
Article 1 
The authorisation of the additive specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is renewed subject to the conditions laid down in that Annex.
Article 2 
Regulation (EC) No 163/2008 is repealed.
Article 3 
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, 29 May 2019.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX

Identification number of the additive Name of the holder of authorisation Additive Composition, chemical formula, description, analytical method Species or category of animal Minimum content Maximum content Other provisions End of period of authorisation
mg of additive/kg of complete feedingstuff with a moisture content of 12 %
Category of zootechnical additives. Functional group: other zootechnical additives (decrease in phosphorous excretion via urine)
4d1 Bayer HealthCare AG Lanthanum carbonate octahydrate 
Preparation of Lanthanum carbonate octahydrate

At least 85 % Lanthanum carbonate octahydrate as active substance.

Lanthanum carbonate octahydrate

La2(CO3)3*8H2O

CAS number 6487-39-4

For the quantification of Carbonate in the feed additive:

Community Method (Reg. (EC) No 152/2009 – Annex III-O)

For the quantification of Lanthanum in the feed additive and feedingstuffs:

Inductively Coupled Plasma Atomic Emission Spectrometry (ICP-AES)
 Cats 1 500 7 500 
1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

2. 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 breathing protection.

3. 
'avoid simultaneous use of feeds with high level of phosphorus.'.
 25 June 2029
