Document ID: 02021R0096-20230129
Language: ENG

02021R0096 — EN — 29.01.2023 — 001.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION IMPLEMENTING REGULATION (EU) 2021/96</p><p>of 28 January 2021</p><p>authorising the placing on the market of 3'-sialyllactose sodium salt as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 031 29.1.2021, p. 201)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p>&#160;</p></td><td><p>&#160;</p></td><td><p>Official Journal</p></td></tr><tr><td><p>&#160;&#160;No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>&#9658;M1</a></p></td><td><p><a>                              COMMISSION IMPLEMENTING REGULATION (EU) 2023/65&#160;of 6&#160;January 2023</a></p></td><td><p>&#160;&#160;L&#160;6</p></td><td><p>1</p></td><td><p>9.1.2023</p></td></tr></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2021/96
of 28 January 2021
authorising the placing on the market of 3'-sialyllactose sodium salt as a novel food 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)
Article 1
1. 3'-Sialyllactose (3'-SL) sodium salt as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.
2. For a period of five years from the date of entry into force of this Regulation only the initial applicant:
Company: Glycom A/S;
Address: Kogle Allé 4, DK-2970 Hørsholm, Denmark,
is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for that novel food without reference to the data protected pursuant to Article 2 or with the agreement of the applicant.
3. The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex.
Article 2
The data contained in the application file on the basis of which 3'-sialyllactose sodium salt has been assessed by the Authority, claimed by the applicant as fulfilling the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283, shall not be used for the benefit of any subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of the applicant.
Article 3
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Article 4
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.
ANNEX
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
(1) in Table 1 (Authorised novel foods), the following entry is inserted in alphabetical order:
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>&#8216;<span>Authorised novel food</span></p></td><td><p><span>Conditions under which the novel food may be used</span></p></td><td><p><span>Additional specific labelling requirements</span></p></td><td><p><span>Other requirements</span></p></td><td><p><span>Data Protection</span></p></td></tr><tr><td><p><a>&#9660;M1</a></p></td></tr><tr><td><p><span>3'-Sialyllactose (3'-SL) sodium salt</span></p><p><span>(microbial source)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels (expressed as 3'-Sialyllactose)</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8220;3'-Sialyllactose sodium salt&#8221;.</p><p>The labelling of food supplements containing 3'-Sialyllactose sodium salt shall bear a statement that they should not be consumed:</p><p>a)&#160;&#160;if foods containing added 3'-Sialyllactose sodium salt are consumed the same day.</p><p>b)&#160;&#160;by infants and young children</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 18&#160;February 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article&#160;26 of Regulation (EU) 2015/2283.</p><p>Applicant: Glycom A/S, Kogle All&#233; 4, DK-2970 H&#248;rsholm, Denmark. During the period of data protection, the novel food 3'-sialyllactose sodium salt is authorised for placing on the market within the Union only by Glycom A/S, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article&#160;26 of Regulation (EU) 2015/2283 or with the agreement of Glycom A/S.</p><p>End date of the data protection: 18&#160;February 2026.