The State Council of the People's Republic of China
announced the revised Regulation on the Control over Safety of Dangerous
Chemicals, hereafter referred to as "the
revised Regulation") on March 02, 2011. It will become effective on
December 1, 2011 and replace the current version, which took effect in 2002
(hereafter referred to as "the current Regulation").
The revised Regulation has 8 chapters and 102 articles,
stipulating the manufacture, use, operation, transportation and registration of
dangerous chemicals. Compared with the current version and the draft published
in 2008, the revised Regulation has some significant changes.
Moreover, the revised Regulation will serve as the
umbrella regulation for various implementing rules to be published by various
government agencies, including GHS implementation in China. These rules will be
announced by responsible agencies individually in the future. We will provide
more details once they become available.
1. General Rules
Article 3 of the revised Regulation provides a refined
definition for dangerous chemicals. Dangerous chemicals are toxic chemicals and
other chemicals that have properties of hazardous, corrosive, explosive,
flammable, combustion-supporting and etc., and are hazardous to human, facility
and environment. A consolidated list of dangerous chemicals will be jointly
announced by governing agencies under the State Council in accordance with the
Chinese hazard classification standards of chemicals which were developed based
on the UN Globally Harmonized System of Classification and Labeling of
Chemicals (GHS). The standards include GB 13690, General rules for classification
and hazard communication of chemicals, and 26 technical standards (GB20576 to GB20599, GB 20601 and GB
20602) issued in 2006. A significant change is that the Ministry of Agriculture
(MOA), which regulates pesticides, will be involved in generating the
consolidated list of dangerous chemicals as well as establishing rules for
handling pesticides that are categorized as dangerous chemicals.
The scheme of regulating dangerous chemicals has been a
complicated and fragmented one. Unfortunately, the revised Regulation does not
seem to make it more streamlined. Ten government agencies are authorized to
regulate dangerous chemicals by imposing different responsibilities prescribed
in Article 5. These agencies include State Administration of Work Safety
(SAWS), Ministry of Industry and Information Technology (MIIT), General
Administration of Quality Supervision, Inspection and Quarantine (AQSIQ),
Ministry of Public Security (MPS), Ministry of Environment Protection (MEP),
Ministry of Health (MOH), Ministry of Transport, Ministry of Railways, Civil
Aviation Administration of China (CAAC), and Ministry of Agriculture (MOA). The
overall responsibility of policy coordination is transferred from the State
Economic and Trade Commission (SETC) of the State Council to SAWS
according to this revised Regulation. As mentioned above, detailed implementing
rules will be prepared by these agencies to stipulate the activities within
their own jurisdiction.
According to Article 14, any company that produces
dangerous chemicals must obtain the Safety Production License of Dangerous
Chemicals from the local work safety agency (i.e., the local authority
exercising the delegated authority of the SAWS) before manufacture. SAWS
published a draft revision of the current rules on issuing production licenses
for dangerous chemicals in November 2010, which would impose more
rigorous requirements, but the final rules have not yet been announced.
Article 15 mandates that the manufacturers of dangerous
chemicals provide the Material Safety Data Sheet (MSDS) and affix precautionary
labels on the package. The MSDS and safety labels must comply with relevant
national standards (GHS-type GBs, such as GB 15258 General rules for
preparation of precautionary label for chemicals and GB 16483 Safety
data sheet for chemical products - Content and order of sections).
When new dangerous characteristics are identified, the producer must notify the
public and update the MSDS accordingly.
Article 29 specifies that any chemical company that uses
dangerous chemicals during production must obtain the Safety Use License of
Dangerous Chemicals from the local work safety agency unless: 1) the amount of
dangerous chemicals is below the threshold; or 2) its use is covered by a
Safety Production License of Dangerous Chemicals issued to a manufacturer of
dangerous chemicals. The threshold of exemption will be determined later and
announced by SAWS along with MPS and MOA. Under the current Regulation, use or
handling of dangerous chemicals is not subject to license so long as the
facility design has appropriately addressed the concerns of waste emission and
fire prevention. The new requirement may impose additional burdens on the
chemical companies that do not produce, but only use dangerous chemicals.
