Document ID: 32017R1903
Language: ENG

<table><col/><col/><col/><col/><tbody><tr><td><p>19.10.2017&#160;&#160;&#160;</p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 269/22</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2017/1903
of 18 October 2017
concerning the authorisation of the preparations of Pediococcus parvulus DSM 28875, Lactobacillus casei DSM 28872 and Lactobacillus rhamnosus DSM 29226 as feed additives for all animal species
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition ( 1 ) , and in particular Article 9(2) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>In accordance with Article 7 of Regulation (EC) No 1831/2003 applications were submitted for the authorisation of the preparations of<span>Pediococcus parvulus</span> DSM 28875,<span>Lactobacillus casei</span> DSM 28872 and<span>Lactobacillus rhamnosus</span> DSM 29226. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Those applications concern the authorisation of the preparations of<span>Pediococcus parvulus</span> DSM 28875,<span>Lactobacillus casei</span> DSM 28872 and<span>Lactobacillus rhamnosus</span> DSM 29226 as feed additives for all animal species to be classified in the additive category &#8216;technological additives&#8217;.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>The European Food Safety Authority (&#8216;the Authority&#8217;) concluded in its respective opinions of 6 December 2016&#160;<a>(<span>2</span>)</a> and 24 January 2017&#160;<a>(<span>3</span>)</a>&#160;<a>(<span>4</span>)</a> that, under the respective proposed conditions of use, the preparation of<span>Lactobacillus rhamnosus</span> DSM 29226,<span>Pediococcus parvulus</span> DSM 28875 and<span>Lactobacillus casei</span> DSM 28872 do not have an adverse effect on animal health, human health or the environment. The Authority also concluded that those preparations have the potential to improve the production of silage prepared from easy and moderately difficult to ensile forage by reducing dry matter loss and enhancing protein preservation. The Authority does not consider that there is a need for specific requirements of post-market monitoring. The Authority also verified the reports on the methods of analysis of the feed additives concerned in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The assessment of the preparations of<span>Pediococcus parvulus</span> DSM 28875,<span>Lactobacillus casei</span> DSM 28872 and<span>Lactobacillus rhamnosus</span> DSM 29226 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No&#160;1831/2003, are satisfied. Accordingly, the use of those preparations should be authorised as specified in the Annex to this Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</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
The preparations specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.
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, 18 October 2017.
For the Commission
The President
Jean-Claude JUNCKER
( 1 ) OJ L 268, 18.10.2003, p. 29 .
( 2 ) EFSA Journal 2017; 15(1):4673.
( 3 ) EFSA Journal 2017; 15(3):4702.
( 4 ) EFSA Journal 2017; 15(3):4703.
ANNEX
<table><col/><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Identification number of the additive</p></td><td><p>Additive</p></td><td><p>Composition, chemical formula, description, analytical method</p></td><td><p>Species or category of animal</p></td><td><p>Maximum age</p></td><td><p>Minimum content</p></td><td><p>Maximum content</p></td><td><p>Other provisions</p></td><td><p>End of period of authorisation</p></td></tr><tr><td><p>CFU of additive/kg of fresh material</p></td></tr><tr><td><p><span>Technological additives: silage additives</span></p></td></tr><tr/><tr><td><p>1k21014</p></td><td><p><span>Pediococcus parvulus</span></p><p>DSM 28875</p></td><td><p><span>Additive composition</span></p><p>Preparation of<span>Pediococcus parvulus</span></p><p>DSM 28875 containing a minimum of 1 &#215; 10<span>11</span> CFU/g additive.</p><p><span>Characterisation of the active substance</span></p><p>Viable cells of<span>Pediococcus parvulus</span></p><p>DSM 28875.</p><p><span>Analytical method</span><a>&#160;(<span>1</span>)</a></p><p>Enumeration in the feed additive: spread plate method: EN 15786:2009.</p><p>Identification of the feed additive: Pulsed Field Gel Electrophoresis (PFGE).</p></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>In the directions for use of the additive and premixtures, the storage conditions shall be indicated.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>Minimum content of the additive when used without combination with other micro-organisms used as silage additives: 5&#160;&#215;&#160;10<span>7</span> CFU/kg of easy and moderately difficult to ensile fresh material<a>&#160;(<span>2</span>)</a>.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>3.</p></td><td><p>For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.</p></td></tr></tbody></table></td><td><p>8 November 2027</p></td></tr><tr><td><p>1k20755</p></td><td><p><span>Lactobacillus casei</span></p><p>DSM 28872</p></td><td><p><span>Additive composition</span></p><p>Preparation of<span>Lactobacillus casei</span></p><p>DSM 28872 containing a minimum of 1 &#215; 10<span>11</span> CFU/g additive.</p><p><span>Characterisation of the active substance</span></p><p>Viable cells of<span>Lactobacillus casei</span></p><p>DSM 28872</p><p><span>Analytical method</span><a>&#160;(<span>1</span>)</a></p><p>Enumeration in the feed additive: spread plate method on MSR agar (EN 15787).</p><p>Identification of the feed additive: Pulsed Field Gel Electrophoresis (PFGE).</p></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>In the directions for use of the additive and premixtures, the storage conditions shall be indicated.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>Minimum content of the additive when used without combination with other micro-organisms as silage additives: 5 &#215; 10<span>7</span> CFU/kg of easy and moderately difficult to ensile fresh material<a>&#160;(<span>2</span>)</a>.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>3.</p></td><td><p>For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.</p></td></tr></tbody></table></td><td><p>8 November 2027</p></td></tr><tr><td><p>1k20756</p></td><td><p><span>Lactobacillus rhamnosus</span></p><p>DSM 29226</p></td><td><p><span>Additive composition</span></p><p>Preparation of<span>Lactobacillus rhamnosus</span></p><p>DSM 29226 containing a minimum of 1 &#215; 10<span>10</span> CFU/g additive.</p><p><span>Characterisation of the active substance</span></p><p>Viable cells of<span>Lactobacillus rhamnosus</span></p><p>DSM 29226</p><p><span>Analytical method</span><a>&#160;(<span>1</span>)</a></p><p>Enumeration in the feed additive: spread plate method on MSR agar (EN 15787).</p><p>Identification of the feed additive: Pulsed Field Gel Electrophoresis (PFGE).</p></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>In the directions for use of the additive and premixtures, the storage conditions shall be indicated.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>Minimum content of the additive when used without combination with other micro-organisms as silage additives: 5 &#215; 10<span>7</span> CFU/kg of easy and moderate difficult to ensile fresh material<a>&#160;(<span>2</span>)</a>.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>3.</p></td><td><p>For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.</p></td></tr></tbody></table></td><td><p>8 November 2027</p></td></tr></tbody></table>
<note>
( 1 ) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
( 2 ) Easy to ensile forage: > 3 % soluble carbohydrates in fresh material. Moderately difficult to ensile forage: 1,5 %-3,0 % soluble carbohydrates in the fresh material. Commission Regulation (EC) No 429/2008 ( OJ L 133, 22.5.2008, p. 1 ).
</note>