Chemical name: 3-difluoromethyl-1-methyl-1H-pyrazole-4-carboxylic acid (9-isopropyl-1,2,3,4 tetrahydro-1,4-methano-naphtalen.5.yl) amide Final regulatory action has been taken for the category: Pesticide Final regulatory action: The chemical is Banned Use or uses prohibited by the final regulatory action: All formulations and uses. The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: Following a risk assessment, the Norwegian Food Safety Authority adopted the following resolution: Pursuant to Regulation 26 July 2004 No. 1138 on pesticides 4 b), the application for registration of Bontima containing the active ingredient isopyrazam is rejected. The under lying reasons were that the toxicity of Isopyrazam's metabolites have not been documented according to what is required for groundwater metabolites when the active substance is suggested as a cat 3 carcinogen. Isopyrazam is persistent in soil and water and accumulation in soil and sediment is likely to result from repeated use under Norwegian agricultural conditions. Isopyrazam is likely to reach the surface water in concentrations that may affect aquatic organisms. Isopyrazam's main soil metabolites are mobile as well as persistent and are likely to reach the groundwater. The reasons for the final regulatory action were relevant to: Human health Summary of known hazards and risks to human health: Isopyrazam's main metabolites CSCD459488 and CSCD465008 are expected to reach the groundwater and their toxicological relevance should therefore be determined. If the metabolites are considered to be relevant according to EU criteria (carcinogenic potential cannot be excluded) then the substance should not be placed on the market. If the active substance is classified as carcinogen category 3, then the carcinogenic potential of the metabolites must also be tested. It is the opinion of the Norwegian Food Safety Authority that isopyrazam fulfills the criteria for classification as a cat 3 carcinogen since isopyrazam has been shown to give adenomas in the liver and uterus in rats. This is also supported by EFSA's conclusion on the substance. The available documentation suggests that the metabolite CSCD459488 gives effects in the liver. However, the available documentation is limited and is not sufficient to conclude that the carcinogenic potential cannot be excluded. Expected effect of the final regulatory action in relation to human health: Reducing the risk to human health from the substance isopyrazam. Date of entry into force of the final regulatory action: 17/12/2013 |