China Simplifies Registration of New Substances

The Ministry of Environmental Protection (MEP) of the People’s Republic of China has updated its Guidance for New Chemical Substance Notification and Registration. The Guidance has been made available to various industry associations and groups, including China Petroleum, the Chemical Industry Federation (CPCIF), and the Association of International Chemical Manufacturers (AICM), so that they can comment on it. The final version is to be published in February or March 2017.

Unlike the version sent to the WTO in March, the updated document has been modified several times. For example, toxicity determinations now require significantly less data then originally intended.

Registration of chemicals in quantities of 1 to 10 tons per year require only one exposure route of acute toxicity studies. Oral studies will be preferred, and 28-day, repeated-dose toxicity studies will not be required.

Registrations of 10–100 tons per year will no longer require 90-day repeated-dose toxicity and toxicokinetics studies. Registrations of 100–1,000 tons or more per year will require less toxicokinetics data.

The Guideline is a technical document without any legal status. It describes the preconditions and steps required to introduce a new chemical into the Chinese Market, either as an individual substance or as an element of a mixture.

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