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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 and renewing such authorisation.
(2)Preparations of Lactiplantibacillus plantarum DSM 3676 (previously taxonomically identified as Lactobacillus plantarum DSM 3676), Lactiplantibacillus plantarum DSM 3677 (previously taxonomically identified as Lactobacillus plantarum DSM 3677) and Lentilactobacillus buchneri DSM 13573 (previously taxonomically identified as Lactobacillus buchneri DSM 13573) were authorised for a period of 10 years as feed additives for all animal species by Commission Implementing Regulation (EU) No 1119/2012note.
(3)In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of preparations of Lactiplantibacillus plantarum DSM 3676, Lactiplantibacillus plantarum DSM 3677 and Lentilactobacillus buchneri DSM 13573 as feed additives for all animal species, requesting the additives to be classified in the additive category ‘technological additives’ and in the functional group ‘silage additives’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.
(4)The European Food Safety Authority (‘the Authority’) concluded in its opinion of 5 July 2023note that the preparations of Lactiplantibacillus plantarum DSM 3676, Lactiplantibacillus plantarum DSM 3677 and Lentilactobacillus buchneri DSM 13573 remain safe for all animal species, the consumers and the environment under the conditions of use currently authorised. It also concluded that the additives are not irritant to skin or eyes and that they should be considered respiratory sensitisers. No conclusions could be drawn on their skin sensitisation potential. The Authority indicated that there is no need for assessing the efficacy of the additives as the application for renewal of the three authorisations does not include a proposal for amending or supplementing the conditions of the original authorisations that would have an impact on the efficacy of the additives.
(5)The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the assessment carried out regarding the method of analysis of the preparations of Lactiplantibacillus plantarum DSM 3676, Lactiplantibacillus plantarum DSM 3677 and Lentilactobacillus buchneri DSM 13573 as feed additives in the context of the previous authorisation are valid and applicable for the current application. In accordance with Article 5(4), point (c) of Commission Regulation (EC) No 378/2005note, an evaluation report of the Reference Laboratory is therefore not required.
(6)In view of the above, the Commission considers that the preparations of Lactiplantibacillus plantarum DSM 3676, Lactiplantibacillus plantarum DSM 3677 and Lentilactobacillus buchneri DSM 13573 satisfy the conditions, as provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of those additives should be renewed. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additives. Those protective measures should be without prejudice to other workers’ safety requirements under Union law.
(7)As a consequence of the renewal of the authorisation of the preparations of Lactiplantibacillus plantarum DSM 3676, Lactiplantibacillus plantarum DSM 3677 and Lentilactobacillus buchneri DSM 13573 as feed additives, Implementing Regulation (EU) No 1119/2012 should be repealed.
(8)Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of preparations of Lactiplantibacillus plantarum DSM 3676, Lactiplantibacillus plantarum DSM 3677 and Lentilactobacillus buchneri DSM 13573, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation.
(9)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 1Renewal of the authorisation#
The authorisation of the preparations specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, is renewed subject to the conditions laid down in that Annex.
Article 2Repeal of Implementing Regulation (EU) No 1119/2012#
Implementing Regulation (EU) No 1119/2012 is repealed.
Article 3Transitional measures#
The preparations specified in the Annex and feed containing them, which are produced and labelled before 13 May 2025 in accordance with the rules applicable before 13 May 2024 may continue to be placed on the market and used until the existing stocks are exhausted.
Article 4Entry 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 | ||||||||
| 1k20731 | Lactiplantibacillus plantarum DSM 3676 | Additive compositionPreparation of Lactiplantibacillus plantarum DSM 3676 containing a minimum of 6 × 1011 CFU/g additiveSolid form—————————Characterisation of the active substanceViable cells of Lactiplantibacillus plantarum DSM 3676—————————Analytical methodnoteEnumeration in the feed additive of Lactiplantibacillus plantarum DSM 3676:Spread plate method on MRS agar (EN 15787)Identification of Lactiplantibacillus plantarum DSM 3676:Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods | All animal species | - | - | 1.In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2.Minimum content of the additive when it is not used in combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.3.The additive shall be used in easy and moderately difficult to ensile fresh materialnote.4.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. | 13 May 2034 | |
| 1k20732 | Lactiplantibacillus plantarum DSM 3677 | Additive compositionPreparation of Lactiplantibacillus plantarum DSM 3677containing a minimum of 4 × 1011 CFU/g additiveSolid form—————————Characterisation of the active substanceViable cells of Lactiplantibacillus plantarum DSM 3677—————————Analytical methodnoteEnumeration in the feed additive of Lactiplantibacillus plantarum DSM 3677:Spread plate method on MRS agar (EN 15787)Identification of Lactiplantibacillus plantarum DSM 3677:Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods | All animal species | - | - | 1.In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2.Minimum content of the additive when it is not used in combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.3.The additive shall be used in easy and moderately difficult to ensile fresh materialnote.4.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. | 13 May 2034 | |
| 1k20733 | Lentilactobacillus buchneri DSM 13573 | Additive compositionPreparation of Lentilactobacillus buchneri DSM 13573 containing a minimum of 2 × 1011 CFU/g additiveSolid form—————————Characterisation of the active substanceViable cells of Lentilactobacillus buchneri DSM 13573—————————Analytical methodnoteEnumeration in the feed additive of Lentilactobacillus buchneri DSM 13573:Spread plate method on MRS agar (EN 15787)Identification of Lentilactobacillus buchneri DSM 13573:Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods | All animal species | - | - | 1.In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2.Minimum content of the additive when it is not used in combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.3.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. | 13 May 2034 |
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