
Article 1 
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.
Article 2 
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.Done at Brussels, 18 September 2012.
For the Commission
The President
José Manuel BARROSO
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
mg/kg of complete feedingstuff with a moisture content of 12 %
Category of zootechnical additives. Functional group: other zootechnical additives (decrease in phosphorus excretion via urine)
4d1 Bayer Animal Health GmbH Lanthanum carbonate octahydrate 
 Additive composition
 Preparation of lanthanum carbonate octahydrate.
 At least 85 % lanthanum carbonate octahydrate as active substance
 Characterisation of the active substance
 Lanthanum carbonate octahydrate
 La2 (CO3)3 · 8H2O
 CAS number 6487-39-4
 Analytical method
 Quantification of carbonate in the feed additive:
Community method (Commission Regulation (EC) No 152/2009)
 Quantification of lanthanum in the feed additive and feedingstuff: inductively coupled plasma atomic emission spectrometry (ICP-AES). Dogs — 1 500 7 500 Post-market monitoring on chronic adverse effects is required.In the directions for use of the additive:'
— for adult dogs
— recommended dose of inclusion in moist feed with 20-25 % dry matter content: 340 to 2 100 mg per kg
— avoid simultaneous use of feeds with high level of phosphorus' 9 October 2022

