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Japan CSCL – Chemical Substance Control Law

  •   14 Jul 2019
  •    Jane Zhou
     
    Japan Japanese regulation:
    Chemical Substance Control Law
    Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (Act No.117 of 1973)
    History
    Published20 May 2009

    Phase I (Transitional)

    1 Apr 2010
    Phase II
    (Final)
    1 Apr 2011
    Legislative evolution
    16 Oct 1973CSCL was first enacted, introducing the world's first pre-manufacturing evaluation and regulation system for new chemical substances
    1986CSCL was amended in a view to control manufacture and import of persistent, non-bioaccumulative but toxic chemicals
    2003CSCL was substantially revised.
    2009CSCL underwent another significant amendment.

    NITE - National Institute of Technology and Evaluation of Japan

    © Copyright 2015 Liu Ming, REACH24H

    All Rights Reserved

    The Japanese “Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc.” is better known as the “Chemical Substance Control Law” (CSCL), which is pronounced as “Kashinho” in Japanese. Since its enactment in 1973, it has imposed strict pre-marketing evaluation of chemical substances to prevent environmental pollution and control chemical risks to human health, plants and animals. It has been amended 3 times in 1986, 2003 and 2009.

    Contents

    Historical Development

    Under the current legal system after the 2009 amendment, chemical management shifted from the “hazard-based mode” that only focused on chemical’s intrinsic hazardous properties to a comprehensive “risk-based management” that takes additional exposure factors into consideration (Risk = Hazard × Exposure). Actually this is a prevalent trend and one that many countries/regions have followed in order to strengthen their chemical management systems as exemplified by the implementation of EU REACH regulations.

    The enforcement of the 2009 amendment was implemented step-wise. The first phase has been enforced since April 1st, 2010, and introduced the concept of “essential uses of prohibited chemicals” and “Polymer of Low Concern”. The second phase started from April 1st, 2011, aiming at gradually establishing the system of:

    • Pre-marketing evaluation of newly manufactured/imported chemical substances;
    • Comprehensive risk assessment of any industrial chemicals on the market (obtaining quantity and hazard information); and
    • Rationalized regulatory measures in accordance with the properties of chemicals, to achieve the WSSD 2020 goal.

     

    Scope

    The chemical substances subject to Japan CSCL are chemical compounds used as general industrial chemical products, excluding those which are controlled by parallel or more stringent regulations (e.g. Poisonous and Deleterious Substances Control Act) or used for more specific purposes (e.g. Food Sanitation Act).

    Japanese chemical regulations overview

    Fig.1 - Overall regulatory framework of chemical management in Japan

    The targets of risk assessment carried out under Japan CSCL are not all the same as those under EU REACH, a comparison table is shown below:

    Table 1 - Comparison of the targets of risk assessment under Japan CSCL and EU REACH

     

    Human via the environment

    Ecosystem

    Workers

    Consumers

    Food additives, fertilizers

    Medicine, cosmetics

    Pesticides

    Biocides

    Japan CSCL

    ×

    ×

    ×

    ×

    ×

    √(Hygiene excluded)

    EU REACH

    ×

    ×

    ×

    ×

     

    Authorities and organizations

    Competent authorities under CSCL are:

    • Ministry of Health, Labour and Welfare (MHLW)
    • Ministry of Economy, Trade and Industry (METI)
    • Ministry of the Environment (MOE)

    Other well-known organizations include: (mainly provide technical supports to the law enforcement)

    • National Institute of Technology and Evaluation (NITE), under METI
    • National Institute of Health Science (NIHS), within MHLW

     

    Terms and Definitions

    From a historical perspective, chemicals can be classified to 3 categories namely "existing chemical substances", "newly notified chemical substances" and "new chemical substances".

    • Existing chemical substances

    The concept of “existing chemical substances” under CSCL is different from that in many other countries. It actually means chemicals that had been in Japan’s market before the enactment of the Law in 1973 (approximately 20,600 substances).

