Japan Regulatory News

Japan’s Ministry of Health, Labour and Welfare (MHLW) has classified 200 substances under Category 1 for carcinogenicity. The announcement was made on 26 December 2022, under an amendment to the Ind...

Japan’s Ministry of Health, Labour and Welfare (MHLW) has classified 200 substances under Category 1 for carcinogenicity. The announcement was made on 26 December 2022, under an amendment to the Industrial Safety and Health Act (ISHA).

Companies handling these compounds are required to adhere to ISHA regulations, which include maintaining records of the safety precautions implemented as a consequence of risk assessment and the level of worker exposure for 30 years.

The mandatory requirement will be implemented in two phases.

Phase 1:

Enforcement will begin on 1 April 2023 for 120 substances which include:

• Biphenyl
• Tetrafluoroethylene
• 1,2,3-trichloropropane

Phase 2:

Enforcement will begin on 1 April 2024 for the remaining 80 substance which include-

• Lead styphnate
• Glycidamide
• Chloramphenicol

On 15 December 2022, the Ministry of Labour, Health and Welfare (MHLW) released a document containing a plan to introduce workplace exposure limits for 860 chemical substances under the Industrial Saf...

On 15 December 2022, the Ministry of Labour, Health and Welfare (MHLW) released a document containing a plan to introduce workplace exposure limits for 860 chemical substances under the Industrial Safety and Health Act (ISHA). Companies will need to implement risk assessments and take the necessary measures to keep workers’ exposure to those substances within allowable limits.

The ministry will publish a list of 120 compounds with exposure limits that will be in effect for the current financial year, which ends on 31 March 2023, following the last expert conference on 30 January 2023. The MHLW is expected to list 170 substances in the financial year 2023, 180 substances in the year 2024 and 390 substances in the year 2025 and after. Once public comments have been received, ISHA will be amended and the exposure limits will be in force. The ministry did not provide a date for its amendment.

On 30 November 2022, Japan informed businesses that in cases where air exposure levels for organic solvents and other compounds have exceeded authorized concentration limits, occupational risk assessments must be conducted using personal sampling techniques. Enforcement begins on 1 April 2024.

The MHLW is not intending to establish workplace exposure limits for the regulated compounds included on the designated chemical substances list at this time. The Ordinance on Prevention of Hazards Due to Specified Chemical Compounds establishes precise guidelines and precautions for certain substances to avoid exposure.

On 12 December 2022, Ministry of Economy, Trade and Industry (METI) of Japan notified the WTO of the proposal to reduce the use of fluorocarbons in air conditioners and meet global warming potential (...

On 12 December 2022, Ministry of Economy, Trade and Industry (METI) of Japan notified the WTO of the proposal to reduce the use of fluorocarbons in air conditioners and meet global warming potential (GWP) targets. Companies are required to meet GWP objectives specified for certain goods by a target fiscal year under the Act on Rational Use and Proper Management of Fluorocarbons. Global warming potential is the heat absorbed by any greenhouse gas in the atmosphere, as a multiple of the heat that would be absorbed by the same mass of carbon dioxide (CO₂).

Fluorocarbons are fluorinated carbon chain polymers, and they belong to the class of per- and polyfluorinated compounds (PFCs). PFCs are used in refrigerants and solvents and have been recognized as chemicals of concern for some time because of their persistence and ecological toxicity.

Following are the newly listed products and their targets:

The enforcement of the proposed changes is anticipated to begin in March 2023 after a 60-day comment period, with the exception of the labelling regulations, which would take effect in October 2023.

Japan establishes GWP targets for the sectors with the highest environmental effect and where non-fluorinated refrigerants or other low-GWP compounds are commercially accessible and energy efficient.

On 21 November 2022, the Japanese Ministry of Health, Labour, and Welfare (MHLW) published an interim report on worker exposure measuring requirements, in order to assist businesses in getting ready t...

On 21 November 2022, the Japanese Ministry of Health, Labour, and Welfare (MHLW) published an interim report on worker exposure measuring requirements, in order to assist businesses in getting ready to comply with proposed changes to the Industrial Safety and Health Act (ISHA). The report includes mandatory personal sampling for certain substances 

The ISHA will be updated by 31 March 2023 to match the suggested measuring requirements contained in the report. The recommendations from the "Panel of Experts on Chemical Substance Management Interim Report" include information on the requirements for measuring worker exposure for the short-term (15 minutes) and long-term (8 hours), sampling location, and evaluation of data for risk assessment. They are intended to ensure that businesses comply with the ministry's allowable concentration limits under the ISHA.  

Recommendation from the 'Panel of Experts on Chemical Substance Management Interim Report'   

Japan approved the revisions to ISHA in May 2022. The revision includes the recruitment of workplace risk assessment managers and safety equipment specialists. Furthermore, modifications to the standards for safety data sheets (SDS) and labelling were included. These changes are expected to be implemented gradually over the following two years 2023-2024. 

MHLW also plans to provide more technical details on requirements for respiratory protective equipment, sample collection and risk assessment methods. 

In Japan, companies must notify new chemical substances manufactured or imported in volumes of less than one tonne a year or apply for small-volume permits. Companies are also required to submit appli...