According to Article 101, these companies must obtain the Safety Use License of
Dangerous Chemicals from the local work safety department within the period to
be determined by SAWS in the future.
"Operation" is defined as sales and
distribution. Any company that "operates" (sells, distributes or
provides storage service) dangerous chemicals must apply for the Safety
Operation License of Dangerous Chemicals from the local work safety department
unless: 1) a manufacturer of dangerous chemical sells its product within its
plant site; or 2) the operator of a harbor who holds the Harbor Operation
License provides storage service of dangerous chemicals in the harbor (Article
33). A slight difference between the current and revised Regulation is the
level within each government agency that is authorized to issue licenses.
Generally, authorities that can issue such licenses are one step down the
administrative hierarchy according to the revised Regulation. More
specifically, the city-level work safety department is responsible for issuing
license to the companies that operate toxic or explosive chemicals or provide
storage service of any dangerous chemicals, while the county-level work safety
department is responsible for other dangerous chemicals (Article 35).
Article 37 also states that companies must not purchase
dangerous chemicals from unlicensed manufacturers or operate dangerous
chemicals without MSDS or precautionary labels.
Chapter 5 (Article 43 to 65) specifies detailed
requirements for the transportation of dangerous chemicals. Only licensed
service providers may be used to transport dangerous chemicals via any route:
road, railway, air or water. The major changes in the transportation of
dangerous chemicals are the issuance of a Road Transportation Permit and the
expansion of inland water transportation.
Under the current Regulation, the consigner must obtain a
Road Transportation Permit from the police department of the destination before
shipping the toxic chemicals via road transport. The revised Regulation allows
the consigner to apply for the permit from the police department of either
origination or destination place. It remains a preclearance procedure of road
transport for toxic chemicals, but the modification will make the process far
Inland water transportation will be allowed for certain
dangerous chemicals. The current Regulation prohibits the transport of toxic
chemicals and other prohibited chemicals via inland rivers and other closed
waters. The revised Regulation narrows the prohibition to inland closed waters.
Other inland waters may be used to transport dangerous chemicals other than
those toxic chemicals and other chemicals explicitly prohibited.
Article 66 and Article 67 specify the registration system
of dangerous chemicals. According to these two articles, all manufacturers and
importers must go through a company/substance-specific registration by
submitting information about hazard characteristics and safe handling. China
has already implemented a registration system, under which MEP is in charge of
registering imported dangerous/toxic chemicals, and the SAWS is handling the
manufacture registration of dangerous chemicals. It is still unclear how the
current system is going to be modified and administered by SAWS collectively.
Penalties are specified in Chapter 7 (Article 75 to 96),
including the new provision regarding the contravention against the
MSDS-related and labeling requirements. Paragraphs 3, 4, 5 and 6 of Article 78
state that a fine up to RMB 100,000 will be imposed, if: 1) the manufacturer
fails to provide MSDS or affix the precautionary label; 2) MSDS or
precautionary label does not match the content in the package or meet relevant
national standards; 3) the manufacturer does not notify the public or update
the MSDS and precautionary label when new dangerous characteristics are
identified; or 4) the company "operates" dangerous chemicals lacking
MSDS or precautionary labeling. The violators may also be ordered to cease
production or operation. Industry must ensure that the MSDS and precautionary
labeling meet the Chinese national standards.
Nonetheless, the revised Regulation is an umbrella
regulation that does not provide much detail in terms of the implementation. We
will continue providing updates when the implementation rules are published by
Should you have any questions regarding the memo, please
do not hesitate to contact Wilfred Feng (firstname.lastname@example.org),
Chen Hu (email@example.com), or Jenny Li (firstname.lastname@example.org) at Keller and Heckman LLP,
Shanghai Representative Office.
Available at http://www.gov.cn/zwgk/2011-03/11/content_1822783.htm
These 26 standards set the criteria to determine the hazard classification of
dangerous chemicals, such as "Explosives", "Flammable
gases", "Flammable aerosols", "Oxidizing gases", etc.
They are being revised in accordance with the updated edition of the GHS.
Available at http://www.chinasafety.gov.cn/newpage/Contents/Channel_5826/2010/1109/112879/content_112879.htm