<span>N</span>-neotetraose fructose isomer (from the current &#8804;&#160;1,0&#160;%).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>On 17&#160;January 2020, the Commission requested the European Food Safety Authority (&#8216;the Authority&#8217;) to carry out an assessment of Lacto-<span>N</span>-neotetraose produced by the combined activity of the derivative strains PS-L<span>N</span>nT-JBT and DS-L<span>N</span>nT-JBT of<span>Escherichia coli</span> strain BL21(DE3) in accordance with the requirements of Article&#160;11 of Regulation (EU) 2015/2283.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>On 22&#160;October 2020, the Authority adopted its scientific opinion &#8216;Safety of lacto-<span>N</span>-neotetraose (LNnT) produced by derivative strains of<span>E. coli</span> BL21 as a novel food pursuant to Regulation (EU) 2015/2283&#8217;&#160;<a>(<span>5</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>In its scientific opinion, the Authority concluded that Lacto-<span>N</span>-neotetraose (LNnT) produced by the combined activity of the derivative strains PS-L<span>N</span>nT-JBT and DS-L<span>N</span>nT-JBT of<span>Escherichia coli</span> strain BL21(DE3) as a novel food pursuant to Regulation (EU) 2015/2283 is safe for the currently authorised conditions of use. Therefore, that scientific opinion gives sufficient grounds to establish that Lacto-<span>N</span>-neotetraose (LNnT) produced by the combined activity of the derivative strains PS-L<span>N</span>nT-JBT and DS-L<span>N</span>nT-JBT of<span>Escherichia coli</span> strain BL21(DE3), complies with Article&#160;12(1) of Regulation (EU) 2015/2283.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>It is therefore appropriate to amend the specifications of the microbiologically produced Lacto-<span>N</span>-neotetraose, to include the derivative strains PS-L<span>N</span>nT-JBT and DS-L<span>N</span>nT-JBT of<span>Escherichia coli</span> strain BL21(DE3) as the source of the novel food in addition to the authorised<span>Escherichia coli strain</span> K12 and to amend the proposed levels for the presence of ash and moulds, and yeast.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>The Annex to Regulation (EU) 2017/2470 should therefore be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(14)</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 entry in the Union list of authorised novel foods as provided for in Article 6 of Regulation (EU) 2015/2283 referring to the substance Lacto- N -neotetraose (microbial source) shall be amended as specified in 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, 4 June 2021.
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 concerning novel food and novel food ingredients ( OJ L 43, 14.2.1997, p. 1 ).
( 5 ) EFSA Journal 2020;18(11):6305.
ANNEX
In Table 2 (Specifications) of the Annex to Implementing Regulation (EU) 2017/2470, 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>Source:</span></p><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>Genetically modified strain of<span>Escherichia coli</span> K-12, or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>a combination of the genetically modified strains PS-L<span>N</span>nT-JBT and DS-L<span>N</span>nT-JBT of<span>Escherichia coli</span> BL21(DE3)</p></td></tr></tbody></table><p><span>Description:</span></p><p>Lacto-<span>N</span>-neotetraose is a white to off-white powder that is produced by a microbiological process.</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>