Authorisation
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
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.
ANNEXSupplementary provisions
ANNEX
Identification number of the feed 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
Number of chlamydospores/kg of complete feedingstuff with a moisture content of 12 %
Category: zootechnical additives. Functional group: other zootechnical additives (reduction of the number of infective nematode larvae on pasture)
4d27
International Animal Health Products Pty Ltd, represented by GAB Consulting GmbH
Duddingtonia flagrans NCIMB 30336
Additive composition
Preparation of Duddingtonia flagrans NCIMB 30336 containing a minimum of 5 × 10 5 chlamydospores/g additive.
Solid form.
Characterisation of the active substance
Viable chlamydospores of Duddingtonia flagrans NCIMB 30336
Analytical method
( 1 )
For the identification of Duddingtonia flagrans NCIMB 30336: DNA based methods.
For the enumeration of viable chlamydospores of Duddingtonia flagrans NCIMB 30336 in the feed additive, premixtures and compound feed: the method using yeast mannitol agar (YMA) with streptomycin and chloramphenicol and a most probable number (MPN) for the enumeration.
Dairy cows
Dairy cows of minor bovine species
-
8,5 × 10 5
8,5 × 10 6
1.
In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
2.
The additive shall only be used in feed for grazing animals.
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 by such procedures and measures, the additive and premixtures shall be used with personal breathing and skin protective equipment.
11 July 2034
Dairy sheep
Dairy goats
1,3 × 10 6
1,3 × 10 7
( 1 ) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en .