Commission Implementing Regulation (EU) 2018/1543 of 15 October 2018 concerning the authorisation of a preparation of Pediococcus pentosaceus DSM 32291 as a feed additive for all animal species (Text with EEA relevance)
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Address https://gelex.eu/eli/EU/regulation/2018/1543@2018-10-15/en
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, 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 Pediococcus pentosaceus DSM 32291. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3) That application concerns the authorisation of a preparation of Pediococcus pentosaceus DSM 32291 as a feed additive for all animal species, to be classified in the additive category technological additives.
(4) The European Food Safety Authority (the Authority) concluded in its opinion of 21 February 2018 that, under the proposed conditions of use, the preparation of Pediococcus pentosaceus DSM 32291 does not have an adverse effect on animal health, human health or the environment. The Authority also concluded that the preparation concerned has the potential to improve the production of silage from easy, and moderately difficult to ensile forage materials. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5) The assessment of the preparation of Pediococcus pentosaceus DSM 32291 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.
(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 1
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 2
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, 15 October 2018. For the Commission The President Jean-Claude Juncker
ANNEX
Grp. composition. Preparation of Pediococcus pentosaceus DSM 32291 containing a minimum of 8 × 1010 CFU/g additive. Grp_of_the_active. substance. Viable cells Pediococcus pentosaceus DSM 32291 Grp. method. Enumeration in the feed additive: spread plate method on MRS agar (EN 15786) Identification of the feed additive: Pulsed Field Gel Electrophoresis (PFGE). Anx. annex. Identification number of the 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 of additive/kg of fresh material Technological additives: silage additives 1k21015 Pediococcus pentosaceus DSM 32291 All animal species — — — In the directions for use of the additive and premixture, the storage conditions shall be indicated. Minimum content of Pediococcus pentosaceus DSM 32291 when used without combination with other micro-organisms as silage additives: 5 × 107 CFU/kg of easy and moderately difficult to ensile fresh material. 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. 5.11.2028
ANNEX 1.2.3.
Identification number of the 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 of additive/kg of fresh material Technological additives: silage additives 1k21015 Pediococcus pentosaceus DSM 32291 All animal species — — — In the directions for use of the additive and premixture, the storage conditions shall be indicated. Minimum content of Pediococcus pentosaceus DSM 32291 when used without combination with other micro-organisms as silage additives: 5 × 107 CFU/kg of easy and moderately difficult to ensile fresh material. 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. 5.11.2028 Grp. composition. Preparation of Pediococcus pentosaceus DSM 32291 containing a minimum of 8 × 1010 CFU/g additive. Grp_of_the_active. substance. Viable cells Pediococcus pentosaceus DSM 32291 Grp. method. Enumeration in the feed additive: spread plate method on MRS agar (EN 15786) Identification of the feed additive: Pulsed Field Gel Electrophoresis (PFGE).
ANNEX Additive composition
Preparation of Pediococcus pentosaceus DSM 32291 containing a minimum of 8 × 1010 CFU/g additive.
Characterisation of the active substance
Viable cells Pediococcus pentosaceus DSM 32291
Analytical method
Enumeration in the feed additive: spread plate method on MRS agar (EN 15786) Identification of the feed additive: Pulsed Field Gel Electrophoresis (PFGE).