About Chemical Management Center

Operations Related to the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc.

Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (Chemical Substances Control Law; CSCL)

The CSCL requires the assessment of new chemical substances prior to their manufacture or import in order to prevent environmental pollution caused by chemical substances that may be hazardous to human health and/or the environment. The CSCL regulates manufacturing, import and use, etc. of chemical substances, as necessary.

1. Support for the assessment of new chemical substances

The Chemical Management Center promotes the efficient assessment of new chemical substances through its database on safety inspection and the assessment results of new chemical substances that are specified in the CSCL. In addition, the Chemical Management Center has developed a database that facilitates information sharing between three key government authorities (MHLW*1, METI*2and MOE*3). By utilizing the database, the Chemical Management Center investigates the information required for the assessment of new chemical substances and compiles assessment materials on chemical safety.
In addition, the Chemical Management Center also functions as a consultation and liaison organization between the ministries and business operations engaged in the "notification" process for new chemical substances. The Chemical Management Center receives inquiries from business operations prior to notification, and conducts interviews during the process of notification. The Chemical Management Center also assigns officially prepared names to new chemical substances.

1. *1 Ministry of Health, Labour and Welfare
2. *2 Ministry of Economy, Trade and Industry
3. *3 Ministry of the Environment

2. Operations related to Good Laboratory Practice (GLP)

The CSCL stipulates that any safety inspection data used to assess new chemical substances should be obtained from facilities conforming to Good Laboratory Practice (GLP). The Chemical Management Center conducts the inspections of GLP facilities to assure reliability of test results and international compatibility.

3. Other operations related to observance and enforcement of the CSCL

To manufacture or import any new chemical substances, business operators need to make the notification of the new chemical substances under the CSCL as well the Industrial Safety and Health Act. The names of these substances are designated according to each of the laws. Though their designated names are given based on the IUPAC nomenclature system*4, there may be multiple naming conventions for the same chemical structure, so even the chemical substance may be designated with different names. Therefore, the Chemical Management Center has been supporting the creation of the commonality rules of the nomenclature between the Industrial Safety and Health Act and the CSCL proceeded with by the Ministry of Health, Labour and Welfare and the Ministry of Economy, Trade and Industry.
In addition, the Chemical Management Center also compiled study reports on the relations between bioconcentration and n-octanol/water (log Pow), and between bioconcentration and molecular weight, and submitted them to the Chemical Substances Council to contribute to the review of assessment standards. These contributions will ensure that prompt and proper assessment procedures are implemented.

*4 IUPAC nomenclature system: Compound nomenclature determined by the International Union of Pure and Applied Chemistry (IUPAC)

4. Operations related to risk assessments

The Chemical Management Center supports operations related to risk assessments under the CSCL, which require the knowledge of chemical substances and assessment methods. The Chemical Management Center supports the enforcement of the CSCL by the state as the core institution of risk assessments under the CSCL by performing “confirmation and aggregation of the notified data, etc. of annual manufacturing and import volumes according to the CSCL," "arrangement of emission factors to estimate the released amounts into the environment and estimations of the released amounts," "estimation of exposure doses and risks to human and ecosystems,” etc.

5. Operations related to the utilization of (Quantitative) Structure-Activity Relationship ((Q)SAR) and category approach

In order to ensure safe and efficient chemical management in Japan, the Chemical Management Center make efforts on development of hazard assessment methods based on (Q) SAR and category approach.

• Creation of reference materials of chemical substances subject to review of the CSCL

  The Chemical Management Center summarizes the results of predictions of biodegradation/bioconcentration of new chemical substances and existing chemical substances subject to the reviews of the CSCL by various structure-activity relationship models and category approaches developed by the Chemical Management Center, and submits them as review reference materials to the committee of the CSCL.



• Hazard Evaluation Support System Integrated Platform

  The Chemical Management Center has developed the "Hazard Evaluation Support System Integrated Platform (HESS)" and HESS DB, which is the database system included in it, as the world first tool to support the assessments of the repeated-dose toxicities of untested chemical substances*5 in the project sponsored by the New Energy and Industrial Technology Development Organization (NEDO)/the Ministry of Economy, Trade and Industry, and published it on the Web site of NITE from June 2012. HESS can classify (categorize) chemical substances based on their molecular structures and the similarities of their toxicities mechanisms and support the assessments of the repeated-dose toxicities of untested chemical substances by category approaches. In addition, HESS is a system compatible with OECD QSAR Toolbox*6 and equipped with repeated-dose toxicity test data, etc. provided from the development projects (EU COSMOS project and US EPA ToxCAST project) of the in silico*7 model, etc. used in Europe and the U.S.
  HESS and HESS DB is a database provided free of charge on the Web site.
  https://www.nite.go.jp/en/chem/qsar/hess-e.html

1. *5 Joint development with Fujitsu Limited, National Institute of Health Sciences, Burgas "Prof. Assen Zlatarov" University, Tohoku University, and Kwansei Gakuin University
2. *6 OECD QSAR Toolbox: Software to support category approaches, developed by OECD. It has databases for biodegradation, bioaccumulation, toxicities, etc., the functions required for grouping of chemical substances, etc. (free software)
3. *7 in silico: Means "Using computers." Method to predict results by calculation without actual tests normeasurements