&#8217;</p></td></tr><tr><td><p>Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products</p></td><td><p>0,25&#160;g/L</p></td></tr><tr><td><p>Unflavoured fermented milk-based products</p></td><td><p>0,25&#160;g/L (beverages)</p></td></tr><tr><td><p>0,5&#160;g/kg (products other than beverages)</p></td></tr><tr><td><p>Flavoured fermented milk-based products including heat-treated products</p></td><td><p>0,25&#160;g/L (beverages)</p></td></tr><tr><td><p>2,5&#160;g/kg (products other than beverages)</p></td></tr><tr><td><p>Beverages (flavoured drinks, excluding drinks with a pH less than 5)</p></td><td><p>0,25&#160;g/L</p></td></tr><tr><td><p>Cereal bars</p></td><td><p>2,5&#160;g/kg</p></td></tr><tr><td><p>Infant formula as defined in Regulation (EU) No&#160;609/2013</p></td><td><p>0,2&#160;g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer</p></td></tr><tr><td><p>Follow-on formula as defined in Regulation (EU) No&#160;609/2013</p></td><td><p>0,15&#160;g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer</p></td></tr><tr><td><p>Processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No&#160;609/2013</p></td><td><p>0,15&#160;g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer</p></td></tr><tr><td><p>1,25&#160;g/kg for products other than beverages</p></td></tr><tr><td><p>Milk-based drinks and similar products intended for young children</p></td><td><p>0,15&#160;g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer</p></td></tr><tr><td><p>Total diet replacement foods for weight control as defined in Regulation (EU) No&#160;609/2013</p></td><td><p>0,5&#160;g/L (beverages)</p></td></tr><tr><td><p>5 g/kg (products other than beverages)</p></td></tr><tr><td><p>Food for special medical purposes as defined in Regulation (EU) No&#160;609/2013</p></td><td><p>In accordance with the particular nutritional requirements of the persons for whom the products are intended</p></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children</p></td><td><p>0,5&#160;g/day</p></td></tr><tr><td><p><a>&#9660;B</a></p></td></tr></tbody></table>
(2) in Table 2 (Specifications), the following entry is inserted in alphabetical order:
<table><col/><col/><tbody><tr><td><p>&#8216;<span>Authorised Novel Food</span></p></td><td><p><span>Specification</span></p></td></tr><tr><td><p><span>3'-Sialyllactose (3'-SL) sodium salt</span></p><p><span>(microbial source)</span></p></td><td><p><span>Description:</span></p><p>3'-Sialyllactose (3'-SL) sodium salt is a purified, white to off-white powder or agglomerate that is produced by a microbial process and contains limited levels of lactose, 3'-sialyl-lactulose, and sialic acid</p><p><span>Source:</span> Genetically modified strain of<span>Escherichia coli</span> K-12 DH1</p><p><span>Definition:</span></p><p>Chemical formula: C<span>23</span>H<span>38</span>NO<span>19</span>Na</p><p>Chemical name:<span>N</span>-Acetyl-&#945;-D-neuraminyl-(2&#8594;3)-&#946;-D-galactopyranosyl-(1&#8594;4)-D-glucose, sodium salt</p><p>Molecular mass: 655,53 Da</p><p>CAS No 128596-80-5</p><p><span>Characteristics/Composition:</span></p><p>Appearance: White to off-white powder or agglomerate</p><p>Sum of 3'-Sialyllactose sodium salt, D-Lactose, and Sialic acid (% of dry matter): &#8805; 90,0 % (w/w)</p><p>3'-Sialyllactose sodium salt (% of dry matter): &#8805; 88,0 % (w/w)</p><p>D-Lactose: &#8804; 5,0 % (w/w)</p><p>Sialic acid: &#8804; 1,5 % (w/w)</p><p>3'-Sialyl-lactulose: &#8804; 5,0 % (w/w)</p><p>Sum of other carbohydrates: &#8804; 3,0 % (w/w)</p><p>Moisture: &#8804; 8,0 % (w/w)</p><p>Sodium: 2,5 &#8211; 4,5 % (w/w)</p><p>Chloride: &#8804; 1,0 % (w/w)</p><p>pH (20 &#176;C, 5 % solution): 4,5 -6,0</p><p>Residual protein: &#8804; 0,01 % (w/w)</p><p><span>Microbiological criteria:</span></p><p>Aerobic mesophilic bacteria total plate count: &#8804; 1000 CFU/g</p><p><span>Enterobacteriaceae</span>: &#8804; 10 CFU/g</p><p><span>Salmonella</span> sp.: Absence in 25 g</p><p>Yeast: &#8804; 100 CFU/g</p><p>Mould: &#8804; 100 CFU/g</p><p>Residual endotoxins: &#8804; 10 EU/mg</p></td></tr></tbody></table>
CFU: Colony Forming Units; EU: Endotoxin Units’