Outline of the 2003 Partial Amendment tothe Chemical Substances Control Law
June 2003
Ministry of Economy, Trade and Industry
Ministry of Health, Labour and Welfare
Ministry of the Environment
Government of Japan

I. Background of the amendment
With the aim of preventing damage to human health caused by environmental
pollution from chemical substances, Japan’s 1973 Law Concerning the Evaluation ofChemical Substances and Regulation of their Manufacture, etc. (hereinafter “ChemicalSubstances Control Law”) requires prior evaluation 1 of certain hazardous properties of
new chemical substances intended for industrial use, and also regulates themanufacture, import and use of chemical substances that persist in the environment (i.e.
persistent) and are toxic to human health if taken in continuously (i.e. having long-term
toxicity to human), such as polychlorinated biphenyls (PCBs) and trichloroethylene, inways that reflect their hazardous properties.
Meanwhile, chemical evaluations and regulations in many industrializedcountries pay attention not only to effects on human health but also to those on livingorganisms in the environment, and take into account the potential for environmentalreleases of chemical substances, in evaluating new chemical substances. In January
2002, the OECD recommended that Japan should further improve effectiveness andefficiency of chemical management, and further extend the scope of regulation to include
ecosystem protection.
Under these circumstances, three governmental councils (the Industrial
Structure Council, the Health Sciences Council, and the Central Environment Council)
reviewed current chemical evaluation and regulation system in Japan and concluded intheir joint report that the government should amend the Chemical Substances Control
Law to (i) introduce evaluation and regulation that could take into account the adverse
effects of chemical substances on living organisms in the environment and (ii) to improvethe effectiveness and efficiency of the system from the standpoint of risk management.
Based on the joint report, the government submitted the Bill for Partial
Amendment to the Chemical Substances Control Law to the Diet on March 7 th, 2003. The
Diet passed the Bill on May 22nd , and the amended law was promulgated on May 28th,
2003.
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The evaluation is made before manufacture and/or import1II. Major contents of the amendment
1. Evaluation and regulation of chemical substances focused on their adverse effect on livingorganisms in the environment(1) Introducing prior evaluation of ecotoxicity

Although it is at present difficult to quantitatively evaluate the adverse effects ofindividual chemical substances on ecosystems, it is considered possible to identify, bymeans of ecotoxicity tests using specific organisms, chemical substances that may haveadverse effects on ecosystems.
Accordingly, ecotoxicity shall be evaluated by using these test results as part of theprior evaluation of new chemical substances under the Chemical Substances Control Law.
(2) Introducing regulations against chemical substances with certain ecotoxicity

It cannot be denied that persistent chemical substances possessing ecotoxicity may
cause irreversible environmental pollution and have adverse effects on the life and growthof living organisms in the environment.
Accordingly, bearing in mind the limit of current scientific knowledge to evaluate
adverse effects of chemical substances on ecosystems or living organisms in theenvironment, regulations have been introduced. Those include measures to promote
appropriate management of chemical substances that have the potential to cause adverse
effects on ecosystems, and measures to restrict manufacturing/import of chemicalsubstances which may cause damage to flora and fauna in the human living environment.
Specifically, measures below are introduced:a) Persistent chemical substances with certain ecotoxicity
・Introducing reporting obligation for manufacturing/ import quantities ofpersistent chemical substances with certain ecotoxicity , etc. (Type III Monitoring
Chemical Substances)
・In cases it is recognized that certain chemical substances may cause damage toflora and fauna in the human living environment, compliance with technicalguidelines of measures to be taken for appropriate management of chemical
substances and labeling are required as Class II Specified Chemical Substances,
and, intended quantities of manufacturing/import may be restricted, whennecessary.
b) Persistent and highly bioaccumulative chemical substances with certain ecotoxicity
・Manufacturing, import and use of chemical substances that are toxic for top
predators (e.g. birds or mammals) in the human living environment shall be2

restricted not to be released into the environment as much as possible as Class I
Specified Chemical Substances.
2. Measures for persistent and highly bioaccumulative existing chemical substances

Even before long-term toxicity or ecotoxicity is identified, persistent and highlybioaccumulative existing chemical substances shall be placed under legal control,according to current status of their manufacturing and use. (Type I Monitoring ChemicalSubstances)
Specifically, measures below are introduced:
・Mandatory reporting of actual quantities of manufacturing/import and uses.
・If a certain potential for risk is presented according to preliminary toxicity evaluationby the government, guidance and advice shall be given to businesses on measures forrisk reduction to minimize release into the environment.
・After risk reduction measures have been taken, the manufacturers and importers are, if
necessary, directed to investigate long-term toxicity. If long-term toxicity is identified,
the substance shall be designated as a Class I Specified Chemical Substance.
3. Reforming prior evaluation system for new chemical substances taking into account theirpossibilities of exposure

