Chemical name: TBT Final regulatory action has been taken for the category: Pesticide Final regulatory action: The chemical is Severely Restricted Use or uses prohibited by the final regulatory action: After 1 January 2003, tri-organostannic compounds 1.May not be placed on the market for use as substances and constituents of preparations when acting as biocides in free association paint. 2.May not be placed on the market or used as substances and constituents of preparations which act as biocides to prevent the fouling by microorganisms, plants or animals of: (a) all craft irrespective of their length intended for use in marine, coastal, estuarine and inland waterways and lakes; (b) cages, floats, nets and any other appliances or equipment used for fish or shellfish farming; (c) any totally or partly submerged appliance or equipment. 3.May not be used as substances and constituents of preparations intended for use in the treatment of industrial waters.' Pesticide use or uses that remain allowed: All uses, including use as preservative for wood, not covered by the Directive 2002/62/EC remain allowed. The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: As from 1 January 2003, the use of tri-organostannic compounds is banned in all paints and products to prevent the fouling of all craft intended for use in marine, coastal, estuarine and inland waterways and lakes, appliances and equipment used for fish or shellfish farming, and any totally or partially submerged appliance or equipment; and in industrial water treatment. The reasons for the final regulatory action were relevant to: Human health and environment Summary of known hazards and risks to human health: Hazards: UN Hazard Class 6.1 (II), EC (T, N, Xn and Xi, with R25, R48/23/25, R21, R36/38, R50/53) In the risk assessment conducted for the European Commission, unacceptable health risks were identified in the following areas: - exposure to atmospheric TBT during the transfer of ingredients to the mixing vessel during anti-fouling paint manufacture; - ingestion of contaminated food (e.g. mussels) where TBT concentrations are high. It was concluded that the risk arising from manufacture and application processes may be reduced by increased control of the process. However, releases of TBT from shipping are more difficult to control because it as been shown that even when the TBTO release rate is reduced to the minimum required to maintain anti-fouling efficiency, the amount released from a large ship is still considerable, leading to possible contamination of food.Expected effect of the final regulatory action in relation to human health: A ban of TBT in anti-fouling paints is expected to significantly reduce input of TBT to the aquatic environment. Tje timescale over which effects will be seen is likely to be biphasic. Initially, a significant drop in water concentrations will be seen and this should result in reduced levels of risks for exposed environments. However, there are likely to be some residual concentrations of TBT in water for some time after implementation of a ban of its use, because of continuing releases from ship hulls and the TBT reservoirs that have accumulated in the sediment of contaminated areas. considering the long half time of degradation for TBT, it is likely that TBT will remain in the water column and sediment for up to twenty years after the cessation of TBT inputs to the environment. These residual concentrations should not presente a threat to population sustainability. Summary of known hazards and risks to the environment: Hazards: UN Hazard Class 6.1 (II), EC (T, N, Xn and Xi, with R25, R48/23/25, R21, R36/38, R50/53). In the risks assessment conducted for the European Commission, unacceptable environmental risks were identified in the following areas: - release to surface water from the manufacture of TBTO; - release to surface water from the manufacture of TBT self polishing co-polymer paints; - release to surface water from dockyard procedures; - release to surface water from the use of TBT on ships in the marine, brackish or freshwater environment.Expected effect of the final regulatory action in relation to the environment: A ban of TBT in anti-fouling paints is expected to significantly reduce input of TBT to the aquatic environment. The timescale over which effects will be seen is likely to be biphasic. Initially, a significant drop in water concentrations will be seen and this should result in reduced levels of risks for exposed environments. However, there are likely to be some residual concentrations of TBT in water for some time after implementation of a ban of its use, because of continuing releases from ship hulls and the TBT reservoirs that have accumulated in the sediment of contaminated areas. Considering the long half time of degradation for TBT, it is likely that TBT will remain in the water column and sediment for up to twenty years after the cessation of TBT inputs to the environment. These residual concentrations should not present a threat to population sustainability. Date of entry into force of the final regulatory action: 01/01/2003 The regulatory action entered into force on the 20th day following that of its publication in the Official Journal of the European Communities. The Member States of the European Community were required to adopt and publish the provisions necessary to comply with this Directive by 31 October 2002 at the latest and apply the measures as from January 2003. |