# L_2022231EN.01011301.xml

| 6.9.2022 | EN | Official Journal of the European Union | L 231/113 |
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6.9.2022

EN

Official Journal of the European Union

L 231/113

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COMMISSION IMPLEMENTING REGULATION (EU) 2022/1471

of 5 September 2022

concerning the authorisation of lanthanum carbonate octahydrate as a feed additive for cats (holder of authorisation Porus GmbH)

(Text with EEA relevance)

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 nutrition (1), 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. |
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(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. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
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(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of lanthanum carbonate octahydrate. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | That application concerns the authorisation of lanthanum carbonate octahydrate as a feed additive for cats to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘other zootechnical additives’. |
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(3)

That application concerns the authorisation of lanthanum carbonate octahydrate as a feed additive for cats to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘other zootechnical additives’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 January 2022 (2) that, under the proposed conditions of use, lanthanum carbonate octahydrate does not have an adverse effect on animal health. The Authority concluded that the additive has a potential to be efficacious as a zootechnical additive in cats. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
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(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 January 2022 (2) that, under the proposed conditions of use, lanthanum carbonate octahydrate does not have an adverse effect on animal health. The Authority concluded that the additive has a potential to be efficacious as a zootechnical additive in cats. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (5) | The assessment of the lanthanum carbonate octahydrate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. |
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(5)

The assessment of the lanthanum carbonate octahydrate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.

| (6) | The use of that preparation should therefore be authorised as specified in the Annex to this Regulation. |
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(6)

The use of that preparation should therefore be authorised as specified in the Annex to this Regulation.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(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 1

The additive 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, 5 September 2022.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  EFSA Journal 2022;20(2):7168.

2

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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 |
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| 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) |
| 4d23 | Porus GmbH | Lanthanum carbonate octahydrate | Additive composition

  Preparation of lanthanum carbonate octahydrate having at least 85 % lanthanum carbonate octahydrate as active substance.
  Solid form

  Characterisation of the active substance

  Lanthanum carbonate octahydrate
  La2(CO3)3*8H2O
  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 (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 premixture, the storage conditions and stability to heat treatment shall be indicated. |

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 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)

4d23

Porus GmbH

Lanthanum carbonate octahydrate

Additive composition

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

Solid form

Characterisation of the active substance

Lanthanum carbonate octahydrate

La2(CO3)3*8H2O

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 (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 premixture, 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. |
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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. | In the directions for use of the additive, the following shall be indicated:
  ‘Avoid simultaneous use of feeds with high level of phosphorus.’ |
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3.

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

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

26 September 2032

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(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

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