Unlike our
(and your)
expectation,
there exist
striking
differences
between the
2009
Proposal (21
May 2009)
and the
adopted 2010
Amendments
(19 January
2010).
Amongst
others, the
following
five points
may need
bigger
attention of
chemical
producers,
industrial
users of
chemicals
and even
article
manufacturers:
Chemicals in products: Even though it is very short, Article 2 of the 2010 Amendments provides a short statement, "This Regulation is applicable to products which releases new chemical substances in their normal use." (设计为常规使用时有意释放出所含新化学物质的物品，按照本办法管理). This statement was not mentioned in the 2009 Proposal. We would like to see which child regulations the Ministry of Environmental Protection may produce in coming months or years.
Globally harmonized system on classification and labeling of chemicals (GHS): The 2010 Amendments is one of the few Chinese regulations clearly referring to the GHS Standards (警示标签和警示性说明安全规范) which were issued on 24 October 2006. This is a positive move as it provides a clear link between law and standards.
Classification of chemicals: The chemical classification envisaged in the 2009 Proposal is gone. There will be three classifications under the 2010 Amendments, i.e., general new chemicals (一般类新化学物质), hazardous new chemicals (危险类新化学物质), and priority hazardous chemicals (重点环境管理危险类新化学物质).
Pollutant release and transfer register (PRTR) or toxic release inventory (TRI): Annual reporting scheme in the 2010 Amendments may provide a framework to implement PRTR requirements in China in a medium- and long-term. In particular, it had extended reporting requirements for producers or importers of hazardous new chemicals (including priority hazardous new chemicals).
Phase-out of hazardous chemicals: There are many promotional provisions for the development and use of environmentally-friendly chemicals in the 2010 Amendments. The Ministry of Environmental Protection may also foresee natural phase-out of hazardous chemicals in China, as it imposes six-month earlier reporting requirements on producers or importers of hazardous new chemicals before it starts a periodic five-year review of chemicals to update the Chinese Inventory of Existing Chemicals. Namely, the Ministry of Environmental Protection may expect that hazardous chemicals have been phased out in the market and there is no need to put them in the Chinese Inventory of Existing Chemicals.
China is
moving fast.
After the
issuance of
the draft
proposal to
the Measures
on
Environmental
Management
of New
Chemical
Substances (新化学物质环境管理办法)
on 21 May
2009, the
Ministry of
Environmental
Protection
adopted the
Measures on
Environmental
Management
of New
Chemical
Substances
on 19
January
2010. This
Chemical New
Chemical
Regulation
will enter
into force
on 15
October
2010. While
making some
significant
changes to
the previous
proposal,
the adopted
Regulation
of 19
January 2010
keeps the
following
main
requirements:
risk management concept for new chemicals in the Chinese chemical control system, i.e. hazard and exposure
new chemicals are classified into a) general new chemicals and b) hazardous new chemicals
tonnage-based notification (e.g. 1 ton, 10 tons, 100 tons, 1,000 tons). The principle of notification information is ‘higher volume, more data’.
simplified notification is available for new chemicals imported or produced less than 1 ton per year. Separate research and development notification is also available when producing or importing a new chemical substance less than 0.1 ton per year.
notification of new chemicals can only be done by a registered Chinese entity.
serial, joint and duplicate notification system is available for easier notification options
producers and importers of new chemicals have annual reporting and record-keeping requirements.
Table of
Contents
(2003, 2009
Proposal,
2010
Amendment)
There exist
significant
differences
between the
2009
Proposal and
the 2010
Amendments.
Compared to
the 2009
proposal,
simply there
is around
25% increase
of
regulatory
texts in the
2010
Amendments.
We see more
than 60% of
changes in
legislative
words.
