On August 17, 2020, the Ministry of Ecology and Environment of the Chinese government has proposed new draft guidance for Environmental Management Registration of New Chemical Substances (Draft for Consultation). Earlier MEE has issued “Measures on the Environmental Management of New Chemical Substances” (MEE Order No. 12) on April 29, 2020, which will replace the current MEP Order No. 7 on January 1, 2021. To Execute the MEE Order no. 12 effectively the MEE has released this draft guidance.

The Ministry of Ecology & Environment’s order no. 12 has given special attention to managing the chemical substances by classifying them based on the level of toxicity as follows:

● Persistent (P)

● Bioaccumulative (B)

● Toxic (T)

Many regulatory wizards were claiming that the Chinese new regulatory measure seems very similar to US EPA’s Toxic Substances Control Act. Ignoring those comments when we dig deeper into the draft guidance, we could find more information & detailed guidelines for companies to register under the Order No.12. Some of the key points of the drafted guidance are as follows:

1. Pharmaceutical & Pesticide ingredients are excluded from registration.

2. A low volume of production or imported chemicals were excluded when used for research purposes. The annual low volume limit is 100 kilograms.

3. The high-hazard substances will not be eligible for the simplified registration regardless of annual volume.

4. High hazard substances- the substances that meet P, B & T, substances that meet very Persistent (vP) & very Bioaccumulative (vB), substances under Category 1 classification, substances with effective concentration at ten percent inhibition (EC10). These high hazard substances are not eligible for the simplified registration regardless of annual volume.

5. The 5year protection period for confidential information on the identity of new chemical substances could be extended if the substance does not have any environmental or health hazard classification

Reference: http://www.mee.gov.cn/xxgk2018/xxgk/xxgk02/202005/t20200507_777913.html