Document ID: 02017R2470-20230606
Language: ENG

02017R2470 — EN — 06.06.2023 — 041.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>COMMISSION IMPLEMENTING REGULATION (EU) 2017/2470</p><p>of 20 December 2017</p><p>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</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 351 30.12.2017, p. 72)</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>&#160;M1</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2018/460&#160;of 20 March 2018</a></p></td><td><p>&#160;&#160;L&#160;78</p></td><td><p>2</p></td><td><p>21.3.2018</p></td></tr><tr><td><p><a>&#160;M2</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2018/461&#160;of 20 March 2018</a></p></td><td><p>&#160;&#160;L&#160;78</p></td><td><p>7</p></td><td><p>21.3.2018</p></td></tr><tr><td><p><a>&#160;M3</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2018/462&#160;of 20 March 2018</a></p></td><td><p>&#160;&#160;L&#160;78</p></td><td><p>11</p></td><td><p>21.3.2018</p></td></tr><tr><td><p><a>&#160;M4</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2018/469&#160;of 21 March 2018</a></p></td><td><p>&#160;&#160;L&#160;79</p></td><td><p>11</p></td><td><p>22.3.2018</p></td></tr><tr><td><p><a>&#160;M5</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2018/991&#160;of 12 July 2018</a></p></td><td><p>&#160;&#160;L&#160;177</p></td><td><p>9</p></td><td><p>13.7.2018</p></td></tr><tr><td><p><a>&#160;M6</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2018/1011&#160;of 17 July 2018</a></p></td><td><p>&#160;&#160;L&#160;181</p></td><td><p>4</p></td><td><p>18.7.2018</p></td></tr><tr><td><p><a>&#160;M7</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2018/1018&#160;of 18 July 2018</a></p></td><td><p>&#160;&#160;L&#160;183</p></td><td><p>9</p></td><td><p>19.7.2018</p></td></tr><tr><td><p><a>&#160;M8</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2018/1032&#160;of 20 July 2018</a></p></td><td><p>&#160;&#160;L&#160;185</p></td><td><p>9</p></td><td><p>23.7.2018</p></td></tr><tr><td><p><a>&#9658;M9</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2018/1023&#160;of 23 July 2018</a></p></td><td><p>&#160;&#160;L&#160;187</p></td><td><p>1</p></td><td><p>24.7.2018</p></td></tr><tr><td><p><a>&#9658;M10</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2018/1122&#160;of 10&#160;August 2018</a></p></td><td><p>&#160;&#160;L&#160;204</p></td><td><p>36</p></td><td><p>13.8.2018</p></td></tr><tr><td><p><a>&#9658;M11</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2018/1123&#160;of 10&#160;August 2018</a></p></td><td><p>&#160;&#160;L&#160;204</p></td><td><p>41</p></td><td><p>13.8.2018</p></td></tr><tr><td><p><a>&#9658;M12</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2018/1132&#160;of 13&#160;August 2018</a></p></td><td><p>&#160;&#160;L&#160;205</p></td><td><p>15</p></td><td><p>14.8.2018</p></td></tr><tr><td><p><a>&#9658;M13</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2018/1133&#160;of 13&#160;August 2018</a></p></td><td><p>&#160;&#160;L&#160;205</p></td><td><p>18</p></td><td><p>14.8.2018</p></td></tr><tr><td><p><a>&#9658;M14</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2018/1293&#160;of 26&#160;September 2018</a></p></td><td><p>&#160;&#160;L&#160;243</p></td><td><p>2</p></td><td><p>27.9.2018</p></td></tr><tr><td><p><a>&#9658;M15</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2018/1631&#160;of 30&#160;October 2018</a></p></td><td><p>&#160;&#160;L&#160;272</p></td><td><p>17</p></td><td><p>31.10.2018</p></td></tr><tr><td><p><a>&#160;M16</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2018/1632&#160;of 30&#160;October 2018</a></p></td><td><p>&#160;&#160;L&#160;272</p></td><td><p>23</p></td><td><p>31.10.2018</p></td></tr><tr><td><p><a>&#9658;M17</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2018/1633&#160;of 30&#160;October 2018</a></p></td><td><p>&#160;&#160;L&#160;272</p></td><td><p>29</p></td><td><p>31.10.2018</p></td></tr><tr><td><p><a>&#9658;M18</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2018/1647&#160;of 31&#160;October 2018</a></p></td><td><p>&#160;&#160;L&#160;274</p></td><td><p>51</p></td><td><p>5.11.2018</p></td></tr><tr><td><p><a>&#160;M19</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2018/1648&#160;of 29&#160;October 2018</a></p></td><td><p>&#160;&#160;L&#160;275</p></td><td><p>1</p></td><td><p>6.11.2018</p></td></tr><tr><td><p><a>&#9658;M20</a></p></td><td><p>Amended by:&#160;<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><tr><td><p><a>&#9658;M21</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2018/1991&#160;of 13&#160;December 2018</a></p></td><td><p>&#160;&#160;L&#160;320</p></td><td><p>22</p></td><td><p>17.12.2018</p></td></tr><tr><td><p><a>&#9658;M22</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2018/2016&#160;of 18&#160;December 2018</a></p></td><td><p>&#160;&#160;L&#160;323</p></td><td><p>1</p></td><td><p>19.12.2018</p></td></tr><tr><td><p><a>&#9658;M23</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2018/2017&#160;of 18&#160;December 2018</a></p></td><td><p>&#160;&#160;L&#160;323</p></td><td><p>4</p></td><td><p>19.12.2018</p></td></tr><tr><td><p><a>&#9658;M24</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2019/108&#160;of 24&#160;January 2019</a></p></td><td><p>&#160;&#160;L&#160;23</p></td><td><p>4</p></td><td><p>25.1.2019</p></td></tr><tr><td><p><a>&#9658;M25</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2019/109&#160;of 24&#160;January 2019</a></p></td><td><p>&#160;&#160;L&#160;23</p></td><td><p>7</p></td><td><p>25.1.2019</p></td></tr><tr><td><p><a>&#9658;M26</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2019/110&#160;of 24&#160;January 2019</a></p></td><td><p>&#160;&#160;L&#160;23</p></td><td><p>11</p></td><td><p>25.1.2019</p></td></tr><tr><td><p><a>&#9658;M27</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2019/387&#160;of 11&#160;March 2019</a></p></td><td><p>&#160;&#160;L&#160;70</p></td><td><p>17</p></td><td><p>12.3.2019</p></td></tr><tr><td><p><a>&#160;M28</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2019/388&#160;of 11&#160;March 2019</a></p></td><td><p>&#160;&#160;L&#160;70</p></td><td><p>21</p></td><td><p>12.3.2019</p></td></tr><tr><td><p><a>&#160;M29</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2019/456&#160;of 20&#160;March 2019</a></p></td><td><p>&#160;&#160;L&#160;79</p></td><td><p>13</p></td><td><p>21.3.2019</p></td></tr><tr><td><p><a>&#9658;M30</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2019/506&#160;of 26&#160;March 2019</a></p></td><td><p>&#160;&#160;L&#160;85</p></td><td><p>11</p></td><td><p>27.3.2019</p></td></tr><tr><td><p><a>&#9658;M31</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2019/760&#160;of 13&#160;May 2019</a></p></td><td><p>&#160;&#160;L&#160;125</p></td><td><p>13</p></td><td><p>14.5.2019</p></td></tr><tr><td><p><a>&#9658;M32</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2019/1272&#160;of 29&#160;July 2019</a></p></td><td><p>&#160;&#160;L&#160;201</p></td><td><p>3</p></td><td><p>30.7.2019</p></td></tr><tr><td><p><a>&#9658;M33</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2019/1294&#160;of 1&#160;August 2019</a></p></td><td><p>&#160;&#160;L&#160;204</p></td><td><p>16</p></td><td><p>2.8.2019</p></td></tr><tr><td><p><a>&#160;M34</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2019/1314&#160;of 2&#160;August 2019</a></p></td><td><p>&#160;&#160;L&#160;205</p></td><td><p>4</p></td><td><p>5.8.2019</p></td></tr><tr><td><p><a>&#9658;M35</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2019/1686&#160;of 8 October 2019</a></p></td><td><p>&#160;&#160;L&#160;258</p></td><td><p>13</p></td><td><p>9.10.2019</p></td></tr><tr><td><p><a>&#9658;M36</a></p></td><td><p>Amended by:&#160;<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><tr><td><p><a>&#9658;M37</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2019/1976&#160;of 25 November 2019</a></p></td><td><p>&#160;&#160;L&#160;308</p></td><td><p>40</p></td><td><p>29.11.2019</p></td></tr><tr><td><p><a>&#9658;M38</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2019/1979&#160;of 26 November 2019</a></p></td><td><p>&#160;&#160;L&#160;308</p></td><td><p>62</p></td><td><p>29.11.2019</p></td></tr><tr><td><p><a>&#160;M39</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2019/2165&#160;of 17 December 2019</a></p></td><td><p>&#160;&#160;L&#160;328</p></td><td><p>81</p></td><td><p>18.12.2019</p></td></tr><tr><td><p><a>&#160;M40</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2020/16&#160;of 10 January 2020</a></p></td><td><p>&#160;&#160;L&#160;7</p></td><td><p>6</p></td><td><p>13.1.2020</p></td></tr><tr><td><p><a>&#160;M41</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2020/24&#160;of 13 January 2020</a></p></td><td><p>&#160;&#160;L&#160;8</p></td><td><p>12</p></td><td><p>14.1.2020</p></td></tr><tr><td><p><a>&#9658;M42</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2020/206&#160;of 14 February 2020</a></p></td><td><p>&#160;&#160;L&#160;43</p></td><td><p>66</p></td><td><p>17.2.2020</p></td></tr><tr><td><p><a>&#9658;M43</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2020/443&#160;of 25 March 2020</a></p></td><td><p>&#160;&#160;L&#160;92</p></td><td><p>7</p></td><td><p>26.3.2020</p></td></tr><tr><td><p><a>&#9658;M44</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2020/478&#160;of 1 April 2020</a></p></td><td><p>&#160;&#160;L&#160;102</p></td><td><p>1</p></td><td><p>2.4.2020</p></td></tr><tr><td><p><a>&#9658;M45</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2020/484&#160;of 2 April 2020</a></p></td><td><p>&#160;&#160;L&#160;103</p></td><td><p>3</p></td><td><p>3.4.2020</p></td></tr><tr><td><p><a>&#9658;M46</a></p></td><td><p>Amended by:&#160;<a>COMMISSION IMPLEMENTING REGULATION (EU) 2021/1318&#160;of 9&#160;August 2021</a></p></td><td><p>&#160;&#160;L&#160;286</p></td><td><p>5</p></td><td><p>10.8.2021</p></td></tr><tr><td><p><a>&#9658;M47</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2020/500&#160;of 6 April 2020</a></p></td><td><p>&#160;&#160;L&#160;109</p></td><td><p>2</p></td><td><p>7.4.2020</p></td></tr><tr><td><p><a>&#9658;M48</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2020/916&#160;of 1 July 2020</a></p></td><td><p>&#160;&#160;L&#160;209</p></td><td><p>6</p></td><td><p>2.7.2020</p></td></tr><tr><td><p><a>&#9658;M49</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2020/917&#160;of 1 July 2020</a></p></td><td><p>&#160;&#160;L&#160;209</p></td><td><p>10</p></td><td><p>2.7.2020</p></td></tr><tr><td><p><a>&#9658;M50</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2020/973&#160;of 6 July 2020</a></p></td><td><p>&#160;&#160;L&#160;215</p></td><td><p>7</p></td><td><p>7.7.2020</p></td></tr><tr><td><p><a>&#9658;M51</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2020/1163&#160;of 6 August 2020</a></p></td><td><p>&#160;&#160;L&#160;258</p></td><td><p>1</p></td><td><p>7.8.2020</p></td></tr><tr><td><p><a>&#9658;M52</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2020/1559&#160;of 26 October 2020</a></p></td><td><p>&#160;&#160;L&#160;357</p></td><td><p>7</p></td><td><p>27.10.2020</p></td></tr><tr><td><p><a>&#9658;M53</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2020/1634&#160;of 4 November 2020</a></p></td><td><p>&#160;&#160;L&#160;367</p></td><td><p>39</p></td><td><p>5.11.2020</p></td></tr><tr><td><p><a>&#9658;M54</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2020/1820&#160;of 2 December 2020</a></p></td><td><p>&#160;&#160;L&#160;406</p></td><td><p>29</p></td><td><p>3.12.2020</p></td></tr><tr><td><p><a>&#9658;M55</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2020/1821&#160;of 2 December 2020</a></p></td><td><p>&#160;&#160;L&#160;406</p></td><td><p>34</p></td><td><p>3.12.2020</p></td></tr><tr><td><p><a>&#9658;M56</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2020/1822&#160;of 2 December 2020</a></p></td><td><p>&#160;&#160;L&#160;406</p></td><td><p>39</p></td><td><p>3.12.2020</p></td></tr><tr><td><p><a>&#9658;M57</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2020/1993&#160;of 4 December 2020</a></p></td><td><p>&#160;&#160;L&#160;410</p></td><td><p>62</p></td><td><p>7.12.2020</p></td></tr><tr><td><p><a>&#9658;M58</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2021/50&#160;of 22 January 2021</a></p></td><td><p>&#160;&#160;L&#160;23</p></td><td><p>7</p></td><td><p>25.1.2021</p></td></tr><tr><td><p><a>&#9658;M59</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2021/51&#160;of 22 January 2021</a></p></td><td><p>&#160;&#160;L&#160;23</p></td><td><p>10</p></td><td><p>25.1.2021</p></td></tr><tr><td><p><a>&#9658;M60</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2021/82&#160;of 27 January 2021</a></p></td><td><p>&#160;&#160;L&#160;29</p></td><td><p>16</p></td><td><p>28.1.2021</p></td></tr><tr><td><p><a>&#9658;M61</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2021/96&#160;of 28 January 2021</a></p></td><td><p>&#160;&#160;L&#160;31</p></td><td><p>201</p></td><td><p>29.1.2021</p></td></tr><tr><td><p><a>&#9658;M62</a></p></td><td><p>Amended by:&#160;<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><tr><td><p><a>&#9658;M63</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2021/120&#160;of 2 February 2021</a></p></td><td><p>&#160;&#160;L&#160;37</p></td><td><p>1</p></td><td><p>3.2.2021</p></td></tr><tr><td><p><a>&#9658;M64</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2021/668&#160;of 23&#160;April 2021</a></p></td><td><p>&#160;&#160;L&#160;141</p></td><td><p>3</p></td><td><p>26.4.2021</p></td></tr><tr><td><p><a>&#9658;M65</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2021/670&#160;of 23&#160;April 2021</a></p></td><td><p>&#160;&#160;L&#160;141</p></td><td><p>14</p></td><td><p>26.4.2021</p></td></tr><tr><td><p><a>&#9658;M66</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2021/882&#160;of 1&#160;June 2021</a></p></td><td><p>&#160;&#160;L&#160;194</p></td><td><p>16</p></td><td><p>2.6.2021</p></td></tr><tr><td><p><a>&#160;M67</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2021/900&#160;of 3&#160;June 2021</a></p></td><td><p>&#160;&#160;L&#160;197</p></td><td><p>71</p></td><td><p>4.6.2021</p></td></tr><tr><td><p><a>&#9658;M68</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2021/912&#160;of 4&#160;June 2021</a></p></td><td><p>&#160;&#160;L&#160;199</p></td><td><p>10</p></td><td><p>7.6.2021</p></td></tr><tr><td><p><a>&#9658;M69</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2021/1318&#160;of 9&#160;August 2021</a></p></td><td><p>&#160;&#160;L&#160;286</p></td><td><p>5</p></td><td><p>10.8.2021</p></td></tr><tr><td><p><a>&#9658;M70</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2021/1319&#160;of 9&#160;August 2021</a></p></td><td><p>&#160;&#160;L&#160;286</p></td><td><p>12</p></td><td><p>10.8.2021</p></td></tr><tr><td><p><a>&#9658;M71</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2021/1326&#160;of 10&#160;August 2021</a></p></td><td><p>&#160;&#160;L&#160;288</p></td><td><p>24</p></td><td><p>11.8.2021</p></td></tr><tr><td><p><a>&#9658;M72</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2021/1377&#160;of 19&#160;August 2021</a></p></td><td><p>&#160;&#160;L&#160;297</p></td><td><p>20</p></td><td><p>20.8.2021</p></td></tr><tr><td><p><a>&#9658;M73</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2021/1974&#160;of 12&#160;November 2021</a></p></td><td><p>&#160;&#160;L&#160;402</p></td><td><p>5</p></td><td><p>15.11.2021</p></td></tr><tr><td><p><a>&#9658;M74</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2021/1975&#160;of 12&#160;November 2021</a></p></td><td><p>&#160;&#160;L&#160;402</p></td><td><p>10</p></td><td><p>15.11.2021</p></td></tr><tr><td><p><a>&#9658;M75</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2021/2029&#160;of 19&#160;November 2021</a></p></td><td><p>&#160;&#160;L&#160;415</p></td><td><p>9</p></td><td><p>22.11.2021</p></td></tr><tr><td><p><a>&#9658;M76</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2021/2079&#160;of 26&#160;November 2021</a></p></td><td><p>&#160;&#160;L&#160;426</p></td><td><p>16</p></td><td><p>29.11.2021</p></td></tr><tr><td><p><a>&#9658;M77</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2021/2129&#160;of 2&#160;December 2021</a></p></td><td><p>&#160;&#160;L&#160;432</p></td><td><p>13</p></td><td><p>3.12.2021</p></td></tr><tr><td><p><a>&#9658;M78</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2021/2191&#160;of 10&#160;December 2021</a></p></td><td><p>&#160;&#160;L&#160;445</p></td><td><p>1</p></td><td><p>13.12.2021</p></td></tr><tr><td><p><a>&#9658;M79</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2022/47&#160;of 13&#160;January 2022</a></p></td><td><p>&#160;&#160;L&#160;9</p></td><td><p>29</p></td><td><p>14.1.2022</p></td></tr><tr><td><p><a>&#9658;M80</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2022/168&#160;of 8&#160;February 2022</a></p></td><td><p>&#160;&#160;L&#160;28</p></td><td><p>5</p></td><td><p>9.2.2022</p></td></tr><tr><td><p><a>&#9658;M81</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2022/169&#160;of 8&#160;February 2022</a></p></td><td><p>&#160;&#160;L&#160;28</p></td><td><p>10</p></td><td><p>9.2.2022</p></td></tr><tr><td><p><a>&#9658;M82</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2022/187&#160;of 10&#160;February 2022</a></p></td><td><p>&#160;&#160;L&#160;30</p></td><td><p>102</p></td><td><p>11.2.2022</p></td></tr><tr><td><p><a>&#9658;M83</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2022/188&#160;of 10&#160;February 2022</a></p></td><td><p>&#160;&#160;L&#160;30</p></td><td><p>108</p></td><td><p>11.2.2022</p></td></tr><tr><td><p><a>&#9658;M84</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2022/196&#160;of 11&#160;February 2022</a></p></td><td><p>&#160;&#160;L&#160;31</p></td><td><p>46</p></td><td><p>14.2.2022</p></td></tr><tr><td><p><a>&#9658;M85</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2022/202&#160;of 14&#160;February 2022</a></p></td><td><p>&#160;&#160;L&#160;33</p></td><td><p>41</p></td><td><p>15.2.2022</p></td></tr><tr><td><p><a>&#9658;M86</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2022/672&#160;of 22&#160;April 2022</a></p></td><td><p>&#160;&#160;L&#160;122</p></td><td><p>24</p></td><td><p>25.4.2022</p></td></tr><tr><td><p><a>&#9658;M87</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2022/673&#160;of 22&#160;April 2022</a></p></td><td><p>&#160;&#160;L&#160;122</p></td><td><p>27</p></td><td><p>25.4.2022</p></td></tr><tr><td><p><a>&#160;M88</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2022/684&#160;of 28&#160;April 2022</a></p></td><td><p>&#160;&#160;L&#160;126</p></td><td><p>10</p></td><td><p>29.4.2022</p></td></tr><tr><td><p><a>&#9658;M89</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2022/961&#160;of 20&#160;June 2022</a></p></td><td><p>&#160;&#160;L&#160;165</p></td><td><p>41</p></td><td><p>21.6.2022</p></td></tr><tr><td><p><a>&#9658;M90</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2022/965&#160;of 21&#160;June 2022</a></p></td><td><p>&#160;&#160;L&#160;166</p></td><td><p>118</p></td><td><p>22.6.2022</p></td></tr><tr><td><p><a>&#9658;M91</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2022/966&#160;of 21&#160;June 2022</a></p></td><td><p>&#160;&#160;L&#160;166</p></td><td><p>125</p></td><td><p>22.6.2022</p></td></tr><tr><td><p><a>&#9658;M92</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2022/1160&#160;of 5&#160;July 2022</a></p></td><td><p>&#160;&#160;L&#160;179</p></td><td><p>25</p></td><td><p>6.7.2022</p></td></tr><tr><td><p><a>&#9658;M93</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2022/1365&#160;of 4&#160;August 2022</a></p></td><td><p>&#160;&#160;L&#160;205</p></td><td><p>230</p></td><td><p>5.8.2022</p></td></tr><tr><td><p><a>&#9658;M94</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2022/1373&#160;of 5&#160;August 2022</a></p></td><td><p>&#160;&#160;L&#160;206</p></td><td><p>28</p></td><td><p>8.8.2022</p></td></tr><tr><td><p><a>&#9658;M95</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2022/1381&#160;of 8&#160;August 2022</a></p></td><td><p>&#160;&#160;L&#160;207</p></td><td><p>12</p></td><td><p>9.8.2022</p></td></tr><tr><td><p><a>&#9658;M96</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2022/2534&#160;of 21&#160;December 2022</a></p></td><td><p>&#160;&#160;L&#160;328</p></td><td><p>85</p></td><td><p>22.12.2022</p></td></tr><tr><td><p><a>&#9658;M97</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2022/2535&#160;of 21&#160;December 2022</a></p></td><td><p>&#160;&#160;L&#160;328</p></td><td><p>91</p></td><td><p>22.12.2022</p></td></tr><tr><td><p><a>&#9658;M98</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2023/4&#160;of 3&#160;January 2023</a></p></td><td><p>&#160;&#160;L&#160;2</p></td><td><p>3</p></td><td><p>4.1.2023</p></td></tr><tr><td><p><a>&#9658;M99</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2023/5&#160;of 3&#160;January 2023</a></p></td><td><p>&#160;&#160;L&#160;2</p></td><td><p>9</p></td><td><p>4.1.2023</p></td></tr><tr><td><p><a>&#9658;M100</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2023/6&#160;of 3&#160;January 2023</a></p></td><td><p>&#160;&#160;L&#160;2</p></td><td><p>16</p></td><td><p>4.1.2023</p></td></tr><tr><td><p><a>&#9658;M101</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2023/7&#160;of 3&#160;January 2023</a></p></td><td><p>&#160;&#160;L&#160;2</p></td><td><p>21</p></td><td><p>4.1.2023</p></td></tr><tr><td><p><a>&#9658;M102</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2023/52&#160;of 4&#160;January 2023</a></p></td><td><p>&#160;&#160;L&#160;3</p></td><td><p>1</p></td><td><p>5.1.2023</p></td></tr><tr><td><p><a>&#9658;M103</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2023/58&#160;of 5&#160;January 2023</a></p></td><td><p>&#160;&#160;L&#160;5</p></td><td><p>10</p></td><td><p>6.1.2023</p></td></tr><tr><td><p><a>&#9658;M104</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><tr><td><p><a>&#9658;M105</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2023/113&#160;of 16&#160;January 2023</a></p></td><td><p>&#160;&#160;L&#160;15</p></td><td><p>1</p></td><td><p>17.1.2023</p></td></tr><tr><td><p><a>&#9658;M106</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2023/267&#160;of 8&#160;February 2023</a></p></td><td><p>&#160;&#160;L&#160;39</p></td><td><p>1</p></td><td><p>9.2.2023</p></td></tr><tr><td><p><a>&#9658;M107</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2023/463&#160;of 3&#160;March 2023</a></p></td><td><p>&#160;&#160;L&#160;68</p></td><td><p>32</p></td><td><p>6.3.2023</p></td></tr><tr><td><p><a>&#9658;M108</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2023/652&#160;of 20&#160;March 2023</a></p></td><td><p>&#160;&#160;L&#160;81</p></td><td><p>23</p></td><td><p>21.3.2023</p></td></tr><tr><td><p><a>&#9658;M109</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2023/667&#160;of 22&#160;March 2023</a></p></td><td><p>&#160;&#160;L&#160;84</p></td><td><p>3</p></td><td><p>23.3.2023</p></td></tr><tr><td><p><a>&#9658;M110</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2023/859&#160;of 25&#160;April 2023</a></p></td><td><p>&#160;&#160;L&#160;111</p></td><td><p>17</p></td><td><p>26.4.2023</p></td></tr><tr><td><p><a>&#9658;M111</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2023/931&#160;of 8&#160;May 2023</a></p></td><td><p>&#160;&#160;L&#160;124</p></td><td><p>1</p></td><td><p>10.5.2023</p></td></tr><tr><td><p><a>&#9658;M112</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2023/937&#160;of 10&#160;May 2023</a></p></td><td><p>&#160;&#160;L&#160;125</p></td><td><p>12</p></td><td><p>11.5.2023</p></td></tr><tr><td><p><a>&#9658;M113</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2023/938&#160;of 10&#160;May 2023</a></p></td><td><p>&#160;&#160;L&#160;125</p></td><td><p>16</p></td><td><p>11.5.2023</p></td></tr><tr><td><p><a>&#9658;M114</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2023/943&#160;of 11&#160;May 2023</a></p></td><td><p>&#160;&#160;L&#160;126</p></td><td><p>41</p></td><td><p>12.5.2023</p></td></tr><tr><td><p><a>&#9658;M115</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2023/948&#160;of 12&#160;May 2023</a></p></td><td><p>&#160;&#160;L&#160;128</p></td><td><p>52</p></td><td><p>15.5.2023</p></td></tr><tr><td><p><a>&#9658;M116</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2023/949&#160;of 12&#160;May 2023</a></p></td><td><p>&#160;&#160;L&#160;128</p></td><td><p>60</p></td><td><p>15.5.2023</p></td></tr><tr><td><p><a>&#9658;M117</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2023/950&#160;of 12&#160;May 2023</a></p></td><td><p>&#160;&#160;L&#160;128</p></td><td><p>68</p></td><td><p>15.5.2023</p></td></tr><tr><td><p><a>&#9658;M118</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2023/951&#160;of 12&#160;May 2023</a></p></td><td><p>&#160;&#160;L&#160;128</p></td><td><p>73</p></td><td><p>15.5.2023</p></td></tr><tr><td><p><a>&#9658;M119</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2023/961&#160;of 12&#160;May 2023</a></p></td><td><p>&#160;&#160;L&#160;129</p></td><td><p>3</p></td><td><p>16.5.2023</p></td></tr><tr><td><p><a>&#9658;M120</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2023/972&#160;of 10&#160;May 2023</a></p></td><td><p>&#160;&#160;L&#160;132</p></td><td><p>46</p></td><td><p>17.5.2023</p></td></tr></table>
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
(Text with EEA relevance)
Article 1
Union list of authorised novel foods
The Union list of novel foods authorised to be placed on the market within the Union as referred to in Article 6(1) of Regulation (EU) 2015/2283 is hereby established and set out 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.
ANNEX
UNION LIST OF NOVEL FOODS
Content of the list
1. The Union list shall consist of Tables 1 and 2.
2. Table 1 includes the authorised novel foods and contains the following information:
<table><col/><col/><col/><tr><td><p>Column 1</p></td><td><p>:</p></td><td><p>Authorised novel food</p></td></tr></table>
<table><col/><col/><col/><tr><td><p>Column 2</p></td><td><p>:</p></td><td><p>Conditions under which the novel food may be used. This column is further subdivided into two: Specified food category and Maximum levels</p></td></tr></table>
<table><col/><col/><col/><tr><td><p>Column 3</p></td><td><p>:</p></td><td><p>Additional specific labelling requirements</p></td></tr></table>
<table><col/><col/><col/><tr><td><p>Column 4</p></td><td><p>:</p></td><td><p>Other requirements</p></td></tr></table>
3. Table 2 includes the specifications on novel foods and contains the following information:
<table><col/><col/><col/><tr><td><p>Column 1</p></td><td><p>:</p></td><td><p>Authorised novel food</p></td></tr></table>
<table><col/><col/><col/><tr><td><p>Column 2</p></td><td><p>:</p></td><td><p>Specifications</p></td></tr></table>
Table 1: Authorised novel foods
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Authorised novel food</p></td><td><p>Conditions under which the novel food may be used</p></td><td><p>Additional specific labelling requirements</p></td><td><p>Other requirements</p></td><td><p><span><a><span>&#9658;M30</span></a></span>&#160;Data Protection<span>&#160;&#9668;</span></p></td></tr><tr><td><p><span><span>N</span>-Acetyl-D-neuraminic acid</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;<span>N</span>-acetyl-D-neuraminic acid&#8217;</p><p>Food supplements containing<span>N</span>-acetyl-D-neuraminic acid shall bear a statement that the food supplement should not be given to infants, young children and children under 10 years of age where they consume breast milk or other foods with added<span>N</span>-acetyl-D-neuraminic acid within the same twenty four hour period.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Infant and follow-on formulae as defined by Regulation (EU) No 609/2013&#160;<a>(<span>1</span>)</a></p></td><td><p>0,05 g/L of reconstituted formula</p></td></tr><tr><td><p>Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013</p></td><td><p>0,05 g/kg for solid foods</p></td></tr><tr><td><p>Foods for special medical purposes for infants and young children as defined by Regulation (EU) No 609/2013</p></td><td><p>In accordance with the particular nutritional requirements of the infants and young children for whom the products are intended but in any case not higher than the maximum levels specified for the category mentioned in the table corresponding to the products.</p></td></tr><tr><td><p>Total diet replacement foods for weight control as defined by Regulation (EU) No 609/2013</p></td><td><p>0,2 g/L (drinks)</p><p>1,7 g/kg (bars)</p></td></tr><tr><td><p>Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014&#160;<a>(<span>2</span>)</a></p></td><td><p>1,25 g/kg</p></td></tr><tr><td><p>Unflavoured pasteurised and sterilised (including UHT) milk-based products</p></td><td><p>0,05 g/L</p></td></tr><tr><td><p>Unflavoured fermented milk-based products, heat treated after fermentation, flavoured fermented milk products including heat-treated products</p></td><td><p>0,05 g/L (beverages)</p><p>0,4 g/kg (solids)</p></td></tr><tr><td><p>Dairy analogues, including beverage whiteners</p></td><td><p>0,05 g/L (beverages)</p><p>0,25 g/kg (solids)</p></td></tr><tr><td><p>Cereal bars</p></td><td><p>0,5 g/kg</p></td></tr><tr><td><p>Table top sweeteners</p></td><td><p>8,3 g/kg</p></td></tr><tr><td><p>Fruit and vegetable-based drinks</p></td><td><p>0,05 g/L</p></td></tr><tr><td><p>Flavoured drinks</p></td><td><p>0,05 g/L</p></td></tr><tr><td><p>Speciality coffee, tea, herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions</p></td><td><p>0,2 g/kg</p></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC&#160;<a>(<span>3</span>)</a></p></td><td><p>300 mg/day for general population older than 10 years</p><p>55 mg/day for infants</p><p>130 mg/day for young children</p><p>250 mg/day for children between 3 to 10 years of age</p></td></tr><tr><td><p><a>&#9660;M99</a></p></td></tr><tr><td><p><span><span>Acheta domesticus</span> (house cricket) partially defatted powder</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels (g/100&#160;g)(marketed as such or reconstituted according to the instructions)</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;<span>Acheta domesticus</span> (house cricket) partially defatted powder&#8217;.</p><p>2.&#160;&#160;The labelling of the foodstuffs containing<span>Acheta domesticus</span> (house cricket) partially defatted powder shall bear a statement that this ingredient may cause allergic reactions to consumers with known allergies to crustaceans, molluscs, and products thereof, and to dust mites.</p><p>This statement shall appear in close proximity to the list of ingredients.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 24.1.2023. 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: &#8216;Cricket One Co. Ltd&#8217;, 383/3/51 Quang Trung street, Ward 10, Go Vap district, Ho Chi Minh City, Vietnam.</p><p>During the period of data protection, the novel food<span>Acheta domesticus</span> (house cricket) partially defatted powder is authorised for placing on the market within the Union only by &#8216;Cricket One Co. Ltd&#8217;, unless a subsequent applicant obtains authorisation for that 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 &#8216;Cricket One Co. Ltd&#8217;.</p><p>End date of the data protection: 24.1.2028.</p></td></tr><tr><td><p>Multigrain bread and rolls; crackers and breadsticks</p></td><td><p>2</p></td></tr><tr><td><p>Cereal bars</p></td><td><p>3</p></td></tr><tr><td><p>Pre-mixes for baked products (dry)</p></td><td><p>3</p></td></tr><tr><td><p>Biscuits</p></td><td><p>1,5</p></td></tr><tr><td><p>Pasta-based products (dry)</p></td><td><p>0,25</p></td></tr><tr><td><p>Stuffed pasta-based products (dry)</p></td><td><p>3</p></td></tr><tr><td><p>Sauces</p></td><td><p>1</p></td></tr><tr><td><p>Processed potato products, legume- and vegetable-based dishes, pizza, pasta-based dishes</p></td><td><p>1</p></td></tr><tr><td><p>Whey powder</p></td><td><p>3</p></td></tr><tr><td><p>Meat analogues</p></td><td><p>5</p></td></tr><tr><td><p>Soups and soup concentrates or powders</p></td><td><p>1</p></td></tr><tr><td><p>Maize flour based snacks</p></td><td><p>4</p></td></tr><tr><td><p>Beer-like beverages</p></td><td><p>0,1</p></td></tr><tr><td><p>Chocolate confectionary</p></td><td><p>2</p></td></tr><tr><td><p>Nuts and oilseeds</p></td><td><p>2</p></td></tr><tr><td><p>Snacks other than chips</p></td><td><p>5</p></td></tr><tr><td><p>Meat preparations</p></td><td><p>2</p></td></tr><tr><td><p>&#160;</p><div/></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span><span>Adansonia digitata</span> (Baobab) dried fruit pulp</span></p></td><td><p>Not specified</p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Baobab fruit pulp&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><a>&#9660;M103</a></p></td></tr><tr><td><p><span>Frozen, paste, dried and powder forms of<span>Alphitobius diaperinus</span> larvae (lesser mealworm)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels (g/100g)</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Frozen/paste<span>Alphitobius diaperinus</span> larvae (lesser mealworm)&#8217; or &#8216;Dried/powder<span>Alphitobius diaperinus</span> larvae (lesser mealworm)&#8217; depending on the form used.</p><p>2.&#160;&#160;The labelling of food supplements containing the novel food shall bear a statement that those food supplements should not be consumed by persons under 18 years of age.</p><p>3.&#160;&#160;The labelling of the foodstuffs containing frozen, paste, dried or powder forms of<span>Alphitobius diaperinus</span> larvae (lesser mealworm) shall bear a statement that this ingredient may cause allergic reactions to consumers with known allergies to crustaceans, and products thereof, and to dust mites.</p><p>This statement shall appear in close proximity to the list of ingredients.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 26.1.2023. This inclusion is based on proprietary scientific data protected in accordance with Article&#160;26 of Regulation (EU) 2015/2283.</p><p>Applicant: Ynsect NL B.V, Harderwijkerweg 141B, 3852 AB Ermelo, the Netherlands.</p><p>During the period of data protection, the novel food is authorised for placing on the market within the Union only by Ynsect NL B.V., unless a subsequent applicant obtains authorisation for that novel food without reference to the proprietary scientific data protected in accordance with Article&#160;26 of Regulation (EU) 2015/2283, or with the agreement of Ynsect NL B.V.</p><p>End date of the data protection: 26.1.2028.</p></td></tr><tr><td><p>Cereal bars</p></td><td><p>25  (Dried form)</p><p>25  (Powder form)</p></td></tr><tr><td><p>Bread and rolls</p></td><td><p>20  (Powder form)</p></td></tr><tr><td><p>Processed and breakfast cereals</p></td><td><p>10  (Dried form)</p><p>10  (Powder form)</p></td></tr><tr><td><p>Porridge</p></td><td><p>15  (Powder form)</p></td></tr><tr><td><p>Pre-mixes (dry) for baked products</p></td><td><p>10  (Powder form)</p></td></tr><tr><td><p>Dried pasta-based products</p></td><td><p>10  (Powder form)</p></td></tr><tr><td><p>Stuffed pasta-based products</p></td><td><p>28  (Frozen or paste form)</p><p>10  (Powder form)</p></td></tr><tr><td><p>Whey powder</p></td><td><p>35  (Powder form)</p></td></tr><tr><td><p>Soups</p></td><td><p>15  (Powder form)</p></td></tr><tr><td><p>Cereal-, pasta-based dishes</p></td><td><p>5  (Powder form)</p></td></tr><tr><td><p>Pizza-based dishes</p></td><td><p>5  (Dried form)</p><p>5  (Powder form)</p></td></tr><tr><td><p>Noodles</p></td><td><p>10  (Powder form)</p></td></tr><tr><td><p>Snacks other than chips</p></td><td><p>10  (Dried form)</p><p>10  (Powder form)</p></td></tr><tr><td><p>Chips/crisps</p></td><td><p>10  (Powder form)</p></td></tr><tr><td><p>Crackers and bread sticks</p></td><td><p>10  (Powder form)</p></td></tr><tr><td><p>Peanut butter</p></td><td><p>15  (Powder form)</p></td></tr><tr><td><p>Ready-to-eat savoury based sandwich</p></td><td><p>20  (Powder form)</p></td></tr><tr><td><p>Meat preparations</p></td><td><p>14  (Frozen or paste form)</p><p>5  (Powder form)</p></td></tr><tr><td><p>Meat analogues</p></td><td><p>40  (Frozen or paste form)</p><p>15  (Powder form)</p></td></tr><tr><td><p>Milk and dairy analogues</p></td><td><p>10  (Powder form)</p></td></tr><tr><td><p>Chocolate confectionary</p></td><td><p>5  (Powder form)</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC for the adult population</p></td><td><p>4  g/day (Powder form)</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span><span>Ajuga reptans</span> extract from cell cultures</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>In line with normal use in food supplements of a similar extract of the flowering aerial parts of<span>Ajuga reptans</span></p></td></tr><tr><td><p><a>&#9660;M80</a></p></td></tr><tr><td><p><span><span>Akkermansia muciniphila</span> (pasteurised)</span></p></td><td><p>Foods for special medical purposes as defined under Regulation (EU) No&#160;609/2013 for the adult population, excluding pregnant and lactating women</p></td><td><p>3,4 &#215; 10<span>10</span> cells/day</p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;pasteurised<span>Akkermansia muciniphila</span>&#8217;.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 1&#160;March 2022. 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: A-Mansia Biotech S.A., rue Granbonpr&#233;, 11, B&#226;timent H, 1435 Mont-Saint-Guibert. Belgium. During the period of data protection, the novel food pasteurised<span>Akkermansia muciniphila</span> is authorised for placing on the market within the Union only by A-Mansia Biotech S.A., 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 Mansia Biotech S.A.</p><p>End date of the data protection: 1&#160;March 2027.</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC for the adult population, excluding pregnant and lactating women</p></td><td><p>3,4 &#215; 10<span>10</span> cells/day</p></td><td><p>The labelling of food supplements containing pasteurised<span>Akkermansia muciniphila</span> shall bear a statement that they should be consumed by adults only, excluding pregnant and lactating women.</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>L-Alanyl-L-Glutamine</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Foods for special medical purposes as defined in Regulation (EU) No 609/2013 excluding foods for infants and young children</p></td></tr><tr><td><p>Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen</p></td></tr><tr><td><p><span>Algal oil from the microalgae<span>Ulkenia</span> sp.</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of DHA</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Oil from the micro-algae<span>Ulkenia sp.</span>&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Bakery products (breads, rolls and sweet biscuits)</p></td><td><p>200 mg/100 g</p></td></tr><tr><td><p>Cereal bars</p></td><td><p>500 mg/100 g</p></td></tr><tr><td><p>Non-alcoholic beverages (including milk based beverages)</p></td><td><p>60 mg/100 ml</p></td></tr><tr><td><p><a>&#9660;M26</a></p></td></tr><tr><td><p><span><span>Allanblackia</span> seed oil</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;<span>Allanblackia</span> seed oil&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Yellow fat spreads and cream based spreads</p></td><td><p>30 g/100 g</p></td></tr><tr><td><p>Mixtures of vegetable oils&#160;(*) and milk (falling under the food category: Dairy analogues, including beverage whiteners)</p></td><td><p>30 g/100 g</p></td></tr><tr><td><p>(*)&#160;&#160;Except olive oils and olive pomace oils as defined in Part&#160;VIII of Annex&#160;VII of Regulation (EU) No&#160;1308/2013.</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span><span>Aloe macroclada</span> Baker leaf extract</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>In line with normal use in food supplements of the similar gel derived<span>from Aloe vera</span> (L.) Burm.</p></td></tr><tr><td><p><span>Antarctic Krill oil from<span>Euphausia superba</span></span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of combined DHA and EPA</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Lipid extract from the crustacean Antarctic Krill (<span>Euphausia superba</span>)&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Dairy products except milk-based drinks</p></td><td><p>200 mg/100 g or for cheese products 600 mg/100 g</p></td></tr><tr><td><p>Dairy analogues except drinks</p></td><td><p>200 mg/100 g or for analogues to cheese products 600 mg/100 g</p></td></tr><tr><td><p>Non-alcoholic beverages</p><p>Milk-based drinks</p><p>Dairy analogue drinks</p></td><td><p>80 mg/100 ml</p></td></tr><tr><td><p>Spreadable fat and dressings</p></td><td><p>600 mg/100 g</p></td></tr><tr><td><p>Cooking fats</p></td><td><p>360 mg/100 ml</p></td></tr><tr><td><p>Breakfast cereals</p></td><td><p>500 mg/100 g</p></td></tr><tr><td><p>Bakery products (breads, rolls and sweet biscuits)</p></td><td><p>200 mg/100 g</p></td></tr><tr><td><p>Nutrition bars/cereal bars</p></td><td><p>500 mg/100 g</p></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>3&#160;000  mg/day for the general population</p><p>450 mg/day for pregnant and lactating women</p></td></tr><tr><td><p>Foods for special medical purposes as defined in Regulation (EU) No 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>Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control</p></td><td><p>250 mg/meal</p></td></tr><tr><td><p>Processed cereal-based food and baby food intended for infants and young children covered by Regulation (EU) No 609/2013</p></td><td><p>200 mg/100 ml</p></td></tr><tr><td><p>Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen</p></td></tr><tr><td><p>Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014</p></td></tr><tr><td><p><span>Antarctic Krill oil rich in phospholipids from<span>Euphausia superba</span></span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of combined DHA and EPA</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Lipid extract from the crustacean Antarctic Krill (<span>Euphausia superba</span>)&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Dairy products except milk-based drinks</p></td><td><p>200 mg/100 g or for cheese products 600 mg/100 g</p></td></tr><tr><td><p>Dairy analogues except drinks</p></td><td><p>200 mg/100 g or for analogues to cheese products 600 mg/100 g</p></td></tr><tr><td><p>Non-alcoholic beverages</p><p>Milk-based drinks</p><p>Dairy analogue drinks</p></td><td><p>80 mg/100 ml</p></td></tr><tr><td><p>Spreadable fat and dressings</p></td><td><p>600 mg/100 g</p></td></tr><tr><td><p>Cooking fats</p></td><td><p>360 mg/100 ml</p></td></tr><tr><td><p>Breakfast cereals</p></td><td><p>500 mg/100 g</p></td></tr><tr><td><p>Bakery products (breads, rolls and sweet biscuits)</p></td><td><p>200 mg/100 g</p></td></tr><tr><td><p>Nutrition bars/cereal bars</p></td><td><p>500 mg/100 g</p></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>3&#160;000  mg/day for the general population</p><p>450 mg/day for pregnant and lactating women</p></td></tr><tr><td><p>Foods for special medical purposes as defined in Regulation (EU) No 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>Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control</p></td><td><p>250 mg/meal</p></td></tr><tr><td><p>Processed cereal-based food and baby food intended for infants and young children covered by Regulation (EU) No 609/2013</p></td><td><p>200 mg/100 ml</p></td></tr><tr><td><p>Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen</p></td></tr><tr><td><p>Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014</p></td></tr><tr><td><p><a>&#9660;M97</a></p></td></tr><tr><td><p><span><span>Antrodia camphorata</span> mycelia powder</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of food supplements containing it shall be &#8216;<span>Antrodia camphorata</span> mycelia powder&#8217;.</p><p>2.&#160;&#160;The labelling of the food supplements containing<span>Antrodia camphorata</span> mycelia powder shall bear a statement that this food supplement should not be consumed by infants, children, and adolescents younger than 14 years of age.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC, excluding infants, children, and adolescents younger than 14 years of age</p></td><td><p>990 mg/day</p></td></tr><tr><td><p><a>&#9660;M120</a></p></td></tr><tr><td><p><span>Aqueous ethanolic extract of<span>Labisia pumila</span></span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;aqueous ethanolic extract of<span>Labisia pumila</span>&#8217;.</p><p>2.&#160;&#160;The labelling of food supplements containing the novel food shall bear a statement that they should only be consumed by persons above 18 years of age excluding pregnant and lactating women.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 6&#160;June 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article&#160;26 of Regulation (EU)&#160;2015/2283.</p><p>Applicant: Medika Natura Sdn. Bhd., No. 44B Jalan Bola Tampar&#160;13/14 Section 13, 40100 Shah Alam Selangor, Malaysia. During the period of data protection, the novel food aqueous ethanolic extract of<span>Labisia pumila</span> is authorised for placing on the market within the Union only by Medika Natura Sdn. Bhd., 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)&#160;2015/2283 or with the agreement of Medika Natura Sdn. Bhd.</p><p>End date of the date protection: 6&#160;June 2028.</p></td></tr><tr><td><p>Food supplements as defined in Directive&#160;2002/46/EC for the adult population, excluding pregnant and lactating women</p></td><td><p>350&#160;mg/day</p></td></tr><tr><td><p><a>&#9660;M46 M69</a></p></td></tr><tr><td><p><span>Arachidonic acid-rich oil from the fungus<span>Mortierella alpina</span></span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Oil from<span>Mortierella alpina&#8217; or &#8216;Mortierella alpina</span> oil&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Infant formula and follow-on formula as defined in Regulation (EU) No&#160;609/2013</p></td><td><p>In accordance with Regulation (EU) No&#160;609/2013</p></td></tr><tr><td><p>Foods for special medical purposes for infants as defined in Regulation (EU) No&#160;609/2013</p></td><td><p>In accordance with Regulation (EU) No&#160;609/2013</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Argan oil from<span>Argania spinosa</span></span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Argan oil&#8217; and if used as seasoning &#8216;Vegetable oil only for seasoning&#8217; shall be mentioned on the label</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>As seasonings</p></td><td><p>Not specified</p></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>In line with normal food use of vegetable oils</p></td></tr><tr><td><p><a>&#9660;M72</a></p></td></tr><tr><td><p><span>Astaxanthin-rich oleoresin from<span>Haematococcus pluvialis</span> algae</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Astaxanthin-rich oleoresin from<span>Haematococcus pluvialis</span> algae&#8217;</p><p>The labelling of food supplements containing Astaxanthin-rich oleoresin from<span>Haematococcus pluvialis</span> algae shall bear a statement that they should not be consumed by infants, children, and adolescents younger than 14 years.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC, excluding infants, young children, children, and adolescents younger than14 years</p></td><td><p>40-80 mg/day of oleoresin, resulting in &#8804;&#160;8 mg astaxanthin per day</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Basil seeds (<span>Ocimum basilicum</span>)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Fruit juice and fruit/vegetable blend beverages</p></td><td><p>3 g/200 ml for addition of whole basil seeds (<span>Ocimum basilicum</span>)</p></td></tr><tr><td><p><a>&#9660;M33</a></p></td></tr><tr><td><p><span>Betaine</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span>&#160;<a>(<span>7</span>)</a></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;betaine&#8217;.</p><p>The labelling of foods containing betaine shall bear a statement that the foods should not be used if food supplements containing betaine are consumed the same day.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 22 August 2019. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.</p><p>Applicant: DuPont Nutrition Biosciences ApS, Langebrogade 1 Copenhagen K, DK-1411, Denmark. During the period of data protection, the novel food betaine is authorised for placing on the market within the Union only by DuPont Nutrition Biosciences ApS unless a subsequent applicantobtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of DuPont Nutrition Biosciences ApS,</p><p>End date of the data protection: 22 August 2024.</p></td></tr><tr><td><p>Drink powders, isotonic and energy drinks intended for sportsmen</p></td><td><p>60 mg/100 g</p></td></tr><tr><td><p>Protein and cereal bars intended for sportsmen</p></td><td><p>500 mg/100 g</p></td></tr><tr><td><p>Meal replacements intended for sportsmen</p></td><td><p>20 mg/100 g</p></td></tr><tr><td><p>Total diet replacement for weight control as defined under Regulation (EU) No 609/2013</p></td><td><p>500 mg/100 g (bar)</p><p>136 mg/100 g (soup)</p><p>188 mg/100 g (porridge)</p><p>60 mg/100 g (beverages)</p></td></tr><tr><td><p>Foods for Special Medical Purposes as defined under Regulation (EU) No 609/2013 for adults</p></td><td><p>400 mg/day</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Fermented black bean extract</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Fermented black bean (Soya) extract&#8217;&#8217; or &#8216;Fermented Soya extract&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>4,5 g/day</p></td></tr><tr><td><p><span>Bovine lactoferrin</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Lactoferrin from cows&#8217; milk&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 (ready to drink)</p></td><td><p>100 mg/100 ml</p></td></tr><tr><td><p>Foods on dairy basis intended for young children (ready to eat/drink)</p></td><td><p>200 mg/100 g</p></td></tr><tr><td><p>Processed cereal food (solid)</p></td><td><p>670 mg/100 g</p></td></tr><tr><td><p>Foods for special medical purposes as defined in Regulation (EU) No 609/2013</p></td><td><p>Depending on the needs of the individual up to 3 g/day</p></td></tr><tr><td><p>Beverages based on milk</p></td><td><p>200 mg/100 g</p></td></tr><tr><td><p>Powdered drink mixes based on milk (ready to drink)</p></td><td><p>330 mg/100 g</p></td></tr><tr><td><p>Beverages based on fermented milk (including yoghurt drinks)</p></td><td><p>50 mg/100 g</p></td></tr><tr><td><p>Non-alcoholic drinks</p></td><td><p>120 mg/100 g</p></td></tr><tr><td><p>Products based on yoghurt</p></td><td><p>80 mg/100 g</p></td></tr><tr><td><p>Products based on cheese</p></td><td><p>2&#160;000  mg/100 g</p></td></tr><tr><td><p>Ice cream</p></td><td><p>130 mg/100 g</p></td></tr><tr><td><p>Cakes and pastries</p></td><td><p>1&#160;000  mg/100 g</p></td></tr><tr><td><p>Candies</p></td><td><p>750 mg/100 g</p></td></tr><tr><td><p>Chewing gum</p></td><td><p>3&#160;000  mg/100 g</p></td></tr><tr><td><p><a>&#9660;M20 M36 M62 M104</a></p></td></tr><tr><td><p><span>Bovine milk basic whey protein isolate</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Milk whey protein isolate&#8217;.</p><p>Food supplements containing bovine milk basic whey protein isolate shall bear the following statement:</p><p>&#8216;This food supplement should not be consumed by infants/children/adolescents under the age of one/three/eighteen (*) years&#8217;</p><p>(*)&#160;&#160;Depending on the age group the food supplement is intended for.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 20&#160;November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article&#160;26 of Regulation (EU) 2015/2283. Applicant: Armor Prot&#233;ines S.A.S., 19 bis, rue de la Lib&#233;ration 35460 Saint-Brice-en-Cogl&#232;s, France. During the period of data protection the novel food bovine milk basic whey protein isolate is authorised for placing on the market within the Union only by Armor Prot&#233;ines S.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 Armor Prot&#233;ines S.A.S. End date of the data protection: 20&#160;November 2023.</p></td></tr><tr><td><p>Infant formulae as defined in Regulation (EU) No&#160;609/2013</p></td><td><p>30 mg/100 g (powder)</p></td></tr><tr><td><p>3,9&#160;mg/100 mL (reconstituted)</p></td></tr><tr><td><p>Follow-on formulae as defined in Regulation (EU) No&#160;609/2013</p></td><td><p>30 mg/100 g (powder)</p></td></tr><tr><td><p>4,2&#160;mg/100 mL (reconstituted)</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>300 mg/day</p></td></tr><tr><td><p>Foods for special medical purposes as defined in Regulation (EU) No&#160;609/2013</p></td><td><p>30 mg/100 g (powder formula for infants during the first months of life until the introduction of appropriate complementary feeding)</p></td></tr><tr><td><p>3,9&#160;mg/100 mL (reconstituted formula for infants during the first months of life until the introduction of appropriate complementary feeding)</p></td></tr><tr><td><p>30 mg/100 g (powder formula for infants when appropriate complementary feeding is introduced)</p></td></tr><tr><td><p>4,2&#160;mg/100 mL (reconstituted formula for infants when appropriate complementary feeding is introduced)</p></td></tr><tr><td><p>58 mg/day for young children</p></td></tr><tr><td><p>380 mg/day for children and adolescents from 3 to 18 years of age</p></td></tr><tr><td><p>610 mg/day for adults</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC</p></td><td><p>25 mg/day for infants</p></td></tr><tr><td><p>58 mg/day for young children</p></td></tr><tr><td><p>250 mg/day for children and adolescents from 3 to 18 years of age</p></td></tr><tr><td><p>610 mg/day for adults</p></td></tr><tr><td><p><a>&#9660;M96</a></p></td></tr><tr><td><p><span>Bovine milk beta-lactoglobulin (<span>&#946;</span>-lactoglobulin)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels (g NF/100 ml)</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;bovine milk beta-lactoglobulin&#8217; or &#8216;bovine milk<span>&#946;</span>-lactoglobulin&#8217;.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 11&#160;January 2023. 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: Arla Foods Ingredients Group P/S, S&#248;nderh&#248;j 10-12, 8260 Viby J, Denmark. During the period of data protection, the novel food beta-lactoglobulin (<span>&#946;</span>-lactoglobulin) is authorised for placing on the market within the Union only by Arla Foods Ingredients Group P/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 Arla Foods Ingredients Group P/S.</p><p>End date of the data protection: 11&#160;January 2028.</p></td></tr><tr><td><p>Soft drinks marketed in relation to physical exercise</p></td><td><p>25</p></td></tr><tr><td><p>Whey powder (reconstituted)</p></td><td><p>8</p></td></tr><tr><td><p>Milk based drinks and similar products</p></td><td><p>12</p></td></tr><tr><td><p>Foods for special medical purposes as defined in Regulation (EU) No&#160;609/2013 intended for the general population older than 3 years of age, excluding pregnant and lactating women</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><a>&#9660;M107</a></p></td></tr><tr><td><p>Bovine milk osteopontin</p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Bovine milk Osteopontin&#8217;.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 26&#160;March 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article&#160;26 of Regulation (EU)&#160;2015/2283.</p><p>Applicant: Arla Foods Ingredients Group&#160;P/S., S&#248;nderh&#248;j 10-12&#160;8260 Viby J Denmark. During the period of data protection, the novel food Bovine milk osteopontin is authorised for placing on the market within the Union only by Arla Foods Ingredients Group&#160;P/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)&#160;2015/2283 or with the agreement of Arla Foods Ingredients Group&#160;P/S.</p><p>End date of the data protection: 26&#160;March 2028.</p></td></tr><tr><td><p>Infant formula as defined in Regulation (EU) No&#160;609/2013&#160;<a>(<span>13</span>)</a></p></td><td><p>151&#160;mg/L in the final product ready for use,</p><p>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&#160;<a>(<span>13</span>)</a></p></td><td><p>151&#160;mg/L in the final product ready for use,</p><p>marketed as such or reconstituted as instructed by the manufacturer</p></td></tr><tr><td><p>Milk-based drinks intended for young children</p></td><td><p>151&#160;mg/L in the final product ready for use,</p><p>marketed as such or reconstituted as instructed by the manufacturer</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span><span>Buglossoides arvensis</span> seed oil</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of stearidonic acid (STA)</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Refined<span>Buglossoides</span> oil&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Dairy products and analogues</p></td><td><p>250 mg/100 g</p></td></tr><tr><td><p>75 mg/100 g for drinks</p></td></tr><tr><td><p>Cheese and cheese products</p></td><td><p>750 mg/100 g</p></td></tr><tr><td><p>Butter and other fat and oil emulsions including spreads (not for cooking or frying purposes)</p></td><td><p>750 mg/100 g</p></td></tr><tr><td><p>Breakfast cereals</p></td><td><p>625 mg/100 g</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>500 mg/day</p></td></tr><tr><td><p>Foods for special medical purposes as defined in Regulation (EU) No 609/2013, excluding foods for special medical purposes intended for infants and young children</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>Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control</p></td><td><p>250 mg/meal</p></td></tr><tr><td><p><a>&#9660;M91</a></p></td></tr><tr><td><p><span><span>Calanus finmarchicus</span> oil</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;oil from<span>Calanus finmarchicus</span> (crustacean)&#8217;.</p><p>2.&#160;&#160;The labelling of food supplements containing<span>Calanus finmarchicus oil</span> shall bear a statement that those food supplements should not be consumed:</p><p>a)&#160;&#160;if other food supplements containing astaxanthin esters are consumed on the same day.</p><p>b)&#160;&#160;by infants and children younger than 3 years.</p><p>c)&#160;&#160;by children younger than 14 years, if the ingredient contains &#8805;&#160;0,1&#160;% astaxanthin.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></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>1,0&#160;g/day (&lt;&#160;0,1&#160;% astaxanthin esters, resulting in &lt;&#160;1,0&#160;mg astaxanthin per day) for the general population, excluding infants and young children</p><p>2,3&#160;g/day (from 0,1&#160;% to &#8804;&#160;0,25&#160;% astaxanthin esters, resulting in &#8804;&#160;5,75&#160;mg astaxanthin per day) for the general population older than 14 years of age</p></td></tr><tr><td><p><a>&#9660;M77</a></p></td></tr><tr><td><p>Calcium fructoborate</p></td><td><p>Specified food category</p></td><td><p>Maximum levels</p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;calcium fructoborate&#8217;.</p><p>2.&#160;&#160;The labelling of food supplements containing calcium fructoborate shall bear a statement that those food supplements should not be consumed by population under 18 years of age and by pregnant and lactating women.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 23&#160;December 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: VDF FutureCeuticals, Inc., 300 West 6th Street Momence, Illinois 60954, the United States.</p><p>During the period of data protection, the novel food calcium fructoborate is authorised for placing on the market within the Union only by VDF FutureCeuticals, Inc., 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 VDF FutureCeuticals, Inc.</p><p>End date of the date protection: 23&#160;December 2026</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC for the adult population, excluding food supplements for pregnant and lactating women</p></td><td><p>220 mg/day</p></td></tr><tr><td><p><a>&#9660;M85</a></p></td></tr><tr><td><p><span>Calcium L-Methylfolate</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels (expressed as folic acid)</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Calcium L-Methylfolate&#8217;.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Foods for special medical purposes and total diet replacement for weight control as defined in Regulation (EU) No&#160;609/2013</p></td><td><p>In accordance with Regulation (EU) No&#160;609/2013</p></td></tr><tr><td><p>Infant formulae and follow-on formula as defined by Regulation (EU) No&#160;609/2013</p></td><td><p>In accordance with Regulation (EU) No&#160;609/2013</p></td></tr><tr><td><p>Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No&#160;609/2013</p></td><td><p>In accordance with Regulation (EU) No&#160;609/2013</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC</p></td><td><p>In accordance with Directive 2002/46/EC</p></td></tr><tr><td><p>Food fortified in accordance with Regulation (EC) No&#160;1925/2006</p></td><td><p>In accordance with Regulation (EC) No&#160;1925/2006</p></td></tr><tr><td><p><a>&#9660;M106</a></p></td></tr><tr><td><p>Dried nuts of<span>Canarium ovatum</span> Engl.</p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;nuts of<span>Canarium ovatum</span>&#8217; and/or &#8216;pilinuts&#8217; and/or &#8216;pili (<span>Canarium ovatum</span>) nuts&#8217;.</p><p>2.&#160;&#160;The labelling of the foodstuffs containing dried nuts of<span>Canarium ovatum</span> Engl. shall bear a statement that the dried nuts of<span>Canarium ovatum</span> Engl. may cause allergic reactions to consumers with known allergies to cashew and walnut. This statement shall appear in close proximity to the list of ingredients or, in the absence of a list of ingredients, in close proximity to the name of the food.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Not specified</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><a>&#9660;M109</a></p></td></tr><tr><td><p><span><span>Canarium indicum</span> L. dried nuts (Kenari) (Traditional food from a third country)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels&#160;(g/100&#160;g)</span></p></td><td><p>1.&#160;&#160;The designation of the traditional food on the labelling of the foodstuffs containing it shall be &#8216;dried kenari<span>(Canarium indicum)</span> nuts&#8217;.</p><p>2.&#160;&#160;The labelling of the foodstuffs containing dried nuts of<span>Canarium indicum</span> L. shall bear a statement that the nuts may cause allergic reactions to consumers with known allergies to hazel, cashew and pistachio. This statement shall appear in close proximity to the list of ingredients or, in the absence of a list of ingredient, in close proximity to the name of the food.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Not specified</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><a>&#9660;M114</a></p></td></tr><tr><td><p><span>Cellobiose</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;cellobiose&#8217;.</p><p>2.&#160;&#160;The labelling of food supplements containing cellobiose shall bear a statement that those food supplements should not be consumed by infants and young children.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 1&#160;June 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article&#160;26 of Regulation (EU)&#160;2015/2283.</p><p>Applicant: SAVANNA Ingredients GmbH, D&#252;rener Stra&#223;e 67, 50189 Elsdorf, Germany. During the period of data protection, the novel food cellobiose is authorised for placing on the market within the Union only by SAVANNA Ingredients GmbH, 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)&#160;2015/2283 or with the agreement of SAVANNA Ingredients GmbH.</p><p>End date of the data protection: 1&#160;June 2028.