Document ID: 02012R1065-20230801
Language: ENG

02012R1065 — EN — 01.08.2023 — 001.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION IMPLEMENTING REGULATION (EU) No 1065/2012</p><p>of 13 November 2012</p><p>concerning the authorisation of preparations of<span>Lactobacillus plantarum</span> (DSM 23375, CNCM I-3235, DSM 19457, DSM 16565, DSM 16568, LMG 21295, CNCM MA 18/5U, NCIMB 30094, VTT E-78076, ATCC PTSA-6139, DSM 18112, DSM 18113, DSM 18114, ATCC 55943 and ATCC 55944) as feed additives for all animal species</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 314 14.11.2012, p. 15)</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>&#9658;M1</a></p></td><td><p><a>                              COMMISSION IMPLEMENTING REGULATION (EU) 2023/1443&#160;of 11&#160;July 2023</a></p></td><td><p>&#160;&#160;L&#160;177</p></td><td><p>59</p></td><td><p>12.7.2023</p></td></tr></table>
COMMISSION IMPLEMENTING REGULATION (EU) No 1065/2012
of 13 November 2012
concerning the authorisation of preparations of Lactobacillus plantarum (DSM 23375, CNCM I-3235, DSM 19457, DSM 16565, DSM 16568, LMG 21295, CNCM MA 18/5U, NCIMB 30094, VTT E-78076, ATCC PTSA-6139, DSM 18112, DSM 18113, DSM 18114, ATCC 55943 and ATCC 55944) as feed additives for all animal species
(Text with EEA relevance)
Article 1
Authorisation
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
Transitional measures
The preparations specified in the Annex and feed containing them, which are produced and labelled before 4 June 2013 in accordance with the rules applicable before 4 December 2012 may continue to be placed on the market and used until the existing stocks are exhausted.
Article 3
Entry into force
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
<table><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Identification number of the additive</p></td><td><p>Name of the holder of authorisation</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/kg of fresh material</p></td></tr><tr><td><p><span>Category of technological additives. Functional group: silage additives</span></p></td></tr><tr><td><p>1k20716</p></td><td><p>&#8212;</p></td><td><p><span>Lactobacillus plantarum</span> (DSM 23375)</p></td><td><div><p><span>Additive composition</span></p><p>Preparation of<span>Lactobacillus plantarum</span> (DSM 23375) containing a minimum of 2&#160;&#215; 10<span>10</span> CFU/g additive</p></div><div><p><span>Characterisation of the active substance</span></p><p><span>Lactobacillus plantarum</span> (DSM 23375)</p></div><div><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)</p><p>Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).</p></div></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#160;</p><div/></td><td><p>&#8212;</p></td><td><p>1.&#160;&#160;In the directions for use of the additive and premixture, indicate the storage temperature and storage life.</p><p>2.&#160;&#160;Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1&#160;&#215; 10<span>8</span> CFU/kg fresh material.</p><p>3.&#160;&#160;For safety: it is recommended to use breathing protection and gloves during handling.</p></td><td><p>4 December 2022</p></td></tr><tr><td><p>1k20717</p></td><td><p>&#8212;</p></td><td><p><span>Lactobacillus plantarum</span> (CNCM I-3235)</p></td><td><div><p><span>Additive composition</span></p><p>Preparation of<span>Lactobacillus plantarum</span> (CNCM I-3235) containing a minimum of 5&#160;&#215; 10<span>10</span> CFU/g additive</p></div><div><p><span>Characterisation of the active substance</span></p><p><span>Lactobacillus plantarum</span> (CNCM I-3235)</p></div><div><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)</p><p>Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).</p></div></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#160;</p><div/></td><td><p>&#8212;</p></td><td><p>1.&#160;&#160;In the directions for use of the additive and premixture, indicate the storage temperature and storage life.</p><p>2.&#160;&#160;Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 2&#160;&#215; 10<span>7</span> CFU/kg fresh material.</p><p>3.&#160;&#160;For safety: it is recommended to use breathing protection and gloves during handling.</p></td><td><p>4 December 2022</p></td></tr><tr><td><p><a>&#9660;M1</a>&#160;&#8212;&#8212;&#8212;&#8212;&#8212;</p></td></tr><tr><td><p><a>&#9660;B</a></p></td></tr><tr><td><p>1k20719</p></td><td><p>&#8212;</p></td><td><p><span>Lactobacillus plantarum</span> (DSM 16565)</p></td><td><div><p><span>Additive composition</span></p><p>Preparation of<span>Lactobacillus plantarum</span> (DSM 16565) containing a minimum of 5&#160;&#215; 10<span>10</span> CFU/g additive</p></div><div><p><span>Characterisation of the active substance</span></p><p><span>Lactobacillus plantarum</span> (DSM 16565)</p></div><div><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)</p><p>Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).