Commission Implementing Regulation (EU) 2019/1313 of 2 August 2019 concerning the authorisation of a preparation of Bacillus amyloliquefaciens NRRL B-50508, Bacillus amyloliquefaciens NRRL B-50509 and Bacillus subtilis NRRL B-50510 as a feed additive for pigs for fattening and minor porcine species for fattening (holder of authorisation Cargill Incorporated, represented by Provimi Holding BV) (Text with EEA relevance.)
Date: 2019-08-02
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, fattening, market approval, swine, texture agent




L_2019205EN.01000101.xml










5.8.2019   


EN


Official Journal of the European Union


L 205/1








            COMMISSION IMPLEMENTING REGULATION (EU) 2019/1313
of 2 August 2019
         
concerning the authorisation of a preparation of Bacillus amyloliquefaciens NRRL B-50508, Bacillus amyloliquefaciens NRRL B-50509 and Bacillus subtilis NRRL B-50510 as a feed additive for pigs for fattening and minor porcine species for fattening (holder of authorisation Cargill Incorporated, represented by Provimi Holding BV)
(Text with EEA relevance)


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 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 amyloliquefaciens NRRL B-50508, Bacillus amyloliquefaciens NRRL B-50509 and Bacillus subtilis NRRL B-50510. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.












(3)


That application concerns the authorisation of a preparation of Bacillus amyloliquefaciens NRRL B-50508, Bacillus amyloliquefaciens NRRL B-50509 and Bacillus subtilis NRRL B-50510 as a feed additive for pigs for fattening and minor porcine species for fattening, to be classified in the additive category ‘zootechnical additives’.












(4)


The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 February 2019 (2) that, under the proposed conditions of use, the preparation Bacillus amyloliquefaciens NRRL B-50508, Bacillus amyloliquefaciens NRRL B-50509 and Bacillus subtilis NRRL B-50510 does not have an adverse effect on animal health or the environment. It also concluded that the additive is considered as a potential respiratory sensitiser, even if with a low dusting potential, and that no conclusion could be drawn on skin or eyes sensitisation or irritation by the additive. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the additive has a potential to be efficacious in feed to gain ratio in pigs for fattening at the recommended dose and that this conclusion can be extended to minor porcine species for fattening. 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 Bacillus amyloliquefaciens NRRL B-50508, Bacillus amyloliquefaciens NRRL B-50509 and Bacillus subtilis NRRL B-50510 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 ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition as set out 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, 2 August 2019.


For the Commission


The President

Jean-Claude JUNCKER
            





(1)  
            OJ L 268, 18.10.2003, p. 29.

(2)  
            EFSA Journal 2019;17(3):5647.




ANNEX














Identification number of the additive


Name of the holder of authorisation


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 complete feedingstuff with a moisture content of 12 %





Category of zootechnical additives. Functional group: gut flora stabilisers






4b1893


Cargill Incorporated, represented by Provimi Holding BV



Bacillus amyloliquefaciens NRRL B-50508, Bacillus amyloliquefaciens NRRL B-50509 and

Bacillus subtilis NRRL B-50510



Additive composition:

Preparation of Bacillus amyloliquefaciens NRRL B-50508, Bacillus amyloliquefaciens NRRL B-50509 and Bacillus subtilis NRRL B-50510 containing a minimum of: Bacillus spp. 2,5 × 109 CFU/g (ratio 1:1:1)
Powder form

Characterisation of the active substance:

Viable spore of Bacillus amyloliquefaciens NRRL B-50508, Bacillus amyloliquefaciens NRRL B-50509 and Bacillus subtilis NRRL B-50510

Analytical method
 (1)

For the identification: Pulsed Field Gel Electrophoresis (PFGE)
For enumeration in the feed additive, premixtures and feedingstuffs: Spread plate method on tryptone soya agar (EN 15784)


Pigs for fattening
Minor porcine species for fattening


—


1,5 × 108



—








1.


In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.










2.


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 and skin protection.






25 August 2029






(1)  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