</p></td></tr><tr><td><p>Food supplements as defined in Directive&#160;2002/46/EC for the general population, excluding infants and young children</p></td><td><p>3&#160;g/day</p></td></tr><tr><td><p>Dried, canned-tinned, raw cured (or seasoned), cooked cured (or seasoned) meat</p></td><td><p>2&#160;g/100 g</p></td></tr><tr><td><p>Fresh raw, preserved or partly preserved sausages</p></td><td><p>2&#160;g/100 g</p></td></tr><tr><td><p>Meat based spreadable-textured specialties</p></td><td><p>2&#160;g/100 g</p></td></tr><tr><td><p>Liver based spreadable-textured specialties</p></td><td><p>2&#160;g/100 g</p></td></tr><tr><td><p>Savoury sauce dry preparation</p></td><td><p>40&#160;g/100 g</p></td></tr><tr><td><p>Table-top sweeteners in powder form</p></td><td><p>60&#160;g/100 g</p></td></tr><tr><td><p>Table-top sweeteners in tablets</p></td><td><p>60&#160;g/100 g</p></td></tr><tr><td><p><a>&#9660;M82</a></p></td></tr><tr><td><p><span>Cetylated fatty acids</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the food supplements containing it shall be &#8216;cetylated fatty acids preparation&#8217;.</p><p>2.&#160;&#160;The labelling of food supplements containing the novel food shall bear a statement that those food supplements should not be consumed by persons under 18 years of age.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 3&#160;March 2022. 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: Pharmanutra S.p.A., Via Delle Lenze 216/b, 56122 Pisa, Italy. During the period of data protection, the novel food cetylated fatty acids is authorised for placing on the market within the Union only by Pharmanutra S.p.A., 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 Pharmanutra S.p.A.</p><p>End date of the date protection: 3&#160;March 2027</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC for the adult population</p></td><td><p>1,6&#160;g/day</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Chewing gum base (monomethoxypolyethylene glycol)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Gum base (including 1,3-butadiene, 2-methyl-homopolymer, maleated, esters with polyethylene glycol mono-Me ether)&#8217; or &#8216;Gum base (including CAS No: 1246080-53-4)&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Chewing gum</p></td><td><p>8  %</p></td></tr><tr><td><p><span>Chewing gum base (Methyl vinyl ether-maleic anhydride copolymer)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Gum base (including methyl vinyl ether-maleic anhydride copolymer)&#8217; or &#8216;Gum base (including CAS No 9011-16-9)&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Chewing gum</p></td><td><p>2  %</p></td></tr><tr><td><p><span>Chia oil from<span>Salvia hispanica</span></span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Chia oil (<span>Salvia hispanica</span>)&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Fats and oils</p></td><td><p>10  %</p></td></tr><tr><td><p>Pure chia oil</p></td><td><p>2 g/day</p></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>2 g/day</p></td></tr><tr><td><p><a>&#9660;M64</a></p></td></tr><tr><td><p><span>Chia seeds (<span>Salvia hispanica</span>)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Chia seeds (<span>Salvia hispanica</span>)&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Bread products</p></td><td><p>5&#160;% (whole or ground chia seeds)</p></td></tr><tr><td><p>Baked products</p></td><td><p>10&#160;% whole chia seeds</p></td></tr><tr><td><p>Breakfast cereals</p></td><td><p>10&#160;% whole chia seeds</p></td></tr><tr><td><p>Sterilised ready to eat meals based on cereal grains, pseudocereal grains and/or pulses</p></td><td><p>5&#160;% whole chia seeds</p></td></tr><tr><td><p>Fruit, nut and seed mixes</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Chia seeds as such</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Confectionery (including chocolate and chocolate products), excluding chewing gums</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Dairy products (including yoghurt) and analogues</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Edible ices</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Fruit and vegetables products (including fruit spreads, compotes with/without cereals, fruit-preparations to underlay or to be mixed with dairy products, fruit desserts, mixed fruits with coconut milk for a twin pot)</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Non-alcoholic beverages (including fruit juice and fruit/vegetable blend beverages)</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Puddings that do not require heat treatment at or above 120&#160;&#176;C in their manufacture, processing or preparation</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Chitin-glucan from<span>Aspergillus niger</span></span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Chitin-glucan from<span>Aspergillus niger</span>&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>5 g/day</p></td></tr><tr><td><p><span>Chitin-glucan complex from<span>Fomes fomentarius</span></span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Chitin-glucan from<span>Fomes fomentarius</span>&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>5 g/day</p></td></tr><tr><td><p><span>Chitosan extract from fungi (<span>Agaricus bisporus</span>;<span>Aspergillus niger</span>)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Chitosan extract from<span>Agaricus bisporus</span>&#8217; or &#8216;Chitosan extract from<span>Aspergillus niger</span>&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>In line with normal use in food supplements of chitosan from crustaceans</p></td></tr><tr><td><p><span>Chondroitin sulphate</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Chondroitin sulphate derived from microbial fermentation and sulphation&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC for adult population, excluding pregnant and lactating women</p></td><td><p>1&#160;200  mg/day</p></td></tr><tr><td><p><span>Chromium Picolinate</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of total chromium</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Chromium Picolinate&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Foods covered by Regulation (EU) No 609/2013</p></td><td><p>250 &#956;g/day</p></td></tr><tr><td><p>Foods fortified in accordance with Regulation (EC) No 1925/2006&#160;<a>(<span>4</span>)</a></p></td></tr><tr><td><p><a>&#9660;M56</a></p></td></tr><tr><td><p><span>Chromium-containing yeast (<span>Yarrowia lipolytica</span>) biomass</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;chromium-containing yeast (<span>Yarrowia lipolytica</span>) biomass&#8217;</p><p>The labelling of food supplements containing chromium-containing yeast (<span>Yarrowia lipolytica</span>) biomass shall bear a statement that the food supplements should not be consumed by infants and young children (children under 3 years of age)/children from 3 to 9 years of age&#160;<a>(<span>12</span>)</a>.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></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>2 g/day for children from 3 to 9 years of age, resulting in 46 &#956;g of chromium per day</p><p>4 g/day for children from 10 years of age, adolescents and adults, resulting in 92 &#956;g of chromium per day</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span><span>Cistus incanus</span> L. Pandalis herb</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;<span>Cistus incanus</span> L. Pandalis herb&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Herbal infusions</p></td><td><p>Intended daily intake: 3 g herbs/day (2 cups/day)</p></td></tr><tr><td><p><span>Citicoline</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Citicoline&#8217;</p><p>2.&#160;&#160;The labelling of foods containing citicoline shall bear a statement that the product is not intended to be consumed by children</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>500 mg/day</p></td></tr><tr><td><p>Foods for special medical purposes as defined in Regulation (EU) No 609/2013</p></td><td><p>250 mg per serving and a maximum daily consumption level of 1&#160;000  mg</p></td></tr><tr><td><p><span><span>Clostridium butyricum</span></span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;<span>Clostridium butyricum</span> MIYAIRI 588 (CBM 588)&#8217; or &#8216;<span>Clostridium butyricum</span> (CBM 588)&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>1,35 &#215; 10<span>8</span> CFU/day</p></td></tr><tr><td><p><a>&#9660;M79</a></p></td></tr><tr><td><p><span>Coffea arabica</span> L. and/or<span>Coffea canephora</span> Pierre ex A.Froehner dried cherry pulp and its infusion (Traditional food from a third country)</p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;coffee cherry pulp&#8217; and/or &#8216;cascara (coffee cherry pulp)&#8217;, and/or &#8216;coffee cherry pulp infusion&#8217; and/or &#8216;coffee cherry pulp dried infusion&#8217;.</p><p>If the product containing the novel food contains more than 150 mg/l of caffeine (as such or after reconstitution), it shall be labelled with the following indication: &#8216;High caffeine content. Not recommended for children or pregnant or breast-feeding women&#8217; in the same field of vision as the name of the food, followed by the caffeine content expressed in mg per 100 ml.</p><p>Typical infusion preparations are prepared with up to 6 g of coffee cherry pulp per 100 ml of hot water (&gt;&#160;75&#160;&#176;C). For the coffee cherry pulp placed on the market as such for the preparation of infusions, instructions shall be given to the consumer on the preparation.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Coffee cherry pulp from<span>Coffea arabica</span> L. and/or<span>Coffea canephora</span> Pierre ex A.Froehner for the preparation of infusions</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Coffee, coffee and chicory extracts, instant coffee, tea, herbal- and fruit-infusions, coffee substitutes, coffee mixes and instant mixes for hot beverages (and their flavoured counterparts).</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Flavoured and unflavoured non-alcoholic ready-to-drink beverages</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><a>&#9660;M30</a></p></td></tr><tr><td><p><span>D-ribose</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;D-ribose&#8217;.</p><p>The labelling of foods containing D-ribose shall bear a statement that the foods should not be used if food supplements containing D-ribose are consumed the same day.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 16 April 2019. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.</p><p>Applicant: Bioenergy Life Science, Inc., 13840 Johnson St. NE, Minneapolis, Minnesota, 55304, USA. During the period of data protection, the novel food D-ribose is authorised for placing on the market within the Union only by Bioenergy Life Science, Inc. 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 26 of Regulation (EU) 2015/2283 or with the agreement of Bioenergy Life Science, Inc.</p><p>End date of the data protection: 16 April 2024 (5 years).</p></td></tr><tr><td><p>Cereal bars</p></td><td><p>0,20 g/100 g</p></td></tr><tr><td><p>Fine bakery wares</p></td><td><p>0,31 g/100 g</p></td></tr><tr><td><p>Chocolate confectionery (excluding chocolate bars)</p></td><td><p>0,17 g/100 g</p></td></tr><tr><td><p>Milk-based drinks (excluding malts and shakes)</p></td><td><p>0,08 g/100 g</p></td></tr><tr><td><p>Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen, isotonic and energy drinks</p></td><td><p>0,80 g/100 g</p></td></tr><tr><td><p>Bars intended to meet the expenditure of intense muscular effort especially for sportsmen</p></td><td><p>3,3 g/100 g</p></td></tr><tr><td><p>Meal replacement for weight control (as drinks)'</p></td><td><p>0,13 g/100 g</p></td></tr><tr><td><p>Meal replacement for weight control (as bars)</p></td><td><p>3,30 g/100 g</p></td></tr><tr><td><p>Confectionery</p></td><td><p>0,20 g/100 g</p></td></tr><tr><td><p>Tea and infusions (in powder form to be reconstituted)</p></td><td><p>0,23 g/100 g</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Extract of defatted cocoa powder</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>Consumers shall be instructed not to consume more than 600 mg polyphenols corresponding to 1,1 g of extract of defatted cocoa powder per day</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Nutrition bars</p></td><td><p>1 g/day and 300 mg polyphenols corresponding to not more than 550 mg of extract of defatted cocoa powder in one portion of food (or food supplement)</p></td></tr><tr><td><p>Milk based beverages</p></td></tr><tr><td><p>Any other foods (including food supplements as defined in Directive 2002/46/EC) which have become established vehicles for functional ingredients and which are typically positioned for consumption by health conscious adults</p></td></tr><tr><td><p><span>Low fat cocoa extract</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>Consumers shall be instructed not to consume more than 600 mg of cocoa flavanols per day</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Foods including food supplements as defined in Directive 2002/46/EC</p></td><td><p>730 mg per serving and around 1,2 g/day</p></td></tr><tr><td><p><span>Coriander seed oil from<span>Coriandrum sativum</span></span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Coriander seed oil&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>600 mg/day</p></td></tr><tr><td><p><a>&#9660;M15</a></p></td></tr><tr><td><p>Cranberry extract powder</p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;cranberry extract powder&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.</p><p>Applicant: Ocean Spray Cranberries Inc. One Ocean Spray Drive Lakeville-Middleboro, MA, 02349, USA.</p><p>During the period of data protection the novel food, cranberry extract powder, is authorised for placing on the market within the Union only by Ocean Spray Cranberries Inc. 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 26 of Regulation (EU) 2015/2283 or with the agreement of Ocean Spray Cranberries Inc.</p><p>End date of the data protection: 20 November 2023.</p></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC for the adult population</p></td><td><p>350 mg/day</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span><span>Crataegus pinnatifida</span> dried fruit</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;<span>Crataegus pinnatifida</span> dried fruit&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Herbal infusions</p></td><td><p>In line with normal food use of<span>Crataegus laevigata</span></p></td></tr><tr><td><p>Jams and jellies in accordance with Directive 2001/113/EC&#160;<a>(<span>5</span>)</a></p></td></tr><tr><td><p>Compotes</p></td></tr><tr><td><p><span>&#945;-cyclodextrin</span></p></td><td><p>Not specified</p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Alpha-cyclodextrin&#8217; or &#8216;&#945;-cyclodextrin&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>&#947;-cyclodextrin</span></p></td><td><p>Not specified</p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Gamma-Cyclodextrin&#8217; or &#8216;&#947;-Cyclodextrin&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><a>&#9660;M22</a></p></td></tr><tr><td><p>Decorticated grains of<span>Digitaria exilis</span> (Kippist) Stapf</p><p>(Traditional food from a third country)</p></td><td><p>Not specified</p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;decorticated fonio (<span>Digitaria exilis</span>) grains&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Dextran preparation produced by<span>Leuconostoc mesenteroides</span></span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Dextran&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Bakery products</p></td><td><p>5  %</p></td></tr><tr><td><p><span>Diacylglycerol oil of plant origin</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Diacylglycerol oil of plant origin (at least 80 % diacylglycerols)&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Cooking oils</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Fat spreads</p></td></tr><tr><td><p>Salad dressings</p></td></tr><tr><td><p>Mayonnaise</p></td></tr><tr><td><p>Meal replacement for weight control (as drinks)</p></td></tr><tr><td><p>Bakery products</p></td></tr><tr><td><p>Yoghurt type products</p></td></tr><tr><td><p><span>Dihydrocapsiate (DHC)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Dihydrocapsiate&#8217;</p><p>2.&#160;&#160;Food supplements containing synthetic dihydrocapsiate will be labelled as &#8216;not intended for children up to 4.5 years&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Cereal bars</p></td><td><p>9 mg/100 g</p></td></tr><tr><td><p>Biscuits, cookies and crackers</p></td><td><p>9 mg/100 g</p></td></tr><tr><td><p>Rice based snacks</p></td><td><p>12 mg/100 g</p></td></tr><tr><td><p>Carbonated drinks, dilutable drinks, fruit juice based beverages</p></td><td><p>1,5 mg/100 ml</p></td></tr><tr><td><p>Vegetable drinks</p></td><td><p>2 mg/100 ml</p></td></tr><tr><td><p>Coffee based drinks, tea based drinks</p></td><td><p>1,5 mg/100 ml</p></td></tr><tr><td><p>Flavoured water &#8212; still</p></td><td><p>1 mg/100 ml</p></td></tr><tr><td><p>Precooked oatmeal cereal</p></td><td><p>2,5 mg/100 g</p></td></tr><tr><td><p>Other cereals</p></td><td><p>4,5 mg/100 g</p></td></tr><tr><td><p>Ice cream, dairy desserts</p></td><td><p>4 mg/100 g</p></td></tr><tr><td><p>Pudding mixes (ready to eat)</p></td><td><p>2 mg/100 g</p></td></tr><tr><td><p>Products based on yoghurt</p></td><td><p>2 mg/100 g</p></td></tr><tr><td><p>Chocolate confectionery</p></td><td><p>7,5 mg/100 g</p></td></tr><tr><td><p>Hard candy</p></td><td><p>27 mg/100 g</p></td></tr><tr><td><p>Sugar-free gum</p></td><td><p>115 mg/100 g</p></td></tr><tr><td><p>Whitener/creamer</p></td><td><p>40 mg/100 g</p></td></tr><tr><td><p>Sweeteners</p></td><td><p>200 mg/100 g</p></td></tr><tr><td><p>Soup (ready to eat)</p></td><td><p>1,1 mg/100 g</p></td></tr><tr><td><p>Salad dressing</p></td><td><p>16 mg/100 g</p></td></tr><tr><td><p>Vegetable protein</p></td><td><p>5 mg/100 g</p></td></tr><tr><td><p>Ready to eat meals</p></td><td><p>3 mg/meal</p></td></tr><tr><td><p>Meal replacements for weight control</p></td><td><p>3 mg/meal</p></td></tr><tr><td><p>Meal replacement for weight control (as drinks)</p></td><td><p>1 mg/100 ml</p></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>3 mg/single intake</p><p>9 mg/day</p></td></tr><tr><td><p>Non-alcoholic powdered drink mixes</p></td><td><p>14,5 mg/kg equivalent to 1,5 mg/100 ml</p></td></tr><tr><td><p><a>&#9660;M54</a></p></td></tr><tr><td><p><span>Dried<span>Euglena gracilis</span></span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;dried biomass of<span>Euglena gracilis</span> algae&#8217;.</p><p>The labelling of food supplements containing dried<span>Euglena gracilis</span> shall bear a statement that those food supplements should not be consumed by infants/children under 3 years of age/children under 10 years of age/children and adolescents under 18 years of age&#160;<a>(<span>12</span>)</a>.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 23 December 2020. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.</p><p>Applicant: Kemin Foods L.C., 2100 Maury Street Des Moines, IA 50317, USA.</p><p>During the period of data protection, the novel food is authorised for placing on the market within the Union only by Kemin Foods L.C. unless a subsequent applicant obtains authorisation for that novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Kemin Foods L.C.</p><p>End date of the data protection: 23 December 2025.</p></td></tr><tr><td><p>Breakfast cereal bars, granola bars and protein bars</p></td><td><p>630 mg/100 g</p></td></tr><tr><td><p>Yoghurt</p></td><td><p>150 mg/100 g</p></td></tr><tr><td><p>Yoghurt Beverages</p></td><td><p>95 mg/100 g</p></td></tr><tr><td><p>Fruit and vegetable juices, nectars, fruit/vegetable blend beverages</p></td><td><p>120 mg/100 g</p></td></tr><tr><td><p>Fruit-Flavoured Drinks</p></td><td><p>40 mg/100 g</p></td></tr><tr><td><p>Meal replacement beverages</p></td><td><p>75 mg/100 g</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants</p></td><td><p>100 mg/day for young children</p><p>150 mg/day for children from 3 to 9 years of age</p><p>225 mg/day for children from 10 years of age and adolescents (to 17 years of age)</p><p>375 mg/day for adults</p></td></tr><tr><td><p>Total diet replacement for weight control as defined by Regulation (EU) No 609/2013</p></td><td><p>190 mg/meal</p></td></tr><tr><td><p><a>&#9660;M13</a></p></td></tr><tr><td><p><span>Dried aerial parts of<span>Hoodia parviflora</span></span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;dried aerial parts of<span>Hoodia parviflora</span>&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 3 September 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.</p><p>Applicant: Desert Labs, Ltd Kibbutz Yotvata, 88820 Israel.</p><p>During the period of data protection the novel food dried aerial parts of<span>Hoodia parviflora</span> is authorised for placing on the market within the Union only by Desert Labs, Ltd unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in&#160;accordance&#160;with Article 26 of Regulation (EU)&#160;2015/2283 or with the agreement of Desert Labs, Ltd.</p><p>End date of the data protection: 3 September 2023.</p></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC for adult population</p></td><td><p>9,4 mg/day</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Dried extract of<span>Lippia citriodora</span> from cell cultures</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;dried extract of<span>Lippia citriodora</span> from cell cultures HTN<span>&#174;</span>Vb&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>In line with normal use in food supplements of a similar extract from the leaves of<span>Lippia citriodora</span></p></td></tr><tr><td><p><span><span>Echinacea angustifolia</span> extract from cell cultures</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>In line with normal use in food supplements of a similar extract from the root of<span>Echinacea angustifolia</span></p></td></tr><tr><td><p><a>&#9660;M32</a></p></td></tr><tr><td><p><span><span>Echinacea purpurea</span></span><span>extract from cell cultures</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;dried extract of<span>Echinacea purpurea</span> from cell cultures EchiPure-PC&#8482;&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>In line with normal use in food supplements of a similar extract from florets within the flower head of<span>Echinacea purpurea</span></p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span><span>Echium plantagineum</span> oil</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of stearidonic acid (STA)</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Refined echium oil&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Milk-based products and drinkable yoghurt products delivered in a single dose</p></td><td><p>250 mg/100 g; 75 mg/100 g for drinks</p></td></tr><tr><td><p>Cheese preparations</p></td><td><p>750 mg/100 g</p></td></tr><tr><td><p>Spreadable fat and dressings</p></td><td><p>750 mg/100 g</p></td></tr><tr><td><p>Breakfast cereals</p></td><td><p>625 mg/100 g</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC</p></td><td><p>500 mg/day</p></td></tr><tr><td><p>Foods for special medical purposes as defined in Regulation (EU) No 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>Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control</p></td><td><p>250 mg/meal</p></td></tr><tr><td><p><a>&#9660;M52</a></p></td></tr><tr><td><p><span><span>Ecklonia cava</span> phlorotannins</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;<span>Ecklonia cava</span> Phlorotannins&#8217;.</p><p>Food supplements containing<span>Ecklonia cava</span> phlorotannins shall bear the following statement:</p><p>(a)&#160;&#160;This food supplement should not be consumed by children/adolescents under the age of twelve/fourteen/eighteen<span>(*)</span> years.</p><p>(b)&#160;&#160;This food supplement should not be consumed by persons with thyroid disease or by persons who are aware of or have been identified as being at risk of developing thyroid disease.</p><p>(c)&#160;&#160;This food supplement should not be consumed if other food supplements containing iodine are also consumed.</p><p>(*)&#160;&#160;Depending on the age group the food supplement is intended for.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC intended for the general population, excluding children under the age of 12 years</p></td><td><p>163 mg/day for adolescents from 12 to 14 years of age</p><p>230 mg/day for adolescents above 14 years of age</p><p>263 mg/day for adults</p></td></tr><tr><td><p><a>&#9660;M18</a></p></td></tr><tr><td><p>Egg membrane hydrolysate</p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;egg membrane hydrolysate&#8217;.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 25 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.</p><p>Applicant: Biova, LLC., 5800 Merle Hay Rd, Suite 14 PO Box 394 Johnston 50131, Iowa USA. During the period of data protection the novel food egg membrane hydrolysate is authorised for placing on the market within the Union only by Biova, LLC. 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 26 of Regulation (EU) 2015/2283 or with the agreement of Biova, LLC.</p><p>End date of the data protection: 25 November 2023</p></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC intended for the general adult population</p></td><td><p>450 mg/day</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Epigallocatechin gallate as a purified extract from green tea leaves (<span>Camellia sinensis</span>)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The labelling shall bear a statement that consumers should not consume more than 300 mg of extract per day</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Foods including food supplements as defined in Directive 2002/46/EC</p></td><td><p>150 mg of extract in one portion of food or food supplement</p></td></tr><tr><td><p><a>&#9660;M52</a></p></td></tr><tr><td><p><span>L-ergothioneine</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;L-ergothioneine&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Alcohol-free beverages</p></td><td><p>0,025 g/kg</p></td></tr><tr><td><p>Milk-based drinks</p></td><td><p>0,025 g/kg</p></td></tr><tr><td><p>&#8216;Fresh&#8217; milk products(*)</p></td><td><p>0,040 g/kg</p></td></tr><tr><td><p>Cereal bars</p></td><td><p>0,2 g/kg</p></td></tr><tr><td><p>Chocolate confectionery</p></td><td><p>0,25 g/kg</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC</p></td><td><p>30 mg/day for general population (excluding pregnant and lactating women)</p><p>20 mg/day for children older than 3 years</p></td></tr><tr><td><p>(*)&#160;&#160;When used in milk products L-ergothioneine may not replace in whole or in part, any milk constituent</p></td></tr><tr><td><p><a>&#9660;M108</a></p></td></tr><tr><td><p><span>Roasted and popped kernels from the seeds of<span>Euryale ferox</span> Salisb. (makhana) (Traditional food from a third country)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;roasted seeds of<span>Euryale ferox</span>&#8217; or &#8216;makhana (<span>Euryale ferox</span>) roasted seeds&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Processed nuts</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><a>&#9660;M52</a></p></td></tr><tr><td><p><span>Extract of three herbal roots (<span>Cynanchum wilfordii</span> Hemsley,<span>Phlomis umbrosa</span> Turcz. and<span>Angelica gigas</span> Nakai)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;extract of three herbal roots (<span>Cynanchum wilfordii</span> Hemsley,<span>Phlomis umbrosa</span> Turcz. and<span>Angelica gigas</span> Nakai)&#8217;.</p><p>The labelling of food supplements containing the extract of mixture of the three herbal roots shall bear a statement in close proximity to the list of ingredients indicating that it should not be consumed by individuals with known celery allergy.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC for adult population</p></td><td><p>175 mg/day</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Ferric Sodium EDTA</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels (expressed as anhydrous EDTA)</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Ferric Sodium EDTA&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC</p></td><td><p>18 mg/day for children</p><p>75 mg/day for adults</p></td></tr><tr><td><p>Foods covered by Regulation (EU) No 609/2013</p></td><td><p>12 mg/100 g</p></td></tr><tr><td><p>Foods fortified in accordance with Regulation (EC) No 1925/2006</p></td></tr><tr><td><p><span>Ferrous ammonium phosphate</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Ferrous ammonium phosphate&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC</p></td><td><p>To be used in compliance with Directive 2002/46/EC, Regulation (EU) No 609/2013 and/or Regulation (EC) No 1925/2006</p></td></tr><tr><td><p>Foods covered by Regulation (EU) No 609/2013</p></td></tr><tr><td><p>Foods fortified in accordance with Regulation (EC) No 1925/2006</p></td></tr><tr><td><p><span>Fish peptides from<span>Sardinops sagax</span></span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels fish peptide product</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Fish (<span>Sardinops sagax</span>) peptides&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Foods based on yoghurt, yoghurt drinks, fermented milk products, and powdered milk</p></td><td><p>0,48 g/100 g (ready to eat/drink)</p></td></tr><tr><td><p>Flavoured water, and vegetable-based drinks</p></td><td><p>0,3 g/100 g (ready to drink)</p></td></tr><tr><td><p>Breakfast cereals</p></td><td><p>2 g/100 g</p></td></tr><tr><td><p>Soups, stews and soup powders</p></td><td><p>0,3 g/100 g (ready to eat)</p></td></tr><tr><td><p><span>Flavonoids from<span>Glycyrrhiza glabra</span></span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of flavonoids from Glycyrrhiza glabra</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Flavonoids from<span>Glycyrrhiza glabra L.</span>&#8217;</p><p>2.&#160;&#160;The labelling of the foods where the product was added as a novel food ingredient shall bear a statement that:</p><p>(a)&#160;&#160;the product should not be consumed by pregnant and breast feeding women, children and young adolescents; and</p><p>(b)&#160;&#160;people taking prescription drugs should only consume the product under medical supervision;</p><p>(c)&#160;&#160;a maximum of 120 mg of flavonoids per day should be consumed.</p><p>3.&#160;&#160;The amount of flavonoids in the final food shall be indicated on the labelling of the food containing it.</p></td><td><p>Beverages containing flavonoids shall be presented to the final consumer as single portions.</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Beverages based on milk</p></td><td><p>120 mg/day</p></td></tr><tr><td><p>Beverages based on yoghurt</p></td></tr><tr><td><p>Beverages based on fruit or vegetables</p></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>120 mg/day</p></td></tr><tr><td><p>Total diet replacement for weight control as defined in Regulation (EU) No 609/2013</p></td><td><p>120 mg/day</p></td></tr><tr><td><p>Foods for special medical purposes as defined in Regulation (EU) No 609/2013</p></td><td><p>120 mg/day</p></td></tr><tr><td><p><a>&#9660;M42</a></p></td></tr><tr><td><p>Fruit pulp, pulp juice, concentrated pulp juice from<span>Theobroma cacao</span> L. (Traditional food from a third country)</p></td><td><p>Not specified</p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;cocoa (<span>Theobroma cacao</span> L.) pulp&#8217;, &#8216;cocoa (<span>Theobroma cacao</span> L.) pulp juice&#8217; or &#8216;cocoa (<span>Theobroma cacao</span> L.) concentrated pulp juice&#8217; depending on the form used.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Fucoidan extract from the seaweed<span>Fucus vesiculosus</span></span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Fucoidan extract from seaweed<span>Fucus vesiculosus</span>&#8217;.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Foods including food supplements as defined in Directive 2002/46/EC for the general population</p></td><td><p>250 mg/day</p></td></tr><tr><td><p><span>Fucoidan extract from the seaweed<span>Undaria pinnatifida</span></span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Fucoidan extract from seaweed Undaria pinnatifida&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Foods including food supplements as defined in Directive 2002/46/EC for the general population</p></td><td><p>250 mg/day</p></td></tr><tr><td><p><a>&#9660;M117</a></p></td></tr><tr><td><p><span>2&#8217;-Fucosyllactose</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;2&#8242;-fucosyllactose&#8217;.</p><p>2.&#160;&#160;The labelling of food supplements containing 2&#8242;-fucosyllactose shall bear a statement that the supplements should not be used if other foods with added 2&#8242;-fucosyllactose are consumed the same day.</p><p>3.&#160;&#160;The labelling of food supplements containing 2&#8242;-fucosyllactose intended for young children shall bear a statement that the supplements should not be used if breast milk or other foods with added 2&#8242;-fucosyllactose are consumed the same day.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Unflavoured pasteurised and sterilised (including UHT) milk-based products</p></td><td><p>1,2&#160;g/l</p></td></tr><tr><td><p>Unflavoured fermented milk-based products</p></td><td><p>1,2&#160;g/l for beverages</p></td></tr><tr><td><p>19,2&#160;g/kg for products other than beverages</p></td></tr><tr><td><p>Flavoured fermented milk-based products including heat-treated products</p></td><td><p>1,2&#160;g/l for beverages</p></td></tr><tr><td><p>19,2&#160;g/kg for products other than beverages</p></td></tr><tr><td><p>Dairy analogues, including beverage whiteners</p></td><td><p>1,2&#160;g/l for beverages</p></td></tr><tr><td><p>12&#160;g/kg for products other than beverages</p></td></tr><tr><td><p>400&#160;g/kg for whitener</p></td></tr><tr><td><p>Cereal bars</p></td><td><p>12&#160;g/kg</p></td></tr><tr><td><p>Table-top sweeteners</p></td><td><p>200&#160;g/kg</p></td></tr><tr><td><p>Infant formula as defined under Regulation (EU) No&#160;609/2013</p></td><td><p>1,2&#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 under Regulation (EU) No&#160;609/2013</p></td><td><p>1,2&#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>Processed cereal-based foods and baby foods for infants and young children as defined under Regulation (EU) No&#160;609/2013</p></td><td><p>12&#160;g/kg for products other than beverages</p></td></tr><tr><td><p>1,2&#160;g/l for liquid food ready for use, marketed as such or reconstituted as instructed by the manufacturer</p></td></tr><tr><td><p>Milk based drinks and similar products intended for young children</p></td><td><p>1,2&#160;g/l for milk-based drinks and similar products in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer</p></td></tr><tr><td><p>Foods for special medical purposes as defined under 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>Total diet replacement for weight control as defined in Regulation (EU) No&#160;609/2013</p></td><td><p>4,8&#160;g/l for drinks</p></td></tr><tr><td><p>40&#160;g/kg for bars</p></td></tr><tr><td><p>Bread and pasta products bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Implementing Regulation (EU) No&#160;828/2014</p></td><td><p>60&#160;g/kg</p></td></tr><tr><td><p>Flavoured drinks</p></td><td><p>1,2&#160;g/l</p></td></tr><tr><td><p>Coffee, tea (excluding black tea), herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products</p></td><td><p>9,6&#160;g/l &#8211; the maximum level refers to the products ready to use</p></td></tr><tr><td><p>Food supplements as defined in Directive&#160;2002/46/EC, for the general population, excluding infants</p></td><td><p>3,0&#160;g/day for general population</p></td></tr><tr><td><p>1,2&#160;g/day for young children</p></td></tr><tr><td><p><a>&#9660;M38</a></p></td></tr><tr><td><p><span>2'-Fucosyllactose/Difucosyllactose mixture (&#8216;2'-FL/DFL&#8217;)</span></p><p><span>(microbial source)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;2'-Fucosyllactose/Difucosyllactose mixture&#8217;.</p><p>The labelling of food supplements containing the 2'-Fucosyllactose/Difucosyllactose mixture shall bear a statement that they should not be used if breast milk or other foods containing added 2'-Fucosyllactose and/or Difucosyllactose are consumed the same day.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 19.12.2019. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 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 2'-Fucosyllactose/Difucosyllactose mixture 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 26 of Regulation (EU) 2015/2283 or with the agreement of Glycom A/S.</p><p>End date of the data protection: 19.12.2024.</p></td></tr><tr><td><p>Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products</p></td><td><p>2,0 g/L</p></td></tr><tr><td><p>Unflavoured fermented milk-based products</p></td><td><p>2,0 g/L (beverages)</p><p>20 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>2,0 g/L (beverages)</p><p>20 g/kg (products other than beverages)</p></td></tr><tr><td><p>Beverages (flavoured drinks)</p></td><td><p>2,0 g/L</p></td></tr><tr><td><p>Cereal bars</p></td><td><p>20 g/kg</p></td></tr><tr><td><p>Infant formula as defined under Regulation (EU) No 609/2013</p></td><td><p>1,6 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 under Regulation (EU) No 609/2013</p></td><td><p>1,2 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 under Regulation (EU) No 609/2013</p></td><td><p>1,2 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer</p><p>10 g/kg for products other than beverages</p></td></tr><tr><td><p>Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013</p></td><td><p>4,0 g/L (beverages)</p><p>40 g/kg (products other than beverages)</p></td></tr><tr><td><p>Food for special medical purposes as defined under Regulation (EU) No 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 intended for the general population excluding infants</p></td><td><p>4,0 g/day</p></td></tr><tr><td><p><a>&#9660;M58</a></p></td></tr><tr><td><p>Milk-based drinks and similar products intended for young children</p></td><td><p>1,2 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><a>&#9660;M75</a></p></td></tr><tr><td><p><span>3-Fucosyllactose (3-FL)</span></p><p><span>(microbial source)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;3-Fucosyllactose&#8217;.</p><p>The labelling of food supplements containing 3-Fucosyllactose (3-FL) shall bear a statement that they should not be consumed:</p><p>a)&#160;&#160;if foods containing added 3-Fucosyllactose are consumed on the same day;</p><p>b)&#160;&#160;by infants and children under 3 years of age.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 12&#160;December 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: DuPont Nutrition &amp; Biosciences ApS Langebrogade 1, 1001 Copenhagen K, Denmark. During the period of data protection, the novel food 3-Fucosyllactose is authorised for placing on the market within the Union only by DuPont Nutrition &amp; Biosciences ApS, 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 DuPont Nutrition &amp; Biosciences ApS.</p><p>End date of the data protection: 12&#160;December 2026.</p></td></tr><tr><td><p>Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products</p></td><td><p>0,85 &#160;g/L</p></td></tr><tr><td><p>Unflavoured and flavoured fermented milk-based products including heat-treated products</p></td><td><p>0,5 &#160;g/L (beverages)</p></td></tr><tr><td><p>5,0 &#160;g/kg (products other than beverages)</p></td></tr><tr><td><p>Dairy analogues</p></td><td><p>0,85 &#160;g/L (beverages)</p></td></tr><tr><td><p>8,5 &#160;g/kg (products other than beverages)</p></td></tr><tr><td><p>Flavoured drinks, energy and sports drinks</p></td><td><p>1,0 &#160;g/L</p></td></tr><tr><td><p>Cereal bars</p></td><td><p>30,0 &#160;g/kg</p></td></tr><tr><td><p>Infant formula as defined under Regulation (EU) No&#160;609/2013</p></td><td><p>0,85 &#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 under Regulation (EU) No&#160;609/2013</p></td><td><p>0,85 &#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>Milk-based drinks and similar products intended for young children</p></td><td><p>0,85 &#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>Processed cereal-based food and baby food for infants and young children as defined under Regulation (EU) No&#160;609/2013</p></td><td><p>0,3 &#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>3,0 &#160;g/kg for products other than beverages</p></td></tr><tr><td><p>Total diet replacement foods for weight control as defined under Regulation (EU) No&#160;609/2013</p></td><td><p>2,0 &#160;g/L (beverages)</p></td></tr><tr><td><p>30,0 &#160;g/kg (products other than beverages)</p></td></tr><tr><td><p>Foods for special medical purposes as defined under 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>5,0 &#160;g/day</p></td></tr><tr><td><p><a>&#9660;M102</a></p></td></tr><tr><td><p><span>3-Fucosyllactose (&#8216;3-FL&#8217;)</span></p><p><span>(produced by a derivative strain of<span>E. coli</span> BL21(DE3))</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;3-fucosyllactose&#8217;.</p><p>The labelling of food supplements containing 3-Fucosyllactose (3-FL) shall bear a statement that</p><p>(a)&#160;&#160;they should not be consumed by children under 3 years of age;</p><p>(b)&#160;&#160;they should not be used if other foods containing added 3-Fucosyllactose are consumed on the same day.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 25.1.2023. 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: &#8216;Chr. Hansen A/S&#8217;, B&#248;ge All&#233; 10-12, 2970 H&#248;rsholm, Denmark. During the period of data protection, the novel food 3-Fucosyllactose is authorised for placing on the market within the Union only by Chr. Hansen 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 &#8216;Chr. Hansen A/S&#8217;.</p><p>End date of the data protection: 25.1.2028.</p></td></tr><tr><td><p>Infant formula as defined under Regulation (EU) No&#160;609/2013</p></td><td><p>0,90&#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 under Regulation (EU) No&#160;609/2013</p></td><td><p>1,20&#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 foods for infants and young children and baby foods for infants and young children as defined under Regulation (EU) No&#160;609/2013</p></td><td><p>1,20&#160;g/l or 1,20&#160;g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer</p></td></tr><tr><td><p>Milk based drinks and similar products intended for young children</p></td><td><p>1,20&#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>Foods for special medical purposes for infants and young children as defined under Regulation (EU) No&#160;609/2013</p></td><td><p>In accordance with the particular nutritional requirements of the infants and young children for whom the products are intended but in any case not higher than 0,9&#160;g/l or 0,9&#160;g/kg (if it is intended for infants from 0 until 6 months) and&#160;1,2&#160;g/l or 1,2&#160;g/kg (if it is intended for infants of 6-12 months and/or for young children) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer.</p></td></tr><tr><td><p>Foods for special medical purposes as defined under Regulation (EU) No&#160;609/2013 excluding foods for infants and young children</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, for the general population, excluding infants and young children</p></td><td><p>3 g/day</p></td></tr><tr><td><p><a>&#9660;M95</a></p></td></tr><tr><td><p><span>Galacto-oligosaccharide</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels (expressed as ratio kg galacto-oligosaccharide/kg final food)</span></p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC</p></td><td><p>0,333</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC, excluding infants and young children</p></td><td><p>0,450 (corresponding to 5,4&#160;g galacto-oligosaccharide/serving; maximum 3 servings/day up to a maximum of 16,2&#160;g/day)</p></td></tr><tr><td><p>Foods for special medical purposes as defined by Regulation (EU) No&#160;609/2013, excluding infants and young children</p></td><td><p>In accordance with the particular nutritional requirements of the persons for whom the products are intended but not more than 0,128 (corresponding to a maximum of 8,25&#160;g galacto-oligosaccharide/day)</p></td></tr><tr><td><p>Milk</p></td><td><p>0,020</p></td></tr><tr><td><p>Milk drinks</p></td><td><p>0,030</p></td></tr><tr><td><p>Meal replacement for weight control (as drinks)</p></td><td><p>0,020</p></td></tr><tr><td><p>Dairy analogue drinks</p></td><td><p>0,020</p></td></tr><tr><td><p>Yoghurt</p></td><td><p>0,033</p></td></tr><tr><td><p>Dairy based desserts</p></td><td><p>0,043</p></td></tr><tr><td><p>Frozen dairy desserts</p></td><td><p>0,043</p></td></tr><tr><td><p>Fruit drinks and energy drinks</p></td><td><p>0,021</p></td></tr><tr><td><p>Infant meal replacement drinks</p></td><td><p>0,012</p></td></tr><tr><td><p>Baby juice</p></td><td><p>0,025</p></td></tr><tr><td><p>Baby yogurt drink</p></td><td><p>0,024</p></td></tr><tr><td><p>Baby dessert</p></td><td><p>0,027</p></td></tr><tr><td><p>Baby snack</p></td><td><p>0,143</p></td></tr><tr><td><p>Baby cereals</p></td><td><p>0,027</p></td></tr><tr><td><p>Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen</p></td><td><p>0,013</p></td></tr><tr><td><p>Juice</p></td><td><p>0,021</p></td></tr><tr><td><p>Fruit pie filling</p></td><td><p>0,059</p></td></tr><tr><td><p>Fruit preparations</p></td><td><p>0,125</p></td></tr><tr><td><p>Bars</p></td><td><p>0,125</p></td></tr><tr><td><p>Cereals</p></td><td><p>0,125</p></td></tr><tr><td><p>Infant formula and follow-on formula as defined in Regulation (EU) No&#160;609/2013</p></td><td><p>0,008</p></td></tr><tr><td><p>Dairy confectionery</p></td><td><p>0,05</p></td></tr><tr><td><p>Cheese and processed cheese</p></td><td><p>0,1</p></td></tr><tr><td><p>Butter and spreadable fats</p></td><td><p>0,1</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Glucosamine HCl</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>In line with normal food use of glucosamine from shell fish</p></td></tr><tr><td><p>Foods covered by Regulation (EU) No 609/2013</p></td></tr><tr><td><p>&#160;</p><div/></td></tr><tr><td><p>Meal replacement for weight control</p></td></tr><tr><td><p>Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen</p></td></tr><tr><td><p>Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014</p></td></tr><tr><td><p><span>Glucosamine sulphate KCl</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>In line with normal food use of glucosamine from shell fish</p></td></tr><tr><td><p><span>Glucosamine sulphate NaCl</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>In line with normal food use of glucosamine from shell fish</p></td></tr><tr><td><p><span>Guar Gum</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Guar Gum&#8217;.</p><p>2.&#160;&#160;A specific mention of the possible risks of digestive discomfort linked to the exposure of children aged under 8 to guar gum must be visible on the label of any foodstuffs containing it.</p><p>For example, &#8216;Excessive consumption of these products may cause digestive discomfort, especially for children under 8 years of age&#8217;.</p><p>3.&#160;&#160;In the case of products with two compartments containing dairy and cereal products respectively, the instructions for use must clearly specify the need to mix the cereal and the dairy product before consumption, in order to take into account the potential risk of gastro-intestinal obstruction.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Fresh dairy products such as yogurts, fermented milks, fresh cheeses and other dairy-based desserts.</p></td><td><p>1,5 g/100 g</p></td></tr><tr><td><p>Fruit or vegetable-based liquid foodstuffs (of the &#8216;smoothie&#8217; variety)</p></td><td><p>1,8 g/100 g</p></td></tr><tr><td><p>Fruit or vegetable-based compotes</p></td><td><p>3,25 g/100 g</p></td></tr><tr><td><p>Cereals accompanied by a dairy product, in packaging containing two compartments</p></td><td><p>10 g/100 g in the cereals</p><p>None in the accompanying dairy product</p><p>1 g/100 g in the product when ready to eat</p></td></tr><tr><td><p><span>Heat-treated milk products fermented with<span>Bacteroides xylanisolvens</span></span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Fermented milk products (in liquid, semi-liquid and spray-dried powder forms)</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Hydroxytyrosol</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the food products containing it shall be &#8216;hydroxytyrosol&#8217;.</p><p>The labelling of the food products containing hydroxytyrosol shall bear the following statements:</p><p>(a)&#160;&#160;This food product should not be consumed by children under the age of three years, pregnant women, and lactating women;</p><p>(b)&#160;&#160;This food product should not be used for cooking, baking or frying&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Fish and vegetable oils, (except olive oils and olive pomace oils as defined in Part VIII of Annex VII of Regulation (EU) No 1308/2013&#160;<a>(<span>6</span>)</a>), placed as such on the market</p></td><td><p>0,215 g/kg</p></td></tr><tr><td><p>Spreadable fats as defined in Part VII of Annex VII of Regulation (EU) No 1308/2013, placed as such on the market</p></td><td><p>0,175 g/kg</p></td></tr><tr><td><p><span>Ice Structuring Protein type III HPLC 12</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Ice Structuring Protein&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Edible ices</p></td><td><p>0,01  %</p></td></tr><tr><td><p><span>Aqueous extracts of dried leaves of<span>Ilex guayusa</span></span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Extracts of dried leaves of<span>Ilex guayusa</span>&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Herbal infusions</p></td><td><p>In line with normal use in herbal infusions and food supplements of a similar aqueous extract of dried leaves of<span>Ilex paraguariensis</span></p></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td></tr><tr><td><p><a>&#9660;M111</a></p></td></tr><tr><td><p>Infusion from coffee leaves of<span>Coffea arabica</span> L.&#160;and/or<span>Coffea canephora</span> Pierre ex A. Froehner</p><p>(Traditional food from a third country)</p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Infusion from coffee leaves&#8217; or &#8216;Dried infusion from coffee leaves&#8217;, depending on the form to be marketed.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Infusion from coffee leaves of<span>Coffea arabica</span> L.&#160;and/or<span>Coffea canephora</span> Pierre ex A. Froehner placed on the market as such</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Flavoured and unflavoured non-alcoholic ready-to-drink beverages&#160;<a>(<span>14</span>)</a></p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Coffee, coffee and chicory extracts, instant coffee, tea, herbal- and fruit-infusions, coffee substitutes, coffee mixes and instant mixes for beverages (and their flavoured counterparts)&#160;<a>(<span>14</span>)</a></p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><a>&#9660;M94</a></p></td></tr><tr><td><p><span>Iron hydroxide adipate tartrate</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;iron hydroxide adipate tartrate (nano)&#8217;.</p><p>The labelling of food supplements containing iron hydroxide adipate tartrate shall bear a statement that they should not be consumed by children and adolescents under the age of 18/children under 4 years of age (*)</p><p>(*)&#160;&#160;Depending on the age group the food supplement is intended for.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 28.8.2022. This inclusion is based on proprietary scientific data protected in accordance with Article&#160;26 of Regulation (EU) 2015/2283.</p><p>Applicant: Nemysis Limited, Suite 4.01 Ormond Building 31-36 Ormond Quay Upper Arran Quay Dublin 7, D07 F6DC, Dublin, Ireland. During the period of data protection, the novel food iron hydroxide adipate tartrate is authorised for placing on the market within the Union only by Nemysis Limited, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific data protected in accordance with Article&#160;26 of Regulation (EU) 2015/2283 or with the agreement of Nemysis Limited.</p><p>End date of the data protection: 28.8.2027.</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC for the adult population</p></td><td><p>&#8804;&#160;100 mg/day (&#8804;&#160;30 mg Fe/day)</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC for children and adolescents under 18 years of age, excluding children under 4 years of age</p></td><td><p>&#8804;&#160;50 mg/day (&#8804;&#160;14 mg Fe/day)</p></td></tr><tr><td><p><a>&#9660;M116</a></p></td></tr><tr><td><p><span>Iron milk caseinate</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;iron milk caseinate&#8217;.</p><p>The labelling of food supplements containing iron milk caseinate shall bear a statement that</p><p>(a)&#160;&#160;they should not be consumed by children under 3 years of age;</p><p>(b)&#160;&#160;they should not be consumed if other foods containing iron milk caseinate&#160;and/or if other foods with added iron are consumed the same day.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 4&#160;June 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article&#160;26 of Regulation (EU)&#160;2015/2283.</p><p>Applicant: &#8216;Soci&#233;t&#233; des Produits Nestl&#233; S.A.&#8217;, Avenue Nestl&#233; 55, 1800 Vevey, Switzerland. During the period of data protection, the iron milk caseinate is authorised for placing on the market within the Union only by &#8216;Soci&#233;t&#233; des Produits Nestl&#233; S.A.&#8217; 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)&#160;2015/2283 or with the agreement of &#8216;Soci&#233;t&#233; des Produits Nestl&#233; S.A.&#8217;.</p><p>End date of the data protection: 4&#160;June 2028.</p></td></tr><tr><td><p>Milk and dairy powder products</p></td><td><p>500&#160;mg/100 g (&#8804;&#160;10 mg&#160;Fe/100 g)</p></td></tr><tr><td><p>Soft-drinks marketed in relation to physical exercise</p></td><td><p>85&#160;mg/100 g (&#8804;&#160;1,7&#160;mg&#160;Fe/100 g)</p></td></tr><tr><td><p>Powder cocoa beverage preparations</p></td><td><p>400&#160;mg/100 g (&#8804;&#160;8 mg&#160;Fe/100 g)</p></td></tr><tr><td><p>Powder or liquid malt-based coffee substitutes</p></td><td><p>1&#160;050  mg/100 g (&#8804;&#160;21 mg&#160;Fe/100 g)</p></td></tr><tr><td><p>Cereal bars</p></td><td><p>350&#160;mg/100 g (&#8804;&#160;7 mg&#160;Fe/100 g)</p></td></tr><tr><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Noodles other than glass noodles</p></td><td><p>75&#160;mg/100 g (&#8804;&#160;1,5&#160;mg&#160;Fe/100 g)</p></td></tr><tr><td><p>Stock cubes or granulates (bouillon base)</p></td><td><p>4&#160;750  mg/100 g (&#8804;&#160;95 mg&#160;Fe/100 g)</p></td></tr><tr><td><p>Single meal replacements for weight control</p></td><td><p>120&#160;mg/100 g (&#8804;&#160;2,4&#160;mg&#160;Fe/100 g)</p></td></tr><tr><td><p>Total diet replacement for weight control as defined under Regulation (EU) No&#160;609/2013</p></td><td><p>235&#160;mg/meal (&#8804;&#160;4,7&#160;mg&#160;Fe/meal) or 700&#160;mg/day (&#8804;&#160;14,0&#160;mg/Fe/day)</p></td></tr><tr><td><p>Foods for special medical purposes as defined under Regulation (EU) No&#160;609/2013 excluding foods for infants and young children</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&#160;2002/46/EC, for the adult population</p></td><td><p>700&#160;mg/day (&#8804;&#160;14 mg&#160;Fe/day)</p></td></tr><tr><td><p>Food supplements as defined in Directive&#160;2002/46/EC, for children and adolescents under 18 years of age, excluding infants and young children</p></td><td><p>350&#160;mg/day (&#8804;&#160;7 mg&#160;Fe/day)</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Isomalto-oligosaccharide</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Isomaltooligosaccharide&#8217;.</p><p>2.&#160;&#160;Foods containing the novel ingredient must be labelled as &#8216;a source of glucose&#8217;.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Energy-Reduced Soft Drinks</p></td><td><p>6,5  %</p></td></tr><tr><td><p>Energy Drinks</p></td><td><p>5,0  %</p></td></tr><tr><td><p>Foods intended to meet the expenditure of intense muscular efforts, especially for sportsmen (including isotonic drinks)</p></td><td><p>6,5  %</p></td></tr><tr><td><p>Fruit Juices</p></td><td><p>5  %</p></td></tr><tr><td><p>Processed Vegetables and Vegetable Juices</p></td><td><p>5  %</p></td></tr><tr><td><p>Other Soft Drinks</p></td><td><p>5  %</p></td></tr><tr><td><p>Cereals Bars</p></td><td><p>10  %</p></td></tr><tr><td><p>Cookies, Biscuits</p></td><td><p>20  %</p></td></tr><tr><td><p>Breakfast Cereal Bars</p></td><td><p>25  %</p></td></tr><tr><td><p>Hard Candies</p></td><td><p>97  %</p></td></tr><tr><td><p>Soft Candies/Chocolate Bars</p></td><td><p>25  %</p></td></tr><tr><td><p>Meal replacement for weight control (as bars or milk based)</p></td><td><p>20  %</p></td></tr><tr><td><p><span>Isomaltulose</span></p></td><td><p>Not specified</p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Isomaltulose&#8217;.</p><p>2.&#160;&#160;The designation of the novel food on the labelling shall be accompanied by indication that the &#8216;Isomaltulose is a source of glucose and fructose&#8217;.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><a>&#9660;M90</a></p></td></tr><tr><td><p><span><span>Jatropha curcas</span> L. (edible variety) kernels</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels (g/100g)</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;kernels from edible<span>Jatropha curcas</span> L.&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 12&#160;July 2022. 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: &#8216;JatroSolutions GmbH&#8217;, Echterdinger Strasse 30, 70599 Stuttgart, Germany. During the period of data protection, the novel food kernels from the edible variety of<span>Jatropha curcas</span> L. is authorised for placing on the market within the Union only by &#8216;JatroSolutions GmbH&#8217;, 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 &#8216;JatroSolutions GmbH&#8217;.</p><p>End date of the data protection: 12&#160;July 2027.</p></td></tr><tr><td><p>Kernels as such, candied or sugar preserved and as processed nuts</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Cereal bars</p></td><td><p>5</p></td></tr><tr><td><p>Breakfast cereals</p></td><td><p>5</p></td></tr><tr><td><p>Dried fruits</p></td><td><p>5</p></td></tr><tr><td><p>&#160;</p><div/></td></tr><tr><td><p><a>&#9660;M14</a></p></td></tr><tr><td><p><span>Lactitol</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the food supplements containing it shall be &#8216;Lactitol&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC (capsules, tablets or powder) intended for the adult population</p></td><td><p>20 g/day</p></td></tr><tr><td><p><a>&#9660;M119</a></p></td></tr><tr><td><p><span>Lacto-<span>N</span>-neotetraose</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;lacto-<span>N</span>-neotetraose&#8217;.</p><p>2.&#160;&#160;The labelling of food supplements containing lacto-<span>N</span>-neotetraose shall bear a statement that the supplements should not be used if other foods with added lacto-N-neotetraose are consumed the same day.</p><p>3.&#160;&#160;The labelling of food supplements containing lacto-<span>N</span>-neotetraose intended for young children shall bear a statement that the supplements should not be used if breast milk or other foods with added lacto-<span>N</span>-neotetraose are consumed the same day.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Unflavoured pasteurised and sterilised (including UHT) milk-based products</p></td><td><p>0,6&#160;g/l</p></td></tr><tr><td><p>Unflavoured fermented milk-based products</p></td><td><p>0,6&#160;g/l for beverages</p></td></tr><tr><td><p>9,6&#160;g/kg for products other than beverages</p></td></tr><tr><td><p>Flavoured fermented milk-based products including heat-treated products</p></td><td><p>0,6&#160;g/l for beverages</p></td></tr><tr><td><p>9,6&#160;g/kg for products other than beverages</p></td></tr><tr><td><p>Dairy analogues, including beverage whiteners</p></td><td><p>0,6&#160;g/l for beverages</p></td></tr><tr><td><p>6&#160;g/kg for products other than beverages</p></td></tr><tr><td><p>200&#160;g/kg for whitener</p></td></tr><tr><td><p>Cereal bars</p></td><td><p>6&#160;g/kg</p></td></tr><tr><td><p>Table-top sweeteners</p></td><td><p>100&#160;g/kg</p></td></tr><tr><td><p>Infant formula as defined under Regulation (EU) No&#160;609/2013</p></td><td><p>0,6&#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 under Regulation (EU) No&#160;609/2013</p></td><td><p>0,6&#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 foods and baby foods for infants and young children as defined under Regulation (EU) No&#160;609/2013</p></td><td><p>6&#160;g/kg for products other than beverages</p></td></tr><tr><td><p>0,6&#160;g/l for liquid food ready for use, marketed as such or reconstituted as instructed by the manufacturer</p></td></tr><tr><td><p>Milk based drinks and similar products intended for young children</p></td><td><p>0,6&#160;g/l for milk-based drinks and similar products in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer</p></td></tr><tr><td><p>Foods for special medical purposes as defined under 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>Total diet replacement for weight control as defined in Regulation (EU) No&#160;609/2013</p></td><td><p>2,4&#160;g/l for drinks</p></td></tr><tr><td><p>20&#160;g/kg for bars</p></td></tr><tr><td><p>Bread and pasta products bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No&#160;828/2014</p></td><td><p>30&#160;g/kg</p></td></tr><tr><td><p>Flavoured drinks</p></td><td><p>0,6&#160;g/l</p></td></tr><tr><td><p>Coffee, tea (excluding black tea), herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products</p></td><td><p>4,8&#160;g/l &#8211; the maximum level refers to the products ready to use</p></td></tr><tr><td><p>Food Supplements as defined in Directive&#160;2002/46/EC, for the general population, excluding infants</p></td><td><p>1,5&#160;g/day for general population</p><p>0,6&#160;g/day for young children</p></td></tr><tr><td><p><a>&#9660;M45</a></p></td></tr><tr><td><p>Lacto-<span>N</span>-tetraose (&#8216;LNT&#8217;)</p><p><span>(microbial source)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;lacto-<span>N-</span>tetraose&#8217;.</p><p>The labelling of food supplements containing lacto-<span>N-</span>tetraose shall bear a statement that they should not be used if breast milk or other foods containing added lacto-<span>N-</span>tetraose are consumed the same day.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 23.4.2020. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 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 lacto-<span>N-</span>tetraose 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 26 of Regulation (EU) 2015/2283 or with the agreement of Glycom A/S.</p><p>End date of the data protection: 23.4.2025.</p></td></tr><tr><td><p>Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products</p></td><td><p>1,0 g/l</p></td></tr><tr><td><p>Unflavoured fermented milk-based products</p></td><td><p>1,0 g/l (beverages)</p><p>10 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>1,0 g/l (beverages)</p><p>10 g/kg (products other than beverages)</p></td></tr><tr><td><p>Beverages (flavoured drinks)</p></td><td><p>1,0 g/l</p></td></tr><tr><td><p>Cereal bars</p></td><td><p>10 g/kg</p></td></tr><tr><td><p>Infant formula as defined under Regulation (EU) No 609/2013</p></td><td><p>0,8 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 under Regulation (EU) No 609/2013</p></td><td><p>0,6 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, baby food for infants and young children as defined under Regulation (EU) No 609/2013</p></td><td><p>0,6 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer</p><p>5 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>0,6 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer</p><p>5 g/kg for products other than beverages</p></td></tr><tr><td><p>Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013</p></td><td><p>2,0 g/l (beverages)</p><p>20 g/kg (products other than beverages)</p></td></tr><tr><td><p>Food for special medical purposes as defined under Regulation (EU) No 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 infants</p></td><td><p>2,0 g/day for young children, children, adolescents, and adults</p></td></tr><tr><td><p><a>&#9660;M101</a></p></td></tr><tr><td><p><span>Lacto-<span>N</span>-tetraose (&#8216;LNT&#8217;)</span></p><p><span>(produced by derivative strains of<span>E. coli</span> BL21(DE3))</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels (expressed as lacto-N-tetraose)</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;lacto-<span>N-</span>tetraose&#8217;.