Chinese Chemical Regulation

Chinese Chemical Regulatory Updates  

Steptoe assists clients in working with the challenging and increasingly high profile Chinese regulatory systems for hazardous chemicals, China REACH, biocides, food safety, and cosmetics.  As Chinese regulatory reforms continue, Steptoe combines in-house technical knowledge and deep experience with global regulatory regimes to advise our international clients.

China implemented its version of REACH in 2010, bringing China’s chemicals control legislation partially in line with the EU’s.  With Decree 591, China has created a licensing regime for producers, importers, and users of hazardous chemicals that aligns its regulatory standards with GHS classification and labeling requirements.  The newly created General Administration for Food and Drugs will partially replace the previously overlapping set of regulating authorities for food and drug safety supervision with a role similar to the US Food and Drug Administration.  These developments highlight the close relationship between developing Chinese regulations and existing regulatory regimes elsewhere around the world.

Steptoe’s China Regulatory Capabilities

Steptoe advises multinational companies on interpreting and ensuring compliance with Chinese chemical regulations for both industrial and consumer products.  Steptoe is also working on projects relating to the emerging regulation of antimicrobials and biocides.  In both the food contact and non-food contact categories, Steptoe is uniquely positioned with the most up to date information on changing regulatory and technical requirements.

In the consumer products category, Steptoe can determine if a product requires registration or approval and if it contains restricted or banned substances, register products and ingredients as necessary, and review labeling to ensure compliance with Chinese GHS requirements.  This work is principally focused in our Beijing office, but also draws upon our regulatory experience in Brussels and Washington. 

Steptoe offers unique and consolidated services that combine technical expertise, strong government affairs connections and capabilities, and deep legal knowledge of the regulatory landscape.  We are well positioned to offer practical and efficient guidance to our clients to help them navigate the changing regulatory system.  We routinely assist our clients to creatively overcome regulatory and market challenges in China.

Representative Cases

  • A client had advanced disinfectant equipment for importation which required governmental approval.  The underlying technology was unfamiliar to the Chinese government, so the government had no process to evaluate or approve the equipment.  We assisted our client in establishing a joint study program, in consultation with government officials and industry experts, to develop an appropriate evaluation methodology for the involved technology.  This allowed our client to effectively train the government and their equipment was quickly approved thereafter.
  • Another client faced a lengthy production interruption due to conflict between old regulations and a newly implemented standard for their food product.  We worked with multiple relevant Chinese agencies to arrive at a solution that ensured compliance and avoided an interruption in their production activities.
  • Another client had a disinfectant wipe product for importation that fell outside of the government’s existing testing protocols.  It was vital in this example to avoid the lengthy process of developing a new standard and testing methodology.  To achieve our client’s aims, we arranged for independent experts to review the product and execute statements attesting to the product’s safety, despite the fact that it contained an active ingredient at more than the prescribed allowable level.  Through our creative approach, a waiver was granted and the product was cleared for importation into China.
  • Another client had a liquid disinfectant product for hard surfaces which was already approved for use in the US.  Despite being a rather common product, the stringency of the Chinese testing process prevented quick approval.  The client’s top priority was to gain quick entry to the Chinese market.  We devised an approach involving revising the labeling which enabled our client to obtain rapid market access.