Authorisation
The vermiculite specified in the Annex, belonging to the additive category ‘technological additives’ and the functional group ‘anticaking agents’, 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 additive
Name of the 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
mg of additive/kg of complete feed with a moisture content of 12 %
Category: technological additives. Functional group: anticaking agents.
1i561
Vermiculite
Additive composition
Magnesium aluminium iron silicate, (vermiculite) containing ≥ 87,0 %, hydroxyapatite ≥ 1,0 % and diopside (Fe +2 -bearing) ≥ 2,4 %
Powder form.
Characterisation of the active substance
Vermiculite (magnesium aluminium iron silicate):
Obtained by mining and followed by thermal expansion (exfoliation)
Chemical formula: (Mg,Fe 2+ ,Al) 3 (Al,Si) 4 O 10 (OH) 2 ·4(H 2 O) 2 .
Nickel ≤ 148 mg/kg
Crystalline silica ≤ 0,06 %
Chromium ≤ 199 mg/kg
Free of asbestos ( 1 )
Analytical method
( 2 )
For the characterisation of the feed additive:
—
X-ray diffraction (XRD) (EN 13925) and
—
X-ray fluorescence (XRF) spectrometry (EN ISO 12677)
Chickens for fattening
Chickens reared for laying or reproduction
Hens
—
10 000
10 000
1.
In the directions for use of the additive and premixtures, the storage conditions shall be indicated.
2.
When the additive is used as an anticaking agent directly in a feed material or complementary feed, it shall be used at a minimum level of 10 000 mg/kg 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 their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including eye, skin and breathing protection. Particular attention shall be given to compliance with Union legislation on the protection of workers from the inhalation risks related to exposure to crystalline silica and nickel.
2 July 2036
( 1 ) Polarised light microscopy (PLM) and dispersion staining microscopy
( 2 ) 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