Japan Regulatory News

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.

On 14 October 2022, Japan's Ministry of Health, Labour and Welfare (MHLW) announced two different public consultation notifications to add 13 more compounds that could be hazardous to the health of wo...

On 14 October 2022, Japan's Ministry of Health, Labour and Welfare (MHLW) announced two different public consultation notifications to add 13 more compounds that could be hazardous to the health of workers under the Labour Standards Act. The start of enforcement is anticipated for late December.

The MHLW identified ten compounds that pose a risk to workers health in a report released on 18 March 2022 that led to the proposed change to Japan's list of occupational illnesses. The findings came after an evaluation process that the MHLW started in July 2019 which covered 216 chemicals.

The list of Newly added substances and diseases are as follows:

Additionally, the amendment eliminates two medical conditions: consciousness disorder for methyl iodide and vasomotor neuropathy disorders for Nitroglycol, calcium cyanamide, and nitroglycerin.

Workers in Japan are eligible for compensation if they develop occupational illnesses linked to chemicals on the list. The Industrial Safety and Health Act (ISHA), also mandates that businesses that use the chemicals on the list put in place mandatory health and safety precautions for employees.

In Table 1-2 of the Labour Standards Act, the MHLW also recommended adding serious heart failure to the list and replacing dissecting aortic aneurysm with aortic dissection.

A subsequent assessment and discussion by the MHLW took place on 7 October 2022, and the announced its recommendations in the "Report of the Expert Review Committee on the Ordinance for Enforcement of the Labor Standards Act, Article 35."

During the Chemical Materials Japan 2022 virtual conference, which took place between 17 and 28 October 2022, the Ministry of the Environment (MOE) and the Ministry of Economy, Trade, and Industry (ME...

During the Chemical Materials Japan 2022 virtual conference, which took place between 17 and 28 October 2022, the Ministry of the Environment (MOE) and the Ministry of Economy, Trade, and Industry (METI) announced their intention to amend the Chemical Substance Control Law (CSCL) to prohibit perfluorohexane sulfonic acid (PFHxS), its salts, and associated compounds next year.

As per the METI, the PFHxS, its salts and related compounds are expected to be designated as class I specified chemical substances. Under CSCL, Class I Specified Chemical Substances are substances that are persistent, highly bioaccumulative, and have a risk of long-term toxicity to humans or predator animals at higher trophic levels. The manufacture, import and use of such substances are prohibited in Japan.

This action aims to bring Japan into compliance with a global ban on the material decided upon by the Stockholm Convention on Persistent Organic Pollutants (POPs) in June 2022. The Basel, Rotterdam and Stockholm conventions are multilateral environmental agreements, which share the common objective of protecting human health and the environment from hazardous chemicals and wastes.

PFHxS is a chemical compound used to make firefighting foams, non-stick cookware, carpet, paper, and fabric stain treatments. It belongs to the group of per- and polyfluoroalkyl compounds (PFASs), whose environmental persistence and presence in water have drawn increasing public scrutiny in recent years. Millions of people will benefit from the decision to prohibit PFHxS, especially firemen who are among those most exposed due to PFHxS's inclusion in firefighting foam.

The ministries of Health, Labour and Welfare (MHLW), METI and MOE will meet after November 2022 to review the strategy.

The Ministry of Health, Labour and Welfare is currently considering a shift from legally compliant risk management to autonomous risk management in response to the growing risk management of new chemi...

The Ministry of Health, Labour and Welfare is currently considering a shift from legally compliant risk management to autonomous risk management in response to the growing risk management of new chemicals in the industrial sector. Chemicals and workplace safety requirements in Japan are managed by the government through a set of laws and regulations. 

On 30 September 2022, Japan released a draft notification to implement guidelines for measuring workplace exposure to certain hazardous substances as it transitions to a self-regulated risk assessment model for chemicals under the Industrial Safety and Health Act (ISHA), and the industry was given a deadline of 29 October 2022, to comment on the suggestions. 

Chemicals and workplace safety requirements in Japan are managed by the government through a set of laws and regulations. The ISHA requires workers exposed to any chemical on a designated list to be screened for occupational diseases on a regular basis.  

In the draft, the Ministry of Health, Labour and Welfare (MHLW) specifies the risk measuring requirements for the compounds like Lead, dust, specific chemical compounds, such as chlorine, ethylene oxide, and chromic acid, and organic solvents like acetone, xylene, and isobutyl acetate. 

Companies that don't follow the suggested working environment measurements for exposure threshold levels to certain chemicals, organic solvents, and lead would have to hire outside consultants to provide them advice on enhancing safety precautions. 

