Contents
THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutritionnote, and in particular Article 9(2) thereof,Whereas:
(1)Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation.
(2)In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of lanthanum carbonate octahydrate as a feed additive. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3)The application concerns the authorisation of lanthanum carbonate octahydrate as a feed additive for dogs, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘other zootechnical additives’.
(4)The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 March 2024note that, under the proposed conditions of use, lanthanum carbonate octahydrate is safe for adult dogs at the maximum recommended level of 7500 mg/kg complete feed. It also concluded that lanthanum carbonate octahydrate is not irritant to skin or eyes, is not a skin sensitiser and exposure by inhalation is considered to be unlikely. The Authority further concluded that lanthanum carbonate octahydrate is efficacious in the reduction of phosphorus bioavailability in adult dogs at the minimum inclusion level of 1500 mg/kg complete feed. It did not consider that there is a need for specific requirements of post-market monitoring.
(5)The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in a previous assessment of the same substance for its use in cats, regarding the methods used for the control of the lanthanum carbonate octahydrate in animal feed, are valid and applicable for the current application. In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005note, an evaluation report of the Reference Laboratory is therefore not required.
(6)In view of the above, the Commission considers that lanthanum carbonate octahydrate satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive.
(7)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1Authorisation#
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 2Entry 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.
| 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 compositionLanthanum carbonate octahydrate having at least 85 % lanthanum carbonate octahydrate as active substance.Solid form.Characterisation of the active substanceLanthanum carbonate octahydrateLa2(CO3)3*8H2OCAS number 6487-39-4Analytical methodnoteFor the quantification of carbonate in the feed additive: EU method Commission Regulation (EC) No 152/2009)note.For the quantification of lanthanum in the feed additive and compound feed: Inductively coupled plasma-atomic emission spectrometry (ICP-AES) | Dogs | - | 1500 | 7500 | 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 |
Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.