</p></div></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#160;</p><div/></td><td><p>&#8212;</p></td><td><p>1.&#160;&#160;In the directions for use of the additive and premixture, indicate the storage temperature and storage life.</p><p>2.&#160;&#160;Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1&#160;&#215; 10<span>8</span> CFU/kg fresh material.</p><p>3.&#160;&#160;For safety: it is recommended to use breathing protection and gloves during handling.</p></td><td><p>4 December 2022</p></td></tr><tr><td><p>1k20720</p></td><td><p>&#8212;</p></td><td><p><span>Lactobacillus plantarum</span> (DSM 16568)</p></td><td><div><p><span>Additive composition</span></p><p>Preparation of<span>Lactobacillus plantarum</span> (DSM 16568) containing a minimum of 5&#160;&#215; 10<span>10</span> CFU/g additive</p></div><div><p><span>Characterisation of the active substance</span></p><p><span>Lactobacillus plantarum</span> (DSM 16568)</p></div><div><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)</p><p>Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).</p></div></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#160;</p><div/></td><td><p>&#8212;</p></td><td><p>1.&#160;&#160;In the directions for use of the additive and premixture, indicate the storage temperature and storage life.</p><p>2.&#160;&#160;Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1&#160;&#215; 10<span>8</span> CFU/kg fresh material.</p><p>3.&#160;&#160;For safety: it is recommended to use breathing protection and gloves during handling.</p></td><td><p>4 December 2022</p></td></tr><tr><td><p>1k20721</p></td><td><p>&#8212;</p></td><td><p><span>Lactobacillus plantarum</span> (LMG 21295)</p></td><td><div><p><span>Additive composition</span></p><p>Preparation of<span>Lactobacillus plantarum</span> (LMG 21295) containing a minimum of 5&#160;&#215; 10<span>10</span> CFU/g additive</p></div><div><p><span>Characterisation of the active substance</span></p><p><span>Lactobacillus plantarum</span> (LMG 21295)</p></div><div><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)</p><p>Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).</p></div></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#160;</p><div/></td><td><p>&#8212;</p></td><td><p>1.&#160;&#160;In the directions for use of the additive and premixture, indicate the storage temperature and storage life.</p><p>2.&#160;&#160;Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1&#160;&#215; 10<span>8</span> CFU/kg fresh material.</p><p>3.&#160;&#160;For safety: it is recommended to use breathing protection and gloves during handling.</p></td><td><p>4 December 2022</p></td></tr><tr><td><p>1k20722</p></td><td><p>&#8212;</p></td><td><p><span>Lactobacillus plantarum</span> (CNCM MA 18/5U)</p></td><td><div><p><span>Additive composition</span></p><p>Preparation of<span>Lactobacillus plantarum</span> (CNCM MA 18/5U) containing a minimum of 2&#160;&#215; 10<span>10</span> CFU/g additive</p></div><div><p><span>Characterisation of the active substance</span></p><p><span>Lactobacillus plantarum</span> (CNCM MA 18/5U)</p></div><div><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)</p><p>Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).</p></div></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#160;</p><div/></td><td><p>&#8212;</p></td><td><p>1.&#160;&#160;In the directions for use of the additive and premixture, indicate the storage temperature and storage life.</p><p>2.&#160;&#160;Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1&#160;&#215; 10<span>8</span> CFU/kg fresh material.</p><p>3.&#160;&#160;For safety: it is recommended to use breathing protection and gloves during handling.</p></td><td><p>4 December 2022</p></td></tr><tr><td><p>1k20723</p></td><td><p>&#8212;</p></td><td><p><span>Lactobacillus plantarum</span> (NCIMB 30094)</p></td><td><div><p><span>Additive composition</span></p><p>Preparation of<span>Lactobacillus plantarum</span> (NCIMB 30094) containing a minimum of 5&#160;&#215; 10<span>10</span> CFU/g additive</p></div><div><p><span>Characterisation of the active substance</span></p><p><span>Lactobacillus plantarum</span> (NCIMB 30094)</p></div><div><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)</p><p>Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).