China Significantly Simplifies Notification and Registration of New Substances

The Ministry of Environmental Protection (MEP) of the People’s Republic of China has defined Guidance for New Chemical Substance Notification and Registration (in Chinese only). The definition is valid as of October 15, 2017.

Registration of substances in a quantity greater than 1–10 tons per year now requires only that studies on acute toxicity examine only data for an exposure path. For genetic toxicity, an Ames test suffices, and 28-day repeated dose toxicity studies are no longer required.

Quantities of 10–100 tons no longer require 90-day repeated dose toxicity studies. The longstanding previous requirement of a 14-day prolonged fish toxicity study has been removed.

To register substances in a quantity of 100–1,000 tons per year, companies need only a toxicokinetic assessment based on existing studies. Data from extended one-generation reproductive toxicity is also accepted. In addition, simplified criteria for the determination of chronic and carcinogenic effects have been defined.

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