Document ID: 32022R0047
Language: ENG

<table><col/><col/><col/><col/><tbody><tr><td><p>14.1.2022&#160;&#160;&#160;</p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 9/29</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2022/47
of 13 January 2022
authorising the placing on the market of Coffea arabica L. and/or Coffea canephora Pierre ex A.Froehner dried cherry pulp and its infusion as a traditional food from a third country 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 15(4),
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. Traditional food from a third country is a novel food defined in Article&#160;3(2)(c) of Regulation (EU) 2015/2283.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Commission Implementing Regulation (EU) 2017/2468&#160;<a>(<span>2</span>)</a> lays down administrative and scientific requirements concerning traditional foods from third countries.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Pursuant to Article&#160;8 of Regulation (EU) 2015/2283, a Union list of authorised novel foods was established by Commission Implementing Regulation (EU) 2017/2470&#160;<a>(<span>3</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Pursuant to Article&#160;15(4) of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a traditional food from a third country.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>On 6&#160;May 2020, the company Societ&#233; de Produits Nestl&#233; SA (&#8216;the applicant&#8217;) submitted a notification to the Commission of their intention to place<span>Coffea arabica</span> L. and<span>Coffea canephora</span> Pierre ex A.Froehner dried cherry pulp and its infusion on the Union market as a traditional food from a third country in accordance with Article&#160;14 of Regulation (EU) 2015/2283. The applicant requested that<span>Coffea arabica</span> L. and<span>Coffea canephora</span> Pierre ex A.Froehner dried cherry pulp and its infusion to be used as an ingredient for infusions (including ready-to-drink beverages) and flavoured drinks intended for the general population.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>On 13&#160;November 2020, the company Luigi Lavazza SpA (&#8216;the applicant&#8217;) submitted a notification to the Commission of their intention to place<span>Coffea arabica</span> L. and<span>Coffea canephora</span> Pierre ex A.Froehner dried cherry pulp and its infusion on the Union market as a traditional food from a third country in accordance with Article&#160;14 of Regulation (EU) 2015/2283. The applicant requested that<span>Coffea arabica</span> L. and<span>Coffea canephora</span> Pierre ex A.Froehner dried cherry pulp and its infusion to be used as an ingredient for infusions and flavoured drinks intended for the general population.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>Pursuant to Article&#160;7(2) of Implementing Regulation (EU) 2017/2468, the Commission requested additional information from the applicants as regards the validity of the notification. Societ&#233; de Produits Nestl&#233; SA submitted the requested information on 17&#160;July 2020, 17&#160;November 2020 and 23&#160;December 2020, while Luigi Lavazza SpA submitted the requested information on 2&#160;April 2021.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>The data presented by the applicants demonstrate that<span>Coffea arabica</span> L. and/or<span>Coffea canephora</span> Pierre ex A.Froehner dried cherry pulp and its infusion has a history of safe food use in Yemen, Ethiopia and Bolivia.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>Pursuant to Article&#160;15(1) of Regulation (EU) 2015/2283, on 4&#160;January 2021 and 6&#160;April 2021, the Commission forwarded the valid notifications to the Member States and to the European Food Safety Authority (&#8216;the Authority&#8217;).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>No duly reasoned safety objections to the placing on the market within the Union of<span>Coffea arabica</span> L. and/or<span>Coffea canephora</span> Pierre ex A.Froehner dried cherry pulp and its infusion were submitted to the Commission by the Member States or the Authority within the 4-month period laid down in Article&#160;15(2) of Regulation (EU) 2015/2283.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>On 27&#160;May 2021, the Authority published its &#8216;Technical Report on the notification of the coffee cherry pulp from<span>Coffea arabica</span> L. and<span>Coffea canephora</span> Pierre ex A.Froehner as a traditional food from a third country pursuant to Article&#160;14 of Regulation (EU) 2015/2283&#8217;&#160;<a>(<span>4</span>)</a>, based on the notification from Soci&#233;t&#233; de Produits Nestl&#233; SA.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>On 2&#160;September 2021, the Authority published its &#8216;Technical Report on the notification of dried cherry pulp from<span>Coffea arabica</span> L. and<span>Coffea canephora</span> Pierre ex A.Froehner as a traditional food from a third country pursuant to Article&#160;14 of Regulation (EU) 2015/2283&#8217;&#160;<a>(<span>5</span>)</a>, based on the notification from Luigi Lavazza SpA.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>In those reports, the Authority concluded that the available data on the composition and the history of the proposed use of<span>Coffea arabica</span> L. and<span>Coffea canephora</span> Pierre ex A.Froehner dried cherry pulp and its infusion do not raise safety concerns.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(14)</p></td><td><p>The Commission should therefore authorise the placing on the market within the Union of<span>Coffea arabica</span> L. and/or<span>Coffea canephora</span> Pierre ex A.Froehner dried cherry pulp and its infusion as a traditional food from a third country and update the Union list of authorised novel foods accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(15)</p></td><td><p>The Authority in its opinion noted that the consumption of beverages containing caffeine is not recommended to children or pregnant or breast-feeding women if the caffeine content exceeds 150 mg/l, as stipulated by Regulation (EU) No&#160;1169/2011 of the European Parliament and of the Council&#160;<a>(<span>6</span>)</a>. Therefore, if the product containing the novel food contains more than 150 mg/l of caffeine, a labelling should be provided in order to properly inform the consumers of the caffeine content and that the product is not recommended for children, pregnant and breast-feeding women.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(16)</p></td><td><p>For the coffee cherry pulp placed on the market as such for the preparation of infusions, a labelling should be provided to properly inform the consumers on the preparation of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(17)</p></td><td><p>Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Coffea arabica L. and/or Coffea canephora Pierre ex A.Froehner dried cherry pulp and its infusion as specified in the Annex to this Regulation, shall be included as a traditional food from a third country in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.
