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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 nutritionnote, and in particular Article 9(2) thereof,Whereas:
(1)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.
(2)In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3)The application concerns the authorisation of the preparation of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 as a feed additive for all animal species, requesting that additive to be classified in the category ‘technological additives’ and in the functional group ‘silage additives’.
(4)The European Food Safety Authority (‘the Authority’) concluded in its opinion of 15 October 2024note that the additive consisting of a preparation of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 is safe for all animal species, consumers and the environment. It also concluded that the additive is not an irritant to the skin but should be considered as a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. The latter conclusion would apply to any preparations containing the active agents. The Authority further concluded that the addition of the additive at a minimum level of 1×108 CFU/kg fresh plant material has the potential to improve the aerobic stability of silage from fresh plant material, with a dry matter range between 32 % and 65 %.
(5)In view of the above, the Commission considers that the preparation of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive.
(6)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1Authorisation#
The preparation specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2Entry 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.
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| CFU/kg of fresh material | ||||||||
| Category: technological additives. Functional group: silage additives | ||||||||
| 1k1802 | Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 | Additive compositionPreparation of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 containing a minimum of 3,6 × 1011 CFU/g additive with a ratio 1:4 (7,2 × 1010 CFU Bacillus subtilis DSM 33862/g and 2,88 × 1011 CFU Lentilactobacillus buchneri DSM 12856/g)Solid formCharacterisation of the active substanceViable cells of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856Analytical methodnoteIdentification of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856:DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) (CEN/TS 17697)Enumeration of Bacillus subtilis DSM 33862 in the feed additive: Spread plate method on tryptone soya agar (EN 15784)Enumeration of Lentilactobacillus buchneri DSM 12856 in the feed additive: Spread plate (or pour plate) method on MRS agar (EN 15787) | All animal species | - | - | - | 1.In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2.Minimum dose of the additive when it is not used in combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh plant material.3.The additive shall only be used with easy and moderately difficult to ensile fresh plant materialnote.4.On the label of the additive and premixtures the following shall be indicated: ‘It is recommended to use the additive 1k1802 only with fresh plant material with a dry matter range 32-65 %.’5.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin and breathing protective equipment. | 12.8.2035 |
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