Commission Implementing Regulation (EU) 2025/313 of 17 February 2025 concerning the authorisation of lanthanum carbonate octahydrate as a feed additive for dogs (holder of authorisation: Porus GmbH)

• CELEX: Implementing Regulation (EU) 2025/313
• Articles: 3

Article 1 Authorisation

The substance 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 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.

Schedules & Appendices

ANNEX

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

mg of additive/kg of complete feedingstuff with a moisture content of 12 %

Category: zootechnical additives. Functional group: other zootechnical additives (decrease in phosphorous excretion via urine)

4d23

Porus GmbH

Lanthanum carbonate octahydrate

Additive composition

Lanthanum carbonate octahydrate having at least 85 % lanthanum carbonate octahydrate as active substance.

Solid form.

Characterisation of the active substance

Lanthanum carbonate octahydrate

La 2 (CO 3 ) 3* 8H 2 O

CAS number 6487-39-4

Analytical method

( 1 )

For the quantification of carbonate in the feed additive: EU method Commission Regulation (EC) No 152/2009)  ( 2 ) .

For the quantification of lanthanum in the feed additive and compound feed: Inductively coupled plasma-atomic emission spectrometry (ICP-AES)

Dogs

-

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.

The additive shall only be fed to adult dogs.

3.

In the directions for use of the additive, the following shall be indicated:

‘For adult dogs. Avoid simultaneous use of feeds with high level of phosphorus.’.

4.

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 protective equipment.

10 March 2035

( 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 .

( 2 )   Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed ( OJ L 54, 26.2.2009, p. 1 , ELI: http://data.europa.eu/eli/reg/2009/152/oj ).