On August 17, 2020, the Ministry of Ecological Environment of China published the “Guideline for Environmental Management and Registration of New Chemical Substances (Draft calling opinions)” and started soliciting opinions. The deadline for solicitation is September 6, 2020. This guideline is revised based on the “New Chemical Substances Environmental Management and Registration Measures” (Ordinance No. 12 of the Ministry of Ecology and Environment) which was amended on April 29, 2020 (hereinafter referred to as “New Law”)
The main points of the revised Guideline are as follows.
Amendment of the scope to be registered
- It was clearly stipulated that medicines (including drug substances) and pesticides (including drug substances for agricultural chemicals) are exempt from the new law.
However, in the cases that a drug (including a drug substance) or an agricultural chemical (including a drug substance for an agricultural chemical) is used for the other industrial applications, or that it is used as a raw material or an intermediate for producing the above products, it must be registered as a new chemical substance.
- Even though a certain chemical substance is already listed on the “List of Existing Chemical Substances in China”, if the substance is used for other industrial applications other than the approved ones, it shall be registered as a new chemical substance requiring the environmental management. The provision is clearly defined.
Clarification of confidential business information (CBI) protection requirements
- The explanations and verifiable documents required for application of information protection are clearly defined. The following are examples of the explanations and certificates required for the application (12 items in total).
- Information protection application by the applicant to other responsible organizations in China and overseas, and status on the relevant approval.
- Whether or not the information for which protection has been requested has been disclosed by the competent organizations concerned?
- Whether or not competitors can manufacture the same chemicals by using reverse engineering?
- The application for extension of information protection period was stipulated as follows.
- For chemical substances that do not belong to the “harmful to the environment” and “hazardous to health” classifications and that protection of identification information such as chemical substance names is permitted, the applicant can apply for the extension of protection period.
Procedures for addition to existing chemical substance list
- Regarding the addition to the “List of Existing Chemical Substances in China”, the definite procedures have been established.
- For chemical substances that have been already manufactured, sold, processed/used or imported in China before October 15, 2003, the applicant may apply for the addition to the existing chemical substance list by submitting the application form and the related verifiable documents online.
Furthermore, the guideline also includes criteria for judging high-risk chemical substances, detailed requirements for data required for registration applications, situations in which polymer “notification” processing is not acceptable (in such cases, regular registration or simplified registration is required), and various requirements for risk assessment reports.
The original text of “Guideline for Environmental Management and Registration of New Chemical Substances (Draft calling opinions)” can be viewed from the following URL (Simplified Chinese).