Details
- Publication date
- 23 January 2023 (Last updated on: 9 March 2023)
- Author
- Joint Research Centre
Description
In the current application authorisation is sought for Avatec® 150G under articles 10(2) and 13(3) for the category "coccidiostats and histomonostats" of Regulation (EC) No 1831/2003. Authorisation is sought for use for chickens for fattening and reared for laying, turkeys and pheasants, partridges, quails and guinea fowl. This feed additive is already authorized in chickens for fattening and reared for laying, in turkeys and in pheasants, partridges, quails and guinea fowl.
Avatec® 150G is a red-brown free flowing granular preparation formulated to contain - 15 % lasalocid A sodium, 4% calcium lignosulphonate binder, 0.1 % ferric oxide colouring agent, and a calcium sulphate dehydrate carrier. Avatec® 150G is meant to be incorporated in feedingstuffs through premixtures. The Applicant suggested a lasalocid A sodium content in feedingstuffs ranging from 75-125 mg/kg for all the animal species of concern.
MRLs for lasalocid A in poultry tissues and eggs are already set by the Commission Regulation (EC) No 37/2010, therefore the corresponding methods of analysis do not need to be evaluated by the EURL.
For the determination of lasalocid A sodium in the feed additive, premixtures and feedingstuffs, the Applicant submitted the European Community method published in Commission Regulation (EC) No 152/2009. In the frame of a previous dossier (cf. FAD-2008-0050) the Applicant demonstrated the applicability of the Community method to the feed additive. Furthermore, the Applicant provided additional experimental data obtained analysing the feed additive, premixtures and feedingstuffs containing Avatec 150G. Based on the experimental evidence provided, the EURL recommends for official control the European Community method published in Commission Regulation (EC) No 152/2009 based on Reversed Phase High Performance Liquid Chromatography coupled to fluorescence detection (RP-HPLC-FL) for the determination of lasalocid A sodium in the feed additive, in premixtures and feedingstuffs.
In addition, the EURL has developed and fully validated a multi-analyte method based on liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) for the determination of the various coccidiostats, including lasalocid A sodium in compound feed. This method has been ring-trial validated for lasalocid A sodium in different feed matrices at additive and at cross-contamination levels and published as CEN standard (EN 17299).
Based on the obtained performance characteristics and the scope of the method in terms of matrices, the EURL considers the multi-analyte ring-trial validated EN 17299 method based on liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) fit for purpose for the determination of lasalocid A sodium in compound feeds.
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) is not considered necessary.
Recommended Method
as of:
-Commission Implementing Regulation (EU) 2023/1172
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