Interban® (a preparation containing 10 % of Narasin and 0.2 % of Diclazuril)

In the current application an authorisation is sought under Article 4(1) for Interban® (a preparation containing 10 % of narasin and 0.2 % of diclazuril), under the category “coccidiostats and histomonostats”, according to Annex I of Regulation (EC) No 1831/2003. The authorisation is sought for chickens for fattening and chickens reared for laying.
According to the Applicant, the feed additive (Interban®) is a preparation containing 10 % of narasin and 0.2 % of diclazuril as active substances.
Interban® is intended to be added into compound feed directly or through premixtures. The Applicant proposed the content of narasin and diclazuril of 50 mg and 1 mg /kg compound feed, respectively.
The maximum residue limits (MRLs) for narasin in chicken tissues of 50 μg/kg are specified in Commission Regulation (EC) No 885/2010. As the MRLs are not covered by the Commission Regulation (EC) No 37/2010 (amended by Commission Implementation Regulation (EU) No 1235/2013), the corresponding methods of analysis were evaluated by the EURL. Concerning MRLs for diclazuril in poultry tissues, they are already set by the Commission Implementation Regulation (EU) No 1235/2013 (amending the Annex to Regulation (EU) No 37/2010), therefore the corresponding methods of analysis do not need to be evaluated by the EURL.
For the determination of narasin in compound feed, the Applicant proposed and submitted the internationally recognised ring-trial validated EN ISO 14183 method based on high performance liquid chromatography with post-column derivatisation coupled with photometric detection (HPLC-PCD-UV-Vis). The method is dedicated for the determination the content of narasin, monensin and salinomycin in animal feedingstuffs, dry and liquid supplements and mineral premixtures. The EN ISO 14183 method is listed in Commission Regulation (EC) No 152/2009. In addition, the Applicant extended the scope of the EN ISO 14183 method for the determination of narasin in the feed additive and vitamin-mineral premixtures.
Based on the overall performance characteristics and available data, the EURL recommends for official control the above-mentioned EN ISO 14183 method based on HPLC-PCD-UV-Vis for the determination of narasin in the feed additive, premixtures and compound feed.
In addition, based on the performance characteristics, the EURL recommends for official control the multi-analyte ring-trial validated EN 17299 method (listed in Commission Regulation (EC) No 152/2009) for the determination of narasin in compound feed. For the determination of diclazuril in compound feed, the Applicant proposed and submitted the ring-trial validated European Union (EU) method based on reversed-phase high performance liquid chromatography coupled with photometric detection (HPLC-UV) and dedicated for the determination of diclazuril in premixtures and compound feed. This method is described in Commission Regulation (EC) No 152/2009.
For the determination of diclazuril in the feed additive, the Applicant proposed and submitted a single-laboratory validated and further verified HPLC-UV method based on the above-mentioned EU method.
Based on the overall performance characteristics and available data, the EURL recommends for official control the single-laboratory validated and further verified HPLC-UV method for the determination of diclazuril in the feed additive and the EU method based on HPLC-UV for the determination of diclazuril in premixtures and compound feed.
In addition, based on the performance characteristics, the EURL recommends for official control the multi-analyte ring-trial validated EN 17299 method (listed in Commission Regulation (EC) No 152/2009) for the determination of diclazuril in compound feed.
For the determination of narasin in chicken tissues the Applicant submitted the ring-trial validated AOAC 2011.24 method based on a reversed-phase high performance liquid chromatography coupled with tandem mass-spectrometry (LC-MS/MS). The method is dedicated for the determination of narasin and monensin in chicken, swine and bovine tissues.
Based on the overall performance characteristics, the EURL recommends for official control the AOAC 2011.24 method based on LC-MS/MS, for the determination of narasin in chicken tissues.
Further testing or validation of the methods to be performed through the consortium of National Reference Laboratories as specified by Article 10 (Commission Regulation (EC) No 378/2005, as last amended by Regulation (EU) 2015/1761) is not considered necessary.