    In the legal context, the term existing chemical substances is used in a narrow sense which refers to existing chemical substances excluding those designated as monitoring chemical substances, priority assessment chemical substances, class I and class II specified chemical substances. However, not all of the existing chemical substances have been completely assessed yet.

    • Newly notified/announced and assessed chemical substances

    They are substances that were notified before April 1st, 2011, in accordance with the pre-amendment CSCL as substances that are either newly manufactured in or imported to Japan, and are not classified as Class I Specified Chemical Substances, Type II Monitoring Chemical Substances or Type III Monitoring Chemical Substances.

    • New chemical substances

    They are chemicals that have never been manufactured in or imported to Japan and not been evaluated. The specification of situations where substances are not considered as new chemical substances can be referred to the “Implementation of the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacturer, etc.”.

    Chemical companies should judge wether a chemical substance is new or not by themselves. Generally speaking, a chemical substance without an assigned MITI number (official gazette or registry number) is considered as a new substance. Please note that MITI numbers do not correspond to the CAS numbers, so there are situations where you can hardly search whether a substance has a MITI number in the ENCS Inventory, and advisory opinions from experienced experts may be needed.

    • ENCS Inventory

    Fig. 2 - Composition of the Japanese Inventory of Existing and New Chemical Substances (ENCS/ CSCL/  MITI List)"

    The Inventory of Existing and New Chemical Substances (Japan ENCS inventory) serves as a key reference to identify whether a chemical is subject to new chemical notification under CSCL, thus it is also known as the CSCL List and METI/MITI List. It’s not officially published but a combined list of existing chemicals and assessed new chemicals. (See Fig.2) The online system Chemical Risk Information Platform (CHRIP) of NITE provides inventory searching service in English.

    All the chemical substances are subject to regulatory classification by going through “Screening Evaluation” and “Step-wise Risk Assessment” with regard to their exposure information (quantity, use, etc.) and hazard information (environmental persistence, bioaccumulation potential and toxicity for humans or plants and animals). (See Fig. 3) If a notified chemical substance is classified as a safe chemical substance, the name will be made public in 5 years after the notification. If a chemical substance is classified as Monitoring Chemical Substance, it will be gazetted approximately one year later.

    Table 2. Overview of the regulatory classifications of chemicals under amended CSCL after 2011
    (Corresponding obligations are introduced in the "Industry Obligations" section.)

    Regulatory category

    Number of substances

    Intrinsic properties
    (including its chemical transformation products through natural processes)

    Major obligations of the industry

    Monitoring Chemical Substances

    38

    (last updated on 2018-04-02)

    • Persistent;
    • Bio-accumulative; and
    • Toxicity unclear
      (Candidates for Class I Specified Chemical Substances)
    • Mandatory reporting of actual amounts of manufacture and import, detailed usage info., etc..

    Priority Assessment Chemical Substances (PAC)

    223

    (last updated on 2019-04-01)

    • Suspected long-term for humans, flora or fauna; or
    • Suspected risk to the inhabitation or growth of living creatures.
    • Mandatory reporting of actual amounts of manufacture and import, detailed usage info., etc.; and
    • Encouraged disclosure of relevant info..

    Class I Specified Chemical Substances

    33

    (last updated on 2018-04-01)

    • Persistent;
    • Highly bio-accumulative; and
    • Has long-term toxicity to humans or predator animals at higher tropic level.
    • Prior permission for essential uses (specified by Cabinet Order), otherwise prohibited;
    • Mandatory labelling;
    • Compliance with handling standards; and
    • Implementation of recall and other measures as required.

    Class II Specified Chemical Substances

    23

    (last updated on 1990-09-12)

    • Has long-term toxicity to humans, flora or fauna; or
    • Poses risk to the inhabitation or growth of living creatures.
    • Mandatory reporting of planned and actual amounts of manufacture and import;
    • Government quota, where applicable;
    • Compliance with official technical guidelines and recommendations; and
    • Mandatory or recommended labelling for products specified by Cabinet Order.

