The Environmental Management Regulations for New Chemical Substances in China (Ministry of Environmental Protection Order No. 7) have been in effect for over three years since October 2010. Manufacturers still face some unresolved issues and challenges in complying with the regulations. The following is a summary of the implementation results in recent years:
The number of routine declarations has increased dramatically year after year, with over 80% belonging to hazardous or key environmentally hazardous new chemical substances. This clearly demonstrates the necessity of registration management and the proactive response from enterprises, as well as the gradual improvement of the government's technical enforcement capabilities. The types of routine declarations are becoming increasingly diverse. Early on, routine and joint declarations were common, but since 2013, series declarations and duplicate declarations have emerged. Furthermore, it can be observed that in addition to declarations from source manufacturers or importers, many overseas manufacturers choose to file their own declarations.
The number of simplified application submissions has been decreasing year by year. This is because after the repeal of the old management regulations (Order No. 17), new chemical substances registered under the old regulations were in a transitional phase and needed to be resubmitted after Order No. 7 came into effect and the old registration certificates expired. Therefore, the number of applications was higher in the early stages of Order No. 7's implementation. Substances that continue to operate in the Chinese market after the implementation of the new regulations (Order No. 7) should be notified accordingly. For details regarding the transition between Order No. 7 and the old Order No. 17, please refer to the Ministry of Environmental Protection's announcement.
– There are approximately 900 simplified application cases for special circumstances (research purposes) each year, indicating that research activities have not significantly affected the application for new chemical substances.
Although China's new regulations on chemical substances are progressing, many issues remain, and manufacturers face considerable challenges in implementation.
Intermediates are subject to routine reporting: The industry generally believes that information requirements for low-risk and low-exposure intermediates should be more lenient than for general substances. However, China requires that intermediates manufactured or imported in quantities of more than 1 ton per year should be regarded as new chemical substances and subject to routine reporting without any data exemption. The Chinese chemical industry has been hoping that when the guidelines for reporting new chemical substances are revised, the information requirements can be lowered, but there has been no positive response from the authorities.
– Lack of communication channels with technical professionals: To prevent applicants from bribing technical personnel who review registration, information about technical professionals is not disclosed to companies applying for registration and the public, resulting in closed communication channels. However, China's Ministry of Environmental Protection (MEP) has taken note of this problem and is actively developing an effective communication platform.
– New Gas Registration: In China, only a few qualified laboratories can perform the basic experiments required for new gas registration, but some qualified laboratories refuse to conduct the experiments.
– Guidelines: Some guidelines for new substance declarations are vague. For example, the guidelines state that if the soil adsorption level is low, terrestrial toxicity information is exempted, but the guidelines do not provide quantitative standards for defining the adsorption level.
– Active Ingredients: Whether active ingredients imported for pesticide and pharmaceutical purposes that are not listed in the existing list of chemical substances (IECSC) should be declared as new substances has sparked widespread discussion. According to Article 2 of Decree No. 7, "Other laws and regulations apply to the production of pharmaceuticals, pesticides, veterinary drugs, cosmetics, food, food additives, and feed additives; however, Decree No. 7 applies to the raw materials or intermediates of the aforementioned products if they are new chemical substances." This means that if an active ingredient is processed into a product raw material, it must be declared as an active ingredient, resulting in duplicate declarations by different competent authorities and a burden on the industry.
Manufacturers are advised to refer to the guidelines provided by the MEP (Manufacturing Execution Program) and further consult the updated Q&A on the website. However, it is worth noting that the information of the certificate holders in the third batch of new chemical substance environmental management registration certificates announced this March has been obscured. This measure will benefit companies by preventing the erosion of their commercial interests due to information disclosure. Source: International Chemicals Trade Regulations (2014-04-23)
