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Commission Implementing Regulation (EU) 2024/220 of 12 January 2024 concerning the renewal of the authorisation of a preparation of Pediococcus pentosaceus NCIMB 30168 as a feed additive for all animal species and amending Implementing Regulation (EU) No 1119/2012

Commission Implementing Regulation (EU) 2024/220 of 12 January 2024 concerning the renewal of the authorisation of a preparation of Pediococcus pentosaceus NCIMB 30168 as a feed additive for all animal species and amending Implementing Regulation (EU) No 1119/2012

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:

  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. The preparation of Pediococcus pentosaceus NCIMB 30168 was authorised for a period of 10 years as a feed additive for all animal species by Commission Implementing Regulation (EU) No 1119/2012(2).

  3. In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of the preparation of Pediococcus pentosaceus NCIMB 30168 as a feed additive for all animal species, requesting the additive 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 that Regulation.

  4. The European Food Safety Authority (‘the Authority’) concluded in its opinion of 11 May 2023(3) that the preparation of Pediococcus pentosaceus NCIMB 30168 remains safe for all animal species, the consumers and the environment under the conditions of use currently authorised, including the proposed use of a new cryoprotectant in the formulation of the preparation. It also concluded that the additive should be considered a respiratory sensitiser but no conclusions could be drawn on the skin sensitisation and on the skin and eye irritancy potential of the additive. The Authority also indicated that there is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

  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 preparation of Pediococcus pentosaceus NCIMB 30168 as a feed additive 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 378/2005(4), an evaluation report of the Reference Laboratory is therefore not required.

  6. In view of the above, the Commission considers that the preparation of Pediococcus pentosaceus NCIMB 30168 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive 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 additive.

  7. As a consequence of the renewal of the authorisation of the preparation of Pediococcus pentosaceus NCIMB 30168 as a feed additive, Implementing Regulation (EU) No 1119/2012 should be amended.

  8. 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 1 Renewal of the authorisation

The authorisation of the preparation 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 2 Amendment to Implementing Regulation (EU) No 1119/2012

In the Annex to Implementing Regulation (EU) No 1119/2012, entry 1k2107 on ‘Pediococcus pentosaceus NCIMB 30168’ is deleted.

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.

Done at Brussels, 12 January 2024.

For the Commission

The President

Ursula von der Leyen

ANNEX