Japan Launches Public Consultation to Establish the OELs for 48 Subtances
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Background
Following amendments to the Enforcement Order of the Industrial Safety and Health Act (ISHA), effective 1 April 2023, employers are required to take measures to minimize workers' exposure to hazardous chemical substances that are subject to risk assessment obligations.
To reduce occupational exposure risks, employers must implement control measures in accordance with the hierarchy of controls, prioritizing the following approaches:
Substitution of hazardous substances with less hazardous or less toxic alternatives wherever feasible;
Engineering controls, including the installation and use of enclosed systems, local exhaust ventilation, or general ventilation equipment to control emissions at the source;
Administrative controls, such as improving work practices and operating procedures; and
Personal protective equipment (PPE), including the use of effective respiratory protective equipment when exposure cannot be adequately controlled through other measures.
Further from 1 April 2024, employers must ensure that worker exposure of substances for which a Concentration Standard Value has been established, does not exceed the specified concentration standard.
To support implementation of the self-regulatory chemical management framework, the Ministry of Health, Labour and Welfare (MHLW) continues to evaluate substances subject to mandatory Safety Data Sheet (SDS) and labelling requirements under ISHA and establish corresponding concentration standards. The current list of substances with concentration standards is available from MHLW (Japanese only) can be found here.
Additionally, the MHLW has published a Technical Guidelines on the Application of Concentration Standards for Preventing Health Hazards Caused by Chemical Substances. This guideline comprehensively specifies matters that employers must implement, in addition to those stipulated by law, regarding the concentration standards, and their application, methods for confirming that workers' exposure levels are below the concentration standards, sampling and analysis methods for measuring the concentration of substances, and the appropriate selection and use of effective protective equipment.
Furthermore, employers who manufacture or handle chemical substances other than those subject to risk assessment must utilize this guideline to minimize the level of worker exposure to such chemical substances.
Public Consultation to Establish the OELs for 48 Subtances
On 26 May 2026, MHLW launched a public consultation proposing the addition of 48 substances to the list of substances subject to Occupational Exposure Limits (OEL).
Documentation Requirements
Employers are required to:
Maintain records of the risk control measures implemented and workers' exposure conditions for a minimum of three years;
Provide workers with an opportunity to express their opinions regarding chemical risk management measures; and
Retain the above-mentioned records relating to carcinogenic substances designated by MHLW for a period of 30 years.
Even workplaces with fewer than 50 employees that are not legally required to establish a Health and Safety Committee must provide opportunities for relevant workers to express their views on these matters, in accordance with Article 23-2 of the Ordinance on Industrial Safety and Health (Ministry of Labour Ordinance No. 32 of 1972).
Penalties
While the Enforcement Order of ISHA does not explicitly prescribe a specific criminal penalty solely for exceeding a concentration standard, employers may be subject to administrative enforcement measures and penalties under the Industrial Safety and Health Act where they fail to implement required exposure control measures, disregard corrective orders, or cause occupational health impairment as a result of inadequate chemical risk management.
Relevant penalties under the ISHA include:
Imprisonment for up to six months or a fine of up to JPY 500,000 for violations of certain provisions relating to the prevention of occupational hazards and health impairment, including failures to implement required protective measures.
Imprisonment for up to three years or a fine of up to JPY 3 million for serious violations involving restricted hazardous substances where worker health damage results.
In addition, employers may be subject to labour inspection orders, corrective actions, business disruptions, workers' compensation claims, and civil damages where exposure to hazardous substances causes occupational illness or injury.
Key Timelines
Tentative Promulgation Date: end of August 2026
Tentative Enforcement Date: 1 October 2027
The draft is open for comments until 25 June 2026 via Japan's e-gov website.
Regulatory Impact
The proposed addition of 48 substances to the list of substances subject to Concentration Standards would increase compliance obligations for employers handling hazardous chemicals in the workplace.
Companies manufacturing, importing, or using the affected substances should assess whether the proposed concentration standards may apply to their operations and evaluate existing exposure control measures accordingly.
As Japan continues to transition towards a risk-based and self-regulatory approach to chemical management, employers are expected to take greater responsibility for identifying, assessing, and controlling occupational chemical risks based on actual exposure conditions rather than relying solely on prescriptive regulatory controls.
Takeaway
The proposal reflects MHLW's ongoing efforts to strengthen occupational chemical safety by progressively expanding the number of substances subject to concentration standards.
Organizations that manufacture, import, or use hazardous chemicals should closely monitor the outcome of the public consultation and begin assessing the potential impact on their operations ahead of the anticipated promulgation and enforcement dates.
Early identification of affected substances, proactive exposure assessments, and timely implementation of risk control measures will be critical to ensuring continued compliance and protecting worker health under Japan's evolving chemical management framework.
Related articles
Public Consultation on the Draft Partial Amendment to the Standards for Substances and Concentrations Specified by the Minister of Health, Labour and Welfare pursuant to Article 577-2, Paragraph 2 of the Enforcement Order of the Industrial Safety and Health
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