    Exempt Chemical Substances

    2,847 

    (last updated on 2019-03-29)
     

    • Substances that are exempt from notification of manufacturing/import amount
    • No need of annual reporting

    General Chemical Substances

    28,000+

    • Industrial chemicals other than Monitoring Chemical Substances, PACs, Class I/II Specified Chemical Substances, and Exempt Chemical Substances
    • Annual notification of imported/manufactured quantities
    New Chemical Substances 
    • Substances that are not listed on the Japanese ENCS or the lists of Monitoring Chemical Substances, PACs, or Class I/II Specified Chemical Substances
    • Notification to MHLW, METI and MOE at least three months before their manufacture/import

     

    Comprehensive Chemical Risk Assessment and Use Category

    The Japanese chemical risk assessment system consists of 3 essential elements: industrial data (including notification/confirmation and annual reporting), screening assessment and stepwise risk assessment. Industrial data are aquired from new chemical notifications/confirmations and annual reports of the amount, usage, etc. of  chemicals already on the market. The Japanese government shoulders the responsibility of data review, decision of prioritization or exemption, and risk assessment.

    Use Category under Japan CSCL

    Fig. 3 - Use Category for chemical notification under Japan CSCL

    The degree of risk is estimated through comparison between the exposure and the hazard by chemicals substances. For example, if hazard (intrinsic properties of chemical substances) outweighs much of the exposure amount, there is no need to be concerned over the risk.

    The Use Category is set up in order to classify chemical substances by their usage. There are about 50 use categories and 280 sub-categories. For each use category, an emission factor is provided to estimate the emission amount. (Emission to the environment = Amount of shipment/manufacture x Emission factor). If the use information is unclear, either “98 Other raw material/additives” is selected or “z Others” of the sub-category is selected. In such circumstances, a risk assessment (screening assessment) will be carried out on the assumption that all the handled chemical substance might be fully released into the environment. In conclusion, it is important to collect the precise use information to produce the reasonable emission amount.

    Table 3. Application of the Use Category in different types of notification

    Substances

    Use information

    Digit number of the Code

    New Chemical Substance

    Use Category

    Double digits (double-digit number)

    Small Amount New Chemical Substance

    Use Category

    Double digits (double-digit number)

    Polymer of Low Concern (PLC)

    Use Category

    Double digits (double-digit number)

    Low Production Volume Chemical Substance

    Use Category

    Double digits (double-digit number)

    General Chemical Substance

    Use Category

    Double digits (double-digit number)

    Priority Assessment Chemical Substance (PAC)

    Use Category + Sub Use Category

    Triple digits (double-digit number + single letter)

    Monitoring Chemical Substance

    Use Category + Sub Use Category

    Triple digits (double-digit number + single letter)

    Class II Specified Chemical Substance

    Use Category + Sub Use Category

    Triple digits (double-digit number + single letter)

     

    Industry obligations

    New Chemical Substances

    1. Notification

    Chemical companies that intend to manufacture or import new chemical substances should notify MHLW, METI and MOE at least three months before their manufacture/import, as long as the substances are used for commercial purposes.

    2. Exemption

    There are situations where Japanese chemical companies can be exempted from the above-mentioned notification obligation. But prior-confirmations issued by the 3 competent authorities are required to avail of the exemption of notification.

    • Small amount new chemical substance

    Starting from January 1, 2019, any new chemical substance with a release volume less than 1 ton/year across Japan can avail of an exemption of prior notification and evaluation, and only a simplified new substance notification is needed. Notably, the maximum import/manufacture amount of small amount notification that a single enterprise can apply for is still 1 ton/year, no matter how small the release volume is.

