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| China - Chemical Regulation in
2008 -2009 |
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Like or unlike your expectation,
China has comprehensive regulatory framework on
chemicals to ensure the public health, safety of
workers and the protection of the environment.
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| Structure
of Chinese Chemical Regulation |
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Also China has long history of regulating chemicals.
At the beginning (1970s), the regulatory focus was
health and safety of workers. In 2000s, Chinese
chemical regulations deal with health and safety of
workers and the protection of the environment in a
balanced manner.
| Development
of Chemical Regulations in China |
 |
Globalization Impacts on Chinese Chemical
Regulations
With the access to the World Trade Organization
(WTO) membership in 2001 and the enactment of the
Measures on the Environmental Management of New
Chemical Substances on 12 September 2003, China has
adopted a series of implementing measures to meet
internationally-acceptable standards, e.g. Technical
Rules on Toxicity Testing of Chemicals of 11 July
2005, Guideline on Good Laboratory Practices for
Chemical Testing (HJ/T155-2004), Guideline for
Chemical Testing (HJ/T153-2004), Guideline for the
Hazard Evaluation of New Substances (HJ/T154-2004).
For example, the Technical Rules of 11 July 2005
referred to the OECD Guideline for Testing of
Chemicals (1981-2002) and the USA Code of Federal
Regulations, Title 40, Volume 28 and USEPA OPPTS
Health Effects Test Guidelines (1996-2000).
The Ministry of the Environmental Protection of
China (previously, State Environmental Protection
Administration) and the Chemical Registration Center
play the main role in the registration of new
chemicals and maintenance of the inventory of
existing chemicals.
Other than the registration of new chemicals, China
has a complex control regime on use and marketing of
chemicals from a health and safety perspective. The
Ministry of Health, the Ministry of Communication,
the Ministry of Public Security, the State
Administration of Quality Supervision, Inspection
and Quarantine, the General Administration of
Customs, the Ministry of Commerce, the State Food
and Drug Administration, the
State Administration of Work Safety,
the State Administration of Standardization, and the
National Development and Reform Commission all have
some control on chemicals in those aspects.
Amongst others, the
Regulation on the Safety Management of Hazardous
Chemicals,
the Measures for Hazardous Chemicals Registration
Management
and
the Regulation on the Labor
Protection in Workplaces Handling Toxic Materials
and
the Occupational Health Law
provides a framework on the control of chemicals at
the workplace.
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Category |
Chinese Chemical
Law and Regulation |
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New & Existing Chemicals Control
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Measures on the Management of New
Chemical Substances
(2003)
List of Existing Chemicals (2007
Version)
Regulation on the Safety Management of
Hazardous Chemicals
Measures on the Registration of
Hazardous ChemicalsList of Acute Toxic Chemicals (2002) |
|
Pollutant Release & Transfer Register |
No applicable law or regulation |
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Chemical Packaging & Labelling |
Standards on the Classification and
Marking
of Commonly Used Hazardous Chemicals
(GB13690-1992)Standards on the Provision of Chemicals
Safety Labels (GB15258-1999) |
|
Use & Marketing Restrictions |
Regulation on the Environmental
Management of the First-Time Import of
Chemicals and Import and Export of Toxic
Chemicals
Measures on the Management of Sales
Permits for Hazardous ChemicalsEnforcement
Measures on Safe Production
Permit for Production of Hazardous
Chemicals
List of Severely Restricted Toxic
Chemicals for Export and Import |
|
Chemical Import & Export Restrictions |
Registration Measures for Environmental
Management of the First-Time Import and
Export of Chemicals
Enforcement Rules of Registration
Measures for Environmental Management of
the First-Time Import/Export of
Chemicals and Import/Export of Toxic
Chemicals |
|
Material Safety Data Sheets |
Standards on the Provision of Chemical
Safety Data Sheets (GB16483-2000) |
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Occupational Exposure Limits &
Protection |
Occupational Health Law
Regulation on the Labour Protection in
Workplaces Handling Toxic Materials
Standards on the Classification of Toxic
Operations (GB12331-1990)
Circular on the List of Highly Toxic
Substances (Weifajianfa(2003)142 |
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Chemical Restrictions in Products |
Management Measures for the Prevention
and Control of Pollution from Electronic
Information Products
Standard of Concentration Limits for
Certain Hazardous Substances in
Electronic Information Products (SJ/T
11363-2006)
Testing Methods for Hazardous Substances
in Electronic Information Products (SJ/T
11365-2006)
Standard of Marking for Control of
Pollution Caused by Electronic
Information Products (SJ/T 11364-2006) |
Chinese Chemical Regulations in 2008 - 2009
On 21 May 2009, the Ministry of Environmental
Protection proposed the amending draft to the
Measures on the Environmental Management of New
Chemical Substances. The key points of the amending
draft are that:
- risk management concept for
new chemicals would be introduced in the
Chinese chemical control system, i.e.
hazard and exposure;
- new chemicals would be classified
into three categories, i.e. general
chemicals, hazardous chemicals, and
chemicals of environmental concern, and
be further regulated;
- basics of notification and
registration system for new chemicals
would remain the same as it was.
