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How to navigate the China REACH regulation

How to navigate the China REACH regulation

Chemical regulations differ from country to country as no two regulations are exactly the same.

For example, on the surface, China REACH may appear to be very similar to other REACH regulations. However, there are many fundamental differences that companies cannot afford to ignore.

Companies looking to import chemicals into China are required to submit new chemical substance notifications firstly under the Regulation of “New Chemical Substance Environmental Protection Measures” (commonly referred to as “China REACH”) to the Ministry of Environmental Protection of the People’s Republic of China Order No.7. This regulation governs the production and use of substances and assesses the potential impacts on both human health and the environment. China REACH is essentially a counterpart to the European Union’s REACH regulation.

Despite being first introduced in 2003 and last amended in 2010, many companies are still not wholly aware of the regulation and their obligations to ensure compliance. A lot of companies will venture out to market chemicals in China and find China REACH to be their first major obstacle.

  • In terms of the overall objective and purpose, REACH regulations are very similar. But when it comes down to the registration process, there are several fundamental differences. First, unlike EU REACH, there is no set deadline for companies to register substances under China REACH. Manufacturers and importers of the new chemical substance are required to submit new chemical substance notifications before importation and production in China

 

  • Perhaps because of this lack of urgency, there are only around 45,612 substances listed in the country’s existing chemical inventory to date; this is far less than other countries with a REACH regulation. In comparison, the EU’s existing database has around 100,204 listed substances

 

  • China REACH legislation aims to control the environmental risk for the new chemical substance, protect human health and protect the ecologic environment. It applies to the new chemical substance activity environmental management for research, manufacture, importation and usage within the People’s Republic of China. While the EU requires registration of substances only if the quantity exceeds one ton per year for both existing and new chemicals, China requires registration for all new substances regardless of quantity

 

  • When it comes to testing, the Chinese version requires companies to provide testing data for the regular notification and simple notification type while the EU and Korea’s K-REACH only require testing proposals at first submission.

 

  • Registering polymers is also different in China. Similar to Korea’s K-REACH regulation, China REACH only requires companies to register a polymer as a single substance notification, whereas the EU requires a more comprehensive registration of all the monomers that comprise the polymer if the concentration of the substance is over two percent and the volume over one ton per year

 

  • Another key difference lies in China REACH’s range of notification types. It is more diverse compared to EU REACH as it includes research notifications, simple notifications and regular notifications

If a substance is not listed in the Inventory of Existing Chemical Substance in China (IECSC), it will be treated as an entirely new substance in China. New chemical substance should prepare new chemical substance notification before production or importation according to the regulation of China REACH. The notification not only applies to substances on their own, in preparation or articles intended to be released, but also to new substances used as ingredients or intermediates for pharmaceutical, pesticide, veterinary drug, cosmetic, food, food additive and feed additive applications.  

 

It is also good to know what substances are exempted from China REACH. These include finished products that are subject to other existing laws and regulations such as cosmetic, food, radioactive substances, military industrial products and pyrotechnics. Others include naturally existing substances, like non-chemically modified natural polymers.

 

While companies within China can submit new substance notifications on their own or appoint a local agent to do so on their behalf, foreign companies must appoint a local Chinese agent to submit new notifications for them. This is where using a qualified partner like DKSH China, who is knowledgeable in the local market and is experienced in undertaking the registration and notification process, can greatly support your business growth. DKSH China’s Regulatory Affairs team keep a close eye on all regulations to support all of its business partners to adapt to the changing regulatory environment.

How are you approaching China REACH and what obstacles are you facing? Drop me a line to share your insights.

Sources:

Nancy Lou

About the Author

Nancy Lou is Senior Manager, Regulatory Affairs and Quality Assurance at DKSH (Shanghai) Ltd.