    When the new chemical substances are manufactured/imported and all of them are used for testing, experiments, R&D, or inspection at school, laboratory, research institute, the new substances are exempt from the above mentioned notification. It doesn’t matter whether these institutes are public or private, neither does it matter whether the experiments are carried out by the manufacturer/importer or outsourced.

    • Low volume new chemical substance

    Starting from January 1, 2019, for new chemical substances which are confirmed as non-biodegradable and non-bio-accumulative with a release volume less than 10 tons/year across Japan, only a simplified new substance notification is needed as well. Notably, the maximum import/manufacture amount of low volume notification that a single enterprise can apply for is still 10 tons/year, no matter how small the release volume is.

    • Polymer of low concern (PLC)

    PLCs are those polymers among new chemical substances that are confirmed by the 3 Ministries to pose no risk of causing damage to human health or the habitat and other matters of plants and animals in the human living environment. PLCs are exempted from mandatory notification of its manufacture/import amount, but the person who holds official confirmation of PLC may be required to collect reporting data and undergo on-site inspection upon requirement.

    The polymers must meet the criteria below to be determined as PLCs:

    • Average molecular weight of 1,000 or more;
    • No observed changes in weight under acids or alkalis;
    • No metal element included, except for Na, Mg, Ca and K;
    • Insoluble in water or organic solvents. (Dissolution therein indicates that the polymer does not include any double or triple bonds between carbon atoms, any epoxy group or sulfonic acid group.)

    Thus, for the PLC verification, testing data are required including molecular weight distribution, physicochemical property data and solubility test data with respect to acid/alkali and water/organic solvents. Applications can be accepted at any time and the notice of evaluation result will be sent in 4 weeks or less. The names of the verified chemical substances will not be disclosed.

    • Substances specified by Cabinet Order

    There are three types of substances specified by the Cabinet Order as exempt from new chemical notification:

    • Intermediates
    • Chemicals to be used in closed systems only
    • Chemicals manufactured or imported for the sole purpose of export

    General Chemical Substances 

    1. Notification

    Companies that manufacture or import 1 ton or more chemical substances must notify the amount, usage (refer to the use category) and other specified information every year. The notified substances have to go through “Screening Evaluation” and are designated as PACs if certain criteria are met.

    Notification should be made between April 1st and June 30th each year. When notifying a General Chemical Substance, the format prescribed by METI related Ordinance for Enforcement of Chemical Substances Control Law (Format No.11) should be used. The volume manufactured, imported and shipped in the previous fiscal year should be notified (1 significant digit). The use should be notified according to the use categories in double digits. Where available, the CAS number should be stated.

    In case that a notifier finds it extremely difficult to identify a chemical or its concentration in a mixture, (e.g. because the chemical identify has been claimed confidential), the notifier is allowed to notify the concerned general chemical substance jointly with the supplier (e.g. the foreign exporter or manufacturer of the substance) under the consent of METI. This rule is not accepted under other laws, or the customs procedures according to CSCL. (METI guidance: Special procedure to submit the annual notification of imported quantity of the previous fiscal year under CSCL)

    The 2017 amendment of CSCL proposed a new category of chemicals, namely "Specified General Chemicals", that are general chemical substances with strong toxicity. The supplier of a "Specified General Substance" needs to convey to the downstream user that the substance is designated as a "Specified General Substance."  The handling situation of a "Specified General Substance" is also required to be reported. Provisions in this regard took effect on April 1, 2018.

    2. Exemption

    • Chemical substances used for research purposes only;
    • Chemical substances less than 1 ton/year in volume;
    • Chemical substances that have been confirmed to be intermediates, etc., or polymers of low concern; (i.e. Polymers announced in April 2004 or assessed during the period of April 1987 to March 2004, as they have received a determination equivalent to the non-hazardous determination by High Molecular Flow Scheme when notified as new chemical substances; Existing chemical substances that have been recognized as non-hazardous by High Molecular Flow Scheme or confirmed to be Polymers of Low Concern.)
    • Chemical substances designated by the 3 Ministries as not necessary to conduct risk assessment, thus exempt from notification.