</p><p>The labelling of food supplements containing lacto-<span>N-</span>tetraose (LNT) shall bear a statement that</p><p>(a)&#160;&#160;they should not be consumed by children under 3 years of age;</p><p>(b)&#160;&#160;they should not be used if other foods containing added lacto-<span>N-</span>tetraose are consumed the same day.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 24.1.2023. 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: &#8216;Chr. Hansen A/S&#8217;, Boege All&#233; 10-12, 2970 Hoersholm, Denmark. During the period of data protection, the novel food Lacto-<span>N-</span>tetraose is authorised for placing on the market within the Union only by &#8216;Chr. Hansen A/S&#8217; 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 &#8216;Chr. Hansen A/S&#8217;.</p><p>End date of the data protection: 24.1.2028.</p></td></tr><tr><td><p>Infant formula as defined under Regulation (EU) No&#160;609/2013</p></td><td><p>1,82&#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 under Regulation (EU) No&#160;609/2013</p></td><td><p>1,82&#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 foods and baby foods for infants and young children as defined under Regulation (EU) No&#160;609/2013</p></td><td><p>1,82&#160;g/L or 1,82&#160;g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer</p></td></tr><tr><td><p>Milk based drinks and similar products intended for young children</p></td><td><p>1,82&#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>Foods for special medical purposes for infants and young children as defined under Regulation (EU) No&#160;609/2013</p></td><td><p>In accordance with the particular nutritional requirements of the infants and young children for whom the products are intended but in any case not higher than 1,82&#160;g/L or 1,82&#160;g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer.</p></td></tr><tr><td><p>Foods for special medical purposes as defined under Regulation (EU) No&#160;609/2013 excluding foods for infants and young children</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, for the general population, excluding infants and young children</p></td><td><p>4,6&#160;g/day</p></td></tr><tr><td><p><a>&#9660;M21</a></p></td></tr><tr><td><p><span>Lonicera caerulea</span> L. berries (haskap)</p><p>(Traditional food from a third country)</p></td><td><p>Not specified</p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;haskap (<span>Lonicera caerulea</span>) berries&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Lucerne leaf extract from<span>Medicago sativa</span></span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Lucerne (<span>Medicago sativa</span>) protein&#8217; or &#8216;Alfalfa (<span>Medicago sativa</span>) protein&#8217;.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC</p></td><td><p>10 g/day</p></td></tr><tr><td><p><span>Lycopene</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Lycopene&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Fruit/vegetable juice-based drinks (including concentrates)</p></td><td><p>2,5 mg/100 g</p></td></tr><tr><td><p>Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen</p></td><td><p>2,5 mg/100 g</p></td></tr><tr><td><p>Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control</p></td><td><p>8 mg/meal</p></td></tr><tr><td><p>Breakfast cereals</p></td><td><p>5 mg/100 g</p></td></tr><tr><td><p>Fats and dressings</p></td><td><p>10 mg/100 g</p></td></tr><tr><td><p>Soups other than tomato soups</p></td><td><p>1 mg/100 g</p></td></tr><tr><td><p>Bread (including crispy breads)</p></td><td><p>3 mg/100 g</p></td></tr><tr><td><p>Foods for special medical purposes as defined in Regulation (EU) No 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</p></td><td><p>15 mg/day</p></td></tr><tr><td><p><span>Lycopene from<span>Blakeslea trispora</span></span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Lycopene&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Fruit/vegetable juice-based drinks (including concentrates)</p></td><td><p>2,5 mg/100 g</p></td></tr><tr><td><p>Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen</p></td><td><p>2,5 mg/100 g</p></td></tr><tr><td><p>Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control</p></td><td><p>8 mg/meal</p></td></tr><tr><td><p>Breakfast cereals</p></td><td><p>5 mg/100 g</p></td></tr><tr><td><p>Fats and dressings</p></td><td><p>10 mg/100 g</p></td></tr><tr><td><p>Soups other than tomato soups</p></td><td><p>1 mg/100 g</p></td></tr><tr><td><p>Bread (including crispy breads)</p></td><td><p>3 mg/100 g</p></td></tr><tr><td><p>Foods for special medical purposes as defined in Regulation (EU) No 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</p></td><td><p>15 mg/day</p></td></tr><tr><td><p><span>Lycopene from tomatoes</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Lycopene&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Fruit/vegetable juice-based drinks (including concentrates)</p></td><td><p>2,5 mg/100 g</p></td></tr><tr><td><p>Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen</p></td><td><p>2,5 mg/100 g</p></td></tr><tr><td><p>Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control</p></td><td><p>8 mg/meal</p></td></tr><tr><td><p>Breakfast cereals</p></td><td><p>5 mg/100 g</p></td></tr><tr><td><p>Fats and dressings</p></td><td><p>10 mg/100 g</p></td></tr><tr><td><p>Soups other than tomato soups</p></td><td><p>1 mg/100 g</p></td></tr><tr><td><p>Bread (including crispy breads)</p></td><td><p>3 mg/100 g</p></td></tr><tr><td><p>Foods for special medical purposes as defined in Regulation (EU) No 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</p></td><td><p>15 mg/day</p></td></tr><tr><td><p><span>Lycopene oleoresin from tomatoes</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of lycopene</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Lycopene oleoresin from tomatoes&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Fruit/vegetable juice-based drinks (including concentrates)</p></td><td><p>2,5 mg/100 g</p></td></tr><tr><td><p>Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen</p></td><td><p>2,5 mg/100 g</p></td></tr><tr><td><p>Total diet replacement for weight control covered by Regulation (EU) No 609/2013 and meal replacements for weight control</p></td><td><p>8 mg/meal</p></td></tr><tr><td><p>Breakfast cereals</p></td><td><p>5 mg/100 g</p></td></tr><tr><td><p>Fats and dressings</p></td><td><p>10 mg/100 g</p></td></tr><tr><td><p>Soups other than tomato soups</p></td><td><p>1 mg/100 g</p></td></tr><tr><td><p>Bread (including crispy breads)</p></td><td><p>3 mg/100 g</p></td></tr><tr><td><p>Foods for special medical purposes as defined in Regulation (EU) No 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><a>&#9660;M52</a></p></td></tr><tr><td><p><span>Hen egg white lysozyme hydrolysate</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of food supplements containing it shall be &#8216;Hen egg white lysozyme hydrolysate&#8217;.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC intended for adult population</p></td><td><p>1000 mg/day</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Magnesium citrate malate</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Magnesium citrate malate&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Magnolia Bark Extract</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Magnolia Bark Extract&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Mints (confectionary products)</p></td><td><p>0,2 % for breath freshening purposes. Based on a 0,2 % maximum incorporation level and a maximum gum/mint size of 1,5 g each, each gum or mint serving will contain no more than 3 mg of magnolia bark extract.</p></td></tr><tr><td><p>Chewing gum</p></td></tr><tr><td><p><span>Maize-germ oil high in unsaponifiable matter</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Maize-germ oil extract&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>2 g/day</p></td></tr><tr><td><p>Chewing gum</p></td><td><p>2  %</p></td></tr><tr><td><p><span>Methylcellulose</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Methylcellulose&#8217;</p></td><td><p>Methylcellulose is not to be used in foods specially prepared for young children</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Edible ices</p></td><td><p>2  %</p></td></tr><tr><td><p>Flavoured drinks</p></td></tr><tr><td><p>Flavoured or unflavoured fermented milk products</p></td></tr><tr><td><p>Cold desserts (dairy, fat, fruit, cereal, egg-based products)</p></td></tr><tr><td><p>Fruit preparations (pulps, purees or compotes)</p></td></tr><tr><td><p>Soups and broths</p></td></tr><tr><td><p><a>&#9660;M11</a></p></td></tr><tr><td><p><span>1-Methylnicotinamide chloride</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;1- Methylnicotinamide chloride&#8217;.</p><p>Food supplements containing 1-Methylnicotinamide shall bear the following statement:</p><p>This food supplement should be consumed by adults only excluding pregnant and lactating women</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 2 September 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.</p><p>Applicant: Pharmena SA, Wolczanska 178, 90 530 Lodz, Poland. During the period of data protection the novel food 1-methylnicotinamide chloride is authorised for placing on the market within the Union only by Pharmena S.A. 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 26 of Regulation (EU) 2015/2283 or with the agreement of Pharmena S.A.</p><p>End date of the data protection: 2 September 2023</p></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC for the adult population excluding pregnant and lactating women</p></td><td><p>58 mg/day</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>(6S)-5-methyltetrahydrofolic acid, glucosamine salt</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;(6S)-5-methyltetrahydrofolic acid, glucosamine salt&#8217; or &#8216;5MTHF-glucosamine&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC as a source of folate</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Monomethylsilanetriol (Organic Silicon)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of silicon</span></p></td><td><p>The designation of the novel food on the labelling of the food supplements containing it shall be &#8216;Organic silicon (monomethylsilanetriol)&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC for adult population (in liquid form)</p></td><td><p>10,40 mg/day</p></td></tr><tr><td><p><a>&#9660;M87</a></p></td></tr><tr><td><p><span>Mung bean (<span>Vigna radiata)</span> protein</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;mung bean protein from<span>Vigna radiata</span>&#8217;.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 15&#160;May 2022. 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: Eat Just, Inc., 2000 Folsom Street San Francisco, CA 94110 USA. During the period of data protection, the novel mung bean protein is authorised for placing on the market within the Union only by Eat Just, Inc., 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 Eat Just, Inc.</p><p>End date of the date protection: 15&#160;May 2027.</p></td></tr><tr><td><p>Protein products</p></td><td><p>20&#160;g/100&#160;g</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Mycelial extract from Shiitake mushroom (<span>Lentinula edodes</span>)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;extract from the mushroom<span>Lentinula edodes</span>&#8217; or &#8216;extract from Shiitake mushroom&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Bread products</p></td><td><p>2 ml/100 g</p></td></tr><tr><td><p>Soft drinks</p></td><td><p>0,5 ml/100 ml</p></td></tr><tr><td><p>Ready prepared meals</p></td><td><p>2,5 ml per meal</p></td></tr><tr><td><p>Foods based on yoghurt</p></td><td><p>1,5 ml/100 ml</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC</p></td><td><p>2,5 ml per day dose</p></td></tr><tr><td><p><a>&#9660;M92</a></p></td></tr><tr><td><p><span>Nicotinamide riboside chloride</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;nicotinamide riboside chloride&#8217;.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 20&#160;February 2020. 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: ChromaDex Inc., 10900 Wilshire Boulevard Suite 600, Los Angeles, CA 90024 USA. During the period of data protection, the novel food is authorised for placing on the market within the Union only by ChromaDex Inc. unless a subsequent applicant obtains authorisation for that 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 ChromaDex Inc.</p><p>End date of the data protection: 20&#160;February 2025.</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC</p></td><td><p>300 mg/day for the adult population, excluding pregnant and lactating women</p><p>230 mg/day for pregnant and lactating women</p></td></tr><tr><td><p>Foods for special medical purposes as defined by Regulation (EU) No&#160;609/2013 for the adult population, excluding pregnant and lactating women</p></td><td><p>In accordance with the particular nutritional requirements of the persons for whom the products are intended</p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;nicotinamide riboside chloride&#8217;</p><p>2.&#160;&#160;The labelling of foodstuffs containing the novel food shall bear a statement that those foods should only be consumed by persons above 18 years of age excluding pregnant and lactating women.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Total diet replacement for weight control as defined by Regulation (EU) No&#160;609/2013 for the adult population, excluding pregnant and lactating women</p></td><td><p>500 mg/day</p></td></tr><tr><td><p>Meal replacements for the adult population, excluding pregnant and lactating women</p></td><td><p>150 mg/meal (maximum 2 meals/day up to a maximum of 300 mg/day)</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Noni fruit juice (<span>Morinda citrifolia</span>)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Noni juice&#8217; or &#8216;Juice of<span>Morinda citrifolia</span>&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Pasteurised fruit and fruit nectar based drinks</p></td><td><p>30 ml with one serving (up to 100 % noni juice)</p><p>or</p><p>20 ml twice a day, not more than 40 ml per day</p></td></tr><tr><td><p><span>Noni fruit juice powder (<span>Morinda citrifolia</span>)</span></p></td><td><p>Food supplements as defined in Directive 2002/46/EC</p></td><td><p>6,6 g/day (equivalent to 30 ml of noni juice)</p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Noni juice powder&#8217; or &#8216;Juice powder of<span>Morinda citrifolia</span>&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Noni fruit puree and concentrate (<span>Morinda citrifolia</span>)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be:</p><p>For fruit puree:</p><p>&#8216;<span>Morinda citrifolia</span> fruit puree&#8217; or &#8216;Noni fruit puree&#8217;</p><p>For fruit concentrate:</p><p>&#8216;<span>Morinda citrifolia</span> fruit concentrate&#8217; or &#8216;Noni fruit concentrate&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>&#160;</p><div/></td><td><p>Fruit puree</p></td></tr><tr><td><p>Candy/confectionery</p></td><td><p>45 g/100 g</p></td></tr><tr><td><p>Cereal bars</p></td><td><p>53 g/100 g</p></td></tr><tr><td><p>Powdered nutritional drink mixes (dry weight)</p></td><td><p>53 g/100 g</p></td></tr><tr><td><p>Carbonated beverages</p></td><td><p>11 g/100 g</p></td></tr><tr><td><p>Ice cream &amp; sorbet</p></td><td><p>31 g/100 g</p></td></tr><tr><td><p>Yoghurt</p></td><td><p>12 g/100 g</p></td></tr><tr><td><p>Biscuits</p></td><td><p>53 g/100 g</p></td></tr><tr><td><p>Buns, cakes and pastries</p></td><td><p>53 g/100 g</p></td></tr><tr><td><p>Breakfast cereals (wholegrain)</p></td><td><p>88 g/100 g</p></td></tr><tr><td><p>Jams and jellies in accordance with Directive 2001/113/EC</p></td><td><p>133 g/100 g</p><p>Based on pre-processing quantity to produce final 100 g product</p></td></tr><tr><td><p>Sweet spreads, fillings and icings</p></td><td><p>31 g/100 g</p></td></tr><tr><td><p>Savoury sauces, pickles, gravies and condiments</p></td><td><p>88 g/100 g</p></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>26 g/day</p></td></tr><tr><td><p>&#160;</p><div/></td><td><p>Fruit concentrate</p></td></tr><tr><td><p>Candy/Confectionery</p></td><td><p>10 g/100 g</p></td></tr><tr><td><p>Cereal bars</p></td><td><p>12 g/100 g</p></td></tr><tr><td><p>Powdered nutritional drink mixes (dry weight)</p></td><td><p>12 g/100 g</p></td></tr><tr><td><p>Carbonated beverages</p></td><td><p>3 g/100 g</p></td></tr><tr><td><p>Ice cream &amp; sorbet</p></td><td><p>7 g/100 g</p></td></tr><tr><td><p>Yoghurt</p></td><td><p>3 g/100 g</p></td></tr><tr><td><p>Biscuits</p></td><td><p>12 g/100 g</p></td></tr><tr><td><p>Buns, cakes and pastries</p></td><td><p>12 g/100 g</p></td></tr><tr><td><p>Breakfast cereals (wholegrain)</p></td><td><p>20 g/100 g</p></td></tr><tr><td><p>Jams and jellies in accordance with Directive 2001/113/EC</p></td><td><p>30 g/100 g</p></td></tr><tr><td><p>Sweet spreads, fillings and icings</p></td><td><p>7 g/100 g</p></td></tr><tr><td><p>Savoury sauces, pickles, gravies and condiments</p></td><td><p>20 g/100 g</p></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>6 g/day</p></td></tr><tr><td><p><span>Noni leaves (<span>Morinda citrifolia</span>)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Noni leaves&#8217; or &#8216;leaves of<span>Morinda citrifolia</span>&#8217;.</p><p>2.&#160;&#160;Instructions shall be given to the consumer that a cup of infusion should not be prepared with more than 1 g of dried and roasted leaves of Morinda citrifolia.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>For the preparation of infusions</p></td><td><p>A cup of infusion to be consumed shall not be prepared with more than 1 g of dried and roasted leaves of<span>Morinda citrifolia</span></p></td></tr><tr><td><p><span>Noni fruit powder (<span>Morinda citrifolia</span>)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Morinda citrifolia fruit powder&#8217; or &#8216;Noni fruit powder&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>2,4 g per/day</p></td></tr><tr><td><p><span><span>Odontella aurita</span> microalgae</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;<span>Odontella aurita</span> microalgae&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Flavoured pasta</p></td><td><p>1,5  %</p></td></tr><tr><td><p>Fish soups</p></td><td><p>1  %</p></td></tr><tr><td><p>Marine terrines</p></td><td><p>0,5  %</p></td></tr><tr><td><p>Broth preparations</p></td><td><p>1  %</p></td></tr><tr><td><p>Crackers</p></td><td><p>1,5  %</p></td></tr><tr><td><p>Frozen breaded fish</p></td><td><p>1,5  %</p></td></tr><tr><td><p><span>Oil enriched with phytosterols/phytostanols</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of phytosterols/ phytostanols</span></p></td><td><p>In accordance with Annex III.5 to Regulation (EU) No 1169/2011</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Spreadable fats as defined in Annex VII, Part VII and Appendix II, points B and C of Regulation (EU) No 1308/2013, and excluding cooking and frying fats and spreads based on butter or other animal fat</p></td><td><p>1.&#160;&#160;The products containing the novel food ingredient shall be presented in such a manner that they can be easily divided into portions that contain either a maximum of 3 g (in case of one portion per day) or a maximum of 1 g (in case of three portions per day) of added phytosterols/phytostanols.</p><p>2.&#160;&#160;The amount of phytosterols/phytostanols added to a container of beverages shall not exceed 3 g.</p><p>3.&#160;&#160;Salad dressings, mayonnaise and spicy sauces shall be packed as single portions.</p></td></tr><tr><td><p>Milk based products, such as products based on semi-skimmed and skimmed milk products, possibly with the addition of fruits and/or cereals, products based on fermented milk such as yoghurt and cheese based products (fat content &#8804; 12 g per 100 g), where possibly the milk fat has been reduced and the fat or protein has been partly or fully replaced by vegetable fat or protein</p></td></tr><tr><td><p>Soya drinks</p></td></tr><tr><td><p>Salad dressings, mayonnaise and spicy sauces</p></td></tr><tr><td><p><span>Oil extracted from squids</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of DHA and EPA combined</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Squid oil&#8217;.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Dairy products except milk-based beverages</p></td><td><p>200 mg/100 g or for cheese products 600 mg/100 g</p></td></tr><tr><td><p>Dairy analogues except drinks</p></td><td><p>200 mg/100 g or for analogues to cheese products 600 mg/100 g</p></td></tr><tr><td><p>Spreadable fat and dressings</p></td><td><p>600 mg/100 g</p></td></tr><tr><td><p>Breakfast cereals</p></td><td><p>500 mg/100 g</p></td></tr><tr><td><p>Bakery products (breads and bread rolls)</p></td><td><p>200 mg/100 g</p></td></tr><tr><td><p>Cereal bars</p></td><td><p>500 mg/100 g</p></td></tr><tr><td><p>Non-alcoholic beverages (including milk-based beverages)</p></td><td><p>60 mg/100 ml</p></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>3&#160;000  mg/day for general population</p><p>450 mg/day for pregnant and lactating women</p></td></tr><tr><td><p>Foods for special medical purposes as defined in Regulation (EU) No 609/2013</p></td><td><p>In accordance with the particular nutritional requirements of the persons for whom the products intended</p></td></tr><tr><td><p>Total diet replacement for weight control defined in Regulation (EU) No 609/2013 and meal replacements for weight control</p></td><td><p>200 mg/meal</p></td></tr><tr><td><p><a>&#9660;M55</a></p></td></tr><tr><td><p><span>Extract from<span>Panax notoginseng</span> and<span>Astragalus membranaceus</span></span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Extract from<span>Panax notoginseng</span> and<span>Astragalus membranaceus</span>&#8217;</p><p>The labelling of food supplements containing extract from<span>Panax notoginseng</span> and<span>Astragalus membranaceus</span> shall bear a statement that those food supplements should not be consumed by the population under 18 years of age and by pregnant women.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 23 December 2020. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.</p><p>Applicant: NuLiv Science, 1050 W. Central Ave., Building C, Brea, CA 92821, USA.</p><p>During the period of data protection, the novel food is authorised for placing on the market within the Union only by NuLiv Science, unless a subsequent applicant obtains authorisation for that novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of NuLiv Science.</p><p>End date of the data protection: 23 December 2025.</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC for the general adult population, excluding food supplements for pregnant women</p></td><td><p>35 mg/day</p></td></tr><tr><td><p><a>&#9660;M47</a></p></td></tr><tr><td><p><span>Partially defatted chia seed (<span>Salvia hispanica</span>) powders</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Partially defatted chia seed (<span>Salvia hispanica</span>) powder&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Powder with high protein content</p></td></tr><tr><td><p>Unflavoured fermented milk products, including natural unflavoured buttermilk (excluding sterilised buttermilk) non-heat-treated after fermentation</p></td><td><p>0,7 %</p></td></tr><tr><td><p>Unflavoured fermented milk products, heat-treated after fermentation</p></td><td><p>0,7 %</p></td></tr><tr><td><p>Flavoured fermented milk products including heat-treated products</p></td><td><p>0,7 %</p></td></tr><tr><td><p>Confectionery</p></td><td><p>10 %</p></td></tr><tr><td><p>Fruit juices as defined by Directive 2001/112/EC&#160;<a>(<span>8</span>)</a> and vegetable juices</p></td><td><p>2,5 %</p></td></tr><tr><td><p>Fruit nectars as defined by Directive 2001/112/EC and vegetable nectars and similar products</p></td><td><p>2,5 %</p></td></tr><tr><td><p>Flavoured drinks</p></td><td><p>3 %</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>7,5 g/day</p></td></tr><tr><td><p>Powder with high fibre content</p></td></tr><tr><td><p>Confectionery</p></td><td><p>4 %</p></td></tr><tr><td><p>Fruit juices as defined by Directive 2001/112/EC and vegetable juices</p></td><td><p>2,5 %</p></td></tr><tr><td><p>Fruit nectars as defined by Directive 2001/112/EC and vegetable nectars and similar products</p></td><td><p>4 %</p></td></tr><tr><td><p>Flavoured drinks</p></td><td><p>4 %</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>12 g/day</p></td></tr><tr><td><p><a>&#9660;M63</a></p></td></tr><tr><td><p><span>Partially defatted rapeseed powder from<span>Brassica rapa</span> L. and</span></p><p><span><span>Brassica napus</span> L.</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Partially defatted Rapeseed powder&#8217;.</p><p>Any foodstuff containing &#8216;Partially defatted Rapeseed powder&#8217; from<span>Brassica rapa</span> L. and<span>Brassica napus</span> L.&#8217; shall bear a statement that this ingredient may cause allergic reaction to consumers who are allergic to mustard and products thereof. That statement shall appear in close proximity to the list of ingredients.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Cereal bars mixed</p></td><td><p>20 g/100 g</p></td></tr><tr><td><p>Muesli and similar breakfast cereals</p></td><td><p>20 g/100 g</p></td></tr><tr><td><p>Extruded breakfast cereal products</p></td><td><p>20 g/100 g</p></td></tr><tr><td><p>Snacks (excluding potato crisps)</p></td><td><p>15 g/100 g</p></td></tr><tr><td><p>Breads and rolls with added special ingredients (such as seeds, raisins, herbs)</p></td><td><p>7 g/100 g</p></td></tr><tr><td><p>Brown breads bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014</p></td><td><p>7 g/100 g</p></td></tr><tr><td><p>Multigrain bread and rolls</p></td><td><p>7 g/100 g</p></td></tr><tr><td><p>Meat substitutes</p></td><td><p>10 g/100 g</p></td></tr><tr><td><p>Meat balls</p></td><td><p>10 g/100 g</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Pasteurised fruit-based preparations produced using high-pressure treatment</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The wording &#8216;pasteurised by high-pressure treatment&#8217; shall be displayed next to the name of the fruit preparations as such and in any product in which it is used</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Types of fruit:</p><p>apple, apricot, banana, blackberry, blueberry, cherry, coconut, fig, grape, grapefruit, mandarin, mango, melon, peach, pear, pineapple, prune, raspberry, rhubarb, strawberry</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><a>&#9660;M100</a></p></td></tr><tr><td><p><span>Pea and rice protein fermented by<span>Lentinula edodes</span> (Shiitake mushroom) mycelia</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Pea and rice protein fermented by Shiitake mushroom mycelia&#8217;.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 24.1.2023. This inclusion is based on proprietary scientific data protected in accordance with Article&#160;26 of Regulation (EU) 2015/2283.</p><p>Applicant: MycoTechnology, Inc., 18250 E. 40th Avenue, Suite 50, Aurora, 80011 Colorado, United States. During the period of data protection, the novel food pea and rice protein fermented by<span>Lentinula edodes</span> (Shiitake mushroom) mycelia is authorised for placing on the market within the Union only by MycoTechnology, Inc. unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific data protected in accordance with Article&#160;26 of Regulation (EU) 2015/2283 or with the agreement of MycoTechnology, Inc.</p><p>End date of the data protection: 24.1.2028.</p></td></tr><tr><td><p>Bakery wares, breads, rolls, croutons, pizza</p></td><td><p>5 g/100 g</p></td></tr><tr><td><p>Breakfast cereals and cereal bars</p></td><td><p>33 g/100 g</p></td></tr><tr><td><p>Fruit- and vegetable-based drinks</p></td><td><p>20 g/100 ml</p></td></tr><tr><td><p>Ready-to-mix beverage powders</p></td><td><p>93 g/100 g</p></td></tr><tr><td><p>Cocoa and chocolate confectionary</p></td><td><p>7 g/100 g</p></td></tr><tr><td><p>Dairy analogues and non-dairy meal replacements for weight control</p></td><td><p>11 g/100 g</p></td></tr><tr><td><p>Fermented milk-based products</p></td><td><p>5 g/100 g</p></td></tr><tr><td><p>Pasta-based products</p></td><td><p>15 g/100 g</p></td></tr><tr><td><p>Meat preparations and meat products</p></td><td><p>14 g/100 g</p></td></tr><tr><td><p>Soups (ready-to-eat) and soup concentrates or powders</p></td><td><p>3 g/100 g</p></td></tr><tr><td><p>Salads</p></td><td><p>26 g/100 g</p></td></tr><tr><td><p>Meat analogues</p></td><td><p>40 g/100 g</p></td></tr><tr><td><p>Milk-based drinks</p></td><td><p>1 g/100 g</p></td></tr><tr><td><p>Single meal replacements for weight control</p></td><td><p>1 g/100 g</p></td></tr><tr><td><p><a>&#9660;M37</a></p></td></tr><tr><td><p><span>Phenylcapsaicin</span></p></td><td><p><span><span>Specified food category</span></span></p></td><td><p><span><span>Maximum levels</span></span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;phenylcapsaicin&#8217;.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 19 December 2019. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.</p><p>Applicant: aXichem AB, S&#246;dergatan 26, SE 211 34, Malm&#246; Sweden. During the period of data protection, the novel food phenylcapsaicin is authorised for placing on the market within the Union only by aXichem AB, 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 26 of Regulation (EU) 2015/2283 or with the agreement of aXichem AB.</p></td></tr><tr><td><p>Foods for special medical purposes as defined under Regulation (EU) No 609/2013 excluding foods for infants, young children and children under the age of 11 years</p></td><td><p>2,5 mg/day</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC intended for the general population, excluding children under the age of 11 years</p></td><td><p>2,5 mg/day</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Phosphated maize starch</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Phosphated maize starch&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Baked bakery products</p></td><td><p>15  %</p></td></tr><tr><td><p>Pasta</p></td></tr><tr><td><p>Breakfast cereals</p></td></tr><tr><td><p>Cereal bars</p></td></tr><tr><td><p><a>&#9660;M112</a></p></td></tr><tr><td><p><span>Phosphated wheat starch</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Phosphated wheat starch&#8217;.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Baked bakery products</p></td><td><p>15 &#160;%</p></td></tr><tr><td><p>Pasta</p></td></tr><tr><td><p>Breakfast cereals</p></td></tr><tr><td><p>Cereal bars</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Phosphatidylserine from fish phospholipids</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of phosphatidylserine</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Fish phosphatidylserine&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Beverages based on yoghurt</p></td><td><p>50 mg/100 ml</p></td></tr><tr><td><p>Powders based on milk powders</p></td><td><p>3&#160;500  mg/100 g (equivalent to 40 mg/100 ml ready to drink)</p></td></tr><tr><td><p>Foods based on yoghurt</p></td><td><p>80 mg/100 g</p></td></tr><tr><td><p>Cereal bars</p></td><td><p>350 mg/100 g</p></td></tr><tr><td><p>Chocolate based confectionary</p></td><td><p>200 mg/100 g</p></td></tr><tr><td><p>Foods for special medical purposes as defined in Regulation (EU) No 609/2013</p></td><td><p>In compliance with Regulation (EU) No 609/2013</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC</p></td><td><p>300 mg/day</p></td></tr><tr><td><p><span>Phosphatidylserine from soya phospholipids</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of phosphatidylserine</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Soya phosphatidylserine&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Beverages based on yoghurt</p></td><td><p>50 mg/100 ml</p></td></tr><tr><td><p>Powders based on milk powder</p></td><td><p>3,5 g/100 g (equivalent to 40 mg/100 ml ready to drink)</p></td></tr><tr><td><p>Foods based on yoghurt</p></td><td><p>80 mg/100 g</p></td></tr><tr><td><p>Cereal bars</p></td><td><p>350 mg/100 g</p></td></tr><tr><td><p>Chocolate based confectionary</p></td><td><p>200 mg/100 g</p></td></tr><tr><td><p>Foods for special medical purposes as defined in Regulation (EU) No 609/2013</p></td><td><p>In compliance with Regulation (EU) No 609/2013</p></td></tr><tr><td><p><span>Phospholipid product containing equal amounts of phosphatidylserine and phosphatidic acid</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of phosphatidylserine</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing shall be &#8216;Soy phosphatidylserine and phosphatidic acid&#8217;</p></td><td><p>The product is not intended to be marketed to pregnant or breast-feeding women</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Breakfast cereals</p></td><td><p>80 mg/100 g</p></td></tr><tr><td><p>Cereal bars</p></td><td><p>350 mg/100 g</p></td></tr><tr><td><p>Foods based on yogurt</p></td><td><p>80 mg/100 g</p></td></tr><tr><td><p>Soy-based yogurt-like products</p></td><td><p>80 mg/100 g</p></td></tr><tr><td><p>Yogurt based-drinks</p></td><td><p>50 mg/100 g</p></td></tr><tr><td><p>Soy-based yogurt-like drinks</p></td><td><p>50 mg/100 g</p></td></tr><tr><td><p>Powders based on milk powder</p></td><td><p>3,5 g/100 g (equivalent to 40 mg/100 ml ready-to drink)</p></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>800 mg/day</p></td></tr><tr><td><p>Foods for special medical purposes as defined in Regulation (EU) No 609/2013</p></td><td><p>In compliance with Regulation (EU) No 609/2013</p></td></tr><tr><td><p><span>Phospholipides from egg yolk</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Not specified</p></td></tr><tr><td><p><span>Phytoglycogen</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Phytoglycogen&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Processed foods</p></td><td><p>25  %</p></td></tr><tr><td><p><span>Phytosterols/phytostanols</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>In accordance with Annex III.5 of Regulation (EU) No 1169/2011</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Rice drinks</p></td><td><p>1.&#160;&#160;They shall be presented in such a manner that they can be easily divided into portions that contain either a maximum of 3 g (in case of 1 portion/day) or a maximum of 1 g (in case of 3 portions/day) of added phytosterols/phytostanols.</p><p>The amount of phytosterols/phytostanols added to a container of beverages shall not exceed 3 g.</p><p>Salad dressings, mayonnaise and spicy sauces shall be packed as single portions</p></td></tr><tr><td><p>Rye bread with flour containing &#8805; 50 % rye (wholemeal rye flour, whole or cracked rye kernels and rye flakes) and &#8804; 30 % wheat; and with &#8804; 4 % added sugar but no fat added.</p></td></tr><tr><td><p>Salad dressings, mayonnaise and spicy sauces.</p></td></tr><tr><td><p>Soya drink</p></td></tr><tr><td><p>Milk type products, such as semi-skimmed and skimmed milk type products, possibly with the addition of fruits and/or cereals, where possibly the milk fat has been reduced, or where milk fat and/or protein has been partly or fully replaced by vegetable fat and/or protein.</p></td></tr><tr><td><p>Products based on fermented milk such as yoghurt and cheese type products (fat content &lt; 12 % per 100 g), where possibly the milk fat has been reduced, or where milk fat and/or protein has been partly or fully replaced by vegetable fat and/or protein</p></td></tr><tr><td><p>Spreadable fats as defined in Annex VII, Part VII and Appendix II, points B and C of Regulation (EU) No 1308/2013, and excluding cooking and frying fats and spreads based on butter or other animal fat.</p></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>3 g/day</p></td></tr><tr><td><p><span>Plum kernel oil</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>For frying and as seasoning</p></td><td><p>In line with normal food use of vegetable oils</p></td></tr><tr><td><p><span>Potato proteins (coagulated) and hydrolysates thereof</span></p></td><td><p>Not specified</p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Potato protein&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Prolyl oligopeptidase (enzyme preparation)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Prolyl oligopeptidase&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC for general adult population</p></td><td><p>120 PPU/day (2,7 g of enzyme preparation/day) (2 &#215; 10<span>6</span> PPI/day)</p><p>PPU &#8211; Prolyl Peptidase Units or Proline Protease Units</p><p>PPI &#8211; Protease Picomole International</p></td></tr><tr><td><p><a>&#9660;M50</a></p></td></tr><tr><td><p><span>Protein extract from pig kidneys</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>3 capsules or 3 tablets/day; equalising 12,6 mg pig kidney extract a day Diamine oxidase (DAO) content: 0,9 mg/day (3 capsules or 3 tablets with a content of DAO of 0,3 mg/capsule or 0,3 mg/tablet)</p></td></tr><tr><td><p>Food for special medical purposes as defined in Regulation (EU) No 609/2013</p></td></tr><tr><td><p><a>&#9660;M10</a></p></td></tr><tr><td><p><span>Pyrroloquinoline quinone disodium salt</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Pyrroloquinoline quinone disodium salt&#8217;.</p><p>Food supplements containing Pyrroloquinoline quinone disodium salt shall bear the following statement:</p><p>This food supplement should be consumed by adults only excluding pregnant and lactating women</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 2 September 2018. This inclusion is&#160;based&#160;on&#160;proprietary scientific evidence and scientific data protected in accordance with Article&#160;26 of Regulation (EU) 2015/2283.</p><p>Applicant: Mitsubishi Gas Chemical Company, Inc., Mitsubishi Building 5-2 Marunouchi 2-chome, Chiyoda-ku, Tokyo 100-8324, Japan. During the period of data protection the novel food Pyrroloquinoline quinone disodium salt is authorised for placing on the market within the Union only by Mitsubishi Gas Chemical Company, Inc., 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 26 of Regulation (EU) 2015/2283 or with the agreement of Mitsubishi Gas Chemical Company, Inc.</p><p>End date of the data protection: 2 september 2023</p></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC intended for the adult population, excluding pregnant and lactating women</p></td><td><p>20 mg/day</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Rapeseed oil high in unsaponifiable matter</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Rapeseed oil extract&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>1,5 g per portion recommended for daily consumption</p></td></tr><tr><td><p><span>Rapeseed Protein</span></p></td><td><p>As a vegetable protein source in foods except in infant formula and follow-on formula</p></td><td><p>&#160;</p><div/></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Rapeseed protein&#8217;.</p><p>2.&#160;&#160;Any foodstuff containing &#8216;rapeseed protein&#8217; shall bear a statement that this ingredient may cause allergic reaction to consumers who are allergic to mustard and products thereof. Where relevant, this statement shall appear in close proximity to the list of ingredients.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><a>&#9660;M17</a></p></td></tr><tr><td><p>Refined shrimp peptide concentrate</p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;refined shrimp peptide concentrate&#8217;.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.</p><p>Applicant: Marealis AS., Stortorget 1, Kystens Hus, 2nd floor, N-9008 Troms&#248; Postal address: P.O. Box 1065, 9261 Troms&#248;, Norway. During the period of data protection the novel food refined shrimp peptide concentrate is authorised for placing on the market within the Union only by Marealis AS 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 26 of Regulation (EU) 2015/2283 or with the agreement of Marealis AS.</p><p>End date of the data protection: 20 November 2023.</p></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC for the adult population</p></td><td><p>1&#160;200  mg/day</p></td></tr><tr><td><p><a>&#9660;M59</a></p></td></tr><tr><td><p><span><span>Trans</span>-resveratrol</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the food supplements containing it shall be &#8216;<span>Trans</span>-resveratrol&#8217;.</p><p>2.&#160;&#160;The labelling of food supplements containing<span>trans</span>-resveratrol shall bear a statement that people using medicines should only consume the product under medical supervision.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC for the adult population</p></td><td><p>150 mg/day</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Trans-resveratrol (microbial source)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the food supplements containing it shall be &#8216;<span>Trans</span>-resveratrol&#8217;.</p><p>2.&#160;&#160;The labelling of food supplements containing trans-resveratrol shall bear a statement that people using medicines should only consume the product under medical supervision.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC</p></td><td><p>In line with normal use in food supplements of resveratrol extracted from Japanese knotweed (<span>Fallopia japonica</span>)</p></td></tr><tr><td><p><span>Rooster comb extract</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Rooster comb extract&#8217; or &#8216;Cockerel comb extract&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Milk-based drinks</p></td><td><p>40 mg/100 g or mg/100 ml</p></td></tr><tr><td><p>Milk based fermented drinks</p></td><td><p>80 mg/100 g or mg/100 ml</p></td></tr><tr><td><p>Yoghurt-type products</p></td><td><p>65 mg/100 g or mg/100 ml</p></td></tr><tr><td><p><span>Fromage frais</span></p></td><td><p>110 mg/100 g or mg/100 ml</p></td></tr><tr><td><p><span>Sacha inchi oil from<span>Plukenetia volubilis</span></span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Sacha inchi oil (Plukenetia volubilis)&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>As for linseed oil</p></td><td><p>In line with normal food use of linseed oil</p></td></tr><tr><td><p><span>Salatrims</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;reduced energy fat (salatrims)&#8217;.</p><p>2.&#160;&#160;There shall be a statement that excessive consumption may lead to gastro-intestinal disturbance.</p><p>3.&#160;&#160;There shall be a statement that the products are not intended for use by children.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Bakery products and confectionary</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><a>&#9660;M93</a></p></td></tr><tr><td><p><span>Schizochytrium</span> sp. oil rich in DHA and EPA</p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of DHA and EPA combined</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;DHA and EPA-rich oil from the microalgae<span>Schizochytrium</span> sp.&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC for the adult population excluding pregnant and lactating women</p></td><td><p>3&#160;000  mg/day</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC for pregnant and lactating women</p></td><td><p>450 mg/day</p></td></tr><tr><td><p>Foods 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>Total diet replacement for weight control as defined in Regulation (EU) No&#160;609/2013 and meal replacements for weight control</p></td><td><p>250 mg/meal</p></td></tr><tr><td><p>Milk-based drinks and similar products intended for young children</p></td><td><p>200 mg/100 g</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></tr><tr><td><p>Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen</p></td></tr><tr><td><p>Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No&#160;828/2014</p></td></tr><tr><td><p>Bakery products (breads, rolls and sweet biscuits)</p></td></tr><tr><td><p>Breakfast cereals</p></td><td><p>500 mg/100 g</p></td></tr><tr><td><p>Cooking fats</p></td><td><p>360 mg/100 g</p></td></tr><tr><td><p>Dairy analogues, except drinks</p></td><td><p>600 mg/100 g for cheese; 200 mg/100 g for soy and imitation milk products (excluding drinks)</p></td></tr><tr><td><p>Dairy products except milk-based drinks</p></td><td><p>600 mg/100 g for cheese; 200 mg/100 g for milk products (including milk,<span>fromage frais</span> and yoghurt products; excluding drinks)</p></td></tr><tr><td><p>Non-alcoholic beverages (including dairy analogue and milk-based drinks)</p></td><td><p>80 mg/100 g</p></td></tr><tr><td><p>Cereal/nutrition bars</p></td><td><p>500 mg/100 g</p></td></tr><tr><td><p>Spreadable fats and dressings</p></td><td><p>600 mg/100 g</p></td></tr><tr><td><p>Fish analogues</p></td><td><p>300 mg/100 g</p></td></tr><tr><td><p>Meat analogues</p></td><td><p>300 mg/100 g</p></td></tr><tr><td><p><a>&#9660;M27</a></p></td></tr><tr><td><p><span><span>Schizochytrium</span></span><span>sp. (ATCC PTA-9695) oil</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of DHA</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Oil from the microalgae<span>Schizochytrium</span> sp.&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Dairy products except milk-based drinks</p></td><td><p>200 mg/100 g or for cheese products 600&#160;mg/100 g</p></td></tr><tr><td><p>Dairy analogues except drinks</p></td><td><p>200 mg/100 g or for analogues to cheese products 600 mg/100 g</p></td></tr><tr><td><p>Spreadable fats and dressings</p></td><td><p>600 mg/100 g</p></td></tr><tr><td><p>Breakfast cereals</p></td><td><p>500 mg/100 g</p></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>250 mg DHA/day for general population</p></td></tr><tr><td><p>450 mg DHA/day for pregnant and lactating women</p></td></tr><tr><td><p>Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control</p></td><td><p>250 mg/meal</p></td></tr><tr><td><p>Milk-based drinks and similar products intended for young children</p></td><td><p>200 mg/100 g</p></td></tr><tr><td><p>Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen</p></td></tr><tr><td><p>Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014</p></td></tr><tr><td><p>Foods for special medical purposes as defined in Regulation (EU) No 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>Bakery products (breads, rolls, and sweet biscuits)</p></td><td><p>200 mg/100 g</p></td></tr><tr><td><p>Cereal bars</p></td><td><p>500 mg/100 g</p></td></tr><tr><td><p>Cooking fats</p></td><td><p>360 mg/100 g</p></td></tr><tr><td><p>Non-alcoholic beverages (including dairy analogue and milk-based drinks)</p></td><td><p>80 mg/100 ml</p></td></tr><tr><td><p>Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013</p></td><td><p>In accordance with Regulation (EU) No 609/2013</p></td></tr><tr><td><p>Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013</p></td><td><p>200 mg/100 g</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Fruit/vegetable puree</p></td><td><p>100 mg/100 g</p></td></tr><tr><td><p><a>&#9660;M71</a></p></td></tr><tr><td><p><span>Schizochytrium</span> sp. (FCC-3204) oil</p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of DHA</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Oil from the microalgae<span>Schizochytrium</span> sp.&#8217;.</p><p>The labelling of food supplements containing<span>Schizochytrium</span> sp. (FCC-3204) oil shall bear a statement that they should not be consumed by infants and children under 3 years of age.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Infant formula and follow-on formula as defined in Regulation (EU) No&#160;609/2013</p></td><td><p>In accordance with Regulation (EU) No&#160;609/2013</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC for the general population above 3 years of age</p></td><td><p>1 g/day</p></td></tr><tr><td><p><a>&#9660;M25</a></p></td></tr><tr><td><p><span><span>Schizochytrium</span></span><span>sp. oil</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of DHA</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Oil from the microalgae<span>Schizochytrium</span> sp.&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Dairy products except milk-based drinks</p></td><td><p>200 mg/100 g or for cheese products 600 mg/100 g</p></td></tr><tr><td><p>Dairy analogues except drinks</p></td><td><p>200 mg/100 g or for analogues to cheese products 600 mg/100 g</p></td></tr><tr><td><p>Spreadable fat and dressings</p></td><td><p>600 mg/100 g</p></td></tr><tr><td><p>Breakfast cereals</p></td><td><p>500 mg/100 g</p></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>250 mg DHA/day for general population</p></td></tr><tr><td><p>450 mg DHA/day for pregnant and lactating women</p></td></tr><tr><td><p>Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control</p></td><td><p>250 mg/meal</p></td></tr><tr><td><p>Milk-based drinks and similar products intended for young children</p></td><td><p>200 mg/100 g</p></td></tr><tr><td><p>Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013</p></td></tr><tr><td><p>Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen</p></td></tr><tr><td><p>Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Implementing Regulation (EU) No 828/2014</p></td></tr><tr><td><p>Foods for special medical purposes as defined in Regulation (EU) No 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>Bakery products (breads, rolls, and, sweet biscuits)</p></td><td><p>200 mg/100 g</p></td></tr><tr><td><p>Cereal bars</p></td><td><p>500 mg/100 g</p></td></tr><tr><td><p>Cooking fats</p></td><td><p>360 mg/100 g</p></td></tr><tr><td><p>Non-alcoholic beverages (including dairy analogue and milk-based drinks)</p></td><td><p>80 mg/100 ml</p></td></tr><tr><td><p>Fruit/vegetable puree</p></td><td><p>100 mg/100 g</p></td></tr><tr><td><p><a>&#9660;M52</a></p></td></tr><tr><td><p><span><span>Schizochytrium</span> sp. (T18) oil</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Oil from the microalgae<span>Schizochytrium</span> sp.&#8217;.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Dairy products except milk-based drinks</p></td><td><p>200 mg/100 g or for cheese products 600 mg/100 g</p></td></tr><tr><td><p>Dairy analogues except drinks</p></td><td><p>200 mg/100 g or for analogues to cheese products 600 mg/100 g</p></td></tr><tr><td><p>Spreadable fats and dressings</p></td><td><p>600 mg/100 g</p></td></tr><tr><td><p>Breakfast cereals</p></td><td><p>500 mg/100 g</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC</p></td><td><p>250 mg DHA/day for general population</p></td></tr><tr><td><p>450 mg DHA/day for pregnant and lactating women</p></td></tr><tr><td><p>Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control</p></td><td><p>250 mg/meal</p></td></tr><tr><td><p>Milk-based drinks and similar products intended for young children</p></td><td><p>200 mg/100 g</p></td></tr><tr><td><p>Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen</p></td></tr><tr><td><p>Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014</p></td></tr><tr><td><p>Foods for special medical purposes as defined in Regulation (EU) No 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>Bakery products (breads, rolls and, sweet biscuits)</p></td><td><p>200 mg/100 g</p></td></tr><tr><td><p>Cereal bars</p></td><td><p>500 mg/100g</p></td></tr><tr><td><p>Cooking fats</p></td><td><p>360 mg/100 g</p></td></tr><tr><td><p>Non-alcoholic beverages (including dairy analogue and milk-based drinks)</p></td><td><p>80 mg/100 ml</p></td></tr><tr><td><p>Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013</p></td><td><p>In accordance with Regulation (EU) No 609/2013</p></td></tr><tr><td><p>Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013</p></td><td><p>200 mg/100 g</p></td></tr><tr><td><p>Fruit/vegetable puree</p></td><td><p>100 mg/100 g</p></td></tr><tr><td><p><a>&#9660;M65</a></p></td></tr><tr><td><p><span><span>Schizochytrium</span> sp. (WZU477) oil</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of DHA</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Oil from the microalgae<span>Schizochytrium</span> sp.&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 16&#160;May 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: Progress Biotech bv, Canaalstaete, Kanaalweg 33, 2903LR Capelle aan den Ijssel, the Netherlands.</p><p>During the period of data protection, the novel food is authorised for placing on the market within the Union only by Progress Biotech bv unless a subsequent applicant obtains authorisation for that 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 Progress Biotech bv.</p><p>End date of the data protection: 16&#160;May 2026 (5 years).</p></td></tr><tr><td><p>Infant formula and follow-on formula as defined in Regulation (EU) No&#160;609/2013</p></td><td><p>In accordance with Regulation (EU) No&#160;609/2013</p></td></tr><tr><td><p><a>&#9660;M57</a></p></td></tr><tr><td><p><span>Selenium-containing yeast (<span>Yarrowia lipolytica</span>) biomass</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;selenium-containing yeast (<span>Yarrowia lipolytica</span>) biomass&#8217;.</p><p>The labelling of food supplements containing selenium-containing yeast (<span>Yarrowia lipolytica</span>) biomass shall bear a statement that the food supplements should not be consumed by infants and children under 4 years of age/children under 7 years of age/children under 11 years of age/children and adolescents under 18 years of age&#160;<a>(<span>3</span>)</a>.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC&#160;<a>(<span>12</span>)</a>, excluding food supplements for infants and children under 4 years of age</p></td><td><p>50 mg/day for children from 4 to 6 years of age, resulting in 10 &#956;g of selenium per day</p><p>100 mg/day for children from 7 to 10 years of age, resulting in 20 &#956;g of selenium per day</p><p>500 mg/day for adolescents from 11 to 17 years of age, resulting in 100 &#956;g of selenium per day</p><p>800 mg/day for adults, resulting in 160 &#956;g of selenium per day</p></td></tr><tr><td><p><a>&#9660;M20 M36 M62 M104</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 &#8216;3'-Sialyllactose sodium salt&#8217;.</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.</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;M105</a></p></td></tr><tr><td><p><span>3&#8242;-Sialyllactose (&#8216;3&#8242;-SL&#8217;) sodium salt</span></p><p><span>(produced by derivative strains of<span>E. coli</span> BL21(DE3))</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;3&#8242;-Sialyllactose sodium salt&#8217;.</p><p>The labelling of food supplements containing 3&#8242;-Sialyllactose (3&#8242;-SL) sodium salt shall bear a statement that</p><p>(a)&#160;&#160;they should not be consumed by children under 3 years of age;</p><p>(b)&#160;&#160;they should not be used if other foods containing added 3&#8242;-sialyllactose sodium salt are consumed the same day.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 6&#160;February 2023. 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: &#8216;Chr. Hansen A/S&#8217;, Boege All&#233; 10-12, 2970 Hoersholm, Denmark. During the period of data protection, the novel food 3&#8242;-Sialyllactose sodium salt is authorised for placing on the market within the Union only by Chr. Hansen 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 &#8216;Chr. Hansen A/S&#8217;.</p><p>End date of the data protection: 6&#160;February 2028.</p></td></tr><tr><td><p>Infant formula as defined under Regulation (EU) No&#160;609/2013</p></td><td><p>0,23&#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 under Regulation (EU) No&#160;609/2013</p></td><td><p>0,28&#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 foods for infants and young children and baby foods for infants and young children as defined under Regulation (EU) No&#160;609/2013</p></td><td><p>0,28&#160;g/L or 0,28&#160;g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer</p></td></tr><tr><td><p>Milk based drinks and similar products intended for young children</p></td><td><p>0,28&#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>Foods for special medical purposes for infants and young children as defined under Regulation (EU) No&#160;609/2013</p></td><td><p>In accordance with the particular nutritional requirements of the infants and young children for whom the products are intended but in any case not higher 0,23&#160;g/L or 0,28&#160;g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer.</p></td></tr><tr><td><p>Foods for special medical purposes as defined under Regulation (EU) No&#160;609/2013 excluding foods for infants and young children</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, for the general population, excluding infants and young children</p></td><td><p>0,7&#160;g/day</p></td></tr><tr><td><p><a>&#9660;M60</a></p></td></tr><tr><td><p><span>6&#8217;-Sialyllactose (6&#8217;-SL) sodium salt</span></p><p><span>(microbial source)</span></p></td><td><p><span><span>Specified food category</span></span></p></td><td><p><span><span>Maximum levels (expressed as 6&#8217;-Sialyllactose)</span></span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;6&#8217;-Sialyllactose sodium salt&#8217;.</p><p>The labelling of food supplements containing 6&#8217;-Sialyllactose (6&#8217;-SL) sodium salt shall bear a statement that they should not be consumed:</p><p>a)&#160;&#160;if foods containing added 6&#8217;-Sialyllactose sodium salt are consumed on 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 17 February 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 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 6&#8217;-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 26 of Regulation (EU) 2015/2283 or with the agreement of Glycom A/S.</p><p>End date of the data protection: 17 February 2026.</p></td></tr><tr><td><p>Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products</p></td><td><p>0,5 g/L</p></td></tr><tr><td><p>Unflavoured fermented milk-based products</p></td><td><p>0,5 g/L (beverages)</p></td></tr><tr><td><p>2,5 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>0,5 g/L (beverages)</p></td></tr><tr><td><p>5,0 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>0,5 g/L</p></td></tr><tr><td><p>Cereal bars</p></td><td><p>5,0 g/kg</p></td></tr><tr><td><p>Infant formula as defined under Regulation (EU) No 609/2013</p></td><td><p>0,4 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 under Regulation (EU) No 609/2013</p></td><td><p>0,3 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 under Regulation (EU) No 609/2013</p></td><td><p>0,3 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>2,5 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>0,3 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>Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013</p></td><td><p>1,0 g/L (beverages)</p></td></tr><tr><td><p>10,0 g/kg (products other than beverages)</p></td></tr><tr><td><p>Food for special medical purposes as defined under Regulation (EU) No 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>1,0 g/day</p></td></tr><tr><td><p><a>&#9660;M115</a></p></td></tr><tr><td><p><span>6&#8217;-Sialyllactose (&#8216;6</span>&#8242;<span>-SL&#8217;) sodium salt</span></p><p><span>(produced by derivative strains of<span>E. coli</span> BL21(DE3))</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;6&#8242;-Sialyllactose sodium salt&#8217;.</p><p>The labelling of food supplements containing 6&#8242;-Sialyllactose (6&#8242;-SL) sodium salt shall bear a statement that</p><p>(a)&#160;&#160;they should not be consumed by children under 3 years of age;</p><p>(b)&#160;&#160;they should not be consumed if other foods containing added 6&#8242;-sialyllactose sodium salt are consumed the same day.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 4&#160;June 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article&#160;26 of Regulation (EU)&#160;2015/2283.</p><p>Applicant: &#8216;Chr. Hansen&#160;A/S&#8217;, B&#248;ge All&#233; 10-12, 2970 Hoersholm, Denmark. During the period of data protection, the novel food 6&#8242;-Sialyllactose sodium salt is authorised for placing on the market within the Union only by Chr. Hansen&#160;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)&#160;2015/2283 or with the agreement of &#8216;Chr. Hansen&#160;A/S&#8217;.</p><p>End date of the data protection: 4&#160;June 2028.</p></td></tr><tr><td><p>Infant formula as defined under Regulation (EU) No&#160;609/2013</p></td><td><p>0,70&#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 under Regulation (EU) No&#160;609/2013</p></td><td><p>0,70&#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 foods for infants and young children and baby foods for infants and young children as defined under Regulation (EU) No&#160;609/2013</p></td><td><p>0,70&#160;g/L or 0,70&#160;g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer</p></td></tr><tr><td><p>Milk based drinks and similar products intended for young children</p></td><td><p>0,70&#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>Foods for special medical purposes for infants and young children as defined under Regulation (EU) No&#160;609/2013</p></td><td><p>In accordance with the particular nutritional requirements of the infants and young children for whom the products are intended but in any case not higher than 0,70&#160;g/L or 0,70&#160;g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer.</p></td></tr><tr><td><p>Foods for special medical purposes as defined under Regulation (EU) No&#160;609/2013 excluding foods for infants and young children</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&#160;2002/46/EC, for the general population, excluding infants and young children</p></td><td><p>1,8&#160;g/day</p></td></tr><tr><td><p><a>&#9660;M23</a></p></td></tr><tr><td><p>Syrup from<span>Sorghum bicolor</span> (L.) Moench</p><p>(Traditional food from a third country)</p></td><td><p>Not specified</p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Sorghum (<span>Sorghum bicolor</span>) syrup&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Fermented soybean extract</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Fermented soybean extract&#8217;.</p><p>2.&#160;&#160;The labelling of food supplements containing fermented soybean extract shall bear a statement that persons taking medication should only consume the product under medical supervision.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC (capsules, tablets or powder form) intended for the adult population, excluding pregnant and lactating women</p></td><td><p>100 mg/day</p></td></tr><tr><td><p><span>Spermidine-rich wheat germ extract (<span>Triticum aestivum</span>)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the food supplements containing it shall be &#8216;spermidine-rich wheat germ extract&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC intended for the adult population, excluding pregnant and lactating women</p></td><td><p>Equivalent of max. 6 mg/day spermidine</p></td></tr><tr><td><p><span>Sucromalt</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Sucromalt&#8217;.</p><p>2.