However, detailed 'general notification'
would be required for new chemicals
depending on tonnage (e.g. 1 tonne, 10
tonnes, 100 tonnes, 1,000 tonnes) of the
chemicals imported or produced. The
principle of notification information
would be 'higher volume, more
information request'.
- simplified notification would be
available for new chemicals imported or
produced less than 1 ton per year.
Separate research and development
notification would be available when
producing or importing a new chemical
substance less than 0.1 ton per year.
- notification of new chemicals would
only be done by a registered Chinese
entity.
- ecotoxicological data should be
generated by a Chinese test laboratory
and be acquired from Chinese test
samples.
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The scope and limit of the amending draft of 21 May
2009 to the Measures on the Environmental Management
of New Chemical Substances is that the provisions
would only be applicable to new chemicals which are
not included in the Chinese Inventory of Existing
Chemicals. However, companies shall not
misunderstand that the Measures on the Environmental
Management of New Chemical Substances are the only
chemical regulation controlling new and existing
chemicals in China. As mentioned in the introductory
part, the Chinese chemical control system has
complex jurisdictional structure controlled by
multiple governmental ministries. This overwhelming
jurisdictional complexity on chemical control may be
prohibitive for integrated chemical control at
workplace and make difficult introduce a holistic
chemical regulation like REACH.
Although a chemical reporting and registration
system exists under the Measures on the Registration
of Hazardous Chemicals, it is not a version of the
pollutant release and transfer register in the terms
of the Organisation for Economic Cooperation and
Development (OECD). Currently, there is no capacity
to track and provide presence of chemicals in the
environment online like the European Pollutant
Emissions Register [5]. In the proposed amending
Regulation of 29 February 2008 on the Safety
Management of Hazardous Chemicals, the State Council
would require hazardous chemicals production
facilities to prepare a hazardous chemical accident
emergency responses plan, introduce a permit system
for the use of hazardous chemicals over certain
threshold amounts and record keeping requirements.
In particular, the proposed Regulation of 29
February 2008 would require hazards and safety
technical data to be registered with the State
Administration of Work Safety.
Despite of the effort to establish internationally-recognisable
Chinese good laboratory practice (GLP) laboratories
by the Ministry of Science and Technology, the
Ministry of Health and the State Food and Drug
Administration, still there is no laboratory which
can generate OECD-acceptable chemical test data. No
experience exists on comprehensive risk assessment
on existing chemicals, e.g., HPV Program. It should
be noted, however, that China has been adopted more
than 120 National Standards on Chemical Testing and
GLP (including 65 Standards on Physico-chemical
Tests, 58 Standards on Toxicities and
Eco-toxicities) in 2008 and 2009. This indicated
that China is aggressively putting scientific and
technical infrastructure for stricter or sound
management of chemicals and this may lead to further
regulatory measures soon.
Regarding GHS, in addition to 26 Standards on
Classification，Precautionary Labelling and
Precautionary Statements of Chemicals, which have
been implemented in China as from 1 January 2008,
the Standard on Labelling of Chemicals based on GHS
(Globally Harmonized System of Classification and
Labelling of Chemicals) (GB/T 22234-2008) provides
further guidance on pictograms, warning words,
hazard statement and precautionary measures.
However, enforcement of these GHS standards is in
question, as the issuing authority (i.e.
Standardization Administration of China) is not a
governmental authority having enforcement power and
the standards are not clearly referred to in
existing chemical regulations.
The REACH system requires a well-structured and
functioning chemical regulatory regime, scientific
infrastructure (e.g. GLP Labs), technical
enforcement capacity, scientific data on chemicals,
a technical expert pool, and a chemical tracking
mechanism locally and nationally. It may be too
early for China to introduce REACH-like elements in
its existing chemical regulations. However, China
has been trying to make more advancement in the
control of new and existing chemicals by upgrading
the Measures on the Management of New Chemical
Substances and/or the Regulation on the Safety
Management of Hazardous Chemicals in 2008 and 2009.
By building more sound capacities on chemical
control through the upgrade of existing chemical
regulations, China may introduce REACH-like elements
in a mid- and long-term legislative planning. |
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