The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
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 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
Content of element (Cu) in mg/kg of complete feedingstuff with a moisture content of 12 %
Category of nutritional additives. Functional group: compounds of trace elements
3b411
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Copper bilysinate
Characterisation of the additive
Powder or granulate with a content of copper ≥ 14,5 % and lysine ≥ 84,0 %.
Characterisation of the active substance
Copper chelate of L-lysinate-HCl
Chemical formula: Cu(C 6 H 13 N 2 O 2 ) 2 × 2HCl
CAS number: 53383-24-7
Analytical methods
( 1 ) :
For the quantification of Lysine content in the feed additive:
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Ion-exchange chromatography combined with post-column derivatisation and colorimetric or fluorescence detection — EN ISO 17180.
For the quantification of total copper content in the feed additive and premixtures:
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Inductively coupled plasma atomic emission spectrometry (ICP-AES) — EN 15510,
or
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Inductively coupled plasma atomic emission spectrometry after pressure digestion, (ICP-AES) — EN 15621.
For the quantification of total copper in the feed materials and compound feed:
—
Atomic absorption spectrometry (AAS) — Commission Regulation (EC) No 152/2009, or
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Inductively coupled plasma atomic emission spectrometry (ICP-AES) — EN 15510, or
—
Inductively coupled plasma atomic emission spectrometry after pressure digestion (ICP-AES) — EN 15621.
All animal species
—
—
Bovines:
—
bovines before the start of rumination: 15 (total),
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other bovines: 35 (total).
Ovines: 15 (total).
Piglets up to 12 weeks: 170 (total).
Crustaceans: 50 (total).
Other animals: 25 (total).
1.
The additive shall be incorporated into feed in the form of a premixture.
2.
For user safety: breathing protection, safety glasses and gloves should be worn during handling.
3.
The following words shall be included in the labelling:
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For feed for sheep if the level of copper in the feed exceeds 10 mg/kg:
‘The level of copper in this feed may cause poisoning in certain breeds of sheep.’
—
For feed for bovines after the start of rumination if the level of copper in the feed is less than 20 mg/kg:
‘The level of copper in this feed may cause copper deficiencies in cattle grazing pastures with high contents of molybdenum or sulphur.’
—
‘The lysine content of the additive should be considered when formulating feed.’
8 December 2024.
( 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