     

    Priority Assessment Chemical Substances (PACs)

    Priority Assessment Chemical Substances (PACs) are designated after undergoing a chemical substance screening assessment by the national government. In FY2010, PACs were chosen from among substances designated as Type II and Type III Monitoring Substances. After April 1st 2010 “Monitoring Chemical Substances” became a distinct category and selection of priority substances was announced in the official gazette on April 1st, 2011 based on council discussions held in January 2011. On 27 October 2011, MHLW, METI and MOE published the " Implementations of Screening Evaluation and Risk Assessment", based on the reported amounts manufactured and imported in 2010. This publication describes the schedule for screening   evaluation of General Chemical Substances and risk assessment of PACs.

    1. Obligation

    • Annual notification: If a company has manufactured/imported a PAC with an amount of 1 ton/year or more, the substance is subject to annual notification. In the case of mixtures where impurities account for 1% or more by weight, the intended products are subject to the obligation of notification, regardless of their weight.
    • Information delivery in the supply chain: When PACs are transferred between different business entities, the supplier is obliged to make utmost efforts to inform the recipient the concerned substances are PACs, etc.

    2. Exemption

    If the manufactured PACs are entirely consumed within the manufacturing company (e.g. intermediate products for in-house use), the PACs are exempt from the notification.

     

    Monitoring Chemical Substances 

    There were three categories of Monitoring Chemical Substances in the first phase implementation of the 2009 CSCL, namely Type I, II, III Monitoring Chemical Substances. The second phase began from April 2011 in which Type II and III were repealed, while Type I remained as “Monitoring Chemical Substances”.

    Obligation:

    • Notification of quantity manufactured and/or imported, intended use of the chemical substance
    • Publication of the name and notified volume of substances whose total manufacturing and import volume is 1 ton or more
    • Guidance and advice are provided by the government to prevent environmental pollution.
    • In case of risk potential, the government directs the manufacturer or importer to conduct a hazard (long-term toxicity to humans or top predators) survey.

     

    Class I Specified Chemical Substances

    The Japanese authorities adopted the Stockholm Convention (and decisions made on the ordinary meetings of the Conference of the Parties to the Convention) when designating Class I Specified Chemical Substances, in order to protect human health and the environment from Persistent Organic Pollutants (POPs), prohibit or control the manufacturing, use and international trade of such chemicals.

    1. Obligation

    Prohibition: Starting from the 2010 fiscal year, the use of Class I Specified Chemical Substances is allowed exceptionally for “Essential Uses” in the manufacture of products which has been confirmed to pose no risk of environmental pollution. Specifically, 3 uses of perfluorooctane sulfonates (PFOS) have been designated as Essential Uses, namely: use of PFOS to make semiconductor etching agents, resistant and commercial photographic films.

    Licensing: Manufacturers, business users, conveyors, storage business operators, etc. of Class I Specified Chemical Substances must be licensed.

    Compliance with technical standards: PFOS handlers should refer to the officially published technical standards in terms of storage, relocation, data archiving, spill disposal, etc.

    Mandatory labeling: Supplier of PFOSs and relevant products should provide proper labels to inform the recipients the fact that PFOS are present and specify percentage content, precaution statements and contact address of the label provider presented.

    Note: Foam fire extinguishing agent is not designated as an Essential Use, but PFOS are widely used in such products and it is difficult to replace them with alternative products in a short period of time. Therefore, such fire extinguishing agent products are subject to labeling, and relevant technical standards have been formulated to follow. (Refer to official publication on 2010-09-03, & 2010-10-01)

    2. Administration fee

    In accordance with Article 49 of CSCL, applicants of relevant permissions should pay certain amount of fees as specified by Cabinet Order No.202.

