Chinese Ministry of Environmental Protection (MEP) has carried out research and discussion on the revision of the Measures for the Environmental Management of New Chemical Substances (MEP Order 7) for several years. In 2016, MEP notified the World Trade Organization (WTO) on the revised draft of the New Chemical Substance Notification Guidance, which is an important supportive regulation to MEP Order 7. In August, MEP issued an announcement and revealed the amendments on the data requirements in China’s New Substance Notification Guidance.
The new data requirements are simplified compared to before (especially on the minimum requirements of toxicological data for regular notification) and aim to reduce the compliance burdens of industry. The detailed updates of the new data requirements can been seen in this ChemLinked expert article. ChemLinked also have an English translation of the new data requirements, including 5 annexes.
At REACH24H’s Chemical Regulatory Annual Conference (CRAC 2017) in Hangzhou on Nov 1st, Ms. Ling Lu, the Director of the Solid Waste and Chemicals Management Center under the Ministry of Environmental Protection (SCC-MEP) gave an overview of the updates in the new data requirements and how enterprises should cope with them.
The new requirements took effect on Oct 15th 2017. Notification materials that were mailed to SCC before that date will be reviewed based on the former requirements. Interestingly there was no great change in the number of notifications and it seems the new requirements didn’t have a major negative impact on industry. However in cases where an enterprise sent the notification materials to SCC before Oct 15th and received the expert opinions on some data, if the expert opinions were based on the former requirements and not consistent with the new requirements, then the enterprise could decide on their own if they want to revise the material based on the expert opinions or not. But if the enterprise chooses to revise this data based on new requirements, then the enterprise needs to make sure that other data in the notification material complies with the new requirements, too.
Ms. Ling Lu also revealed the guidelines MEP followed during the revision of MEP Order 7. According to Lu the revision of MEP Order 7 focused on the determination and clarification of the responsibilities and duties of MEP and other governmental branches in chemical management, the identification of chemicals of priority environmental management, information collection on chemicals emission into the environment, the reinforcement of the regulation implementation (such as the chemicals that are supposed to be notified but haven’t been notified), and the alignment with other domestic chemical regulations, etc. The management and notification procedure of low tonnage new chemicals are under discussion inside SCC and will probably be simplified. The data sharing will be more encouraged in the revised Measures. Tonnage accumulation in repeat notifications and joint notifications (which often caused issues for data sharing among enterprises) will be revised too.
SCC has already completed a draft of the revised Measures and plans to release it for public consultation by the end of the year. MEP also welcomes the industry to provide feedback during practical notifications and help them with the revision.
