Publication date: 8 February 2010,
Updated on 16 February 2010
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.
| 2010 Amendment |
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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)
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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. 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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