Commission Implementing Regulation (EU) 2020/180 of 7 February 2020 concerning the authorisation of a preparation of Bacillus subtilis KCCM 10673P and Aspergillus oryzae KCTC 10258BP as a feed additive for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/180
• Articles: 3

Article 1

The preparation specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘other technological additives’, 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

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 soybeans

Category of technological additives. Functional group: other technological additives (reduction of anti-nutritional factors in soybean)

1o01

Bacillus subtilis KCCM 10673P

Aspergillus oryzae KCTC 10258BP

Additive composition:

Preparation of Bacillus subtilis KCCM 10673P and Aspergillus oryzae KCTC 10258BP containing respectively a minimum of 1,2 × 10 8 CFU/g additive and 2,0 × 10 8 CFU/g additive.

All animal species

—

Bacillus subtilis

1,2 × 10 6

Aspergillus oryzae

2,0 × 10 6

—

1.

In the directions for use of the additive and premixture, indicate the storage conditions.

2.

The additive shall only be used in soybeans.

3.

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 skin, eyes and breathing protection.

1 March 2030

Characterisation of the active substance:

Viable cells of Bacillus subtilis KCCM 10673P and Aspergillus oryzae KCTC 10258BP.

Analytical method

( 1 )

Enumeration of Bacillus subtilis KCCM 10673P in the feed additive, premixtures and feedingstuffs: Spread plate method on tryptone soya agar (EN 15784).

Identification of Bacillus subtilis KCCM 10673P in the feed additive:

Pulsed Field Gel Electrophoresis (PFGE).

Identification of Aspergillus oryzae KCTC 10258BP in the feed additive: Polymerase Chain Reaction (PCR) typing.

( 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