&#160;&#160;The designation of the novel food on the labelling shall be accompanied by indication that the product is a source of glucose and fructose.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Not specified</p></td></tr><tr><td><p><span>Sugar cane fibre</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Bread</p></td><td><p>8  %</p></td></tr><tr><td><p>Bakery goods</p></td><td><p>5  %</p></td></tr><tr><td><p>Meat and muscle products</p></td><td><p>3  %</p></td></tr><tr><td><p>Seasonings and spices</p></td><td><p>3  %</p></td></tr><tr><td><p>Grated cheeses</p></td><td><p>2  %</p></td></tr><tr><td><p>Special diet foods</p></td><td><p>5  %</p></td></tr><tr><td><p>Sauces</p></td><td><p>2  %</p></td></tr><tr><td><p>Beverages</p></td><td><p>5  %</p></td></tr><tr><td><p><a>&#9660;M53</a></p></td></tr><tr><td><p><span>Sugars obtained from cocoa (<span>Theobroma cacao</span> L.) pulp</span></p></td><td><p>Not specified</p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;sugars obtained from cocoa (<span>Theobroma cacao</span> L.) pulp&#8217;, &#8216;Glucose obtained from cocoa (<span>Theobroma cacao</span> L.) pulp&#8217; or &#8216;Fructose obtained from cocoa (<span>Theobroma cacao</span> L.) pulp&#8217;, depending on the form used.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Sunflower oil extract</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Sunflower oil extract&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>1,1 g/day</p></td></tr><tr><td><p><a>&#9660;M73</a></p></td></tr><tr><td><p><span>Synsepalum dulcificum dried fruits</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of food supplements containing it shall be &#8216;dried<span>Synsepalum dulcificum</span> fruits&#8217;</p><p>2.&#160;&#160;The labelling of food supplements containing<span>Synsepalum dulcificum</span> dried fruits shall bear a statement that this food supplement should be consumed by adults only excluding pregnant and lactating women.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 5&#160;December 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: Medicinal Gardens S.L. Marqu&#233;s de Urquijo 47, 1&#176; D, Office 1, Madrid, 28008, Spain.</p><p>During the period of data protection, the novel food is authorised for placing on the market within the Union only by Medicinal Gardens S.L. unless a subsequent applicant obtains authorisation for that 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 Medicinal Gardens S.L.</p><p>End date of the data protection: 5&#160;December 2026.</p></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC for adult population excluding pregnant and lactating women</p></td><td><p>0,7&#160;g/day</p></td></tr><tr><td><p><a>&#9660;M89</a></p></td></tr><tr><td><p><span>Tetrahydrocurcuminoids</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;tetrahydrocurcuminoids&#8217;.</p><p>The labelling of food supplements containing tetrahydrocurcuminoids shall bear a statement that</p><p>a)&#160;&#160;they should be consumed by adults only, excluding pregnant and lactating women;</p><p>b)&#160;&#160;they should not be consumed if other food supplements containing curcumin and/or curcuminoids are consumed on the same day.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 11&#160;July 2022. 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: &#8216;Sabinsa Europe GmbH&#8217;, Monzastrasse 4, 63225 Langen, Germany. During the period of data protection, the novel food tetrahydrocurcuminoids is authorised for placing on the market within the Union only by &#8216;Sabinsa Europe GmbH&#8217; 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 &#8216;Sabinsa Europe GmbH&#8217;.</p><p>End date of the data protection: 11&#160;July 2027.</p></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC for the adult population, excluding pregnant and lactating women</p></td><td><p>140 mg/day</p></td></tr><tr><td><p><a>&#9660;M66</a></p></td></tr><tr><td><p><span>Dried<span>Tenebrio molitor</span> larva (yellow mealworm)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Dried<span>Tenebrio molitor</span> larva (yellow mealworm)&#8217;.</p><p>2.&#160;&#160;The labelling of the foodstuffs containing dried<span>Tenebrio molitor</span> larva (yellow mealworm) shall bear a statement that this ingredient may cause allergic reactions to consumers with known allergies to crustaceans and products thereof, and to dust mites. This statement shall appear in close proximity to the list of ingredients.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 22&#160;June 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: SAS EAP Group, 35 Boulevard du Libre &#201;change, 31650 Saint-Orens-de-Gameville, France.</p><p>During the period of data protection, the novel food is authorised for placing on the market within the Union only by SAS EAP Group, unless a subsequent applicant obtains authorisation for that 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 SAS EAP Group.</p><p>End date of the data protection: 22&#160;June 2026.</p></td></tr><tr><td><p>Dried<span>Tenebrio molitor</span> larva, whole or in powder</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Protein products</p></td><td><p>10 g/100 g</p></td></tr><tr><td><p>Biscuits</p></td><td><p>10 g/100 g</p></td></tr><tr><td><p>Legumes-based dishes</p></td><td><p>10 g/100 g</p></td></tr><tr><td><p>Pasta-based products</p></td><td><p>10 g/100 g</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Dried<span>Tetraselmis chuii</span> microalgae</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Dried microalgae<span>Tetraselmis chuii</span>&#8217; or &#8216;Dried microalgae<span>T. chuii</span>&#8217;</p><p>Food supplements containing dried microalgae<span>Tetraselmis chuii</span> shall bear the following statement: &#8216;Contains negligible amounts of iodine&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Sauces</p></td><td><p>20 % or 250mg/day</p></td></tr><tr><td><p>Special salts</p></td><td><p>1  %</p></td></tr><tr><td><p>Condiment</p></td><td><p>250 mg/day</p></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>250 mg/day</p></td></tr><tr><td><p><span><span>Therapon barcoo</span>/Scortum</span></p></td><td><p>Intended use identical to that of the salmon, namely the preparation of culinary fish products and dishes, including cooked, raw, smoked and baked fish products</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>D-Tagatose</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;D-Tagatose&#8217;.</p><p>2.&#160;&#160;The labelling of any product where the level of D-Tagatose exceeds 15 g per serving and all beverages containing greater than 1 % D-Tagatose (as consumed) shall bear a statement &#8216;excessive consumption may produce laxative effects&#8217;.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Not specified</p></td></tr><tr><td><p><a>&#9660;M52</a></p></td></tr><tr><td><p><span>Taxifolin-rich extract</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;taxifolin-rich extract&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Yogurt plain/Yogurt with fruits<span>(*)</span></p></td><td><p>0,020 g/kg</p></td></tr><tr><td><p>Kephir<span>(*)</span></p></td><td><p>0,008 g/kg</p></td></tr><tr><td><p>Buttermilk<span>(*)</span></p></td><td><p>0,005 g/kg</p></td></tr><tr><td><p>Milk powder<span>(*)</span></p></td><td><p>0,052 g/kg</p></td></tr><tr><td><p>Cream<span>(*)</span></p></td><td><p>0,070 g/kg</p></td></tr><tr><td><p>Sour cream<span>(*)</span></p></td><td><p>0,050 g/kg</p></td></tr><tr><td><p>Cheese<span>(*)</span></p></td><td><p>0,090 g/kg</p></td></tr><tr><td><p>Butter<span>(*)</span></p></td><td><p>0,164 g/kg</p></td></tr><tr><td><p>Chocolate confectionery</p></td><td><p>0,070 g/kg</p></td></tr><tr><td><p>Non-alcoholic beverages</p></td><td><p>0,020 g/L</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC intended for the general population, excluding infants, young children, children and adolescents younger than 14 years</p></td><td><p>100 mg/day</p></td></tr><tr><td><p>(*)&#160;&#160;When used in milk products Taxifolin-rich extract may not replace in whole or in part, any milk constituent</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Trehalose</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Trehalose&#8217; and shall be displayed on the labelling of the product as such or in the list of ingredients of foodstuffs containing it.</p><p>2.&#160;&#160;The designation of the novel food on the labelling shall be accompanied by indication that the &#8216;Trehalose is a source of glucose&#8217;.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Not specified</p></td></tr><tr><td><p><a>&#9660;M52</a></p></td></tr><tr><td><p><span>UV-treated mushrooms (<span>Agaricus bisporus</span>)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of vitamin D<span>2</span></span></p></td><td><p>1.&#160;&#160;The designation on the label of the novel food as such or of the foodstuffs containing it shall be &#8216;UV-treated mushrooms (<span>Agaricus bisporus</span>)&#8217;.</p><p>2.&#160;&#160;The designation on the label of the novel food as such or of the foodstuffs containing it shall be accompanied by indication that a &#8216;controlled light treatment was used to increase vitamin D levels&#8217; or &#8216;UV treatment was used to increase vitamin D<span>2</span> levels&#8217;.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Mushrooms (<span>Agaricus bisporus</span>)</p></td><td><p>20 &#956;g of vitamin D<span>2</span>/100 g fresh weight</p></td></tr><tr><td><p><a>&#9660;M84</a></p></td></tr><tr><td><p><span>UV-treated baker&#8217;s yeast (<span>Saccharomyces cerevisiae</span>)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of vitamin D<span>2</span></span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;vitamin D yeast&#8217; or &#8216;vitamin D<span>2</span> yeast&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Yeast-leavened breads and rolls</p></td><td><p>5 &#956;g/100 g</p></td></tr><tr><td><p>Yeast-leavened fine bakery wares</p></td><td><p>5 &#956;g/100 g</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC</p></td><td><p>In accordance with Directive 2002/46/EC</p></td></tr><tr><td><p>Pre-packed fresh or dry yeast for home baking</p></td><td><p>45 &#956;g/100 g for fresh yeast</p><p>200 &#956;g/100 g for dried yeast</p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs shall be &#8216;vitamin D yeast&#8217; or &#8216;vitamin D<span>2</span> yeast&#8217;.</p><p>2.&#160;&#160;The labelling of the novel food shall bear a statement that the foodstuff is only intended for baking and that it should not be eaten raw.</p><p>3.&#160;&#160;The labelling of the novel food shall bear instructions for use for the final consumers so that a maximum concentration of 5 &#956;g/100 g of vitamin D<span>2</span> in final home-baked products is not exceeded.</p></td></tr><tr><td><p>Dishes, incl. ready-to-eat meals (excluding soups and salads)</p></td><td><p>3 &#956;g/100 g</p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;vitamin D yeast&#8217; or &#8216;vitamin D<span>2</span> yeast&#8217;</p></td></tr><tr><td><p>Soups and salads</p></td><td><p>5 &#956;g/100 g</p></td></tr><tr><td><p>Fried or extruded cereal, seed or root-based products</p></td><td><p>5 &#956;g/100 g</p></td></tr><tr><td><p>Infant formula and follow-on formula as defined by Regulation (EU) No&#160;609/2013</p></td><td><p>In accordance with Regulation (EU) No&#160;609/2013</p></td></tr><tr><td><p>Processed cereal-based food as defined by Regulation (EU) No&#160;609/2013</p></td><td><p>In accordance with Regulation (EU) No&#160;609/2013</p></td></tr><tr><td><p>Processed fruit products</p></td><td><p>1,5&#160;&#956;g/100 g</p></td></tr><tr><td><p>Processed vegetables</p></td><td><p>2 &#956;g/100 g</p></td></tr><tr><td><p>Bread and similar products</p></td><td><p>5 &#956;g/100 g</p></td></tr><tr><td><p>Breakfast cereals</p></td><td><p>4 &#956;g/100 g</p></td></tr><tr><td><p>Pasta, doughs and similar products</p></td><td><p>5 &#956;g/100 g</p></td></tr><tr><td><p>Other cereal based products</p></td><td><p>3 &#956;g/100 g</p></td></tr><tr><td><p>Spices, seasonings, condiments, sauce ingredients, dessert sauces/toppings</p></td><td><p>10 &#956;g/100 g</p></td></tr><tr><td><p>Protein products</p></td><td><p>10 &#956;g/100 g</p></td></tr><tr><td><p>Cheese</p></td><td><p>2 &#956;g/100 g</p></td></tr><tr><td><p>Dairy dessert and similar products</p></td><td><p>2 &#956;g/100 g</p></td></tr><tr><td><p>Fermented milk or fermented cream</p></td><td><p>1,5&#160;&#956;g/100 g</p></td></tr><tr><td><p>Dairy powders and concentrates</p></td><td><p>25 &#956;g/100 g</p></td></tr><tr><td><p>Milk based products, whey and cream</p></td><td><p>0,5&#160;&#956;g/100 g</p></td></tr><tr><td><p>Meat and dairy analogues</p></td><td><p>2,5&#160;&#956;g/100 g</p></td></tr><tr><td><p>Total diet replacement for weight control as defined by Regulation (EU) No&#160;609/2013</p></td><td><p>5 &#956;g/100 g</p></td></tr><tr><td><p>Meal replacements for weight control</p></td><td><p>5 &#956;g/100 g</p></td></tr><tr><td><p>Foods 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><a>&#9660;M9</a></p></td></tr><tr><td><p><span>UV-treated bread</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of vitamin D<span>2</span></span></p></td><td><p>The designation on the label of the novel food shall be accompanied by &#8216;contains vitamin D produced by UV-treatment&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Yeast leavened bread and rolls (without toppings)</p></td><td><p>3 &#956;g vitamin D<span>2</span>/100 g</p></td></tr><tr><td><p><span>UV-treated milk</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of vitamin D<span>3</span></span></p></td><td><p>1.&#160;&#160;The designation on the label of the novel food shall be &#8216;UV-treated&#8217;.</p><p>2.&#160;&#160;Where UV-treated milk contains an amount of vitamin D that is considered significant in accordance with Point 2 of Part A of Annex XIII to Regulation (EU) No 1169/2011 of the European Parliament and of the Council, the designation for the labelling shall be accompanied by &#8216;contains vitamin D produced by UV-treatment&#8217; or &#8216;milk containing vitamin D resulting from UV-treatment&#8217;.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Pasteurised whole milk as defined in Regulation (EU) No 1308/2013 to be consumed as such</p></td><td><p>5-32 &#956;g/kg for general population excluding infants</p></td></tr><tr><td><p>Pasteurised semi-skimmed milk as defined in Regulation (EU) No 1308/2013 to be consumed as such</p></td><td><p>1-15 &#956;g/kg for general population excluding infants</p></td></tr><tr><td><p><a>&#9660;M51</a></p></td></tr><tr><td><p><span>Vitamin D<span>2</span> mushroom powder</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of vitamin D<span>2</span></span>&#160;<a>(<span/>)</a></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;UV-treated mushroom powder containing vitamin D&#8217; or &#8216;UV-treated mushroom powder containing vitamin D<span>2</span>&#8217;</p><p>The labelling of food supplements containing vitamin D<span>2</span> mushroom powder shall bear a statement that they should not be consumed by infants</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 27 August 2020. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.</p><p>Applicant: Oakshire Naturals, LP., PO Box 388 Kennett Square, Pennsylvania 19348, United States. During the period of data protection, the novel food vitamin D<span>2</span> mushroom powder is authorised for placing on the market within the Union only by Oakshire Naturals, LP., 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 26 of Regulation (EU) 2015/2283 or with the agreement of Oakshire Naturals, LP.</p><p>End date of the data protection: 27 August 2025.</p></td></tr><tr><td><p>Breakfast cereals</p></td><td><p>2,25 &#956;g of vitamin D<span>2</span>/100 g</p></td></tr><tr><td><p>Yeast-leavened bread and pastries</p></td><td><p>2,25 &#956;g of vitamin D<span>2</span>/100 g</p></td></tr><tr><td><p>Grain products and pastas</p></td><td><p>2,25 &#956;g of vitamin D<span>2</span>/100 g</p></td></tr><tr><td><p>Fruit juice and fruit/vegetable blend beverages</p></td><td><p>1,125 &#956;g of vitamin D<span>2</span>/100 mL</p></td></tr><tr><td><p>Milk and dairy products (excluding fluid milks)</p></td><td><p>2,25 &#956;g of vitamin D<span>2</span>/100 g/1,125 &#956;g of vitamin D<span>2</span>/100 mL (beverages)</p></td></tr><tr><td><p>Cheese (excluding cottage cheese, ricotta cheese, and hard-grating cheeses)</p></td><td><p>2,25 &#956;g of vitamin D<span>2</span>/100 g</p></td></tr><tr><td><p>Meal replacement bars and beverages</p></td><td><p>2,25 &#956;g of vitamin D<span>2</span>/100 g/1,125 &#956;g of vitamin D<span>2</span>/100 mL (beverages)</p></td></tr><tr><td><p>Dairy analogues</p></td><td><p>2,25 &#956;g of vitamin D<span>2</span>/100 g/1,125 &#956;g of vitamin D<span>2</span>/100 mL (beverages)</p></td></tr><tr><td><p>Meat analogues</p></td><td><p>2,25 &#956;g of vitamin D<span>2</span>/100 g</p></td></tr><tr><td><p>Soups and broths</p></td><td><p>2,25 &#956;g of vitamin D<span>2</span>/100 g</p></td></tr><tr><td><p>Extruded vegetable snacks</p></td><td><p>2,25 &#956;g of vitamin D<span>2</span>/100 g</p></td></tr><tr><td><p>Foods for Special Medical Purposes as defined under Regulation (EU) No 609/2013 excluding those intended for infants</p></td><td><p>15 &#956;g/day</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC intended for the general population excluding infants</p></td><td><p>15 &#956;g/day</p></td></tr><tr><td><p><a>&#9660;M76</a></p></td></tr><tr><td><p><span>Vitamin D<span>2</span> mushroom powder</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of vitamin D<span>2</span></span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;UV-treated mushroom powder containing vitamin D<span>2</span>&#8217;</p><p>2.&#160;&#160;The labelling of food supplements containing vitamin D<span>2</span> mushroom powder shall bear a statement that they should not be consumed by infants and children under 3 years of age.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 19&#160;December 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: MBio, Monaghan Mushrooms, Tullygony, Tyholland, Co. Monaghan, Ireland. During the period of data protection, the novel food vitamin D<span>2</span> mushroom powder is authorised for placing on the market within the Union only by MBio, Monaghan Mushrooms, 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 MBio, Monaghan Mushrooms.</p><p>End date of the date protection: 19&#160;December 2026.</p></td></tr><tr><td><p>Breakfast cereals</p></td><td><p>2,1 &#956;g/100 g</p></td></tr><tr><td><p>Yeast leavened bread and similar pastries</p></td><td><p>2,1 &#956;g/100 g</p></td></tr><tr><td><p>Grain products and pasta and similar products</p></td><td><p>2,1 &#956;g/100 g</p></td></tr><tr><td><p>Fruit/vegetable juices and nectars</p></td><td><p>1,1 &#956;g/100 ml (marketed as such or reconstituted as instructed by the manufacturer)</p></td></tr><tr><td><p>Dairy products and analogues other than beverages</p></td><td><p>2,1 &#956;g/100 g (marketed as such or reconstituted as instructed by the manufacturer)</p></td></tr><tr><td><p>Dairy products and analogues as beverages</p></td><td><p>1,1 &#956;g/100 ml (marketed as such or reconstituted as instructed by the manufacturer)</p></td></tr><tr><td><p>Milk and dairy powders</p></td><td><p>21,3 &#956;g/100 g (marketed as such or reconstituted as instructed by the manufacturer)</p></td></tr><tr><td><p>Meat analogues</p></td><td><p>2,1 &#956;g/100 g</p></td></tr><tr><td><p>Soups</p></td><td><p>2,1 &#956;g/100 ml (marketed as such or reconstituted as instructed by the manufacturer)</p></td></tr><tr><td><p>Extruded vegetable snack</p></td><td><p>2,1 &#956;g/100 g</p></td></tr><tr><td><p>Meal replacement for weight control</p></td><td><p>2,1 &#956;g/100 g</p></td></tr><tr><td><p>Foods for Special Medical Purposes as defined under Regulation (EU) No&#160;609/2013 excluding those intended for infants</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 intended for infants and young children</p></td><td><p>15 &#956;g of vitamin D<span>2</span>/day</p></td></tr><tr><td><p><a>&#9660;M98</a></p></td></tr><tr><td><p><span>Vitamin D<span>2</span> mushroom powder</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of vitamin D<span>2</span> (&#956;g/100 g or 100 ml)</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;UV-treated mushroom powder containing vitamin D<span>2</span>&#8217;</p><p>2.&#160;&#160;The labelling of food supplements containing vitamin D<span>2</span> mushroom powder shall bear a statement that they should not be consumed by infants and children under 3 years of age.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 24&#160;January 2023. 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: Monterey Mushrooms Inc, 260 Westgate Drive Watsonville, CA 95076, the United States.</p><p>During the period of data protection, the novel food vitamin D<span>2</span> mushroom powder is authorised for placing on the market within the Union only by Monterey Mushrooms Inc, 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 Monterey Mushrooms Inc.</p><p>End date of the date protection: 24&#160;January 2028.</p></td></tr><tr><td><p>Milk analogues</p></td><td><p>1,1</p></td></tr><tr><td><p>Dairy analogues other than milks</p></td><td><p>2,2</p></td></tr><tr><td><p>Breakfast cereals and cereal bars</p></td><td><p>2,2</p></td></tr><tr><td><p>Soups</p></td><td><p>2,2</p></td></tr><tr><td><p>Dried soups</p></td><td><p>22,5</p></td></tr><tr><td><p>Whey powder</p></td><td><p>14,1</p></td></tr><tr><td><p>Fruit/vegetable juices and nectars</p></td><td><p>1,1</p></td></tr><tr><td><p>Fruit/vegetable juice powder</p></td><td><p>12,4</p></td></tr><tr><td><p>Fruit/vegetable juice concentrate (liquid)</p></td><td><p>3,4</p></td></tr><tr><td><p>Soft drinks marketed in relation to physical exercise and fermented non-alcoholic drinks (with exclusion of dairy fermented drinks)</p></td><td><p>1,1</p></td></tr><tr><td><p>Foods for Special Medical Purposes as defined under Regulation (EU) No&#160;609/2013 excluding those intended for infants</p></td><td><p>In accordance with the particular nutritional requirements of the persons for whom the products are intended but not higher than 15 &#956;g/day</p></td></tr><tr><td><p>Total diet replacement for weight control as defined in</p><p>Regulation (EU) No&#160;609/2013</p></td><td><p>15 &#956;g/day</p></td></tr><tr><td><p>Meal replacements for weight control</p></td><td><p>5 &#956;g/meal</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>15 &#956;g/day</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Vitamin K<span>2</span> (menaquinone)</span></p></td><td><p>To be used in compliance with Directive 2002/46/EC, Regulation (EU) No 609/2013 and/or Regulation (EC) No 1925/2006</p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Menaquinone&#8217; or &#8216;Vitamin K<span>2</span>&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Wheat bran extract</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Wheat bran extract&#8217;</p></td><td><p>The &#8216;Wheat Bran Extract&#8217; may not be introduced onto the market as a food supplement or food supplement ingredient. Nor may it be added to infant formula.</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Beer and substitutes</p></td><td><p>0,4 g/100 g</p></td></tr><tr><td><p>Ready to eat cereals</p></td><td><p>9 g/100 g</p></td></tr><tr><td><p>Dairy products</p></td><td><p>2,4 g/100 g</p></td></tr><tr><td><p>Fruit and vegetable juices</p></td><td><p>0,6 g/100 g</p></td></tr><tr><td><p>Soft drinks</p></td><td><p>0,6 g/100 g</p></td></tr><tr><td><p>Meat preparations</p></td><td><p>2 g/100 g</p></td></tr><tr><td><p><a>&#9660;M78</a></p></td></tr><tr><td><p><span>Wolffia arrhiza</span> and/or<span>Wolffia globosa</span> fresh plants (Traditional food from a third country)</p></td><td><p>Specified food category</p></td><td><p>Maximum levels</p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;<span>Wolffia arrhiza</span> and<span>Wolffia globosa</span>&#8217; or &#8216;<span>Wolffia arrhiza</span>&#8217; or &#8216;<span>Wolffia globosa</span>&#8217; depending on the plant used.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Wolffia arrhiza</span> and/or<span>Wolffia globosa</span> fresh plants as such</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><a>&#9660;M48</a></p></td></tr><tr><td><p><span>Xylo-oligosaccharides</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span>&#160;<a>(<span>10</span>)</a></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Xylo-oligosaccharides&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>White bread</p></td><td><p>14 g/kg</p></td></tr><tr><td><p>Wholemeal bread</p></td><td><p>14 g/kg</p></td></tr><tr><td><p>Breakfast cereals</p></td><td><p>14 g/kg</p></td></tr><tr><td><p>Biscuits</p></td><td><p>14 g/kg</p></td></tr><tr><td><p>Soy drink</p></td><td><p>3,5 g/kg</p></td></tr><tr><td><p>Yoghurt&#160;<a>(<span>9</span>)</a></p></td><td><p>3,5 g/kg</p></td></tr><tr><td><p>Fruit spreads</p></td><td><p>30 g/kg</p></td></tr><tr><td><p>Chocolate confectionery</p></td><td><p>30 g/kg</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC for the general adult population</p></td><td><p>2 g/day</p></td></tr><tr><td><p><a>&#9660;M113</a></p></td></tr><tr><td><p><span>Yarrowia lipolytica</span> yeast biomass</p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;<span>Yarrowia lipolytica</span> yeast biomass&#8217;.</p><p>2.&#160;&#160;The labelling of meal replacements for weight control containing<span>Yarrowia lipolytica</span> yeast biomass shall bear a statement that they should only be used by persons above 18 years of age and should not be used if food supplements containing<span>Yarrowia lipolytica</span> yeast biomass are consumed on the same day.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food supplements as defined in Directive&#160;2002/46/EC, excluding food supplements for infants and young children</p></td><td><p>6&#160;g/day for children from 10 years of age, adolescents and general adult population</p><p>3&#160;g/day for children from 3 to 9 years of age</p></td></tr><tr><td><p>Meal replacements for weight control for the adult population</p></td><td><p>3&#160;g/meal (maximum 2&#160;meals/day up to a maximum of 6&#160;g/day)</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Yeast beta-glucans</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels of pure beta-glucans from yeast (Saccharomyces cervisiae)</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Yeast (<span>Saccharomyces cerevisiae</span>) beta-glucans&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></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>1,275 g/day for children older than 12 years and general adult population</p><p>0,675 g/day for children younger than 12 years</p></td></tr><tr><td><p>Total diet replacement for weight control as defined in Regulation (EU) No 609/2013</p></td><td><p>1,275 g/day</p></td></tr><tr><td><p>Food for special medical purposes as defined in Regulation (EU) No 609/2013, excluding food for special medical purposes intended for infants and young children</p></td><td><p>1,275 g/day</p></td></tr><tr><td><p>Beverages based on fruit and/or vegetable juices including concentrate and dehydrated juices</p></td><td><p>1,3 g/kg</p></td></tr><tr><td><p>Fruit-flavoured drinks</p></td><td><p>0,8 g/kg</p></td></tr><tr><td><p>Cocoa beverages preparation powder</p></td><td><p>38,3 g/kg (powder)</p></td></tr><tr><td><p>Other beverages</p></td><td><p>0,8 g/kg (ready to drink)</p></td></tr><tr><td><p>7 g/kg (powder)</p></td></tr><tr><td><p>Cereal bars</p></td><td><p>6 g/kg</p></td></tr><tr><td><p>Breakfast cereals</p></td><td><p>15,3 g/kg</p></td></tr><tr><td><p>Wholegrain and high fibre instant hot breakfast cereals</p></td><td><p>1,5 g/kg</p></td></tr><tr><td><p>Cookie-type biscuits</p></td><td><p>6,7 g/kg</p></td></tr><tr><td><p>Cracker-type biscuits</p></td><td><p>6,7 g/kg</p></td></tr><tr><td><p>Milk based beverages</p></td><td><p>3,8 g/kg</p></td></tr><tr><td><p>Fermented milk products</p></td><td><p>3,8 g/kg</p></td></tr><tr><td><p>Milk product analogues</p></td><td><p>3,8 g/kg</p></td></tr><tr><td><p>Dried milk/milk powder</p></td><td><p>25,5 g/kg</p></td></tr><tr><td><p>Soups and soup mixes</p></td><td><p>0,9 g/kg (ready to eat)</p></td></tr><tr><td><p>1,8 g/kg (condensed)</p></td></tr><tr><td><p>6,3 g/kg (powder)</p></td></tr><tr><td><p>Chocolate and confectionery</p></td><td><p>4 g/kg</p></td></tr><tr><td><p>Protein bars and powders</p></td><td><p>19,1 g/kg</p></td></tr><tr><td><p>Jam, marmalade and other fruit spreads</p></td><td><p>11,3 g/kg</p></td></tr><tr><td><p><a>&#9660;M12</a></p></td></tr><tr><td><p><span>Zeaxanthin</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Zeaxanthin&#8217;.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td><td><p>2 mg/day</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Zinc L-pidolate</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Zinc L-pidolate&#8217;</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Foods covered by Regulation (EU) No 609/2013</p></td><td><p>3 g/day</p></td></tr><tr><td><p>Milk based drinks and similar products intended for young children</p></td></tr><tr><td><p>Meal replacement for weight control</p></td></tr><tr><td><p>Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen</p></td></tr><tr><td><p>Food bearing statement on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014</p></td></tr><tr><td><p>Food Supplements as defined in Directive 2002/46/EC</p></td></tr><tr><td><div><a>(<span>1</span>)&#160;&#160;&#160;</a><p>Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).</p></div><div><a>(<span>2</span>)&#160;&#160;&#160;</a><p>Commission Implementing Regulation (EU) No 828/2014 of 30 July 2014 on the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food (OJ L 228, 31.7.2014, p. 5).</p></div><div><a>(<span>3</span>)&#160;&#160;&#160;</a><p>Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).</p></div><div><a>(<span>4</span>)&#160;&#160;&#160;</a><p>Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (OJ L 404, 30.12.2006, p. 26).</p></div><div><a>(<span>5</span>)&#160;&#160;&#160;</a><p>Council Directive 2001/113/EC of 20 December 2001 relating to fruit jams, jellies and marmalades and sweetened chestnut pur&#233;e intended for human consumption (OJ L 10, 12.1.2002, p. 67).</p></div><div><a>(<span>6</span>)&#160;&#160;&#160;</a><p>Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulation (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) 1234/2007 (OJ L 347, 20.12.2013, p. 671).</p></div><div><span><a><span>&#9658;M33</span></a></span>&#160;<a>(<span>7</span>)&#160;&#160;&#160;</a><p>Maximum use levels in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer.</p><span>&#160;&#9668;</span></div><div><span><a><span>&#9658;M47</span></a></span>&#160;<a>(<span>8</span>)&#160;&#160;&#160;</a><p>Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for human consumption (OJ L 10, 12.1.2002, p. 58).</p><span>&#160;&#9668;</span></div><div><span><a><span>&#9658;M48</span></a></span>&#160;<a>(<span>9</span>)&#160;&#160;&#160;</a><p>When used in milk products xylo-oligosaccharides shall not replace, in whole or in part, any milk constituent.</p></div><div><a>(<span>10</span>)&#160;&#160;&#160;</a><p>Maximum levels calculated on the basis of the specifications of Powder form 1.</p><span>&#160;&#9668;</span></div><div><a>(<span>11</span>)&#160;&#160;&#160;</a><p>The minimum specification for vitamin D content in vitamin D<span>2</span> mushroom powder of 1&#160;000  &#956;g vitamin D<span>2</span>/gram of mushroom powder is used.</p></div><div><a>(<span>12</span>)&#160;&#160;&#160;</a><p>Depending on the age group the food supplement is intended for.</p></div><div><a>(<span>13</span>)&#160;&#160;&#160;</a><p>Without prejudice to the requirements of Regulation (EU) No&#160;609/2013 and Regulation (EU)&#160;2016/127.</p></div><div><a>(<span>14</span>)&#160;&#160;&#160;</a><p>Not a traditional food use.</p></div></td></tr></tbody></table>
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p><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;M83</a></p></td></tr><tr><td><p><span>Frozen, dried and powder forms of<span>Acheta domesticus</span> (house cricket)</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span> (g/100g)</p><p>(marketed as such or reconstituted according to the instructions)</p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;Frozen<span>Acheta domesticus</span> (house cricket)&#8217;, &#8216;Dried/powdered<span>Acheta domesticus</span> (house cricket)&#8217;depending on the form used.</p><p>2.&#160;&#160;The labelling of the foodstuffs containing frozen, dried or powder forms of<span>Acheta domesticus</span> (house cricket) shall bear a statement that this ingredient may cause allergic reactions to consumers with known allergies to crustaceans, molluscs and products thereof, and to dust mites.</p><p>This statement shall appear in close proximity to the list of ingredients.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 3&#160;March&#160;2022. 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: Fair Insects BV, Industriestraat 3, 5107 NC Dongen, the Netherlands.</p><p>During the period of data protection, the novel food is authorised for placing on the market within the Union only by Fair Insects BV, unless a subsequent applicant obtains authorisation for that 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 Fair Insects BV.</p><p>End date of the data protection: 3&#160;March&#160;2027.</p></td></tr><tr><td><p>Frozen</p></td><td><p>Dried or powder</p></td></tr><tr><td><p>Frozen, dried, and powder forms of<span>Acheta domesticus</span></p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Protein products other than meat analogues</p></td><td><p>40</p></td><td><p>20</p></td></tr><tr><td><p>Bread and rolls</p></td><td><p>30</p></td><td><p>10</p></td></tr><tr><td><p>Bakery wares, cereal bars, and stuffed pasta products</p></td><td><p>30</p></td><td><p>15</p></td></tr><tr><td><p>Biscuits</p></td><td><p>30</p></td><td><p>8</p></td></tr><tr><td><p>Pasta-based products (dry)</p></td><td><p>3</p></td><td><p>1</p></td></tr><tr><td><p>Soups and soup concentrates or powders</p></td><td><p>20</p></td><td><p>5</p></td></tr><tr><td><p>Processed potato products, legumes- and vegetable- based dishes, and pasta- or pizza-based products</p></td><td><p>15</p></td><td><p>5</p></td></tr><tr><td><p>Corn flour based snacks</p></td><td><p>40</p></td><td><p>20</p></td></tr><tr><td><p>Beer-like beverages, alcoholic drink mixes</p></td><td><p>1</p></td><td><p>1</p></td></tr><tr><td><p>Nuts, oilseeds and chickpeas</p></td><td><p>40</p></td><td><p>25</p></td></tr><tr><td><p>Sauces</p></td><td><p>30</p></td><td><p>10</p></td></tr><tr><td><p>Meat preparations</p></td><td><p>40</p></td><td><p>16</p></td></tr><tr><td><p>Meat analogues</p></td><td><p>80</p></td><td><p>50</p></td></tr><tr><td><p>Chocolate confectionary</p></td><td><p>30</p></td><td><p>10</p></td></tr><tr><td><p>Frozen fermented milk based products</p></td><td><p>15</p></td><td><p>5</p></td></tr><tr><td><p><a>&#9660;M74</a></p></td></tr><tr><td><p>Frozen, dried and powder forms of<span>Locusta migratoria</span> (migratory locust)</p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels (g/100&#160;g)</span></p><p><span>(marketed as such or reconstituted according to the instructions)</span></p></td><td><p>1.&#160;&#160;The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;frozen<span>Locusta migratoria</span> (migratory locust)&#8217;, &#8216;dried/powder<span>Locusta migratoria</span> (migratory locust)&#8217;, &#8216;Whole<span>Locusta migratoria</span> (migratory locust) powder&#8217; depending on the form used.</p><p>2.&#160;&#160;The labelling of the foodstuffs containing frozen dried or powder forms of<span>Locusta migratoria</span> (migratory locust) shall bear a statement that this ingredient may cause allergic reactions to consumers with known allergies to crustaceans, molluscs and products thereof, and to mites.</p><p>This statement shall appear in close proximity to the list of ingredients.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 5.12.2021.</p><p>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: Fair Insects BV, Industriestraat 3, 5107 NC Dongen, the Netherlands.</p><p>During the period of data protection, the novel food is authorised for placing on the market within the Union only by Fair Insects BV, unless a subsequent applicant obtains authorisation for that 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 Fair Insects BV.</p><p>End date of the data protection: 5.12.2026.</p></td></tr><tr><td><p><span>Frozen</span></p></td><td><p><span>Dried or</span></p><p><span>Powder</span></p></td></tr><tr><td><p>Frozen, dried and powder forms of<span>Locusta migratoria</span></p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Processed potato products; legumes-based dishes and pasta-based products</p></td><td><p>15</p></td><td><p>5</p></td></tr><tr><td><p>Meat analogues</p></td><td><p>80</p></td><td><p>50</p></td></tr><tr><td><p>Soups and concentrated soups</p></td><td><p>15</p></td><td><p>5</p></td></tr><tr><td><p>Canned/jarred legumes and vegetables</p></td><td><p>20</p></td><td><p>15</p></td></tr><tr><td><p>Salads</p></td><td><p>15</p></td><td><p>5</p></td></tr><tr><td><p>Beer-like beverages, Alcoholic drink mixes</p></td><td><p>2</p></td><td><p>2</p></td></tr><tr><td><p>Chocolate confectionery</p></td><td><p>30</p></td><td><p>10</p></td></tr><tr><td><p>Nuts, oilseeds and chickpeas</p></td><td><p>&#160;</p><div/></td><td><p>20</p></td></tr><tr><td><p>Frozen fermented milk-based products</p></td><td><p>15</p></td><td><p>5</p></td></tr><tr><td><p>Sausages</p></td><td><p>30</p></td><td><p>10</p></td></tr><tr><td><p><a>&#9660;M81</a></p></td></tr><tr><td><p>Frozen, dried and powder forms of yellow mealworm (<span>Tenebrio molitor</span> larva)</p></td><td><p>Specified food category</p></td><td><p>Maximum levels (g/100g)</p><p>(marketed as such or reconstituted according to the instructions)</p></td><td><p>1.&#160;&#160;Depending on the form used, the designation of the novel food on the labelling of the foodstuffs containing it shall be &#8216;frozen yellow mealworm (<span>Tenebrio molitor</span> larva)&#8217;, &#8216;dried yellow mealworm (<span>Tenebrio molitor</span> larva)&#8217;, or &#8216;yellow mealworm (<span>Tenebrio molitor</span> larva) powder&#8217;.</p><p>2.&#160;&#160;The labelling of the foodstuffs containing frozen, dried and powder forms of yellow mealworm (<span>Tenebrio molitor</span> larva) shall bear a statement that this ingredient may cause allergic reactions to consumers with known allergies to crustaceans and products thereof and to dust mites. This statement shall appear in close proximity to the list of ingredients.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 1&#160;March 2022. 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: Fair Insects BV, Industriestraat 3, 5107 NC Dongen, the Netherlands.</p><p>During the period of data protection, the novel food is authorised for placing on the market within the Union only by Fair Insects BV, unless a subsequent applicant obtains authorisation for that 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 Fair Insects BV.</p><p>End date of the date protection: 1&#160;March 2027.</p></td></tr><tr><td><p>Frozen</p></td><td><p>Dried or powder</p></td></tr><tr><td><p>Frozen, dried and powder forms of yellow mealworm (<span>Tenebrio molitor</span> larva)</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Multigrain bread and rolls; crackers and breadsticks</p></td><td><p>30</p></td><td><p>10</p></td></tr><tr><td><p>Cereal bars</p></td><td><p>30</p></td><td><p>15</p></td></tr><tr><td><p>Dried pasta based products; pasta based dishes (excluding dried puffed pasta); pizza and pizza-like dishes</p></td><td><p>15</p></td><td><p>10</p></td></tr><tr><td><p>Dried stuffed pasta based products</p></td><td><p>30</p></td><td><p>15</p></td></tr><tr><td><p>Pre-mixes (dry) for baked products</p></td><td><p>30</p></td><td><p>15</p></td></tr><tr><td><p>Sauces</p></td><td><p>30</p></td><td><p>10</p></td></tr><tr><td><p>Potato, legumes based dishes</p></td><td><p>15</p></td><td><p>10</p></td></tr><tr><td><p>Whey powder</p></td><td><p>40</p></td><td><p>20</p></td></tr><tr><td><p>Meat analogues</p></td><td><p>80</p></td><td><p>50</p></td></tr><tr><td><p>Soups and salads</p></td><td><p>20</p></td><td><p>5</p></td></tr><tr><td><p>Chips/crisps</p></td><td><p>40</p></td><td><p>20</p></td></tr><tr><td><p>Beer-like beverages; mixed alcoholic drinks; alcoholic drink mixes</p></td><td><p>1</p></td><td><p>1</p></td></tr><tr><td><p>Chocolate confectionary</p></td><td><p>30</p></td><td><p>10</p></td></tr><tr><td><p>Nuts, oilseeds and chickpeas</p></td><td><p>40</p></td><td><p>30</p></td></tr><tr><td><p>Frozen fermented milk-based products</p></td><td><p>15</p></td><td><p>5</p></td></tr><tr><td><p>Meat preparations</p></td><td><p>40</p></td><td><p>16</p></td></tr></tbody></table>
Table 2: Specifications
<table><col/><col/><col/><col/><col/><tbody><tr><td><p>Authorised Novel Food</p></td><td><p>Specifications</p></td></tr><tr><td><p><span><span>N</span>-Acetyl-D-neuraminic acid</span></p></td><td><p><span>Description:</span></p><p><span>N</span>-Acetyl-D-neuraminic acid is a white to off-white crystalline powder</p><p><span>Definition:</span></p><p><span>Chemical name:</span></p><p>IUPAC names:</p><p><span>N</span>-Acetyl-D-neuraminic acid (dihydrate)</p><p>5-Acetamido-3,5-dideoxy-D-glycero-D-galacto-non-2-ulopyranosonic acid (dihydrate)</p><p>Synonyms:</p><p>Sialic acid (dihydrate)</p><p><span>Chemical formula:</span></p><p>C<span>11</span>H<span>19</span>NO<span>9</span> (acid)</p><p>C<span>11</span>H<span>23</span>NO<span>11</span> (C<span>11</span>H<span>19</span>NO<span>9</span> * 2H<span>2</span>O) (dihydrate)</p><p><span>Molecular mass:</span></p><p>309,3 Da (acid)</p><p>345,3 (309,3 + 36,0) (dihydrate)</p><p><span>CAS No.:</span></p><p>131-48-6 (free acid)</p><p>50795-27-2 (dihydrate)</p><p><span>Specifications:</span></p><p>Description: white to off-white crystalline powder</p><p>pH (20 &#176;C, 5 % solution): 1,7 &#8211; 2,5</p><p><span>N</span>-Acetyl-D-neuraminic acid (dihydrate): &gt; 97,0 %</p><p>Water (dihydrate calculates to 10,4 %): &#8804; 12,5 % (w/w)</p><p>Ash, sulphated: &lt; 0,2 % (w/w)</p><p>Acetic acid (as free acid and/or sodium acetate): &lt; 0,5 % (w/w)</p><p><span>Heavy Metals:</span></p><p>Iron: &lt; 20,0 mg/kg</p><p>Lead: &lt; 0,1 mg/kg</p><p>Residual proteins: &lt; 0,01 % (w/w)<span>Residual solvents:</span></p><p>2-Propanol: &lt; 0,1 % (w/w)</p><p>Acetone: &lt; 0,1 % (w/w)</p><p>Ethyl acetate: &lt; 0,1 % (w/w)</p><p><span>Microbiological criteria:</span></p><p><span>Salmonella:</span> Absence in 25 g</p><p>Aerobic mesophilic total count:&lt; 500 CFU/g</p><p>Enterobacteriaceae: Absence in 10 g</p><p><span>Cronobacter (Enterobacter) sakazakii:</span> Absence in 10 g</p><p><span>Listeria monocytogenes:</span> Absence in 25 g</p><p><span>Bacillus cereus:</span> &lt; 50 CFU/g</p><p>Yeasts: &lt; 10 CFU/g</p><p>Moulds: &lt; 10 CFU/g</p><p>Residual endotoxins: &lt; 10 EU/mg</p><p>CFU: Colony Forming Units; EU: Endotoxin Units.</p></td></tr><tr><td><p><a>&#9660;M83</a></p></td></tr><tr><td><p><span>Frozen, dried and powder forms of<span>Acheta domesticus</span> (house cricket)</span></p></td><td><p><span>Description/Definition:</span></p><p>The novel food consists of the whole, frozen, dried and powder forms of the house cricket. The term &#8216;house cricket&#8217; refers to the adult<span>Acheta domesticus</span>, an insect species that belongs to the Gryllidae family.</p><p>The novel food is intended to be marketed in three different forms, namely: (i) thermally processed and frozen whole<span>A. domesticus</span> (AD frozen); (ii) thermally processed and freeze-dried whole<span>A. domesticus</span> (AD dried), and (iii) thermally processed freeze-dried and ground whole<span>A. domesticus</span> (whole AD powder).</p><p>A minimum 24 hours fasting period is required before killing the insects by freezing, to allow the adults to discard their bowel content.</p></td></tr><tr><td><p><span>Characteristics/Composition (AD frozen):</span></p><p>Ash (% w/w): 0,6&#8211;1,2</p><p>Moisture (% w/w): 76&#8211;82</p><p>Crude protein (N x 6,25) (% w/w): 12&#8211;21</p><p>Digestible Carbohydrates (% w/w): 0,1&#8211;2</p><p>Fat (% w/w): 3&#8211;12</p><p>of which saturated (% w/w): 36&#8211;45</p><p>Peroxide value (Meq O<span>2</span>/kg fat): &#8804; 5</p><p>Dietary fibre (% w/w): 0,8&#8211;3</p><p>&#160;<a>(<span>18</span>)</a>Chitin (% w/w): 0,7&#8211;3,0</p><p><span>Heavy metals:</span></p><p>Lead: &#8804; 0,05 mg/kg</p><p>Cadmium: &#8804; 0,06 mg/kg</p><p><span>Mycotoxins:</span></p><p>Aflatoxins (Sum of B1, B2, G1, G2): &#8804; 4 &#956;g/kg</p><p>Aflatoxin B1 (&#956;g/kg): &#8804; 2</p><p>Deoxynivalenol: &#8804; 200 &#956;g/kg</p><p>Ochratoxin A: &#8804; 1 &#956;g/kg</p><p><span>Dioxins and dioxin like PCBs</span></p><p>Sum of dioxins and dioxin-like PCBs UB, (&#160;<a>(<span>19</span>)</a>WHO<span>2005</span> PCDD/F-PCB-TEQ): &#8804; 1,25 pg/g fat</p><p><span>Microbiological criteria:</span></p><p>Total aerobic colony count: &#8804; 10<span>5</span>&#160;<a>(<span>7</span>)</a>CFU/g</p><p>Yeasts and moulds: &#8804; 100 CFU/g</p><p><span>Escherichia coli</span>: &#8804; 50 CFU/g</p><p><span>Salmonella</span> spp.: Absence in&#160;25 g</p><p><span>Listeria monocytogenes</span>: Absence in&#160;25 g</p><p>Sulfite-reducing Anaerobes: &#8804; 30 CFU/g</p><p><span>Bacillus cereus</span> (presumptive): &#8804; 100 CFU/g</p><p>Enterobacteriaceae (presumptive): &lt; 100 CFU/g</p><p>Coagulase-positive<span>staphylococci</span>: &#8804; 100 CFU/g</p></td><td><p><span>Characteristics/Composition (AD dried or powder):</span></p><p>Ash (% w/w): 2,9&#8211;5,1</p><p>Moisture (% w/w): &#8804; 5</p><p>Crude protein (N x 6,25) (% w/w): 55&#8211;65</p><p>Digestible Carbohydrates (% w/w): 1&#8211;4</p><p>Fat (% w/w): 29&#8211;35</p><p>of which saturated (% w/w): 36&#8211;45</p><p>Peroxide value (Meq O<span>2</span>/kg fat): &#8804; 5</p><p>Dietary fibre (% w/w): 3&#8211;6</p><p>&#160;<a>(<span>18</span>)</a>Chitin (% w/w): 5,3-10,0</p><p><span>Heavy metals:</span></p><p>Lead: &#8804; 0,05 mg/kg</p><p>Cadmium: &#8804; 0,06 mg/kg</p><p><span>Mycotoxins:</span></p><p>Aflatoxins (Sum of B1, B2, G1, G2): &#8804; 4 &#956;g/kg</p><p>Aflatoxin B1 (&#956;g/kg): &#8804; 2</p><p>Deoxynivalenol: &#8804; 200 &#956;g/kg</p><p>Ochratoxin A: &#8804; 1 &#956;g/kg</p><p><span>Dioxins and dioxin like PCBs</span></p><p>Sum of dioxins and dioxin-like PCBs UB, (&#160;<a>(<span>19</span>)</a>WHO<span>2005</span> PCDD/F-PCB-TEQ): &#8804; 1,25 pg/g fat</p><p><span>Microbiological criteria:</span></p><p>Total aerobic colony count: &#8804; 10<span>5</span> CFU/g</p><p>Yeasts and moulds: &#8804; 100 CFU/g</p><p><span>Escherichia coli</span>: &#8804; 50 CFU/g</p><p><span>Salmonella</span> spp.: Absence in&#160;25 g</p><p><span>Listeria monocytogenes</span>: Absence in&#160;25 g</p><p>Sulfite-reducing Anaerobes: &#8804; 30 CFU/g</p><p><span>Bacillus cereus</span> (presumptive): &#8804; 100 CFU/g</p><p>Enterobacteriaceae (presumptive): &lt; 100 CFU/g</p><p>Coagulase-positive<span>staphylococci</span>: &#8804; 100 CFU/g</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><a>&#9660;M99</a></p></td></tr><tr><td><p><span><span>Acheta domesticus</span> (house cricket) partially defatted powder</span></p></td><td><p><span>Description/Definition</span>:</p><p>The novel food is partially defatted powder obtained from whole<span>Acheta domesticus</span> (house cricket) following a series of steps involving a&#160;24 hours fasting period of the insects to allow them to discard their bowel content, the sacrifice of the insects by freezing, washing, thermal processing, drying, oil extraction (mechanical extrusion), and grinding.</p></td></tr><tr><td><p><span>Characteristics/Composition</span>:</p><p>Crude protein (N x 6,25) (% w/w): 74,0 - 78,0</p><p>Fat (% w/w): 9,0 &#8211; 12,0</p><p>Moisture (% w/w): 3,0 &#8211; 6,0</p><p>Crude fibre (% w/w): 8,0 &#8211; 10,0</p><p>Chitin&#160;<a>(<span>22</span>)</a> (% w/w): 4,0-8,5</p><p>Ash (% w/w): &#8804; 5,6</p><p>Peroxide value (Meq O<span>2</span>/kg fat): &#8804; 5,0</p><p>Manganese: &#8804; 100,0 mg/kg</p><p>Cyanide: &#8804; 5,0 mg/kg</p><p><span>Heavy metals</span>:</p><p>Lead: &#8804; 0,1 mg/kg</p><p>Cadmium: &#8804; 0,025 mg/kg</p><p><span>Mycotoxins</span>:</p><p>Aflatoxins (Sum of B1, B2, G1, G2): &#8804; 0,4 &#956;g/kg</p><p>Deoxynivalenol: &#8804; 200,0 &#956;g/kg</p><p>Ochratoxin A: &#8804; 1,0 &#956;g/kg</p><p><span>Dioxins and dioxin like PCBs:</span></p><p>Sum of dioxins and dioxin-like PCBs UB, (&#160;<a>(<span>23</span>)</a>WHO<span>2005</span> PCDD/F-PCB-TEF): &#8804; 1,25 pg/g fat</p><p><span>Microbiological criteria:</span></p><p>Total aerobic microbial count: &#8804; 10<span>5</span> CFU/g</p><p>Yeasts and moulds: &#8804; 100 CFU/g</p><p><span>Escherichia coli</span>: &#8804; 50 CFU/g</p><p><span>Salmonella</span> spp.: Not detected in&#160;25 g</p><p><span>Listeria monocytogenes</span>: Not detected in&#160;25 g</p><p><span>Bacillus cereus</span> (presumptive): &#8804; 100 CFU/g</p><p>Enterobacteriaceae (presumptive): &lt; 100 CFU/g</p><p>Coagulase-positive<span>staphylococci</span>: &#8804; 100 CFU/g</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span><span>Adansonia digitata</span> (Baobab) dried fruit pulp</span></p></td><td><p><span>Description/Definition:</span></p><p>The Baobab (<span>Adansonia digitata</span>) fruits are harvested from trees. The hard shells are cracked open and the pulp is separated from the seeds and the shell. This is milled, separated into coarse and fine lots (particle size 3 to 600 &#956;) and then packaged.</p><p><span>Typical nutritional components:</span></p><p>Moisture (loss on drying) (g/100 g): 4,5-13,7</p><p>Protein (g/100 g): 1,8-9,3</p><p>Fat (g/100 g): 0-1,6</p><p>Total carbohydrate (g/100 g): 76,3-89,5</p><p>Total sugars (as glucose): 15,2-36,5</p><p>Sodium (mg/100 g): 0,1-25,2</p><p><span>Analytical specifications:</span></p><p>Foreign matter: Not more than 0,2 %</p><p>Moisture (loss on drying) (g/100 g): 4,5-13,7</p><p>Ash (g/100 g): 3,8-6,6</p></td></tr><tr><td><p><span><span>Ajuga reptans</span> extract from cell cultures</span></p></td><td><p><span>Description/Definition:</span></p><p>Hydroalcoholic extract from<span>Ajuga reptans</span> L. tissue cultures which is substantially equivalent to extracts from flowering aerial parts of<span>Ajuga reptans</span> obtained by traditional cultures.</p></td></tr><tr><td><p><a>&#9660;M80</a></p></td></tr><tr><td><p><span><span>Akkermansia muciniphila</span> (pasteurised)</span></p></td><td><p><span>Description:</span></p><p>Pasteurised<span>Akkermansia muciniphila</span> (strain ATCC BAA-835, CIP 107961) is produced by anaerobic growth of the bacteria followed by pasteurisation, concentration of the cells, cryopreservation, and freeze drying.</p><p><span>Characteristics/Composition:</span></p><p>Total<span>A. muciniphila</span> cell count (cells/g): 2,5 &#215; 10<span>10</span> to 2,5 &#215; 10<span>12</span></p><p>Viable<span>A. muciniphila</span> cell count (CFU/g): &lt;&#160;10 (LoD)(*)</p><p>Water activity: &#8804;&#160;0,43</p><p>Moisture (%): &#8804;&#160;12,0</p><p>Protein (%): &#8804;&#160;35,0</p><p>Fat (%): &#8804;&#160;4,0</p><p>Crude ash (%): &#8804;&#160;21,0</p><p>Carbohydrates (%): 36,0 &#8211; 86,0</p><p><span>Microbiological criteria:</span></p><p>Aerobic mesophilic total count: &#8804;&#160;500 CFU(**)/g</p><p>Sulphite reducing anaerobes: &#8804;&#160;50 CFU/g</p><p>Coagulase<span>+</span> Staphylococci: &#8804;&#160;10 CFU/g</p><p>Enterobacteriaceae: &#8804;&#160;10 CFU/g</p><p>Yeast: &#8804;&#160;10 CFU/g</p><p>Mould: &#8804;&#160;10 CFU/g</p><p><span>Bacillus cereus</span>: &#8804;&#160;100 CFU/g</p><p><span>Listeria</span> spp.: Absence in&#160;25 g</p><p><span>Salmonella</span> spp.: Absence in&#160;25 g</p><p><span>Escherichia coli</span>: Absence in&#160;1 g</p><p>(*)&#160;&#160;LoD: Limit of Detection;</p><p>(**)&#160;&#160;Colony Forming Units.</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>L-Alanyl-L-Glutamine</span></p></td><td><p><span>Description/Definition:</span></p><p>L-Alanyl-L-Glutamine is produced by fermentation with a genetically modified strain of<span>Escherichia coli</span>. During the fermentation process, the ingredient is secreted into the growth medium from which it is subsequently separated and purified to a concentration of &gt; 98 %.</p><p>Appearance: White crystalline powder</p><p>Purity: &gt; 98 %</p><p>Infrared spectroscopy: Conformity with ref. standard</p><p>Appearance of solution: Colourless and clear</p><p>Assay (dry basis): 98-102 %</p><p>Related substances (each): &#8804; 0,2 %</p><p>Residue on ignition: &#8804; 0,1 %</p><p>Loss on drying: &#8804; 0,5 %</p><p>Optical rotation: +9,0 - +11,0<span>o</span></p><p>pH (1 %; H<span>2</span>O): 5,0-6,0</p><p>Ammonium (NH<span>4</span>): &#8804; 0,020 %</p><p>Chloride (Cl): &#8804; 0,020 %</p><p>Sulphate (SO<span>4</span>): &#8804; 0,020 %</p><p><span>Microbiological criteria:</span></p><p><span>Escherichia coli</span>: Absence/g</p></td></tr><tr><td><p><span>Algal oil from the microalgae<span>Ulkenia</span> sp.</span></p></td><td><p><span>Description/Definition:</span></p><p>Oil from the micro-algae<span>Ulkenia</span> sp.</p><p>Acid value: &#8804; 0,5 mg KOH/g</p><p>Peroxide value (PV): &#8804; 5,0 meq/kg oil</p><p>Moisture and volatiles: &#8804; 0,05 %</p><p>Unsaponifiables: &#8804; 4,5 %</p><p>Trans-fatty acids: &#8804; 1,0 %</p><p>DHA content: &#8805; 32 %</p></td></tr><tr><td><p><a>&#9660;M26</a></p></td></tr><tr><td><p><span><span>Allanblackia</span> seed oil</span></p></td><td><p><span>Description/Definition:</span></p><p><span>Allanblackia</span> seed oil is obtained from the seeds of the allanblackia species:<span>A. floribunda</span> (synonymous with<span>A. parviflora</span>) and<span>A. stuhlmannii</span>.</p><p><span>Composition of fatty acids (as a % of the total fatty acids):</span></p><p>Lauric acid &#8212; Myristic acid &#8212; Palmitic acid (C12:0 &#8211; C14:0 &#8211; C16:0): sum of these acids &lt; 4,0&#160;%</p><p>Stearic acid (C18:0): 45-58 %</p><p>Oleic acid (C18:1): 40-51 %</p><p>Poly unsaturated fatty acids (PUFA): &lt; 2 %</p><p><span>Characteristics:</span></p><p>Free fatty acids: max 0,1 % of total fatty acids</p><p>Trans fatty acids: max 1,0 % of total fatty acids</p><p>Peroxide value: max 1,0 meq/kg</p><p>Unsaponifiable matter: max 1,0 % (w/w) of the oil</p><p>Saponification value: 185-198 mg KOH/g</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span><span>Aloe macroclada</span> Baker leaf extract</span></p></td><td><p><span>Description/Definition:</span></p><p>Powdered gel extract derived from the leaves of<span>Aloe macroclada</span> Baker which is substantially equivalent to the same gel derived from<span>Aloe vera</span> (L.) Burm.f. leaves.</p><p>Ash: 25 %</p><p>Dietary fibres: 28,6 %</p><p>Fat: 2,7 %</p><p>Moisture: 4,7 %</p><p>Polysaccharides: 9,5 %</p><p>Protein: 1,63 %</p><p>Glucose: 8,9 %</p></td></tr><tr><td><p><a>&#9660;M103</a></p></td></tr><tr><td><p><span>Frozen, paste, dried and powder forms of<span>Alphitobius diaperinus</span> larvae (lesser mealworm)</span></p></td><td><p><span>Description/Definition:</span></p><p>The novel food consists of the frozen, paste, dried, and powder forms of the whole lesser mealworm. The term &#8216;lesser mealworm&#8217; refers to the larval form of<span>Alphitobius diaperinus</span>, an insect species that belongs to the family of<span>Tenebrionidae</span> (darkling beetles).</p><p>The entire lesser mealworms are meant for human consumption, no parts are removed.</p><p>The novel food is intended to be marketed in&#160;4 different forms, namely: (i) whole blanched and frozen<span>A. diaperinus</span> larvae (ADL frozen), (ii) paste from whole blanched, ground, and frozen<span>A. diaperinus</span> larvae (ADL paste), (iii) whole blanched, and freeze-dried<span>A. diaperinus</span> larvae (ADL dried), and (iv) powder from whole blanched, freeze-dried and ground<span>A. diaperinus</span> larvae (ADL powder).</p><p>A minimum 24 hours fasting period is required to allow the larvae to discard their bowel content before killing the insects by a thermal treatment.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Characteristics/Composition (ADL frozen or paste):</span></p><div><p>Ash (% w/w): &#8804;&#160;1,5</p></div><div><p>Moisture (% w/w): 65-80</p></div><div><p>Crude protein (N &#215; 6,25) (% w/w): 12-25</p></div><div><p>Digestible Carbohydrates (% w/w): 0,4-2</p></div><div><p>Fat (% w/w): 5-12</p></div><div><p>Peroxide value (Meq O<span>2</span>/kg fat): &#8804;&#160;0,2</p></div><div><p>Dietary fibre (% w/w): 1-4</p></div><div><p>&#160;<a>(<span>27</span>)</a>Chitin (% w/w): 1,0-2,6</p></div><p><span>Heavy metals:</span></p><div><p>Lead: &#8804;&#160;0,1&#160;mg/kg</p></div><div><p>Cadmium: &#8804;&#160;0,05&#160;mg/kg</p></div><p><span>Mycotoxins:</span></p><div><p>Aflatoxins (Sum of B1, B2, G1, G2): &#8804;&#160;4 &#956;g/kg</p></div><div><p>Aflatoxin B1 (&#956;g/kg): &#8804;&#160;2</p></div><div><p>Deoxynivalenol: &#8804;&#160;200 &#956;g/kg</p></div><div><p>Ochratoxin A: &#8804;&#160;1 &#956;g/kg</p></div><p><span>Microbiological criteria:</span></p><div><p>Total aerobic colony count: &#8804;&#160;10<span>5</span>&#160;<a>(<span>25</span>)</a>CFU/g</p></div><div><p>Yeasts and moulds: &#8804;&#160;100 CFU/g</p></div><div><p><span>Escherichia coli</span>: &#8804;&#160;50 CFU/g</p></div><div><p><span>Salmonella</span> spp.: Absence in&#160;25 g</p></div><div><p><span>Listeria monocytogenes</span>: Absence in&#160;25 g</p></div><div><p>Sulphite-reducing Anaerobes: &#8804;&#160;30 CFU/g</p></div><div><p><span>Bacillus cereus</span>: &#8804;&#160;100 CFU/g</p></div><div><p>Enterobacteriaceae: &#8804;&#160;100 CFU/g</p></div><div><p>Coagulase-positive<span>staphylococci</span>: &#8804;&#160;100 CFU/g</p></div></td><td><p><span>Characteristics/Composition (ADL dried or powder):</span></p><div><p>Ash (% w/w): &#8804;&#160;5</p></div><div><p>Moisture (% w/w): 1-5</p></div><div><p>Crude protein (N &#215; 6,25) (% w/w): 50-70</p></div><div><p>Digestible Carbohydrates (% w/w): 1,5-3,5</p></div><div><p>Fat (% w/w): 20-35</p></div><div><p>Peroxide value (Meq O<span>2</span>/kg fat): &#8804;&#160;5</p></div><div><p>Dietary fibre (% w/w): 3-6</p></div><div><p>&#160;<a>(<span>27</span>)</a>Chitin (% w/w): 3,0-9,1</p></div><p><span>Heavy metals:</span></p><div><p>Lead: &#8804;&#160;0,1&#160;mg/kg</p></div><div><p>Cadmium: &#8804;&#160;0,05&#160;mg/kg</p></div><p><span>Mycotoxins:</span></p><div><p>Aflatoxins (Sum of B1, B2, G1, G2): &#8804;&#160;4 &#956;g/kg</p></div><div><p>Aflatoxin B1 (&#956;g/kg): &#8804;&#160;2</p></div><div><p>Deoxynivalenol: &#8804;&#160;200 &#956;g/kg</p></div><div><p>Ochratoxin A: &#8804;&#160;1 &#956;g/kg</p></div><p><span>Microbiological criteria:</span></p><div><p>Total aerobic colony count: &#8804;&#160;10<span>5</span> CFU/g</p></div><div><p>Yeasts and moulds: &#8804;&#160;100 CFU/g</p></div><div><p><span>Escherichia coli</span>: &#8804;&#160;50 CFU/g</p></div><div><p><span>Salmonella</span> spp.: Absence in&#160;25 g</p></div><div><p><span>Listeria monocytogenes</span>: Absence in&#160;25 g</p></div><div><p>Sulfite-reducing Anaerobes: &#8804;&#160;30 CFU/g</p></div><div><p><span>Bacillus cereus</span>: &#8804;&#160;100 CFU/g</p></div><div><p>Enterobacteriaceae: &#8804;&#160;100 CFU/g</p></div><div><p>Coagulase-positive<span>staphylococci</span>: &#8804;&#160;100 CFU/g</p></div></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><a>&#9660;M24</a></p></td></tr><tr><td><p><span>Antarctic Krill oil from</span><span><span>Euphausia superba</span></span></p></td><td><p><span>Description/Definition:</span></p><p>To produce lipid extract from Antarctic Krill (<span>Euphausia superba</span>) deep-frozen crushed krill or dried krill meal is subjected to lipid extraction with an approved extraction solvent (under Directive 2009/32/EC). Proteins and krill material are removed from the lipid extract by filtration. The extraction solvents and residual water are removed by evaporation.</p><p>Saponification value: &#8804; 230 mg KOH/g</p><p>Peroxide value (PV): &#8804; 3 meq O<span>2</span>/kg oil</p><p>Oxidative stability: All food products containing Antarctic Krill oil from<span>Euphausia superba</span> should demonstrate oxidative stability by appropriate and recognised national/international test methodology (e.g. AOAC).</p><p>Moisture and volatiles: &#8804; 3 % or 0,6 expressed as water activity at 25 &#176;C</p><p>Phospholipids: &#8805; 35 % to &lt; 60 %</p><p>Trans-fatty acids: &#8804; 1 %</p><p>EPA (eicosapentaenoic acid): &#8805; 9 %</p><p>DHA (docosahexaenoic acid): &#8805; 5 %</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Antarctic Krill oil rich in phospholipids from<span>Euphausia superba</span></span></p></td><td><p><span>Description/Definition:</span></p><p>Oil rich in phospholipids is produced from Antarctic krill (<span>Euphausia superba</span>) by repeated solvent washings with an approved solvent (under Directive 2009/32/EC) to increase phospholipid content of the oil. Solvents are removed from the final product by evaporation.</p><p>Saponification value: &#8804; 230 mg KOH/g</p><p>Peroxide value (PV): &#8804; 3 meq O<span>2</span>/kg oil</p><p>Moisture and volatiles: &#8804; 3 % or 0,6 expressed as water activity at 25 &#176;C</p><p>Phospholipids: &#8805; 60 %</p><p>Trans-fatty acids: &#8804; 1 %</p><p>EPA (eicosapentaenoic acid): &#8805; 9 %</p><p>DHA (docosahexaenoic acid): &#8805; 5 %</p></td></tr><tr><td><p><a>&#9660;M97</a></p></td></tr><tr><td><p><span><span>Antrodia camphorata</span> mycelia powder</span></p></td><td><p><span>Description/Definition:</span></p><p>The novel food is the freeze-dried mycelia of the fungus<span>Antrodia camphorata</span> (strain BCRC 39106), which has been grown by solid-state cultivation. The freeze-dried mycelia are then milled into a powder.<span>Antrodia camphorata</span> is a synonym of<span>Taiwanofungus camphoratus</span> (family: Fomitopsidaceae).</p><p><span>Characteristics/Composition:</span></p><p>Loss on drying (Moisture): &lt;&#160;10&#160;%</p><p>Carbohydrates: &#8804;&#160;80 g/100 g</p><p>Protein: &#8804;&#160;20 g/100 g</p><p>Ash: &#8804;&#160;6 g/100g</p><p>Fat: &#8804;&#160;6 g/100 g</p><p>Total triterpenoids: 1,0 &#8211; 10,0&#160;g/100 g</p><p>Antroquinonol: 1,0 &#8211; 20,0&#160;mg/g</p><p><span>Heavy metals:</span></p><p>Arsenic: &lt;&#160;0,5&#160;mg/kg</p><p><span>Microbiological criteria:</span></p><p>Total aerobic microbial count: &#8804;&#160;10<span>3 *</span>CFU/g</p><p>Total yeast and mould count: &#8804;&#160;100 CFU/g</p><p><span>Escherichia coli</span>: Not detected in&#160;10 g</p><p><span>Salmonella</span> spp.: Not detected in&#160;25 g</p><p><span>Staphylococcus aureus</span>: Not detected in&#160;10 g</p><p>*CFU: Colony Forming Units</p></td></tr><tr><td><p><a>&#9660;M120</a></p></td></tr><tr><td><p><span>Aqueous ethanolic extract of<span>Labisia pumila</span></span></p></td><td><p><span>Description/Definition:</span></p><p>The novel food is a hydroalcoholic extract obtained from a dried whole plant of<span>Labisia pumila</span> (Blume) Fern.-Vill.</p><p>The production process of the novel food starts with washing, drying and grinding of the plant<span>Labisia pumila</span>. The ground plant material is then extracted twice with a mixture of water and ethanol&#160;(50/50 v/v). The liquid extract is then concentrated, mixed with maltodextrin (which is used as a drying aid) in a ratio of&#160;2:1 and spray-dried.