Document ID: 32019R0388
Language: ENG

<table><col/><col/><col/><col/><tbody><tr><td><p>12.3.2019&#160;&#160;&#160;</p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 70/21</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2019/388
of 11 March 2019
authorising the change of the specifications of the novel food 2′-fucosyllactose 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
(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 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470&#160;<a>(<span>2</span>)</a> which establishes a 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 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) 2016/376&#160;<a>(<span>3</span>)</a> authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council&#160;<a>(<span>4</span>)</a>, the placing on the market of synthetic 2&#8242;-fucosyllactose as a novel food ingredient.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Commission Implementing Decision (EU) 2017/2201&#160;<a>(<span>5</span>)</a> authorised, in accordance with Regulation (EC) No 258/97, the placing on the market of 2&#8242;-fucosyllactose produced with<span>Escherichia coli</span> strain BL21 as a novel food ingredient.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>On 23&#160;June 2016, the company Glycom A/S (the Applicant), informed the Commission, pursuant to Article 5 of Regulation (EC) No 258/97, of its intention to place on the market 2&#8242;-fucosyllactose produced by bacterial fermentation with<span>Escherichia coli</span> strain K-12.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>In the notification to the Commission, the Applicant also submitted a report issued on 10&#160;June 2016 by the competent authority of Ireland pursuant to Article 3(4) of Regulation (EC) No 258/97, which, on the basis of the scientific evidence submitted by the Applicant, had concluded that 2&#8242;-fucosyllactose produced with<span>Escherichia coli</span> strain K-12 is substantially equivalent to the synthetic 2&#8242;-fucosyllactose authorised by Commission Implementing Decision (EU) 2016/376.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>On 16&#160;August 2018, the Applicant made a request to the Commission to change in the specifications of the 2&#8242;-fucosyllactose produced with<span>Escherichia coli</span> strain K-12 within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The requested changes concern a decrease in the levels of the 2&#8242;-fucosyllactose from 90&#160;% to 83&#160;%, and increases in the levels of the minor saccharides present in the novel food, namely an increase in the levels of D-lactose from up to 3,0&#160;% to up to 10,0&#160;%, an increase in the levels of difucosyl-D-lactose from up to 2,0&#160;% to up to 5,0&#160;%.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>To ensure that the overall purity of the novel food following the introduction of the above changes in its specifications, remains as high as the currently authorised 2&#8242;-fucosyllactose produced by either<span>Escherichia coli</span> strain&#160;K12 or<span>Escherichia coli</span> strain BL 21, the Applicant also proposes that the overall levels of 2&#8242;-fucosyllactose together with the minor saccharides (D-lactose, L-fucose, difucosyl-D-lactose, and 2&#8242;-fucosyl-D-lactulose) in the novel food is equal or higher than 90,0&#160;%.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>The proposed changes in the specifications of the novel food are due to the modifications in its manufacturing process that entail the replacement of the crystallisation purification step with a spray drying step which is currently used in the production of 2&#8242;-fucosyllactose by<span>Escherichia coli</span> strain BL21. This change in the purification step of the novel food production requires the increase in the use of D-lactose as the fermentation substrate in the production of 2&#8242;-fucosyllactose that explains the slight decrease in the level of 2&#8242;-fucosyllactose and the concomitant slight increases in the levels of D-lactose and of difucosyl-D-lactose in the final novel food. These proposed changes in the manufacturing are deemed necessary by the Applicant in order to reduce the energy and environmental impact of the 2&#8242;-fucosyllactose manufacturing process and to reduce the cost per unit produced.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>The proposed changes do not alter the safety considerations that supported the authorisation of the 2&#8242;-fucosyllactose produced with<span>Escherichia coli</span> strain K-12. Therefore, it is appropriate to amend the specifications of the novel food &#8216;2&#8242;-fucosyllactose&#8217; at the proposed levels of 2&#8242;-fucosyllactose, of D-lactose, of difucosyl-D-lactose, and of the overall levels of 2&#8242;-fucosyllactose together with the minor saccharides (D-lactose, L-fucose, difucosyl-D-lactose, and 2&#8242;-fucosyl-D-lactulose).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>The information provided in the application gives sufficient grounds to establish that the proposed changes to the specifications of the novel food &#8216;2&#8242;-fucosyllactose&#8217; comply with Article 12 of Regulation (EU) 2015/2283.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>The Annex to Implementing 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 and included in Implementing Regulation (EU) 2017/2470, referring to the novel food 2′-fucosyllactose produced with Escherichia coli strain K-12, 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, 11 March 2019.
For the Commission
The President
Jean-Claude JUNCKER
( 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 authorising the placing on the market of 2′-O-fucosyllactose 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 January 1997 concerning novel food and novel food ingredients ( OJ L 43, 14.2.1997, p. 1 ).
