Commission Implementing Regulation (EU) 2023/1172 of 15 June 2023 concerning the authorisation of a preparation of lasalocid A sodium (Avatec 150 G) as a feed additive for chickens for fattening, the denial of authorisation of a preparation of lasalocid A sodium (Avatec 150 G) as a feed additive for chickens reared for laying, the withdrawal from the market of a preparation of lasalocid A sodium (Avatec 15 % cc) as a feed additive for chickens for fattening and chickens reared for laying and repealing Regulation (EC) No 1455/2004 and Implementing Regulation (EU) 2021/932 (holder of authorisation: Zoetis Belgium S.A.) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/1172
• Articles: 6

Article 1 Authorisation

The preparation specified in the Annex, belonging to the additive category ‘coccidiostats and histomonostats’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2 Denial of authorisation

The authorisation of the preparation of lasalocid A sodium (Avatec 150 G) as an additive in animal nutrition belonging to the category ‘coccidiostats and histomonostats’ for use for chickens reared for laying, is denied.

Article 3 Withdrawal from the market

The feed additive lasalocid A sodium (Avatec 15 % cc) shall be withdrawn from the market.

Article 4 Repeals

Regulation (EC) No 1455/2004 and Implementing Regulation (EU) 2021/932 are repealed.

Article 5 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 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

Maximum residue limits (MRLs) in the relevant foodstuffs of animal origin

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

Category: coccidiostats and histomonostats

51763

Zoetis Belgium S.A.

Lasalocid A sodium 15 g/100 g (Avatec 150 G)

Additive composition

Preparation of:

Lasalocid A sodium: 15 g/100 g

Calcium lignosulphonate: 4 g/100 g

Ferric oxide: 0,1 g/100 g

Calcium sulphate dihydrate: quantum satis

Characterisation of the active substance

Lasalocid A sodium:

—

C 34 H 54 O 8 Na

—

CAS number: 25999-20-6

—

sodium 6-3R, 4S,5S,7R)-7-[2S,3S,5S)-5-ethyl-5-[(2R,5R,6S)-5-ethyl-5-hydroxy-6-methyltetrahydro-2H-pyran-2-yl]-tetrahydro-3-methyl-2-furyl]-4-hydroxy-3,5-dimethyl-6-oxononyl]-2,3-cresotate

—

produced by Streptomyces lasaliensis subsp. lasaliensis (ATCC 31180)

Related impurities: lasalocid sodium B-E: ≤ 10 %

Analytical method

( 1 )

For the determination of lasalocid A sodium in the feed additive and premixtures: Reversed-Phase High Performance Liquid Chromatography with fluorescence detection (RP-HPLC-FL) – Commission Regulation (EC) No 152/2009.

For the determination of lasalocid A sodium in compound feed:

—

Reversed-Phase High Performance Liquid Chromatography with fluorescence detection (RP-HPLC-FL) – Commission Regulation (EC) No 152/2009 or

—

High Performance Liquid Chromatography coupled with tandem mass spectrometry (LC-MS/MS) – EN 17299

Chickens for fattening

-

90

90

1.

In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.

2.

Use prohibited at least 3 days before slaughter.

3.

Indicate in the directions for use of the additive, premixture and compound feed: ‘Dangerous for equine species’

‘This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances, including tiamulin, can be contra-indicated.’

4.

A post-market monitoring program on the resistance of Eimeria spp. shall be planned and executed by the holder of authorisation, in accordance with Commission Regulation (EC) No 429/2008.

5.

The additive shall be incorporated in compound feed in form of a premixture.

6.

Lasalocid A sodium shall not be mixed with other coccidiostats.

6 July 2033

Regulation (EU) No 37/2010

( 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