</p><p><span>Characteristics/composition (including maltodextrin):</span></p><div><p>Particle size: &gt; 90&#160;% through 120 mesh (125 &#956;m)</p></div><div><p>Ash: &lt; 10&#160;%</p></div><div><p>Acid-insoluble ash: &lt; 1&#160;%</p></div><div><p>Moisture: &lt; 8&#160;%</p></div><div><p>Ethanol: &lt; 1&#160;% (w/w)</p></div><div><p>Gallic acid: 2-10&#160;% (w/w)</p></div><div><p>Carbohydrate: 70-90&#160;g/100 g</p></div><div><p>Protein: &lt; 9&#160;% (w/w)</p></div><div><p>Total fat: &lt; 3&#160;% (w/w)</p></div><div><p>Saponin (as ardisiacripsin A): &lt; 1,5&#160;% (w/w)</p></div><p><span>Microbiological criteria:</span></p><div><p>Aerobic plate count: &lt; 1&#215;10<span>4</span> CFU/g</p></div><div><p>Yeast and mould: &lt; 5&#215;10<span>2</span> CFU/g</p></div><div><p><span>E. coli</span>: not detected in&#160;10 g</p></div><div><p><span>S.aureus</span>: not detected in&#160;10 g</p></div><div><p>Salmonella: not detected in&#160;25 g</p></div><div><p><span>P. aeruginosa</span>: not detected in&#160;10 g</p></div><p>cfu: colony forming units</p><p>w/w: weight per weight</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Arachidonic acid-rich oil from the fungus<span>Mortierella alpina</span></span></p></td><td><p><span>Description/Definition:</span></p><p>The clear yellow arachidonic acid-rich oil is obtained by fermentation of the non-genetically modified strains IS-4, I49-N18, FJRK-MA01 and CBS 210.32 of the fungus<span>Mortierella alpina</span> using a suitable liquid. The oil is then extracted from the biomass and purified.</p><p>Arachidonic acid: &#8805; 40 % by weight of the total fatty acid content</p><p>Free fatty acids: &#8804; 0,45 % of the total fatty acid content</p><p>Trans fatty acids: &#8804; 0,5 % of the total fatty acid content</p><p>Unsaponifiable matter: &#8804; 1,5 % Peroxide value (PV): &#8804; 5 meq/kg</p><p>Anisidin value: &#8804; 20</p><p>Acid value: &#8804; 1,0 KOH/g</p><p>Moisture: &#8804; 0,5 %</p></td></tr><tr><td><p><span>Argan oil from<span>Argania spinosa</span></span></p></td><td><p><span>Description/Definition:</span></p><p>Argan oil is the oil obtained by cold pressing of the almond like kernels of the fruits of<span>Argania spinosa</span> (L.) Skeels. Kernels may be roasted prior to pressing, but with no direct contact with a flame.</p><p><span>Composition:</span></p><p>Palmitic acid (C16:0): 12-15 %</p><p>Stearic acid (C18:0): 5-7 %</p><p>Oleic acid (C18:1): 43-50 %</p><p>Linoleic acid (C18:2): 29-36 %</p><p>Unsaponifiable matter: 0,3-2 %</p><p>Total sterols: 100-500 mg/100 g</p><p>Total tocopherols: 16-90 mg/100 g</p><p>Oleic acidity: 0,2-1,5 %</p><p>Peroxide value (PV): &lt; 10 meq O<span>2</span>/kg</p></td></tr><tr><td><p><span>Astaxanthin-rich oleoresin from<span>Haematococcus pluvialis</span> algae</span></p></td><td><p><span>Description/Definition:</span></p><p>Astaxanthin is a carotenoid produced by<span>Haematococcus pluvialis</span> algae. Production methods for the growth of the algae are variable; using either closed systems exposed to sunlight or strictly controlled illuminated light; alternatively open ponds may be used. The algal cells are harvested and dried; the oleoresin is extracted using either super critical CO<span>2</span> or a solvent (ethyl acetate). The Astaxanthin is diluted and standardized to 2,5 %, 5,0 %, 7,0 %, 10 %, 15 % or 20 % using olive oil, safflower oil, Sunflower oil or MCT (Medium Chain Triglycerides).</p><p><span>Composition of the Oleoresin:</span></p><p>Fat: 42,2- 99 %</p><p>Protein: 0,3-4,4 %</p><p>Carbohydrate: 0-52,8 %</p><p>Fibre: &lt; 1,0 %</p><p>Ash: 0,0-4,2 %</p><p>Specification of Carotenoids w/w%</p><p>Total Astaxanthins: 2,9-11,1 % 9-cis-astaxanthin: 0,3-17,3 %</p><p>13-cis-astaxanthin: 0,2-7,0 %</p><p>Astaxanthin monoesters: 79,8-91,5 %</p><p>Astaxanthin diesters: 0,16-19,0 %</p><p>&#914;-Carotene: 0,01-0,3 %</p><p>Lutein: 0-1,8 %</p><p>Canthaxanthin: 0-1,30 %</p><p><span>Microbiological criteria:</span></p><p>Total aerobic bacteria: &lt; 3&#160;000  CFU/g</p><p>Yeast and Moulds: &lt; 100 CFU/g</p><p>Coliforms: &lt; 10 CFU/g</p><p><span>E. coli</span>: Negative</p><p><span>Salmonella</span>: Negative</p><p><span>Staphylococcus</span>: Negative</p></td></tr><tr><td><p><span>Basil seeds (<span>Ocimum basilicum</span>)</span></p></td><td><p><span>Description/Definition:</span></p><p>Basil (<span>Ocimum basilicum</span> L.) belongs to the family &#8216;<span>Lamiaceae</span>&#8217; within the order &#8216;Lamiales&#8217;. Post-harvest the seeds are cleaned mechanically. Flowers, leaves and other parts of the plant are removed. Highest level of purity of Basil seeds has to be ensured by filtering (optical, mechanical). Production process of fruit juice and fruit/vegetable blend beverages containing Basil seeds (<span>Ocimum basilicum</span> L.) includes seed pre-hydration and pasteurisation steps. Microbiological controls and monitoring systems are in place.</p><p>Dry Matter: 94,1 %</p><p>Protein: 20,7 %</p><p>Fat: 24,4 %</p><p>Carbohydrate: 1,7 %</p><p>Dietary Fibre: 40,5 % (Method: AOAC 958,29)</p><p>Ash: 6,78 %</p></td></tr><tr><td><p><a>&#9660;M33</a></p></td></tr><tr><td><p><span>Betaine</span></p></td><td><p><span>Description/Definition:</span></p><p>Betaine (N,N,N-trimethylglycine or carboxy-N,N,N-trimethylmethanaminium), in anhydrous (CH<span>3</span>)<span>3</span>N<span>+</span>CH<span>2</span>COO<span>&#8211;</span> (CAS No: 107-43-7) and monohydrate (CH<span>3</span>)3N<span>+</span>CH<span>2</span>COO<span>&#8211;</span>.H<span>2</span>O (CAS No: 590-47-6) forms is obtained from processing of sugar beets (i.e. molasses, vinasses or betaine-glycerol).</p><p><span>Characteristics/Composition</span></p><p>Appearance: Free-flowing white crystals</p><p>Betaine: &#8805; 99,0 % (w/w on dry weight basis)</p><p>Moisture: &#8804; 2,0 % (anhydrous); &#8804; 15,0 % (monohydrate)</p><p>Ash: &#8804; 0,1 %</p><p>pH: 5,0-7,0</p><p>Residual protein: &#8804; 1,0 mg/g</p><p><span>Heavy metals:</span></p><p>Arsenic: &lt; 0,1 mg/kg</p><p>Mercury: &lt; 0,005 mg/kg</p><p>Cadmium: &lt; 0,01 mg/kg</p><p>Lead: &lt; 0,05 mg/kg</p><p><span>Microbiological criteria:</span></p><p>Total viable count: &#8804; 100 CFU/g</p><p>Coliforms: Negative/10 g</p><p><span>Salmonella</span> sp.: Negative/25 g</p><p>Yeast: &#8804; 10 CFU/g</p><p>Mould: &#8804; 10 CFU/g</p><p>CFU: Colony Forming Units.</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Fermented black bean extract</span></p></td><td><p><span>Description/Definition:</span></p><p>Fermented black bean extract (Touchi extract) is a fine light-brown protein-rich powder obtained by water extraction of small soybeans (<span>Glycine max (L.) Merr.</span>) fermented with<span>Aspergillus oryzae</span>. The extract contains an &#945;-glucosidase inhibitor.</p><p><span>Characteristics:</span></p><p>Fat: &#8804; 1,0 %</p><p>Protein: &#8805; 55 % Water: &#8804; 7,0 %</p><p>Ash: &#8804; 10 %</p><p>Carbohydrate: &#8805; 20 %</p><p>&#945;-glucosidase inhibitory activity: IC50 min 0,025 mg/ml</p><p>Soy isoflavone: &#8804; 0,3 g/100 g</p></td></tr><tr><td><p><span>Bovine lactoferrin</span></p></td><td><p><span>Description/Definition:</span></p><p>Bovine lactoferrin is a protein that occurs naturally in cows&#8217; milk. It is an iron-binding glycoprotein of approximately 77 kDa and consists of a single polypeptide chain of 689 amino acids.</p><p>Production process: Bovine lactoferrin is isolated from skimmed milk or cheese whey via ion exchange and subsequent ultra-filtration steps. Finally, it is dried by freeze drying or spraying and the large particles are sieved out. It is a virtually odourless, light pinkish powder.</p><p><span>Physical-Chemical properties of Bovine lactoferrin:</span></p><p>Moisture: &lt; 4,5 %</p><p>Ash: &lt; 1,5 %</p><p>Arsenic: &lt; 2,0 mg/kg</p><p>Iron: &lt; 350 mg/kg</p><p>Protein: &gt; 93 %</p><p>of which bovine lactoferrin: &gt; 95 %</p><p>of which other proteins: &lt; 5,0 %</p><p>pH (2 % solution, 20 &#176;C): 5,2-7,2</p><p>Solubility (2 % solution, 20 &#176;C): complete</p></td></tr><tr><td><p><a>&#9660;M35</a></p></td></tr><tr><td><p>Bovine milk basic whey protein isolate</p></td><td><p><span>Description</span></p><p>Bovine milk basic whey protein isolate is a yellowish grey powder obtained from bovine skimmed milk via a series of isolation and purification steps.</p><p><span>Characteristics/Composition</span></p><p>Total protein (w/weight of product): &#8805; 90 %</p><p>Lactoferrin (w/weight of product): 25-75 %</p><p>Lactoperoxidase (w/weight of product): 10-40 %</p><p>Other proteins (w/weight of product): &#8804; 30 %</p><p>TGF-&#946;2: 12-18 mg/100 g</p><p>Moisture: &#8804; 6,0 %</p><p>pH (5 % solution w/v): 5,5 &#8211; 7,6</p><p>Lactose: &#8804; 3,0 %</p><p>Fat: &#8804; 4,5 %</p><p>Ash: &#8804; 3,5 %</p><p>Iron: &#8804; 25 mg/100 g</p><p><span>Heavy Metals</span></p><p>Lead: &lt; 0,1 mg/kg</p><p>Cadmium: &lt; 0,2 mg/kg</p><p>Mercury: &lt; 0,6 mg/kg</p><p>Arsenic: &lt; 0,1 mg/kg</p><p><span>Microbiological criteria:</span></p><p>Aerobic mesophilic count: &#8804; 10&#160;000  CFU/g</p><p><span>Enterobacteriaceae</span>: &#8804; 10 CFU/g</p><p><span>Escherichia coli</span>: Negative/g</p><p>Coagulase positive<span>Staphylococci:</span> Negative/g</p><p><span>Salmonella</span>: Negative/25 g</p><p><span>Listeria</span>: Negative/25 g</p><p><span>Cronobacter</span> spp.: Negative/25 g</p><p>Moulds: &#8804; 50 CFU/g</p><p>Yeasts: &#8804; 50 CFU/g</p><p>CFU: Colony Forming Units</p></td></tr><tr><td><p><a>&#9660;M96</a></p></td></tr><tr><td><p><span>Bovine milk beta-lactoglobulin (<span>&#946;</span>-lactoglobulin)</span></p></td><td><p><span>Description:</span></p><p>Beta-lactoglobulin (<span>&#946;</span>-lactoglobulin) protein is a white to cream powder produced from bovine whey by a series of steps involving filtration, concentration, crystallisation, re-dissolution (in water), pH adjustment to acidic or neutral pH, re-concentration and drying.</p><p>CAS number: 9045-23-2</p><p>Molecular weight: 36,7 kDa (dimer); 18,3 kDa (monomer)</p><p><span>Characteristics/Composition:</span></p><p>pH (10&#160;% solution): 3,5-8,0</p><p>Protein (N x 6,38) (%): &#8805;&#160;86,0</p><p>Beta-lactoglobulin (% of protein): &#8805;&#160;90,0</p><p>Lactose (%): &#8804;&#160;1,0</p><p>Fat (%): &#8804;&#160;1,0</p><p>Ash (%): &#8804;&#160;5,0</p><p>Moisture (%): &#8804;&#160;5,5</p><p><span>Heavy Metals</span>:</p><p>Cadmium (mg/kg): &lt;&#160;0,2</p><p>Lead (mg/kg): &lt;&#160;0,1</p><p>Mercury (mg/kg): &lt;&#160;0,01</p><p><span>Contaminants:</span></p><p>Aflatoxin M1 (&#956;g/kg): &lt;&#160;0,01</p><p><span>Microbiological criteria:</span></p><p>Total plate count: &#8804;&#160;5&#160;000  CFU/g</p><p>Total yeast/moulds count: &#8804;&#160;10 CFU/g</p><p>Enterobacteriaceae: &#8804;&#160;10 CFU/g</p><p><span>Salmonella</span> spp.: Absent in&#160;25 g</p><p><span>Bacillus cereus</span>: &lt;&#160;100 CFU/g</p><p><span>Listeria monocytogenes</span>: Absent in&#160;25 g</p><p><span>Staphylococcus aureus</span>: &lt;&#160;10 CFU/g</p><p>Sulfite-reducing clostridia: &lt;&#160;10 CFU/g</p><p>CFU: Colony Forming Units; kDa: kiloDaltons</p></td></tr><tr><td><p><a>&#9660;M107</a></p></td></tr><tr><td><p><span>Bovine milk osteopontin</span></p></td><td><p><span>Description</span></p><p>Bovine milk osteopontin is isolated from pasteurised or microfiltered bovine whey or milk by ion exchange chromatography, ultrafiltration to remove low molecular weight components and spray drying. During this filtration steps lactose and whey proteins predominantly alpha-lactalbumin and beta lactoglobulin are removed.</p><p><span>Characteristics/Composition</span></p><p>Protein % as is (N &#215; 6,38): 76,5&#8211;80,5</p><p>Bovine milk osteopontin (bmOPN) (% of protein): &#8805;&#160;84,5</p><p>Full-length bmOPN (MW 33,9 kDa) (% of bmOPN): &#8805;&#160;15</p><p>N-terminal fragment bmOPN (MW 19,8 kDa) (% of bmOPN): &#8805;&#160;70</p><p>Other milk protein (% of protein): &#8804;&#160;14,5</p><p>Moisture: &lt;&#160;9,5&#160;%</p><p>Lactose: &#8804;&#160;1,0&#160;%</p><p>Fat: &#8804;&#160;1,0&#160;%</p><p>Ash: &#8804;&#160;11&#160;%</p><p>Insolubility index (mL) &#8804;&#160;1,0</p><p><span>Heavy metals</span></p><p>Lead: &lt;&#160;0,05&#160;mg/kg</p><p>Cadmium: &lt;&#160;0,05&#160;mg/kg</p><p>Mercury: &lt;&#160;0,05&#160;mg/kg</p><p>Arsenic: &lt;&#160;0,5&#160;mg/kg</p><p>Aflatoxin M1 &lt;&#160;0,1&#160;&#956;g/kg</p><p><span>Microbiological criteria</span></p><p>Total plate count (30&#160;&#176;C)&#160;(CFU/g): &#8804;&#160;5&#160;000</p><p>Mould/yeast (CFU/g): &#8804;&#160;100</p><p><span>Bacillus cereus</span> (CFU/g): &lt;&#160;50</p><p>Sulfur-reducing Clostridia&#160;(CFU/g): &lt;&#160;10</p><p><span>Staphylococcus aureus</span>: Not detected in&#160;1 g</p><p>Enterobacteriaceae (CFU/g): &lt;&#160;10</p><p><span>Salmonella</span> spp.: Not detected in&#160;25 g</p><p>CFU: Colony Forming Units</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span><span>Buglossoides arvensis</span> seed oil</span></p></td><td><p><span>Description/Definition:</span></p><p>Refined Buglossoides oil is extracted from the seeds of<span>Buglossoides arvensis</span> (L.) I.M.Johnst</p><p>Alpha-linolenic acid: &#8805; 35 % w/w of total fatty acids</p><p>Stearidonic acid: &#8805; 15 % w/w of total fatty acids</p><p>Linoleic acid: &#8805; 8,0 % w/w of total fatty acids</p><p>Trans fatty acids: &#8804; 2,0 % w/w of total fatty acids</p><p>Acid value: &#8804; 0,6 mg KOH/g</p><p>Peroxide value (PV): &#8804; 5,0 meq O<span>2</span>/kg</p><p>Unsaponifiable content: &#8804; 2,0 %</p><p>Protein content (total nitrogen): &#8804; 10 &#956;g/ml</p><p>Pyrrolizidine alkaloids: Not detectable with a detection limit of 4,0 &#956;g/kg</p></td></tr><tr><td><p><a>&#9660;M91</a></p></td></tr><tr><td><p><span><span>Calanus finmarchicus</span> oil</span></p></td><td><p><span>Description/Definition:</span></p><p>The novel food is ruby coloured, slightly viscous oil with a slight shellfish odour extracted from the crustacean (marine zooplankton)<span>Calanus finmarchicus</span>. The ingredient consists primarily of wax esters (&gt;&#160;85&#160;%) with minor amounts of triglycerides and other neutral lipids.</p><p><span>Specifications:</span></p><p>Water: &lt;&#160;1,0&#160;%</p><p>Wax esters: &gt;&#160;85&#160;%</p><p>Total fatty acids: &gt;&#160;46&#160;%</p><p>Eicosapentaenoic acid (EPA): &gt;&#160;3,0&#160;%</p><p>Docosahexaenoic acid (DHA): &gt;&#160;4,0&#160;%</p><p>Total fatty alcohols: &gt;&#160;28&#160;%</p><p>C20:1 n-9 fatty alcohol: &gt;&#160;9,0&#160;%</p><p>C22:1 n-11 fatty alcohol: &gt;&#160;12&#160;%</p><p>Trans fatty acids: &lt;&#160;1,0&#160;%</p><p>Astaxanthin esters: &#8804;&#160;0,25&#160;%</p><p>Peroxide value (PV): &lt;&#160;3,0 meq. O<span>2</span>/kg</p></td></tr><tr><td><p><a>&#9660;M77</a></p></td></tr><tr><td><p>Calcium fructoborate</p></td><td><p><span>Description/Definition</span></p><p>The novel food is calcium fructoborate, a calcium salt tetrahydrate of a bis(fructose) ester of boric acid in the form of a powder, represented by Ca[(C6H10O6)2B]2&#8226;4H2O, with a molecular mass of 846 Da.</p><p>The novel food is produced by chemical synthesis whereby fructose is combined with boric acid in water to produce a bis(fructose) ester of boric acid through various heating and mixing processes. Calcium carbonate is then added to produce a solution containing the calcium salt of fructoborate (tetrahydrate). The solution is freeze-dried, ground to produce the final powdered product, and then packaged and stored under representative storage conditions (22 &#177; 1&#176;C RH 55-60&#160;%).</p><p><span>Characteristics/composition</span></p><p>Free moisture: &lt; 5,0&#160;%</p><p>Calcium: 4,5-5&#160;%</p><p>Boron: 2,5-2,9&#160;%</p><p>Fructose: 80-85&#160;%</p><p>Ash: 15-16&#160;%</p><p><span>Heavy metals</span></p><p>Arsenic: &#8804; 1 mg/kg</p><p><span>Microbiological criteria</span></p><p>Total plate count: &#8804; 1&#160;000  CFU/g<span>(a)</span></p><p>Yeast and mould: &lt; 100 CFU/g</p><p>Coliforms: &#8804; 10 CFU/g</p><p><span>Escherichia coli</span>: &lt; 10 CFU/g</p><p><span>Salmonella</span> spp.: Absence in&#160;25 g</p><p>Coagulase-positive staphylococci: Absence in&#160;1 g</p><p>(a)&#160;&#160;CFU: colony forming units</p></td></tr><tr><td><p><a>&#9660;M85</a></p></td></tr><tr><td><p><span>Calcium L-Methylfolate</span></p></td><td><p><span>Description:</span></p><p>The novel food is produced by chemical synthesis starting from folic acid.</p><p>It is a white to light yellowish, almost odourless, crystalline powder, sparingly soluble in water and very slightly soluble or insoluble in most organic solvents.</p><p><span>Definition:</span></p><p>Chemical formula: C<span>20</span>H<span>23</span>CaN<span>7</span>O<span>6</span></p><p>Systematic name: N-{4-[[((6S)-2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl)methyl]amino]benzoyl}-L-glutamic acid, calcium salt.</p><p>CAS Numbers: 129025-21-4 (Calcium salt with an unspecified ratio of L-5-MTHF/Ca<span>2+</span>) and&#160;151533-22-1 (Calcium salt with specified 1:1 ratio of L-5-MTHF/Ca<span>2+</span>).</p><p>Molecular weight: 497,5 Daltons</p><p>Synonyms: L-methylfolate, calcium; L-5-methyltetrahydrofolic acid, calcium salt [(L-5-MTHF-Ca)]; (6S)-5-methyltetrahydrofolic acid, calcium salt [(6S)-5-MTHF-Ca]; (6S)-5-methyl-5,6,7,8-tetrahydropteroyl-L-glutamic acid, calcium salt, and L-5-methyl-tetrahydrofolic acid (L-5-MTHF) without the cation specified.</p><p>Structural formula:</p><p><img/></p><p><span>Characteristics</span></p><p>Purity: &gt;&#160;95&#160;% (Dry basis)</p><p>Water: &#8804;&#160;17,0&#160;%</p><p>Calcium (on anhydrous and solvent free basis): 7,0 &#8211; 8,5&#160;%</p><p>Calcium D-methylfolate (6R, &#945;S isomer): &#8804;&#160;1,0&#160;%</p><p>Other folates and related substances: &#8804;&#160;2,5&#160;%</p><p>Ethanol: &#8804;&#160;0,5&#160;%</p><p><span>Contaminants</span></p><p>CFU: colony forming units</p></td></tr><tr><td><p>Infants and young children</p></td><td><p>General population excluding infants and young children</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Lead: &#8804;&#160;1 mg/kg</p></td><td><p>Lead: &#8804;&#160;1 mg/kg</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Boron: &#8804;&#160;10 mg/kg</p></td><td><p>Boron: &#8804;&#160;10 mg/kg</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Cadmium &#8804;&#160;0,5&#160;mg/kg</p></td><td><p>Cadmium &#8804;&#160;0,5&#160;mg/kg</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Mercury &#8804;&#160;1,0&#160;mg/kg</p></td><td><p>Mercury &#8804;&#160;1,5&#160;mg/kg</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Arsenic &#8804;&#160;1,5&#160;mg/kg</p></td><td><p>Arsenic &#8804;&#160;1,5&#160;mg/kg</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Platinum &#8804;&#160;2 mg/kg</p></td><td><p>Platinum &#8804;&#160;10 mg/kg</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Microbiological criteria:</span></p><p>Total viable aerobic counts: &#8804;&#160;1&#160;000  CFU/g</p><p>Total yeast and mould count: &#8804;&#160;100 CFU/g</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><a>&#9660;M106</a></p></td></tr><tr><td><p>Dried nuts of<span>Canarium ovatum</span> Engl.</p></td><td><p><span>Description/Definition:</span></p><p>The traditional food consists of the unroasted dried nuts of<span>Canarium ovatum</span> Engl. (family: Burseraceae) commonly known as Pili nuts. Pili nuts are produced only by plants of<span>Canarium ovatum</span> Engl. varieties Laysa, Magnaye, M. Orolfo, Lanuza and Magayon and can be placed on the market with or without the shell. The edible part of the nut is the kernel.</p><p><span>Typical composition range:</span></p><div><p>Fat: 57-73&#160;%</p></div><div><p>Protein: 11-15&#160;%</p></div><div><p>Water: 1-5&#160;%</p></div><div><p>Carbohydrates: 8-16,5&#160;%</p></div><div><p>Ash: 2,8-3,4&#160;%</p></div><p><span>Microbiological criteria:</span></p><div><p>Moulds and yeasts: &#8804;&#160;100 CFU/g</p></div><div><p>Total colony count at 30&#160;&#176;C: &#8804;&#160;10&#160;000  CFU/g</p></div><div><p>Coliforms: &#8804;&#160;100 CFU/g</p></div><div><p><span>Escherichia coli</span>: &#8804;&#160;10 CFU/g</p></div><div><p><span>Staphylococcus aureus</span>: Absence in&#160;25 g</p></div><div><p><span>Salmonella</span> spp.: Absence in&#160;25 g</p></div><div><p><span>Listeria monocytogenes</span>: Absence in&#160;25 g</p></div><div><p>Sulphite reducing anaerobes: &#8804;&#160;10 CFU/g</p></div><p>CFU: Colony Forming Units</p></td></tr><tr><td><p><a>&#9660;M109</a></p></td></tr><tr><td><p><span><span>Canarium indicum</span> L. dried nuts (Kenari) (Traditional food from a third country)</span></p></td><td><p><span>Description/Definition:</span></p><p>The traditional food is processed dried kenari nuts. The term &#8216;Kenari Nuts&#8217; refers to the kernels of ripe Kenari Fruit, scientifically known as<span>Canarium indicum</span> L. (or<span>Canarium amboinense</span> Hochr.; family: Burseraceae).</p><p><span>Composition:</span></p><div><p>Ash: &#8804;&#160;5&#160;(g/100&#160;g)</p></div><div><p>Moisture: &#8804;&#160;6&#160;(g/100&#160;g)</p></div><div><p>Protein: 12,8 &#8211; 14,4&#160;g/100&#160;g</p></div><div><p>Carbohydrates: 11,0 &#8211; 16,4&#160;g/100&#160;g</p></div><div><p>Fat: 59,3 &#8211; 66,3&#160;g/100&#160;g</p></div><div><p>Dietary fibre: 4,4 &#8211; 9,8&#160;g/100&#160;g</p></div><p><span>Microbiological criteria:</span></p><div><p>Aerobic Plate Count: &#8804;&#160;5,0 &#215; 10<span>3</span> CFU/g</p></div><div><p>Coliforms: &lt;&#160;3&#160;MPN/g</p></div><div><p>E. coli: &lt;&#160;3&#160;MPN/g</p></div><div><p>Yeasts and moulds: &lt;&#160;10&#160;CFU/g</p></div><div><p><span>Salmonella</span>: Absent in&#160;25&#160;g</p></div><div><p><span>Staphylococcus aureus</span> (absent/25&#160;g)</p></div><div><p><span>Listeria monocytogenes</span> (absent/25&#160;g)</p></div><div><p><span>Aflatoxins</span></p></div><div><p>Aflatoxins B1: &#8804;&#160;2&#160;mcg/kg</p></div><div><p>Aflatoxins (Sum of B1, B2, G1, G2): &#8804;&#160;4&#160;mcg/kg</p></div><div><p><span>Dioxins and dioxin like PCBs</span></p></div><div><p>Sum of dioxins: &#8804;&#160;0,75&#160;pg/g fat</p></div><div><p>Sum of dioxins and dioxin-like PCBs: &#8804;&#160;1,5&#160;pg/g fat</p></div><div><p><span>Heavy metals</span></p></div><div><p>Cadmium (Cd): &#8804;&#160;0,02&#160;mg/kg</p></div><div><p>Lead (Pb): &#8804;&#160;0,07&#160;mg/kg</p></div><p>CFU: Colony Forming Units</p></td></tr><tr><td><p><a>&#9660;M114</a></p></td></tr><tr><td><p><span>Cellobiose</span></p></td><td><p><span>Description/Definition:</span></p><p>Cellobiose is a disaccharide with two glucose monomers linked by a &#946;-(1&#8211;4) glucosidic bond, that is produced from sucrose and glucose in a two-step enzymatic reaction, followed by a series of purification steps.</p><p><span>Characteristics/composition:</span></p><p>Cellobiose DM (%): &#8805;&#160;99</p><p>Moisture (%): &lt;&#160;1</p><p>Other identified sugars (%): &#8804;&#160;1</p><p>Optical rotation [&#945;]<span>D</span> (c 10, water): +33&#8211;36</p><p>Ash&#160;(g/100 g): &lt;&#160;0,1</p><p>Protein content&#160;(g/100 g): &lt;&#160;0,01</p><p><span>Heavy metals:</span></p><p>Arsenic: &lt;&#160;0,1&#160;mg/kg</p><p><span>Microbiological criteria:</span></p><p>Total aerobic count&#160;(cfu/g): &#8804;&#160;1&#160;000</p><p>Yeast and moulds&#160;(cfu/g): &#8804;&#160;100</p><p>Salmonella (in 25 g): n.d.</p><p>Coliforms&#160;(cfu/g): &#8804;&#160;10</p><p><span>E. coli</span> (in 10 g): n.d.</p><p>cfu: colony forming units</p><p>n.d.: not detected</p></td></tr><tr><td><p><a>&#9660;M82</a></p></td></tr><tr><td><p><span>Cetylated fatty acids</span></p></td><td><p><span>Description/Definition:</span></p><p>The novel food concerns primarily a mixture of cetylated myristic acid and cetylated oleic acid synthesised from cetyl alcohol, myristic acid and oleic acid, and to a lesser degree, other cetylated fatty acids and other compounds from olive oil.</p><p><span>Characteristics/composition:</span></p><p>Ester content: 70-80&#160;%, of which: Cetyl oleate: 22-30&#160;%, Cetyl myristate: 41-56&#160;%</p><p>Triglycerides: 22-25&#160;%</p><p>Acid value (mg KOH/g): &#8804;&#160;5</p><p>Saponification value (mg KOH/g): 130-150</p><p><span>Microbiological criteria:</span></p><p>Total aerobic microbial count: &#8804;&#160;1&#160;000  CFU/g</p><p>Yeasts and moulds: &#8804;&#160;100 CFU/g</p><p>KOH: potassium hydroxide</p><p>CFU: colony forming units</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Chewing gum base (monomethoxypolyethylene glycol)</span></p></td><td><p><span>Description/Definition:</span></p><p>The novel food ingredient is a synthetic polymer (Patent number WO2006016179). It consists of branched polymers of monomethoxypolyethylene glycol (MPEG) grafted onto polyisoprene-graft-maleic anhydride (PIP-g-MA), and unreacted MPEG (less than 35 % by weight).</p><p>White to off-white colour.</p><p>CAS No.: 1246080-53-4</p><p><span>Characteristics:</span></p><p>Moisture: &lt; 5,0 %</p><p>Aluminium: &lt; 3,0 mg/kg</p><p>Lithium: &lt; 0,5 mg/kg</p><p>Nickel: &lt; 0,5 mg/kg</p><p>Residual anhydride: &lt; 15 &#956;mol/g</p><p>Polydispersity index: &lt; 1,4</p><p>Isoprene: &lt; 0,05 mg/kg</p><p>Ethylene oxide: &lt; 0,2 mg/kg</p><p>Free maleic anhydride: &lt; 0,1 %Total oligomeres (less than 1&#160;000  Dalton): &#8804; 50 mg/kg</p><p>Ethylene glycol: &lt; 200 mg/kg</p><p>Diethylene glycol: &lt; 30 mg/kg</p><p>Monoethylene glycol methyl ether: &lt; 3,0 mg/kg</p><p>Diethylene glycol methyl ether: &lt; 4,0 mg/kg</p><p>Triethylene glycol methyl ether: &lt; 7,0 mg/kg</p><p>1,4-Dioxane: &lt; 2,0 mg/kg</p><p>Formaldehyde: &lt; 10 mg/kg</p></td></tr><tr><td><p><span>Chewing gum base (Methyl vinyl ether-maleic anhydride copolymer)</span></p></td><td><p><span>Description/Definition:</span></p><p>Methyl vinyl ether-maleic anhydride copolymer is an anhydrous copolymer of methyl vinyl ether and maleic anhydride.</p><p>Free-flowing, white to white-off powder</p><p>CAS No: 9011-16-9</p><p><span>Purity:</span></p><p>Assay value: At least 99,5 % in dry matter</p><p>Specific viscosity (1 % MEK): 2-10</p><p>Residual methyl vinyl ether: &#8804; 150 ppm</p><p>Residual maleic anhydride: &#8804; 250 ppm</p><p>Acetaldehyde: &#8804; 500 ppm</p><p>Methanol: &#8804; 500 ppm</p><p>Dilauroyl peroxide: &#8804; 15 ppm</p><p>Total heavy metals: &#8804; 10 ppm</p><p><span>Microbiological criteria:</span></p><p>Total aerobic plate count: &#8804; 500 CFU/g</p><p>Mould/yeast: &#8804; 500 CFU/g</p><p><span>Escherichia coli</span>: Negative to test</p><p><span>Salmonella</span>: Negative to test</p><p><span>Staphylococcus aureus:</span> Negative to test</p><p><span>Pseudomonas aeruginosa</span>: Negative to test</p></td></tr><tr><td><p><span>Chia oil from<span>Salvia hispanica</span></span></p></td><td><p><span>Description/Definition:</span></p><p>Chia oil is produced from Chia (<span>Salvia hispanica</span> L.) seeds (99,9 % pure) by cold pressing. No solvents are used and, once pressed, the oil is held in decantation tanks and a filtration process employed to remove impurities. It can also be produced by extraction with supercritical CO<span>2</span>.</p><p><span>Production process:</span></p><p>Produced by cold pressing. No solvents are used and, once pressed, the oil is held in decantation tanks and a filtration process employed to remove impurities.</p><p>Acidity expressed as oleic acid: &#8804; 2,0 %</p><p>Peroxide value (PV): &#8804; 10 meq/kg</p><p>Insoluble impurities: &#8804; 0,05 %</p><p>Alpha linolenic acid: &#8805; 60 %</p><p>Linoleic acid: 15-20 %</p></td></tr><tr><td><p><span>Chia seeds (<span>Salvia hispanica</span>)</span></p></td><td><p><span>Description/Definition:</span></p><p>Chia (<span>Salvia hispanica</span> L.) is a summer annual herbaceous plant belonging to the<span>Labiatae</span> family. Post-harvest the seeds are cleaned mechanically. Flowers, leaves and other parts of the plant are removed.</p><p>Dry matter: 90-97 %</p><p>Protein: 15-26 %</p><p>Fat: 18-39 %</p><p>Carbohydrate (*): 18-43 %</p><p>Crude Fibre(**): 18-43 %</p><p>Ash: 3-7 %</p><p>(*)&#160;&#160;Carbohydrates include the fibre value</p><p>(**)&#160;&#160;Crude fibre is the part of fibre made mainly of indigestible cellulose, pentosans and lignin</p><p><span>Production process:</span></p><p>Production process of fruit juices and fruit juice blends beverages, containing Chia seeds, includes seed pre-hydration and pasteurisation steps. Microbiological controls and monitoring systems are in place.</p></td></tr><tr><td><p><span>Chitin-glucan from<span>Aspergillus niger</span></span></p></td><td><p><span>Description/Definition:</span></p><p>Chitin-glucan is obtained from the mycelium of<span>Aspergillus niger</span>; it is a slightly yellow, odourless, free-flowing powder. It has a dry matter content of 90 % or more.</p><p>Chitin-glucan is composed largely of two polysaccharides:</p><div><p>&#8212;&#160;chitin, composed of repeating units of N-acetyl-D-glucosamine (CAS No: 1398-61-4),</p></div><div><p>&#8212;&#160;beta (1, 3)-glucan, composed of repeating units of D-glucose (CAS No: 9041-22-9).</p></div><p>Loss on drying: &#8804; 10 %</p><p>Chitin-glucan: &#8805; 90 %</p><p>Ratio of chitin to glucan: 30:70 to 60:40</p><p>Ash: &#8804; 3,0 %</p><p>Lipids: &#8804; 1,0 %</p><p>Proteins: &#8804; 6,0 %</p></td></tr><tr><td><p><span>Chitin-glucan complex from<span>Fomes fomentarius</span></span></p></td><td><p><span>Description/Definition:</span></p><p>Chitin-glucan complex is obtained from the cell walls of the fruit bodies of the fungus<span>Fomes fomentarius</span>. It consists primarily of two polysaccharides:</p><div><p>&#8212;&#160;Chitin, composed of repeating units of N-acetyl-D-glucosamine (CAS No: 1398-61-4);</p></div><div><p>&#8212;&#160;Beta-(1,3)(1,6)-D-glucan, composed of repeating units of D-glucose (CAS No: 9041-22-9).</p></div><p>The production process consists of several steps, including: cleaning, reduction in size and grinding, softening in water and heating in an alkaline solution, washing, drying. No hydrolysis is applied during the production process.</p><p>Appearance: Powder, odourless, flavourless, brown</p><p><span>Purity:</span></p><p>Moisture: &#8804; 15 %</p><p>Ash: &#8804; 3,0 %</p><p>Chitin-glucan: &#8805; 90 %</p><p>Ratio of chitin to glucan: 70:20</p><p>Total carbohydrates, excluding glucans: &#8804; 0,1 %</p><p>Proteins: &#8804; 2,0 %</p><p>Lipids: &#8804; 1,0 %</p><p>Melanins: &#8804; 8,3 %</p><p>Additives: None</p><p>pH: 6,7-7,5</p><p><span>Heavy metals:</span></p><p>Lead (ppm): &#8804; 1,00</p><p>Cadmium (ppm): &#8804; 1,00</p><p>Mercury (ppm): &#8804; 0,03</p><p>Arsenic (ppm): &#8804; 0,20<span>Microbiological criteria:</span></p><p>Total mesophilic bacteria: &#8804; 10<span>3</span>/g</p><p>Yeast and moulds: &#8804; 10<span>3</span>/g</p><p>Coliforms at 30 &#176;C: &#8804; 10<span>3</span>/g</p><p><span>E. coli</span>: &#8804; 10/g</p><p><span>Salmonella</span> and other pathogenic bacteria: Absence/25 g</p></td></tr><tr><td><p><span>Chitosan extract from fungi (<span>Agaricus bisporus</span>;<span>Aspergillus niger</span>)</span></p></td><td><p><span>Description/Definition:</span></p><p>The chitosan extract (containing mainly poly(D-glucosamine)) is obtained from stems of<span>Agaricus bisporus</span> or from the mycelium of<span>Aspergillus niger</span>.</p><p>The patented production process consists of several steps, including: extraction and deacetylation (hydrolysis) in alkaline medium, solubilisation in acidic medium, precipitation in alkaline medium, washing and drying.</p><p>Synonym: Poly(D-glucosamine)</p><p>Chitosan CAS number: 9012-76-4</p><p>Chitosan formula: (C<span>6</span>H<span>11</span>NO<span>4</span>)<span>n</span></p><p>Appearance: fine free-flowing powder</p><p>Aspect: Off &#8211;white to slightly brownish</p><p>Odour: Odourless</p><p><span>Purity:</span></p><p>Chitosan content (% w/w dry weight):&#8805; 85</p><p>Glucan content (% w/w dry weight): &#8804; 15</p><p>Loss on drying (% w/w dry weight): &#8804; 10</p><p>Viscosity (1 % in 1 % acetic acid): 1-15</p><p>Degree of acetylation (in % mol/wet weight): 0-30</p><p>Viscosity (1 % in 1 % acetic acid) (mPa.s): 1-14 for chitosan from Aspergillus niger; 12-25 for chitin from<span>Agaricus bisporus</span></p><p>Ash (% w/w dry weight): &#8804; 3,0</p><p>Proteins (% w/w dry weight): &#8804; 2,0</p><p>Particle size: &gt; 100 nm</p><p>Tapped density (g/cm<span>3</span>): 0,7-1,0</p><p>Fat binding capacity 800 &#215; (w/w wet weight): pass<span>Heavy metals:</span></p><p>Mercury (ppm): &#8804; 0,1</p><p>Lead (ppm): &#8804; 1,0</p><p>Arsenic (ppm): &#8804; 1,0</p><p>Cadmium (ppm): &#8804; 0,5</p><p><span>Microbiological criteria:</span></p><p>Aerobic count (CFU/g): &#8804; 10<span>3</span></p><p>Yeast and mould count (CFU/g): &#8804; 10<span>3</span></p><p><span>Escherichia coli</span> (CFU/g): &#8804; 10</p><p>Enterobacteriaceae (CFU/g): &#8804; 10</p><p><span>Salmonella</span>: Absence/25g</p><p><span>Listeria monocytogenes</span>: Absence/25g</p></td></tr><tr><td><p><span>Chondroitin sulphate</span></p></td><td><p><span>Description/Definition:</span></p><p>Chondroitin sulphate (sodium salt) is a biosynthetic product. It is obtained by chemical sulphation of chondroitin derived from fermentation by the bacterium<span>Escherichia coli</span> O5:K4:H4 strain U1-41 (ATCC 23502).</p><p>Chondroitin sulphate (sodium salt) (% dry basis): 95-105</p><p>MWw (weight avg.) (kDa): 5-12</p><p>MWn (number avg.) (kDa): 4-11</p><p>Dispersity (w<span>h</span>/w<span>0,05</span>): &#8804; 0,7</p><p>Sulphation pattern (&#916;Di-6S) (%): &#8804; 85</p><p>Loss on drying (%) (105 &#176;C to constant weight): &#8804; 10,0</p><p>Residue on ignition (% dry basis): 20-30</p><p>Protein (% dry basis): &#8804; 0,5</p><p>Endotoxins (EU/mg): &#8804; 100</p><p>Total organic impurities (mg/kg): &#8804; 50</p></td></tr><tr><td><p><span>Chromium Picolinate</span></p></td><td><p><span>Description/Definition:</span></p><p>Chromium picolinate is a reddish free-flowing powder, slightly soluble in water at pH 7. The salt is also soluble in polar organic solvents.</p><p>Chemical name: tris(2pyridinecarboxylato-N,O)chromium(III) or 2-pyridinecarboxylic acid chromium(III) salt</p><p>CAS No.: 14639-25-9Chemical formula: Cr(C<span>6</span>H<span>4</span>NO<span>2</span>)<span>3</span></p><p>Chemical characteristics:</p><p>Chromium Picolinate: &#8805; 95 %</p><p>Chromium (III): 12-13 %</p><p>Chromium (VI): not detected</p><p>Water: &#8804; 4,0 %</p></td></tr><tr><td><p><a>&#9660;M56</a></p></td></tr><tr><td><p><span>Chromium-containing yeast (<span>Yarrowia lipolytica</span>) biomass</span></p></td><td><p><span>Description/Definition:</span></p><p>The novel food is the dried and heat-killed chromium-containing biomass of the yeast<span>Yarrowia lipolytica</span>.</p><p>The novel food is produced by fermentation in the presence of chromium chloride followed by a number of purification steps and a heat-killing step of the yeast to ensure the absence of viable<span>Yarrowia lipolytica</span> cells in the novel food.</p><p><span>Characteristics/Composition:</span></p><div><p>Total chromium: 18&#8211;23 &#956;g/g</p></div><div><p>Chromium (VI): &lt; 10 &#956;g/kg (i.e. limit of detection)</p></div><div><p>Protein: 40&#8211;50 g/100 g</p></div><div><p>Dietary fibre: 24&#8211;32 g/100 g</p></div><div><p>Sugars: &lt; 2 g/100 g</p></div><div><p>Fat: 6&#8211;12 g/100 g</p></div><div><p>Total ash: &#8804; 15 %</p></div><div><p>Water: &#8804; 5 %</p></div><div><p>Dry matter: &#8805; 95 %</p></div><p><span>Heavy metals:</span></p><div><p>Lead: &#8804; 3,0 mg/kg</p></div><div><p>Cadmium: &#8804; 1,0 mg/kg</p></div><div><p>Mercury: &#8804; 0,1 mg/kg</p></div><p><span>Microbiological criteria:</span></p><div><p>Total aerobic microbial count: &#8804; 5 &#215; 10<span>3</span> CFU/g</p></div><div><p>Total yeast and mould count: &#8804; 10<span>2</span> CFU/g</p></div><div><p>Viable<span>Yarrowia lipolytica</span> cells&#160;<a>(<span>13</span>)</a>: &lt; 10 CFU/g (i.e. limit of detection)</p></div><div><p>Coliforms: &#8804; 10 CFU/g</p></div><div><p><span>Salmonella</span> spp.: Absence in 25 g</p></div><div><p>CFU: colony forming units</p></div></td></tr><tr><td><p><a>&#9660;M85</a></p></td></tr><tr><td><p><span><span>Cistus incanus</span> L. Pandalis herb&#8217;</span></p></td><td><p><span>Description:</span></p><p><span>Cistus incanus</span> L. Pandalis herb; species belonging to the Cistaceae family and native to the Mediterranean region, Chalkidiki Peninsula.</p><p>The novel food consists of the dried and cut aerial parts (young shoots with woody parts) of<span>Cistus incanus</span> L. Pandalis</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Citicoline</span></p></td><td><p><span>Description/Definition:</span></p><p>Citicoline is produced by a microbial process.</p><p>Citicoline is composed of cytosine, ribose, pyrophosphate and choline.</p><p>White crystalline powder</p><p>Chemical name: Choline cytidine 5&#8242;-pyrophosphate, Cytidine 5&#8242;-(trihydrogen diphosphate) P&#8217;-[2-(trimethylammonio)ethyl]ester inner salt</p><p>Chemical formula: C<span>14</span>H<span>26</span>N<span>4</span>O<span>11</span>P<span>2</span></p><p>Molecular weight: 488,32 g/mol</p><p>CAS No.: 987-78-0</p><p>pH (sample solution of 1 %): 2,5-3,5</p><p><span>Purity:</span></p><p>Assay value: &#8805; 98 % of dry matter</p><p>Loss on drying (100 &#176;C for 4 hours): &#8804; 5,0 %</p><p>Ammonium: &#8804; 0,05 %</p><p>Arsenic: Not more than 2 ppm</p><p>Free phosphoric acids: &#8804; 0,1 %</p><p>5&#8242;-Cytidylic acid: &#8804; 1,0 %</p><p><span>Microbiological criteria:</span></p><p>Total plate count: &#8804; 10<span>3</span> CFU/g</p><p>Yeast and moulds: &#8804; 10<span>2</span> CFU/g</p><p><span>Escherichia coli</span>: Absence in 1 g</p></td></tr><tr><td><p><span><span>Clostridium butyricum</span></span></p></td><td><p><span>Description/Definition:</span></p><p><span>Clostridium butyricum</span> (CBM-588) is a Gram-positive, spore-forming, obligate anaerobic, non-pathogenic, non-genetically modified bacterium. Depository number FERM BP-2789</p><p><span>Microbiological criteria:</span></p><p>Total viable aerobic count: &#8804; 10<span>3</span> CFU/g</p><p><span>Escherichia coli</span>: Not detected in 1 g<span>Staphylococcus aureus</span>: Not detected in 1 g</p><p><span>Pseudomonas aeruginosa</span>: Not detected in 1 g</p><p>Yeast and moulds: &#8804; 10<span>2</span> CFU/g</p></td></tr><tr><td><p><a>&#9660;M79</a></p></td></tr><tr><td><p><span>Coffea arabica</span> L. and/or<span>Coffea canephora</span> Pierre ex A.Froehner dried cherry pulp and its infusion (Traditional food from a third country)</p></td><td><p><span>Description/Definition:</span></p><p>The traditional food consists of the dried unroasted coffee cherry pulp of<span>Coffea arabica</span> L. and/or<span>Coffea canephora</span> Pierre ex A.Froehner (genus:<span>Coffea</span> family: Rubiaceae) and its infusion. The infusion can be used as such or concentrated or dried.</p><p>Ripe coffee cherries are collected, and then the coffee beans are mechanically removed, prior or after a drying process, leaving the dried coffee cherry pulp, which can be milled to a powder.</p><p>The separated coffee cherry pulp is also known as &#8216;cascara&#8217;, from the Spanish &#8216;c&#225;scara&#8217;, meaning &#8216;husk&#8217;.</p><p>Typically, the infusion is prepared by mixing up to 6 g of cascara pulp or husk in&#160;100 ml of hot water (&gt;&#160;75&#160;&#176;C) for a few minutes and then pouring through a strainer, or using corresponding amounts in dried or instant infusions.</p><p><span>Composition of the dried coffee cherry pulp:</span></p><div><p>Water: &lt;&#160;18&#160;%</p></div><div><p>Water activity (a<span>w</span>): &#8804;&#160;0,65</p></div><div><p>Ash: &lt;&#160;10,4&#160;% DM</p></div><div><p>Protein: &lt;&#160;15&#160;% DM</p></div><div><p>Fat: &lt;&#160;5&#160;% DM</p></div><div><p>Carbohydrates: &lt;&#160;85&#160;% DM</p></div><p><span>Microbiological criteria:</span></p><div><p>Aerobic Plate Count: &lt;&#160;10<span>4</span> CFU/g</p></div><div><p>Total yeasts and moulds: &lt;&#160;100 CFU/g</p></div><div><p>Enterobacteriaceae: &lt;&#160;50 CFU/g</p></div><div><p><span>Salmonella</span>: Absence in&#160;25 g</p></div><div><p><span>Bacillus cereus</span>: &lt;&#160;100 CFU/g</p></div><p><span>Mycotoxins:</span></p><div><p>Ochratoxin A: &lt;&#160;5,0 &#956;g/kg</p></div><div><p>Aflatoxin B1: &lt;&#160;2,0 &#956;g/kg</p></div><div><p>Aflatoxin B1, B2, G1, G2 (as sum): &lt;&#160;4,0 &#956;g/kg</p></div><p><span>Heavy metals:</span></p><div><p>Cadmium (Cd): &lt;&#160;0,05&#160;mg/kg</p></div><div><p>Lead (Pb): &lt;&#160;1,0&#160;mg/kg</p></div><div><p>Copper: &#8804;&#160;50 mg/kg</p></div><div><p>Mercury: &#8804;&#160;0,02&#160;mg/kg</p></div><div><p>Arsenic: &#8804;&#160;0,2&#160;mg/kg</p></div><p><span>Impurities:</span></p><div><p>Benzo(a)pyrene: &lt;&#160;10,0 &#956;g/kg</p></div><div><p>Sum of benzo(a)pyrene, benz(a)anthracene, benzo(b)fluoranthene and chrysene: &lt;&#160;50,0 &#956;g/kg</p></div><p><span>Pesticides:</span></p><p>Pesticide levels in the traditional food shall comply with levels set by Regulation (EC) No&#160;396/2005 for &#8216;0639000&#8217; for &#8216;Herbal infusions from any other parts of the plant&#8217;.</p><p>CFU: Colony Forming Units</p><p>DM: Dry Matter</p></td></tr><tr><td><p><a>&#9660;M30</a></p></td></tr><tr><td><p><span>D-ribose</span></p></td><td><p><span>Description</span></p><p>D-ribose is an aldopentose monosaccharide which is produced by fermentation using a transketolase-de&#64257;cient strain of<span>Bacillus subtilis</span>.</p><p>Chemical formula: C<span>5</span>H<span>10</span>O<span>5</span></p><p>CAS No: 50-69-1</p><p>Molecular mass: 150,13 Da</p><p><span>Characteristics/Composition</span></p><p>Appearance: Dry with powdery texture, white to slightly yellow in colour</p><p>Speci&#64257;c rotation [&#945;]<span>D</span><span>25</span>: &#8211; 19,0&#176; to &#8211; 21,0&#176;</p><p>D-ribose purity (% dry basis):</p><p>-HPLC/RI&#160;<a>(<span>8</span>)</a> Method 98,0&#8211;102,0 %</p><p>Ash: &lt; 0,2 %</p><p>Loss on drying (moisture): &lt; 0,5 %</p><p>Clarity on solution: &#8805; 95 % transmittance</p><p><span>Heavy metals</span></p><p>Lead: &#8804; 0,1 mg/kg</p><p>Arsenic: &#8804; 0,1 mg/kg</p><p>Cadmium: &#8804; 0,1 mg/kg</p><p>Mercury: &#8804; 0,1 mg/kg</p><p><span>Microbiological criteria</span></p><p>Total plate count: &#8804; 100 CFU&#160;<a>(<span>9</span>)</a>/g</p><p>Yeast: &#8804; 100 CFU/g</p><p>Moulds: &#8804; 100 CFU/g</p><p>Coliforms: &#8804; 10 CFU/g</p><p><span>Salmonella</span> sp: Negative/25 g</p></td></tr><tr><td><p><a>&#9660;M54</a></p></td></tr><tr><td><p><span>Dried<span>Euglena gracilis</span></span></p></td><td><p><span>Description/Definition:</span></p><p>The novel food is dried whole cell Euglena, which is the dried biomass of the microalga<span>Euglena gracilis</span>.</p><p>The novel food is produced by fermentation followed by filtration and a heat-killing step of the microalga to ensure the absence of viable<span>Euglena gracilis</span> cells in the novel food.</p><p><span>Characteristics/Composition:</span></p><p>Total carbohydrates: &#8804; 75 %</p><p>&#946;-glucan: &gt; 50 %</p><p>Protein: &#8805; 15 %</p><p>Fat: &#8804; 15 %</p><p>Ash: &#8804; 10 %</p><p>Moisture: &#8804; 6 %</p><p><span>Heavy metals:</span></p><p>Lead: &#8804; 0,5 mg/kg</p><p>Cadmium: &#8804; 0,5 mg/kg</p><p>Mercury: &#8804; 0,05 mg/kg</p><p>Arsenic: &#8804; 0,02 mg/kg</p><p><span>Microbiological criteria:</span></p><p>Aerobic plate count: &#8804; 10&#160;000  CFU/g</p><p>Coliforms: &#8804; 100 MPN/g</p><p>Yeast and mould: &#8804; 500 CFU/g</p><p><span>Escherichia coli</span>: Absence in 10 g</p><p><span>Staphylococcus aureus</span>: Absence in 10 g</p><p><span>Salmonella</span>: Absence in 25 g</p><p><span>Listeria monocytogenes</span>: Absence in 25 g</p><p>CFU: colony forming units.</p><p>MPN: most probable number</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Extract of defatted cocoa powder</span></p></td><td><p>Cocoa (<span>Theobroma cacao</span> L.) Extract</p><p>Appearance: Dark brown powder free of visible impurities</p><p>Physical and chemical properties:</p><p>Polyphenol content: Min 55,0 % GAE</p><p>Theobromine content: Max 10,0 %</p><p>Ash content: Max 5,0 %</p><p>Moisture content: Max 8,0 %</p><p>Bulk density: 0,40-0,55 g/cm<span>3</span></p><p>pH: 5,0-6,5</p><p>Residual solvent: Max 500 ppm</p></td></tr><tr><td><p><span>Low fat cocoa extract</span></p></td><td><p>Low fat Cocoa (<span>Theobroma cacao</span> L.) extract</p><p>Appearance: Dark red to purple powder</p><p>Cocoa extract, concentrate: Min 99 %</p><p>Silicon dioxide (technological aid): Max 1,0 %</p><p>Cocoa flavanols: Min. 300 mg/g</p><div><p>&#8212;&#160;Epicatechin: Min. 45 mg/g</p></div><p>Loss on drying: Max. 5,0 %</p></td></tr><tr><td><p><a>&#9660;M70</a></p></td></tr><tr><td><p>Coriander seed oil from<span>Coriandrum sativum</span></p></td><td><p>Description/Definition:</p><p>Coriander seed oil is an oil containing glycerides of fatty acids that is produced from the seeds of the coriander plant<span>Coriandrum sativum</span> L.</p><p>Yellowish to brown colour, bland taste</p><p>CAS No.: 8008-52-4</p><p>Composition of fatty acids:</p><p>Palmitic acid (C16:0): 2-5&#160;%</p><p>Stearic acid (C18:0): &lt;&#160;1,5&#160;%</p><p>Petroselinic acid (cis-C18:1(n-12)): 60-75&#160;%</p><p>Oleic acid (cis-C18:1 (n-9)): 7-15&#160;%</p><p>Linoleic acid (C18:2): 12-19&#160;%</p><p>&#945;-Linolenic acid (C18:3): &lt;&#160;1,0&#160;%</p><p>Trans fatty acids: &#8804;&#160;1,0&#160;%</p><p>Purity:</p><p>Refractive index (20&#160;&#176;C): 1.466-1.474</p><p>Acid value: &#8804;&#160;4 mg KOH/g</p><p>Peroxide value (PV): &#8804;&#160;5,0 meq/kg</p><p>Iodine value: 88-110 units</p><p>Saponification value: 179-200 mg KOH/g</p><p>Unsaponifiable matter: &#8804;&#160;15 g/kg</p></td></tr><tr><td><p><a>&#9660;M15</a></p></td></tr><tr><td><p>Cranberry extract powder</p></td><td><p><span>Description/Definition:</span></p><p>Cranberry extract powder is a water-soluble phenolic-rich powder extract prepared through an ethanolic extraction from the juice concentrate of sound, mature berries of the cranberry cultivar<span>Vaccinium macrocarpon</span>.</p><p><span>Characteristics/Composition</span></p><p>Moisture (% w/w): &#8804; 4</p><p>Proanthocyanidins &#8212; PACs (% w/w dry weight)</p><div><p>&#8212;&#160;OSC-DMAC method&#160;<a>(<span>3</span>)</a>&#160;<a>(<span>5</span>)</a>: 55.0-60.0 or</p></div><div><p>&#8212;&#160;BL-DMAC method&#160;<a>(<span>4</span>)</a>&#160;<a>(<span>5</span>)</a>: 15.0-18.0</p></div><p>Total phenolics (GAE&#160;<a>(<span>6</span>)</a>, % w/w dry weight)&#160;<a>(<span>5</span>)</a></p><div><p>&#8212;&#160;Folin-Ciocalteau method: &gt; 46.2</p></div><p>Solubility (water): 100 %, with no visible insoluble particles</p><p>Ethanol Content (mg/kg): &#8804; 100</p><p>Screen Analysis: 100 % through 30 mesh screen</p><p>Appearance and aroma, as powder: Free-flowing, deep red colour. Earthy aroma with no burnt character.</p><p><span>Heavy metals:</span></p><p>Arsenic (ppm): &lt; 3</p><p><span>Microbiological criteria:</span></p><p>Yeast: &lt; 100 CFU&#160;<a>(<span>7</span>)</a>/g</p><p>Mould: &lt; 100 CFU/g</p><p>Aerobic plate count: &lt; 1&#160;000  CFU/g</p><p>Coliforms: &lt; 10 CFU/g</p><p><span>Escherichia coli</span>: &lt; 10 CFU/g</p><p><span>Salmonella</span>: Absent in 375 g</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span><span>Crataegus pinnatifida</span> dried fruit</span></p></td><td><p><span>Description/Definition:</span></p><p>Dried fruits of<span>Crataegus pinnatifida</span> species belonging to the<span>Rosaceae</span> family and native to north China and Korea.</p><p><span>Composition:</span></p><p>Dry matter: 80 %</p><p>Carbohydrates: 55 g/kg fresh weight</p><p>Fructose: 26,5&#8211;29,3 g/100 g</p><p>Glucose: 25,5&#8211;28,1 g/100 g</p><p>Vitamin C: 29,1 mg/100 g fresh weight</p><p>Sodium: 2,9 g/100 g fresh weight</p><p>Compotes are products obtained by thermal processing of the edible part of one or several species of fruits, whole or in pieces, sieved or not, without significant concentration. Sugars, water, cider, spices and lemon juice may be used.</p></td></tr><tr><td><p><span>&#945;-cyclodextrin</span></p></td><td><p><span>Description/Definition:</span></p><p>A non-reducing cyclic saccharide consisting of six &#945;-1,4-linked D-glucopyranosyl units produced by the action of cyclodextrin glucosyltransferase (CGTase, EC 2.4.1.19) on hydrolyzed starch. Recovery and purification of &#945;-cyclodextrin may be carried out using one of the following procedures: precipitation of a complex of &#945;-cyclodextrin with 1-decanol, dissolution in water at elevated temperature and re-precipitation, steam-stripping of the complexant, and crystallisation of &#945;-cyclodextrin from the solution; or chromatography with ion-exchange or gel filtration followed by crystallisation of &#945;-cyclodextrin from the purified mother liquor; or membrane separation methods such as ultra-filtration and reverse osmosis: Description: Virtually odourless, white or almost white crystalline solid.</p><p>Synonyms: &#945;-cyclodextrin, &#945;-dextrin, cyclohexaamylose, cyclomaltohexaose, &#945;-cycloamylase</p><p>Chemical name: CyclohexaamyloseCAS No.: 10016-20-3</p><p>Chemical formula: (C<span>6</span>H<span>10</span>O<span>5</span>)<span>6</span></p><p>Formula weight: 972,85</p><p>Assay: &#8805; 98 % (dry basis)</p><p><span>Identification:</span></p><p>Melting range: Decomposes above 278 &#176;C</p><p>Solubility: Freely soluble in water; very slightly soluble in ethanol</p><p>Specific rotation: [&#945;]<span>D</span><span>25</span>: Between +145<span>o</span> and +151<span>o</span> (1 % solution)</p><p>Chromatography: The retention time for the major peak in a liquid chromatogram of the sample corresponds to that for &#945;-cyclodextrin in a chromatogram of reference &#945;-cyclodextrin (available from<span>Consortium f&#252;r Elektrochemische Industrie GmbH, M&#252;nchen, Germany or Wacker Biochem Group, Adrian, MI, USA</span>) using the conditions described in the METHOD OF ASSAY</p><p><span>Purity:</span></p><p>Water: &#8804; 11 % (Karl Fischer Method)</p><p>Residual complexant: &#8804; 20 mg/kg</p><p>(1-decanol)</p><p>Reducing substances: &#8804; 0,5 % (as glucose)</p><p>Sulphated ash: &#8804; 0,1 %</p><p>Lead: &#8804; 0,5 mg/kg</p><p><span>Method of assay:</span></p><p>Determine by liquid chromatography using the following conditions:</p><p>Sample solution: Weigh accurately about 100 mg of test sample into a 10 ml volumetric flask and add 8 ml of deionised water. Dissolve the sample completely using an ultra-sonification bath (10-15 min) and dilute to the mark with purified deionised water. Filter through a 0,45-micrometer filter</p><p>Reference solution: Weigh accurately about 100 mg of &#945;-cyclodextrin into a 10 ml volumetric flask and add 8 ml of deionised water. Dissolve the sample completely using an ultra-sonification bath and dilute to the mark with purified deionised water.</p><p>Chromatography: Liquid chromatograph equipped with a refractive index detector and an integrating recorder.</p><p>Column and packing: Nucleosil-100-NH<span>2</span> (10 &#956;m) (<span>Macherey &amp; Nagel Co. D&#252;ren</span>, Germany) or similar</p><p>Length: 250 mm</p><p>Diameter: 4 mm</p><p>Temperature: 40 &#176;C</p><p>Mobile phase: acetonitrile/water (67/33, v/v)</p><p>Flow rate: 2,0 ml/min</p><p>Injection volume: 10 &#956;lProcedure: Inject the sample solution into the chromatograph, record the chromatogram, and measure the area of the &#945;-CD peak. Calculate the percentage of &#945;-cyclodextrin in the test sample as follows:</p><p>% &#945;-cyclodextrin (dry basis) = 100 &#215; (A<span>S</span>/A<span>R</span>) (W<span>R</span>/W<span>S</span>)</p><p>where</p><p>A<span>S</span> and A<span>R</span> are the areas of the peaks due to &#945;-cyclodextrin for the sample solution and reference solution, respectively.</p><p>W<span>S</span> and W<span>R</span> are the weights (mg) of the test sample and reference &#945;-cyclodextrin, respectively, after correcting for water content.</p></td></tr><tr><td><p><span>&#947;-cyclodextrin</span></p></td><td><p><span>Description/Definition:</span></p><p>A non-reducing cyclic saccharide consisting of eight &#945;-1,4-linked D-glucopyranosyl units produced by the action of cyclodextrin glucosyltransferase (CGTase, EC 2.4.1.19) on hydrolysed starch. Recovery and purification of &#947;-cyclodextrin may be carried out by precipitation of a complex of &#947;-cyclodextrin with 8-cyclohexadecen-1-one, dissolution of the complex with water and n-decane, steam-stripping of the aqueous phase and recovery of gamma-CD from the solution by crystallisation.</p><p>Virtually odourless, white or almost white crystalline solid</p><p>Synonyms: &#947;-cyclodextrin, &#947;-dextrin, cyclooctaamylose, cyclomaltooctaose, &#947;-cycloamylase</p><p>Chemical name: Cyclooctaamylose</p><p>CAS number: 17465-86-0</p><p>Chemical formula: (C<span>6</span>H<span>10</span>O<span>5</span>)<span>8</span></p><p>Assay: &#8805; 98 % (dry basis)</p><p><span>Identification:</span></p><p>Melting range: Decomposes above 285 &#176;C</p><p>Solubility: Freely soluble in water; very slightly soluble in ethanol</p><p>Specific rotation: [&#945;]<span>D</span><span>25</span>: between + 174<span>o</span> and + 180<span>o</span> (1 % solution)</p><p><span>Purity:</span></p><p>Water: &#8804; 11 %</p><p>Residual complexant (8-cyclohexadecen-1-one (CHDC)): &#8804; 4 mg/kg</p><p>Residual solvent (n-decane): &#8804; 6mg/kg</p><p>Reducing substances: &#8804; 0,5 % (as glucose)</p><p>Sulphated ash: &#8804; 0,1 %</p></td></tr><tr><td><p><a>&#9660;M22</a></p></td></tr><tr><td><p>Decorticated grains of<span>Digitaria exilis</span> (Kippist) Stapf (fonio)</p><p>(Traditional food from a third country)</p></td><td><p><span>Description/Definition</span></p><p>The traditional food is the decorticated grain (bran removed) of<span>Digitaria exilis</span> (Kippist) Stapf.</p><p><span>Digitaria exilis</span> (Kippist) Stapf) is an annual herbaceous plant belonging to the<span>Poaceae</span> family.</p><p><span>Typical nutritional components of decorticated grain of fonio</span></p><p>Carbohydrates: 76,1 g/100 g of fonio</p><p>Water: 12,4 g/100 g of fonio</p><p>Protein: 6,9 g/100 g of fonio</p><p>Fat: 1,2 g/100 g of fonio</p><p>Fibre: 2,2 g/100 g of fonio</p><p>Ash: 1,2 g/100 g of fonio</p><p>Phytate content: &#8804; 2,1 mg/g</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Dextran preparation produced by<span>Leuconostoc mesenteroides</span></span></p></td><td><p>1.&#160;&#160;<span>Powdered form:</span></p><p>Carbohydrates: 60 % with: (Dextran: 50 %, Mannitol: 0,5 %, Fructose: 0,3 %, Leucrose: 9,2 %)</p><p>Protein: 6,5 %</p><p>Lipid: 0,5 %</p><p>Lactic acid: 10 %</p><p>Ethanol: traces</p><p>Ash: 13 %</p><p>Moisture: 10 %</p><p>2.&#160;&#160;<span>Liquid form:</span></p><p>Carbohydrates: 12 % with: (Dextran: 6,9 %, Mannitol: 1,1 %, Fructose: 1,9 %, Leucrose: 2,2 %)</p><p>Protein: 2,0 %</p><p>Lipid: 0,1 %</p><p>Lactic acid: 2,0 %</p><p>Ethanol: 0,5 %</p><p>Ash: 3,4 %</p><p>Moisture: 80 %</p></td></tr><tr><td><p><span>Diacylglycerol oil of plant origin</span></p></td><td><p><span>Description/Definition:</span></p><p>Manufactured from glycerol and fatty acids derived from edible vegetable oils, in particular from soybean oil (<span>Glycine max</span>) or rapeseed oil (<span>Brassica campestris, Brassica napus</span>) using a specific enzyme.</p><p><span>Acylglycerol Distribution:</span></p><p>Diacylglycerols (DAG): &#8805; 80 %</p><p>1,3-Diacylglycerols (1,3-DAG): &#8805; 50 %</p><p>Triacylglycerols (TAG): &#8804; 20 %</p><p>Monoacylglycerols (MAG): &#8804; 5,0 %</p><p><span>Fatty Acid Composition (MAG, DAG, TAG):</span></p><p>Oleic acid (C18:1): 20-65 %</p><p>Linoleic acid (C18:2): 15-65 %</p><p>Linolenic acid (C18:3): &#8804; 15 %</p><p>Saturated fatty acids: &#8804; 10 %</p><p><span>Others:</span></p><p>Acid value: &#8804; 0,5 mg KOH/g</p><p>Moisture and volatile: &#8804; 0,1 %</p><p>Peroxide value (PV): &#8804; 1,0 meq/kg</p><p>Unsaponifiables: &#8804; 2,0 %</p><p>Trans fatty acids&#8804; 1,0 %</p><p>MAG = monoacylglycerols, DAG = diacylglycerols, TAG = triacylglycerols</p></td></tr><tr><td><p><span>Dihydrocapsiate (DHC)</span></p></td><td><p><span>Description/Definition:</span></p><p>Dihydrocapsiate is synthesised by enzyme-catalysed esterification of vanillyl alcohol and 8-methylnonanoic acid. Following the esterification dihydrocapsiate is extracted with n-hexane.</p><p>Viscous to colourless to yellow liquid</p><p>Chemical formula: C<span>18</span> H<span>28</span> O<span>4</span></p><p>CAS No: 205687-03-2</p><p><span>Physical-chemical properties:</span></p><p>Dihydrocapsiate: &gt; 94 %</p><p>8-Methylnonanoic acid: &lt; 6,0 %</p><p>Vanillyl acohol: &lt; 1,0 %</p><p>Other synthesis related substances: &lt; 2,0 %</p></td></tr><tr><td><p><a>&#9660;M13</a></p></td></tr><tr><td><p><span>Dried aerial parts of<span>Hoodia parviflora</span></span></p></td><td><p><span>Description/Definition:</span></p><p>It is the whole dried aerial parts of<span>Hoodia parviflora</span> N.E.Br., (family<span>Apocynaceae</span>)</p><p><span>Characteristics/Composition</span></p><p>Plant material: Aerial parts of at least 3-year-old plants</p><p>Appearance: Light green to tan fine powder</p><p>Solubility (water): &gt; 25 mg/mL</p><p>Moisture: &lt; 5,5 %</p><p>A<span>w</span>: &lt; 0,3</p><p>pH: &lt; 5,0</p><p>Protein: &lt; 4,5 g/100 g</p><p>Fat: &lt; 3 g/100 g</p><p>Carbohydrate (including dietary fibre): &lt; 80 g/100 g</p><p>Dietary fibre: &lt; 55 g/100 g</p><p>Total sugars: &lt; 10,5 g/100 g</p><p>Ash: &lt; 20 %</p><p><span>Hoodigosides</span></p><p>P57: 5&#8211;50 mg/kg</p><p>L: 1&#160;000 &#8211;6&#160;000  mg/kg</p><p>O: 500&#8211;5&#160;000  mg/kg</p><p>Total: 1&#160;500 &#8211;11&#160;000  mg/kg</p><p><span>Heavy metals:</span></p><p>Arsenic: &lt; 1,00 mg/kg</p><p>Mercury: &lt; 0,1 mg/kg</p><p>Cadmium: &lt; 0,1 mg/kg</p><p>Lead: &lt; 0,5 mg/kg</p><p><span>Microbiological criteria:</span></p><p>Aerobic plate count: &lt; 10<span>5</span> CFU/g</p><p><span>Escherichia coli</span>: &lt; 10 CFU/g</p><p><span>Staphylococcus aureus</span>: &lt; 50 CFU/g</p><p>Total coliforms: &lt; 10 CFU/g</p><p>Yeast: &#8804; 100 CFU/g</p><p>Mould: &#8804; 100 CFU/g</p><p><span>Salmonella</span> species: Negative/25 g</p><p><span>Listeria monocytogenes</span>: Negative/25 g</p><p>CFU: Colony Forming Units</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Dried extract of<span>Lippia citriodora</span> from cell cultures</span></p></td><td><p><span>Description/Definition:</span></p><p>Dried extract of<span>Lippia citriodora</span> (Palau) Kunth from cell cultures HTN<span>&#174;</span>Vb.</p></td></tr><tr><td><p><span><span>Echinacea angustifolia</span> extract from cell cultures</span></p></td><td><p><span>Description/Definition:</span></p><p>Extract of the roots of<span>Echinacea angustifolia</span> obtained from plant tissue culture which is substantially equivalent to a root extract from<span>Echinacea angustifolia</span> obtained in ethanol-water titrated to 4 % echinacoside.</p></td></tr><tr><td><p><a>&#9660;M32</a></p></td></tr><tr><td><p><span><span>Echinacea purpurea</span></span><span>extract from cell cultures</span></p></td><td><p><span>Description/Definition:</span></p><p>Dried extract of<span>Echinacea purpurea</span> from cell cultures EchiPure-PC&#8482;</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span><span>Echium plantagineum</span> oil</span></p></td><td><p><span>Description/Definition:</span></p><p>Echium oil is the pale yellow product obtained by refining oil extracted from the seeds of<span>Echium plantagineum</span> L. Stearidonic acid: &#8805; 10 % w/w of total fatty acids</p><p>Trans fatty acids: &#8804; 2,0 % (w/w of total fatty acids)</p><p>Acid value: &#8804; 0,6 mg KOH/g</p><p>Peroxide value (PV): &#8804; 5,0 meq O<span>2</span>/kg</p><p>Unsaponifiable content: &#8804; 2,0 %</p><p>Protein content (total nitrogen): &#8804; 20 &#956;g/ml</p><p>Pyrrolizidine alkaloids: Not detectable with a detection limit 4,0 &#956;g/kg</p></td></tr><tr><td><p><a>&#9660;M52</a></p></td></tr><tr><td><p><span><span>Ecklonia cava</span> phlorotannins</span></p></td><td><p><span>Description/Definition</span></p><p><span>Ecklonia cava</span> phlorotannins are obtained via alcohol extraction from the edible marine alga<span>Ecklonia cava.</span> The extract is a dark brown powder, rich in phlorotannins, polyphenolic compounds found as secondary metabolites in certain brown algae species.</p><p><span>Characteristics/Composition</span></p><p>Phlorotannin content: 90 &#177; 5 %</p><p>Antioxidant activity: &gt; 85 %</p><p>Moisture: &lt; 5 %</p><p>Ash: &lt; 5 %</p><p><span>Microbiological criteria</span></p><p>Total viable cell count: &lt; 3&#160;000  CFU/g</p><p>Mould/yeast: &lt; 300 CFU/g</p><p>Coliforms: Negative to test</p><p><span>Salmonella</span> spp.: Negative to test</p><p><span>Staphylococcus aureus:</span> Negative to test</p><p><span>Heavy metals and Halogens</span></p><p>Lead: &lt; 3,0 mg/kg</p><p>Mercury: &lt; 0,1 mg/kg</p><p>Cadmium: &lt; 3,0 mg/kg</p><p>Arsenic: &lt; 25,0 mg/kg</p><p>Inorganic Arsenic: &lt; 0,5 mg/kg</p><p>Iodine: 150,0 &#8211; 650,0 mg/kg</p><p>CFU: Colony Forming Units</p></td></tr><tr><td><p><a>&#9660;M18</a></p></td></tr><tr><td><p>Egg membrane hydrolysate</p></td><td><p><span>Description</span></p><p>The egg membrane hydrolysate is derived from the eggshell membranes of chicken eggs. The eggshells undergo hydro-mechanical separation in order to obtain the egg membranes, which are then further processed using a patented solubilisation method. Following the solubilisation process, the solution is filtered, concentrated, spray-dried and packaged.</p><p><span>Characteristics/Composition</span></p></td></tr><tr><td><p><span>Chemical parameters</span></p></td><td><p><span>Methods</span></p></td></tr><tr><td><p>Total nitrogen-containing compounds (% w/w): &#8805; 88</p></td><td><p>Combustion according to AOAC 990.03 and AOAC 992.15</p></td></tr><tr><td><p>Collagen (% w/w): &#8805; 15</p></td><td><p>Sircol<span>TM</span> Soluble Collagen Assay</p></td></tr><tr><td><p>Elastin (% w/w): &#8805; 20</p></td><td><p>Fastin<span>TM</span> Elastin Assay</p></td></tr><tr><td><p>Total glycosaminoglycans (% w/w): &#8805; 5</p></td><td><p>USP26 (chondroitin sulphate K0032 method)</p></td></tr><tr><td><p>Calcium: &#8804; 1 %</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Physical parameters</span></p><p>pH: 6,5 &#8211; 7,6</p><p>Ash (% w/w): &#8804; 8</p><p>Moisture (% w/w): &#8804; 9</p><p>Water activity: &#8804; 0,3</p><p>Solubility (in water): soluble</p><p>Bulk density: &#8805; 0,6 g/cc</p><p><span>Heavy metals</span></p><p>Arsenic &#8804; 0,5 mg/kg</p><p><span>Microbiological criteria</span></p><p>Aerobic plate count: &#8804; 2&#160;500  CFU/g</p><p><span>Escherichia coli</span>: &#8804; 5 MPN/g</p><p><span>Salmonella</span>: Negative (in 25 g)</p><p>Coliforms: &#8804; 10 MPN/g</p><p><span>Staphylococcus aureus</span>: &#8804; 10 CFU/g</p><p>Mesophilic spore count: &#8804; 25 CFU/g</p><p>Thermophilic spore count: &#8804; 10 CFU/10 g</p><p>Yeast: &#8804; 10 CFU/g</p><p>Mould: &#8804; 200 CFU/g</p><p>CFU: Colony Forming Units; MPN = Most Probable Number; USP: United States Pharmacopeia.</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Epigallocatechin gallate as a purified extract from green tea leaves (<span>Camellia sinensis</span>)</span></p></td><td><p><span>Description/Definition:</span></p><p>A highly purified extract from the leaves of green tea (<span>Camellia sinensis (L.) Kuntze</span>) in the form of a fine, off-white to pale pink powder. It is composed of a minimum of 90 % epigallo-catechin gallate (EGCG), and has a melting point between approx. 