Document ID: 32021R0668
Language: ENG

<table><col/><col/><col/><col/><tbody><tr><td><p>26.4.2021&#160;&#160;&#160;</p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 141/3</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2021/668
of 23 April 2021
authorising a change of the conditions of use of chia seeds ( Salvia hispanica ) 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&#160;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 Decision 2009/827/EC&#160;<a>(<span>3</span>)</a> authorised, in accordance with Regulation (EC) No&#160;258/97 of the European Parliament and of the Council&#160;<a>(<span>4</span>)</a>, the placing on the market in the Union of chia seeds (<span>Salvia hispanica</span>) as a novel food to be used in bread products.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Commission Implementing Decision 2013/50/EU&#160;<a>(<span>5</span>)</a> authorised, in accordance with Regulation (EC) No&#160;258/97, an extension of use of chia seeds as a novel food to be used in additional food categories as follows: baked products; breakfast cereals; fruit, nut and seed mixes and pre-packaged chia seeds as such.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>On 18&#160;September 2015, the competent authority of Ireland issued an official letter&#160;<a>(<span>6</span>)</a> in accordance with Regulation (EC) No&#160;258/97, authorising an extension of use of the novel food chia seeds in additional food categories, namely fruit juice and fruit/vegetable blend beverages.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>On 17&#160;October 2017, the competent authority of Austria issued an official letter&#160;<a>(<span>7</span>)</a> in accordance with Regulation (EC) No&#160;258/97, authorising an extension of use of the novel food chia seeds in an additional food category, namely fruit spreads.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>On 2&#160;November 2017, the competent authority of Spain issued an official letter&#160;<a>(<span>8</span>)</a> in accordance with Regulation (EC) No&#160;258/97, authorising an extension of use of the novel food chia seeds in additional food categories, namely sterilised ready meals based on cereal grains, pseudocereal grains and/or pulses.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>Commission Implementing Decision (EU) 2017/2354&#160;<a>(<span>9</span>)</a> authorised, in accordance with Regulation (EC) No&#160;258/97, an extension of use of chia seeds as a novel food to be used in an additional food category, namely yoghurt.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>Commission Implementing Regulation (EU) 2020/24&#160;<a>(<span>10</span>)</a> authorised an extension of use of the novel food chia seeds to be used in a number of additional food categories, certain changes of the conditions of use and the specific labelling requirements of chia seeds in accordance with Regulation (EU) 2015/2283.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>In line with previous authorisations, chia seeds are authorised for placing on the market within the Union under the specified conditions of use, including &#8216;pre-packaged chia seed as such&#8217;. In January 2020, the Commission received a query from the association &#8216;R&#233;seau Vrac&#8217; on whether non pre-packaged (loose, bulk) chia seeds as such may also be placed on the Union market.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>Following this query, the Commission has further evaluated whether the removal of the term &#8216;pre-packaged&#8217; from the category &#8216;pre-packaged chia seed as such&#8217; is also safe. That amendment would allow food business operators to place chia seeds as such on the Union market in both pre-packaged and non-pre-packaged (loose, bulk) forms. Therefore, the Commission is of the view that the Union list should be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>In accordance with Article&#160;10(1) of Regulation (EU) 2015/2283, the Commission started the procedure for updating the Union list of novel foods on its own initiative.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>In its opinion of 14&#160;March 2019 concerning the &#8216;Safety of chia seeds (<span>Salvia hispanica</span> L.) as a novel food for extended uses pursuant to Regulation (EU) 2015/2283&#8217;&#160;<a>(<span>11</span>)</a>, the European Food Safety Authority (&#8216;the Authority&#8217;) concluded that the use of chia seeds in foods which do not require heat treatment at or above 120&#160;&#176;C in their manufacture, processing or preparation is safe without any specific restrictions and precautions regarding their use levels.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(14)</p></td><td><p>The Commission considers that a safety evaluation by the Authority of the proposed change to the conditions of use in accordance with Article&#160;10(3) of Regulation (EU) 2015/2283 is not necessary, as the change of the conditions of use of the novel food chia seeds (<span>Salvia hispanica</span>), by removing forms in which chia seeds as such may be placed on the market is not liable to have an effect on human health.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(15)</p></td><td><p>It is therefore appropriate to authorise the placing on the market of chia seeds also without pre-packaging.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(16)</p></td><td><p>Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(17)</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. The entry in the Union list of authorised novel foods as provided for in Article 6 of Regulation (EU) 2015/2283 and included in the Annex to Implementing Regulation (EU) 2017/2470, referring to the novel food chia seeds ( Salvia hispanica ), shall be amended as specified in the Annex to this Regulation.
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 to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 23 April 2021.
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 Decision 2009/827/EC of 13 October 2009 authorising the placing on the market of Chia seed ( Salvia hispanica ) as novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council ( OJ L 294, 11.11.2009, p. 14 ).
( 4 ) Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients ( OJ L 43, 14.2.1997, p. 1 ).
( 5 ) Commission Implementing Decision 2013/50/EU of 22 January 2013 authorising an extension of use of Chia ( Salvia hispanica ) seed as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council ( OJ L 21, 24.1.2013, p. 34 ).
( 6 ) Letter of 18 September 2015 (https://ec.europa.eu/food/sites/food/files/safety/docs/novel-food_authorisation_2015_auth-letter_chia-seeds-2_en.pdf).
( 7 ) Letter of 17 October 2017 (https://ec.europa.eu/food/sites/food/files/safety/docs/novel-food_authorisation_2017_auth-letter_chia-seeds_en.pdf).
( 8 ) Letter of 2 November 2017 (https://ec.europa.eu/food/sites/food/files/safety/docs/novel-food_authorisation_2017_auth-letter_chia-seeds-ext-steri_en.pdf).
( 9 ) Commission Implementing Decision (EU) 2017/2354 of 14 December 2017 authorising an extension of use of Chia seeds ( Salvia hispanica ) as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council ( OJ L 336, 16.12.2017, p. 49 ).
( 10 ) Commission Implementing Regulation (EU) 2020/24 of 13 January 2020 authorising an extension of use of chia seeds ( Salvia hispanica ) as a novel food and the change of the conditions of use and the specific labelling requirements of chia seeds ( Salvia hispanica ) under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 ( OJ L 8, 14.1.2020, p. 12 ).
( 11 ) EFSA Journal 2019;17(4):5657.
ANNEX
The entry for ‘Chia seeds ( Salvia hispanica )’ in Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is replaced by the following:
<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;Chia seeds (<span>Salvia hispanica</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;Chia seeds (<span>Salvia hispanica</span>)&#8221;&#8217;</p></td><td><p>&#160;</p></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></td></tr><tr><td><p>Chia seeds as such</p></td><td><p>&#160;</p></td></tr><tr><td><p>Confectionery (including chocolate and chocolate products), excluding chewing gums</p></td><td><p>&#160;</p></td></tr><tr><td><p>Dairy products (including yoghurt) and analogues</p></td><td><p>&#160;</p></td></tr><tr><td><p>Edible ices</p></td><td><p>&#160;</p></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></td></tr><tr><td><p>Non-alcoholic beverages (including fruit juice and fruit/vegetable blend beverages)</p></td><td><p>&#160;</p></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></td></tr></tbody></table>