Request a Demo
China MEP is to revise Measures on the Environmental Management of New Chemical Substance (MEP Order 7). The authority is currently accepting feedback and comments from industry to aid development of an updated regulation. Below are some preliminary ideas and potential regulatory reform strategies put forward in a seminar held by the SCC-MEP on Sep 26th/27th, 2017.
Exemption:
Under current regulation new chemical substance notification (China NCSN) is required for cosmetic ingredients if they are also new chemical substances. However, the authority may consider offering NCSN exemptions for cosmetic ingredients.
Notifier:
The definition of notifiers for import activities needs further clarification specifically the scope of who/what is considered a notifier. Currently, Chinese importers or the overseas exporters who export products directly to the Chinese market need to notify. Whether an overseas supplier or a Chinese importer who signs trade agreement or the one actually for customs clearance can be considered notifiers should be explained in the updated regulation.
Notification type:
Some types of substances are relatively low risk, e.g. PLC, polymers with low concentration of new chemical substance monomer (<2 % w/w) and substances for the purpose of scientific research and development in small amount. The authority is considering reducing their notification requirements. It is expected that under the new system they may be subject to record filing only.
Intermediates:
For intermediates, only non-isolated intermediates are exempt from China NCSN. Data reduction may be considered in the future for isolated intermediate with low exposure.
Risk assessment:
Whether or not the release amount (not concentration) to the environment in production or use of chemicals will be emphasized in risk assessment is a point to be discussed.
Further supplementation of data
If a notification has been approved, whether or not the authority in a retrospective review can require more data from the notifier is still under consideration.
Environmental management category:
So far, more than a quarter of the notified new substances are classified as “hazardous new chemical substances of priority environmental concern”. The authority is discussing whether the classification criteria (using GHS classification) for environmental management category is reasonable. There is speculation about new criteria in the future.
CBI protection:
The authority plans to clarify eligibility criteria for CBI non-disclosure. In addition, the confidentiality validity may be limited to a specific duration in contrast to the current practice in which CBI protection never expires.
Supervision:
Customs inspection may be introduced to improve supervision of new chemical substances entering Chinese markets.
China MEP recommended an initial revision of MEP Order 7 first and then the subsequent publication of revised Guidance. The amendments on data requirements in China’s New Substance Notification Guidance were published on Aug 28th 2017 as an individual announcement (CL news). After the revision of MEP Order 7, the whole revised Guidance will be published. As planned, the revision of MEP Order 7 will be drafted and published for public comments by the end of this year.
Please stay tuned with our site.
