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Chemical Regulation in China

Overview:

The rapid economic development in Asia offers opportunities for the manufacture and marketing of chemical substances, making China of significant interest to multinational companies and to those that elect to source chemicals from the region for import. The regulatory regimes for chemicals in China continue evolving. Chemical regulations in China currently proceed under two primary enabling Decrees/Orders -- the “Decree of the State Council -- People’s Republic of China -- Number 591 -- Regulations on Safe Management of Hazardous Chemicals” (Decree No. 591) and the “Order of the Ministry of Ecology and Environment (MEE) Number 12 -- Measures on the Environmental Management Registration of New Chemical Substances” (MEE Order No. 12).

Decree No. 591 is currently under revision with the second draft revision, “Law on Safety of Hazardous Chemicals,” issued on October 2, 2020. The third draft revision is expected in 2022. In addition, China currently implements the 4th revised edition of the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) through a series of national standards (GB30000 series, GB15258, GB/T16483, and GB/T17519), and adoption of the 7th revised edition of GHS and the 20th revised edition of the United Nations Recommendations on the Transport of Dangerous Goods is under consultation.

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.

In the global system of chemical management, China has made and continues to make extensive progress quickly. China’s chemical management programs are still evolving and its regulators continue to gain experience. Foundation regulations such as Decree No. 591 require interaction among multiple agencies, each 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 and its many moving parts operate 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 support of notification of new chemical substances as well as Hazardous Chemicals Management (Decree No. 591), and troubleshooting complex issues that require significant insights and experience in navigating Chinese regulations.

Our Experience:

Since inception of notification of new chemical substances, 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 impressive scientific and toxicological team includes Jane Vergnes, Ph.D., DABT®, an esteemed toxicologist with a Ph.D. in Human Genetics and an impressive track record of success directing global product stewardship for Fortune 500-listed chemical companies. Before joining Acta, Dr. Vergnes started her career as a research scientist and laboratory supervisor. Dr. Vergnes has particular expertise in toxicological testing among various regulatory schemes, including study design, laboratory practices, and data requirements for new chemical introductions.

Meibao Zhuang, Ph.D., an experienced multidiscipline scientist, project leader, and regulatory expert, offers clients in-depth scientific knowledge and exceptional skills in developing and implementing regulatory strategies. Dr. Zhuang holds a Ph.D. in Environmental Toxicology, and an M.S. and B.S. in Entomology and Genetics. Fluent in English and Mandarin, Dr. Zhuang assists clients with regulatory strategy development, study planning and monitoring, dossier development, product defense, and project leadership to deliver key results for global business targets.

Lara Hall, MS, RQAP-GLP, a Registered Quality Assurance Professional in Good Laboratory Practices (RQAP-GLP), earned both a B.S. and M.S. in Biology and has over a decade of experience in environmental research, study monitoring, and international regulatory support. Ms. Hall assists clients in placing and monitoring studies to assist with new chemicals; developing testing plans for chemicals seeking regulatory approval; and assessing studies for conformance with testing guidelines, data compensation, and regulatory and GLP requirements. 

Karin F. Baron, MSPH, Senior Regulatory Consultant, provides extensive experience in the complex strategies necessary to navigate regulations in China. Ms. Baron assists clients in developing appropriate data packages and dossiers to register successfully new products in various applications, including industrial, food contact, and cosmetics. Ms. Baron’s experience in industrial and specialty chemicals brings clients’ skills in the fundamentals necessary to protect proprietary business information while addressing complex regulatory requirements. Ms. Baron has over 20 years of regulatory experience, including strong hazard communication skills for the development of compliant Safety Data Sheets and labels.  

Acta’s resources in China include an extensive experienced team of partners in Beijing, Shanghai, and Guangzhou. Our team has been active in performing registrations at all levels, and offering laboratory selection assistance, project management, and regulatory support while providing sound scientific and business advice to our clients on the complexities and nuances of Decree No. 591, MEE Order No. 12, and other guidance documents. 

What We Do:

Acta’s extensive involvement in notification of new chemical substances, and the manufacture, import, and export of chemicals in China, makes us especially well-suited to address client issues that arise under MEE Order No. 12, Decree No. 591, State Administration of Work Safety (SAWS) Order No. 53, and Decree No. 727. 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 MEE Order No. 12 and Solid Waste and Chemical Management Center (SCC), Decree No. 591, SAWS Order No. 53, and Decree No. 727, including new guidance and tools
  • Provide targeted technical services
  • Provide agent services
  • Provide consultant services
  • Provide Safety Data Sheet and label services

Representative Engagements:

Acta routinely assists its multinational clients in all aspects of notification of new chemical substances under MEE Order No. 12, Hazardous Chemicals Management under Decree No. 591, and SAWS Order No. 53, as well as cosmetics and new ingredients under Decree No. 727 and relevant National Medical Products Administration (NMPA) orders.

  • Provided tailored client training to regulatory and management teams regarding MEE Order No. 12 impacts, particularly for businesses not routinely impacted by regulations on notification of new chemical substances.
  • 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-MEE 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 MEE Order No. 12.
  • Consulted with SAWS to resolve complex issues with a multinational company.
  • Review for compliance Safety Data Sheets and labels for hazardous chemical substances and mixtures. When needed, develop and draft with translations.
  • Conducted comprehensive multi-facility audit of Chinese business in China.
  • Assisted a multinational company in evaluating cosmetic ingredient selection and safety information submission in China.

 
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