Commission Implementing Regulation (EU) 2020/148 of 3 February 2020 concerning the authorisation of robenidine hydrochloride (Robenz 66G) as a feed additive for chickens for fattening and amending Regulation (EC) No 1800/2004 (holder of authorisation Zoetis SA) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/148
• Articles: 5

Article 1

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

Regulation (EC) No 1800/2004 is amended as follows:

(1)

Article 2 is deleted;

(2)

the Annex is deleted.

Article 3

The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 25 August 2020 in accordance with the rules applicable before 25 February 2020 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 4

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 additive

Name of the holder of authorisation

Additive (Trade name)

Composition, chemical formula, description

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 %

Additive category: Coccidiostats and histomonostats

5a758

Zoetis SA

Robenidine

hydrochloride

(Robenz 66G)

Additive composition :

Robenidine hydrochloride: 66 g/kg

Lignosulfonate: 40 g/kg

Calcium sulfate dihydrate: 894 g/kg

Chickens for fattening

—

36

36

1.

Use of the additive prohibited at least five days before slaughter.

2.

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

3.

The additive shall not be mixed with other coccidiostats.

4.

Post-market monitoring programmes shall be carried out by the holder of authorisation for: resistance to bacteria and Eimeria spp.

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks of their 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.

25 February 2030

800 μg robenidine hydrochloride/kg of wet liver.

350 μg robenidine hydrochloride/kg of wet kidney.

200 μg robenidine hydrochloride/kg of wet muscle.

1300 μg robenidine hydrochloride/kg of wet skin/fat.

Active substance :

Robenidine hydrochloride, C 15 H 13 Cl 2 N 5

. HCl,

1,3-bis[(p-chlorobenzylidene) amino]-

guanidine hydrochloride (97 %)

CAS number: 25875-50-7,

Related impurities:

—

N,N’,N"-tris[(p-chlorobenzylidene) amino]guanidine (TRIS) ≤ 0,5 %

—

bis-(4-chlorobenzylidene)hydrazine (AZIN) ≤ 0,5 %

—

unknown impurity ≤ 1 % (individual unknown impurity ≤ 0,2 %)

Analytical method

( 1 )

For the quantification of robenidine hydrochloride in the feed additive and premixtures: High Performance Liquid Chromatography coupled to Ultraviolet detection (HPLC-UV)

For the quantification of robenidine hydrochloride in feedingstuffs: High Performance Liquid Chromatography coupled to Ultraviolet detection (HPLC-UV) – Commission Regulation (EC) No 152/2009

For the quantification of robenidine hydrochloride in tissues: Reversed-Phase High Performance Liquid Chromatography coupled to a triple quadrupole mass spectrometer (RP-HPLC-MS/MS) or any equivalent methods complying with the requirements set by Commission Decision 2002/657/EC.

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports