Azamethiphos extend to fin fish
Azamethiphos is an organothiophosphate insecticide. It is a veterinary drug used in Atlantic salmon fish farming to control parasites.
On 23 May 2012 the European Commission adopted a Regulation1 establishing maximum residue limits for azamethiphos in fin fish, valid throughout the European Union. These maximum residue limits were based on the favourable opinion and the assessment report adopted by the Committee for Medicinal Products for Veterinary Use.
Azamethiphos(CAS NO:35575-96-3) is intended for use in fish farming to control external parasites with an application rate of 0.1 to 0.2 mg/litre as a bath treatment. Fish Vet Group Ltd submitted the application for the extension of maximum residue limits to the European Medicines Agency, on 26 January 2011.
Based on the available data, the Committee for Medicinal Products for Veterinary Use recommended on 15 September 2012 the establishment of maximum residue limits for azamethiphos in fin fish. Subsequently the Commission recommended on 14 March 2012 that maximum residue limits in fin fish are established. This recommendation was confirmed on 4 April 2012 by the Standing Committee on Veterinary Medicinal Products and adopted by the European Commission on 23 May 2012.
Azamethiphos(CAS NO:35575-96-3) is an organophosphorus insecticide which acts by inhibition of cholinesterase activity. In Atlantic salmon azamethiphos is used in fish farming to control external parasites with an application rate of 0.1 to 0.2 mg/litre as a bath treatment.
Azamethiphos was previously used as a pesticidal spray for control of flies and cockroaches in warehouses and other buildings, but the authorisation was withdrawn by Commission Regulation (EC) No. 2076/2002 of 20 November 2002. It was previously assessed by the CVMP and a pharmacological ADI of 0.025 mg/kg bw, i.e. 1.5 mg/person was established.
Fish Vet Group Limited submitted the application for the extension of maximum residue limits for azamethiphos from Salmonidae to fin fish to the European Medicines Agency on 21 February 2011. Azamethiphos is intended for use in fin fish (e.g. sea bass, sea bream, coy and tilapia) for the treatment of external parasites with an intended application rate for this use of 0.1 to 0.2 mg/litre as a bath treatment.
Azamethiphos was previously assessed by the CVMP and a pharmacological ADI of 0.025 mg/kg bw, i.e. 1.5 mg/person was established based on the NOEL of 2.5 mg/kg bw/day from a dog study (brain cholinesterase activity) and applying a safety factor of 100. Therefore, no further assessment regarding the consumer safety of the substance is required for the purpose of this extension application.
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