Document ID: 32020R1822
Language: ENG

<table><col/><col/><col/><col/><tbody><tr><td><p>3.12.2020&#160;&#160;&#160;</p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 406/39</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2020/1822
of 2 December 2020
authorising the placing on the market of chromium-containing yeast ( Yarrowia lipolytica ) biomass as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 ( 1 ) , and in particular Article 12 thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470&#160;<a>(<span>2</span>)</a> establishing a Union list of authorised novel foods was adopted.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Commission Implementing Regulation (EU) 2019/760&#160;<a>(<span>3</span>)</a> authorised, in accordance with Regulation (EU) 2015/2283, the placing on the market of<span>Yarrowia lipolytica</span> yeast biomass as a novel food to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council&#160;<a>(<span>4</span>)</a>, excluding food supplements for infants and young children.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>On 22 August 2018, the company Skotan S.A. (&#8216;the applicant&#8217;) introduced an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place chromium-enriched biomass of the yeast<span>Yarrowia lipolytica</span> on the Union market as a novel food. The applicant requested for chromium-enriched biomass of the yeast<span>Yarrowia lipolytica</span> to be used as a novel food in food supplements, excluding food supplements for infants and young children. The maximum use levels proposed by the applicant are 2 g per day for children from 3 to 9 years of age, and 4 g per day for adolescents and adults.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (&#8216;Authority&#8217;) on 18 February 2019, asking it to provide a scientific opinion by carrying out an assessment for chromium-containing yeast (<span>Yarrowia lipolytica</span>) biomass as a novel food.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>On 23 January 2020, the Authority adopted its scientific opinion &#8216;Safety of chromium-enriched biomass of<span>Yarrowia lipolytica</span> as a novel food pursuant to Regulation (EU) 2015/2283&#8217;&#160;<a>(<span>5</span>)</a>. That opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>In its opinion, the Authority concluded that chromium-containing yeast (<span>Yarrowia lipolytica</span>) biomass is safe under the proposed uses and use levels, when used in food supplements intended for the general population above 3 years of age.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>The opinion of the Authority gives sufficient grounds to establish that chromium-containing yeast (<span>Yarrowia lipolytica</span>) biomass under the proposed conditions of use complies with Article 12(1) of Regulation (EU) 2015/2283.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>Regulation (EU) 2017/2470 should be therefore amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
1. Chromium-containing yeast ( Yarrowia lipolytica ) biomass as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.
2. The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex.
Article 2
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 2 December 2020.
For the Commission
The President
Ursula VON DER LEYEN
( 1 ) OJ L 327, 11.12.2015, p. 1 .
( 2 ) Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods ( OJ L 351, 30.12.2017, p. 72 ).
( 3 ) Commission Implementing Regulation (EU) 2019/760 of 13 May 2019 authorising the placing on the market of Yarrowia lipolytica yeast biomass as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 ( OJ L 125, 14.5.2019, p. 13 ).
( 4 ) 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 ).
( 5 ) EFSA Journal 2020;18(3):6005.
ANNEX
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>in Table 1 (Authorised novel foods), the following entry is inserted:</p><table><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></tr><tr><td><p>&#8216;<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 &#8220;chromium-containing yeast (<span>Yarrowia lipolytica</span>) biomass&#8221;</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<a>&#160;(<span>*1</span>)</a>.</p></td><td><p>&#160;</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>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></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>in Table 2 (Specifications), the following entry is inserted:</p><table><col/><col/><tbody><tr><td><p>Authorised Novel Food</p></td><td><p>Specification</p></td></tr><tr><td><p>&#8216;<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><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Total chromium: 18&#8211;23 &#956;g/g</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Chromium (VI): &lt; 10 &#956;g/kg (i.e. limit of detection)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Protein: 40&#8211;50 g/100 g</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Dietary fibre: 24&#8211;32 g/100 g</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Sugars: &lt; 2 g/100 g</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Fat: 6&#8211;12 g/100 g</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Total ash: &#8804; 15 %</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Water: &#8804; 5 %</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Dry matter: &#8805; 95 %</p></td></tr></tbody></table><p><span>Heavy metals:</span></p><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Lead: &#8804; 3,0 mg/kg</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Cadmium: &#8804; 1,0 mg/kg</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Mercury: &#8804; 0,1 mg/kg</p></td></tr></tbody></table><p><span>Microbiological criteria:</span></p><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Total aerobic microbial count: &#8804; 5 &#215; 10<span>3</span> CFU/g</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Total yeast and mould count: &#8804; 10<span>2</span> CFU/g</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Viable<span>Yarrowia lipolytica</span> cells<a>&#160;(<span>*2</span>)</a>: &lt; 10 CFU/g (i.e. limit of detection)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Coliforms: &#8804; 10 CFU/g</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p><span>Salmonella</span> spp.: Absence in 25 g</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>CFU: colony forming units</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table>
<note>
( *1 ) Depending on the age group the food supplement is intended for.’
( *2 ) Applicable at all stages after the heat-treatment step to guarantee the absence of viable Yarrowia lipolytica cells and to be first tested immediately after the heat-treatment step. Measures have to be in place to prevent cross-contamination with viable Yarrowia lipolytica cells during packaging and/or storage of the novel food.’
</note>