As for new chemical substances with low possibilities of exposure throughenvironmental pollution, flexible measures may be taken. Provided that risks are avoidable
by prior verification and ex-post monitoring (e.g. on-the-spot inspection), those include (i)exemption from being the subject of prior evaluation procedures (i.e. there is no need tosubmit hazard data); (ii) stepwise evaluation of toxicity for chemical substances with low
volume manufacturing/import.
(1) Exemptions when exposure can be controlled

Prior evaluation for new chemical substances could be exempted in the following
cases where there is little or no possibility of exposure, provided the following handling
methods are sure to be used.
◇ Chemical substances to be used as intermediates;◇ Chemical substances to be used for process in which the possibilities ofenvironmental release is extremely low, such as in closed systems;◇ Chemical substances for export only (provided the prior evaluation system is wellestablished in the country of destination)3

(2) Stepwise evaluation of chemical substances with low volume manufacturing/ import◇ New chemical substances with total amount of domestic manufacturing/importquantities equal or less than 1 ton per year continue to be exempted from prior evaluation
procedures.
◇ New chemical substances with total amount of domestic manufacturing/importquantities equal or less than 10 ton could be manufactured or imported withoutobligatory submission of toxicity data, if the chemical substances are judged persistent
but not highly bioaccumulative, and considered not to present significant risk to humanhealth and living organisms in the environment according to the evaluation based on theinformation already-known, because there is very little possibility of polluting theenvironment in a wide area by those chemical substances.
4. Introducing obligatory reporting system for hazard information voluntarily obtained bybusinesses

In order to utilize hazard data for reviewing evaluation on new chemical substances andto promote evaluation of existing chemical substances by the government, obligatory
reporting system is introduced. Under the system, the manufacturers and importers arerequired to submit self-obtained information indicating that chemical substances theyhandle possess a hazard listed in the evaluation items under the Chemical Substances
Control Law.

III. Schedule for enforcement of the amended law
The amended Chemical Substances Control Law will come into force on the day
determined by cabinet order, which shall be no later than one year after the promulgation ofthe law (May 28th, 2003).

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New Framework for evaluation and regulation of chemical substances in Japan
under amended Chemical Substances Control Law
Existing
chemicalsubstances

New chemical substances
Planned manufacture andimport (nationwide)
over certain amount (1t/y)*

Planned manufacture andimport (nationwide)
up to certain amount (1t/y)*(Notification)

Hazard assessment

Chemical substances for certain use(e.g. intermediate)*with extremely low potential for
release into the environment* To be determinedby cabinet order

Prior evaluation** of persistence,bioaccumulation, long-term
toxicity for humans, ecotoxicity

Prior verification** before manufacture
and/or import• Persistent• Not highly bioaccumulative• Planned manufacture
and import (nationwide)
up to certain amount (10t/y)*Approval for
manufacture and/or import

Priorverification• Persistent• Highlybioaccumulative

Type I Monitoring
Chemical Substance• Mandatory reporting of actual
amounts manufactured and/or
imported, etc.
• Guidance, advice, etc.
Government directs
manufactures and importers
to investigate long-term
toxicity for human / toxicity
for top predators(when necessary)• Persistent• Highly bioaccumulative• Has long-term toxicity forhumans, or
toxicity for top predators

Class I Specified
Chemical Substance• Prior permission is required for
manufacture and/or import (virtuallyprohibited)• Any uses other than specified uses areprohibited• Import of certain products
specified by cabinet order is prohibited• Other restrictions• Persistent• Not highlybioaccumulative• Suspected long-term
toxicity for humans(screening level)

Ex-post monitoring(collection of report
onsite and on-the-spotinspection)• Persistent• Not highlybioaccumulative• Has ecotoxicity

Type II Monitoring
Chemical Substance(“Designated Chemical Substance”
before revision of the law)
• Mandatory reporting of actual
amounts manufactured and/orimported, etc.
• Guidance, advice, etc.

Type III Monitoring
Chemical Substance• Mandatory reporting of actual
amounts manufactured and/orimported, etc.
• Guidance, advice, etc.

Government directs
manufactures and importersto investigate long-term
toxicity for humans (whennecessary)

Government directs manufactures andimporters to investigate long-term
toxicity for flora and fauna in thehuman living environment (whennecessary)• Persistent• Not highly bioaccumulative• Has long-term toxicity for humans• Confirmed to have the potential tocause damage by environmental
pollution• Persistent• Not highly bioaccumulative• Has toxicity for flora and faunain the human living environment• Confirmed to have the potential
to cause damage by environmental
pollution

Class II Specified
Chemical Substance• Mandatory reporting of planned and actual
amounts manufactured and imported• If deemed necessary, government issues orders tochange the planned manufacture and importamounts• Government provides technical guidelines,
recommendations• Mandatory labeling, related recommendations
from government, etc.

Note: If a substance does
not meet any abovementioned criteria, it will
not be subject to regulation
under the Chemical
Substances Control Law

Manufacturers and importers of chemical substances are required to reportvoluntarily-obtained hazard information of the substances（Current revisions to the law are marked with）