European public MRL assessment report (EPMAR) - Lufenuron (fin fish)

On 12 September 2014 the European Commission adopted a Regulation1 establishing a maximum residue limit for lufenuron in fin fish, valid throughout the European Union. This maximum residue limit was based on the favourable opinion and the assessment report adopted by the CVMP. Lufenuron is intended for use in fin fish for the control of sea lice infestations as a premix formulation. Novartis Animal Health Inc (Switzerland) submitted the application for the establishment of maximum residue limits to the European Medicines Agency, on 6 March 2013. Based on the original and complementary data in the dossier, the CVMP recommended on 12 December 2013 the establishment of maximum residue limits for lufenuron in fin fish. Subsequently the Commission recommended on 19 March 2014 that a maximum residue limit in fin fish is established. This recommendation was confirmed on 9 April 2014 by the Standing Committee on Veterinary Medicinal Products and adopted by the European Commission on 12 September 2014.