Japan

Japan was one of the first countries globally to legislate and regulate chemicals in order to protect human health and the environment. Japan has established comprehensive and complex regulatory systems covering both substances for special applications and general industrial uses.

Table 1 - Major Japanese laws regulating chemical substances (in chronological order of enactment)

Law

Competent Authority

Regulated Chemicals

Building Standard Act

Act No.201 of 1950

MLIT

Substances that may cause hygiene problems in rooms (i.e. chlorpyrifos and formaldehyde)

Poisonous and Deleterious Substances Control Act

Act No. 303 of 1950

MHLW

Specified substances with acute toxicity

Industrial Safety and Health Act

Act No.57 of 1972

MHLW

Chemicals supplied/used in workplaces

Act on Control of Household Products Containing Harmful Substances

Act No. 112 of 1973

MHLW

Hazardous substances contained in household products

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

Act No. 117 of 1973

MHLW, METI, MOE

Industrial chemicals, except agro-chemicals, drugs, etc. regulated by other laws

Act on Prohibition of Chemical Weapons and Control, etc. of Specific Chemicals

Act No. 65 of 1995

METI

Chemical weapons and precursors

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

Act No. 86 of 1999

METI, MOE

Industrial chemicals

*MLIT: Ministry of Land, Infrastructure, Transport and Tourism

MHLW: Ministry of Health, Labour and Welfare

METI: Ministry of Economy, Trade and Industry

MOE: Ministry of the Environment

The following legislations play pivotal roles in the overall manage of chemical risk in Japan:

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

CSCL was first introduced in 1973 and has gone through 3 major amendments in 1986, 2003 and 2009. It’s currently being reviewed for another amendment aiming at streamlining and accelerating risk assessment of chemical substances under CSCL to reach the “WSSD 2020 goal”.

As indicated by the name, CSCL's purpose is to evaluate whether or not chemical substances are persistent, bioaccumulative or toxic (to human or flora and fauna) and thus require necessary control measures to prevent chemical risks. New chemical substances are subject to notification and government review prior to manufacture and import, while existing chemicals are subject to annual report of manufacture/import quantity, usage information, etc., based on which the reviewing authorities may request relevant companies to submit additional toxicity information. Stringent prohibition of manufacture/import and usage controls are imposed upon Class I Specified Substances (PBT substances, e.g. PBC) and Class II Specified Substances (persistent and non-bioaccumulative substances, e.g. certain chlorinated carbons and TBTs).

>>Read more

  1. Industrial Safety and Health Act (ISHL)

ISHL was first enacted and enforced in 1972 to ensure the safety and health of workers in the workplace, and facilitate the establishment of comfortable working environments.

Among numerous responsibilities of employers as specified in ISHL, there are mainly four aspects related to chemical management in workplaces, including:

  1. Prohibition and administrative approval of manufacturing or importing of specified chemicals
  2. New chemical notification - An employer who intends to manufacture or import a new chemical substance shall, in advance, undertake an investigation of toxicity, and shall notify MHLW of the name of the said new chemical substance and the result of the investigation of the toxicity, and other matters.  (When M/I  100kg/year)
  3. Labeling and SDS – As of June 1, 2016, both labeling and SDS are required for supply or transference of 640 specified chemicals or products containing these chemicals at concentrations above the threshold values.
  4. Risk assessment - An employer shall conduct an investigation to assess the risks associated with “notifiable substances” (which means substances subject to mandatory labeling and SDS) as specified by Ordinance of the MHLW.
  1. Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof (a.k.a. Law concerning Pollutant Release and Transfer Register, PRTR Law)

The PRTR Law was enacted in 1999 and enforced in 2000 in a bid to raise the awareness of relevant business operators of the amounts of substances released from their premises to the outside environment so that they can improve chemical management and prevent environmental pollution.

Under the PRTR Law, 562 substances are identified as prioritized targets, including “Class 1 Designated Chemical Substances” (462 substances) and “Class 2 Designated Chemical Substances” (100 substances). Business operators who produce or use Class 1 Designated Chemical Substances or products that contain these substances are required to provide details of the amount of emissions released into the environment (including the atmosphere, rivers and other waterways, and soil) to regional or municipal governmental authority. (“PRTR system”) Companies which provide and transfer any specified substances (including both Class 1 & 2 Designated Substances) or products containing them should provide SDS to the receiving entity. (“SDS system”)

The law also promotes self-management of chemical substances by providing Guidelines for the Management of Chemical Substances, which details on-site handling methods of specified chemicals. Business operators are also required to exert all possible efforts to deepen the public understanding of management practices.

  1. Poisonous and Deleterious Substance Control Act (PDSCL)

PDSCL was enacted and enforced in 1950 to control substances with acute toxicity (namely “poisonous substances” and “deleterious substances”) in order to protect public health and hygiene.

Major industrial obligations under PDSCL include:

  • Registration of “Poisonous and Deleterious Substances Business Operator”
  • Label the containers and packaging
  • Delivery of Safety Data Sheet (SDS)
  • Special procedures for transfer
  • Emergency response measures
  • Standards for transport or disposal.
  1. Japan GHS

For industrial chemicals, many laws and regulations have specified requirements on labeling and provision of a document with more detailed information of the chemical product, though not all of them are the same. Japan’s implements The Globally Harmonized System of Classification and Labelling and the issuance of industrial standard JIS Z 7250 ~ 7253, the latest editions of Japan GHS standards are:

Labels and SDSs compliant with the two standards mentioned above are compliant with ISHL, PRTR Law and PDSCL.

  •  1902

    Comparison of GHS Classifications among EU, US, Japan and Other Countries

      February 8, 2017    Matt Lu

    Network for Strategic Response on International Chemical Management published a comparison table, in which the GHS classifications adopted by various countries were compared with Japan’s GHS standard, which is Japanese Industrial Standard JIS z...
  •  1285

    Japan Small Amount New Chemicals Notification to Begin in 2017

      December 15, 2016    Matt Lu

    Japanese MHLW, METI and MOE issued a joint notice, announcing the notification window for the 1st batch of small amount new chemicals under Chemical Substance Control Law (CSCL) in 2017.
  •  1885

    Japan MHLW Plans to Add 7 Substances to ISHL List

      October 20, 2016    Matt Lu

    Japan Ministry of Health, Labor and Welfare (MHLW) issued a notice on the draft amendments of the designated substances under Industrial Safety and Health Law (ISHL). The draft is open to public comments until Nov 16th.
  •  676

    Japan MHLW Issues Warning on Increased Bladder Cancer Risk Associated with MOCA

      September 29, 2016    Jane Zhou

    4,4'-Methylene-bis(2-chloroaniline) (MOCA, CAS#101-14-4) is a substance used as a curing agent in waterproof materials. It is associated with the development of bladder cancer as seen in 5 workers in a Japanese chemical plant. 
  •  863

    Schedule for New Chemical Notification under Japan CSCL in 2017

      September 29, 2016    Jane Zhou

    On Sep 20, the three competent authorities of Japan’s Chemical Substances Control Law (CSCL), namely METI, MHLW and MOE, jointly announced the schedule (Jan ~ Dec, 2017) for new chemical substance notification under the relevant articles in CSCL:
  •  835

    Japan ISHL: 228 Existing Chemical Substances Added

      September 29, 2016    Matt Lu

    On Sep 27th 2016, Japan Ministry of Health, Labor and Welfare (MHLW) published the latest batch of notified chemical substances that are added as existing chemical substances under the Industrial Safety and Health Law (ISHL) through an official...