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FUELS & LUBES INTERNATIONAL
Quarter Three 2014
The official systemhas actually
been around for 19 years. However, it was updated
three years ago to move it closer to the European
REACH (Registration, Evaluation, Authorisation
and Restriction of Chemicals) system, which has
been the well-established and globally adhered-to
regulation concerning chemicals.
Conceived in 1994, the first official edition of
the IECSCwas published in 1997 and listed 21,822
substances. Several thousand new substances were
added into the IECSC every year until 2005 as
shown in the adjacent graph.
The chemical substance inventories in Europe
and the U.S. are more far reaching compared to the
IECSC (2013). The European Inventory of Existing
Commercial Chemical Substances (EINECS) re-
corded the commercially available chemicals in the
EU from January 1, 1972 to September 18, 1981 as
a total of 100,204 unique substances. The European
List of Notified Chemical Substances (ELINCS), a
supplement of the EINECS that includes the Dan-
gerous Substances Directive Notification of New
Substances (NONS), became commercially available
after September 18, 1981 and included 4,381 unique
substances.
In the U.S., the Toxic Substances Control Act
(TSCA) Chemical Substance Inventory is main-
tained and updated by the U.S. Environmental
Protection Agency (EPA). The inventory listed
more than 83,000 substances as of the end of 2010.
Around 700 new chemical substances are added
into the inventory every year.
The IECSCwas updated in 2013 in compliance
with the “NewMeasures for the Environmental
Management of NewChemical Substances” Order
No. 7 (2010) of the Ministry of Environmental Pro-
tection, which came into force on October 15, 2010.
This new set of measures updated the registration
system to improve the identification, monitoring
and supervision of hazardous chemicals in order to
prevent environmental pollution and protect human
health at the source.
As a result of the steps undertaken to improve
and update the IECSC, it has gained global recogni-
tion. The Chemical Abstracts Service (CAS) an-
nounced on July 31, 2013 that the IECSC (2013) has
been added to its database containing international
regulatory information for chemical substances,
CHEMLIST®.
Registrationprocesssimplified
The registration process covers several aspects.
“The NewMeasures for the Environmental Man-
agement of NewChemical Substances” applies to
all “new substances” that are not in the IECSC. As
specified, the newmeasures only cover andmanage
chemical substances in four activities: research,
manufacture, import and process. “Process” has
been included for the first time into the regulation
to improve the supervision andmanagement of
hazardous chemicals in the whole supply chain.
A substance with an import or manufacture vol-
ume lower than 1 ton per year, which was previously
exempted from registration, is required to be filed as
a simplified notification under these newmeasures.
The modified item is similar to the U.S. TSCA,
which requires chemical substances less than 1 ton
to undergo the notification process with the EPA at
least 90 days prior to manufacture or introduction
of the new chemical by filling in a pre-manufacture
notice (PMN).
The newmeasures aim to encourage technology
and scientific research through the simplified no-
tification process for research-purpose substances.
In the previous version, substances for technology
and scientific research withmanufacture or import
volumes of less than 1 ton per year can apply for the
simplified notification. The validation time is one
year. The latest version raised the volume to 10 tons
per year; the validation time was extended to two
years.
With the newmeasures, the volume of the
substance will determine the information to be
submitted to the registration dossier. Simply put,
they define four tonnage bands—1 to <10 tons, 10
to <100 tons, 100 to <1,000 tons and 1,000 tons or
more per year—with higher volume substances re-
quiring a more detailed and complete safety report.
This latest requirement is similar to that of REACH,
where the calculation of volume is based on the
same four tonnage bands. Similarly, substances of
less than one ton are exempted from registration or
notification with ECHA unless they fall under the
Substances of Very High Concern (SVHC).
The newmeasures aim for the systematic man-
agement of substances. There are three categories:
normal new chemical substances; hazardous chemi-
cal substances; and hazardous substances of priority
environmental management.
At the same time, the Hazardous Chemicals
Control Ordinance was enacted in December 2011
by the state council, which required all registered
hazardous chemicals to abide by the ordinance.
Although the management system is improved,
the administrative penalties are considered weak.
The maximumpenalty imposed on a violation of
the ordinance if there is no reported casualty is
CNY200,000 (USD32,455).
Riskassessment
Risk assessment has been added into the Haz-
ard Evaluation of NewChemical Substances as part
of the registration process under the newmeasures.
Also, substances manufactured or imported at one
ton or more per year now have to be submitted for
evaluation during the registration process. Besides
toxicity assessment and exposure pre-assessment,
risk assessment has beenmade part of the evalu-
ation to achieve better risk control and prevent
environmental pollution and human health hazard
at the source.
AChemical Safety Report (CSR) is required for
substances manufactured or imported at 10 tons or
more per year. CSR requires reports of environmen-
tal fate properties, human health hazard assessment,
human health hazard assessment of physicochemi-
cal properties, environmental hazard assessment,
PBT (persistent, bio-accumulative and toxic) and
To ensure public health and safety and environ-
mental protection, China’s Ministry of Environ-
mental Protection (MEP) started a compilation of
the Inventory of Existing Chemical Substances in
China (IECSC) in 1994 and published it in 1995.
The MEP aims to track and manage the manufac-
ture, transportation and usage of chemical sub-
stances in China.
By Alfred Wong
IECSC
EINECS/ELINCS
TSCA INVENTORY
Year Initiated
1995
1981
1976
Existing Substances
45,612
104,585
83,000+
Regulation
New Measures for the
Environmental Management of
New Chemical Substances
REACH
(Registration, Evaluation,
Authorisation and
Restriction of Chemicals)
TSCA
(Toxic Substance
Control Act)
Regulatory Authorities
CRC-MEP
(Chemical Registration Centre
of the Ministry of
Environmental Protection)
ECHA
(European Chemical
Agency)
EPA
(Environmental Protection
Agency)