210 and 215 &#176;C</p><p>Appearance: off-white to pale pink powder</p><p>Chemical name: polyphenol (-) epigallocatechin-3-gallate</p><p>Synonyms: epigallocatechin gallate (EGCG)</p><p>CAS No.: 989-51-5</p><p>INCI name: epigallocatechin gallate</p><p>Molecular mass: 458,4 g/mol</p><p>Loss on drying: max 5,0 %</p><p><span>Heavy metals:</span></p><p>Arsenic: max 3,0 ppm</p><p>Lead: max 5,0 ppm</p><p><span>Assay:</span></p><p>Min. 94 % EGCG (on dry material)</p><p>max. 0,1 % caffeine</p><p>Solubility: EGCG is fairly soluble in water, ethanol, methanol and acetone</p></td></tr><tr><td><p><span>L-ergothioneine</span></p></td><td><p><span>Definition</span></p><p>Chemical name (IUPAC): (2S)-3-(2-thioxo-2,3-dihydro-1<span>H</span>-imidazol-4-yl)-2-(trimethylammonio)-Propanoate</p><p>Chemical formula: C<span>9</span>H<span>15</span>N<span>3</span>O<span>2</span>S</p><p>Molecular mass: 229,3 Da</p><p>CAS No.: 497-30-3</p></td></tr><tr><td><p><span>Parameter</span></p></td><td><p><span>Specification</span></p></td><td><p><span>Method</span></p></td></tr><tr><td><p>Appearance</p></td><td><p>White powder</p></td><td><p>Visual</p></td></tr><tr><td><p>Optical rotation</p></td><td><p>[&#945;]<span>D</span> &#8805; (+) 122&#176; (c = 1, H<span>2</span>O)<span>a)</span></p></td><td><p>Polarimetry</p></td></tr><tr><td><p>Chemical purity</p></td><td><p>&#8805; 99,5 %</p><p>&#8805; 99,0 %</p></td><td><p>HPLC [Eur. Ph. 2,2.29]</p><p>1H-NMR</p></td></tr><tr><td><p>Identification</p></td><td><p>Compliant with the structure</p><p>C: 47,14 &#177; 0,4 %</p><p>H: 6,59 &#177; 0,4 %</p><p>N: 18,32 &#177; 0,4 %</p></td><td><p>1H-NMR</p><p>Elemental analysis</p></td></tr><tr><td><p>Total residual solvents</p><p>(methanol, ethyl acetate, isopropanol, ethanol)</p></td><td><p>[Eur. Ph. 01/2008:50400]</p><p>&lt; 1&#160;000  ppm</p></td><td><p>Gas chromatography</p><p>[Eur. Ph. 01/2008:20424]</p></td></tr><tr><td><p>Loss on drying</p></td><td><p>Internal standard &lt; 0,5 %</p></td><td><p>[Eur. Ph. 01/2008:20232]</p></td></tr><tr><td><p>Impurities</p></td><td><p>&lt; 0,8 %</p></td><td><p>HPLC/GPC or 1H-NMR</p></td></tr><tr><td><p><span>Heavy metals</span><span>b) c)</span></p></td></tr><tr><td><p>Lead</p></td><td><p>&lt; 3,0 ppm</p></td><td><p>ICP/AES</p></td></tr><tr><td><p>Cadmium</p></td><td><p>&lt; 1,0 ppm</p></td><td><p>(Pb, Cd)</p></td></tr><tr><td><p>Mercury</p></td><td><p>&lt; 0,1 ppm</p></td><td><p>Atomic fluorescence (Hg)</p></td></tr><tr><td><p><span>Microbiological specifications</span><span>b)</span></p></td></tr><tr><td><p>Total viable aerobic count (TVAC)</p></td><td><p>&#8804; 1 x 10<span>3</span> CFU/g</p></td><td><p>[Eur. Ph. 01/2011:50104]</p></td></tr><tr><td><p>Total yeast and mould count (TYMC)</p></td><td><p>&#8804; 1 x 10<span>2</span> CFU/g</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Escherichia coli</span></p></td><td><p>Absence in 1 g</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Eur. Ph.: European Pharmacopoeia; 1H-NMR: proton nuclear magnetic resonance; HPLC: high-performance liquid chromatography; GPC: gel permeation chromatography; ICP/AES: Inductively coupled plasma atomic emission spectroscopy;</p><p>CFU: colony-forming units.</p><p>a)&#160;&#160;Lit. [&#945;]<span>D</span> = (+) 126,6<span>o</span> (c = 1, H<span>2</span>O)</p><p>b)&#160;&#160;Analyses conducted on each batch</p><p>c)&#160;&#160;Maximum levels in accordance with Regulation (EC) No 1881/2006</p></td></tr><tr><td><p><a>&#9660;M108</a></p></td></tr><tr><td><p><span>Roasted and popped kernels from the seeds of<span>Euryale ferox</span> Salisb. (makhana) (Traditional food from a third country)</span></p></td><td><p><span>Description/Definition</span></p><p>The traditional food consists of the roasted and popped kernels of the seeds of the fresh plants of<span>Euryale ferox</span> Salisb. (family: Nymphaeaceae, commonly referred to also as prickly water lily) to be consumed as a snack. The traditional food is produced via a series of steps involving the collection, washing, and drying of the seeds, a first roasting in oil, tempering at ambient temperatures, a subsequent second roasting in oil to pop the kernels, followed by hitting of the hot seeds to release the popped kernels. The traditional food is also known as makhana or fox nuts.</p><p><span>Typical nutritional components:</span></p><p>Fat: 13,0&#160;g/100 g</p><p>Carbohydrates: 75,0&#160;g/100 g</p><p>Fibre: 2,5&#160;g/100 g</p><p>Protein: 7&#160;g/100 g</p><p>Moisture (% w/w): &lt;&#160;5,0</p><p>Ash: &lt;&#160;0,5&#160;g/100 g</p><p><span>Microbiological criteria:</span></p><p>Total plate count: &lt;&#160;10<span>3</span> CFU/g</p><p>Total yeast and mould count: &lt;&#160;100&#160;CFU/g</p><p>Total Enterobacteriaceae: &lt;&#160;10&#160;CFU/g</p><p><span>Salmonella</span> spp.: Absence in&#160;25 g</p><p><span>Listeria monocytogenes</span>: Absence in&#160;25 g</p><p><span>Heavy metals:</span></p><p>Selenium: &#8804;&#160;0,8&#160;mg/kg</p><p>Copper: &#8804;&#160;30,0&#160;mg/kg</p><p>Lead: &#8804;&#160;0,1&#160;mg/kg</p><p>Arsenic: &#8804;&#160;0,1&#160;mg/kg</p><p>Cadmium: &#8804;&#160;0,1&#160;mg/kg</p><p>Tin: &#8804;&#160;3,5&#160;mg/kg</p><p>Mercury: &#8804;&#160;0,025&#160;mg/kg</p><p><span>Mycotoxins:</span></p><p>Aflatoxin B1: &#8804;&#160;2,0&#160;&#956;g/kg</p><p>Sum of aflatoxins B1, B2, G1, and G2: &#8804;&#160;4,0&#160;&#956;g/kg</p><p>Ochratoxin A: &#8804;&#160;1,0&#160;&#956;g/kg</p><p>Citrinin: &#8804;&#160;20,0&#160;&#956;g/kg</p><p><span>Cyanotoxins:</span></p><p>Microcystins: &#8804;&#160;0,0015&#160;mg/kg</p><p><span>Pesticides:</span></p><p>Pesticides: &#8804;&#160;0,01&#160;mg/kg</p><p><span>Process contaminants:</span></p><p>Acrylamide: &#8804;&#160;40,0&#160;&#956;g/kg</p><p>Sum of PAHs: &#8804;&#160;10,0&#160;&#956;g/kg</p><p>Sum of dioxin-like PCBs: &#8804;&#160;0,35&#160;pg/g</p><p>3-MCPD: &#8804;&#160;20,0&#160;&#956;g/kg</p><p>Glycidyl fatty acid esters (expressed as glycidol): &#8804;&#160;500,0&#160;&#956;g/kg</p><p>Sum of 3-MCPD and&#160;3-MCPD fatty acid esters: &#8804;&#160;750,0&#160;&#956;g/kg</p><p>CFU: Colony Forming Units; PAHs: Polycyclic Aromatic Hydrocarbons; PCBs: Polychlorinated Biphenyls; 3-MCPD: 3-MonoChloroPropane Diol.</p></td></tr><tr><td><p><a>&#9660;M52</a></p></td></tr><tr><td><p><span>Extract of three herbal roots<span>(Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai)</span></span></p></td><td><p><span>Description/Definition</span></p><p>The mixture of the three herbal roots is yellowish brown fine powder produced by hot-water extraction, concentration by evaporation, and spray drying</p><p><span>Composition of the extract of mixture of the 3 herbal roots</span></p><p><span>Cynanchum wilfordii</span> root: 32,5 % (w/w)</p><p><span>Phlomis umbrosa</span> root: 32,5 % (w/w)</p><p><span>Angelica gigas</span> root: 35,0 % (w/w)</p><p><span>Specifications</span></p><p>Loss on drying: NMT 100 mg/g</p><p><span>Assay</span></p><p>Cinnamic acid: 0,012 &#8211; 0,039 mg/g</p><p>Shanzhiside methyl ester: 0,20 &#8211; 1,55 mg/g</p><p>Nodakenin: 3,35 &#8211; 10,61 mg/g</p><p>Methoxsalen: &lt; 3 mg/g</p><p>Phenols: 13,0 &#8211; 40,0 mg/g</p><p>Coumarins: 13,0 &#8211; 40,0 mg/g</p><p>Iridoids: 13,0 &#8211; 39,0 mg/g</p><p>Saponins: 5,0 &#8211; 15,5 mg/g</p><p><span>Nutritive components</span></p><p>Carbohydrates: 600 &#8211; 880 mg/g</p><p>Proteins: 70 &#8211; 170 mg/g</p><p>Fats: &lt; 4 mg/g</p><p><span>Microbiological parameters</span></p><p>Total viable plate count: &lt; 5000 CFU/g</p><p>Total mold and yeast: &lt; 100 CFU/g</p><p>Coliform bacteria: &lt; 10 CFU/g</p><p><span>Salmonella</span>: Negative/25 g</p><p><span>Escherichia coli</span>: Negative/25 g</p><p><span>Staphylococcus aureus</span>: Negative/25 g</p><p><span>Heavy metals</span></p><p>Lead: &lt; 0,65 mg/kg</p><p>Arsenic: &lt; 3,0 mg/kg</p><p>Mercury: &lt; 0,1 mg/kg</p><p>Cadmium: &lt; 1,0 mg/kg</p><p>CFU: Colony Forming Units</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Ferric Sodium EDTA</span></p></td><td><p><span>Description/Definition:</span></p><p>Ferric Sodium EDTA (ethylenediaminetetraacetic acid) is an odourless free-flowing, yellow to brown powder with a chemical purity of more than 99 % (w/w). It is freely soluble in water.</p><p>Chemical formula: C<span>10</span>H<span>12</span>FeN<span>2</span>NaO<span>8</span> * 3H<span>2</span>O</p><p>Chemical characteristics:</p><p>pH of 1 % solution: 3,5-5,5</p><p>Iron: 12,5-13,5 %</p><p>Sodium: 5,5 %</p><p>Water: 12,8 %</p><p>Organic matter (CHNO): 68,4 %</p><p>EDTA: 65,5-70,5 %</p><p>Water insoluble matter: &#8804; 0,1 %</p><p>Nitrilo-triacetic acid: &#8804; 0,1 %</p></td></tr><tr><td><p><span>Ferrous ammonium phosphate</span></p></td><td><p><span>Description/Definition:</span></p><p>Ferrous ammonium phosphate is a grey/green fine powder, practically insoluble in water and soluble in dilute mineral acids.</p><p>CAS No.: 10101-60-7</p><p>Chemical formula: FeNH<span>4</span>PO<span>4</span></p><p>Chemical characteristics:</p><p>pH of 5 % suspension in water: 6,8-7,8</p><p>Iron (total): &#8805; 28 %</p><p>Iron (II): 22-30 % (w/w)</p><p>Iron (III): &#8804; 7,0 % (w/w)</p><p>Ammonia: 5-9 % (w/w)</p><p>Water: &#8804; 3,0 %</p></td></tr><tr><td><p><span>Fish peptides from<span>Sardinops sagax</span></span></p></td><td><p><span>Description/Definition:</span></p><p>The novel food ingredient is a peptide mixture, which is obtained by an alkaline protease-catalysed hydrolysis of fish (<span>Sardinops sagax</span>) muscle, subsequent isolation of the peptide fraction by column chromatography, concentration under vacuum and spray drying.</p><p>Yellowish white powderPeptides (<span>1</span>) (short chain peptides, dipeptides and tripeptides with a molecular weight of less than 2 kDa): &#8805; 85 g/100 g</p><p>Val-Tyr (dipeptide): 0,1-0,16 g/100 g</p><p>Ash: &#8804; 10 g/100 g</p><p>Moisture: &#8804; 8 g/100 g</p><p>(<span>1</span>)&#160;&#160;Kjeldahl method</p></td></tr><tr><td><p><span>Flavonoids from<span>Glycyrrhiza glabra</span></span></p></td><td><p><span>Description/Definition:</span></p><p>Flavonoids derived from the roots or rootstock of<span>Glycyrrhiza glabra</span> L. are extracted with ethanol followed by further extraction of this ethanolic extract with medium-chain triglycerides. It is a dark-brown coloured liquid, containing 2,5 % to 3,5 % of glabridin.</p><p>Moisture: &lt; 0,5 %</p><p>Ash: &lt; 0,1 %</p><p>Peroxide value (PV): &lt; 0,5 meq/kg</p><p>Glabridin: 2,5-3,5 % of fat</p><p>Glycyrrhizinic acid: &lt; 0,005 %</p><p>Fat including polyphenol-type substances: &#8805; 99 %</p><p>Protein: &lt; 0,1 %</p><p>Carbohydrates: not detectable</p></td></tr><tr><td><p><a>&#9660;M42</a></p></td></tr><tr><td><p>Fruit pulp, pulp juice, concentrated pulp juice from<span>Theobroma cacao</span> L.</p><p>(Traditional food from a third country)</p></td><td><p><span>Description/Definition</span></p><p>The traditional food is the fruit pulp from the cocoa (<span>Theobroma cacao</span> L) plant, which is the &#8216;aqueous, mucilaginous and acidic substance in which the seeds are embedded&#8217;.</p><p>Cocoa fruit pulp is obtained by splitting cocoa pods followed by separation from husks and beans; the pulp is then subject to pasteurisation and freezing. Cocoa pulp juice and/or cocoa concentrated pulp juice are produced following processing (enzymatic treatment, pasteurization, filtration, and concentration).</p><p><span>Typical compositional data of cocoa fruit pulp, pulp juice, concentrated pulp juice</span></p><p>Protein (g/100 g): 0,0 to 2,0</p><p>Total fat (g/100 g): 0,0 to 0,2</p><p>Total sugars (g/100 g): &gt; 11,0</p><p>Brix level (&#176; Brix): &#8805; 14</p><p>pH: 3,3 to 4,0</p><p><span>Microbiological criteria</span></p><p>Total Plate Count (aerobic): &lt; 10&#160;000  cfu&#160;<a>(<span>9</span>)</a>/g</p><p>Enterobacteriaceae: &#8804; 10 cfu/g</p><p><span>Salmonella</span>: Absence in 25 g</p></td></tr><tr><td><p><a>&#9660;M74</a></p></td></tr><tr><td><p>Frozen, dried and powder forms of<span>Locusta migratoria</span> (migratory locust)</p></td><td><p><span>Description/Definition:</span></p><p>The novel food consists of the frozen, dried and powder forms of migratory locust. The term &#8216;migratory locust&#8217; refers to the adult of<span>Locusta migratoria</span>, an insect species that belongs to the Acrididae family (subfamily Locustinae).</p><p>The novel food is intended to be marketed in three different forms, namely: (i) thermally processed and frozen<span>L. migratoria</span> (LM frozen); (ii) thermally processed and freeze-dried<span>L. migratoria</span> (LM dried), and (iii) thermally processed freeze-dried and ground whole<span>L. migratoria</span> (whole LM powder). The LM dried may be marketed as such or in powder.</p><p>For LM frozen and LM dried, legs and wings must be removed to reduce the risk of intestinal constipation that could be possibly caused by ingestion of the large spines on the insect tibia. The whole LM powder is obtained via mechanical grinding of the insect with legs and wings, and sieving to reduce particle size below 1 mm.</p><p>A minimum 24 hours fasting period is required before killing the insects by freezing, to allow the adults to discard their bowel content.</p></td></tr><tr><td><p><span>Parameters</span></p></td><td><p><span>LM frozen</span></p></td><td><p><span>LM dried</span></p></td><td><p><span>Whole LM powder</span></p></td></tr><tr><td><p><span>Characteristics/Composition</span></p></td></tr><tr><td><p>Ash (% w/w)</p></td><td><p>0,6 -1,0</p></td><td><p>2,0 -3,1</p></td><td><p>1,8 -1,9</p></td></tr><tr><td><p>Moisture (% w/w)</p></td><td><p>67 -73</p></td><td><p>&#8804;&#160;5</p></td><td><p>&#8804;&#160;5</p></td></tr><tr><td><p>Crude protein (N &#215; 6,25 ) (% w/w)</p></td><td><p>11 -21</p></td><td><p>43 -53</p></td><td><p>50  &#8211; 60</p></td></tr><tr><td><p>Fat (% w/w)</p></td><td><p>7 -13</p></td><td><p>31 -41</p></td><td><p>31 -41</p></td></tr><tr><td><p>Saturated fatty acids (% fat)</p></td><td><p>35 -43</p></td><td><p>35 -43</p></td><td><p>35 -43</p></td></tr><tr><td><p>Digestible carbohydrates (% w/w)</p></td><td><p>0,1 -2,0</p></td><td><p>0,1 -2,0</p></td><td><p>1,0 -3,5</p></td></tr><tr><td><p>&#160;<a>(<span>18</span>)</a>Dietary fibre (% w/w)</p></td><td><p>1,5 -3,5</p></td><td><p>5,5 -9,0</p></td><td><p>5,5 -9,0</p></td></tr><tr><td><p>Chitin (% w/w)</p></td><td><p>1,7 -2,4</p></td><td><p>6,4 -10,4</p></td><td><p>10,5 -13,9</p></td></tr><tr><td><p>Peroxide value (Meq O<span>2</span>/kg fat)</p></td><td><p>&#8804;&#160;5</p></td><td><p>&#8804;&#160;5</p></td><td><p>&#8804;&#160;5</p></td></tr><tr><td><p><span>Contaminants</span></p></td></tr><tr><td><p>Lead (mg/kg)</p></td><td><p>&#8804;&#160;0,07</p></td><td><p>&#8804;&#160;0,07</p></td><td><p>&#8804;&#160;0,07</p></td></tr><tr><td><p>Cadmium (mg/kg)</p></td><td><p>&#8804;&#160;0,05</p></td><td><p>&#8804;&#160;0,05</p></td><td><p>&#8804;&#160;0,05</p></td></tr><tr><td><p>Aflatoxins (Sum of B1, B2, G1, G2) (&#956;g/kg)</p></td><td><p>&#8804;&#160;4</p></td><td><p>&#8804;&#160;4</p></td><td><p>&#8804;&#160;4</p></td></tr><tr><td><p>Aflatoxin B1 (&#956;g/kg)</p></td><td><p>&#8804;&#160;2</p></td><td><p>&#8804;&#160;2</p></td><td><p>&#8804;&#160;2</p></td></tr><tr><td><p>Deoxynivalenol (&#956;g/kg)</p></td><td><p>&#8804;&#160;200</p></td><td><p>&#8804;&#160;200</p></td><td><p>&#8804;&#160;200</p></td></tr><tr><td><p>Ochratoxin A (&#956;g/kg)</p></td><td><p>&#8804;&#160;1</p></td><td><p>&#8804;&#160;1</p></td><td><p>&#8804;&#160;1</p></td></tr><tr><td><p>Sum of dioxins and dioxins-like PCBs UB (&#160;<a>(<span>19</span>)</a>WHO<span>2&#160;005</span> PCDD/F-PCB-TEQ) (pg/g fat)</p></td><td><p>&#8804;&#160;1,2</p></td><td><p>&#8804;&#160;1,2</p></td><td><p>&#8804;&#160;1,2</p></td></tr><tr><td><p><span>Microbiological criteria</span></p></td></tr><tr><td><p>Total aerobic colony count (&#160;<a>(<span>7</span>)</a>CFU/g)</p></td><td><p>&#8804;&#160;10<span>5</span></p></td><td><p>&#8804;&#160;10<span>5</span></p></td><td><p>&#8804;&#160;10<span>5</span></p></td></tr><tr><td><p>Enterobacteriaceae (presumptive) (CFU/g)</p></td><td><p>&#8804;&#160;100</p></td><td><p>&#8804;&#160;100</p></td><td><p>&#8804;&#160;100</p></td></tr><tr><td><p><span>Escherichia coli</span> (CFU/g)</p></td><td><p>&#8804;&#160;50</p></td><td><p>&#8804;&#160;50</p></td><td><p>&#8804;&#160;50</p></td></tr><tr><td><p><span>Listeria monocytogenes</span></p></td><td><p>Not detected in 25 g</p></td><td><p>Not detected in 25 g</p></td><td><p>Not detected in 25 g</p></td></tr><tr><td><p><span>Salmonella</span> spp.</p></td><td><p>Not detected in 25 g</p></td><td><p>Not detected in 25 g</p></td><td><p>Not detected in 25 g</p></td></tr><tr><td><p><span>Bacillus cereus</span> (presumptive) (CFU/g)</p></td><td><p>&#8804;&#160;100</p></td><td><p>&#8804;&#160;100</p></td><td><p>&#8804;&#160;100</p></td></tr><tr><td><p>Coagulase positive<span>Staphylococci</span> (CFU/g</p></td><td><p>&#8804;&#160;100</p></td><td><p>&#8804;&#160;100</p></td><td><p>&#8804;&#160;100</p></td></tr><tr><td><p><span>Sulfite-reducing Anaerobes</span> (CFU/g)</p></td><td><p>&#8804;&#160;30</p></td><td><p>&#8804;&#160;30</p></td><td><p>&#8804;&#160;30</p></td></tr><tr><td><p>Yeasts and moulds (CFU/g)</p></td><td><p>&#8804;&#160;100</p></td><td><p>&#8804;&#160;100</p></td><td><p>&#8804;&#160;100</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Fucoidan extract from the seaweed<span>Fucus vesiculosus</span></span></p></td><td><p><span>Description/Definition:</span></p><p>Fucoidan from the seaweed<span>Fucus vesiculosus</span> is extracted using aqueous extraction in acidic solution and filtration processes without the use of organic solvents. The resulting extract is concentrated and dried to yield the fucoidan extract with the following specifications:</p><p>Off-white to brown powder</p><p>Odour and Taste: Bland odour and taste</p><p>Moisture: &lt; 10 % (105 &#176;C for 2 hours)</p><p>pH value: 4,0-7,0 (1 % suspension at 25 &#176;C)</p><p><span>Heavy metals:</span></p><p>Arsenic (inorganic): &lt; 1,0 ppm</p><p>Cadmium: &lt; 3,0 ppm</p><p>Lead: &lt; 2,0 ppm</p><p>Mercury: &lt; 1,0 ppm<span>Microbiological criteria:</span></p><p>Total aerobic microbial count: &lt; 10&#160;000  CFU/g</p><p>Yeast and mould count: &lt; 100 CFU/g</p><p>Total enterobacteria count: Absence/g</p><p><span>Escherichia coli</span>: Absence/g</p><p><span>Salmonella</span>: Absence/10 g</p><p><span>Staphylococcus aureus</span>: Absence/g</p><p>Composition of the two permitted types of extracts, based on the level of fucoidan:</p><p><span>Extract 1:</span></p><p>Fucoidan: 75-95 %</p><p>Alginate: 2,0-5,5 %</p><p>Polyphloroglucinol: 0,5-15 %</p><p>Mannitol: 1-5 %</p><p>Natural salts/Free Minerals: 0,5-2,5 %</p><p>Other carbohydrates: 0,5-1,0 %</p><p>Protein: 2,0-2,5 %</p><p><span>Extract 2:</span></p><p>Fucoidan: 60-65 %</p><p>Alginate: 3,0-6,0 %</p><p>Polyphloroglucinol: 20-30 %</p><p>Mannitol: &lt; 1,0 %</p><p>Natural salts/Free Minerals: 0,5-2,0 %</p><p>Other carbohydrates: 0,5-2,0 %</p><p>Protein: 2,0-2,5 %</p></td></tr><tr><td><p><span>Fucoidan extract from the seaweed<span>Undaria pinnatifida</span></span></p></td><td><p><span>Description/Definition:</span></p><p>Fucoidan from seaweed<span>Undaria pinnatifida</span> is extracted using aqueous extraction in acidic solution and filtration processes without the use of organic solvents. The resulting extract is concentrated and dried to yield the fucoidan extract with the following specifications:</p><p>Off-white to brown powder</p><p>Odour and Taste: Bland odour and tasteMoisture: &lt; 10 % (105 &#176;C for 2 hours)</p><p>pH value: 4,0-7,0 (1 % suspension at 25 &#176;C)</p><p><span>Heavy metals:</span></p><p>Arsenic (inorganic): &lt; 1,0 ppm</p><p>Cadmium: &lt; 3,0 ppm</p><p>Lead: &lt; 2,0 ppm</p><p>Mercury: &lt; 1,0 ppm</p><p><span>Microbiology:</span></p><p>Total aerobic microbial count: &lt; 10&#160;000  CFU/g</p><p>Yeast and mould count: &lt; 100 CFU/g</p><p>Total enterobacteria count: Absence/g</p><p><span>Escherichia coli</span>: Absence/g</p><p><span>Salmonella</span>: Absence/10 g</p><p><span>Staphylococcus aureus</span>: Absence/g</p><p>Composition of the two permitted types of extracts, based on the level of fucoidan:</p><p><span>Extract 1:</span></p><p>Fucoidan: 75-95 %</p><p>Alginate: 2,0-6,5 %</p><p>Polyphloroglucinol: 0,5-3,0 %</p><p>Mannitol: 1-10 %</p><p>Natural salts/Free Minerals: 0,5-1,0 %</p><p>Other carbohydrates: 0,5-2,0 %</p><p>Protein: 2,0-2,5 %</p><p><span>Extract 2:</span></p><p>Fucoidan: 50-55 %</p><p>Alginate: 2,0-4,0 %</p><p>Polyphloroglucinol: 1,0-3,0 %</p><p>Mannitol: 25-35 %</p><p>Natural salts/Free Minerals: 8-10 %</p><p>Other carbohydrates: 0,5-2,0 %</p><p>Protein: 1,0-1,5 %</p></td></tr><tr><td><p><span>2&#8242;-Fucosyllactose</span></p><p><span>(synthetic)</span></p></td><td><p><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><p><span>Description:</span></p><p>2&#8242;-fucosyllactose is a white to off-white powder that is produced by a chemical synthesis process.</p><p><span>Purity:</span></p><p>2'-Fucosyllactose: &#8805; 95 %</p><p>D-Lactose: &#8804; 1,0 w/w %</p><p>L-Fucose: &#8804; 1,0 w/w %</p><p>Difucosyl- D-lactose isomers: &#8804; 1,0 w/w %</p><p>2&#8242;-Fucosyl- D-lactulose: &#8804; 0,6 w/w %</p><p>pH (20 &#176;C, 5 % solution): 3,2-7,0</p><p>Water (%): &#8804; 9,0 %</p><p>Ash, sulphated: &#8804; 0,2 %</p><p>Acetic acid: &#8804; 0,3 %</p><p>Residual solvents (methanol, 2-propanol, methyl acetate, acetone): &#8804; 50,0 mg/kg singly, &#8804; 200,0 mg/kg in combination</p><p>Residual proteins: &#8804; 0,01 %</p><p><span>Heavy Metals:</span></p><p>Palladium: &#8804; 0,1 mg/kg</p><p>Nickel: &#8804; 3,0 mg/kg</p><p><span>Microbiological criteria:</span></p><p>Aerobic mesophilic bacteria total count: &#8804; 500 CFU/g</p><p>Yeasts and Moulds: &#8804; 10 CFU/g</p><p>Residual endotoxins: &#8804; 10 EU/mg</p></td></tr><tr><td><p><a>&#9660;M110</a></p></td></tr><tr><td><p>Specifications</p></td><td><p>&#160;</p><div/></td><td><p>Data protection</p></td></tr><tr><td><p>&#160;</p><div/></td><td><p><span>Definition:</span></p><div><p>Chemical name: &#945;-L-Fucopyranosyl-(1&#8594;2)-&#946;-D-galactopyranosyl-(1&#8594;4)-D-glucopyranose</p></div><div><p>Chemical formula: C<span>18</span>H<span>32</span>O<span>15</span></p></div><div><p>CAS No: 41263-94-9</p></div><div><p>Molecular weight: 488,44&#160;g/mol</p></div></td><td><p>2&#8242;-Fucosyllactose produced with a genetically modified strain of Corynebacterium glutamicum ATCC 13032 authorised on 16&#160;May 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article&#160;26 of Regulation (EU)&#160;2015/2283.</p><p>Applicant: &#8216;Advanced Protein Technologies Corporation&#8217;, 7th Floor GyeongGi-BioCenter, 147, Gwanggyo-ro, Yeongtong-gu, Suwon-si Gyeonggi-do, 16229 South Korea. During the period of data protection, 2&#8242;-Fucosyllactose produced with a genetically modified strain of Corynebacterium glutamicum ATCC 13032 is authorised for placing on the market within the Union only by &#8216;Advanced Protein Technologies Corporation&#8217; 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)&#160;2015/2283 or with the agreement of &#8216;Advanced Protein Technologies Corporation&#8217;.</p><p>End date of the data protection: 16&#160;May 2028.</p></td></tr><tr><td><p><span>2&#8217;-Fucosyllactose (microbial source)</span></p></td><td><p><span>Source:</span> Genetically modified strain of<span>Escherichia coli</span> K-12</p></td><td><p><span>Source:</span> Genetically modified strain of<span>Escherichia coli</span> BL-21</p></td><td><p><span>Source</span>: Genetically modified strain of<span>Corynebacterium glutamicum</span> ATCC 13032</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 microbiological process.</p><p><span>Purity:</span></p><div><p>2&#8242;-Fucosyllactose: &#8805;&#160;83&#160;%</p></div><div><p>D-Lactose: &#8804;&#160;10,0&#160;%</p></div><div><p>L-Fucose: &#8804;&#160;2,0&#160;%</p></div><div><p>Difucosyl-D-lactose: &#8804;&#160;5,0&#160;%</p></div><div><p>2&#8242;-Fucosyl-D-lactulose: &#8804;&#160;1,5&#160;%</p></div><div><p>Sum of saccharides (2&#8242;-Fucosyllactose, D-Lactose, L-Fucose, Difucosyl-D-lactose, 2&#8242;-Fucosyl-D-lactulose): &#8805;&#160;90&#160;%</p></div><div><p>pH (20 C, 5&#160;% solution): 3,0-7,5</p></div><div><p>Water: &#8804;&#160;9,0&#160;%</p></div><div><p>Sulphated ash: &#8804;&#160;2,0&#160;%</p></div><div><p>Acetic acid: &#8804;&#160;1,0&#160;%</p></div><div><p>Residual proteins: &#8804;&#160;0,01&#160;%</p></div><p><span>Microbiological criteria:</span></p><div><p>Aerobic mesophilic bacteria total count: &#8804;&#160;3&#160;000  CFU/g</p></div><div><p>Yeasts: &#8804;&#160;100&#160;CFU/g</p></div><div><p>Moulds: &#8804;&#160;100&#160;CFU/g</p></div><div><p>Endotoxins: &#8804;&#160;10&#160;EU/mg</p></div><div><p>CFU: Colony Forming Units; EU: Endotoxin Units</p></div></td><td><p><span>Description:</span></p><p>2&#8242;-Fucosyllactose is a white to off white powder and the liquid concentrate (45&#160;%&#160;&#177;&#160;5&#160;% w/v) aqueous solution is a colourless to slight yellow clear aqueous solution.&#160;2&#8242;-Fucosyllactose is produced by a microbiological process.</p><p><span>Purity:</span></p><div><p>2&#8242;-Fucosyllactose: &#8805;&#160;90&#160;%</p></div><div><p>Lactose: &#8804;&#160;5,0&#160;%</p></div><div><p>Fucose: &#8804;&#160;3,0&#160;%</p></div><div><p>3-Fucosyllactose: &#8804;&#160;5,0&#160;%</p></div><div><p>Fucosylgalactose: &#8804;&#160;3,0&#160;%</p></div><div><p>Difucosyllactose: &#8804;&#160;5,0&#160;%</p></div><div><p>Glucose: &#8804;&#160;3,0&#160;%</p></div><div><p>Galactose: &#8804;&#160;3,0&#160;%</p></div><div><p>Water: &#8804;&#160;9,0&#160;% (powder)</p></div><div><p>Ash, sulphated: &#8804;&#160;0,5&#160;% (powder and liquid)</p></div><div><p>Residual proteins: &#8804;&#160;0,01&#160;% (powder and liquid)</p></div><p><span>Heavy Metals:</span></p><div><p>Lead: &#8804;&#160;0,02&#160;mg/kg (powder and liquid)</p></div><div><p>Arsenic: &#8804;&#160;0,2&#160;mg/kg (powder and liquid)</p></div><div><p>Cadmium: &#8804;&#160;0,1&#160;mg/kg (powder and liquid)</p></div><div><p>Mercury: &#8804;&#160;0,5&#160;mg/kg (powder and liquid)</p></div><p><span>Microbiological criteria:</span></p><div><p>Total plate count: &#8804;&#160;104&#160;CFU/g (powder), &#8804;&#160;5&#160;000  CFU/g (liquid)</p></div><div><p>Yeasts and Moulds: &#8804;&#160;100&#160;CFU/g (powder); &#8804;&#160;50&#160;CFU/g (liquid)</p></div><div><p>Enterobacteriaceae/Coliforms: absence in&#160;11 g (powder and liquid)</p></div><div><p>Salmonella: negative/100 g (powder), negative/200 ml (liquid)</p></div><div><p>Cronobacter: negative/100 g (powder), negative/200 ml (liquid)</p></div><div><p>Endotoxins: &#8804;&#160;100&#160;EU/g (powder), &#8804;&#160;100&#160;EU/ml (liquid)</p></div><div><p>Aflatoxin M1: &#8804;&#160;0,025&#160;&#956;g/kg (powder and liquid)</p></div><div><p>CFU: Colony Forming Units; EU: Endotoxin Units</p></div></td><td><p><span>Description:</span></p><p>2&#8242;-Fucosyllactose is a white to off&#160;white/ivory powder that is produced by a microbiological process.</p><p><span>Purity:</span></p><div><p>2&#8242;-Fucosyllactose&#160;(w/w dry matter): &#8805;&#160;94,0&#160;%</p></div><div><p>D-Lactose&#160;(w/w dry matter): &#8804;&#160;3,0&#160;%</p></div><div><p>L-Fucose&#160;(w/w dry matter): &#8804;&#160;3,0&#160;%</p></div><div><p>3-Fucosyllactose&#160;(w/w dry matter): &#8804;&#160;3,0&#160;%</p></div><div><p>Difucosyllactose&#160;(w/w dry matter): &#8804;&#160;2,0&#160;%</p></div><div><p>D-Glucose&#160;(w/w dry matter): &#8804;&#160;3,0&#160;%</p></div><div><p>D-Galactose&#160;(w/w dry matter): &#8804;&#160;3,0&#160;%</p></div><div><p>Water: &#8804;&#160;9,0&#160;%</p></div><div><p>Ash: &#8804;&#160;0,5&#160;%</p></div><div><p>Residual proteins: &#8804;&#160;0,005&#160;%</p></div><p><span>Contaminants</span>:</p><div><p>Arsenic: &#8804;&#160;0,03&#160;mg/kg</p></div><div><p>Aflatoxin M1: &#8804;&#160;0,025&#160;&#956;g/kg</p></div><div><p>Ethanol: &#8804;&#160;1&#160;000  mg/kg</p></div><p><span>Microbiological criteria</span>:</p><div><p>Total plate count: &#8804;&#160;500&#160;CFU/g</p></div><div><p>Yeasts and Moulds: &#8804;&#160;100&#160;CFU/g</p></div><div><p>Enterobacteriaceae: absence in&#160;10 g</p></div><div><p><span>Salmonella</span>: absence in&#160;25 g</p></div><div><p><span>Cronobacter</span> spp.: absence in&#160;10 g</p></div><div><p>Endotoxins: &#8804;&#160;100&#160;EU/g</p></div><div><p>CFU: Colony Forming Units; EU: Endotoxin Units</p></div></td></tr><tr><td><p><a>&#9660;M58</a></p></td></tr><tr><td><p><span>2&#8242;-Fucosyllactose/Difucosyllactose mixture (&#8216;2&#8242;-FL/DFL&#8217;)</span></p><p><span>(microbial source)</span></p></td><td><p><span>Description/Definition:</span></p><p>2&#8242;-Fucosyllactose/Difucosyllactose mixture is a purified, white to off-white powder or agglomerates thereof that is produced by a microbial process.</p><p><span>Source</span>: Genetically modified<span>Escherichia coli</span> strain K-12 DH1</p><p><span>Characteristics/Composition:</span></p><p>Appearance: White to off white powder or agglomerates</p><p>Sum of 2&#8242;-Fucosyllactose, Difucosyllactose, D-Lactose, L-Fucose, and 3-Fucosyllactose (% of dry matter): &#8805; 92,0 % (w/w)</p><p>Sum of 2&#8242;-Fucosyllactose and Difucosyllactose (% of dry matter): &#8805; 85,0 % (w/w)</p><p>2&#8242;-Fucosyllactose (% of dry matter): &#8805; 75,0 % (w/w)</p><p>Difucosyllactose (% of dry matter): &#8805; 5,0 % (w/w)</p><p>D-Lactose: &#8804; 10,0 % (w/w)</p><p>L-Fucose: &#8804; 1,0 % (w/w)</p><p>2&#8242;-Fucosyl-D-lactulose: &#8804; 2,0 (w/w)</p><p>Sum of other carbohydrates&#160;<a>(<span>11</span>)</a>: &#8804; 6,0 % (w/w)</p><p>Moisture: &#8804; 6,0 % (w/w)</p><p>Ash, sulfated: &#8804; 0,8 % (w/w)</p><p>pH (20 &#176;C, 5 % solution): 4,0 -6,0</p><p>Residual protein: &#8804; 0,01 % (w/w)</p><p><span>Microbiological criteria:</span></p><p>Aerobic mesophilic total plate count: &#8804; 1000 CFU/g</p><p>Enterobacteriaceae: &#8804; 10 CFU/g</p><p><span>Salmonella</span> sp.: Negative/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><p>CFU: Colony Forming Units; EU: Endotoxin Units</p></td></tr><tr><td><p><a>&#9660;M75</a></p></td></tr><tr><td><p>3-Fucosyllactose (&#8216;3-FL&#8217;)</p><p>(microbial source)</p></td><td><p><span>Description:</span></p><p>3-Fucosyllactose (3-FL) is a purified, white to off-white powder that is produced by microbial fermentation and contains limited levels of D-Lactose, L-Fucose, D-Galactose, and D-Glucose.</p><p><span>Source:</span> Genetically modified strain of<span>Escherichia coli</span> K-12.</p><p><span>Definition:</span></p><p>Chemical formula: C<span>18</span>H<span>32</span>O<span>15</span></p><p>Chemical name: &#946;-D-galactopyranosyl-(1&#8594;4)[-&#945;-L-fucopyranosyl-(1&#8594;3)]-D-glucopyranose</p><p>Molecular mass: 488,44 Da</p><p>CAS No&#160;41312-47-4</p><p><span>Characteristics/Composition:</span></p><p>3-Fucosyllactose (% of dry matter): &#8805;&#160;90,0&#160;% (w/w)</p><p>D-Lactose (% of dry matter): &#8804;&#160;5,0&#160;% (w/w)</p><p>L-Fucose (% of dry matter): &#8804;&#160;3,0&#160;% (w/w)</p><p>Sum of D-Galactose/D-Glucose (% of dry matter): &#8804;&#160;3,0&#160;% (w/w)</p><p>Sum of other carbohydrates<span>a</span> (% of dry matter): &#8804;&#160;3,0&#160;% (w/w)</p><p>Moisture: &#8804;&#160;5,0&#160;% (w/w)</p><p>pH (20&#160;&#176;C, 5&#160;% solution): 3,0-7,5</p><p>Residual protein: &#8804;&#160;0,01&#160;% (w/w)</p><p>Ash (%): &#8804;&#160;0,5</p><p><span>Heavy metals/Contaminants:</span></p><p>Arsenic: &#8804;&#160;0,2&#160;mg/kg</p><p>Cadmium: &#8804;&#160;0,05&#160;mg/kg</p><p>Lead: &#8804;&#160;0,05&#160;mg/kg</p><p>Mercury: &#8804;&#160;0,1&#160;mg/kg</p><p>Aflatoxin M1: &#8804;&#160;0,025 &#956;g/kg</p><p>Aflatoxin B1: &#8804;&#160;0,1 &#956;g/kg</p><p>Residual endotoxins: &#8804;&#160;0,3 EU/mg</p><p><span>Microbiological criteria:</span></p><p>Total plate count: &#8804;&#160;1&#160;000  CFU/g</p><p>Enterobacteriaceae: Absence in&#160;10 g</p><p><span>Salmonella</span> sp.: Absence in&#160;25 g</p><p><span>Cronobacter (Enterobacter) sakazakii</span>: Absence in&#160;10 g</p><p><span>Listeria monocytogenes</span>: Absence in&#160;25 g</p><p><span>Bacillus cereus</span>: &#8804;&#160;10 CFU/g</p><p>Yeast: &#8804;&#160;100 CFU/g</p><p>Mould: &#8804;&#160;100 CFU/g</p><p>CFU: Colony Forming Units; EU: Endotoxin Units;<span>a</span>Sum of other carbohydrates: 3-Fucosyllactose isomer, difucosyllactose isomer, and oligomers.</p></td></tr><tr><td><p><a>&#9660;M102</a></p></td></tr><tr><td><p><span>3-Fucosyllactose (&#8216;3-FL&#8217;)</span></p><p><span>(produced by a derivative strain of<span>E. coli</span> BL21(DE3))</span></p></td><td><p><span>Description:</span></p><p>3-Fucosyllactose (3-FL) is a purified, white to off-white powder that is produced by microbial fermentation and contains limited levels of D-Lactose, L-Fucose, D-Galactose, and D-Glucose.</p><p><span>Definition:</span></p><p>Chemical name: &#946;-D-Galactopyranosyl-(1&#8594;4)- [&#945;-L-fucopyranosyl-(1&#8594;3)]- D-glucopyranose</p><p>Chemical formula: C<span>18</span>H<span>32</span>O<span>15</span></p><p>Molecular mass: 488,44 Da</p><p>CAS No: 41312-47-4</p><p><span>Source:</span> A genetically modified strain of<span>Escherichia coli</span> BL21(DE3)</p><p><span>Characteristics/Composition:</span></p><div><p>3-Fucosyllactose (% of dry matter): &#8805;&#160;90,0&#160;% (w/w)</p></div><div><p>D-Lactose (% of dry matter): &#8804;&#160;5,0&#160;% (w/w)</p></div><div><p>D-glucose (% of dry matter): &#8804;&#160;3,0&#160;% (w/w)</p></div><div><p>D-galactose (% of dry matter): &#8804;&#160;3,0&#160;% (w/w)</p></div><div><p>L-Fucose (% of dry matter): &#8804;&#160;3,0&#160;% (w/w)</p></div><div><p>Sum of other carbohydrates (% of dry matter)&#160;<a>(<span>24</span>)</a>: &#8804;&#160;5,0&#160;% (w/w)</p></div><div><p>Moisture: &#8804;&#160;9,0&#160;% (w/w)</p></div><div><p>Ash: &#8804;&#160;1,0&#160;% (w/w)</p></div><div><p>Residual protein: &#8804;&#160;0,01&#160;% (w/w)</p></div><p><span>Heavy metals and contaminants:</span></p><div><p>Arsenic: &#8804;&#160;0,2&#160;mg/kg</p></div><div><p>Aflatoxin M1: &#8804;&#160;0,025 &#956;g/kg</p></div><p><span>Microbiological criteria:</span></p><div><p>Standard plate count: &#8804;&#160;1&#160;000  CFU&#160;<a>(<span>25</span>)</a>/g</p></div><div><p>Enterobacteriaceae: &#8804;&#160;10 CFU/g</p></div><div><p><span>Salmonella</span> spp.: Absence in&#160;25 g</p></div><div><p>Yeast and mould: &#8804;&#160;100 CFU/g</p></div><div><p><span>Cronobacter</span> (<span>Enterobacter</span>)<span>sakazakii</span>.: Absence in&#160;10 g</p></div><div><p>Residual endotoxins: &#8804;&#160;10 EU&#160;<a>(<span>26</span>)</a>/mg</p></div></td></tr><tr><td><p><a>&#9660;M20 M36 M62 M104</a></p></td></tr><tr><td><p><span>Galacto-oligosaccharide</span></p></td><td><p><span>Description/Definition:</span></p><p><span>Galacto-oligosaccharide is produced from milk lactose by an enzymatic process using &#946;-galactosidases from<span>Aspergillus oryzae, Bifidobacterium bifidum, Pichia pastoris, Sporobolomyces singularis, Kluyveromyces lactis and Papiliotrema terrestris</span>.</span></p><p>GOS: min.&#160;46&#160;% Dry Matter (DM)</p><p>Lactose: max. 40&#160;% DM</p><p>Glucose: max. 22&#160;% DM</p><p>Galactose: min.&#160;0,8&#160;% DM</p><p>Ash: max. 4,0&#160;% DM</p><p>Protein: max. 4,5&#160;% DM</p><p>Nitrite: max. 2 mg/kg</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Glucosamine HCl from<span>Aspergillus niger</span> and genetically modified strain of<span>E. coli</span> K-12</span></p></td><td><p>White crystalline odourless powder</p><p>Molecular formula: C<span>6</span>H<span>13</span>NO<span>5</span> &#903; HCl</p><p>Relative molecular mass: 215,63 g/mol</p><p>D-Glucosamine HCl 98,0-102,0 % of reference standard (HPLC)</p><p>Specific rotation + 70,0<span>o</span> - + 73,0<span>o</span></p></td></tr><tr><td><p><span>Glucosamine sulphate KCl from<span>Aspergillus niger</span> and genetically modified strain of<span>E. coli</span> K-12</span></p></td><td><p>White crystalline odourless powder</p><p>Molecular formula: (C<span>6</span>H<span>14</span>NO<span>5</span>)<span>2</span>SO<span>4</span> &#903; 2KCl</p><p>Relative molecular mass: 605,52 g/mol</p><p>D-Glucosamine Sulphate 2KCl 98,0-102,0 % of reference standard (HPLC)</p><p>Specific Rotation +50,0<span>o</span> to +52,0<span>o</span></p></td></tr><tr><td><p><span>Glucosamine sulphate NaCl from<span>Aspergillus niger</span> and genetically modified strain of<span>E. coli</span> K-12</span></p></td><td><p>White crystalline odourless powder</p><p>Molecular formula: (C<span>6</span>H<span>14</span>NO<span>5</span>)<span>2</span>SO<span>4</span> &#903; 2NaCl</p><p>Relative molecular mass: 573,31 g/mol</p><p>D-Glucosamine HCl: 98-102 % of reference standard (HPLC)</p><p>Specific Optical Rotation: +52<span>o</span> - +54<span>o</span></p></td></tr><tr><td><p><span>Guar Gum</span></p></td><td><p><span>Description/Definition:</span></p><p>Native guar gum is the ground endosperm of seeds from natural strains of guar<span>Cyamopsis tetragonolobus</span> L. Taub. (<span>Leguminosae</span> family). It consists of a high molecular weight polysaccharide, primarily composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as a galactomannan (galactomannan content not less than 75 %).</p><p>Appearance: White to yellowish powder</p><p>Molecular weight: Between 50&#160;000  &#8211; 8&#160;000&#160;000  Daltons</p><p>CAS number: 9000-30-0</p><p>Einecs Number: 232-536-8</p><p>Purity: As specified by Commission Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council&#160;<a>(<span>1</span>)</a> &amp; by Commission Implementing Regulation (EU) 2015/175 of 5 February 2015 laying down special conditions applicable to the import of guar gum originating in or consigned from India due to contamination risks by pentachlorophenol and dioxins&#160;<a>(<span>2</span>)</a>.</p><p><span>Physico-chemical properties:</span></p><p><span>Powder</span></p><p>Shelf-life: 2 years</p><p>Colour: White</p><p>Odour: Light</p><p>Average diameter of particles: 60-70&#956;m</p><p>Moisture: Max 15 %</p><p>Viscosity * at 1 hour &#8212;Viscosity * at 2 hours: Min 3&#160;600  mPa.s</p><p>Viscosity * at 24 hours: Min 4&#160;000  mPa.s</p><p>Solubility: Soluble in hot and cold water</p><p>pH for 10g/L, at 25 &#176;C - 6-7,5</p><p><span>Flakes</span></p><p>Useful life: 1 year</p><p>Colour: White/off white with absence or minimal presence of black spots</p><p>Odour: Light</p><p>Average diameter of particles: 1-10 mm</p><p>Moisture: Max 15 %</p><p>Viscosity * at 1 hour: Min 3&#160;000  mPa.s</p><p>Viscosity * at 2 hours &#8212;</p><p>Viscosity * at 24 hours &#8212;</p><p>Solubility &#8212; Soluble in hot and cold water</p><p>pH for 10g/L, at 25 &#176;C - 5-7,5</p><p>(*)&#160;&#160;The measurements of viscosity are carried out under the following conditions: 1 %, 25 &#176;C, 20 rpm</p></td></tr><tr><td><p><span>Heat-treated milk products fermented with<span>Bacteroides xylanisolvens</span></span></p></td><td><p><span>Description/Definition:</span></p><p>Heat-treated fermented milk products are produced with<span>Bacteroides xylanisolvens</span> (DSM 23964) as starter culture.</p><p>Semi-skimmed milk (between 1,5 % and 1,8 % fat) or skimmed milk (0,5 % fat or less) is pasteurised or ultra-heat-treated before starting the fermentation with<span>Bacteroides xylanisolvens</span> (DSM 23964). The resulting fermented milk product is homogenised and then heat-treated to inactivate<span>Bacteroides xylanisolvens</span> (DSM 23964). The final product does not contain viable cells of<span>Bacteroides xylanisolvens</span> (DSM 23964)(<span>1</span>).</p><p>(<span>1</span>)&#160;&#160;Modified DIN EN ISO 21528-2.</p></td></tr><tr><td><p><span>Hydroxytyrosol</span></p></td><td><p><span>Description/Definition:</span></p><p>Hydroxytyrosol is a pale yellow viscous liquid obtained by chemical synthesis</p><p>Molecular formula: C<span>8</span>H<span>10</span>O<span>3</span></p><p>Molecular weight: 154,6 g/mol</p><p>CAS No: 10597-60-1</p><p>Moisture &#8804; 0,4 %</p><p>Odour: CharacteristicTaste: Slightly bitter</p><p>Solubility (water): Miscible with water</p><p>pH: 3,5-4,5</p><p>Refractive Index: 1,571-1,575</p><p><span>Purity:</span></p><p>Hydroxytyrosol: &#8805; 99 %</p><p>Acetic acid: &#8804; 0,4 %</p><p>Hydroxytyrosol acetate: &#8804; 0,3 %</p><p>Sum of homovanillic acid, iso-homovanilic acid, and 3-methoxy-4hydroxyphenylglycol: &#8804; 0,3 %</p><p><span>Heavy Metals</span></p><p>Lead: &#8804; 0,03 mg/kg</p><p>Cadmium: &#8804; 0,01 mg/kg</p><p>Mercury: &#8804; 0,01 mg/kg</p><p><span>Residual Solvents</span></p><p>Ethyl acetate: &#8804; 25,0 mg/kg</p><p>Isopropanol: &#8804; 2,50 mg/kg</p><p>Methanol: &#8804; 2,00 mg/kg</p><p>Tetrahydrofuran: &#8804; 0,01 mg/kg</p></td></tr><tr><td><p><span>Ice Structuring Protein type III HPLC 12</span></p></td><td><p><span>Description/Definition:</span></p><p>The Ice Structuring Protein (ISP) preparation is a light-brown liquid produced by submerged fermentation of a genetically-modified strain of food-grade baker&#8217;s yeast (<span>Saccharomyces cerevisiae</span>) in which a synthetic gene for the ISP has been inserted into the yeast&#8217;s genome. The protein is expressed and secreted into the growth medium where it is separated from the yeast cells by micro-filtration and concentrated by ultra-filtration. As a result, the yeast cells are not transferred into the ISP preparation as such or under an altered form. The ISP preparation consists of native ISP, glycosylated ISP and proteins and peptides from the yeast and sugars as well as acids and salts commonly found in food. The concentrate is stabilised with 10 mM citric acid buffer.</p><p>Assay: &#8805; 5 g/l active ISP</p><p>pH: 2,5-3,5</p><p>Ash: &#8804; 2,0 %</p><p>DNA: Not detectable</p></td></tr><tr><td><p><span>Aqueous extract of dried leaves of<span>Ilex guayusa</span></span></p></td><td><p><span>Description/Definition:</span></p><p>Dark brown liquid. Aqueous extracts of dried leaves of<span>Ilex guayusa.</span><span>Composition:</span></p><p>Protein: &lt; 0,1 g/100 ml</p><p>Fat: &lt; 0,1 g/100 ml</p><p>Carbohydrate: 0,2&#8211;0,3 g/100 ml</p><p>Total sugars: &lt; 0,2 g/100 ml</p><p>Caffeine: 19,8&#8211;57,7 mg/100 ml</p><p>Theobromine: 0,14&#8211;2,0 mg/100 ml</p><p>Chlorogenic acids: 9,9&#8211;72,4 mg/100ml</p></td></tr><tr><td><p><a>&#9660;M49</a></p></td></tr><tr><td><p><span>Infusion from coffee leaves of<span>Coffea arabica</span> L. and/or<span>Coffea canephora</span> Pierre ex A. Froehner</span></p><p><span>(Traditional food from a third country)</span></p></td><td><p><span>Description/Definition:</span></p><p>The traditional food consists of an infusion of leaves from<span>Coffea arabica</span> L. and/or<span>Coffea canephora</span> Pierre ex A.Froehner (family: Rubiaceae).</p><p>The traditional food is prepared by mixing a maximum of 20 g of dried leaves from<span>Coffea arabica</span> L. and/or<span>Coffea canephora</span> Pierre ex A.Froehner with 1 L of hot water. Leaves are removed and the infusion is then subjected to pasteurization (at least 71 &#176;C for 15 seconds).</p><p><span>Composition:</span></p><p>Visual: Brown green liquid</p><p>Odour and taste: Characteristic</p><p>Chlorogenic acid (5-CQA): &lt; 100 mg/L</p><p>Caffeine: &lt; 80 mg/L</p><p>Epigallocatechin gallate (EGCG): &lt; 700 mg/L</p><p><span>Microbiological criteria:</span></p><p>Total plate count: &lt; 500 CFU/g</p><p>Total yeast and mould count: &lt; 100 CFU/g</p><p>Total coliforms: &lt; 100 CFU/g</p><p><span>Escherichia coli</span>: Absence in 1 g</p><p><span>Salmonella</span>: Absence in 25 g</p><p><span>Heavy metals:</span></p><p>Lead (Pb): &lt; 3,0 mg/L</p><p>Arsenic (As): &lt; 2,0 mg/L</p><p>Cadmium (Cd): &lt; 1,0 mg/L</p><p>CFU: Colony Forming Units</p></td></tr><tr><td><p><a>&#9660;M94</a></p></td></tr><tr><td><p><span>Iron hydroxide adipate tartrate</span></p></td><td><p><span>Description/Definition:</span></p><p>Iron hydroxide adipate tartrate (IHAT) is an odourless, engineered nanomaterial in powder form that is insoluble in water and is manufactured by a chemical synthesis involving a series of steps involving acid-base reaction, precipitation, filtration, and drying.</p><p>The food supplements containing the novel food are manufactured in capsular form. Excess adipate, tartrate and sodium chloride are used at levels resulting from the production process to help stabilise IHAT and ensure the authorised particle size distribution. If other forms of food supplements (e.g. tablets, pastilles, sachets of powders, gummies, syrups, etc.) are used in combination with adipate, tartrate and sodium chloride or in combination with other substances, or if other substances are used in the capsular form food supplements containing the novel food, it must be ensured that the authorised IHAT particle size distribution is maintained.</p></td></tr><tr><td><p><span>Common name</span></p></td><td><p>Iron oxo-hydroxide adipate tartrate</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Other names</span></p></td><td><p>Iron hydroxide adipate tartrate, Iron oxyhydroxide adipate tartrate</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Trade name</span></p></td><td><p>IHAT</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>CAS number</span></p></td><td><p>2460638-28-0</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Molecular formula</span></p><p><span>(calculated)</span></p></td><td><p>FeO<span>m</span>(OH)<span>n</span>(H<span>2</span>O)<span>x</span>(C<span>4</span>H<span>6</span>O<span>6</span>)<span>y</span>(C<span>6</span>H<span>10</span>O<span>4</span>)<span>z</span></p><p><span>where: m and n are undefined as per accepted practice for ferric iron oxohydroxides</span>&#160;<a>(<span>*1</span>)</a></p><p>x&#160;= 0,28-0,88</p><p>y&#160;= 0,78-1,50</p><p>z&#160;= 0,04-0,19</p><p>Tartaric (C<span>4</span>H<span>6</span>O<span>6</span>) and adipic (C<span>6</span>H<span>10</span>O<span>4</span>) acid are represented in their protonated form.</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Molecular weight</span></p></td><td><p>Average molecular weight: 35&#160;803,4  Da (lower-upper bound: 27&#160;670,5 -45&#160;319,4  Da)</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Characteristics/Composition:</span></p><p><span>Physical/chemical</span></p><p>Iron (% dry matter): 24,0-36,0</p><p>Adipate: (% dry matter): 1,5-4,5</p><p>Tartrate: (% dry matter): 28,0-40,0</p><p>Water content (%): 10,0-21,0</p><p>Sodium (% dry matter): 9,0-11,0</p><p>Chloride (% dry matter): 2,6-4,2</p><p><span>Phase distribution</span></p><p>Soluble (%): 2,0-4,0</p><p>Nano (%): 92,0-98,0</p><p>Micro (%): 0,0-3,0</p><p><span>Primary particle size</span></p><p>Median diameter&#160;<a>(<span>20</span>)</a>: 1,5-2,3 nm</p><p>Mean diameter&#160;<a>(<span>20</span>)</a>: 1,8-2,8 nm</p><p>Dv(10)&#160;<a>(<span>21</span>)</a>: 1,5-2,5 nm</p><p>Dv(50)&#160;<a>(<span>21</span>)</a>: 2,5-3,5 nm</p><p>Dv(90)&#160;<a>(<span>21</span>)</a>: 5,0-6,0 nm</p><p><span>Heavy metals</span></p><p>Arsenic: &lt;&#160;0,80&#160;mg/kg</p><p>Nickel: &lt;&#160;50,0&#160;mg/kg</p><p><span>Residual solvents</span></p><p>Ethanol: &lt;&#160;500 mg/kg</p><p><span>Microbiological criteria</span></p><p>Total aerobic microbial count: &lt;&#160;10 CFU/g</p><p>Total yeast and mould count: &lt;&#160;10 CFU/g</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p><a>&#9660;M116</a></p></td></tr><tr><td><p><span>Iron milk caseinate</span></p></td><td><p><span>Description:</span></p><p>Iron milk caseinate is an iron-casein-phosphate complex in the form of a creamy or beige powder produced by the dissolution of ferric iron salts (ferric sulfate or ferric chloride) in a casein solution obtained from bovine milk in the presence of potassium orthophosphate following a series of steps involving pasteurisation, concentration, and drying.</p><p><span>Characteristics/Composition:</span></p><p>Protein (%): 50,0 &#8211; 65,0</p><p>Ash (%): 20,0 &#8211; 40,0</p><p>Moisture (%): &lt;&#160;8,0</p><p>Fat (%): &lt;&#160;1,0</p><p>Iron (%): 2,0 &#8211; 4,0</p><p>Potassium (%): 5,0 &#8211; 15,0</p><p>Phosphorus (%): 2,0 &#8211; 6,0</p><p>Sodium (%): &lt;&#160;4,0</p><p><span>Heavy metals:</span></p><p>Lead: &lt;&#160;0,5&#160;mg/kg</p><p>Arsenic: &#8804;&#160;1,0&#160;mg/kg</p><p>Cadmium: &lt;&#160;0,5&#160;mg/kg</p><p>Mercury: &lt;&#160;0,1&#160;mg/kg</p><p><span>Mycotoxins:</span></p><p>Aflatoxin M1: &#8804;&#160;0,02&#160;mg/kg</p><p><span>Microbiological criteria:</span></p><p>Aerobic plate count: &#8804;&#160;1&#160;000  CFU/g</p><p>Coliforms: &#8804;&#160;10&#160;CFU/g</p><p><span>Salmonella</span> spp.: Absence in&#160;25 g</p><p>Yeast and mould: &#8804;&#160;10&#160;CFU/g</p><p><span>Escherichia coli:</span> &#8804;&#160;10&#160;CFU/g</p><p><span>Staphylococcus aureus</span>: Absence in&#160;1 g</p><p>CFU: Colony Forming Units</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Isomalto-oligosaccharide</span></p></td><td><p><span>Powder:</span></p><p>Solubility (water) (%): &gt; 99</p><p>Glucose (% dry basis): &#8804; 5,0</p><p>Isomaltose + DP3 to DP9 (% dry basis): &#8805; 90</p><p>Moisture (%): &#8804; 4,0</p><p>Sulphated ash(g/100 g): &#8804; 0,3</p><p><span>Heavy metals:</span></p><p>Lead (mg/kg): &#8804; 0,5</p><p>Arsenic (mg/kg): &#8804; 0,5</p><p><span>Syrup:</span></p><p>Dried solids (g/100 g): &gt; 75</p><p>Glucose (% dry basis): &#8804; 5,0</p><p>Isomaltose + DP3 to DP9 (% dry basis): &#8805; 90</p><p>pH: 4 - 6</p><p>Sulphated ash(g/100 g): &#8804; 0,3</p><p><span>Heavy metals:</span></p><p>Lead (mg/kg): &#8804; 0,5</p><p>Arsenic (mg/kg): &#8804; 0,5</p></td></tr><tr><td><p><span>Isomaltulose</span></p></td><td><p><span>Description/Definition:</span></p><p>A reducing disaccharide that consists of one glucose and one fructose moiety linked by an alpha-1,6-glycosidic bond. It is obtained from sucrose by an enzymatic process. The commercial product is the monohydrate. Appearance: Virtually odourless, white or almost white crystals with a sweet tasteChemical name: 6-O-&#945;-D-glucopyranosyl-D-fructofuranose, monohydrate</p><p>CAS No.: 13718-94-0</p><p>Chemical formula: C<span>12</span>H<span>22</span>O<span>11</span> &#903; H<span>2</span>O</p><p>Structural formula</p><p><img/></p><p>Formula weight: 360,3 (monohydrate)</p><p><span>Purity:</span></p><p>Assay: &#8805; 98 % on the dry basis</p><p>Loss on drying: &#8804; 6,5 % (60 &#176;C, 5 hours)</p><p><span>Heavy metals:</span></p><p>Lead: &#8804; 0,1 mg/kg</p><p>Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the method described in FNP 5(<span>1</span>), &#8216;Instrumental methods&#8217;</p><p>(<span>1</span>)&#160;&#160;Food and Nutrition Paper 5 Rev. 2 &#8212; Guide to specifications for general notices, general analytical techniques, identification tests, test solutions and other reference materials (JECFA), 1991, 322 pp., English, ISBN 92-5-102991-1.</p></td></tr><tr><td><p><a>&#9660;M90</a></p></td></tr><tr><td><p><span><span>Jatropha curcas</span> L. (edible variety) kernels</span></p></td><td><p><span>Description:</span></p><p>The kernels are obtained from the seeds of the ripe fruits of the edible variety of the<span>Jatropha curcas</span> L. plants that produce kernels with non-detectable levels of phorbol esters, following a series of steps involving the cleaning and de-husking of the fruits to obtain the seeds, the drying of the seeds, the cleaning of the seeds to remove debris and other residues, mechanical deshelling of the seeds to obtain the kernels, and the hydrothermal treatment (&gt;&#160;120&#160;&#176;C for 40 minutes) of the kernels to reduce anti-nutrients and the microbiological load.</p><p>As the edible variety of the<span>Jatropha curcas</span> L. plants, producing kernels that contain non-detectable levels of phorbol esters, are phenotypically undistinguishable from the non-edible variety, only the appropriate edible variety of<span>Jatropha curcas</span> L. plants should be used in the production of the novel food. The entire production process must ensure that the mixing of edible and non-edible kernels does not occur.</p><p>The absence of mixing of edible with non-edible kernels shall be confirmed by analytical controls for phorbol esters carried on each batch of the seeds after the seed-drying step and before the deshelling step according to the sampling procedure of Table A. Five laboratory samples extracted from each aggregate sample are de-shelled, ground, and analysed for phorbol esters using a validated UHPLC-UV-MS<span>(b)</span> method. Only the batches in which phorbol esters are undetectable in all five samples are further processed to the seed deshelling and kernel hydrothermal treatment steps.</p><p><span>Table A</span></p></td></tr><tr><td><p>Batch weight (tons)</p></td><td><p>Weight or number of sublots</p></td><td><p>Number of incremental samples</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>&#8805;&#160;500</p></td><td><p>100 tons</p></td><td><p>100</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>&gt;&#160;100 and &lt;&#160;500</p></td><td><p>5 sub-lots</p></td><td><p>100</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>&gt;&#160;10 and &#8804;&#160;100</p></td><td><p>5 sub-lots</p></td><td><p>100</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>&gt;&#160;5,0 and &#8804;&#160;10</p></td><td><p>-</p></td><td><p>80</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>&gt;&#160;1 and &#8804;&#160;5,0</p></td><td><p>-</p></td><td><p>60</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>&gt;&#160;0,1 and &#8804;&#160;1,0</p></td><td><p>-</p></td><td><p>30</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>&#8804;&#160;0,1</p></td><td><p>-</p></td><td><p>10</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Each sub-lot shall be sampled separately. Aggregate samples are composed by a minimum of 10 incremental samples. The minimum amount of an aggregate sample shall be 3,5&#160;kg. This amount may increase proportionally according to the number of incremental samples taken.</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Characteristics/Composition:</span></p><div><p>Moisture: &#8804;&#160;3,0&#160;%</p></div><div><p>Total fat: 54,0 &#8211; 61,0&#160;%</p></div><div><p>Total protein: 21,0 &#8211; 32,0&#160;%</p></div><div><p>Total fibre: 6,0 &#8211; 10,0&#160;%</p></div><div><p>Ash: 3,0 &#8211; 5,0&#160;%</p></div><p><span>Contaminants:</span></p><div><p>Phorbol esters (&#956;g TPA eq<span>(a)</span>/g kernel)<span>(b)</span>: &#8804;&#160;0,75 (LOD)<span>(c)</span></p></div><div><p>Lead: &#8804;&#160;0,20&#160;mg/kg</p></div><div><p>Cadmium: &#8804;&#160;0,20&#160;mg/kg</p></div><div><p>Sum of aflatoxins B1, B2, G1, G2: &#8804;&#160;4,0&#160;&#956;g/kg</p></div><div><p><span>Microbiological criteria:</span></p></div><div><p>Total aerobic microbial count: &#8804;&#160;1&#160;000  CFU/g</p></div><div><p>Total yeast/moulds count: &#8804;&#160;100 CFU/g</p></div><div><p>Enterobacteriaceae: &#8804;&#160;10 CFU/g</p></div><div><p><span>Salmonella</span> sp.: Absent in&#160;25 g</p></div><div><p><span>Listeria monocytogenes</span>: &#8804;&#160;100 CFU/g</p></div><p><span>(a)</span> TPAeq: 12-O-tetradecanoylphorbol-13-acetate equivalent;<span>(b)</span>Validated Ultra-High-Performance Liquid Chromatography coupled to Ultraviolet Spectrophotometry and Mass Spectrometry (UHPLC-UV-MS) method for detection of phorbol ester peaks;<span>(c)</span> Limit of Detection (Only batches with concentrations of PEs below the LOD can be fully processed.); CFU: Colony Forming Units</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Lactitol</span></p></td><td><p><span>Description/Definition:</span></p><p>Crystalline powder or colourless solution manufactured via catalytic hydrogenation of lactose. Crystalline products occur in anhydrous, monohydrate and dihydrate forms. Nickel is used as a catalyst.</p><p>Chemical name: 4-O-&#946;-D-Galactopyranosyl-D-glucitol</p><p>Chemical formula: C<span>12</span>H<span>24</span>O<span>11</span></p><p>Molecular weight: 344,31 g/mol</p><p>CAS No: 585-86-4<span>Purity:</span></p><p>Solubility (in water): Very soluble in water</p><p>Specific rotation [&#945;]<span>D</span><span>20</span> = + 13<span>o</span> to + 16<span>o</span></p><p>Assay: &#8805; 95 % d.b (d.b &#8212; expressed on the dry weight basis)</p><p>Water: &#8804; 10,5 %</p><p>Other polyols: &#8804; 2,5 % d.b</p><p>Reducing sugars: &#8804; 0,2 % d.b</p><p>Chlorides: &#8804; 100 mg/kg d.b</p><p>Sulphates: &#8804; 200 mg/kg d.b</p><p>Sulphated ash: &#8804; 0,1 % d.b</p><p>Nickel: &#8804; 2,0 mg/kg d.b</p><p>Arsenic: &#8804; 3,0 mg/kg d.b</p><p>Lead: &#8804; 1,0 mg/kg d.b</p></td></tr><tr><td><p><span>Lacto-<span>N</span>-neotetraose</span></p><p><span>(synthetic)</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 g/mol</p><p><span>Description:</span></p><p>Lacto-<span>N</span>-neotetraose is a white to off-white powder. Produced by a chemical synthesis process and is isolated by crystallisation.</p><p><span>Purity:</span></p><p>Assay (water free): &#8805; 96 %</p><p>D-Lactose: &#8804; 1,0 %</p><p>Lacto-N-triose II: &#8804; 0,3 %</p><p>Lacto-N-neotetraose fructose isomer: &#8804; 0,6 %</p><p>pH (20 &#176;C, 5 % solution): 5,0-7,0</p><p>Water: &#8804; 9,0 %</p><p>Ash, sulphated: &#8804; 0,4 %</p><p>Acetic acid: &#8804; 0,3 %Residual solvents (methanol, 2-propanol, methyl acetate, acetone): &#8804; 50 mg/kg singly, &#8804; 200 mg/kg in combination</p><p>Residual proteins: &#8804; 0,01 %</p><p>Palladium: &#8804; 0,1 mg/kg</p><p>Nickel: &#8804; 3,0 mg/kg</p><p><span>Microbiological criteria:</span></p><p>Aerobic mesophilic bacteria total count: &#8804; 500 CFU/g</p><p>Yeasts: &#8804; 10 CFU/g</p><p>Moulds: &#8804; 10 CFU/g</p><p>Residual endotoxins: &#8804; 10 EU/mg</p></td></tr><tr><td><p><a>&#9660;M68</a></p></td></tr><tr><td><p><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><div><p>&#8212;&#160;Genetically modified strain of<span>Escherichia coli</span> K-12, or</p></div><div><p>&#8212;&#160;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></div><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</p></td></tr><tr><td><p><a>&#9660;M46 M69</a></p></td></tr><tr><td><p><span>Lacto-<span>N</span>-tetraose (&#8216;LNT&#8217;) (microbial source)</span></p></td><td><p><span>Definition:</span></p><p>Chemical formula: C<span>26</span>H<span>45</span>NO<span>21</span></p><p>Chemical name: &#946;-D-Galactopyranosyl-(1&#8594;3)-2-acetamido-2-deoxy-&#946;-D-glucopyranosyl-(1&#8594;3)-&#946;-D-galactopyranosyl-(1&#8594;4)-D-glucopyranose</p><p>Molecular mass: 707.63 Da</p><p>CAS No&#160;14116-68-8</p><p><span>Description:</span></p><p>Lacto-<span>N</span>-tetraose is a purified, white to off-white amorphous powder or agglomerates that is produced by a microbial process.</p><p><span>Source:</span></p><p>Genetically modified strain of<span>Escherichia coli</span> strain K-12 DH1</p><p><span>Characteristics/Composition:</span></p><div><p>Appearance: White to off white powder or agglomerates</p></div><div><p>Sum of lacto-<span>N</span>-tetraose, D-Lactose and lacto-<span>N</span>-triose II (% of dry matter): &#8805;&#160;90.0&#160;% (w/w)</p></div><div><p>Lacto-<span>N</span>-tetraose (% of dry matter): &#8805;&#160;70.0&#160;% (w/w)</p></div><div><p>D-Lactose: &#8804;&#160;12.0&#160;% (w/w)</p></div><div><p>Lacto-<span>N</span>-triose II: &#8804;&#160;10.0&#160;% (w/w)</p></div><div><p><span>Para</span>-lacto-<span>N</span>-hexaose-2: &#8804;&#160;3.5&#160;% (w/w)</p></div><div><p>Lacto-<span>N</span>-tetraose fructose isomer: &#8804;&#160;1.0&#160;% (w/w)</p></div><div><p>Sum of other carbohydrates: &#8804;&#160;5.0&#160;% (w/w)</p></div><div><p>Moisture: &#8804;&#160;6.0&#160;% (w/w)</p></div><div><p>Ash, sulfated: &#8804;&#160;0.5&#160;% (w/w)</p></div><div><p>pH (20&#160;&#176;C, 5&#160;% solution): 4.0 -6.0</p></div><div><p>Residual protein: &#8804;&#160;0.01&#160;% (w/w)</p></div><p><span>Microbiological criteria:</span></p><div><p>Aerobic mesophilic bacteria total plate count: &#8804;&#160;1&#160;000  CFU/g</p></div><div><p><span>Enterobacteriaceae</span>: &#8804;&#160;10 CFU/g</p></div><div><p><span>Salmonella</span> spp.: Negative/25 g</p></div><div><p>Yeast: &#8804;&#160;100 CFU/g</p></div><div><p>Mould: &#8804;&#160;100 CFU/g</p></div><div><p>Residual endotoxins: &#8804;&#160;10 EU/mg</p></div><div><p>CFU: Colony Forming Units</p></div></td></tr><tr><td><p><a>&#9660;M101</a></p></td></tr><tr><td><p><span>Lacto-<span>N</span>-tetraose (&#8216;LNT&#8217;)</span></p><p><span>(produced by derivative strains of<span>E. coli</span> BL21(DE3))</span></p></td><td><p><span>Description:</span></p><p>Lacto-<span>N</span>-tetraose is a purified and concentrated white to off-white powder that is produced by a microbial fermentation process.</p><p><span>Definition:</span></p><p>Chemical name: &#946;-D-Galactopyranosyl-(1&#8594;3)-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: 14116-68-8</p><p>Molecular mass: 707.63 Da</p><p><span>Source:</span> Two genetically modified strains (a production strain and an optional degradation strain) of<span>Escherichia coli</span> BL21(DE3)</p><p><span>Characteristics/Composition:</span></p><p>Lacto-<span>N</span>-tetraose (% of dry matter): &#8805;&#160;75,0&#160;% (w/w)</p><p>D-Lactose (% of dry matter): &#8804;&#160;5,0&#160;% (w/w)</p><p>Lacto-<span>N</span>-triose II (% of dry matter): &#8804;&#160;5,0&#160;% (w/w)</p><p><span>Para</span>-lacto-<span>N</span>-hexaose (% of dry matter): &#8804;&#160;5,0&#160;% (w/w)</p><p>D-galactose and D-glucose (% of dry matter): &#8804;&#160;5,0&#160;% (w/w)</p><p>Sum of other carbohydrates<span>a</span>: &#8804;&#160;15,0&#160;% (w/w)</p><p>Moisture: &#8804;&#160;9,0&#160;% (w/w)</p><p>Ash: &#8804;&#160;1,0&#160;% (w/w)</p><p>Residual protein: &#8804;&#160;0,01&#160;% (w/w)</p><p><span>Heavy metals and contaminants:</span></p><p>Arsenic: &#8804;&#160;0,2&#160;mg/kg</p><p>Aflatoxin M1: &#8804;&#160;0,025 &#956;g/kg</p><p><span>Microbiological criteria:</span></p><p>Standard plate count: &#8804;&#160;1&#160;000  CFU/g</p><p>Enterobacteriaceae: &#8804;&#160;10 CFU/g</p><p><span>Salmonella</span> spp.: Absence in&#160;25 g</p><p>Yeast and mould: &#8804;&#160;100 CFU/g</p><p><span>Cronobacter</span> (<span>Enterobacter</span>)<span>sakazaki:</span> Absence in&#160;10 g</p><p>Residual endotoxins: &#8804;&#160;10 EU/mg</p><p><span>a</span> Sum of other carbohydrates&#160;= 100 (% (w/w) of dry matter) &#8211; quantified carbohydrates (% (w/w) of dry matter) &#8211; Ash (% (w/w) of dry matter). CFU: Colony Forming Units; EU: Endotoxin Units</p></td></tr><tr><td><p><a>&#9660;M21</a></p></td></tr><tr><td><p><span>Lonicera caerulea</span> L. berries (haskap)</p><p>(Traditional food from a third country)</p></td><td><p><span>Description/Definition:</span></p><p>The traditional food are fresh and frozen berries from<span>Lonicera caerulea</span> var. edulis.</p><p><span>Lonicera caerulea</span> L. is a deciduous shrub belonging to the<span>Caprifoliaceae</span> family.</p><p><span>Typical nutritional components of haskap berries</span> (given in fresh berries):</p><p>Carbohydrates: 12,8 %</p><p>Fibre: 2,1 %</p><p>Lipids: 0,6 %</p><p>Proteins: 0,7 %</p><p>Ash: 0,4 %</p><p>Water: 85,5 %</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Lucerne leaf extract from<span>Medicago sativa</span></span></p></td><td><p><span>Description/Definition:</span></p><p>The Lucerne (<span>Medicago sativa</span> L.) is processed within 2 hours after harvest. It is chopped and crushed. By passing through an oleaginous-type press, the Lucerne provides a fibrous residue and press juice (10 % of dry matter). The dry matter of this juice contains about 35 % of crude protein. The press juice (pH 5,8-6,2) is neutralised. Preheating and vapour injection allows coagulation of proteins associated with carotenoid and chlorophyll pigments. The protein precipitate is separated by centrifugation and thereafter dried. After adding ascorbic acid the Lucerne protein concentrate is granulated and stored in inert gas or in cold storage.</p><p><span>Composition:</span></p><p>Protein: 45-60 %</p><p>Fat: 9-11 %</p><p>Free carbohydrates (soluble fibre): 1-2 %</p><p>Polysaccharides (insoluble fibre): 11-15 %</p><p>including cellulose: 2-3 %</p><p>Minerals: 8-13 %</p><p>Saponins: &#8804; 1,4 %</p><p>Isoflavones: &#8804; 350 mg/kg</p><p>Coumestrol: &#8804; 100 mg/kg</p><p>Phytates: &#8804; 200 mg/kg</p><p>L-canavanine: &#8804; 4,5 mg/kg</p></td></tr><tr><td><p><span>Lycopene</span></p></td><td><p><span>Description/Definition:</span></p><p>Synthetic lycopene is produced by the Wittig condensation of synthetic intermediates commonly used in the production of other carotenoids used in food. Synthetic lycopene consists of &#8805; 96 % lycopene and minor quantities of other related carotenoid components. Lycopene is presented either as a powder in a suitable matrix or an oily dispersion. The colour is dark red or red-violet. Antioxidative protection has to be assured.