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APPLICATION SUMMARY Application code: HSR09050 Application category: To import or manufacture any hazardous substance (category A) under the Hazardous Substances and New Organisms (HSNO) Act 1996 Ancare Scientific Limited Floor 1, 17 Shea Terrace, Takapuna PO Box 36240 Auckland Lidija Petreska Applicant: Applicant contact: Purpose: To import or manufacture LMCIL-25 as a topical veterinary medicine for the treatment and prevention of parasites in livestock (Category A). Date application received: 26 May 2009 ERMA New Zealand contact: Johanna Prankerd Application Summary prepared by Ancare Scientific Limited This application is being made to gain approval for LMCIL-25 to be imported, manufactured and released in New Zealand. LMCIL-25 will be topically administered to farm animals using standard procedure, to treat and prevent farm animal disease conditions (e.g. parasitism).Products containing the same active ingredients are already on the NZ market, however this substance has not been notified as a hazardous substance and therefore requires assessment according to the HSNO Act. LMCIL-25 triggers the HSNO thresholds for toxicity and ecotoxicity (6.1D, 6.8C, 6.9B, 9.1A, 9.2C, 9.3C, 9.4A). The main risks associated with this substance are those to the user if not handled appropriately or to the environment in the case of accidental spills or inappropriate disposal. The magnitude of these risks are judged to be minimal as these events are unlikely and in the event that they did occur would be localised and of short duration. These risks will be further controlled by the product labelling including information on the administration to animals and the method of disposal. Therefore the risks resulting from this substance will be insignificant. LMCIL-25 will not pose any additional economic, social or environmental cost. The introduction of LMCIL-25 to the market will not increase the amount sold, it will simply increase market choice with a safer product. This increased choice may translate into cheaper prices for the farmer and LMCIL-25 will also have a number of benefits in terms of animal welfare.