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Operations Related to the Act on Confirmation, etc. of Releases Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof

Act on Confirmation, etc. of Releases Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof (Law concerning Pollutant Release and Transfer Register; PRTR Law)

The PRTR Law, enacted in 1999, operates using the PRTR and SDS systems. The purpose of the law is to promote the improvement of voluntary management of chemical substances by business operators and to prevent environmental problems from occurring. Under the PRTR system, business operators are required to the amount of chemical substances discharged into the environment and transferred in waste by-products to government authorities through the notification process.
Chemical substances which may be harmful to human health and the ecosystems and which are recognized to widely exist in the environment are regulated by the law. Every year, business operators submit their data related to the release and transfer of these substances to the ministers via local governments. The minister aggregates the data for publication.
The SDS system is a system that requires businesses intending to transfer or supply designated chemical substances to other businesses to provide information on the properties and handling.
As the sole agency handling the series of the PRTR law affairs from notification to publication, the Chemical Management Center conducts the following activities to ensure appropriate enforcement of the law.

1. Operations related to summarizing release and other data

The Chemical Management Center established an electronic notification system to facilitate communication with business operators regarding chemical discharge information. The Chemical Management Center also established a notification management system that ministers governing business required the PRTR notification or the PRTR law, and local governments can use to review the notified data, and accurately receive and confirm notification by business operators. The Chemical Management Center also provides an inquiry service for those who want to learn how to use the electronic notification system.
In addition, the Chemical Management Center makes efforts to improve the accuracy of notified data by reviewing them and plays a central role in the PRTR system by recording and summarizing received notified data and by issuing publications, etc.

2. Operations related to dissemination of the PRTR Law

The Chemical Management Center established the PRTR Support Center to respond to technical and practical inquiries from business operators and other related parties, to support the calculation of released amounts limits required by the PRTR system, to disseminate notification requirements, and to resolve any problems with the SDS system, including compilation and provision of information.
In order to improve understanding of the published PRTR data, the Chemical Management Center provides PRTR maps consisted of the release amount map and the concentration map. In addition to, the Chemical Management Center summarizes the comparison reports of past fiscal year data by each substance, industry, and prefecture.

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Operations Related to the Act on the Prohibition of Chemical Weapons and the Regulation of Specific Chemicals

Act on the Prohibition of Chemical Weapons and the Regulation of Specific Chemicals (Chemical Weapons Act)

The Chemical Weapons Act prohibits the production, use and possession of chemical weapons and regulates the production and the use of specific chemicals in order to ensure appropriate enforcement of an international treaty (i.e., the Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on their Destruction).

1. Attending International Inspections and Inspecting Businesses

The Chemical Management Center attends international inspections by the Organization for the Prohibition of Chemical Weapons (OPCW), and also verifies the analysis results when any international inspectors perform an analysis. The Chemical Management Center also performs on-site inspections for permitted (or approved) manufacturers and permitted (or approved) users of specific substances based on the Chemical Weapons Act by order of the Minister of Economy, Trade and Industry.

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Provision of Information on Chemical Management

1. Developing the Chemical Risk Information Platform (NITE-CHRIP)

The Chemical Management Center collects the reliable information on the domestic and foreign laws and regulations related to chemical management and the risks of chemical substances. The Chemical Management Center provides those information through the database "Chemical Risk Information Platform (NITE-CHRIP)" for compliance with the chemical management laws and regulation by business operators, municipalities, and people and appropriate assessments and voluntary management of risks. The Chemical Management Center provides the general information such as the name, CAS Registry Number, etc. of chemical substances, domestic and foreign laws and regulations information, hazard information, and exposure-related information. The Chemical Management Center confirms and updates the listed data regularly, and secures the reliability of the database.
NITE-CHRIP is a database provided free of charge on the Web site.
https://www.nite.go.jp/en/chem/chrip/index.html

2. GHS-related information

"The Globally Harmonized System of Classification and Labelling of Chemicals (GHS)" is the system to classify and show chemicals by an internationally recommended method in order to convey correct information on the hazards of chemicals to all people who handle them and protect the health of people and the environment. The Chemical Management Center publishes the classification results conducted by the GHS-related ministries and agencies and the related information on the Web site in order to knowledge diffusion and promotion of the implementation of GHS. In addition, the classification in English is published on the English Web site in order to share the Japanese classification results internationally. The classification is searchable and available from NITE-CHRIP. https://www.nite.go.jp/chem/english/ghs/ghs_index.html

3. Guidance on a consumer product risk assessment for GHS labelling

It is allowed to determine the necessity for labelling based on the result of the risk assessment conducted by the method recognized by the governing agency when adding GHS labelling to any consumer products for chronic hazards on human health.
The Chemical Management Center reviewed the method to assess chronic health risks of consumer products and summarized it as a guidance receiving a request from the Ministry of Economy, Trade and Industry. This guidance is published together with the Program for the Estimation Human Exposure Used in the Risk Assessment of Consumer Products (CHEM-NITE) compatible with the guidance on the Web site.
https://www.nite.go.jp/en/chem/risk/ghs_consumer_product.html

Chemical Management Center ~Brochure~ [PDF:1.61MB]