</p><p>Chemical name: Lycopene</p><p>CAS No.: 502-65-8 (<span>all</span>-trans lycopene)</p><p>Chemical formula: C<span>40</span>H<span>56</span></p><p>Formula weight: 536,85 Da</p></td></tr><tr><td><p><span>Lycopene from<span>Blakeslea trispora</span></span></p></td><td><p><span>Description/Definition:</span></p><p>The purified lycopene from<span>Blakeslea trispora</span> consists of &#8805; 95 % lycopene and &#8804; 5 % other carotenoids. It is presented either as a powder in a suitable matrix or an oily dispersion. The colour is dark red or red-violet. Anti-oxidative protection has to be assured.</p><p>Chemical name: Lycopene</p><p>CAS No.: 502-65-8 (all trans lycopene)</p><p>Chemical formula: C<span>40</span>H<span>56</span></p><p>Formula weight: 536,85 Da</p></td></tr><tr><td><p><span>Lycopene from tomatoes</span></p></td><td><p><span>Description/Definition:</span></p><p>The purified lycopene from tomatoes (<span>Lycopersicon esculantum</span> L.) consists of &#8805; 95 % lycopene and &#8804; 5 % other carotenoids. It is presented either as a powder in a suitable matrix or an oily dispersion. The colour is dark red or red-violet. Anti-oxidative protection has to be assured.</p><p>Chemical name: Lycopene</p><p>CAS No.: 502-65-8 (all trans lycopene)</p><p>Chemical formula: C<span>40</span>H<span>56</span></p><p>Formula weight: 536,85 Da</p></td></tr><tr><td><p><span>Lycopene oleoresin from tomatoes</span></p></td><td><p><span>Description/Definition:</span></p><p>Lycopene oleoresin from tomatoes is obtained by solvent extraction of ripe tomatoes (<span>Lycopersicon esculentum Mill.</span>) with subsequent removal of the solvent. It is a red to dark brown viscous, clear liquid.</p><p>Total lycopene: 5-15 %</p><p>Thereof trans-lycopene: 90-95 %</p><p>Total carotenoids (calculated as lycopene): 6,5-16,5 %</p><p>Other carotenoids: 1,75 %</p><p>(Phytoene/phytofluene/&#946;-carotene): (0,5-0,75/0,4-0,65/0,2-0,35 %)</p><p>Total tocopherols: 1,5-3,0 %</p><p>Unsaponifiable matter: 13-20 %</p><p>Total fatty acids: 60-75 %</p><p>Water (Karl Fischer): &#8804; 0,5 %</p></td></tr><tr><td><p><a>&#9660;M52</a></p></td></tr><tr><td><p><span>Hen egg white lysozyme hydrolysate</span></p></td><td><p><span>Description/Definition</span></p><p>Hen egg white lysozyme hydrolysate is obtained from hen egg white lysozyme by an enzymatic process, using subtilisin from<span>Bacillus licheniformis</span>.</p><p>The product is a white to light yellow powder.</p><p><span>Specification</span></p><p>Protein (TN(*) x 5,30): 80-90 %</p><p>Tryptophan: 5-7 %</p><p>Ratio Tryptophan/LNAA(**): 0,18-0.25</p><p>Degree of hydrolysis: 19-25 %</p><p>Moisture: &lt; 5 %</p><p>Ash: &lt; 10 %</p><p>Sodium: &lt; 6 %</p><p><span>Heavy metals</span></p><p>Arsenic: &lt; 1 ppm</p><p>Lead: &lt; 1 ppm</p><p>Cadmium: &lt; 0,5 ppm</p><p>Mercury: &lt; 0,1 ppm</p><p><span>Microbiological criteria</span></p><p>Total aerobic count: &lt; 10<span>3</span> CFU/g</p><p>Total combined yeasts/moulds count: &lt; 10<span>2</span> CFU/g</p><p>Enterobacteria: &lt; 10 CFU/g</p><p><span>Salmonella</span> spp: Absence in 25 g</p><p><span>Escherichia coli</span>: Absence in 10 g</p><p><span>Staphylococcus aureus</span>: Absence in 10 g</p><p><span>Pseudomonas aeruginosa</span>: Absence in 10 g</p><p>*&#160;&#160;TN: total nitrogen</p><p>**&#160;&#160;LNAA: large neutral amino acids</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Magnesium citrate malate</span></p></td><td><p><span>Description/Definition:</span></p><p>Magnesium citrate malate is a white to yellowish-white, amorphous powder.Chemical formula: Mg<span>5</span>(C<span>6</span>H<span>5</span>O<span>7</span>)<span>2</span>(C<span>4</span>H<span>4</span>O<span>5</span>)<span>2</span></p><p>Chemical name: Pentamagnesium di-(2-hydroxybutanedioate)-di-(2- hydroxypropane-1,2,3-tricarboxylate)</p><p>CAS No.: 1259381-40-2</p><p>Molecular weight: 763,99 Daltons (anhydrous)</p><p>Solubility: Freely soluble in water (about 20 g in 100 ml)</p><p>Description of the physical state: Amorphous powder</p><p>Assay magnesium: 12,0-15,0 %</p><p>Loss on drying (120 &#176;C/4 hours): &#8804; 15 %</p><p>Colour (solid): White to yellowish-white</p><p>Colour (20 % aqueous solution): Colourless to yellowish</p><p>Appearance (20 % aqueous solution): Clear solution</p><p>pH (20 % aqueous solution): Approx. 6,0</p><p><span>Impurities:</span></p><p>Chloride: &#8804; 0,05 %</p><p>Sulphate: &#8804; 0,05 %</p><p>Arsenic: &#8804; 3,0 ppm</p><p>Lead: &#8804; 2,0 ppm</p><p>Cadmium: &#8804; 1 ppm</p><p>Mercury: &#8804; 0,1 ppm</p></td></tr><tr><td><p><span>Magnolia Bark Extract</span></p></td><td><p><span>Description/Definition:</span></p><p>Magnolia bark extract is obtained from the bark of the plant<span>Magnolia officinalis</span> L. and produced with supercritical carbon dioxide. The bark is washed and oven dried to reduce moisture content before being crushed and extracted with supercritical carbon dioxide. The extract is dissolved in medical-grade ethanol and re-crystallised to yield magnolia bark extract.</p><p>Magnolia bark extract is mainly composed of two phenolic compounds, magnolol and honokiol.</p><p>Appearance: Light brownish powder</p><p><span>Purity:</span></p><p>Magnolol: &#8805; 85,2 %</p><p>Honokiol: &#8805; 0,5 %</p><p>Magnolol &amp; Honokiol: &#8805; 94 %</p><p>Total Eudesmol: &#8804; 2 %</p><p>Moisture: 0,50 %<span>Heavy metals:</span></p><p>Arsenic (ppm): &#8804; 0,5</p><p>Lead (ppm): &#8804; 0,5</p><p>Methyl eugenol (ppm): &#8804; 10</p><p>Tubocurarine (ppm): &#8804; 2,0</p><p>Total Alkaloid (ppm): &#8804; 100</p></td></tr><tr><td><p><span>Maize-germ oil high in unsaponifiable matter</span></p></td><td><p><span>Description/Definition:</span></p><p>Maize-germ oil high in unsaponifiable matter is produced by vacuum distillation and it is different from refined maize-germ oil in the concentration of the unsaponifiable fraction (1,2 g in refined maize-germ oil and 10 g in &#8216;maize-germ oil high in unsaponifiable matter&#8217;).</p><p><span>Purity:</span></p><p>Unsaponifiable matter: &gt; 9,0 g/100 g</p><p>Tocopherols: &#8805; 1,3 g/100 g</p><p>&#945;-tocopherol (%): 10-25 %</p><p>&#946;-tocopherol (%): &lt; 3,0 %</p><p>&#947;-tocopherol (%): 68-89 %</p><p>&#948;-tocopherol (%): &lt; 7,0 %</p><p>Sterols, triterpenic alcohols, methylsterols: &gt; 6,5 g/100 g</p><p>Fatty acids in triglycerides:</p><p>palmitic acid: 10,0-20,0 %</p><p>stearic acid: &lt; 3,3 %</p><p>oleic acid: 20,0-42,2 %</p><p>linoleic acid: 34,0-65,6 %</p><p>linolenic acid: &lt; 2,0 %</p><p>Acid value: &#8804; 6,0 mg KOH/g</p><p>Peroxide value (PV): &#8804; 10 mEq O<span>2</span>/kg</p><p><span>Heavy metals:</span></p><p>Iron (Fe): &lt; 1&#160;500  &#956;g/kg</p><p>Copper (Cu): &lt; 100 &#956;g/kg</p><p><span>Impurities:</span></p><p>Polycyclic aromatic hydrocarbons (PAH) Benzo(a)pyrene: &lt; 2 &#956;g/kg</p><p>Treatment with active carbon is required to ensure that polycyclic aromatic hydrocarbons (PAH) are not enriched in the production of &#8216;maize-germ oil high in unsaponifiable matter&#8217;</p></td></tr><tr><td><p><span>Methylcellulose</span></p></td><td><p><span>Description/Definition:</span></p><p>Methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl groups.</p><p>Chemical name: Methyl ether of cellulose</p><p>Chemical formula: The polymers contain substituted anhydroglucose units with the following general formula:</p><p>C6H7O2(OR1)(OR2)(OR3) where R1, R2, R3 each may be one of the following:</p><div><p>&#8212;&#160;H</p></div><div><p>&#8212;&#160;CH<span>3</span> or</p></div><div><p>&#8212;&#160;CH<span>2</span>CH<span>3</span></p></div><p>Molecular weight: Macromolecules: from about 20&#160;000  (n about 100) up to about 380&#160;000  g/mol (n about 2&#160;000 )</p><p>Assay: Content not less than 25 % and not more than 33 % of methoxyl groups (-OCH<span>3</span>) and not more than 5 % of hydroxyethoxyl groups (-OCH<span>2</span>CH<span>2</span>OH)</p><p>Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder.</p><p>Solubility: Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Insoluble in ethanol, ether and chloroform. Soluble in glacial acetic acid.</p><p><span>Purity:</span></p><p>Loss on drying: &#8804; 10 % (105 &#176;C, 3 hours)</p><p>Sulphated Ash: &#8804; 1,5 % determined at 800 &#177; 25 &#176;C</p><p>pH: &#8805; 5,0 and &#8804; 8,0 (1 % colloidal solution)</p><p><span>Heavy metals:</span></p><p>Arsenic: &#8804; 3,0 mg/kg</p><p>Lead: &#8804; 2,0 mg/kg</p><p>Mercury: &#8804; 1,0 mg/kg</p><p>Cadmium: &#8804; 1,0 mg/kg</p></td></tr><tr><td><p><a>&#9660;M11</a></p></td></tr><tr><td><p><span>1-Methylnicotinamide chloride</span></p></td><td><p><span>Definition:</span></p><p>Chemical name: 3-carbamoyl-1-methyl-pyridinium chloride</p><p>Chemical formula: C<span>7</span>H<span>9</span>N<span>2</span>OCl</p><p>CAS No: 1005-24-9</p><p>Molecular weight: 172,61 Da</p><p><span>Description</span></p><p>1-Methylnicotinamide chloride is white or off-white, crystalline solid produced by a chemical synthesis process.</p><p><span>Characteristics/Composition</span></p><p>Appearance: White &#8211; off-white, crystalline solid</p><p>Purity: &#8805; 98,5 %</p><p>Trigonelline: &#8804; 0,05 %</p><p>Nicotinic Acid: &#8804; 0,10 %</p><p>Nicotinamide: &#8804; 0,10 %</p><p>Largest unknown impurity: &#8804; 0,05 %</p><p>Sum of unknown impurities: &#8804; 0,20 %</p><p>Sum of all impurities: &#8804; 0,50 %</p><p>Solubility: soluble in water and methanol. Practically insoluble in 2-propanol and dichloromethane</p><p>Moisture: &#8804; 0,3 %</p><p>Loss on drying: &#8804; 1,0 %</p><p>Residue on ignition: &#8804; 0,1 %</p><p><span>Residual Solvents and Heavy Metals</span></p><p>Methanol: &#8804; 0,3 %</p><p>Heavy metals: &#8804; 0,002 %</p><p><span>Microbiological criteria:</span></p><p>Total aerobic microbial count: &#8804; 100 CFU/g</p><p>Mould/yeast: &#8804; 10 CFU/g</p><p>Enterobacteriaceae: absence in 1 g</p><p><span>Pseudomonas aeruginosa</span>: absence in 1 g</p><p><span>Staphylococcus aureus</span>: absent in 1 g</p><p>CFU: Colony Forming Units</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>(6S)-5-methyltetrahydrofolic acid, glucosamine salt</span></p></td><td><p><span>Description/Definition:</span></p><p>Chemical name: N-[4-[[[(6S)-2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl]methyl]amino]benzoyl]-L-glutamic acid, glucosamine salt</p><p>Chemical formula: C<span>32</span>H<span>51</span>N<span>9</span>O<span>16</span></p><p>Molecular weight: 817,80 g/mol (anhydrous)</p><p>CAS No.: 1181972-37-1</p><p>Appearance: Creamy to light-brown powder<span>Purity:</span></p><p>Diastereoisomeric purity: At least 99 % of (6S)-5-methyltetrahydrofolic acid</p><p>Glucosamine assay: 34-46 % in dry basis</p><p>5-Methyltetrahydrofolic acid assay: 54-59 % in dry basis</p><p>Water: &#8804; 8,0 %</p><p><span>Heavy metals:</span></p><p>Lead: &#8804; 2,0 ppm</p><p>Cadmium: &#8804; 1,0 ppm</p><p>Mercury: &#8804; 0,1 ppm</p><p>Arsenic: &#8804; 2,0 ppm</p><p>Boron: &#8804; 10 ppm</p><p><span>Microbiological criteria:</span></p><p>Total aerobic microbial count: &#8804; 100 CFU/g</p><p>Yeasts and moulds: &#8804; 100 CFU/g</p><p><span>Escherichia coli</span>: Absence in 10g</p></td></tr><tr><td><p><span>Monomethylsilanetriol (Organic Silicon)</span></p></td><td><p><span>Description/Definition:</span></p><p>Chemical name: Silanetriol, 1-methyl-</p><p>Chemical formula: CH<span>6</span>O<span>3</span>Si</p><p>Molecular weight: 94,14 g/mol</p><p>CAS No: 2445-53-6</p><p><span>Purity:</span></p><p>Organic Silicon (monomethylsilanetriol) preparation (aqueous solution):</p><p>Acidity (pH): 6,4-6,8</p><p>Silicon: 100-150 mg Si/l</p><p><span>Heavy metals:</span></p><p>Lead: &#8804; 1,0 &#956;g/l</p><p>Mercury: &#8804; 1,0 &#956;g/l</p><p>Cadmium: &#8804; 1,0 &#956;g/l</p><p>Arsenic: &#8804; 3,0 &#956;g/l</p><p><span>Solvents:</span></p><p>Methanol: &#8804; 5,0 mg/kg (residual presence)</p></td></tr><tr><td><p><a>&#9660;M87</a></p></td></tr><tr><td><p><span>Mung bean (<span>Vigna radiata</span>) protein</span></p></td><td><p><span>Description/Definition:</span></p><p>The novel food is mung bean protein powder extracted from seeds of the plant<span>Vigna radiata</span> by several processing steps followed by pasteurization and spray drying.</p><p><span>Characteristics/composition:</span></p><p>Moisture: &#8804;&#160;6&#160;%</p><p>Protein (w/w)<span>(a)</span>: &#8805;&#160;84&#160;%</p><p>Ash (w/w): &#8804;&#160;6,0&#160;%</p><p>Fat (w/w): &#8804;&#160;5,5&#160;%</p><p>Carbohydrate (w/w): &#8804;&#160;5,0 by calculation</p><p><span>Microbiological criteria:</span></p><p>Aerobic plate count: &lt;&#160;5&#160;000  CFU/g<span>(b)</span></p><p>Yeasts and moulds: &lt;&#160;100 CFU/g</p><p>Coliforms: &lt;&#160;100 CFU/g</p><p><span>Escherichia coli</span>: &lt;&#160;10 CFU/g</p><p><span>Listeria monocytogenes:</span> Not detected in&#160;25 g</p><p><span>Salmonella</span> spp.: Not detected in&#160;25 g</p><p>(<span>a</span>)&#160;&#160;w/w: weight per weight.</p><p>(<span>b</span>)&#160;&#160;CFU: colony forming units.</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Mycelial extract from Shiitake mushroom (<span>Lentinula edodes</span>)</span></p></td><td><p><span>Description/Definition:</span></p><p>The novel food ingredient is a sterile aqueous extract obtained from the mycelium of<span>Lentinula edodes</span> cultivated in a submerged fermentation. It is a light brown, slightly turbid liquid.</p><p>Lentinan is a &#946;-(1-3) &#946;-(1-6)-D-glucan which has a molecular weight of approximately 5 &#215; 10<span>5</span> Daltons, a degree of branching of 2/5 and a triple helical tertiary structure.</p><p><span>Purity/Composition of the mycelial extract from<span>Lentinula edodes</span>:</span></p><p>Moisture: 98 %</p><p>Dry matter: 2 %</p><p>Free glucose: &lt; 20 mg/ml</p><p>Total protein(<span>1</span>): &lt; 0,1 mg/ml</p><p>N-containing constituents(<span>2</span>): &lt; 10 mg/ml</p><p>Lentinan: 0,8 &#8211; 1,2 mg/ml\</p><p>(<span>1</span>)&#160;&#160;Bradford method</p><p>(<span>2</span>)&#160;&#160;Kjeldahl method</p></td></tr><tr><td><p><a>&#9660;M92</a></p></td></tr><tr><td><p><span>Nicotinamide riboside chloride</span></p></td><td><p><span>Description/Definition:</span></p><p>The novel food is a synthetic form of nicotinamide riboside. The novel food contains &#8805;&#160;90&#160;% nicotinamide riboside chloride, predominantly in its &#946; form, the remaining components being residual solvents, reaction by-products and degradation products.</p><p>Nicotinamide riboside chloride:</p><p>CAS number: 23111-00-4</p><p>EC number: 807-820-5</p><p>IUPAC name: 1-[(2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]pyridin-1-ium-3-carboxamide;chloride</p><p>Chemical formula: C11H15N2O5Cl</p><p>Molecular weight: 290,7&#160;g/mol</p><p><span>Characteristics/Composition:</span></p><p>Colour: White to light brown</p><p>Form: Powder</p><p>Identification: Conforms by NMR (nuclear magnetic resonance)</p><p>Nicotinamide riboside chloride: &#8805;&#160;90&#160;%</p><p>Water content: &#8804;&#160;2&#160;%</p><p><span>Residual solvents:</span></p><p>Acetone: &#8804;&#160;5&#160;000  mg/kg</p><p>Methanol: &#8804;&#160;1&#160;000  mg/kg</p><p>Acetonitrile: &#8804;&#160;50 mg/kg</p><p>Methyl tert-butyl ether: &#8804;&#160;500 mg/kg</p><p><span>Reaction by-products:</span></p><p>Methyl acetate: &#8804;&#160;1&#160;000  mg/kg</p><p>Acetamide: &#8804;&#160;27 mg/kg</p><p>Acetic acid: &#8804;&#160;5&#160;000  mg/kg</p><p><span>Heavy metals:</span></p><p>Arsenic: &#8804;&#160;1 mg/kg</p><p>Mercury*: &#8804;&#160;0,1&#160;mg/kg</p><p>Cadmium*: &#8804;&#160;1 mg/kg</p><p>Lead*: &#8804;&#160;0,5&#160;mg/kg</p><p><span>Microbiological criteria:</span></p><p>Total Plate Count: &#8804;&#160;1&#160;000  CFU/g</p><p>Yeast and Mould: &#8804;&#160;100 CFU/g</p><p><span>Escherichia coli</span>: Absence in&#160;10 g</p><p>CFU: colony forming units</p><p>(*)&#160;&#160;only for foods for special medical purposes, total diet replacement for weight control and meal replacements</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Noni fruit juice (<span>Morinda citrifolia</span>)</span></p></td><td><p><span>Description/Definition:</span></p><p>Noni fruits (fruits of<span>Morinda citrifolia</span> L.) are pressed. The obtained juice is pasteurised. An optional fermentation step before or after the pressing may occur.</p><p>Rubiadin: &#8804; 10 &#956;g/kg</p><p>Lucidin: &#8804; 10 &#956;g/kg</p></td></tr><tr><td><p><span>Noni fruit juice powder (<span>Morinda citrifolia</span>)</span></p></td><td><p><span>Description/Definition:</span></p><p>Seeds and skin of the sun-dried fruits of<span>Morinda citrifolia</span> are separated. The obtained pulp is filtered to separate juice from the flesh. Desiccation of the produced juice occurs in one or two ways:</p><p>Either by atomisation using maize maltodextrins, this mixture is obtained by keeping the rates of inflow of the juice and maltodextrins constant</p><p>Or by zeodratation or drying and then mixing with an excipient, this process allows the juice to be dried initially and then mixed with maltodextrins (same amount as used in atomisation).</p></td></tr><tr><td><p><span>Noni fruit puree and concentrate (<span>Morinda citrifolia</span>)</span></p></td><td><p><span>Description/Definition:</span></p><p>The fruits of<span>Morinda citrifolia</span> are harvested by hand. Seeds and skin may be separated mechanically from the pureed fruits. After pasteurisation, the puree is packaged in aseptic containers and stored under cold conditions.no_br<span>Morinda citrifolia</span> concentrate is prepared from<span>M. citrifolia</span> puree by treatment with pectinolytic enzymes (50&#8211; 60 &#176;C for 1-2 h). Then the puree is heated to inactivate the pectinases and then immediately cooled. The juice is separated in a decanter centrifuge. Afterwards the juice is collected and pasteurised, prior to being concentrated in a vacuum evaporator from a brix of 6 to 8 to a brix of 49 to 51 in the final concentrate.</p><p><span>Composition:</span></p><p><span>Puree:</span></p><p>Moisture: 89-93 %</p><p>Protein: &lt; 0,6 g/100 g</p><p>Fat: &#8804; 0,4 g/100 g</p><p>Ash: &lt; 1,0 g/100 g</p><p>Total carbohydrates: 5-10 g/100 g</p><p>Fructose: 0,5-3,82 g/100 g</p><p>Glucose: 0,5-3,14 g/100 g</p><p>Dietary fibre: &lt; 0,5-3 g/100 g</p><p>5,15-dimethylmorindol (1): &#8804; 0,254 &#956;g/ml</p><p>Lucidin (1): Not detectable</p><p>Alizarin (1): Not detectable</p><p>Rubiadin (1): Not detectable</p><p><span>Concentrate:</span></p><p>Moisture: 48-53 %</p><p>Protein: 3-3,5 g/100 g</p><p>Fat: &lt; 0,04 g/100 g</p><p>Ash: 4,5-5,0 g/100 g</p><p>Total carbohydrates: 37-45 g/100 g</p><p>Fructose: 9-11 g/100 g</p><p>Glucose: 9-11 g/100 g</p><p>Dietary fibre: 1,5-5,0 g/100 g</p><p>5,15-dimethylmorindol (<span>1</span>): &#8804; 0,254 &#956;g/ml</p><p>(<span>1</span>)&#160;&#160;<span>By an HPLC-UV method developed and validated for the analysis of anthraquinones in Morinda citrifolia puree and concentrate. Limits of detection: 2,5 ng/ml (5,15 dimethylmorindol); 50,0 ng/ml (lucidin); 6,3 ng/ml (alizarin) and 62,5 ng/ml (rubiadin).</span></p></td></tr><tr><td><p><span>Noni leaves (<span>Morinda citrifolia</span>)</span></p></td><td><p><span>Description/Definition:</span></p><p>After cutting, the leaves of<span>Morinda citrifolia</span> are subject to drying and roasting steps. The product has a particle size ranging from broken leaves to coarse powder with fines. It is of greenish brown to brown colour.</p><p><span>Purity/Composition:</span></p><p>Moisture: &lt; 5,2 %</p><p>Protein: 17- 20 %</p><p>Carbohydrate: 55-65 %</p><p>Ash: 10-13 %</p><p>Fat: 4-9 %</p><p>Oxalic acid: &lt; 0,14 %</p><p>Tannic acid: &lt; 2,7 %</p><p>5,15-dimethylmorindol: &lt; 47 mg/kg</p><p>Rubiadin: non detectable, &#8804; 10 &#956;g/kg</p><p>Lucidin: non detectable, &#8804; 10 &#956;g/kg</p></td></tr><tr><td><p><span>Noni fruit powder (<span>Morinda citrifolia</span>)</span></p></td><td><p><span>Description/Definition:</span></p><p>Noni fruit powder is made from pulped noni (<span>Morinda citrifolia L.)</span> fruits by freeze-drying. Fruits are pulped and seeds are removed. After freeze-drying during which water is removed from noni fruits, the remaining noni pulp is milled to a powder and encapsulated.</p><p><span>Purity/Composition</span></p><p>Moisture: 5,3-9 %</p><p>Protein: 3,8-4,8 g/100 g</p><p>Fat: 1-2 g/100 g</p><p>Ash: 4,6-5,7 g/100 g</p><p>Total carbohydrates: 80-85 g/100 g</p><p>Fructose: 20,4-22,5 g/100 g</p><p>Glucose: 22-25 g/100 g</p><p>Dietary fibre: 15,4-24,5 g/100 g</p><p>5,15-dimethylmorindol (<span>1</span>): &#8804; 2,0 &#956;g/ml</p><p>(<span>1</span>)&#160;&#160;<span>By an HPLC-UV method developed and validated for the analysis of anthraquinones in Morinda citrifolia fruit powder. Limits of detection: 2,5 ng/ml (5,15 dimethylmorindol)</span></p></td></tr><tr><td><p><span><span>Odontella aurita</span> microalgae</span></p></td><td><p>Silicon: 3,3 %</p><p>Crystalline silica: max 0,1-0,3 % as impurity</p></td></tr><tr><td><p><span>Oil enriched with phytosterols/phytostanols</span></p></td><td><p><span>Description/Definition:</span></p><p>Oil enriched with phytosterols/phytostanols is composed of an oil fraction and a phytosterol fraction.</p><p><span>Acylglycerol Distribution:</span></p><p>Free fatty acids (expressed as oleic acid): &#8804; 2,0 %</p><p>Monoacylglycerols (MAG): &#8804; 10 %</p><p>Diacylglycerols (DAG): &#8804; 25 %</p><p>Triacylglycerols (TAG): Making up the balance</p><p><span>Phytosterol fraction:</span></p><p>&#946;-sitosterol: &#8804; 80 %</p><p>&#946;-sitostanol: &#8804; 15 %</p><p>campesterol: &#8804; 40 %</p><p>campestanol: &#8804; 5,0 %</p><p>stigmasterol: &#8804; 30 %</p><p>brassicasterol &#8804; 3,0 %</p><p>other sterols/stanols: &#8804; 3,0 %</p><p><span>Others:</span></p><p>Moisture and volatile: &#8804; 0,5 %</p><p>Peroxide value (PV): &lt; 5,0 meq/kg</p><p>Trans fatty acids: &#8804; 1 %</p><p>Contamination/Purity (GC-FID or equivalent method) of phytosterols/phytostanols:</p><p>Phytosterols and phytostanols extracted from sources other than vegetable oil suitable for food have to be free of contaminants, best ensured by a purity of more than 99 %.</p></td></tr><tr><td><p><span>Oil extracted from squids</span></p></td><td><p>Acid value: &#8804; 0,5 KOH/g oil</p><p>Peroxide value (PV): &#8804; 5 meq O<span>2</span>/kg oil</p><p>p-Anisidine value: &#8804; 20</p><p>Cold test at 0 &#176;C: &#8804; 3 hours</p><p>Moisture: &#8804; 0,1 % (w/w)</p><p>Unsaponifiable matter: &#8804; 5,0 %Trans fatty acids: &#8804; 1,0 %</p><p>Docosahexaeonic acid: &#8805; 20 %</p><p>Eicosapentaenoic acid: &#8805; 10 %</p></td></tr><tr><td><p><a>&#9660;M47</a></p></td></tr><tr><td><p><span>Partially defatted chia seed (<span>Salvia hispanica</span>) powders</span></p></td><td><p><span>Description/Definition:</span></p><p>The novel foods are partially defatted chia seed (<span>Salvia hispanica</span>) powders obtained by pressing and grinding of the whole seeds of<span>Salvia hispanica</span> L.</p><p><span>Physical&#8211;sensorial:</span></p><p>Foreign matter: 0,1 %</p></td></tr><tr><td><p>&#160;</p><div/></td><td><p>Powder with high protein content</p></td><td><p>Powder with high fibre content</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Particle size</p></td><td><p>&#8804; 130 &#956;m</p></td><td><p>&#8804; 400 &#956;m</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Chemical composition:</span></p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>&#160;</p><div/></td><td><p><span>Salvia hispanica</span> powder with high protein content</p></td><td><p><span>Salvia hispanica</span> powder with high fibre content</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Moisture</p></td><td><p>&#8804; 9,0 %</p></td><td><p>&#8804; 9,0 %</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Protein</p></td><td><p>&#8805; 40,0 %</p></td><td><p>&#8805; 24,0 %</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Fat</p></td><td><p>&#8804; 17 %</p></td><td><p>&#8804; 12 %</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Fibre</p></td><td><p>&#8804; 30 %</p></td><td><p>&#8805; 50 %</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Microbiological criteria:</span></p><p>Total plate count: &#8804; 10&#160;000  CFU/g</p><p>Yeasts: &#8804; 500 CFU/g</p><p>Moulds: &#8804; 500 CFU/g</p><p><span>Staphylococcus aureus</span>: &#8804; 10 CFU/g</p><p>Coliforms: &lt; 100 MPN/g</p><p>Enterobacteriaceae: &#8804; 100 CFU/g</p><p><span>Bacillus cereus</span>: &#8804; 50 CFU/g</p><p><span>Escherichia coli</span>: &lt; 10 MPN/g</p><p><span>Listeria monocytogenes</span>: Absence/g</p><p><span>Salmonella</span> spp.: Absence in 25 g</p><p><span>Contaminants</span>:</p><p>Arsenic: &#8804; 0,1 ppm</p><p>Cadmium: &#8804; 0,1 ppm</p><p>Lead: &#8804; 0,1 ppm</p><p>Mercury: &#8804; 0,1 ppm</p><p>Total aflatoxins: &#8804; 4 ppb</p><p>Ochratoxin A: &#8804; 1 ppb</p></td></tr><tr><td><p><a>&#9660;M63</a></p></td></tr><tr><td><p><span>Partially defatted rapeseed powder from<span>Brassica rapa</span> L. and</span></p><p><span><span>Brassica napus</span> L.</span></p></td><td><p><span>Definition:</span> The powder is produced from the partially defatted seeds of non-genetically modified<span>Brassica rapa</span> L. and<span>Brassica napus</span> L. double low (00) cultivars through a series of processing steps to reduce glucosinolates and phytates.</p><p><span>Source:</span><span>Brassica rapa</span> L. and<span>Brassica napus</span> L. seeds</p><p><span>Characteristics/Composition:</span></p><p>Protein (N &#215; 6,25): 33,0-43,0 %</p><p>Lipids: 14,0 &#8211; 22,0 %</p><p>Total Carbohydrates(*): 33,0 &#8211; 40,0 %</p><p>Total Fibre(**): 33,0 &#8211; 43,0 %</p><p>Moisture: &lt; 7,0 %</p><p>Ash: 2,0&#8211;5,0 %</p><p>Total Glucosinolates: &lt; 0,3 mmol/kg (&#8804; 120 mg/kg)</p><p>Phytate: &lt; 1,5 %</p><p>Peroxide value (in novel food weight): &#8804; 3,0 mEq O<span>2</span>/kg</p><p><span>Heavy Metals:</span></p><p>Lead: &lt; 0,2 mg/kg</p><p>Arsenic (inorganic): &lt; 0,2 mg/kg</p><p>Cadmium: &lt; 0,2 mg/kg</p><p>Mercury: &lt; 0,1 mg/kg</p><p>Aluminium: &lt; 35,0 mg/kg</p><p><span>Microbiological criteria:</span></p><p>Total plate count (30 &#176;C): &lt; 5&#160;000  CFU/g</p><p><span>Enterobacteriaceae</span>: &lt; 10 CFU/g</p><p><span>Salmonella</span> sp.: Negative/25 g</p><p>Yeast and mould: &lt; 100 CFU/g</p><p><span>Bacillus cereus</span>: &lt; 100 CFU/g</p><p>(*) By difference: 100 % &#8211; [protein % + moisture % + fat % + ash %]</p><p>(**) AOAC 2011.25 (Enzymatic gravimetry)</p><p>CFU: Colony Forming Units, AOAC: Association of Official Agricultural Chemists</p></td></tr><tr><td><p><a>&#9660;M55</a></p></td></tr><tr><td><p><span>Extract from<span>Panax notoginseng</span> and<span>Astragalus membranaceus</span></span></p></td><td><p><span>Description/Definition:</span></p><p>The novel food contains two extracts. One is an ethanol extract of the roots of<span>Astragalus membranaceus</span> (Fisch.) Bunge. The other is a hot water extract of the roots of<span>Panax notoginseng</span> (Burkill) F.H. Chen that is further concentrated using absorption on a resin and subsequent elution with 60 % ethanol. At the end of the manufacturing process both extracts are mixed (45&#8211;47,5 % of each extract) with maltodextrin (5&#8211;10 %).</p><p><span>Characteristics/Composition:</span></p><p>Total saponins: 1,5-5 %</p><p>Ginsenoside Rb1: 0,1-0,5 %</p><p>Astragaloside I: 0,01-0,1 %</p><p>Carbohydrates: &#8805; 90 %</p><p>Protein: &#8804; 4,5 %</p><p>Ash: &#8804; 1 %</p><p>Moisture: &#8804; 5 %</p><p>Fat: &#8804; 1,5 %</p><p><span>Heavy metals:</span></p><p>Arsenic: &#8804; 0,3 mg/kg</p><p><span>Microbiological criteria:</span></p><p>Total plate count: &#8804; 5&#160;000  CFU/g</p><p>Total yeast and mould count: &#8804; 500 CFU/g</p><p>Enterobacteriaceae: &lt; 10 CFU/g</p><p><span>Escherichia coli</span>: Absence in 25 g</p><p><span>Salmonella</span>: Absence in 375 g</p><p><span>Staphylococcus aureus</span>: Absence in 25 g</p><p>CFU: colony forming units</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Pasteurised fruit-based preparations produced using high-pressure treatment</span></p></td><td><p><span>Parameter</span></p></td><td><p><span>Target</span></p></td><td><p><span>Comments</span></p></td></tr><tr><td><p>Fruit storage before high-pressure treatment</p></td><td><p>Minimum 15 days at &#8211; 20 &#176;C</p></td><td><p>Fruit harvested and stored in conjunction with good/hygienic agricultural and manufacturing practices</p></td></tr><tr><td><p>Fruit added</p></td><td><p>40 % to 60 % of thawed fruit</p></td><td><p>Fruit homogenised and added to other ingredients</p></td></tr><tr><td><p>pH</p></td><td><p>3,2 to 4,2</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>o</span> Brix</p></td><td><p>7 to 42</p></td><td><p>Assured by added sugars</p></td></tr><tr><td><p>a<span>w</span></p></td><td><p>&lt; 0,95</p></td><td><p>Assured by added sugars</p></td></tr><tr><td><p>Final storage</p></td><td><p>60 days maximum at + 5 &#176;C maximum</p></td><td><p>Equivalent to storage regimen for conventionally processed product</p></td></tr><tr><td><p><a>&#9660;M100</a></p></td></tr><tr><td><p><span>Pea and rice protein fermented by<span>Lentinula edodes</span> (Shiitake mushroom) mycelia</span></p></td><td><p><span>Description:</span></p><p>The novel food is produced from the fermentation of a mixture of 65&#160;% pea and&#160;35&#160;% rice protein concentrates by the mycelia of the Shiitake mushroom (<span>Lentinula edodes</span>) followed by heat treatment to terminate the fermentation and a series of drying steps to form a powder.</p><p><span>Characteristics/Composition:</span></p><p>Protein (% dry weight, N x 6,25): &#8805;&#160;75,0</p><p>Moisture: &#8804;&#160;7,0</p><p>Total fat (% dry weight): &#8804;&#160;10,0</p><p>Ash (% dry weight): &#8804;&#160;10,0</p><p>Carbohydrates (% by calculation): &#8804;&#160;15,0</p><p><span>Mycotoxins</span>:</p><p>Aflatoxin B1 (&#956;g/kg): &lt;&#160;1,0</p><p>Aflatoxin B2 (&#956;g/kg): &lt;&#160;1,0</p><p>Aflatoxin G1 (&#956;g/kg): &lt;&#160;1,0</p><p>Aflatoxin G2 (&#956;g/kg): &lt;&#160;1,0</p><p>Aflatoxin total (B1+B2+G1+G2) (&#956;g/kg): &lt;&#160;3,0</p><p><span>Heavy metals:</span></p><p>Arsenic (&#956;g/g): &lt;&#160;0,1</p><p>Cadmium (&#956;g/g): &lt;&#160;0,1</p><p>Lead (&#956;g/g): &lt;&#160;0,3</p><p>Mercury (&#956;g/g): &lt;&#160;0,1</p><p><span>Microbiological criteria:</span></p><p>Total aerobic microbial count: &lt;&#160;1&#160;000  CFU/g</p><p>Total yeast/moulds count: &lt;&#160;100 CFU/g</p><p>Coliforms: &#8804;&#160;10 CFU/g</p><p><span>Salmonella</span> spp.: Absent in&#160;25 g</p><p><span>Escherichia coli</span>: &lt;&#160;10 CFU/g</p><p><span>Listeria monocytogenes</span>: Absent in&#160;25 g</p><p>*CFU: Colony Forming Units</p></td></tr><tr><td><p><a>&#9660;M37</a></p></td></tr><tr><td><p><span>Phenylcapsaicin</span></p></td><td><p><span>Description/Definition:</span></p><p>Phenylcapsaicin (<span>N</span>-[(4-hydroxy-3-methoxyphenyl)methyl]-7-phenylhept-6-ynamide, C<span>21</span>H<span>23</span>NO<span>3</span>, CAS no: 848127-67-3), is synthesized chemically via a two step synthesis process involving in a first step the production of the acetylenic acid intermediate through a reaction of phenyl acetylene with a carboxylic acid derivative, and in a second step a series of reactions of the acetylenic acid intermediate with vanillylamine derivative to produce phenylcapsaicin.</p><p><span>Characteristics/Composition:</span></p><p>Purity (% of dry matter): &#8805; 98 %</p><p>Moisture: &#8804; 0,5 %</p><p>Total synthesis related production by-products: &#8804; 1,0 %</p><p><span>N,N</span>-dimethyl formamide: &#8804; 880 mg/kg</p><p>Dichloromethane: &#8804; 600 mg/kg</p><p>Dimethoxyethane: &#8804; 100 mg/kg</p><p>Ethyl acetate: &#8804; 0,5 %</p><p>Other solvents: &#8804; 0,5 %</p><p><span>Heavy metals:</span></p><p>Lead: &#8804; 1,0 mg/kg</p><p>Cadmium: &#8804; 1,0 mg/kg</p><p>Mercury: &#8804; 0,1 mg/kg</p><p>Arsenic: &#8804; 1,0 mg/kg</p><p><span>Microbiological criteria:</span></p><p>Total plate count: &#8804; 10 CFU/g</p><p>Coliforms: &#8804; 10 CFU/g</p><p><span>Escherichia coli</span>: Negative/10 g</p><p><span>Salmonella</span> sp.: Negative/10 g</p><p>Yeast and mould: &#8804; 10 CFU/g</p><p>CFU: Colony Forming Units</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Phosphated maize starch</span></p></td><td><p><span>Description/Definition:</span></p><p>Phosphated maize starch (phosphated distarch phosphate) is a chemically modified resistant starch derived from high amylose starch by combining chemical treatments to create phosphate cross-links between carbohydrate residues and esterified hydroxyl groups.</p><p>The novel food ingredient is a white or nearly white powder.</p><p>CAS No: 11120-02-8</p><p>Chemical formula: (C<span>6</span>H<span>10</span>O<span>5</span>)<span>n</span> [(C<span>6</span>H<span>9</span>O<span>5</span>)<span>2</span>PO<span>2</span>H]x [(C<span>6</span>H<span>9</span>O<span>5</span>)PO<span>3</span>H<span>2</span>]y</p><p>n = number of glucose units; x, y = degrees of substitution</p><p>The chemical characteristics of phosphated distarch phosphate:</p><p>Loss on drying: 10-14 %</p><p>pH: 4,5-7,5</p><p>Dietary fibre: &#8805; 70 %</p><p>Starch: 7-14 %</p><p>Protein: &#8804; 0,8 %</p><p>Lipids: &#8804; 0,8 %</p><p>Residual bound phosphorus: &#8804; 0,4 % (as phosphorus) &#8216;high amylose maize&#8217; as source</p></td></tr><tr><td><p><a>&#9660;M112</a></p></td></tr><tr><td><p><span>Phosphated wheat starch</span></p></td><td><p><span>Description:</span></p><p>Phosphated distarch phosphate produced from wheat starch (phosphated wheat starch) is a chemically modified resistant starch derived from wheat starch by combining chemical treatments to create phosphate cross-links within and between individual starch molecules.</p><p>The novel food ingredient is a white or near white free flowing powder.</p><p><span>Characteristic/Composition:</span></p><p>CAS No: 11120-02-8</p><p>Chemical formula: (C<span>6</span>H<span>10</span>O<span>5</span>)<span>n</span> [(C<span>6</span>H<span>9</span>O<span>5</span>)<span>2</span>PO<span>2</span>H]<span>x</span> [(C<span>6</span>H<span>9</span>O<span>5</span>)PO<span>3</span>H<span>2</span>]<span>y</span></p><p>n = number of glucose units; x, y = degrees of substitution</p></td></tr><tr><td><p>Parameter</p></td><td><p>Powder form 1</p></td><td><p>Powder form 2</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Phosphated Distarch Phosphate (Dry basis)</p></td><td><p>&#8805;&#160;85 &#160;%</p></td><td><p>&#8805;&#160;75 &#160;%</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Unmodified Wheat Starch (Dry basis)</p></td><td><p>&#8804;&#160;15 &#160;%</p></td><td><p>&#8804;&#160;25 &#160;%</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Moisture</p></td><td><p>9 -12 &#160;%</p></td></tr><tr><td><p>Total dietary fibre (dry matter basis)</p></td><td><p>&#8805;&#160;76,0 &#160;%</p></td><td><p>&#8805;&#160;66,0 &#160;%</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Ash</p></td><td><p>&#8804;&#160;3 &#160;%</p></td></tr><tr><td><p>Protein</p></td><td><p>&#8804;&#160;0,5 &#160;%</p></td></tr><tr><td><p>Total fat</p></td><td><p>&#8804;&#160;0,50 &#160;%</p></td><td><p>&#8804;&#160;0,34 &#160;%</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Residual bound phosphorus</p></td><td><p>&#8804;&#160;0,4 &#160;% (as phosphorus)</p></td></tr><tr><td><p>pH (25&#160;% slurry)</p></td><td><p>4,5  &#8211; 6,5</p></td></tr><tr><td><p><span>Heavy metals:</span></p><p>Arsenic: &#8804;&#160;1  mg/kg</p><p>Lead: &#8804;&#160;2  mg/kg</p><p>Mercury: &#8804;&#160;0,1 &#160;mg/kg</p><p><span>Microbiological criteria:</span></p><p>Total viable aerobic counts: &#8804;&#160;10<span>4</span> CFU/g</p><p>Total yeast and mould count: &#8804;&#160;200  CFU/g</p><p><span>Escherichia coli</span>: Negative to test</p><p><span>Salmonella</span> spp.: Negative to test</p><p>CFU: Colony Forming Units</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Phosphatidylserine from fish phospholipids</span></p></td><td><p><span>Description/Definition:</span></p><p>The novel food ingredient is yellow to brown powder. Phosphatidylserine is obtained from fish phospholipids by an enzymatic transphosphorylation with the amino acid L-serine.</p><p><span>Specification of the phosphatidylserine product manufactured from fish phospholipids:</span></p><p>Moisture: &lt; 5,0 %</p><p>Phospholipids: &#8805; 75 %</p><p>Phosphatidylserine: &#8805; 35 %</p><p>Glycerides: &lt; 4,0 %</p><p>Free L-serine: &lt; 1,0 %</p><p>Tocopherols: &lt; 0,5 % (<span>1</span>)</p><p>Peroxide value (PV): &lt; 5,0 meq O<span>2</span>/kg</p><p>(<span>1</span>)&#160;&#160;Tocopherols may be added as antioxidants according to Commission Regulation (EU) No 1129/2011</p></td></tr><tr><td><p><span>Phosphatidylserine from soya phospholipids</span></p></td><td><p><span>Description/Definition:</span></p><p>The novel food ingredient is off-white to light yellow powder. It is also available in liquid form with a clear brown to orange colour. The liquid form contains medium chain triacylglycerides (MCT) as a carrier. It contains lower levels of Phosphatidylserine due to the fact that it includes significant amounts of oil (MCT).</p><p>Phosphatidylserine from soya phospholipids is obtained through enzymatic transphosphatidylation of high-phosphatidylcholine soybean lecithin with the amino acid L-serine. Phosphatidylserine consists of a glycerophosphate skeleton conjugated with two fatty acids and L-serine via a phosphodiester linkage.</p><p><span>Characteristics of Phosphatidylserine from soya phospholipids:</span></p><p><span>Powder form:</span></p><p>Moisture: &lt; 2,0 %</p><p>Phospholipids: &#8805; 85 %</p><p>Phosphatidylserine: &#8805; 61 %</p><p>Glycerides: &lt; 2,0 %</p><p>free L-serine: &lt; 1,0 %</p><p>Tocopherols: &lt; 0,3 %</p><p>Phytosterols: &lt; 0,2 %</p><p><span>Liquid form:</span></p><p>Moisture: &lt; 2,0 %</p><p>Phospholipids: &#8805; 25 %Phosphatidylserine: &#8805; 20 %</p><p>Glycerides: not applicable</p><p>free L-serine: &lt; 1,0 %</p><p>Tocopherols: &lt; 0,3 %</p><p>Phytosterols: &lt; 0,2 %</p></td></tr><tr><td><p><span>Phospholipid product containing equal amounts of phosphatidylserine and phosphatidic acid</span></p></td><td><p><span>Description/Definition:</span></p><p>The product is manufactured through enzymatic conversion of soy lecithin. The phospholipid product is a highly concentrated, yellow-brown powder form of phosphatidylserine and phosphatidic acid at an equal level.</p><p><span>Specification of the product:</span></p><p>Moisture: &#8804; 2,0 %</p><p>Total phospholipids: &#8805; 70 %</p><p>Phosphatidylserine: &#8805; 20 %</p><p>Phosphatidic acid: &#8805; 20 %</p><p>Glycerides: &#8804; 1,0 %</p><p>Free L-serine: &#8804; 1,0 %</p><p>Tocopherols: &#8804; 0,3 %</p><p>Phytosterols: &#8804; 2,0 %</p><p>Silicon dioxide is used with a maximum content of 1,0 %</p></td></tr><tr><td><p><span>Phospholipides from egg yolk</span></p></td><td><p>85 % and 100 % pure Phospholipides from egg yolk</p></td></tr><tr><td><p><span>Phytoglycogen</span></p></td><td><p><span>Description:</span> White to off-white powder which is an odourless, colourless, flavourless polysaccharide derived from non-GM sweet corn using conventional food processing techniques</p><p><span>Definition:</span> Glucose polymer (C<span>6</span>H<span>12</span>O<span>6</span>)n with linear linkages of &#945;(1 &#8211; 4) glycosidic bonds branched every 8 to 12 glucose units by &#945;(1 &#8211; 6) glycosidic bonds</p><p><span>Specifications:</span></p><p>Carbohydrates: 97 %</p><p>Sugars: 0,5 %</p><p>Fibre: 0,8 %</p><p>Fat: 0,2 %</p><p>Protein: 0,6 %</p></td></tr><tr><td><p><span>Phytosterols/phytostanols</span></p></td><td><p><span>Description/Definition:</span></p><p>Phytosterols and phytostanols are sterols and stanols that are extracted from plants and may be presented as free sterols and stanols or esterified with food grade fatty acids.</p><p><span>Composition</span> (with GC-FID or equivalent method):</p><p>&#946;-sitosterol: &lt; 81 %</p><p>&#946;-sitostanol: &lt; 35 %</p><p>campesterol: &lt; 40 %</p><p>campestanol: &lt; 15 %</p><p>stigmasterol: &lt; 30 %</p><p>brassicasterol: &lt; 3,0 %</p><p>other sterols/stanols: &lt; 3,0 %</p><p><span>Contamination/Purity</span> (GC-FID or equivalent method):</p><p>Phytosterols and phytostanols extracted from sources other than vegetable oil suitable for food have to be free of contaminants, best ensured by a purity of more than 99 % of the phytosterol/phytostanol ingredient.</p></td></tr><tr><td><p><span>Plum kernel oil</span></p></td><td><p><span>Description/Definition:</span></p><p>Plum kernel oil is a vegetable oil obtained by cold pressing of plum (<span>Prunus domestica</span>) kernels.</p><p><span>Composition:</span></p><p>Oleic acid (C18:1): 68 %</p><p>Linoleic acid (C18:2): 23 %</p><p>&#947;-Tocopherol:80 % of total tocopherols</p><p>&#946;-Sitosterol: 80-90 % of total sterols</p><p>Triolein: 40-55 % of triglycerides</p><p>Cyanhydric acid: maximum 5 mg/kg oil</p></td></tr><tr><td><p><span>Potato proteins (coagulated) and hydrolysates thereof</span></p></td><td><p>Dry substance: &#8805; 800 mg/g</p><p>Protein (N * 6,25): &#8805; 600 mg/g (dry substance)</p><p>Ash: &#8804; 400 mg/g (dry substance)</p><p>Glycoalkaloid (total): &#8804; 150 mg/kg</p><p>Lysinoalanine (total): &#8804; 500 mg/kg</p><p>Lysinoalanine (free): &#8804; 10 mg/kg</p></td></tr><tr><td><p><span>Prolyl oligopeptidase (enzyme preparation)</span></p></td><td><p><span>Specification of the enzyme:</span></p><p>Systematic name: Prolyl oligopeptidase</p><p>Synonyms: Prolyl endopeptidase, proline-specific endopeptidase, endoprolylpeptidase</p><p>Molecular weight: 66 kDa</p><p>Enzyme Commission number: EC 3.4.21.26</p><p>CAS number: 72162-84-6</p><p>Source: A genetically modified strain of<span>Aspergillus niger</span> (GEP-44)</p><p><span>Description:</span> Prolyl oligopeptidase is available as an enzyme preparation containing approximately 30 % maltodextrin.</p><p><span>Specifications of the enzyme preparation of prolyl oligopeptidase:</span></p><p>Activity: &gt; 580&#160;000  PPI(<span>1</span>)/g (&gt; 34,8 PPU(<span>2</span>)/g)</p><p>Appearance: Microgranulate</p><p>Colour: Off-white to orange yellowish. The colour may change from batch to batch</p><p>Dry Matter: &gt; 94 %</p><p>Gluten: &lt; 20 ppm</p><p><span>Heavy metals:</span></p><p>Lead: &#8804; 1,0 mg/kg</p><p>Arsenic: &#8804; 1,0 mg/kg</p><p>Cadmium: &#8804; 0,5 mg/kg</p><p>Mercury: &#8804; 0,1 mg/kg</p><p><span>Microbiological criteria:</span></p><p>Total aerobic plate count: &#8804; 10<span>3</span> CFU/g</p><p>Total yeasts and moulds: &#8804; 10<span>2</span> CFU/g</p><p>Sulphite reducing anaerobes: &#8804; 30 CFU/g</p><p><span>Enterobacteriaceae</span>: &lt; 10 CFU/g</p><p><span>Salmonella</span>: Absence in 25 g</p><p><span>Escherichia coli</span>: Absence in 25 g</p><p><span>Staphylococcus aureus</span>: Absence in 10 g</p><p><span>Pseudomonas aeruginosa</span>: Absence in 10 g</p><p><span>Listeria monocytogenes</span>: Absence in 25 g</p><p>Antimicrobial activity: AbsentMycotoxins: Below limits of detection: Aflatoxin B1, B2, G1, G2 (&lt; 0,25 &#956;g/kg), total Aflatoxins (&lt; 2,0 &#956;g/kg), Ochratoxin A (&lt; 0,20 &#956;g/kg), T-2 Toxin (&lt; 5 &#956;g/kg), Zearalenone (&lt; 2,5 &#956;g/kg), Fumonisin B1 and B2 (&lt; 2,5 &#956;g/kg)</p><p>(<span>1</span>)&#160;&#160;PPI &#8211; Protease Picomole International</p><p>(<span>2</span>)&#160;&#160;PPU &#8211; Prolyl Peptidase Units or Proline Protease Units</p></td></tr><tr><td><p><a>&#9660;M118</a></p></td></tr><tr><td><p><span>Protein extract from pig kidneys</span></p></td><td><p><span>Description/Definition:</span></p><p>The protein extract is obtained from homogenised pig kidneys through a combination of salt precipitation and high speed centrifugation. The obtained precipitate contains essentially proteins with 7&#160;% of the enzyme diamine oxidase (enzyme nomenclature E.C. 1.4.3.22) and is resuspended in a physiologic buffer system. The obtained pig kidney extract is formulated as encapsulated enteric coated pellets or enteric coated tablets to reach the active sites of digestion.</p><p><span>Basic Product:</span></p><p>Specification: pig kidney protein extract with natural content of Diamine oxidase (DAO):</p><div><p>Physical condition: liquid</p></div><div><p>Colour: brownish</p></div><div><p>Appearance: slightly turbid solution</p></div><div><p>pH value: 6,4&#8211;6,8</p></div><div><p>Enzymatic activity: &gt;&#160;2&#160;677  kHDU&#160;DAO/ml (DAO REA (DAO Radioextractionassay))</p></div><p><span>Microbiological criteria:</span></p><div><p>Brachyspira spp.: negative (Real Time PCR)</p></div><div><p>Listeria monocytogenes: negative (Real Time PCR)</p></div><div><p>Staphylococcus aureus: &lt;&#160;100&#160;CFU/g</p></div><div><p>Influenza A: negative (Reverse Transcription Real Time PCR)</p></div><div><p>Escherichia coli: &lt;&#160;10&#160;CFU/g</p></div><div><p>Total aerobic microbiological count: &lt;&#160;10<span>5</span> CFU/g</p></div><div><p>Yeasts/moulds count: &lt;&#160;10<span>5</span> CFU/g</p></div><div><p>Salmonella: Absence/10g</p></div><div><p>Bile salt resistant enterobacteriaceae: &lt;&#160;10<span>4</span> CFU/g</p></div><p><span>Final product:</span></p><p>Specification pig kidney protein extract with natural content of DAO (E.C. 1.4.3.22) in an enteric coated formulation:</p><div><p>Physical condition: solid</p></div><div><p>Colour: yellow grey</p></div><div><p>Appearance: micropellets or tablets</p></div><div><p>Enzymatic activity: 110-220 kHDU&#160;DAO/g pellet or g tablet (DAO REA (DAO Radio Extraction Assay))</p></div><div><p>Acid stability 15 min 0,1M HCl followed by 60 min Borat pH&#160;= 9,0: &gt;&#160;68 kHDU&#160;DAO/g pellet or g tablet (DAO REA (DAO Radio Extraction Assay))</p></div><div><p>Humidity: &lt;&#160;10&#160;%</p></div><p><span>Microbiological criteria:</span></p><div><p><span>Staphylococcus aureus</span>: &lt;&#160;100&#160;CFU/g</p></div><div><p><span>Escherichia coli</span>: &lt;&#160;10&#160;CFU/g</p></div><div><p>Total aerobic microbiological count: &lt;&#160;10<span>4</span> CFU/g</p></div><div><p>Total combined&#160;yeasts/moulds count: &lt;&#160;10<span>3</span> CFU/g</p></div><div><p><span>Salmonella</span>: Absence/10g</p></div><div><p>Bile salt resistant enterobacteriaceae: &lt;&#160;10<span>2</span> CFU/g</p></div><div><p>PCR: Polymerase Chain Reaction; HDU (Histamine Degrading Units);</p></div></td><td><p><span>Description/Definition:</span></p><p>The protein extract is obtained from homogenised pig kidneys through a series of steps involving a number of acetone washes to defat and dehydrate the homogenized pig kidneys, followed by draining, drying, milling, and sieving to produce a powder containing essentially proteins with a&#160;7-9&#160;% (on average) content of the enzyme diamine oxidase (enzyme nomenclature E.C. 1.4.3.22). The pig kidney extract powder is formulated either in enteric coated capsules or as encapsulated enteric coated pellets or enteric coated tablets to reach the active sites of digestion.</p><p><span>Basic Product:</span></p><p>Specification: pig kidney protein extract with natural content of Diamine oxidase (DAO):</p><div><p>Physical condition: powder</p></div><div><p>Colour: pale brown</p></div><div><p>Enzymatic activity: &#8805;&#160;0,10&#160;mU/mg (UHPLC-FLD (Ultra High Performance Liquid Chromatography linked with Fluorescent Detection)).</p></div><div><p>Humidity: &lt;&#160;10&#160;%</p></div><p><span>Residual Solvents:</span></p><div><p>Acetone: &lt;&#160;5&#160;000 &#160;mg/kg</p></div><p><span>Microbiological criteria:</span></p><div><p><span>Staphylococcus aureus</span>: &lt;&#160;100&#160;CFU/g</p></div><div><p><span>Escherichia coli</span>: &lt;&#160;10&#160;CFU/g</p></div><div><p>Total aerobic microbiological count: &lt;&#160;10<span>4</span> CFU/g</p></div><div><p>Total combined&#160;yeasts/moulds count: &lt;&#160;10<span>3</span> CFU/g</p></div><div><p><span>Salmonella</span>: Absence/10g</p></div><div><p>Bile salt resistant enterobacteriaceae: &lt;&#160;10<span>2</span> CFU/g</p></div><div><p><span>Listeria monocytogenes</span>: absence in&#160;25 g</p></div><p><span>Final product:</span></p><p>Specification pig kidney protein extract with natural content of DAO (E.C. 1.4.3.22) in an enteric coated formulation:</p><div><p>Physical condition: solid</p></div><div><p>Colour: pale brown</p></div><div><p>Appearance: micropellets, capsules, or tablets</p></div><div><p>Enzymatic activity (micropellets, capsules or tablets): 2,29 &#8211; 4,6&#160;mU/g pellet or g tablet or g capsule (UHPLC-FLD (Ultra High Performance Liquid Chromatography linked with Fluorescent Detection)).</p></div><div><p>Acid stability 15 min 0,1M HCl followed by 60 min Borat pH&#160;= 9,0: &gt;&#160;1,4 mU&#160;DAO/g pellet or g tablet or g capsule (UHPLC-FLD (Ultra High Performance Liquid Chromatography linked with Fluorescent Detection))</p></div><div><p>Humidity: &lt;&#160;10&#160;%</p></div><p><span>Microbiological criteria:</span></p><div><p><span>Staphylococcus aureus</span>: &lt;&#160;100&#160;CFU/g</p></div><div><p><span>Escherichia coli</span>: &lt;&#160;10&#160;CFU/g</p></div><div><p>Total aerobic microbiological count: &lt;&#160;10<span>4</span> CFU/g</p></div><div><p>Total combined&#160;yeasts/moulds count: &lt;&#160;10<span>3</span> CFU/g</p></div><div><p><span>Salmonella</span>: Absence/10g</p></div><div><p>Bile salt resistant enterobacteriaceae: &lt;&#160;10<span>2</span> CFU/g</p></div><div><p><span>Listeria monocytogenes</span>: absence in&#160;25 g</p></div><p>mU: milliUnit (expressed in&#160;mU/mg) measures nanomols (nmol) of histamine degraded by the DAO per minute using Ultra High Performance Liquid Chromatography linked with Fluorescent Detection (UHPLC-FLD) (O. Comas-Bast&#233; et al. Analytical and Bioanalytical Chemistry&#160;411:7595-7602 (2019)). 1 mU corresponds to 48&#160;000  HDU of the DAO Radio Extraction Assay (REA) method.</p></td></tr><tr><td><p><a>&#9660;M10</a></p></td></tr><tr><td><p><span>Pyrroloquinoline quinone disodium salt</span></p></td><td><p><span>Definition:</span></p><p>Chemical name: disodium 9-carboxy-4,5-dioxo-1<span>H</span>-pyrrolo[5,4-f]quinoline-2,7-dicarboxylate</p><p>Chemical formula: C<span>14</span>H<span>4</span>N<span>2</span>Na<span>2</span>O<span>8</span></p><p>CAS No: 122628-50-6</p><p>Molecular weight: 374,17 Da</p><p><span>Description</span></p><p>Pyrroloquinoline quinone disodium salt is a reddish&#8211;brown powder produced by the non-genetically modified bacterium<span>Hyphomicrobium denitrificans</span> strain CK-275.</p><p><span>Characteristics/Composition</span></p><p>Appearance: Reddish-brown powder</p><p>Purity: &#8805; 99,0 % (dry weight)</p><p>UV absorbance (A322/A259): 0,56 &#177; 0,03</p><p>UV absorbance (A233/A259): 0,90 &#177; 0,09</p><p>Moisture: &#8804; 12,0 %</p><p><span>Residual Solvent</span></p><p>Ethanol: &#8804; 0,05 %</p><p><span>Heavy metals</span></p><p>Lead: &lt; 3 mg/kg</p><p>Arsenic: &lt; 2 mg/kg</p><p><span>Microbiological criteria:</span></p><p>Total viable cell count: &#8804; 300 CFU/g</p><p>Mould/yeast: &#8804; 12 CFU/g</p><p>Coliforms: absent in 1 g</p><p><span>Hyphomicrobium denitrificans</span>: &#8804; 25 CFU/g</p><p>CFU: Colony Forming Units</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Rapeseed oil high in unsaponifiable matter</span></p></td><td><p><span>Description/Definition:</span></p><p>Rapeseed oil high in unsaponifiable matter&#8217; is produced by vacuum distillation and it is different from refined rapeseed oil in the concentration of the unsaponifiable fraction (1 g in refined rapeseed oil and 9 g in &#8216;rapeseed oil high in unsaponifiable matter&#8217;). There is a minor reduction of triglycerides containing monounsaturated and polyunsaturated fatty acids.</p><p><span>Purity:</span></p><p>Unsaponifiable matter: &gt; 7,0 g/100 g</p><p>Tocopherols: &gt; 0,8 g/100 g</p><p>&#945;-tocopherol (%): 30-50 %</p><p>&#947;-tocopherol (%): 50-70 %</p><p>&#948;-tocopherol (%): &lt; 6,0 %</p><p>Sterols, triterpenic alcohols, methylsterols: &gt; 5,0 g/100 g</p><p><span>Fatty acids in triglycerides:</span></p><p>palmitic acid: 3-8 %</p><p>stearic acid: 0,8-2,5 %</p><p>oleic acid: 50-70 %</p><p>linoleic acid: 15-28 %</p><p>linolenic acid: 6-14 %</p><p>erucic acid: &lt; 2,0 %</p><p>Acid value: &#8804; 6,0 mg KOH/g</p><p>Peroxide value (PV): &#8804; 10 mEq O<span>2</span>/kg</p><p><span>Heavy metals:</span></p><p>Iron (Fe): &lt; 1&#160;000  &#956;g/kg</p><p>Copper (Cu): &lt; 100 &#956;g/kg</p><p><span>Impurities:</span></p><p>Polycyclic aromatic hydrocarbons (PAH) Benzo(a)pyrene: &lt; 2 &#956;g/kg</p><p>Treatment with active carbon is required to ensure that polycyclic aromatic hydrocarbons (PAH) are not enriched in the production of &#8216;rapeseed oil high in unsaponifiable matter.</p></td></tr><tr><td><p><span>Rapeseed Protein</span></p></td><td><p><span>Definition:</span></p><p>Rapeseed protein is an aqueous protein-rich extract from rapeseed press cake originating from non-genetically modified<span>Brassica napus</span> L. and<span>Brassica rapa</span> L.</p><p><span>Description:</span></p><p>White to off-white, spray dried powder</p><p>Total protein: &#8805; 90 %</p><p>Soluble protein: &#8805; 85 %</p><p>Moisture: &#8804; 7,0 %</p><p>Carbohydrates: &#8804; 7,0 %</p><p>Fat: &#8804; 2,0 %</p><p>Ash: &#8804; 4,0 %</p><p>Fibre: &#8804; 0,5 %</p><p>Total glucosinolates: &#8804; 1 mmol/kg</p><p><span>Purity:</span></p><p>Total phytate: &#8804; 1,5 %</p><p>Lead: &#8804; 0,5 mg/kg</p><p><span>Microbiological criteria:</span></p><p>Yeast and mould count: &#8804; 100 CFU/g</p><p>Aerobic bacteria count: &#8804; 10&#160;000  CFU/g</p><p>Total coliform count: &#8804; 10 CFU/g</p><p><span>Escherichia coli:</span> Absence in 10 g</p><p><span>Salmonella</span>: Absence in 25 g</p></td></tr><tr><td><p><a>&#9660;M17</a></p></td></tr><tr><td><p>Refined shrimp peptide concentrate</p></td><td><p><span>Description</span></p><p>Refined shrimp peptide concentrate is a peptide mixture obtained from northern shrimp (<span>Pandalus borealis</span>) shells and heads via a series of purification steps following enzymatic proteolysis using a protease from<span>Bacillus licheniformis</span> and/or<span>Bacillus amyloliquefaciens</span>.</p><p><span>Characteristics/Composition</span></p><p>Total Dry matter (%): &#8805; 95,0 %</p><p>Peptides (w/weight dry matter): &#8805; 87,0 % of which peptides with molecular weight &lt; 2 kDa: &#8805; 99,9 %</p><p>Fat (w/w): &#8804; 1,0 %</p><p>Carbohydrates (w/w): &#8804; 1,0 %</p><p>Ash (w/w): &#8804; 15,0 %</p><p>Calcium: &#8804; 2,0 %</p><p>Potassium: &#8804; 0,15 %</p><p>Sodium: &#8804; 3,5 %</p><p><span>Heavy Metals</span></p><p>Arsenic (inorganic): &#8804; 0,22 mg/kg</p><p>Arsenic (organic): &#8804; 51,0 mg/kg</p><p>Cadmium: &#8804; 0,09 mg/kg</p><p>Lead: &#8804; 0,18 mg/kg</p><p>Total mercury: &#8804; 0,03 mg/kg</p><p><span>Microbiological criteria:</span></p><p>Total viable cell count: &#8804; 20&#160;000  CFU/g</p><p><span>Salmonella</span>: ND/25g</p><p><span>Listeria monocytogenes</span>: ND/25g</p><p><span>Escherichia coli</span>: &#8804; 20 CFU/g</p><p>Coagulase positive<span>Staphylococcus aureus:</span> &#8804; 200 CFU/g</p><p><span>Pseudomonas aeruginosa</span>: ND/25g</p><p>Mould/yeast: &#8804; 20 CFU/g</p><p>CFU: Colony Forming Units</p><p>ND: Not Detectable</p></td></tr><tr><td><p><a>&#9660;M86</a></p></td></tr><tr><td><p><span>Trans</span>-resveratrol</p></td><td><p><span>Description/Definition:</span></p><p><span>Synthetic</span>: Trans-resveratrol is off-white to beige crystals.</p><p>Chemical name: 5-[(E)-2-(4-hydroxyphenyl)ethenyl]benzene-1,3-diol</p><p>Chemical formula: C<span>14</span>H<span>12</span>O<span>3</span></p><p>Molecular weight: 228,25 Da</p><p>CAS No: 501-36-0</p><p><span>Purity:</span></p><p>Trans-resveratrol: &#8805;&#160;98&#160;%-99&#160;%</p><p>Total by-products (related substances): &#8804;&#160;0,5&#160;%</p><p>Any single related substance: &#8804;&#160;0,1&#160;%</p><p>Sulphated ash: &#8804;&#160;0,1&#160;%</p><p>Loss on drying: &#8804;&#160;0,5&#160;%</p><p><span>Heavy metals:</span></p><p>Lead: &#8804;&#160;1,0 ppm</p><p>Mercury: &#8804;&#160;0,1 ppm</p><p>Arsenic: &#8804;&#160;1,0 ppm</p><p><span>Impurities:</span></p><p>Diisopropylamine: &#8804;&#160;50 mg/kg</p><p><span>Microbial source</span>: A genetically modified strain of Saccharomyces cerevisiae</p><p>Appearance: Off-white to slight yellow powder</p><p>Trans-resveratrol content: Min.&#160;98&#160;% w/w (dry weight basis)</p><p>Ash: Max. 0,5&#160;% w/w</p><p>Moisture: Max. 3&#160;% w/w</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Rooster comb extract</span></p></td><td><p><span>Description/Definition:</span></p><p>Rooster comb extract is obtained from<span>Gallus gallus</span> by enzymatic hydrolysis of rooster comb and by subsequent filtration, concentration and precipitation steps. The principal constituents of rooster comb extract are the glycosaminoglycans hyaluronic acid, chondroitin sulphate A and dermatan sulphate (chondroitin sulphate B). White or almost white hygroscopic powder.</p><p>Hyaluronic acid: 60-80 %</p><p>Chondroitin sulphate A: &#8804; 5,0 %Dermatan sulphate (chondroitin sulphate B): &#8804; 25 %</p><p>pH: 5,0-8,5</p><p><span>Purity:</span></p><p>Chlorides: &#8804; 1,0 %</p><p>Nitrogen: &#8804; 8,0 %</p><p>Loss on drying: (105 &#176;C for 6 hours): &#8804; 10 %</p><p><span>Heavy metals:</span></p><p>Mercury: &#8804; 0,1 mg/kg</p><p>Arsenic: &#8804; 1,0 mg/kg</p><p>Cadmium: &#8804; 1,0 mg/kg</p><p>Chromium: &#8804; 10 mg/kg</p><p>Lead: &#8804; 0,5 mg/kg</p><p><span>Microbiological criteria:</span></p><p>Total viable aerobic count: &#8804; 10<span>2</span> CFU/g</p><p><span>Escherichia coli</span>: Absence in 1 g</p><p><span>Salmonella</span>: Absence in 1 g</p><p><span>Staphylococcus aureus</span>: Absence in 1 g</p><p><span>Pseudomonas aeruginosa</span>: Absence in 1g</p></td></tr><tr><td><p><span>Sacha Inchi oil from<span>Plukenetia volubilis</span></span></p></td><td><p><span>Description/Definition:</span></p><p>Sacha inchi oil is a 100 % cold pressed vegetable oil obtained from the seeds of<span>Plukenetia volubiis</span> L. It is a transparent, fluid (liquid) and shiny oil at room temperature. It has a fruity, light, green vegetable taste without undesirable flavours.</p><p>Aspect, limpidity, shine, colour: Fluid at room temperature, clean, shiny yellow gold</p><p>Odour and taste: Fruity, vegetable without non acceptable taste or odour</p><p><span>Purity:</span></p><p>Water and Volatiles: &lt; 0,2 g/100 g</p><p>Impurities insoluble in hexane: &lt; 0,05 g/100 g</p><p>Oleic acidity: &lt; 2,0 g/100 g</p><p>Peroxide value (PV): &lt; 15 meq O<span>2</span>/kg</p><p>Trans fatty acids: &lt; 1,0 g/100 g</p><p>Total unsaturated fatty acids: &gt; 90 %Omega 3 alpha linolenic acid (ALA): &gt; 45 %</p><p>Saturated fatty acids: &lt; 10 %</p><p>No trans fatty acids (&lt; 0,5 %)</p><p>No erucic acid (&lt; 0,2 %)</p><p>More than 50 % of tri-linolenin and di-linolenin-triglycerides</p><p>Phytosterols composition and level</p><p>No cholesterol (&lt; 5,0 mg/100 g)</p></td></tr><tr><td><p><span>Salatrims</span></p></td><td><p><span>Description/Definition:</span></p><p>Salatrim is the internationally recognised acronym for (short and long chain acyl triglyceride molecules). Salatrim is prepared by non-enzymatic inter-esterification of triacetin, tripropionin, tributyrin, or their mixtures with hydrogenated canola, soybean, cottonseed, or sunflower oil. Description: Clear, slightly amber liquid to a light coloured waxy solid at room temperature. Free of particulate matter and of foreign or rancid odour.</p><p>Glycerol ester disribution:</p><p>Triacylglycerols: &gt; 87 %</p><p>Diacylglycerols: &#8804; 10 %</p><p>Monoacylglycerols: &#8804; 2,0 %</p><p>Fatty acid composition:</p><p>MOLE % LCFA (long chain fatty acids): 33-70 %</p><p>MOLE % SCFA (short chain fatty acids): 30-67 %</p><p>Saturated long chain fatty acids: &lt; 70 % by weight</p><p>Trans fatty acids: &#8804; 1,0 %</p><p>Free fatty acids as oleic acid: &#8804; 0,5 %</p><p>Triacylglycerol profile:</p><p>Triesters (short/long of 0,5 to 2,0): &#8805; 90 %</p><p>Triesters (short/long = 0): &#8804; 10 %</p><p>Unsaponifiable material: &#8804; 1,0 %</p><p>Moisture: &#8804; 0,3 %</p><p>Ash: &#8804; 0,1 %</p><p>Colour: &#8804; 3,5 Red (Lovibond)</p><p>Peroxide value (PV): &#8804; 2,0 Meq/Kg</p></td></tr><tr><td><p><span><span>Schizochytrium sp.</span> oil rich in DHA and EPA</span></p></td><td><p>Acid value: &#8804; 0,5 mg KOH/g</p><p>Peroxide value (PV): &#8804; 5,0 meq/kg oil</p><p>Oxidative stability: All food products containing<span>Schizochytrium sp.</span> oil rich in DHA and EPA should demonstrate oxidative stability by appropriate and recognised national/international test methodology (e.g. AOAC)</p><p>Moisture and volatiles: &#8804; 0,05 %</p><p>Unsaponifiables: &#8804; 4,5 %</p><p>Trans-fatty acids: &#8804; 1 %</p><p>DHA content: &#8805; 22,5 %</p><p>EPA content: &#8805; 10 %</p></td></tr><tr><td><p><a>&#9660;M27</a></p></td></tr><tr><td><p><span><span>Schizochytrium</span></span><span>sp. (ATCC PTA-9695) oil</span></p></td><td><p>The novel food is obtained from the strain ATCC PTA-9695 of the microalgae<span>Schizochytrium</span> sp.</p><p>Peroxide value (PV): &#8804; 5,0 meq/kg oil</p><p>Unsaponifiables: &#8804; 3,5 %</p><p>Trans-fatty acids: &#8804; 2,0 %</p><p>Free fatty acids: &#8804; 0,4 %</p><p>Docosapentaenoic acid (DPA) n-6: &#8804; 7,5 %</p><p>DHA content: &#8805; 35 %</p></td></tr><tr><td><p><a>&#9660;M71</a></p></td></tr><tr><td><p><span>Schizochytrium</span> sp. (FCC-3204) oil</p></td><td><p><span>Description/Definition:</span></p><div><p>The novel food is an oil produced from the strain FCC-3204 of the microalgae<span>Schizochytrium</span> sp.</p></div><p><span>Composition:</span></p><div><p>Acid value: &#8804;&#160;0,5&#160;mg KOH/g</p></div><div><p>Peroxide value (PV): &#8804;&#160;5,0 meq/kg oil</p></div><div><p>Moisture and volatiles: &#8804;&#160;0,05&#160;%</p></div><div><p>Unsaponifiables: &#8804;&#160;4,5&#160;%</p></div><div><p>Trans-fatty acids: &#8804;&#160;1,0&#160;%</p></div><div><p>Docosahexaenoic acid (DHA): &#8805;&#160;32,0&#160;%</p></div><div><p>p-anisidine value: &#8804;&#160;10</p></div></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span><span>Schizochytrium</span> sp. oil</span></p></td><td><p>Acid value: &#8804; 0,5 mg KOH/g</p><p>Peroxide value (PV): &#8804; 5,0 meq/kg oil</p><p>Moisture and volatiles: &#8804; 0,05 %</p><p>Unsaponifiables: &#8804; 4,5 %</p><p>Trans-fatty acids: &#8804; 1,0 %</p><p>DHA content: &#8805; 32,0 %</p></td></tr><tr><td><p><a>&#9660;M44</a></p></td></tr><tr><td><p><span><span>Schizochytrium</span> sp. (T18) oil</span></p></td><td><p>Acid value: &#8804; 0,8 mg KOH/g</p><p>Peroxide value (PV): &#8804; 5,0 meq/kg oil</p><p>Moisture and volatiles: &#8804; 0,05 %</p><p>Unsaponifiables: &#8804; 3,5 %</p><p>Trans-fatty acids: &#8804; 2,0 %</p><p>Free fatty acids: &#8804; 0,4 %</p><p>DHA content: &#8805; 35 %</p></td></tr><tr><td><p><a>&#9660;M65</a></p></td></tr><tr><td><p><span><span>Schizochytrium</span> sp. (WZU477) oil</span></p></td><td><p><span>Description/Definition:</span></p><p>The novel food is an oil produced from the strain WZU477 of the microalgae<span>Schizochytrium</span> sp.</p><p><span>Composition:</span></p><p>Acid value: &#8804;&#160;0,5&#160;mg KOH/g</p><p>Peroxide value (PV): &#8804;&#160;5,0 meq/kg oil</p><p>Moisture and volatiles: &#8804;&#160;0,05&#160;%</p><p>Unsaponifiables: &#8804;&#160;4,5&#160;%</p><p>Trans-fatty acids: &#8804;&#160;1,0&#160;%</p><p>Docosahexaenoic acid (DHA): &#8805;&#160;32,0&#160;%</p><p>p-anisidine value: &#8804;&#160;10</p></td></tr><tr><td><p><a>&#9660;M23</a></p></td></tr><tr><td><p>Syrup from<span>Sorghum bicolor</span> (L.) Moench.</p><p>(Traditional food from a third country)</p></td><td><p><span>Description/Definition</span></p><p>The traditional food is syrup from<span>Sorghum bicolor</span> (L.) Moench (genus,<span>Sorghum</span>; family,<span>Poaceae</span> (alt.<span>Gramineae</span>)).