Document ID: 02017R0447-20231220
Language: ENG

02017R0447 — EN — 20.12.2023 — 001.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION IMPLEMENTING REGULATION (EU) 2017/447</p><p>of 14 March 2017</p><p>concerning the authorisation of the preparation of<span>Bacillus subtilis</span> (DSM 5750) and<span>Bacillus licheniformis</span> (DSM 5749) as a feed additive for sows, weaned piglets, pigs for fattening, calves for rearing and turkeys for fattening and amending Regulations (EC) No 1453/2004, (EC) No 2148/2004 and (EC) No 600/2005 (holder of authorisation Chr. Hansen A/S)</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 069 15.3.2017, p. 18)</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) 2023/2662&#160;of 29&#160;November 2023</a></p></td><td><p>&#160;&#160;L&#160;</p></td><td><p>1</p></td><td><p>30.11.2023</p></td></tr></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2017/447
of 14 March 2017
concerning the authorisation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) as a feed additive for sows, weaned piglets, pigs for fattening, calves for rearing and turkeys for fattening and amending Regulations (EC) No 1453/2004, (EC) No 2148/2004 and (EC) No 600/2005 (holder of authorisation Chr. Hansen A/S)
(Text with EEA relevance)
Article 1
Authorisation
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2
Amendment to Regulation (EC) No 1453/2004
Annex I to Regulation (EC) No 1453/2004 is deleted.
Article 3
Amendment to Regulation (EC) No 2148/2004
In Annex II to Regulation (EC) No 2148/2004 the entry E 1700 on Bacillus licheniformis (DSM 5749) and Bacillus subtilis (DSM 5750) is deleted.
Article 4
Amendment to Regulation (EC) No 600/2005
In Annex III to Regulation (EC) No 600/2005 the entry E 1700 on Bacillus licheniformis (DSM 5749) and Bacillus subtilis (DSM 5750) is deleted.
Article 5
Transitional measures
The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 4 October 2017 in accordance with the rules applicable before 4 April 2017 may continue to be placed on the market and used until the existing stocks are exhausted.
Article 6
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/><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>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 complete feedingstuff with a moisture content of 12 %</p></td><td><p>CFU/l of water for drinking</p></td></tr><tr><td><p><span>Category of zootechnical additives. Functional group: gut flora stabilisers</span></p></td></tr><tr><td><p>4b1700i</p></td><td><p>Chr. Hansen A/S</p></td><td><p>Bacillus subtilis</p><p>(DSM 5750) and<span>Bacillus licheniformis</span> (DSM 5749)</p></td><td><p><span>Additive composition</span></p><p>Preparation of<span>Bacillus subtilis</span></p><p>(DSM 5750) and<span>Bacillus licheniformis</span> (DSM 5749) containing a minimum of 3,2 &#215; 10<span>10</span> CFU/g of additive</p><p>(1:1 ratio)</p><p>Solid form</p><p><span>Characterisation of the active substance</span></p><p>Viable spores of<span>Bacillus subtilis</span></p><p>(DSM 5750) and<span>Bacillus licheniformis</span> (DSM 5749)</p><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>Identification and enumeration of<span>Bacillus subtilis</span> (DSM 5750) and<span>Bacillus licheniformis</span> (DSM 5749) in the feed additive, premixtures, feedingstuffs and water:</p><div><p>&#8212;&#160;Identification: Pulsed Field Gel Electrophoresis (PFGE)</p></div><div><p>&#8212;&#160;Enumeration: Spread plate method using tryptone soya agar &#8212; EN 15784.</p></div></td><td><p>Weaned piglets</p><p>Pigs for fattening</p><p>Sows</p><p>Calves for rearing</p><p>Turkeys for fattening</p></td><td><p><span>&#8212;</span></p></td><td><p>1,3 &#215; 10<span>9</span></p></td><td><p>&#8212;</p></td><td><p>6,5 &#215; 10<span>8</span></p></td><td><p>&#8212;</p></td><td><p> 1.&#160;&#160;In the directions for use of the additive and premixtures, indicate the storage temperature, storage life and stability to pelleting.<br/> 2.&#160;&#160;The additive may be used in water for drinking.<br/> 3.&#160;&#160;For use of the additive in water for drinking a homogeneous dispersion of the additive shall be ensured.<br/> 4.&#160;&#160;For use in weaned piglets up to 35 kg of body weight.<br/> 5.&#160;&#160;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 and skin protection.<span><a><span>&#9658;M1</span></a></span>&#160;<br/> 6.&#160;&#160;The additive may be used in turkeys for fattening in compound feed containing formic acid, or containing the following coccidiostats, where authorised as feed additives for the same animal species and category: semduramycin, maduramicin ammonium, diclazuril, monensin sodium and lasalocid sodium with a maximum content of 90 mg of lasalocid&#160;sodium/kg of complete feedingstuff with a moisture content of 12 %.<span>&#160;&#9668;</span></p></td><td><p>4 April 2027</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: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports</p></div></td></tr></tbody></table>