The entry in the Union list referred to in paragraph 1 shall include the conditions of use and the labelling requirements laid down in the Annex to this Regulation.
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, 13 January 2022.
For the Commission
The President
Ursula VON DER LEYEN
( 1 ) OJ L 327, 11.12.2015, p. 1 .
( 2 ) Commission Implementing Regulation (EU) 2017/2468 of 20 December 2017 laying down administrative and scientific requirements concerning traditional foods from third countries 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. 55 ).
( 3 ) 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 ).
( 4 ) EFSA Supporting publications, https://doi.org/10.2903/sp.efsa.2021.EN-6657
( 5 ) EFSA Supporting publications, https://doi/10.2903/sp.efsa.2021.EN-6808
( 6 ) Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 ( OJ L 304, 22.11.2011, p. 18 ).
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>the following entry is inserted in Table 1 (Authorised novel foods):</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>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>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 &#8220;coffee cherry pulp&#8221; and/or &#8220;cascara (coffee cherry pulp)&#8221;, and/or &#8220;coffee cherry pulp infusion&#8221; and/or &#8220;coffee cherry pulp dried infusion&#8221;.</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: &#8220;High caffeine content. Not recommended for children or pregnant or breast-feeding women&#8221; 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.&#8217;</p></td><td><p>&#160;</p></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></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></td></tr><tr><td><p>Flavoured and unflavoured non-alcoholic ready-to-drink beverages</p></td><td><p>&#160;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>the following entry is inserted in Table 2 (Specifications):</p><table><col/><col/><tbody><tr><td><p>Authorised Novel Food</p></td><td><p>Specifications</p></td></tr><tr><td><p>&#8216;<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 &#8220;cascara&#8221;, from the Spanish &#8220;c&#225;scara&#8221;, meaning &#8220;husk&#8221;.</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><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Water: &lt;&#160;18&#160;%</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Water activity (a<span>w</span>): &#8804;&#160;0,65</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Ash: &lt;&#160;10,4&#160;% DM</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Protein: &lt;&#160;15&#160;% DM</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Fat: &lt;&#160;5&#160;% DM</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Carbohydrates: &lt;&#160;85&#160;% DM</p></td></tr></tbody></table><p><span>Microbiological criteria:</span></p><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Aerobic Plate Count: &lt;&#160;10<span>4</span> CFU/g</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Total yeasts and moulds: &lt;&#160;100 CFU/g</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Enterobacteriaceae: &lt;&#160;50 CFU/g</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p><span>Salmonella</span>: Absence in&#160;25 g</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p><span>Bacillus cereus</span>: &lt;&#160;100 CFU/g</p></td></tr></tbody></table><p><span>Mycotoxins:</span></p><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Ochratoxin A: &lt;&#160;5,0 &#956;g/kg</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Aflatoxin B1: &lt;&#160;2,0 &#956;g/kg</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Aflatoxin B1, B2, G1, G2 (as sum): &lt;&#160;4,0 &#956;g/kg</p></td></tr></tbody></table><p><span>Heavy metals:</span></p><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Cadmium (Cd): &lt;&#160;0,05&#160;mg/kg</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Lead (Pb): &lt;&#160;1,0&#160;mg/kg</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Copper: &#8804;&#160;50 mg/kg</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Mercury: &#8804;&#160;0,02&#160;mg/kg</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Arsenic: &#8804;&#160;0,2&#160;mg/kg</p></td></tr></tbody></table><p><span>Impurities:</span></p><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Benzo(a)pyrene: &lt;&#160;10,0 &#956;g/kg</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>Sum of benzo(a)pyrene, benz(a)anthracene, benzo(b)fluoranthene and chrysene: &lt;&#160;50,0 &#956;g/kg</p></td></tr></tbody></table><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 &#8220;0639000&#8221; for &#8220;Herbal infusions from any other parts of the plant&#8221;.</p><p>CFU: Colony Forming Units</p><p>DM: Dry Matter&#8217;</p></td></tr></tbody></table></td></tr></tbody></table>