</p><p>The syrup is obtained from stalks of<span>S. bicolor</span>, after applying production processes such as crushing, extraction, and evaporation including a heat treatment in order to obtain a minimum of 74 &#176;Brix syrup</p><p><span>Compositional data of syrup from<span>Sorghum bicolor</span> (L.) Moench</span></p><p>Water: 22,7 g/100 g</p><p>Ash: 2,4</p><p>Sugars, total: &gt; 74,0 g/100 g</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Fermented soybean extract</span></p></td><td><p><span>Description/Definition:</span></p><p>Fermented soybean extract is an odourless milk-white coloured powder. It is comprised of 30 % fermented soybean extract powder and 70 % resistant dextrin (as carrier) from corn-starch, which is added during the processing. Vitamin K<span>2</span> is removed during the manufacturing process.</p><p>Fermented soybean extract contains nattokinase isolated from natto, a foodstuff produced by the fermentation of non-genetically modified soybeans (<span>Glycine max</span> (L.)) with a selected strain of<span>Bacillus subtilis</span> var. natto.</p><p>Nattokinase activity: 20&#160;000  -28&#160;000  Fibrin degradation unit/g(<span>1</span>)</p><p>Identity: Confirmable</p><p>Condition: No offensive taste or smell</p><p>Loss on drying: &#8804; 10 %</p><p>Vitamin K<span>2</span>: &#8804; 0,1 mg/kg</p><p><span>Heavy metals:</span></p><p>Lead: &#8804; 5,0 mg/kg</p><p>Arsenic: &#8804; 3,0 mg/kg</p><p><span>Microbiological criteria:</span></p><p>Total viable aerobic count: &#8804; 10<span>3</span> CFU(<span>3</span>)/g</p><p>Yeast and mould: &#8804; 10<span>2</span> CFU/g</p><p>Coliforms: &#8804; 30 CFU/g</p><p>Spore-forming bacteria: &#8804; 10 CFU/g</p><p><span>Escherichia coli</span>: Absence/25 g</p><p><span>Salmonella</span>: Absence/25 g</p><p><span>Listeria</span>: Absence/25 g</p><p>(<span>1</span>)&#160;&#160;Assay method as described by Takaoka et al. (2010).</p></td></tr><tr><td><p><a>&#9660;M57</a></p></td></tr><tr><td><p><span>Selenium-containing yeast (<span>Yarrowia lipolytica</span>) biomass</span></p></td><td><p><span>Description/Definition:</span></p><p>The novel food is the dried and heat-killed selenium-containing biomass of the yeast<span>Yarrowia lipolytica</span>.</p><p>The novel food is produced by fermentation in the presence of sodium selenite followed by a number of purification steps including a heat-killing step of the yeast to ensure the absence of viable<span>Yarrowia lipolytica</span> cells in the novel food.</p><p><span>Characteristics/Composition:</span></p><p>Total selenium: 165&#8211;200 &#956;g/g</p><p>Se-methionine&#160;<a>(<span>14</span>)</a>: 100&#8211;140 &#956;g/g</p><p>Protein: 40&#8211;50 g/100 g</p><p>Dietary fibre: 24&#8211;32 g/100 g</p><p>Sugars: &lt; 1 g/100 g</p><p>Fat: 6&#8211;12 g/100 g</p><p>Total ash: &#8804; 15 %</p><p>Water: &#8804; 5 %</p><p>Dry matter: &#8805; 95 %</p><p><span>Heavy metals:</span></p><p>Lead: &#8804; 3,0 mg/kg</p><p>Cadmium: &#8804; 1,0 mg/kg</p><p>Mercury: &#8804; 0,1 mg/kg</p><p><span>Microbiological criteria:</span></p><p>Total aerobic microbial count: &#8804; 5 &#215; 10<span>3</span> CFU/g</p><p>Total yeast and mould count: &#8804; 10<span>2</span> CFU/g</p><p>Viable<span>Yarrowia lipolytica</span> cells&#160;<a>(<span>13</span>)</a>: &lt; 10 CFU/g (i.e. limit of detection)</p><p>Coliforms: &#8804; 10 CFU/g</p><p><span>Salmonella</span> spp.: Absence in 25 g</p><p>CFU: colony forming units</p></td></tr><tr><td><p><a>&#9660;M61</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>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><p>CFU: Colony Forming Units; EU: Endotoxin Units.</p></td></tr><tr><td><p><a>&#9660;M105</a></p></td></tr><tr><td><p><span>3&#8242;-Sialyllactose (&#8216;3&#8242;-SL&#8217;) sodium salt</span></p><p><span>(produced by derivative strains of<span>E. coli</span> BL21(DE3))</span></p></td><td><p><span>Description:</span></p><p>3'-Sialyllactose (3&#8242;-SL) sodium salt is a purified, white to off-white powder or agglomerate produced by a microbial process and contains limited levels of lactose, 3'-sialyl-lactulose, and sialic acid.</p><p><span>Definition:</span></p><p>Chemical name: N-Acetyl-&#945;-D-neuraminyl-(2&#8594;3)-&#946;-D-galactopyranosyl-(1&#8594;4)-D-glucose, sodium salt</p><p>Chemical formula: C<span>23</span>H<span>38</span>NO<span>19</span>Na</p><p>Molecular mass: 655,53 Da</p><p>CAS No: 128596-80-5</p><p><span>Source:</span> Two genetically modified strains (a production strain and an optional degradation strain) of<span>Escherichia coli</span> BL21(DE3)</p><p><span>Characteristics/Composition:</span></p><div><p>3&#8242;-Sialyllactose sodium salt (% of dry matter): &#8805;&#160;88,0&#160;% (w/w)</p></div><div><p>3&#8242;-Sialyl-lactulose (% of dry matter): &#8804;&#160;5,0&#160;% (w/w)</p></div><div><p>D-Lactose (% of dry matter): &#8804;&#160;5,0&#160;% (w/w)</p></div><div><p>Sialic acid (% of dry matter): &#8804;&#160;1,5&#160;% (w/w)</p></div><div><p>N-acetyl-D-glucosamine (% of dry matter): &#8804;&#160;1,0&#160;% (w/w)</p></div><div><p>Sum of other carbohydrates (% of dry matter)<span>a</span>: &#8804;&#160;5,0&#160;% (w/w)</p></div><div><p>Moisture: &#8804;&#160;9,0&#160;% (w/w)</p></div><div><p>Ash: &#8804;&#160;8,5&#160;% (w/w)</p></div><div><p>Residual protein: &#8804;&#160;0,01&#160;% (w/w)</p></div><div><p>Sodium: &#8804;&#160;4,2&#160;% (w/w)</p></div><p><span>Microbiological criteria:</span></p><p>Standard plate count: &#8804;&#160;1&#160;000  *CFU/g</p><p>Enterobacteriaceae: &#8804;&#160;10 CFU/g</p><p><span>Salmonella</span> spp.: Absence in&#160;25 g</p><p>Yeast and mould: &#8804;&#160;100 CFU/g</p><p><span>Cronobacter</span> (<span>Enterobacter</span>)<span>sakazakii</span>: Absence in&#160;10 g</p><p>Residual endotoxins: &#8804;&#160;10 **EU/mg</p><p><span>a</span>&#160;&#160;Sum of other carbohydrates&#160;= 100 (% (w/w) of dry matter) &#8211; 3'-Sialyllactose sodium salt (% (w/w) of dry matter) &#8211; quantified carbohydrates (% (w/w) of dry matter) &#8211; Ash (% (w/w) of dry matter);</p><p>*&#160;&#160;CFU: Colony Forming Units;</p><p>**&#160;&#160;EU: Endotoxin Units</p></td></tr><tr><td><p><a>&#9660;M60</a></p></td></tr><tr><td><p><span>6&#8217;-Sialyllactose (&#8216;6&#8217;-SL&#8217;) sodium salt</span></p><p><span>(microbial source)</span></p></td><td><p><span>Description:</span></p><p>6&#8217;-Sialyllactose (6&#8217;-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, 6&#8217;-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: N-Acetyl-&#945;-D-neuraminyl-(2&#8594;6)-&#946;-D-galactopyranosyl-(1&#8594;4)-D-glucose, sodium salt</p><p>Molecular mass: 655,53 Da</p><p>CAS No 157574-76-0</p><p><span>Characteristics/Composition:</span></p><p>Appearance: White to off-white powder or agglomerate</p><p>Sum of 6&#8217;-Sialyllactose sodium salt, D-Lactose and Sialic acid (% of dry matter): &#8805; 94,0 % (w/w)</p><p>6&#8217;-Sialyllactose sodium salt (% of dry matter): &#8805; 90,0 % (w/w)</p><p>D-Lactose: &#8804; 5,0 % (w/w)</p><p>Sialic acid: &#8804; 2,0 % (w/w)</p><p>6&#8217;-Sialyl-lactulose: &#8804; 3,0 % (w/w)</p><p>Sum of other carbohydrates: &#8804; 3,0 % (w/w)</p><p>Moisture: &#8804; 6,0 % (w/w)</p><p>Sodium: 2,5-4,5 % (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; 1&#160;000  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><p>CFU: Colony Forming Units; EU: Endotoxin Units.</p></td></tr><tr><td><p><a>&#9660;M115</a></p></td></tr><tr><td><p>6&#8217;<span>-Sialyllactose (&#8216;6&#8217;-SL&#8217;) sodium salt</span></p><p><span>(produced by derivative strains of<span>E. coli</span> BL21(DE3))</span></p></td><td><p><span>Description:</span></p><p>6'-Sialyllactose (6&#8242;-SL) sodium salt is a purified, white to off-white powder or agglomerate produced by a microbial process and contains limited levels of lactose, 6'-sialyl-lactulose, and sialic acid.</p><p><span>Definition:</span></p><div><p>Chemical name: N-Acetyl-&#945;-D-neuraminyl-(2&#8594;6)-&#946;-D-galactopyranosyl-(1&#8594;4)-D-glucose, sodium salt</p></div><div><p>Chemical formula: C<span>23</span>H<span>38</span>NO<span>19</span>Na</p></div><div><p>Molecular mass: 655,53 Da</p></div><div><p>CAS No: 157574-76-0</p></div><p><span>Source:</span> Two genetically modified strains (a production strain and an optional degradation strain) of<span>Escherichia coli</span> BL21(DE3)</p><p><span>Characteristics/Composition:</span></p><div><p>6&#8242;-Sialyllactose sodium salt (% of dry matter): &#8805;&#160;90,0&#160;% (w/w)</p></div><div><p>6&#8242;-Sialyl-lactulose (% of dry matter): &#8804;&#160;3,0&#160;% (w/w)</p></div><div><p>D-Lactose (% of dry matter): &#8804;&#160;5,0&#160;% (w/w)</p></div><div><p>Sialic acid (% of dry matter): &#8804;&#160;2,0&#160;% (w/w)</p></div><div><p>N-acetyl-D-glucosamine (% of dry matter): &#8804;&#160;3,0&#160;% (w/w)</p></div><div><p>Sum of other carbohydrates (% of dry matter)&#160;<a>(<span>28</span>)</a>: &#8804;&#160;5,0&#160;% (w/w)</p></div><div><p>Moisture: &#8804;&#160;9,0&#160;% (w/w)</p></div><div><p>Ash: &#8804;&#160;8,5&#160;% (w/w)</p></div><div><p>Residual protein: &#8804;&#160;0,01&#160;% (w/w)</p></div><div><p>Sodium: &#8804;&#160;4,2&#160;% (w/w)</p></div><p><span>Contaminants:</span></p><div><p>Arsenic: &#8804;&#160;0,2&#160;(mg/kg)</p></div><div><p>Aflatoxin M1: &#8804;&#160;0,025&#160;(&#956;g/kg)</p></div><p><span>Microbiological criteria:</span></p><div><p>Standard plate count: &#8804;&#160;1&#160;000  CFU/g</p></div><div><p>Enterobacteriaceae: &#8804;&#160;10&#160;CFU/g</p></div><div><p><span>Salmonella</span> spp.: Absence in&#160;25 g</p></div><div><p>Yeast and mould: &#8804;&#160;100&#160;CFU/g</p></div><div><p><span>Cronobacter spp.</span>: Absence in&#160;10 g</p></div><div><p>Residual endotoxins: &#8804;&#160;10&#160;EU/mg</p></div></td></tr><tr><td><p><a>&#9660;M43</a></p></td></tr><tr><td><p><span>Spermidine-rich wheat germ extract (<span>Triticum aestivum</span>)</span></p></td><td><p><span>Description/Definition:</span></p><p>Spermidine-rich wheat germ extract is obtained from non-fermented, non-sprouting wheat germs (<span>Triticum aestivum</span>) by the process of solid-liquid extraction targeting specifically, but not exclusively polyamines.</p><p>Spermidine:(N-(3-aminopropyl)butane-1,4-diamine):0,8-2,4 mg/g</p><p>Spermine: 0,4-1,2 mg/g</p><p>Spermidine trichloride &lt; 0,1 &#956;g/g</p><p>Putrescine: &lt; 0,3 mg/g</p><p>Cadaverine: &#8804; 16,0 &#956;g/g</p><p><span>Mycotoxins:</span></p><p>Aflatoxins (total): &lt; 0,4 &#956;g/kg</p><p><span>Microbiological criteria:</span></p><p>Total aerobic bacteria: &lt; 10&#160;000  CFU/g</p><p>Yeast and moulds: &lt; 100 CFU/g</p><p><span>Escherichia coli:</span> &lt; 10 CFU/g</p><p><span>Salmonella:</span> Absence/25g</p><p><span>Listeria monocytogenes:</span> Absence/25g</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Sucromalt</span></p></td><td><p><span>Description/Definition:</span></p><p>Sucromalt is a complex mixture of saccharides which is produced from sucrose and a starch hydrolysate by means of an enzymatic reaction. In this process, glucose units are attached to saccharides from the starch hydrolysate by means of an enzyme produced by the bacterium<span>Leuconostoc citreum</span> or by means of a recombinant strain of the production organism<span>Bacillus licheniformis</span>. The resulting oligosaccharides are characterised by the presence of &#945;-(1&#8594;6) and &#945;-(l&#8594;3) glycosidic compounds. The overall product is syrup, in addition to these oligosaccharides, contains mainly fructose but also the disaccharide leucrose and other disaccharides.</p><p>Total solids: 75-80 %</p><p>Moisture: 20-25 %</p><p>Sulphatase: Max 0,05 %</p><p>pH: 3,5-6,0</p><p>Conductivity &lt; 200 (30 %)</p><p>Nitrogen &lt; 10 ppm</p><p>Fructose: 35-45 % d.w.</p><p>Leucrose: 7-15 % d.w.</p><p>Other disaccharides: M&#1072;&#1093; 3 %</p><p>Higher saccharides: 40-60 % d.w</p></td></tr><tr><td><p><span>Sugar cane fibre</span></p></td><td><p><span>Description/Definition:</span></p><p>Sugar Cane Fibre is derived from the dry cell wall or fibrous residue remaining after expression or extraction of sugar juice from sugar cane, of the Saccharum genotype. It consists primarily of cellulose and hemicellulose.</p><p>The production process consists of several steps, including: chipping, alkaline digestion, removal of lignins and other non-cellulosic components, bleaching of purified fibres, acid washing and neutralization.Moisture: &#8804; 7,0 %</p><p>Ash: &#8804; 0,3 %</p><p>Total Dietary Fibre (AOAC) dry basis (all insoluble): &#8805; 95 %</p><p>of which: Hemicellulose (20-25 %) and cellulose (70-75 %)</p><p>Silica (ppm): &#8804; 200</p><p>Protein: 0,0 %</p><p>Fat: Trace</p><p>pH: 4-7</p><p><span>Heavy metals:</span></p><p>Mercury (ppm): &#8804; 0,1</p><p>Lead (ppm): &#8804; 1,0</p><p>Arsenic (ppm): &#8804; 1,0</p><p>Cadmium (ppm): &#8804; 0,1</p><p><span>Microbiological criteria:</span></p><p>Yeast and moulds (CFU/g): &#8804; 1&#160;000</p><p><span>Salmonella</span>: Absence</p><p><span>Listeria monocytogenes</span>: Absence</p></td></tr><tr><td><p><a>&#9660;M53</a></p></td></tr><tr><td><p><span>Sugars obtained from cocoa (<span>Theobroma cacao</span> L.) pulp</span></p></td><td><p><span>Description/Definition:</span></p><p>Sugars are obtained from the concentrated cocoa pulp (<span>Theobroma cacao</span> L.) juice either via a drying process or via a purification process to produce high purity glucose or fructose.</p><p><span>Sugars produced by a drying process</span></p><p>Nutritional composition:</p><p>Total sugars (g/100g): &gt; 80</p><p>Moisture (%): &lt; 5</p><p>Microbiological criteria:</p><p>Total Plate Count (aerobic) (cfu/g): &lt; 10<span>4</span></p><p>Moulds and Yeasts (cfu/g): &lt; 50</p><p>Enterobacteriaceae (cfu/g): &lt; 10</p><p><span>Salmonella</span> spp.: Absence in 25 g</p><p><span>Alicyclobacillus:</span> Absence in 50 g</p><p>Thermo-acidophilic bacteria: Absence in 50 g</p><p><span>Sugars produced by a purification process</span></p><p>Nutritional composition of Glucose obtained from cocoa (<span>Theobroma cacao</span> L.) pulp:</p><p>Glucose content (%): &gt; 93</p><p>Ash (%): &lt; 0,2</p><p>Moisture (%): &lt; 1,0</p><p>Nutritional composition of Fructose obtained from cocoa (<span>Theobroma cacao</span> L.) pulp:</p><p>Fructose content (%): &gt; 98</p><p>Glucose content (%): &lt; 0,5 %</p><p>Ash (%): &lt; 0,2</p><p>Moisture (%):&lt; 0,5</p><p>Microbiological criteria for glucose and fructose obtained from cocoa (<span>Theobroma cacao</span> L.) pulp:</p><p>Total Plate Count (aerobic) (cfu/g): &lt; 10<span>4</span></p><p><span>Salmonella</span> spp.: Absence in 25 g</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Sunflower oil extract</span></p></td><td><p><span>Description/Definition:</span></p><p>The sunflower extract is obtained by a concentration factor of 10 of the unsaponifiable fraction of refined sunflower oil extracted from the seeds of the sunflower,<span>Helianthus Annuus</span> L.</p><p><span>Composition:</span></p><p>Oleic acid (C18:1): 20 %</p><p>Linoleic acid (C18:2): 70 %</p><p>Unsaponifiable matter: 8,0 %</p><p>Phytosterols: 5,5 %</p><p>Tocopherols: 1,1 %</p></td></tr><tr><td><p><a>&#9660;M73</a></p></td></tr><tr><td><p><span><span>Synsepalum dulcificum</span> dried fruits</span></p></td><td><p><span>Description/Definition:</span></p><p>The novel food is lyophilised pulp and skin of pitted fruits of<span>Synsepalum dulcificum</span> (Schumach. &amp; Thonn.) Daniell that belongs to the Sapotaceae family. The resulting dried cake is milled into a powder.</p><p><span>Characteristics/Composition:</span></p><p>Moisture (g/100 g): &lt;&#160;6</p><p>Ash (g/100 g): 3,5-8,5</p><p>Total carbohydrates (g/100 g): 70-87</p><p>Sugars (g/100 g): 50-75</p><p>Fibre (g/100 g): 1-6,5</p><p>Total protein (g/100 g): 3,5-6,0</p><p>Miraculin&#160;<a>(<span>16</span>)</a>(g/100 g): 1,5-2,5</p><p>Total fat (g/100 g): 0,50-3,50</p><p><span>Microbiological criteria:</span></p><p>Total aerobic colony count: &lt;&#160;10<span>4</span> CFU&#160;<a>(<span>7</span>)</a>/g</p><p><span>Bacillus cereus</span> (presumptive): &lt;&#160;100 CFU/g</p><p>Sulfite-reducing<span>Clostridia</span>: &#8804;&#160;30 CFU/g</p><p>Total Enterobacteriaceae: &lt;&#160;100 CFU/g</p><p>Yeasts and moulds: &lt;&#160;500 CFU/g</p><p><span>Pesticides:</span></p><p>Pesticide levels in accordance with Code number 0820990 (&#8216;others&#8217; in the group of fruit spices) set out in Regulation (EC) No&#160;396/2005&#160;<a>(<span>17</span>)</a></p></td></tr><tr><td><p><a>&#9660;M66</a></p></td></tr><tr><td><p><span>Dried<span>Tenebrio molito</span>r larva (yellow mealworm)</span></p></td><td><p><span>Description/Definition:</span></p><p>The novel food is the whole, thermally dried yellow mealworm, either whole (blanched, oven-dried larva) or in the form of a powder (blanched, oven-dried, ground larva). The term &#8216;mealworm&#8217; refers to the larval form of<span>Tenebrio molitor</span>, an insect species that belongs to the family of<span>Tenebrionidae</span> (darkling beetles).</p><p>The entire mealworms are meant for human consumption and no parts are removed.</p><p>A minimum 24 hours fasting period is required before the thermal drying step, to allow the larvae to discard their bowel content.</p><p><span>Characteristics/Composition:</span></p><div><p>Ash (% w/w): 3,5 &#8211; 4,5</p></div><div><p>Moisture (% w/w): 1-8</p></div><div><p>Crude protein (N x 6,25) (% w/w): 56&#8211;61</p></div><div><p>Digestible Carbohydrates&#160;<a>(<span>15</span>)</a> (% w/w): 1&#8211;6</p></div><div><p>Fat (% w/w): 25&#8211;30</p></div><div><p>of which saturated (% w/w): 4&#8211;9</p></div><div><p>Peroxide value (Meq O<span>2</span>/kg fat): &#8804;&#160;5</p></div><div><p>Dietary fibre (% w/w): 4&#8211;7</p></div><div><p>Chitin (% w/w): 4&#8211;7</p></div><p><span>Heavy metals:</span></p><div><p>Lead: &#8804;&#160;0,075&#160;mg/kg</p></div><div><p>Cadmium: &#8804;&#160;0,1&#160;mg/kg</p></div><p><span>Mycotoxins:</span></p><div><p>Aflatoxins (Sum of B1, B2, G1, G2): &#8804;&#160;4 &#956;g/kg</p></div><div><p>Aflatoxin B1: &#8804;&#160;2 &#956;g/kg</p></div><div><p>Deoxynivalenol: &#8804;&#160;200 &#956;g/kg</p></div><div><p>Ochratoxin A: &#8804;&#160;1 &#956;g/kg</p></div><p><span>Microbiological criteria:</span></p><div><p>Total aerobic colony count: &#8804;&#160;10<span>5</span> CFU&#160;<a>(<span>7</span>)</a>/g</p></div><div><p>Yeasts and moulds: &#8804;&#160;100 CFU/g</p></div><div><p><span>Escherichia coli</span>: &#8804;&#160;50 CFU/g</p></div><div><p><span>Salmonella</span> spp.: Not detected in&#160;25 g</p></div><div><p><span>Listeria monocytogenes</span>: Not detected in&#160;25 g</p></div><div><p>Sulfite-reducing Anaerobes: &#8804;&#160;30 CFU/g</p></div><div><p><span>Bacillus cereus</span> (presumptive): &#8804;&#160;100 CFU/g</p></div><div><p>Enterobacteriaceae (presumptive): &lt;&#160;10 CFU/g</p></div><div><p>Coagulase-positive<span>staphylococci</span>: &#8804;&#160;100 CFU/g</p></div></td></tr><tr><td><p><a>&#9660;M81</a></p></td></tr><tr><td><p><span>Frozen, dried and powder forms of yellow mealworm (<span>Tenebrio molitor</span> larva)</span></p></td><td><p><span>Description/Definition:</span></p><p>The novel food are frozen, dried and powder forms of yellow mealworm (<span>Tenebrio molitor</span> larva). The term &#8216;mealworm&#8217; refers to the larval form of<span>Tenebrio molitor</span>, an insect species that belongs to the family of Tenebrionidae (darkling beetles). Another identified scientific synonym is<span>Tenebrio molitor</span> Linnaeus.</p><p>The entire mealworms are meant for human consumption, no parts are removed.</p><p>A minimum 24 hours fasting period is required before killing the insects by freezing, to allow the larvae to discard their bowel content.</p><p>The novel food is intended to be placed on the market in three different forms, namely: whole, blanched and frozen<span>T. molitor</span> larva (frozen); whole, blanched and freeze-dried<span>T. molitor</span> larva (dried) which may be in powder form (powder).</p></td></tr><tr><td><p>Parameters</p></td><td><p>Frozen</p></td><td><p>Dried or powder</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Characteristics/Composition</span></p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Ash</p></td><td><p>0,9-1,10</p></td><td><p>3,6-4,1</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Moisture (% w/w)</p></td><td><p>69-75</p></td><td><p>&#8804;&#160;5</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Crude protein (N x 6,25) (% w/w)</p></td><td><p>14-19</p></td><td><p>54-60</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Fat (% w/w)</p><div><p>&#8212;&#160;of which saturated fatty acids (% fat)</p></div></td><td><p>7-12,5</p><p>20-29</p></td><td><p>27-30</p><p>20-29</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Digestible carbohydrates (% w/w)</p></td><td><p>1-2</p></td><td><p>4-8</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Dietary fibre (% w/w)</p></td><td><p>1,2-3,5</p></td><td><p>4-6</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Chitin(*) (% w/w)</p></td><td><p>&#8804;&#160;3</p></td><td><p>4-9</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Peroxide value (Meq O<span>2</span>/kg fat)</p></td><td><p>&#8804;&#160;5</p></td><td><p>&#8804;&#160;5</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Contaminants</span></p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Heavy metals</span></p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Lead (mg/kg)</p></td><td><p>&#8804;&#160;0,01</p></td><td><p>&#8804;&#160;0,075</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Cadmium (mg/kg)</p></td><td><p>&#8804;&#160;0,05</p></td><td><p>&#8804;&#160;0,1</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Mycotoxins</span></p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Aflatoxins (Sum of B1, B2, G1, G2) (&#956;g/kg)</p></td><td><p>&#8804;&#160;4</p></td><td><p>&#8804;&#160;4</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Aflatoxin B1 (&#956;g/kg)</p></td><td><p>&#8804;&#160;2</p></td><td><p>&#8804;&#160;2</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Deoxynivalenol (&#956;g/kg)</p></td><td><p>&#8804;&#160;200</p></td><td><p>&#8804;&#160;200</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Ochratoxin A (&#956;g/kg)</p></td><td><p>&#8804;&#160;1</p></td><td><p>&#8804;&#160;1</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Dioxins and PCBs</span></p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Sum of dioxins and dl-PCBs (UB, WHO-TEQ2005)(**) (pg/g fat)</p></td><td><p>&#8804;&#160;0,75</p></td><td><p>&#8804;&#160;0,75</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Microbiological criteria</span></p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Total aerobic colony count (CFU/g)</p></td><td><p>&#8804;&#160;10<span>5</span></p></td><td><p>&#8804;&#160;10<span>5</span></p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Enterobacteriaceae (presumptive) (CFU/g)</p></td><td><p>&#8804;&#160;100</p></td><td><p>&#8804;&#160;100</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Escherichia coli</span> (CFU/g)</p></td><td><p>&#8804;&#160;50</p></td><td><p>&#8804;&#160;50</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Listeria monocytogenes</span></p></td><td><p>Absence in&#160;25g</p></td><td><p>Absence in&#160;25g</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Salmonella</span> spp.</p></td><td><p>Absence in&#160;25g</p></td><td><p>Absence in&#160;25g</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><span>Bacillus cereus</span> (presumptive) (CFU/g)</p></td><td><p>&#8804;&#160;100</p></td><td><p>&#8804;&#160;100</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Coagulase positive Staphylococci (CFU/g</p></td><td><p>&#8804;&#160;100</p></td><td><p>&#8804;&#160;100</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Sulfite-reducing Anaerobes (CFU/g)</p></td><td><p>&#8804;&#160;30</p></td><td><p>&#8804;&#160;30</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Yeasts and moulds (CFU/g)</p></td><td><p>&#8804;&#160;100</p></td><td><p>&#8804;&#160;100</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>(*)&#160;&#160;Chitin calculated as the difference between the Acid Detergent Fibre fraction and the Acid Detergent Lignin fraction (ADF-ADL), as described by Hahn et al. (2018).</p><p>(**)&#160;&#160;Upper bound sum of polychlorinated dibenzo-para-dioxins (PCDDs)-polychlorinated dibenzofurans (PCDFs) and dioxin-like polychlorinated biphenyls (PCBs) expressed as World Health Organization toxic equivalent (using WHO-TEFs of 2005)).</p><p>CFU: colony forming units.</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p><a>&#9660;M89</a></p></td></tr><tr><td><p><span>Tetrahydrocurcuminoids</span></p></td><td><p><span>Description:</span></p><p>The tetrahydrocurcuminoids are produced via a series of steps involving the extraction of curcuminoids from the dried, pulverised rhizomes of turmeric (<span>Curcuma longa</span> L.), hydrogenation (using palladium on carbon (Pd/C) as a catalyst), concentration, crystallisation, drying, and milling into a powder.</p><p><span>Characteristics/Composition:</span></p><p>Total tetrahydrocurcuminoids (dry basis) (% w/w): &gt;&#160;95,0</p><p>Moisture (% w/w): &#8804;&#160;1,0</p><p>Ash (% w/w): &#8804;&#160;1,0</p><p>Palladium (mg/kg): &lt;&#160;5,0</p><p><span>Microbiological criteria:</span></p><p>Total aerobic microbial count: &#8804;&#160;5&#160;000  CFU/g</p><p>Total yeast/moulds count: &#8804;&#160;100 CFU/g</p><p><span>Escherichia coli</span>: &lt;&#160;10 CFU/g</p><p><span>Staphylococcus aureus</span>: &#8804;&#160;10 CFU/g</p><p>Enterobacteriaceae: &#8804;&#160;10 CFU/g</p><p><span>Salmonella</span> spp.: Absence in&#160;25 g</p><p>Coliforms: &#8804;&#160;10 CFU/g</p><p>CFU: Colony Forming Units</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Dried<span>Tetraselmis chuii</span> microalgae</span></p></td><td><p><span>Description/Definition:</span></p><p>The dried product is obtained from the marine microalgae<span>Tetraselmis chuii</span>, belonging to the<span>Chlorodendraceae</span> family, cultivated in sterile sea water in closed photobioreactors insulated from the outside air.<span>Purity/Composition:</span></p><p>Identified by means of nuclear marker rDNA 18 S (sequence analysed no less than 1&#160;600  base pairs) in the National Centre for Biotechnology information (NCBI) database: Not less than 99,9 %</p><p>Humidity: &#8804; 7,0 %</p><p>Proteins: 35-40 %</p><p>Ashes: 14-16 %</p><p>Carbohydrates: 30-32 %</p><p>Fibre: 2-3 %</p><p>Fat: 5-8 %</p><p>Saturated fatty acids: 29-31 % of total fatty acids</p><p>Monounsaturated fatty acids: 21-24 % of total fatty acids</p><p>Polyunsaturated fatty acids: 44-49 % of total fatty acids</p><p>Iodine: &#8804; 15 mg/kg</p></td></tr><tr><td><p><span><span>Therapon barcoo</span>/Scortum</span></p></td><td><p><span>Description/Definition:</span></p><p>Scortum/<span>Therapon barcoo</span> is a species of fish in the family Terapontidae. It is an endemic fresh water species from Australia. It is now reared in fish farms.</p><p>Taxonomic Identification: Class: Actinopterygii &gt; order: Perciformes &gt; family: Terapontidae &gt; genus:<span>Therapon</span> or<span>Scortum barcoo</span></p><p>Composition of fish flesh:</p><p>Protein (%): 18-25</p><p>Moisture (%): 65-75</p><p>Ash (%): 0,5-2,0</p><p>Energy (KJ/Kg): 6000-11500</p><p>Carbohydrates (%): 0,0</p><p>Fat (%): 5-15</p><p>Fatty acids (mg FA/g fillet):</p><p>&#931; PUFA n-3: 1,2-20,0</p><p>&#931; PUFA n-6: 0,3-2,0</p><p>PUFA n-3/n-6: 1,5-15,0</p><p>Total omega 3 acids: 1,6-40,0</p><p>Total omega 6 acids: 2,6-10,0</p></td></tr><tr><td><p><span>D-Tagatose</span></p></td><td><p><span>Description/Definition:</span></p><p>Tagatose is produced by isomerization of galactose by means of chemical or enzymatic conversion, or by epimerization of fructose by means of enzymatic conversion. These are single-step conversions.</p><p>Appearance: White or almost white crystals</p><p>Chemical name: D-tagatose</p><p>Synonym: D-<span>lyxo</span>-Hexulose</p><p>CAS number: 87-81-0</p><p>Chemical formula: C<span>6</span>H<span>12</span>O<span>6</span></p><p>Formula weight: 180,16 (g/mol)</p><p><span>Purity:</span></p><p>Assay: &#8805; 98 % on a dry weight basis</p><p>Loss on drying: &#8804; 0,5 % (102 &#176;C, 2 hours)</p><p>Specific Rotation: [&#945;]<span>D</span><span>20</span>: &#8211; 4 to &#8211; 5,6<span>o</span> (1 % aqueous solution)(<span>1</span>)</p><p>Melting range: 133&#8211; 137 &#176;C</p><p><span>Heavy metals:</span></p><p>Lead: &#8804; 1,0 mg/kg(*)</p><p>(*)&#160;&#160;Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the method described in FNP 5. &#8216;Instrumental methods&#8217;(<span>1</span>).</p><p>(<span>1</span>)&#160;&#160;Food and nutrition paper 5 Rev 2 &#8211; Guide to specifications for general notices, general analytical techniques, identification tests, test solutions and other reference materials (JECFA) 1991, 307 p.; English &#8211; ISBN 92-5-102991-1</p></td></tr><tr><td><p><span><a><span>&#9658;M52</span></a></span>&#160;<span>Taxifolin-rich extract</span><span>&#160;&#9668;</span></p></td><td><p><span>Description:</span></p><p>Taxifolin-rich extract from the wood of Dahurian Larch (<span>Larix gmelinii</span> (Rupr.) Rupr) is a white to pale-yellow powder that crystallizes from hot aqueous solutions.</p><p><span><a><span>&#9658;M52</span></a></span>&#160;<span>Definition:</span></p><p>Chemical name: [(2R,3R)-2-(3,4 dihydroxyphenyl)-3,5,7-trihydroxy-2,3-dihydrochromen-4-one, also called (+) trans (2R,3R)- dihydroquercetin] and with no more than 2 % of the cis-form<span>&#160;&#9668;</span></p><p><span>Specifications:</span></p><p><span>Physical parameter</span></p><p>Moisture: &#8804; 10 %<span>Compound analysis</span></p><p>Taxifolin (m/m): &#8805; 90,0 % of the dry weight</p><p><span><span>Heavy Metals, Pesticide</span></span></p><p>Lead: &#8804; 0,5 mg/kg</p><p>Arsenic: &#8804; 0,02 mg/kg</p><p>Cadmium: &#8804; 0,5 mg/kg</p><p>Mercury: &#8804; 0,1 mg/kg</p><p>Dichlorodiphenyltrichloroethane (DDT): &#8804; 0,05 mg/kg</p><p><span><span>Residual solvents</span></span></p><p>Ethanol: &lt; 5&#160;000  mg/kg</p><p><span><span>Microbiological criteria</span></span></p><p>Total Plate Count (TPC): &#8804; 10<span>4</span> CFU/g</p><p>Enterobacteria: &#8804; 100/g</p><p>Yeast and Mould: &#8804; 100 CFU/g</p><p><span>Escherichia coli</span>: Absence/1 g</p><p><span>Salmonella</span>: Absence/10 g</p><p><span>Staphylococcus aureus</span>: Absence/1 g</p><p><span>Pseudomonas</span>: Absence/1g</p><p><span>Usual range of components of the Taxifolin-rich extract (as per dry substance)</span></p></td></tr><tr><td><p><span>Extract component</span></p></td><td><p><span>Content, usual observed range (%)</span></p></td></tr><tr><td><p>Taxifolin</p></td><td><p>90 &#8211; 93</p></td></tr><tr><td><p>Aromadendrin</p></td><td><p>2,5 &#8211; 3,5</p></td></tr><tr><td><p>Eriodictyol</p></td><td><p>0,1 &#8211; 0,3</p></td></tr><tr><td><p>Quercetin</p></td><td><p>0,3 &#8211; 0,5</p></td></tr><tr><td><p>Naringenin</p></td><td><p>0,2 &#8211; 0,3</p></td></tr><tr><td><p>Kaempferol</p></td><td><p>0,01 &#8211; 0,1</p></td></tr><tr><td><p>Pinocembrin</p></td><td><p>0,05 &#8211; 0,12</p></td></tr><tr><td><p>Unidentified flavonoids</p></td><td><p>1 &#8211; 3</p></td></tr><tr><td><p>Water(*)</p></td><td><p>1,5</p></td></tr><tr><td><p>(*)&#160;&#160;Taxifolin in its hydrated form and during the drying process is a crystal. This results on the inclusion of water of crystallisation in a quantity of 1,5 %.</p></td></tr><tr><td><p><span>Trehalose</span></p></td><td><p><span>Description/Definition:</span></p><p>A non-reducing disaccharide that consists of two glucose moieties linkes by an &#945;-1,1-glucosidic bond. It is obtained from liquefied starch or from sucrose by a multistep enzymatic process. The commercial product is the dihydrate. Virtually odourless, white or almost white crystals with a sweet taste</p><p>Synonyms: &#945;,&#945;-trehalose</p><p>Chemical name: &#945;-D-glucopyranosyl-&#945;-D-glucopyranoside, dihydrate</p><p>CAS No.: 6138-23-4 (dihydrate)</p><p>Chemical formula: C<span>12</span>H<span>22</span>O<span>11</span> &#903; 2H<span>2</span>O (dihydrate)</p><p>Formula weight: 378,33 (dihydrate)</p><p>Assay: &#8805; 98 % on the dry basis</p><p>Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the method described in FNP 5 (1), &#8216;Instrumental methods&#8217;</p><p><span>Method of assay:</span></p><p>Principle: trehalose is identified by liquid chromatography and quantified by comparison to a reference standard containing standard trehalose</p><p>Preparation of sample solution: weigh accurately about 3 g of dry sample into a 100 ml volumetric flask and add about 80 ml of purified, deionised water. Bring sample to complete dissolution and dilute to mark with purified deionised water. Filter through a 0,45 micron filter</p><p>Preparation of standard solution: dissolve accurately weighed quantities of dry standard reference trehalose in water to obtain a solution having known concentration of about 30 mg of trehalose per ml.</p><p>Apparatus: liquid chromatography equipped with a refractive index detector and integrating recorder</p><p>Conditions:</p><p>Column: Shodex Ionpack KS-801 (Showa Denko Co.) or equivalent</p><div><p>&#8212;&#160;length: 300 mm</p></div><div><p>&#8212;&#160;diameter: 10 mm</p></div><div><p>&#8212;&#160;temperature: 50 &#176;C</p></div><p>Mobile phase: water</p><p>flow rate: 0,4 ml/min</p><p>Injection volume: 8 &#956;l</p><p>Procedure: inject separately equal volumes of the sample solution and the standard solution into the chromatograph.</p><p>Record the chromatograms and measure the size of response of the trehalose peak</p><p>Calculate the quantity, in mg, of trehalose in 1 ml of the sample solution by the following formula: % trehalose = 100 &#215; (R<span>U</span>/R<span>S</span>) (W<span>S</span>/W<span>U</span>)</p><p>where</p><p>R<span>S</span> = peak area of trehalose in the standard preparation</p><p>R<span>U</span> = peak area of trehalose in the sample preparation</p><p>W<span>S</span> = weight in mg of trehalose in the standard preparation</p><p>W<span>U</span> = weight of dry sample in mg</p><p><span>Characteristics:</span></p><p>Identification:</p><p>Solubility: Freely soluble in water, very slightly soluble in ethanol</p><p>Specific rotation: [&#945;]<span>D</span><span>20</span> = +179<span>o</span> (5 % aqueous solution, dihydrate), +199<span>o</span> (5 % aqueous solution, anhydrous substance)</p><p>Melting point: 97 &#176;C (dihydrate)</p><p><span>Purity:</span></p><p>Loss on drying: &#8804; 1,5 % (60 &#176;C, 5h)</p><p>Total ash: &#8804; 0,05 %</p><p><span>Heavy metals:</span></p><p>Lead: &#8804; 1,0 mg/kg</p></td></tr><tr><td><p><a>&#9660;M52</a></p></td></tr><tr><td><p><span>UV-treated mushrooms<span>(Agaricus bisporus)</span></span></p></td><td><p><span>Description/Definition</span></p><p>Commercially grown<span>Agaricus bisporus</span> to which UV light treatment is applied to harvested mushrooms.</p><p>UV radiation: a process of radiation in ultraviolet light within the wavelength of 200-800 nm.</p><p><span>Vitamin D<span>2</span></span></p><p>Chemical name: (3&#946;,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol</p><p>Synonym: Ergocalciferol</p><p>CAS No: 50-14-6</p><p>Molecular weight: 396,65 g/mol</p><p><span>Contents</span></p><p>Vitamin D<span>2</span> in the final product: 5-20 &#956;g/100 g fresh weight at the expiration of shelf life.</p></td></tr><tr><td><p><a>&#9660;M84</a></p></td></tr><tr><td><p><span>UV-treated baker&#8217;s yeast (<span>Saccharomyces cerevisiae</span>)</span></p></td><td><p><span>Description/Definition</span></p><p>Baker&#8217;s yeast (<span>Saccharomyces cerevisiae</span>) is treated with ultraviolet light to induce the conversion of ergosterol to vitamin D<span>2</span> (ergocalciferol). Vitamin D<span>2</span> content in the yeast concentrate varies between 800&#160;000 &#8211; 3&#160;500&#160;000 IU vitamin D/100 g (200-875 &#956;g/g).</p><p>The yeast shall be inactivated for use in infant formula and follow-on formula, processed cereal-based food and foods for special medical purposes as defined by Regulation (EU) No&#160;609/2013, while for use in other foods the yeast may or may not be inactivated.</p><p>The yeast concentrate is blended with regular baker&#8217;s yeast in order not to exceed the maximum level in the pre-packed fresh or dry yeast for home baking.</p><p>Tan-coloured, free-flowing granules.</p><p><span>Vitamin D<span>2</span></span></p><p>Chemical name: (5Z,7E,22E)-(3S)-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol</p><p>Synonym: Ergocalciferol</p><p>CAS No.: 50-14-6</p><p>Molecular weight: 396,65&#160;g/mol</p><p><span>Microbiological criteria for the yeast concentrate</span></p><p>Coliforms: &#8804;&#160;10<span>3</span>/g</p><p><span>Escherichia coli</span>: &#8804;&#160;10/g</p><p><span>Salmonella</span>: Absence in&#160;25 g</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>UV-treated bread</span></p></td><td><p><span>Description/Definition:</span></p><p>UV-treated bread is yeast leavened bread and rolls (without toppings) to which a treatment with ultraviolet radiation is applied after baking in order to convert ergosterol to vitamin D<span>2</span> (ergocalciferol).</p><p>UV radiation: A process of radiation in ultraviolet light within the wavelength of 240-315 nm for maximum of 5 seconds with energy input of 10-50 mJ/cm<span>2</span>.</p><p><span>Vitamin D<span>2</span>:</span></p><p>Chemical name: (5Z,7E,22E)-3S-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol</p><p>Synonym: Ergocalciferol</p><p>CAS No: 50-14-6</p><p>Molecular weight: 396,65 g/mol</p><p><span>Contents:</span></p><p>Vitamin D<span>2</span> (ergocalciferol) in the final product: 0,75-3 &#956;g/100 g(<span>1</span>)</p><p>Yeast in dough: 1-5 g/100 g (<span>2</span>)</p><p>(<span>1</span>)&#160;&#160;EN 12821, 2009, European Standard.</p><p>(<span>2</span>)&#160;&#160;Recipe calculation.</p></td></tr><tr><td><p><span>UV-treated milk</span></p></td><td><p><span>Description/Definition:</span></p><p>UV-treated milk is cow&#8217;s milk (whole and semi-skimmed) to which a treatment with ultraviolet (UV) radiation via turbulent flow is applied after pasteurisation. The treatment of the pasteurised milk with UV radiation results in an increase in the vitamin D<span>3</span> (cholecalciferol) concentrations by conversion of 7-dehydrocholesterol to vitamin D<span>3</span>.</p><p>UV radiation: A process of radiation in ultraviolet light within the wavelength of 200-310 nm with energy input of 1&#160;045  J/l.</p><p><span>Vitamin D<span>3</span>:</span></p><p>Chemical name: (1S,3Z)-3-[(2E)-2-[(1R,3aS,7aR)-7a-methyl-1-[(2R)-6-methylheptan-2-yl]-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol</p><p>Synonym: Cholecalciferol</p><p>CAS No: 67-97-0</p><p>Molecular weight: 384,6377 g/mol</p><p><span>Contents:</span></p><p>Vitamin D<span>3</span> in the final product:</p><p>Whole milk(<span>1</span>)0,5-3,2 &#956;g/100 g(<span>2</span>)</p><p>Semi-skimmed milk(1): 0,1&#8211;1,5 &#956;g/100 g(<span>2</span>)</p><p>(<span>1</span>)&#160;&#160;As defined by Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, p. 671).</p><p>(<span>2</span>)&#160;&#160;HPLC</p></td></tr><tr><td><p><a>&#9660;M51</a></p></td></tr><tr><td><p><span>Vitamin D<span>2</span> mushroom powder</span></p></td><td><p><span>Description/Definition</span></p><p>Vitamin D<span>2</span> mushroom powder is a granular powder made from homogenised<span>Agaricus bisporus</span> mushrooms that have been exposed to UV light.</p><p>The mushrooms are washed, homogenised and suspended in water to produce a mushroom slurry. The mushroom slurry is passed under a UV lamp. The slurry is then filtered, dried and ground, producing vitamin D<span>2</span> mushroom powder.</p><p>UV radiation: A process of radiation in ultraviolet light within a range of wavelength similar to those UV-treated novel foods authorised under the novel food regulation.</p><p><span>Characteristics/Composition</span></p><p>Vitamin D<span>2</span> content: 1 000&#8211;1 300 &#956;g/g of mushroom powder&#160;<a>(<span>12</span>)</a></p><p>Moisture: &#8804; 10,0 %</p><p>Ash: &#8804; 13,5 %</p><p><span>Heavy Metals</span></p><p>Lead (as Pb): &#8804; 0,5 mg/kg</p><p>Cadmium: &#8804; 0,5 mg/kg</p><p>Mercury: &#8804; 0,1 mg/kg</p><p>Arsenic: &#8804; 0,3 mg/kg</p><p><span>Mycotoxins</span></p><p>Aflatoxins (sum of B1+B2+G1+G2): &lt; 4 &#956;g/kg</p><p><span>Microbiological criteria:</span></p><p>Total plate count: &#8804; 5&#160;000  CFU&#160;<a>(<span>7</span>)</a>/g</p><p>Yeast and mould: &#8804; 100 CFU/g</p><p><span>Salmonella</span> sp.: Absent in 25 g</p><p><span>Staphylococcus aureus</span>: &#8804; 10 CFU/g</p><p><span>Escherichia coli</span>: &#8804; 10 CFU/g</p><p>Coliforms: &#8804; 10 CFU/g</p><p><span>Enterobacteriaceae</span>: &#8804; 10 CFU/g</p><p><span>Listeria monocytogenes</span>: Absent in 25 g</p></td></tr><tr><td><p><a>&#9660;M76</a></p></td></tr><tr><td><p><span>Vitamin D<span>2</span> mushroom powder</span></p></td><td><p><span>Description/Definition:</span></p><p>The novel food is mushroom powder produced from the dried whole<span>Agaricus bisporus</span> mushrooms. The process includes drying, milling and the controlled exposure of the mushroom powder to UV irradiation.</p><p>UV radiation: A process of radiation in ultraviolet light within a range of wavelength similar to those UV-treated novel foods authorised under Regulation (EU) 2015/2283.</p><p><span>Characteristics/composition:</span></p><p>Vitamin D<span>2</span> content: 580-595 &#956;g/g of mushroom powder</p><p>Ash: &#8804; 13,5&#160;%</p><p>Water activity: &lt; 0,5</p><p>Moisture content: &#8804; 7,5&#160;%</p><p>Carbohydrates: &#8804; 35,0&#160;%</p><p>Total Dietary Fibre: &#8805; 15&#160;%</p><p>Crude protein (N &#215; 6,25): &#8805; 22&#160;%</p><p>Fat: &#8804; 4,5&#160;%</p><p><span>Heavy metals:</span></p><p>Lead: &#8804; 0,5 mg/kg</p><p>Cadmium: &#8804; 0,5 mg/kg</p><p>Mercury: &#8804; 0,1 mg/kg</p><p>Arsenic: &#8804; 0,3 mg/kg</p><p><span>Mycotoxins:</span></p><p>Aflatoxin B1: &#8804; 0,10 &#956;g/kg</p><p>Aflatoxins (sum of B1 + B2 + G1 + G2): &lt; 4 &#956;g/kg</p><p><span>Microbiological criteria:</span></p><p>Total plate count: &#8804; 5&#160;000  CFU&#160;<a>(<span>7</span>)</a></p><p>Total yeast and mould count: &lt; 100 CFU/g</p><p><span>E. coli</span>: &lt; 10 CFU/g</p><p><span>Salmonella</span> spp.: Absence in&#160;25 g</p><p><span>Staphylococcus aureus</span>: &#8804; 10 CFU/g</p><p>Coliforms: &#8804; 10 CFU/g</p><p><span>Listeria</span> spp.: Absence in&#160;25 g</p><p>Enterobacteriaceae: &lt; 10 CFU/g</p></td></tr><tr><td><p><a>&#9660;M98</a></p></td></tr><tr><td><p><span>Vitamin D<span>2</span> mushroom powder</span></p></td><td><p><span>Description/Definition:</span></p><p>The novel food is produced by controlled exposure of sliced/diced<span>Agaricus bisporus</span> mushrooms to UV irradiation followed by dehydration and grinding into a powder.</p><p>UV radiation: A process of radiation in ultraviolet light within a range of wavelength similar to those UV-treated novel foods authorised under Regulation (EU) 2015/2283.</p><p><span>Characteristics/composition:</span></p><p>Vitamin D<span>2</span> content: 125&#8211;375 &#956;g/g</p><p>Moisture: &#8804;&#160;7&#160;%</p><p>Ash: &#8804;&#160;13,5&#160;%</p><p>Water activity: &lt;&#160;0,5</p><p>Fat: &#8804;&#160;4,5&#160;%</p><p>Total carbohydrates: &#8804;&#160;60&#160;%</p><p>Protein: &#8804;&#160;40&#160;%</p><p><span>Heavy metals:</span></p><p>Lead: &#8804;&#160;0,5&#160;mg/kg</p><p>Cadmium: &#8804;&#160;0,5&#160;mg/kg</p><p>Mercury: &#8804;&#160;0,1&#160;mg/kg</p><p>Arsenic: &#8804;&#160;0,3&#160;mg/kg</p><p><span>Mycotoxins:</span></p><p>Aflatoxin B1: &#8804;&#160;2 &#956;g/kg</p><p>Aflatoxins (sum of B1&#160;+&#160;B2&#160;+&#160;G1&#160;+&#160;G2): &lt;&#160;4 &#956;g/kg</p><p><span>Microbiological criteria:</span></p><p>Total aerobic microbial count: &#8804;&#160;5&#160;000  CFU/g</p><p>Total yeast and mould count: &lt;&#160;100 CFU/g</p><p>Coliforms: &lt;&#160;100 MPN/g</p><p><span>Salmonella</span> spp.: Absence in&#160;25 g</p><p><span>Staphylococcus aureus</span>: Absence in&#160;10 g</p><p><span>Escherichia coli</span>: Absence in&#160;10 g</p><p><span>Listeria monocytogenes</span>: Absence in&#160;25 g</p><p>CFU: colony forming units. MPN: most probable number.</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Vitamin K<span>2</span> (menaquinone)</span></p></td><td><p>This novel food is produced by a synthetic or microbiological process.</p><p>Vitamin K<span>2</span> (2-methyl-3-all-trans-polyprenyl-1,4-naphthoquinones), or the menaquinone series, is a group of prenylated naphthoquinone derivatives. The number of isoprene residues, where 1 isoprene unit consists of 5 carbons comprising the side chain, is used to characterise the menaquinone homologues containing primarily MK-7 and to a smaller extent MK-6.</p><p>Vitamin K<span>2</span> (menaquinones) series with menaquinone-7 (MK-7)(n = 6) being C<span>46</span>H<span>64</span>O<span>2</span>, menaquinone-6 (MK-6)(n = 5) being C<span>41</span>H<span>56</span>O<span>2</span> and menaquinone-4 (MK-4)(n = 3) being C<span>31</span>H<span>40</span>O<span>2</span>.</p><p>Chemical Name: (all-E)-2-(3,7,11,15,19,23,27-Heptamethyl-2,6,10,14,18,22,26-octacosaheptaenyl)-3-methyl-1,4-naphtalenedione</p><p>CAS Number: 2124-57-4</p><p>Molecular formula: C<span>46</span>H<span>64</span>O<span>2</span></p><p>Molecular weight: 649 g/mol</p><p><img/></p><p><span><span>Specification of synthetic Vitamin K<span>2</span> (menaquinone-7)</span></span></p><p>Appearance: Yellow powder</p><p>Purity: Max 6,0 % cis-isomer, max 2,0 % other impurities</p><p>Content: 97-102 % Menaquinone-7 (including at least 92 % all-trans Menaquinone-7)</p><p><span><span>Specifications of microbiologically produced Vitamin K<span>2</span> (menaquinone-7)</span></span></p><p>Source:<span>Bacillus subtilis</span> spp. natto and<span>Bacillus licheniformis</span></p><p>Appearance: Yellow powder or oil suspension</p></td></tr><tr><td><p><span>Wheat bran extract</span></p></td><td><p><span>Description/Definition:</span></p><p>White crystalline powder obtained by enzymatic extraction from<span>Triticum aestivum</span> L. bran, rich in arabinoxylan oligosaccharides</p><p>Dry matter: Min. 94 %</p><p>Arabinoxylan oligosaccharides: Min 70 % of dry matter</p><p>Average degree of polymerisation of arabinoxylan oligosaccharides: 3-8</p><p>Ferulic acid (bound to arabinoxylan oligosaccharides): 1-3 % of dry matter</p><p>Total poly/oligosaccharides: Min 90 %</p><p>Protein: Max 2 % of dry matter</p><p>Ash: Max 2 % of dry matter</p><p><span>Microbiological parameters:</span></p><p>Mesophilic bacteria &#8211; total count: Max 10 000/g</p><p>Yeasts: Max 100/g</p><p>Fungi: Max 100/g</p><p><span>Salmonella</span>: Absence in 25g</p><p><span>Bacillus cereus</span>: Max 1000/g</p><p><span>Clostridium perfringens</span>: Max 1000/g</p></td></tr><tr><td><p><a>&#9660;M78</a></p></td></tr><tr><td><p><span>Wolffia arrhiza</span> and/or<span>Wolffia globosa</span> fresh plants (Traditional food from a third country)</p></td><td><p><span>Description/Definition:</span></p><p>The traditional food consists of fresh plants of<span>Wolffia arrhiza</span> (L.) Horkel ex Wimm. and/or of<span>Wolffia globosa</span> (Roxb.) Hartog &amp; Plas (family: Araceae).</p><p><span>Microbiological criteria:</span></p><p>Total plate count: &lt;&#160;10<span>3</span> CFU/g</p><p>Total yeast and mould count: &lt;&#160;100 CFU/g</p><p>Total Enterobacteriaceae: &lt;&#160;100 CFU/g</p><p><span>Escherichia coli</span>: &lt;&#160;100 CFU/g</p><p><span>Salmonella</span>: Absence in&#160;25 g</p><p><span>Listeria monocytogenes</span>: Absence in&#160;25 g</p><p><span>Staphylococcus aureus</span>: Absence/10 g</p><p><span>Heavy metals:</span></p><p>Lead: &lt;&#160;0,3&#160;mg/kg</p><p>Arsenic (inorganic): &lt;&#160;0,10&#160;mg/kg</p><p>Cadmium: &lt;&#160;0,2&#160;mg/kg</p><p>Chromium: &lt;&#160;1 mg/kg</p><p>Mercury: &lt;&#160;0,10&#160;mg/kg</p><p><span>Trace elements:</span></p><p>Copper: &lt;&#160;0,8&#160;mg/kg</p><p>Molybdenum: &lt;&#160;0,3&#160;mg/kg</p><p>Zinc: &lt;&#160;5 mg/kg</p><p>Boron: &lt;&#160;5 mg/kg</p><p>Manganese: &lt;&#160;6 mg/kg</p><p><span>Cyanotoxins:</span></p><p>Microcystins: 0,006 &#956;g/g</p><p><span>Pesticides:</span></p><p>Pesticide levels in accordance with Code number 0254000 (&#8216;Subgroup (d) watercresses&#8217; in the group of Leaf vegetables, herbs and edible flowers) set out in Regulation (EC) No&#160;396/2005&#160;<a>(<span>17</span>)</a>.</p></td></tr><tr><td><p><a>&#9660;M20 M36 M62 M104</a></p></td></tr><tr><td><p><span>Xylo-oligosaccharides</span></p></td><td><p><span>Description:</span></p><p>The novel food is a mixture of xylo-oligosaccharides (XOS) which are obtained from corncobs (<span>Zea mays</span> subsp.<span>mays</span>) via hydrolysis by a xylanase from<span>Trichoderma reesei</span> followed by a purification process.</p><p><span>Characteristics/Composition:</span></p></td></tr><tr><td><p><span>Parameter</span></p></td><td><p><span>Powder form 1</span></p></td><td><p><span>Powder form 2</span></p></td><td><p><span>Syrup form</span></p></td></tr><tr><td><p>Moisture (%)</p></td><td><p>&#8804;&#160;5,0</p></td><td><p>&#8804;&#160;5,0</p></td><td><p>-</p></td></tr><tr><td><p>Dry material (%)</p></td><td><p>-</p></td><td><p>-</p></td><td><p>70 -75</p></td></tr><tr><td><p>Protein (g/100 g)</p></td><td><p>&lt;&#160;0,2</p></td></tr><tr><td><p>Ash (%)</p></td><td><p>&#8804;&#160;0,3</p></td></tr><tr><td><p>pH</p></td><td><p>3,5 -5,0</p></td></tr><tr><td><p>Total carbohydrate content (g/100 g)</p></td><td><p>&#8805;&#160;97</p></td><td><p>&#8805;&#160;95</p></td><td><p>&#8805;&#160;70</p></td></tr><tr><td><p>XOS content (dry basis) (g/100 g)</p></td><td><p>&#8805;&#160;95</p></td><td><p>&#8805;&#160;70</p></td><td><p>&#8805;&#160;70</p></td></tr><tr><td><p>Other carbohydrates (g/100 g)<span>a</span></p></td><td><p>2,5 -7,5</p></td><td><p>2 -16</p></td><td><p>1,5 -31,5</p></td></tr><tr><td><p>Monosaccharides total (g/100 g)</p></td><td><p>0 -4,5</p></td><td><p>0 -13</p></td><td><p>0 -29</p></td></tr><tr><td><p>Glucose (g/100 g)</p></td><td><p>0 -2</p></td><td><p>0 -5</p></td><td><p>0 -4</p></td></tr><tr><td><p>Arabinose (g/100 g)</p></td><td><p>0 -1,5</p></td><td><p>0 -3</p></td><td><p>0 -10</p></td></tr><tr><td><p>Xylose (g/100 g)</p></td><td><p>0 -1,0</p></td><td><p>0 -5</p></td><td><p>0 -15</p></td></tr><tr><td><p>Disaccharides total (g/100 g)</p></td><td><p>27,5 -48</p></td><td><p>25 -43</p></td><td><p>26,5 -42,5</p></td></tr><tr><td><p>Xylobiose (XOS DP2) (g/100 g)</p></td><td><p>25 -45</p></td><td><p>23 -40</p></td><td><p>25 -40</p></td></tr><tr><td><p>Cellobiose (g/100 g)</p></td><td><p>2,5 -3</p></td><td><p>2 -3</p></td><td><p>1,5 -2,5</p></td></tr><tr><td><p>Oligosaccharides total (g/100 g)</p></td><td><p>41 -77</p></td><td><p>36 -72</p></td><td><p>32 -71</p></td></tr><tr><td><p>xylotriose (XOS DP3) (g/100 g)</p></td><td><p>27 -35</p></td><td><p>18 -30</p></td><td><p>18 -30</p></td></tr><tr><td><p>xylotetraose (XOS DP4) (g/100 g)</p></td><td><p>10 -20</p></td><td><p>10 -20</p></td><td><p>8 -20</p></td></tr><tr><td><p>xylopentaose (XOS DP5) (g/100 g)</p></td><td><p>3 -10</p></td><td><p>5 -10</p></td><td><p>3 -10</p></td></tr><tr><td><p>xylohexaose (XOS DP6) (g/100 g)</p></td><td><p>1 -5</p></td><td><p>1 -5</p></td><td><p>1 -5</p></td></tr><tr><td><p>Xyloheptaose (XOS DP7) (g/100 g)</p></td><td><p>0 -7</p></td><td><p>2 -7</p></td><td><p>2 -6</p></td></tr><tr><td><p>Maltodextrin (g/100 g)<span>b</span></p></td><td><p>0</p></td><td><p>20 -25</p></td><td><p>0</p></td></tr><tr><td><p>Copper (mg/kg)</p></td><td><p>&lt;&#160;5,0</p></td></tr><tr><td><p>Lead (mg/kg)</p></td><td><p>&lt;&#160;0,5</p></td></tr><tr><td><p>Arsenic (mg/kg)</p></td><td><p>&lt;&#160;0,3</p></td></tr><tr><td><p><span>Salmonella</span> (CFU<span>c</span>/25 g)</p></td><td><p>Negative</p></td></tr><tr><td><p><span>E. coli</span> (MPN<span>d</span>/100 g)</p></td><td><p>Negative</p></td></tr><tr><td><p>Yeast (CFU/g)</p></td><td><p>&lt;&#160;10</p></td></tr><tr><td><p>Mould (CFU/g)</p></td><td><p>&lt;&#160;10</p></td></tr><tr><td><p><span><span>a</span></span>&#160;&#160;Other carbohydrates include monosaccharides (glucose, xylose and arabinose) and cellobiose.</p><p><span><span>b</span></span>&#160;&#160;Maltodextrin content is calculated according to the amount added in the process.</p><p>DP:&#160;&#160;Degree of polymerization</p><p><span><span>c</span></span>&#160;&#160;CFU: Colony Forming Units</p><p><span><span>d</span></span>&#160;&#160;MPN: Most Probable Number</p></td></tr><tr><td><p><a>&#9660;M31</a></p></td></tr><tr><td><p><span>Yarrowia lipolytica</span> yeast biomass</p></td><td><p><span>Description/Definition:</span></p><p>The novel food is the dried and heat-killed biomass of the yeast<span>Yarrowia lipolytica</span>.</p><p><span>Characteristics/Composition:</span></p><p>Protein: 45-55 g/100 g</p><p>Dietary fibre: 24-30 g/100 g</p><p>Sugars: &lt; 1,0 g/100 g</p><p>Fat: 7-10 g/100 g</p><p>Total ash: &#8804; 12 %</p><p>Water content: &#8804; 5 %</p><p>Dry matter content: &#8805; 95 %</p><p><span>Microbiological criteria:</span></p><p>Total Aerobic Microbial Count: &#8804; 5 &#215; 10<span>3</span> CFU/g</p><p>Total Yeast and Mould Count: &#8804; 10<span>2</span> CFU/g</p><p>Viable<span>Yarrowia lipolytica</span> cells&#160;<a>(<span>10</span>)</a>: &lt; 10 CFU/g (i.e. limit of detection)</p><p>Coliforms: &#8804; 10 CFU/g</p><p><span>Salmonella</span> spp.: Absence in 25 g</p></td></tr><tr><td><p><a>&#9660;M9</a></p></td></tr><tr><td><p><span>Yeast beta-glucans</span></p></td><td><p><span>Description/Definition:</span></p><p>Beta-glucans are complex, high molecular mass (100&#8211;200 kDa) polysaccharides, found in the cell wall of many yeasts and cereals.</p><p>The chemical name for &#8216;yeast beta-glucans&#8217; is (1-3),(1-6)-&#223;-D-glucans.</p><p>Beta-glucans consist of a backbone of &#223;-1-3-linked glucose residues that are branched by &#223;-1-6-linkages, to which chitin and mannoproteins are linked by &#223;-1-4-bonds.</p><p>Beta-glucans are isolated from yeast<span>Saccharomyces cerevisiae</span>.</p><p>The tertiary structure of the glucan cell wall of<span>Saccharomyces cerevisiae</span> consists of chains of &#223;-1,3-linked glucose residues, branched by &#223;-1,6-linkages, forming a backbone to which are linked chitin via &#223;-1,4- bonds, &#223;-1,6-glucans and some mannoproteins.</p><p>This novel food is available in three different forms: soluble, insoluble and insoluble in water, but dispersible in many liquid matrices.</p><p><span>Chemical characteristics yeast (<span>Saccharomyces cerevisiae</span>) beta-glucans:</span></p><p><span>Soluble form:</span></p><p>Total carbohydrates: &gt; 75 %</p><p>Beta-glucans (1,3/1,6): &gt; 75 %</p><p>Ash: &lt; 4,0 %</p><p>Moisture: &lt; 8,0 %</p><p>Protein: &lt; 3,5 %</p><p>Fat: &lt; 10 %</p><p><span>Insoluble form:</span></p><p>Total carbohydrates: &gt; 70 %</p><p>Beta-glucans (1,3/1,6): &gt; 70 %</p><p>Ash: &#8804; 12 %</p><p>Moisture: &lt; 8,0 %</p><p>Protein: &lt; 10 %</p><p>Fat: &lt; 20 %</p><p><span>Insoluble in water, but dispersible in many liquid matrices:</span></p><p>(1,3)-(1,6)-&#223;-D-Glucans: &gt; 80 %</p><p>Ash: &lt; 2,0 %</p><p>Moisture: &lt; 6,0 %</p><p>Protein: &lt; 4,0 %</p><p>Total fat: &lt; 3,0 %</p><p><span>Microbiological data for insoluble in water, but dispersible in many liquid matrices:</span></p><p>Total plate count: &lt; 1&#160;000  CFU/g</p><p>Enterobacteriaceae: &lt; 100 CFU/g</p><p>Total coliforms: &lt; 10 CFU/g</p><p>Yeast: &lt; 25 CFU/g</p><p>Mould: &lt; 25 CFU/g</p><p><span>Salmonella</span>: Absence in 25 g</p><p><span>Escherichia coli</span>: Absence in 1 g</p><p><span>Bacillus cereus</span>: &lt; 100 CFU/g</p><p><span>Staphylococcus aureus</span>: Absence in 1 g</p><p><span>Heavy metals for insoluble in water, but dispersible in many liquid matrices:</span></p><p><span><a><span>&#9658;M32</span></a></span>&#160;Lead: &lt; 0,2 mg/kg</p><p>Arsenic: &lt; 0,2 mg/kg</p><p>Mercury: &lt; 0,1 mg/kg</p><p>Cadmium: &lt; 0,1 mg/kg<span>&#160;&#9668;</span></p></td></tr><tr><td><p><span>Zeaxanthin</span></p></td><td><p><span>Description/Definition:</span></p><p>Zeaxanthin is a naturally occurring xanthophyll pigment, it is an oxygenated carotenoid.</p><p>The synthetic zeaxanthin is presented either as a spray-dried powder of gelatin or starch base (&#8216;beadlets&#8217;) with added &#945;-tocopherol and ascorbyl palmitate or as a corn oil suspension with added &#945;-tocopherol. Synthetic zeaxanthin is produced by a multi-step chemical synthesis from smaller molecules.</p><p>Orange-red crystalline powder with little or no odour.</p><p>Chemical formula: C<span>40</span>H<span>56</span>O<span>2</span></p><p>CAS No: 144-68-3</p><p>Molecular weight: 568,9 daltons</p><p><span>Physical-chemical properties:</span></p><p>Loss on drying: &lt; 0,2 %</p><p><span>All</span>-trans zeaxanthin: &gt; 96 %</p><p>Cis-zeaxanthin: &lt; 2,0 %</p><p>Other carotenoids: &lt; 1,5 %</p><p>Triphenylphosphine oxid (CAS No 791-28-6): &lt; 50 mg/kg</p></td></tr><tr><td><p><span>Zinc L-pidolate</span></p></td><td><p><span>Description/Definition:</span></p><p>Zinc L-pidolate is a white to off-white powder, with characteristic odour.</p><p>International non-proprietary name (INN): L-pyroglutamic acid, Zinc salt</p><p>Synonyms: Zinc 5-oxoproline, Zinc pyroglutamate, Zinc pyrrolidone carboxylate, Zinc PCA, L-Zinc pidolate</p><p>CAS No.: 15454-75-8</p><p>Molecular formula: (C<span>5</span> H<span>6</span> NO<span>3</span>)<span>2</span> Zn</p><p>Relative anhydrous molecular mass: 321,4</p><p>Appearance: White to slightly white powder</p><p><span>Purity:</span></p><p>Zinc L-pidolate (purity): &#8805; 98 %</p><p>pH (10 % aqueous sol.): 5,0-6,0</p><p>Specific rotation: 19,6<span>o</span>- 22,8<span>o</span></p><p>Water: &#8804; 10,0 %</p><p>Glutamic acid: &lt; 2,0 %</p><p><span>Heavy metals:</span></p><p>Lead: &#8804; 3,0 ppm</p><p>Arsenic: &#8804; 2,0 ppm</p><p>Cadmium: &#8804; 1,0 ppm</p><p>Mercury: &#8804; 0,1 ppm</p><p><span>Microbiological criteria:</span></p><p>Total viable mesophilic count: &#8804; 1&#160;000  CFU/g</p><p>Yeasts and moulds: &#8804; 100 CFU/g</p><p>Pathogen: Absence</p></td></tr><tr><td><div><a>(<span>1</span>)&#160;&#160;&#160;</a><p>Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).</p></div><div><a>(<span>2</span>)&#160;&#160;&#160;</a><p>Commission Implementing Regulation (EU) 2015/175 of 5 February 2015 laying down special conditions applicable to the import of guar gum originating in or consigned from India due to contamination risks by pentachlorophenol and dioxins (OJ L 30, 6.2.2015, p. 10).</p></div><div><span><a><span>&#9658;M15</span></a></span>&#160;<a>(<span>3</span>)&#160;&#160;&#160;</a><p>OSC-DMAC (4-dimethylaminocinnamaldehyde) method (Ocean Spray Cranberries, Inc) Martin MA, Ramos S, Mateos R, Marais JPJ, Bravo-Clemente, L, Khoo C and Goya L. Food Res Intl 2015 71: 68-82. Modified from Cunningham DG, Vannozzi S, O'Shea E, Turk R (2002) In: Ho C-T, Zheng QY (eds) Quality Management of Nutraceuticals ACS Symposium series 803, Washington DC.<span>Quantitation of PACs by DMAC Color Reaction pp</span> 151-166.</p></div><div><a>(<span>4</span>)&#160;&#160;&#160;</a><p>BL-DMAC 4-dimethylaminocinnamaldehyde) method (Brunswick Lab) Multi-laboratory validation of a standard method for quantifying proanthocyanidins in cranberry powders. Prior RL, Fan E, Ji H, Howell A, Nio C, Payne MJ, Reed J.<span>J Sci Food Agric.</span> 2010 Jul;90(9):1473-8.</p></div><div><a>(<span>5</span>)&#160;&#160;&#160;</a><p>The different values for these three parameters are due to the different methods used.</p></div><div><a>(<span>6</span>)&#160;&#160;&#160;</a><p>GAE: Gallic Acid Equivalents.</p></div><div><a>(<span>7</span>)&#160;&#160;&#160;</a><p>CFU: Colony Forming Units.</p><span>&#160;&#9668;</span></div><div><a>(<span>8</span>)&#160;&#160;&#160;</a><p>HPLC/RI: High-performance liquid chromatography coupled with refractive index detection.</p></div><div><a>(<span>9</span>)&#160;&#160;&#160;</a><p>CFU: Colony-forming unit.</p></div><div><a>(<span>10</span>)&#160;&#160;&#160;</a><p>To be tested immediately after the heat-treatment step. Measures have to be in place to prevent cross-contamination with viable<span>Yarrowia lipolytica</span> cells during packaging and/or storage of the NF.</p></div><div><a>(<span>11</span>)&#160;&#160;&#160;</a><p>2&#8242;-Fucosyl-galactose, Glucose, Galactose, Mannitol, Sorbitol, Galactitol, Trihexose, Allo-lactose and other structurally related carbohydrates.</p></div><div><span><a><span>&#9658;M51</span></a></span>&#160;<a>(<span>12</span>)&#160;&#160;&#160;</a><p>Converted from International Units (IU) using the conversion factor of 0,025 &#956;g = 1 IU.</p><span>&#160;&#9668;</span></div><div><a>(<span>13</span>)&#160;&#160;&#160;</a><p>Applicable at all stages after the heat-treatment step to guarantee the absence of viable<span>Yarrowia lipolytica</span> cells and to be first tested immediately after the heat-treatment step. Measures have to be in place to prevent cross-contamination with viable<span>Yarrowia lipolytica</span> cells during packaging and/or storage of the novel food.</p></div><div><a>(<span>14</span>)&#160;&#160;&#160;</a><p>Expressed as selenium.</p></div><div><a>(<span>15</span>)&#160;&#160;&#160;</a><p>Digestible carbohydrates&#160;= 100 &#8211; (crude protein&#160;+&#160;fat&#160;+&#160;dietary fibre&#160;+&#160;ash&#160;+&#160;moisture).</p></div><div><a>(<span>16</span>)&#160;&#160;&#160;</a><p>Miraculin is part of the total protein content.</p></div><div><a>(<span>17</span>)&#160;&#160;&#160;</a><p>Regulation (EC) No&#160;396/2005 of the European Parliament and of the Council of 23&#160;February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L&#160;70, 16.3.2005, p.&#160;1).</p></div><div><a>(<span>18</span>)&#160;&#160;&#160;</a><p>Dietary fibre may not include chitin due to different analytical methods.</p></div><div><a>(<span>19</span>)&#160;&#160;&#160;</a><p>Upper bound sum of polychlorinated dibenzo-para-dioxins (PCDDs)-polychlorinated dibenzofurans (PCDFs) and dioxin-like polychlorinated biphenyls (PCBs) expressed as World Health Organization toxic equivalent (using WHO-TEFs of 2005)).</p></div><div><a>(<span>*1</span>)&#160;&#160;&#160;</a><p>Cornell RM and Schwertmann U, 2003. The Iron Oxides: Structure, Properties, Reactions, Occurrences and Uses. 2nd Edition. Wiley. https://doi.org/10.1002/3527602097</p></div><div><a>(<span>20</span>)&#160;&#160;&#160;</a><p>Number-based (by Transmission Electron Microscopy (TEM)).</p></div><div><a>(<span>21</span>)&#160;&#160;&#160;</a><p>Volume-based (hydrodynamic diameter by Dynamic Light Scattering (DLS)); CFU: Colony Forming Units.</p></div><div><a>(<span>22</span>)&#160;&#160;&#160;</a><p>Chitin calculated as the difference between the Acid Detergent Fibre fraction and the Acid Detergent Lignin fraction (ADF-ADL), as described by Hahn et al. (2018).</p></div><div><a>(<span>23</span>)&#160;&#160;&#160;</a><p>Upper bound sum of polychlorinated dibenzo-para-dioxins (PCDDs)-polychlorinated dibenzofurans (PCDFs) and dioxin-like polychlorinated biphenyls (PCBs) expressed as World Health Organization Toxic Equivalent Factors (using WHO-TEFs of 2005)).</p><br/><p>CFU: Colony Forming Units.</p></div><div><a>(<span>24</span>)&#160;&#160;&#160;</a><p>Sum of other carbohydrates&#160;= 100 (% (w/w) of dry matter) &#8211; quantified carbohydrates (% (w/w) of dry matter) &#8211; Ash (% (w/w) of dry matter).</p></div><div><a>(<span>25</span>)&#160;&#160;&#160;</a><p>CFU: Colony Forming Units.</p></div><div><a>(<span>26</span>)&#160;&#160;&#160;</a><p>EU: Endotoxin Units.</p></div><div><a>(<span>27</span>)&#160;&#160;&#160;</a><p>Chitin calculated as Acid Detergent Fibre.</p></div><div><a>(<span>28</span>)&#160;&#160;&#160;</a><p>Sum of other carbohydrates&#160;= 100 (% (w/w) of dry matter) &#8211; 6'-Sialyllactose sodium salt (% (w/w) of dry matter) &#8211; quantified carbohydrates (% (w/w) of dry matter) &#8211; Ash (% (w/w) of dry matter); CFU: Colony Forming Units; EU: Endotoxin Units.</p></div></td></tr></tbody></table>