Pharmaceutical Compound: 10% Narasin and 0.2% Diclazuril within Interban® Formula
The European Union is considering an application from Huvepharma NV to authorize the use of Interban®, a feed additive containing 10% narasin and 0.2% diclazuril, under the category "coccidiostats and histomonostats."
Interban® is intended for use in chickens for fattening and chickens reared for laying. The proposed content of narasin and diclazuril in compound feed is 50 mg and 1 mg per kg, respectively.
The European Union References Laboratory (EURL) has evaluated the methods of analysis for the maximum residue limits (MRLs) of narasin in chicken tissues. The MRL for narasin in chicken tissues is 50 μg/kg, as specified in Commission Regulation (EC) No 885/2010.
For the determination of narasin in chicken tissues, the Applicant submits the ring-trial validated AOAC 2011.24 method based on LC-MS/MS. The EURL recommends the use of this method for official control of narasin in the feed additive, premixtures, and compound feed.
Similarly, for the determination of diclazuril in compound feed, the Applicant proposes the use of a ring-trial validated EU method based on HPLC-UV. The EURL recommends the single-laboratory validated HPLC-UV method for the determination of diclazuril in the feed additive.
The Applicant also proposes a single-laboratory validated HPLC-UV method for determining diclazuril in the feed additive. It is important to note that the MRL for diclazuril in chicken tissues is not specified in the text.
Further testing or validation of the methods will not be necessary, as specified by Article 10 of Commission Regulation (EC) No 378/2005. The EURL has also evaluated the methods of analysis for MRLs of narasin in chicken tissues.
In conclusion, Huvepharma NV's application for Interban® seeks to bring a new feed additive to the European market, subject to regulatory approval. The proposed methods of analysis for narasin and diclazuril have been evaluated and recommended by the EURL, ensuring the safety and efficacy of the product.
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