( 5 ) Commission Implementing Decision (EU) 2017/2201 of 27 November 2017 authorising the placing on the market of 2′-fucosyllactose 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 ).
ANNEX
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
The entry for ‘2′-Fucosyllactose’ (microbial source) in Table 2 (Specifications) is replaced by the following:
<table><col/><col/><tbody><tr><td><p>&#8216;<span>Definition:</span></p><p>Chemical name: &#945;-L-Fucopyranosyl-(1&#8594;2)-&#946;-D-galactopyranosyl-(1&#8594;4)-D-glucopyranose</p><p>Chemical formula: C<span>18</span>H<span>32</span>O<span>15</span></p><p>CAS No: 41263-94-9</p><p>Molecular weight: 488,44 g/mol</p></td></tr><tr><td><p><span>Source:</span></p><p>Genetically modified strain of<span>Escherichia coli</span> K-12</p></td><td><p><span>Source:</span></p><p>Genetically modified strain of<span>Escherichia coli</span> BL21</p></td></tr><tr><td><p><span>Description:</span></p><p>2&#8242;-Fucosyllactose is a white to off-white powder that is produced by a microbial process.</p><p><span>Purity:</span></p><p>2&#8242;-Fucosyllactose: &#8805; 83 %</p><p>D-Lactose: &#8804; 10,0 %</p><p>L-Fucose: &#8804; 2,0 %</p><p>Difucosyl-D-lactose: &#8804; 5,0 %</p><p>2&#8242;-Fucosyl-D-lactulose: &#8804; 1,5 %</p><p>Sum of saccharides (2&#8242;-Fucosyllactose, D-Lactose, L-Fucose, Difucosyl-D-lactose, 2&#8242;-Fucosyl-D-lactulose): &#8805; 90 %</p><p>pH (20 C, 5 % solution): 3,0-7,5</p><p>Water: &#8804; 9,0 %</p><p>Sulphated ash: &#8804; 2,0 %</p><p>Acetic acid: &#8804; 1,0 %</p><p>Residual proteins: &#8804; 0,01 %</p><p><span>Microbiological criteria:</span></p><p>Aerobic mesophilic bacteria total count: &#8804; 3&#160;000  CFU/g</p><p>Yeasts: &#8804; 100 CFU/g</p><p>Moulds: &#8804; 100 CFU/g</p><p>Endotoxins: &#8804; 10 EU/mg</p></td><td><p><span>Description:</span></p><p>2&#8242;-Fucosyllactose is a white to off white powder and the liquid concentrate (45 % &#177; 5 % w/v) aqueous solution is a colourless to slight yellow clear aqueous solution. 2&#8242;-Fucosyllactose is produced by a microbiological process.</p><p><span>Purity:</span></p><p>2&#8242;-Fucosyllactose: &#8805; 90 %</p><p>Lactose: &#8804; 5,0 %</p><p>Fucose: &#8804; 3,0 %</p><p>3-Fucosyllactose: &#8804; 5,0 %</p><p>Fucosylgalactose: &#8804; 3,0 %</p><p>Difucosyllactose: &#8804; 5,0 %</p><p>Glucose: &#8804; 3,0 %</p><p>Galactose: &#8804; 3,0 %</p><p>Water: &#8804; 9,0 % (powder)</p><p>Ash, sulphated: &#8804; 0,5 % (powder and liquid)</p><p>Residual proteins: &#8804; 0,01 % (powder and liquid)</p><p><span>Heavy Metals:</span></p><p>Lead: &#8804; 0,02 mg/kg (powder and liquid)</p><p>Arsenic: &#8804; 0,2 mg/kg (powder and liquid)</p><p>Cadmium: &#8804; 0,1 mg/kg (powder and liquid)</p><p>Mercury: &#8804; 0,5 mg/kg (powder and liquid)</p><p><span>Microbiological criteria:</span></p><p>Total plate count: &#8804; 10<span>4</span> CFU/g (powder), &#8804; 5&#160;000  CFU/g (liquid)</p><p>Yeasts and Moulds: &#8804; 100 CFU/g (powder); &#8804; 50 CFU/g (liquid)</p><p>Enterobacteriaceae/Coliforms: absence in 11 g (powder and liquid)</p><p><span>Salmonella</span>: negative/100 g (powder), negative/200 ml (liquid)</p><p><span>Cronobacter</span>: negative/100 g (powder), negative/200 ml (liquid)</p><p>Endotoxins: &#8804; 100 EU/g (powder), &#8804; 100 EU/ml (liquid)</p><p>Aflatoxin M1: &#8804; 0,025 &#956;g/kg (powder and liquid)&#8217;</p></td></tr></tbody></table>