    Table 4. Administration fees for business activities permits of Class I Specified Substances

    Subject

    Fee (JPY)

    Online (JPY)

    Production permit of Class I Specified Substances

    220,600

    213,700

    Manufacturer information renewal of Class I Specified Substances

    120,700

    117,200

    Import permit of Class I Specified Substances (for use of experiments)

    46,700

    39,900

     

    Class II Specified Chemical Substances

    1. Inventory management

    Designation of products containing Class II Specified Chemical Substances (e.g. dry cleaning fluids and metal cleaning fluids containing tetrachloroethylene) was published on April 1st, 2010.

    2. Obligation

    • Mandatory reporting: Annual reporting of planned and actual amounts manufactured and/or imported and information on usage, etc.
    • Government-directed quota: Where the authority considers necessary, the planned manufacture and import amounts of specified substances are subject to change in accordance with government orders.
    • Compliance with technical standards: The facilities, inspection and control, work instructions, spill disposal, etc. are specified.
    • Mandatory or recommended labeling: In case that any Class II Specified Chemical Substance is used in the concerned product, the probable hazards to human health and handling instructions should be presented on labels of the container, package and invoice.

    Note: In addition to manufacturers and importers of Class II Specified Chemical Substances, distributors and other relevant roles in the supply chain are also subject to the technical guidelines and labeling obligation.

     

    Reporting of Hazard Information

    In addition to the obligations mentioned above, chemical companies may be required by government offices to supplement more information or report updated hazard information.

    Table 5. Cases where chemical hazard information reporting to governmental agencies is required

    Cases

    Substances

    Information

    Penalty

    Where a chemical company already has unpublished knowledge

    PACs, Monitoring Chemical Substances, Class II Specified Chemical Substances

    • Physicochemical properties;
    • Degradability;
    • Accumulative property;
    • Toxicity to human and flora & fauna
    • Other important toxicological impacts

    None

    (Due diligence)

    Where new tests, etc., have been conducted to obtain hazard knowledge

    General Chemical Substances, PACs, Monitoring Chemical Substances, Class II Specified Chemical Substances

    • Any persistent knowledge
    • Any high enrichment property
    • Any long-term toxicity to human
    • Any toxicity to flora & fauna
    • Chemically instability

    Imposed

    (Obligatory cases)

    Where any government office requires submission of information

    PACs

    • Testing data of physicochemical properties
    • Testing data of degradability
    • Testing data of accumulative property
    • Testing data concerning adverse effects on human health, and on flora & fauna

    None

    Where any government office designate a hazardous property study

    PACs and Monitoring Chemical Substances

    • Investigation into health effects (carcinogenicity, teratogenicity, chronic toxicity, mutagenicity, etc.)
    • For Monitoring Substances: Investigation into effects on higher order predators
    • For PACs: Investigation into effects on flora & fauna

    Imposed

     

    References:

    NITE: Chemical Risk Assessment under Japan CSCL and comparison with EU REACH

    METI: Guidance on special procedure to submit the annual notification of imported quantity of the previous fiscal year under CSCL

    METI: Policy information on the 2003 Amendment of Japan CSCL

    Chemlinked news: Japan Designated 13 more “Priority Assessment Chemical Substances” 2014-04-01

    Chemlinked news: Japan Consulting on Loosening Notification Requirements for Small Amount of New Chemical Substances 2014-03-28

    Chemlinked news: Japan Publishes 2014 List of Substances Exempt from Notification 2014-03-24

    Chemlinked news: Japan to Amend Enforcement Decree of Chemical Substances Control Law 2014-01-17

    Chemlinked news: Japan Proposes to Amend New Chemicals Notification Process 2013-12-20

    Chemlinked news: Japan METI Issues Annual Report for Chemical Substances Control Law Implementation 2013-12-12

    Chemlinked news: Japan Published the Third Version of Emission Factor Tables for Risk Assessment under the CSCL 2013-11-04