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)
Building Standard Act
Act No.201 of 1950
Substances that may cause hygiene problems in rooms (i.e. chlorpyrifos and formaldehyde)
Poisonous and Deleterious Substances Control Act
Act No. 303 of 1950
Specified substances with acute toxicity
Industrial Safety and Health Act
Act No.57 of 1972
Chemicals supplied/used in workplaces
Act on Control of Household Products Containing Harmful Substances
Act No. 112 of 1973
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
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
*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:
- 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).
- 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:
- Prohibition and administrative approval of manufacturing or importing of specified chemicals
- 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)
- 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.
- 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.
- 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.
- 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.
- 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:
- JIS Z 7252:2014 Classification of chemicals based on Globally Harmonized System of Classification and Labelling of Chemicals (GHS)
- JIS Z 7253:2012 Hazard Communication of Chemicals Based on GHS- Labelling and Safety Data Sheet (SDS)
Labels and SDSs compliant with the two standards mentioned above are compliant with ISHL, PRTR Law and PDSCL.
- Takehome: The Japanese METI plans to adjust the criteria of substance selection as well as the substances list under its PRTR system.
- The positive list system applies to food contact plastics only; Current regulations on food contact materials are still applicable; The positive list system is expected to be implemented before June 22, 2020.
- Japan’s official food contact materials positive lists were finally opened to public feedback, following previous informal disclosure of an internal version on Jun 13.
- On July 31, 2019, the Japanese Ministry of Economy, Trade and Industry (METI), Ministry of the Environment (MOE), and Ministry of Health, Labor and Welfare (MHLW) released the Joint Notice No.2 , announcing the names, serial numbers, and MITI numbers of 210...
- Takehome： Japan announced that it will remove South Korea from the “whitelist” in the Export Trade Management Order through an amendment act, and South Korea’s imports from Japan will lose preferential treatment. The export of fluorinated polyimides,...
- The informal draft of positive lists of additives and polymers used in food contact materials was disclosed, however the official consultation draft is expected to face the public in July or August.
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