</p></div></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#160;</p><div/></td><td><p>&#8212;</p></td><td><p>1.&#160;&#160;In the directions for use of the additive and premixture, indicate the storage temperature and storage life.</p><p>2.&#160;&#160;Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1&#160;&#215; 10<span>9</span> CFU/kg fresh material.</p><p>3.&#160;&#160;For safety: it is recommended to use breathing protection and gloves during handling.</p></td><td><p>4 December 2022</p></td></tr><tr><td><p>1k20724</p></td><td><p>&#8212;</p></td><td><p><span>Lactobacillus plantarum</span> (VTT E-78076)</p></td><td><div><p><span>Additive composition</span></p><p>Preparation of<span>Lactobacillus plantarum</span> (VTT E-78076) containing a minimum of 1&#160;&#215; 10<span>11</span> CFU/g additive</p></div><div><p><span>Characterisation of the active substance</span></p><p><span>Lactobacillus plantarum</span> (VTT E-78076)</p></div><div><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)</p><p>Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).</p></div></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#160;</p><div/></td><td><p>&#8212;</p></td><td><p>1.&#160;&#160;In the directions for use of the additive and premixture, indicate the storage temperature and storage life.</p><p>2.&#160;&#160;Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1&#160;&#215; 10<span>9</span> CFU/Kg fresh material.</p><p>3.&#160;&#160;The additive shall be used in easy and moderately difficult to ensile material&#160;<a>(<span>2</span>)</a>.</p><p>4.&#160;&#160;For safety: it is recommended to use breathing protection and gloves during handling.</p></td><td><p>4 December 2022</p></td></tr><tr><td><p>1k20725</p></td><td><p>&#8212;</p></td><td><p><span>Lactobacillus plantarum</span> (ATCC PTSA-6139)</p></td><td><div><p><span>Additive composition</span></p><p>Preparation of<span>Lactobacillus plantarum</span> (ATCC PTSA-6139) containing a minimum of 1&#160;&#215; 10<span>10</span> CFU/g additive</p></div><div><p><span>Characterisation of the active substance</span></p><p><span>Lactobacillus plantarum</span> (ATCC PTSA-6139)</p></div><div><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)</p><p>Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).</p></div></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>1.&#160;&#160;In the directions for use of the additive and premixture, indicate the storage temperature and storage life.</p><p>2.&#160;&#160;Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 2&#160;&#215; 10<span>7</span> CFU/kg fresh material.</p><p>3.&#160;&#160;The additive shall be used in easy to ensile material&#160;<a>(<span>3</span>)</a>.</p><p>4.&#160;&#160;For safety: it is recommended to use breathing protection and gloves during handling.</p></td><td><p>4 December 2022</p></td></tr><tr><td><p>1k20726</p></td><td><p>&#8212;</p></td><td><p><span>Lactobacillus plantarum</span> (DSM 18112)</p></td><td><div><p><span>Additive composition</span></p><p>Preparation of<span>Lactobacillus plantarum</span> (DSM 18112) containing a minimum of 1&#160;&#215; 10<span>10</span> CFU/g additive</p></div><div><p><span>Characterisation of the active substance</span></p><p><span>Lactobacillus plantarum</span> (DSM 18112)</p></div><div><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)</p><p>Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).</p></div></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>1.&#160;&#160;In the directions for use of the additive and premixture, indicate the storage temperature and storage life.</p><p>2.&#160;&#160;Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 5&#160;&#215; 10<span>6</span> CFU/kg fresh material.</p><p>3.&#160;&#160;The additive shall be used in easy to ensile material&#160;<a>(<span>3</span>)</a>.</p><p>4.&#160;&#160;For safety: it is recommended to use breathing protection and gloves during handling.</p></td><td><p>4 December 2022</p></td></tr><tr><td><p>1k20727</p></td><td><p>&#8212;</p></td><td><p><span>Lactobacillus plantarum</span> (DSM 18113)</p></td><td><div><p><span>Additive composition</span></p><p>Preparation of<span>Lactobacillus plantarum</span> (DSM 18113) containing a minimum of 1&#160;&#215; 10<span>10</span> CFU/g additive</p></div><div><p><span>Characterisation of the active substance</span></p><p><span>Lactobacillus plantarum</span> (DSM 18113)</p></div><div><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)</p><p>Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).</p></div></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>1.