Commission Implementing Regulation (EU) 2024/2389 of 9 September 2024 concerning the authorisation of a preparation of semduramicin sodium (Aviax 5 %) as a feed additive for chickens for fattening (holder of authorisation: Phibro Animal Health s.a.) and repealing Regulation (EC) No 1443/2006

• CELEX: Implementing Regulation (EU) 2024/2389
• Articles: 5

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 Transitional measures

1.   The feed additive semduramicin sodium (Aviax 5 %), as authorised by Regulation (EC) No 1443/2006, and premixtures containing this additive, which are produced and labelled before 30 March 2025 in accordance with the rules applicable before 30 September 2024 may continue to be placed on the market and used until the stocks concerned are exhausted.

2.   Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 30 September 2025 in accordance with the rules applicable before 30 September 2024 may continue to be placed on the market and used until the stocks concerned are exhausted.

Article 3 Repeal

Regulation (EC) No 1443/2006 is repealed.

Article 4 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 (trade name)

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

Category: coccidiostats and histomonostats

51773

Phibro Animal Health s.a.

Semduramicin sodium (Aviax 5 %)

Additive composition

Preparation of:

—

Mycelium: 166–333 g/kg additive, containing 48,7–53,9 g semduramicin sodium,

—

food grade mineral oil: 30–50 g/kg additive,

—

sodium carbonate: 40 g/kg additive,

—

sodium aluminosilicate: 20 g/kg additive,

—

Soybean mill run: quantum satis.

Solid form.

Characterisation of the active substance

Semduramicin sodium:

—

C 45 H 75 O 16 Na

—

CAS number: 119068-77-8

—

sodium {(2R,3S,4S,5R,6S)-2,4-dihydroxy-6-[(1R)-1-{(2S,5R,7S,8R,9S)-9-hydroxy-2-[(2S,2’R,3’S,5R,5’R)-5’-[(2S,3S,5R,6S)-6-hydroxy-3,5,6-trimethyloxan-2-yl]-3’-{[(2S,5S,6R)-5-methoxy-6-methyloxan-2-yl]oxy}-2-methyl[2,2’-bioxolan]-5-yl]-2,8-dimethyl-1,6-dioxaspiro[4.5]decan-7-yl}ethyl]-5-methoxy-3-methyloxan-2-yl}acetate

Produced from Actinomadura spp. ATCC 53664.

Related impurities: semduramicin epimer, semduramicin aglycon (without G ring), desmethyl semduramicin (A ring), desmethyl semduramicin (G ring), hydroxyl semduramicin (F ring), desmethoxyl semduramicin (A ring) and descarboxyl semduramicin: < 3 % each.

Total impurities: ≤ 7 %.

Analytical methods

( 1 )

For the quantification of semduramicin sodium in the feed additive and premixtures: High Performance Liquid Chromatography using post-column derivatisation coupled with photometric detection (HPLC-PCD-UV-Vis).

For the quantification of semduramicin sodium in compound feeds:

—

High Performance Liquid Chromatography using single mass spectrometry (HPLC-MS) or post-column derivatisation coupled with photometric detection (HPLC-PCD-UV-Vis) – EN 16158, or

—

High performance liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) – EN 17299.

Chickens for fattening

—

20

25

1.

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

2.

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

3.

Semduramicin sodium shall not be mixed with other coccidiostats.

4.

The following shall be indicated on the label of the additive, as well as of premixtures and compound feed containing it:

‘This feedingstuff contains an ionophore: simultaneous use with tiamulin is contra-indicated’.

5.

A post-market monitoring programme on the resistance of Eimeria spp. to semduramicin sodium shall be planned and executed by the holder of authorisation, in accordance with Commission Regulation (EC) No 429/2008  ( 2 ) .

6.

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 by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

30 September 2034

( 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 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives ( OJ L 133, 22.5.2008, p. 1 , ELI: http://data.europa.eu/eli/reg/2008/429/oj ).