China Looks to Strengthen Its
Market Surveillance Policies
With the beginning of a new year, companies doing business in and with China will need to be compliant with another new regulation: the Chinese law on restriction of hazardous substance in electronic and information products (RoHS).
Initiated and drafted by the Ministry of Information Industry (MII, www.mii.gov.cn), the first legislation aimed at environment protection—Administrative Management Methods on Controlling Pollutions by Electronic Information Products” (Order #35)—was jointly issued by some of the most powerful ministries, including the Ministry of Commerce; China Customs; General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ); State Administration for Industry and Commerce; as well as the State Environmental Protection Administration. The aforementioned order was officially released on March 2, 2006, with the implementation date set for March 1, 2007.
A Look at China’s RoHS
The Chinese RoHS law is intended to limit the use of hazardous substances imbedded in products sold on the Chinese markets. The hazardous substances are lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls and polybrominated diphenyl ethers. As a top-level policy statement, this Chinese RoHS law outlines the scope of the control and implementation procedures. On the implementation date of March 1, businesses that make electronic information products are required to properly label their products according to the labeling regulation and provide a table of hazardous-substance contents in their user’s manuals according to the labeling standard (standard number: SJ/T 11364-2006).
Although the labels will be required on the implementation date, products are not yet required to pass mandatory testing. The Ministry of Information Industry is still drafting its mandatory list of products. Once issued, the products on this list will be subject to testing by authorized Chinese testing laboratories according to the official Testing Method Standard (#SJ/T 11365-2006) and evaluated based on the Limitation Standard (#SJ/T 11363-2006).
In essence, this policy is fostering an environment-friendly atmosphere in China, through forcing companies to adopt a mindset of environmental protection in the design and manufacture of products, while promoting consumer awareness by the prominently displayed RoHS symbols on products. The joint force by various ministries also signifies the Chinese government’s determination to enforce such regulations on all business fronts.
Under this law, importers and marketers should manage their procurement sources and refuse to import and sell noncompliant products. Failure to comply with this regulation could result in penalties for manufacturers, importers and marketers. All ministries cosigned this regulation will participate in the enforcement within their jurisdictions.
RoHS in China vs Europe
Also similar to Europe’s version of RoHS is the self-declaration requirement. Under the Chinese law, manufacturers that make products in or sell products to China must label their products with the appropriate RoHS logos and include in the user’s manual a list containing the quantity of each the six substances for each product (Table 1). “X” represents the content of the hazardous substance above the required level; “O” represents below the required level.
China’s new RoHS law does have some differences from the European Union’s version. For example, China will not issue an exempt list of products—instead, it will issue a mandatory list of products that must comply with RoHS. Products included in the list must be subject to testing (according to the aforementioned standards) in Chinese laboratories under management of the China Quality Center—this is the second step of RoHS implementation. As of press time, the mandatory list has not been released yet and no other detailed implementation procedures are under consideration within the ministries.
Potentially Broader Applications
Although this regulation was drafted by the MII and initially focused on electronic and information products, its impact surely will reach beyond this industry as the regulation gains its popularity and exposure in the open market.
Medical devices companies, especially those whose products have 60% or more electronic contents in a product, should consider complying with this regulation immediately. To help companies assess their potential compliance needs, the MII issued a reference product list, which includes the following medical device categories:
• Medical electronic instruments and equipment (monitors and recording devices used for heart, brain, muscle movement, eye and other vital sign monitors)
• Medical ultrasound systems
• Medical laser instruments (diagnostic, measurement and treatment instruments)
• In-vitro diagnostic instruments and centrifuges
• High-frequency and ultra-frequency diagnostic and treatment equipment (including X-ray, nuclear treatment systems)
• Chinese medicine instruments (including electromagnetic treatment, light therapy and acupuncture instruments)
• Other medical electronic instruments (including medical lighting instruments, dialysis and circulation/purification equipment)
Please note that this list is not the mandatory control list but, instead, a guidance document. It is likely that some products on this list would be selected to be on the mandatory list in the future. But by March no medical products are subject to mandatory testing.
Just as with other new regulations, this Chinese RoHS law is not complete (or necessarily thorough) at present. Gray areas and ambiguities surely will be identified and need to be addressed in future regulations. Stay tuned for more developments.