&#160;&#160;In the directions for use of the additive and premixture, indicate the storage temperature and storage life.</p><p>2.&#160;&#160;Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 2&#160;&#215; 10<span>7</span> CFU/kg fresh material.</p><p>3.&#160;&#160;The additive shall be used in easy to ensile material&#160;<a>(<span>3</span>)</a>.</p><p>4.&#160;&#160;For safety: it is recommended to use breathing protection and gloves during handling.</p></td><td><p>4 December 2022</p></td></tr><tr><td><p>1k20728</p></td><td><p>&#8212;</p></td><td><p><span>Lactobacillus plantarum</span> (DSM 18114)</p></td><td><div><p><span>Additive composition</span></p><p>Preparation of<span>Lactobacillus plantarum</span> (DSM 18114) containing a minimum of 1&#160;&#215; 10<span>10</span> CFU/g additive</p></div><div><p><span>Characterisation of the active substance</span></p><p><span>Lactobacillus plantarum</span> (DSM 18114)</p></div><div><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)</p><p>Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).</p></div></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>1.&#160;&#160;In the directions for use of the additive and premixture, indicate the storage temperature and storage life.</p><p>2.&#160;&#160;Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 2&#160;&#215; 10<span>7</span> CFU/kg fresh material.</p><p>3.&#160;&#160;The additive shall be used in easy to ensile material&#160;<a>(<span>3</span>)</a>.</p><p>4.&#160;&#160;For safety: it is recommended to use breathing protection and gloves during handling.</p></td><td><p>4 December 2022</p></td></tr><tr><td><p>1k20729</p></td><td><p>&#8212;</p></td><td><p><span>Lactobacillus plantarum</span> (ATCC 55943)</p></td><td><div><p><span>Additive composition</span></p><p>Preparation of<span>Lactobacillus plantarum</span> (ATCC 55943) containing a minimum of 1&#160;&#215; 10<span>10</span> CFU/g additive</p></div><div><p><span>Characterisation of the active substance</span></p><p><span>Lactobacillus plantarum</span> (ATCC 55943)</p></div><div><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)</p><p>Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).</p></div></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>1.&#160;&#160;In the directions for use of the additive and premixture, indicate the storage temperature and storage life.</p><p>2.&#160;&#160;Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 2&#160;&#215; 10<span>7</span> CFU/kg fresh material.</p><p>3.&#160;&#160;The additive shall be used in easy to ensile material&#160;<a>(<span>3</span>)</a>.</p><p>4.&#160;&#160;For safety: it is recommended to use breathing protection and gloves during handling.</p></td><td><p>4 December 2022</p></td></tr><tr><td><p>1k20730</p></td><td><p>&#8212;</p></td><td><p><span>Lactobacillus plantarum</span> (ATCC 55944)</p></td><td><div><p><span>Additive composition</span></p><p>Preparation of<span>Lactobacillus plantarum</span> (ATCC 55944) containing a minimum of 1&#160;&#215; 10<span>10</span> CFU/g additive</p></div><div><p><span>Characterisation of the active substance</span></p><p><span>Lactobacillus plantarum</span> (ATCC 55944)</p></div><div><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)</p><p>Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).</p></div></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>1.&#160;&#160;In the directions for use of the additive and premixture, indicate the storage temperature and storage life.</p><p>2.&#160;&#160;Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 5&#160;&#215; 10<span>6</span> CFU/kg fresh material.</p><p>3.&#160;&#160;The additive shall be used in easy to ensile material&#160;<a>(<span>3</span>)</a>.</p><p>4.&#160;&#160;For safety: it is recommended to use breathing protection and gloves during handling.</p></td><td><p>4 December 2022</p></td></tr><tr><td><div><a>(<span>1</span>)&#160;&#160;&#160;</a><p>Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx</p></div><div><a>(<span>2</span>)&#160;&#160;&#160;</a><p>Easy to ensile forage: &gt; 3&#160;% soluble carbohydrates in fresh material (e.g. whole plant maize, ryegrass, brome grass or sugar beet pulp). Moderately difficult to ensile forages: 1,5-3,0&#160;% soluble carbohydrate in fresh material (e.g. meadow grass, fescue or wilted alfalfa). Commission Regulation (EC) No 429/2008 (OJ L 133, 22.5.2008, p. 1).</p></div><div><a>(<span>3</span>)&#160;&#160;&#160;</a><p>Easy to ensile forage: &gt; 3&#160;% soluble carbohydrates in fresh material (e.g. whole plant maize, ryegrass, brome grass or sugar beet pulp). Regulation (EC) No 429/2008.</p></div></td></tr></tbody></table>