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China - Final Regulatory Action
Endosulfan CAS number:
Date circular:

Chemical name: 6,9-Methano-2,4,3-benzodioxathiepin, 6,7,8,9,10,10-hexachloro-1,5,5a,6,9,9a-hexahydro-, 3-oxide

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 endosulfan have all been banned in China except for the acceptable purpose or specific exemption.

Pesticide use or uses that remain allowed:

The specific exemption: The production and use of endosulfan for control of cotton bollworm and tobacco budworm.

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
endosulfan have all been banned in China except for the acceptable purpose or specific exemption.

The reasons for the final regulatory action were relevant to: Human health and environment

Summary of known hazards and risks to human health:

The toxicity and ecotoxicity of endosulfan is well documented. Endosulfan is highly toxic for humans and for most animal taxa, showing both acute and chronic effects at relatively low exposure levels. Acute lethal poisoning in humans and clear environmental effects on aquatic and terrestrial communities has been observed under standard use conditions when the risk mitigation measures have not been followed. Several countries have found that endosulfan poses unacceptable risks, or has caused unacceptable harm, to human health and the environment, and have banned or severely restricted it.
However, the information on its genotoxicity and its potential for endocrine disruption is not fully conclusive. Finally, the role of endosulfan metabolites other than endosulfan sulfate has received limited attention.Endosulfan lactone has the same chronic NOEC value as the parent endosulfan isomers.
The assessment of the POP characteristics of endosulfan, including endosulfan sulfate, confirms the concern regarding endosulfan and its main metabolite; it should be also considered that other metabolites, formed through both environmental and biota transformations, maintains the chemical structure and in some cases have significant toxicity.
Based on the inherent properties, and given the widespread occurrence in environmental compartments and biota in remote areas, together with the uncertainty associated with the insufficiently understood role of the metabolites which maintain the endosulfan chemical structure, it is concluded that endosulfan is likely, as a result of its long-range environmental transport, to lead to significant adverse human health and environmental efTects, such that global action is warranted.

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:

Endosulfan aerobic transformation occurs via biologically mediated oxidation. The main metabolite formed is endosulfan sulfate. This compound is slowly degraded to the more polar metabolites endosulfan diol, endosulfan lactone, endosulfan ether. The combined median half-life DT50 measured in laboratory studies for and 13 endosulfan and endosulfan sulfate, was selected as a relevant parameter for quantifying the persistence, it ranges typically between 28 and 391 days. In the aquatic compartment, endosulfan is stable to photolysis; a rapid hydrolysis is only observed at high pH values, and it is non-readily biodegradable. In water/sediment systems, DT50 > 120 d was demonstrated. There is a uncertainty on the degradation rate of endosulfan in the atmosphere, however it is expected that the half life exceeds the 2 days threshold. The bioconcentration potential of endosulfan in aquatic organisms is confirmed by experimental data. The validated bioconcentration factor (BCF) values range between 1000 and 3000 for fish, from 12 to 600 for aquatic invertebrates; and up to 3278 in algae. Thus, reported BCFs are below the criterion of 5,000; and the log Kow is measured at 4.7, which is below the criterion of 5. However, measured BAF and BMF in Arctic organisms show that endosulfan has an inherent high bioaccumulation and biomagnification potential. Additionally, endosulfan was detected in adipose tissue and blood of animals in the Arctic and the Antarctic. Endosulfan has also been detected in the blubber of minke whales and in the liver of northern fulmars. Therefore, there is sufficient evidence that endosulfan enters the food chain and that it bioaccumulates and has the potential to biomagnify in food webs.
The potential of endosulfan for long range transport (LRT) has been confirmed from three main information sources: the analysis of the endosulfan properties, the application of LRT models, and the review of existing monitoring data in remote areas.
LRT has been confirmed by the presence of endosulfan in air and biota from remote areas. Most studies measure a- and 13-endosulfan, and in some cases, endosulfan sulfate. Other endosulfan metabolites are only rarely quantified. The presence of endosulfan in remote areas, far away from intensive use areas, in particular, the Arctic and Antarctica has been confirmed. The potential for LRT seems to be mostly related to volatilization following by atmospheric transfer;deposition at high altitude mountain areas has been also observed.

Expected effect of the final regulatory action in relation to the environment:

Similar concerns to those identified could be encountered in othr countries where the pesticide is used.

Date of entry into force of the final regulatory action: 26/03/2014