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.)

• CELEX: Implementing Regulation (EU) 2019/1313
• Articles: 3

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 .

Schedules & Appendices

ANNEX

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 × 10 9 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 × 10 8

—

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