Chemical name: Cyclohexane, 1,2,3,4,5,6-hexachloro-, (1.alpha.,2.beta.,3.alpha.,4.beta.,5.alpha.,6.beta.)- 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: The production, circulation, use, import and export of beta-HCH have all been banned in China. The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: Since March 26th 2014, the production, circulation, use, import and export of beta-HCH have all been banned in China. The reasons for the final regulatory action were relevant to: Human health and environment Summary of known hazards and risks to human health: Beta-HCH is present in terrestrial and aquatic food chains. Beta-HCH may bioaccumulate and biomagnify in biota and Arctic food webs, especially in upper trophic levels. In humans, accumulation in fat tissue and high concentrations in blood and breast milk may occur. Beta-HCH transfers from mothers to embryos and nursing infants. Toxicological studies with beta-HCH have demonstrated neurotoxicity and hepatotoxicity. Also, reproductive and immunosuppressive effects and effects on fertility were seen in laboratory animals. Beta-HCH has been classified in group 2B as possibly carcinogenic to humans by the International Agency on Research and Cancer (IARC). Several epidemiological studies indicate that beta-HCH might play a role in human breast cancer. Human exposure to beta-HCH results mostly from ingestion of contaminated plants, animals and animal products. High exposure is expected in contaminated areas due to extensive use, former production, disposal sites and stockpiles. Given the hazard profile and the exposure levels in the environment including the food chain, it can be concluded that beta-HCH may adversely affect wildlife and human health in contaminated and remote regions including the Arctic region. Arctic public health authorities believe the significant social, cultural and economic benefits of traditional foods outweigh the risks of contaminants such as HCH at present but give another reason for the quick control and elimination of all HCH isomers from traditional foods. Based on the hazard profile, together with estimated daily intakes of beta-HCH of Arctic indigenous people that exceeds safe intake reference values, and given the widespread occurrence of beta-HCH in biota, including in remote areas far from likely it is concluded that the substance is likely, as a result of its long-range sources, environmental transport, to lead to significant adverse human health and environmental effects. Expected effect of the final regulatory action in relation to human health: To protect the environment and human health. Summary of known hazards and risks to the environment: Abiotic degradation processes do not play an important role in the fate of beta-HCH in the environment. Thus photolysis and hydrolysis are not significant. Under favourable conditions, beta-HCH is susceptible to biodegradation. However, compared to the gamma- and alpha-HCH, it is the most recalcitrant isomer. Laboratory and field data including a long-term soil study suggest that beta-HCH is persistent in soil, especially under low temperatures. It is mainly associated with particles and has a low leaching potential. The physico-chemical properties of beta-HCH allow the dispersal of the substance from its sources to the Arctic mainly by long-range environmental transport via ocean currents. Beta-HCH has been detected in the Arctic Ocean and is present in marine, terrestrial species, and humans. Beta-HCH exposure levels in local areas have declined after worldwide prohibitions and restrictions. However regions with recent exposure and/or high pollution can still show elevated levels. A special concern also arises from exposure of hazardous waste sites and dumping grounds from disposed beta-HCH residues from lindane production. Due to its persistence, beta-HCH can still be detected at low background levels in all environmental media except in regions with recent usage and/or high pollution. Data from the abiotic environment in the Arctic are scarce, partly due to low levels compared with the other HCH isomers. In contrast to this fact,fairly high concentrations in Arctic biota including marine mammals and birds were detected with increasing levels. Beta-HCH is acutely toxic to aquatic organisms and shows estrogenic effects in fish. Reduced fitness of offspring in birds as well as reduced retinol concentrations in polar bears is associated with beta-HCH and HCHs levels. Expected effect of the final regulatory action in relation to the environment: To protect the environment and human health. Date of entry into force of the final regulatory action: 26/03/2014 |