According to the ministry, businesses will be able to assess the overall workplace environment to better manage and control these substances by tracking samples from two or more employees who have experienced similar substance exposures and gathering sample data over the course of an entire working day. The document also outlines specifications for respiratory protective equipment. 

The MHLW suggested new, obligatory procedures in July 2021 to enhance ISHA’s chemical risk assessments and workplace safety. The rules will be published in late November, according to the ministry, and will start to be enforced on 1st April 2024. 

The draft also suggests that workplaces designated for controls under the MHLW's working environment evaluation standard, or where air exposure levels are above the limits specified in the draft, conduct personal sampling strategies — using wearable portable sample collectors — to measure substance exposure. 

On 14 October 2022, Japan’s Ministry of Economy, Trade and Industry (METI), released a notice to revise the Export Trade Control Order, regarding the export approval of Decabromodiphenyl ether (d...

On 14 October 2022, Japan’s Ministry of Economy, Trade and Industry (METI), released a notice to revise the Export Trade Control Order, regarding the export approval of Decabromodiphenyl ether (decaBDE) and Perfluorooctanoic acid (PFOA), its salts and related compounds. Decabromodiphenyl ether is a technical mixture of different Polybromated Dipheny Ether (PBDE) congeners, with PBDE congener number 209 (decabromodiphenyl ether) and nonabromodiphenyl ether being the most common. It is a brominated flame retardant that was widely used in electronic plastics and fabrics. Perfluorooctanoic acid is a perfluorinated carboxylic acid produced and used worldwide as an industrial surfactant in chemical processes and as a material feedstock.

Both compounds are classified as Persistent Organic Pollutants (POPs) in Annex A of the Stockholm Convention, making it mandatory to stop using and producing them, and parties must take action to do so. The updated notification becomes effective on 21 October 2022.

The Chemical Substance and Control Law (CSCL) and the Export Control Ordinance govern the production, use, import, and export of POPs in Japan. On 19 August 2022, METI proposed revisions to the Export Trade Control Order under the Foreign Exchange and Foreign Trade Act.

Businesses must comply with the Rotterdam Convention's export limitations and get approval from the Ministry of Trade, Economy and Industry (METI) before they may export the chemicals. The Rotterdam Convention aims to improve responsibility on importing hazardous chemicals, notably through the "prior informed consent" (PIC) procedure. The PIC procedure is a method for formally obtaining and disseminating the decisions of importing parties regarding whether or not they wish to receive subsequent shipments of the chemicals listed under the Rotterdam Convention, as well as for ensuring compliance with these decisions by exporting Parties.

In order to help companies, comply with the regulations for chemicals in the Pollutant Release and Transfer Register (PRTR), Japan's Ministry of Economy, Trade, and Industry (METI) has issued its ...

In order to help companies, comply with the regulations for chemicals in the Pollutant Release and Transfer Register (PRTR), Japan's Ministry of Economy, Trade, and Industry (METI) has issued its 2022 Safety Data Sheet (SDS) and labelling advice. The updated guidance in Japanese was released on the METI website on 4th October 2022.

The purpose of the Japanese PRTR (Pollutant Release and Transfer Register) system is to encourage business operators to improve their management of chemical substances on a voluntary basis and to prevent any obstructions to the preservation of the environment by taking steps to confirm the release amounts, etc., of specific chemical substances in the environment.

The revised guidance provides details on the following:

• The Globally Harmonized System (GHS) and mixture classification system - The Industrial Safety and Health Act (ISHL), the Pollutant Release and Transfer Register (PRTR) Law, and the Poisonous and Deleterious Substances Control Act (PDSCL) are the three laws that govern the implementation of GHS in Japan.
• Information about the list of compounds covered by PRTR.
• Details on the necessary elements for SDSs, labels, and SDS transfer procedures.

A government gazette notice published on 20 October 2021, states that the Ministry of Economy, Trade, and Industry (METI) has raised the number of compounds included in its Pollutant Release and Transfer Register (PRTR) from 562 to 649. Under Class I, 53 chemical compounds have been added bringing the total number of chemicals listed in this class to 515. Under Class II, 34 chemical compounds have been added by the ministry, bringing the total number of chemicals listed under Class II to 134. These are substances that are specified as being harmful to humans and ecosystems and are deemed to disperse widely into the environment, or are highly likely to disperse widely into the environment at a future time. Enforcement will begin on 1 April 2023.

According to PRTR regulations, businesses are required to give SDSs to other business operators when sharing information about compounds included in the register and goods that contain them.