In Japan, companies must notify new chemical substances manufactured or imported in volumes of less than one tonne a year or apply for small-volume permits. Companies are also required to submit applications for new chemical substances manufactured or imported in volumes of less than ten tonnes per year under the Chemical Substances Control Law (CSCL). The CSCL aims to reduce the risks that chemicals pose to human health and avoid environmental degradation.

The Ministry of Economy, Trade, and Industry (METI) has recently published a manual to assist companies in submitting the necessary data online when applying for authorization to manufacture or import new chemicals. The manual guides through how to set up an e-Gov account, confirm browser settings, install and setup e-applications, and gives instructions for providing information online.

According to METI, all applications should be submitted online by 2025.

The Ministry of Health, Labour and Welfare (MHLW) is a cabinet-level ministry of the Japanese government which provides services on health, labour and welfare.   The MHLW published a proposal on ...

The Ministry of Health, Labour and Welfare (MHLW) is a cabinet-level ministry of the Japanese government which provides services on health, labour and welfare.  

The MHLW published a proposal on 21 October 2022, to categorise carcinogenic compounds as Category 1 for carcinogenicity (excluding ethanol), in accordance with national criteria. The industry was given a deadline of 19 November 2022, to comment on the proposal. Early December is anticipated for promulgation, and the first day of enforcement will be 1 April 2023. 

The proposal is in line with the government's hazard classification of chemical substances conducted in accordance with the Japanese Industrial Standard (JIS) Z 7252 classification method which is based on the sixth revised edition of the Globally Harmonized System (GHS) of classification and labelling of chemicals implemented on 24 May 2022.  

The Japanese Industrial Standards (JIS) are the standards used for industrial activities in Japan, coordinated by the Japanese Industrial Standards Committee (JISC) and published by the Japanese Standards Association (JSA). The JIS Z 7252 standard covers the chemical classification for GHS labelling and JIS Z 7253 covers the hazard communication for labelling and safety data sheets (SDSs).  

To ensure workers' safety and health in the workplace, companies handling carcinogenic substances are required to keep records of safety measures implemented in response to risk assessment results, the status of workers' exposure to the substance, and interviews with workers for three years. They must also keep records of each worker's name, job description, work schedule, worker exposure status, and other information for 30 years under the Industrial Safety and Health Act (ISHA). However, companies handling the chemicals on a transitory basis are exempt from following the requirements. 

The Industrial Safety and Health Act (ISHA) is the main law implementing the Globally Harmonized System (GHS) of the classification and labelling of chemicals in Japan. 

The Ministry of Land, Infrastructure, Transport and Tourism (MLIT) is the Japanese government agency responsible for the comprehensive and systematic use, development and conservation of the land, con...

The Ministry of Land, Infrastructure, Transport and Tourism (MLIT) is the Japanese government agency responsible for the comprehensive and systematic use, development and conservation of the land, consistent development of social capital, promotion of transportation policies, development of meteorological services, and ensuring maritime safety and security.

To comply with the International Maritime Dangerous Goods Code's 41^st amendment, Japan’s MLTI has recommended that the rules for carrying and storing dangerous products aboard ships should be updated for several chemicals.

The International Maritime Dangerous Goods Code (IMDG Code) is an international code for the maritime transport of dangerous goods in packaged form, implemented to enhance and harmonize the safe carriage of dangerous goods and to prevent pollution of the environment. The Code sets out in detail the requirements applicable for each substance, material or article, covering matters such as packing, container traffic and stowage, with particular reference to the segregation of incompatible substances.

The 41^st amendment of the IMDG Code will be mandatory from 1 January 2024; however, International Maritime Organization (IMO) invites administrations to apply it from 1 January 2023. Japan also decided to adopt the IMO's suggestions and begin implementing the updated IMDG code on 1 January 2023 in order to ensure a seamless transition.

In a notice for public comment published on 26 October 2022, the ministry proposes to:

• revise the transport requirements for cobalt (II) hydroxide powder and substances containing 10% or more of its respiratory particles
• revise the dangerous goods list's classification of UN1891 ethyl bromide from hazard class 6.1 (a poisonous substance) to main hazard class 3 (flammable liquids) and secondary hazards 6.1, as well as its allowable capacity and mass for safety measures
• remove differentiated quarantine requirements for acids and strong acids
• provide new transport guidelines for liquid compounds such as isoalkanes
• consolidate 'UN1169 fragrant liquid extract (essential oil)' and 'UN1197 fragrant liquid extract (fragrant)' as 'UN1197 fragrant extract (essential oils or fragrant)

The deadline for public comment is 28 November 2022. Late December is anticipated for promulgation, with enforcement beginning on 1 January 2023.

The International Maritime Organization (IMO) previously known as the Inter-Governmental Maritime Consultative Organization until 1982, is a specialized agency of the United Nations responsible for regulating shipping. The IMO's primary purpose is to develop and maintain a comprehensive regulatory framework for shipping and its remit today includes maritime safety, environmental concerns, legal matters, technical cooperation, maritime security, and the efficiency of shipping.