Chemical Regulation in China

Documents are officially published in Chinese and “official” English translations are not available. While unofficial translations are readily available, the official document published in Chinese prevails in cases of discrepancies.  There are significant variations in the written and verbal Chinese language, making it important to understand the intent behind Orders, Decrees, and guidance being offered.

Multinational corporations accustomed to Western regulatory systems typically anticipate a highly detailed written regulatory framework characterized by rigid rules, with compliance driven by the issuance, or threat, of penalties, public disgrace, and reputational damage. In China, however, the framework is very different, as is the conduct of business within the Asian framework. Regulations typically offer only an outline of the details to be followed, which allows for much more flexibility than is typical under Western systems. The regulation may be comprised of both what is written and unwritten, with the intent that its flexibility will allow for it to be interpreted and re-interpreted as circumstances indicate. For instance, Decree No. 591 is viewed as a foundational regulation on which other regulations are based for the full implementation of managing hazardous chemicals in China. Regulators have considerable leeway in addressing issues that may arise while trying to remain consistent and within the scope of the regulation. 

One must also remember that in the global system of chemical management, China has made and continues to make extensive progress quickly. China’s chemical management programs are still relatively new and its regulators are continuing to gain experience. Foundation regulations such as Decree No. 591 require interaction with multiple agencies, all offering a different perspective and employing different means to accomplish the end goal. As a result, there is more often than not a significant time period until a regulation becomes fully operational with the foundation and its many moving parts operating smoothly. Assistance is often needed to determine how to navigate such complex matters.

The Acta Group (Acta®) is active and knowledgeable in assisting its clients in dealing with the complexities of chemical management regulations in China. We are most active in New Chemical Substance Notification (NCSN) MEP Order No. 7 supports as well as Hazardous Chemicals Management (Decree No. 591), and troubleshooting complex issues that require significant insights and experience in navigating Chinese regulations.

Since MEP Order No. 7’s inception, and with each subsequent Chinese Decree, Acta staff has actively assessed the legislation and the myriad of related guidance documents to guide our clients through the complex web of regulation.

Acta’s extensive involvement in NCSN, and the manufacture, import, and export of chemicals in China, makes us especially well-suited to address client issues that arise under MEP Order No. 7, Decree No. 591, and SAWS Order No. 53. Areas in which we advise clients include the following:

• General Compliance Reviews
  • Review in detail client product portfolios to identify obligations, opportunities, and ramifications
• Specific Compliance Assistance, such as:
  • Design, implement, and complete cost-effective testing programs and proposals
  • Prepare study summaries or robust study summaries
  • Perform exposure and risk assessments
  • Perform successful, cost-effective, and timely registrations at all levels
  • Evaluate substances to determine their inclusion on the lists
  • Assist in registration activities
  • Liaise with local and national authorities
• Provide laboratory coordination and support services
  • Assist with placing studies and assessing laboratory qualifications
  • Troubleshoot technical issues
• Provide regular updates on the latest developments regarding MEP Order No. 7 and Solid Waste and Chemical Management Center (SCC), Decree No. 591, and SAWS Order No. 53, including new guidance and tools
• Provide targeted technical services
• Provide agent services
• Provide consultant services

Acta routinely assists its multinational clients in all aspects of NCSN under MEP Order No. 7 and hazardous chemicals management under Decree No. 591, and SAWS Order No. 53.

• Provided tailored client training to regulatory and management teams regarding MEP Order No. 7 impacts, particularly for businesses not routinely impacted by NCSN regulations.
• Worked with a multinational company undergoing a sale transaction to transfer successfully its existing and pending registrations to the new owner. This was achieved by working with SCC-MEP to offer a path forward that was not prescriptively addressed in existing guidance documents.
• Assisted a multinational client in selecting a quality laboratory that was able to meet the designated timelines, which required extensive engagement with the laboratory.
• Established a global test plan and registration strategy for a multinational client that included submission under MEP Order No. 7.
• Consulted with SAWS to resolve complex issues with a multinational company.
• Conducted comprehensive multi-facility audit of Chinese business in China.