Commission Implementing Regulation (EU) 2017/930 of 31 May 2017 concerning the authorisation of a preparation of a microorganism strain DSM 11798 of the Coriobacteriaceae family as a feed additive for all avian species and amending Implementing Regulation (EU) No 1016/2013 (Text with EEA relevance. )
Authorisation
The preparation specified in Annex I, belonging to the additive category ‘technological additives’ and to the functional group ‘substances for the reduction of the contamination of feed by mycotoxins’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
Amendments to Implementing Regulation (EU) No 1016/2013
The Annex to Implementing Regulation (EU) No 1016/2013 is replaced by Annex II to this Regulation.
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Supplementary provisions
ANNEX ISupplementary provisions
ANNEX I
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 technological additives. Functional group: substances for the reduction of the contamination of feed by mycotoxins: trichothecenes
1m01
—
Microorganism strain DSM 11798 of the Coriobacteriaceae family
Additive composition
Preparation of a microorganism strain DSM 11798 of the Coriobacteriaceae family containing a minimum of 5 × 10 9 CFU/g of additive.
Solid form
Characterisation of the active substance
Viable cells of: microorganism strain DSM 11798 of the Coriobacteriaceae family
Analytical method
( 1 )
Enumeration of microorganism strain DSM 11798 of the Coriobacteriaceae family: pour plate method using VM agar supplemented with Oxyrase.
Identification of microorganism strain DSM 11798 of the Coriobacteriaceae family: Pulsed Field Gel Electrophoresis (PFGE).
All avian species
—
1,7 × 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.
The use of the additive is allowed in feedingstuffs complying with the European Union legislation on undesirable substances in animal feed.
3.
The use is permitted in feed containing the following authorised coccidiostats: narasin/nicarbazin, salinomycin sodium, monensin sodium, robenidine hydrochloride, diclazuril, narasin, or nicarbazin.
4.
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 breath protections.
21 June 2027
( 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
ANNEX IISupplementary provisions
ANNEX II
‘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 technological additives. Functional group: substances for the reduction of the contamination of feed by mycotoxins: trichothecenes
1m01
—
Microorganism strain DSM 11798 of the Coriobacteriaceae family
Additive composition
Preparation of a microorganism strain DSM 11798 of the Coriobacteriaceae family containing a minimum of 5 × 10 9 CFU/g of additive.
Solid form
Characterisation of the active substance
Viable cells of: microorganism strain DSM 11798 of the Coriobacteriaceae family
Analytical method
( 1 )
Enumeration of microorganism strain DSM 11798 of the Coriobacteriaceae family: pour plate method using VM agar supplemented with Oxyrase.
Identification of microorganism strain DSM 11798 of the Coriobacteriaceae family: Pulsed Field Gel Electrophoresis (PFGE).
Pigs
—
1,7 × 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.
The use of the additive is allowed in feedingstuffs complying with the European Union legislation on undesirable substances in animal feed.
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 breath protections.
13 November 2023
’
( 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
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.