2003
2009 Proposal
2010 Amendment
Chapter I General Provisions
Chapter II Notification
Chapter III Registration
Chapter IV Supervision and Administration
Chapter V Legal Liabilities
Chapter VI Supplementary Provisions
(In total, 29 articles)
Chapter I General Provision
Article 1 (Objective)
Article 2 (Applicability)
Article 3 (Definitions and Inventory)
Article 4 (General Management Policy)
Article 5 (Main System)
Article 6 (Scientific Support)
Article 7 (Due Diligence Principle)
Chapter II Notification Procedure
Article 8 (Types of Notification)
Article 9 (Compliance Requirement)
Article 10 (Fast-Track Notification)
Article 11 (Testing Laboratories)
Article 12 (Confidentiality Requirement)
Chapter III Registration Process
Article 13 (Notification and Registration)
Article 14 (Registration Processing Period)
Article 15 (Registration Details)
Article 16 (Registration Modification and Renewal)
Article 17 (Periodic Publication)
Chapter IV Follow-Up Compliance Control
Article 18 (Condition of Environmental Impact Assessment)
Article 19 (Risk Control I)
Article 20 (Risk Control II)
Article 21 (Risk Control III)
Article 22 (Research and Development Control)
Article 23 (First-Time Activity Reporting)
Article 24 (Annual Reporting)
Article 25 (Record-keeping)
Article 26 (Administrative Control Notice)
Article 27 (Supervision and Inspection)
Article 28 (Processing of New Information)
Article 29 (Public Supervision)
Article 30 (Closure of Operation)
Chapter V Inventory Modification
Article 31 (Inventory Entry)
Article 32 (Early Entry)
Article 33 (General Review)
Article 34 (Follow-Up Management)
Chapter VI Penalties
Article 35 (Penalties by Ministry of Environmental Protection)
Article 36 (Penalties by Local Authorities)
Article 37 (Penalties on Misconduct)
Chapter VII Schedule
Article 38 (Definitions)
Article 39 (Related Documents)
Article 40 (Implementation Date)
Article 41 (Interpretation Authority)
Chapter I General Provision
Article 1 (Purpose)
Article 2 (Applicability)
Article 3 (Classification)
Article 4 (Framework Control System)
Article 5 (Registration Certificate)
Article 7 (CBI Protection)
Article 8 (Public Supervision)
Chapter II Notification Procedure
Article 9 (Modes of Notifications)
Article 10 (General Notification Requirement)
Article 11 (Classification of General Notification)
Article 12 (Basic Conditions for Simplified Notification)
Article 13 (Special Conditions for Simplified Notification)
Article 14 (Research and Development Record Register)
Article 15 (Serial Notification, Joint Notification, Duplicate Notification)
Article 16 (Qualification of Entities for the Notification of New Chemical Substances)
Article 17 (Accurate Reporting)
Article 18 (Disclosure of Environmental Information)
Article 19 (Testing Laboratories)
Chapter III Registration Management
Article 20 (Registration Procedure for General Notification of New Chemical Substances)
Article 21 (Registration Procedure of Simplified Notification for New Chemical Substances)
Article 22 (Registration Procedure for Research and Development Record Register Notification of New Chemical Substances)
Article 23 (Publication of Registration of New Chemical Substances)
Article 24 (Administrative Time for the Registration of New Chemical Substances)
Article 25 (Content of Registration Certificate)
Article 26 (Reporting and Handling of Newly Acquired Information on Chemicals)
Article 27 (Re-Notification of New Chemical Substances)
Article 28 (Information Communication)
Chapter IV Follow-Up Control Measures
Article 29 (Review of Environmental Impact Assessment)
Article 30 (Information Transfer)
Article 31 (General Risk Management Measures)
Article 32 (Priority Risk Management Measures)
Article 33 (Prohibition of Transfer)
Article 34 (Requirements on Research and Development)
Article 35 (Activity Reporting)
Article 36 (Annual Reporting)
Article 37 (Record-keeping)
Article 38 (Supervisory Notice)
Article 39 (Supervisory Inspection)
Article 40 (Cancellation of Registration)
Article 41 (Procedure for the Entry in Chinese Inventory of Existing Chemical Substances)
Article 42 (Periodic Review)
Chapter V Liability
Article 43 (False Notification)
Article 44 (Punishment by Ministry of Environmental Protection)
Article 45 (Punishment by Local Authorities - I)
Article 46 (Punishment by Local Authorities - II)
Article 47 (Punishment on Members of Expert Review Committee)
Article 48 (Punishment on Chemical Testing Laboratories)
Article 49 (Punishment on the Misconduct of Governmental Staff)
Chapter VI (Schedules)
Article 50 (Definitions)
Article 51 (Document Forms)
Article 52 (Entry into Force Date)
China
Chemical Law
& Regulation
2008 - 2009
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.
Structure
of Chinese Chemical Regulation
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.
Category
Chinese Chemical Law and Regulation
New & Existing Chemicals Control
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
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)
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
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.
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.
