Registration of New Chemicals in China Becoming More Difficult

Industry representatives, including the American Chemistry Council (ACC), have criticized the draft guidance published in mid-August by the Chinese Ministry of Ecology and Environment (MEE). As part of the period allowed for public comments, which ended on September 6, representatives of the ACC stated that the new requirements for registration of new chemicals are more likely to make things more difficult, rather than simpler. Why? Because more data is required.

Background: In a sense, the guidance required companies to implement the new chemical law, MEE Regulation No. 12, that takes effect at the beginning of 2021. It will then replace the previous MEP Regulation No. 7.

For chemicals classified as persistent and imported or manufactured in a quantity greater than 10 tons, companies must provide a greater scope of data than they were required to supply previously. That is especially difficult because 9 of 10 chemicals are considered persistent according to the new law. For a simpler registration, companies would have to submit the chemicals to laborious tests to prove that the substances are not persistent in the environment. Most companies would recoil from this effort.

The EU classifies only according to PBT characteristics, which combine persistent, bioaccumulative, and toxic properties, but Chinese agencies look at persistent and bioaccumulative properties separately and set the hurdles for chemical registration correspondingly high.

It is unclear when the Ministry will publish the final version of the guidelines. Industry experts do not expect that the guidelines will be reevaluated as part of the consultation.

We are familiar with the market and laws in China. Please contact us at sds@kft.de.

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