Chemical name: Cyclohexane, 1,2,3,4,5,6-hexachloro-, (1.alpha.,2.alpha.,3.beta.,4.alpha.,5.alpha.,6.beta.)- 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: The production, circulation, use, import and export of Lindane have all been banned in China except for the acceptable purpose or specific exemption. Pesticide use or uses that remain allowed: The production and use of Lindane for control of head lice and scabies as a human health pharmaceutical only. 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 Lindane have all been banned in China except for the acceptable purpose or specific exemption. The reasons for the final regulatory action were relevant to: Environment Summary of known hazards and risks to human health: Published risk assessrnent reports on Lindane indicate that Lindane is persistent, bioaccumulative and toxic. Lindane has been found in environmental samples all over the world as well as in human blood, human breast milk and human adipose tissue in different studied populations, especially in Arctic communities that depend on subsistence foods. At high doses Lindane has been shown to be neurotoxic, hepatotoxic, immunotoxic and to have reproductive effects in laboratory animals. Human acute intoxication data show that Lindane can cause severe neurological effects, and chronic data suggest possible haematological effects. The International Agency for Research on Cancer (IARC) has classified Lindane as possibly carcinogenic to humans.Expected effect of the final regulatory action in relation to human health: To protect the environment and human health. Implementation of control measures is expected to reduce the risks from exposure of humans and the environment to Lindane, especially in the Arctic where Lindane accumulates easily in the wildlife, and where communities depend on subsistence foods. Summary of known hazards and risks to the environment: Once released into the environment, lindane can partition into all environmental media. Hydrolysis and photolysis are not considered important degradation pathways and reported half-lifes in air, water and soil are: 2.3 days, 3-300 days and up to 2 to 3 years, respectively. A half-life of 96 days in air has also been estimated. Lindane can bio-accumulate easily in the food chain due to its high lipid solubility and can bioconcentrate rapidly in microorganisms, invertebrates, fish, birds and mammals. The bioconcentration factors in aquatic organisms under laboratory conditions ranged from approximately 10 up to 4220 under field conditions, the bioconcentration factors ranged from 10 up to 2600. Although lindane may bioconcentrate rapidly, bio-transformation, depuration and elimination are also relatively rapid, once exposure is eliminated. Many studies have reported lindane residues throughout North America, the Arctic, Southern Asia, the Western Pacific, and Antarctica. HCH isomers, including lindane, are the most abundant and persistent organochlorine contaminants in the Arctic where they have not been used, pointing at evidence of their long-range transport. The hypothesis that isomerization of gamma HCH to alpha HCH in air emerged as a possible explanation for higher than expected alpha HCH/gamma HCH ratios in the Arctic. However no conclusive experimental evidence of isomerization taking place in air has been produced to date. Also, although there is evidence that bioisomerization of lindane can take place through biological degradation, it seems that this process may play an insignificant role in the overall degradation of gamma-HCH. Lindane can be found in all environmental compartments, and levels in air, water, soil sediment, aquatic and terrestrial organisms and food have been measured worldwide. Humans are therefore being exposed to lindane as demonstrated by detectable levels in human blood, human adipose tissue and human breast milk in different studies in diverse countries. Exposure of children and pregnant women to lindane are of particular concern. Hepatotoxic, immunotoxic, reproductive and developmental effects have been reported for lindane in laboratory animals. The US EPA has classified lindane in the category of "Suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential". Lindane is highly toxic to aquatic organisms and moderately toxic to birds and mammals following acute exposures. Chronic effects to birds and mammals measured by reproduction studies show adverse effects at low levels such as reductions in egg production, growth and survival parameters in birds, and decreased body weight gain in mammals, with some effects indicative of endocrine disruption. These findings and the evidence of its long range transport, as well as the fact that lindane is currently the object of local and global action initiatives, that also include thorough analysis and selection procedures, should be sufficient to warrant global action under the Stockholm Convention.Date of entry into force of the final regulatory action: 26/03/2014 |