Commission Implementing Regulation (EU) 2020/1395 of 5 October 2020 concerning the renewal of the authorisation of Bacillus amyloliquefaciens CECT 5940 as a feed additive for chickens for fattening, its authorisation for chickens reared for laying, and repealing Regulation (EC) No 1292/2008 (holder of authorisation Evonik Nutrition & Care GmbH) (Text with EEA relevance)

Type Implementing Regulation
Publication 2020-10-05
State In force
Department European Commission, SANTE
Source EUR-Lex
Reform history JSON API

Article 1

The authorisation of the additive specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’ for chickens reared for laying, and for the same category and functional group for chickens for fattening is renewed subject to the conditions laid down in that Annex.

Article 2

Regulation (EC) No 1292/2008 is repealed.

Article 3

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.

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.
4b1822 Evonik Operations GmbH Bacillus amyloliquefaciens CECT 5940 Additive composition Preparation of Bacillus amyloliquefaciens CECT 5940 containing a minimum of: — 1 × 109 CFU/g additive Solid forms Chickens for fattening Chickens reared for laying - 1 × 109 - 1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. 2. May be used in feed containing the permitted coccidiostats: diclazuril, monensin sodium, or nicarbazin. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their 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, glasses and gloves. 26.10.2030
Characterisation of active substance Spores of Bacillus amyloliquefaciens CECT 5940
Analytical method (1) Enumeration: spread plate method using tryptone soya agar (EN 15 784 ) Identification: pulsed-field gel electrophoresis (PFGE) method.
(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

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