Japan Regulatory News

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.

On 20 October 2022, the Japanese Ministry of Health, Labour, and Welfare (MHLW), the Ministry of Economy, Trade, and Industry (METI), and the Ministry of Environment (MOE) have jointly published the 2...

On 20 October 2022, the Japanese Ministry of Health, Labour, and Welfare (MHLW), the Ministry of Economy, Trade, and Industry (METI), and the Ministry of Environment (MOE) have jointly published the 2023 schedule for companies to notify new chemical substances manufactured or imported in volumes of less than one tonne per annum (TPA), or to apply for small-volume permits under the Chemical Substances Control Law (CSCL).

An applicant code must be requested by 9 December 2022 from businesses submitting online applications for the first time. In order to fulfil the deadline for the initial online application, the ministry anticipates notifying the code on 11 January 2023.

For receiving the confirmation of manufacturing or importing small amount of chemicals substances from the Government of Japan, one can apply through following methods under the given dates:

• Online electronic submission on e-Gov website
• Optical disc by mail to METI
• Paper documents filed with the MOE

On the same day the three Ministries also published the deadline for companies to submit applications for low volume chemical permits under the Chemical Substances Control Law (CSCL) or to notify new chemical substances manufactured or imported in volumes of less than ten TPA in a separate notice.

Applicants can submit their applications for the permits via the e-Gov website, METI, or via mail that is addressed to the ministry. One month after the application deadline, the results of the applications will be made public. Detailed instructions for submissions are available on the METI website.

Companies must provide biodegradation studies and/or bioaccumulation studies to support their applications, as well as the projected amounts they anticipate to import or manufacture. The government must be able to evaluate the substance's potential for bioaccumulation, human toxicity, and ecotoxicity through biodegradation studies that provide information and analytical data on degradation products. Good laboratory practice (GLP) compliance is required for test data.

Companies who are making their first online application must have an applicant code. Companies must apply for the code by 10 January 2023 and may anticipate receiving it on 8 February 2023 in order to fulfil the first application deadline.

Applicants who want to manufacture or import the chemicals must include all the relevant details about company name, addresses, notifier or responsible person, volume, uses of chemicals to be exported, and the structural formula of the chemicals in the application. To guarantee that the overall national yearly volume is within the acceptable range for the given substance, the government will modify the authorised amounts for each application.

The Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE) and Ministry of Economy, Trade and Industry (METI) are jointly responsible for processing the applications.

The penalty for non-compliance is prison of up to one year or a maximum fine of 50 M Japanese yen.

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.

On July 15, 2022, the Ministry of Health, Labor, and Welfare (MHLW), the Ministry of Environment (MoE), and the Ministry of Economy, Trade, and Industry (METI) announced that they have revised the gui...

On July 15, 2022, the Ministry of Health, Labor, and Welfare (MHLW), the Ministry of Environment (MoE), and the Ministry of Economy, Trade, and Industry (METI) announced that they have revised the guidance documents to "rationalise and expedite classifications of substances for risk assessment and management". Revised technical guidance and related documents were expected to be published in September 2022, however, to date (October) nothing has been published. 

The Japanese Chemical Substances Control Law (CSCL) defines the risk assessment for Priority Assessment Chemical Substances (PACS) as, “the assessment to determine whether there exists a risk of damage to human health or to the population and/or growth of animals and plants in the human living environment, due to environmental contamination attributable to chemical substances.”

This risk assessment enables the Minister of Health, Labor and Welfare, the Minister of Economy, Trade, and Industry and the Minister of the Environment to determine the necessity for their exercise of regulatory authority such as the “Designation as Class II Specified Chemical Substances” and the “Rescission of Designation as Priority Assessment Chemical Substances” under the Japanese Chemical Substances Control Law.

As of April 1 2022, Japan has added 4 substances and removed of another 13 from its PACS list under the country's Chemical Substances Control Law (CSCL). Currently, there is a total of 218 substances on the PACS list, according to METI.

The guidance documents in the following list have been revised. These documents were previously revised in 2019:

• The basic concept of screening assessments for PACS
• Screening assessment methods
• The basic concept of risk assessments for PACS
• The methods of risk assessment

The sections of the Technical Guidance on Risk Assessment for PACS under the CSCL listed below have also been revised: 

• Assessment criteria for the removal of substances with no risk concerns from the PACS list
• Methods for prioritizing chemicals for risk assessment
• Evaluating risk from mutagenic substances using carcinogenicity test results or existing quantitative information 
• Screening requirements for mutagenic and hazardous substances using in vivo test results

While evaluating PACS, METI gathers detailed information from the industry regarding their production and uses. Based on the collected information the ministry then performs a risk assessment (Tier 1) to decide whether to reclassify the substance, cancel its PACS designation, or prioritise it for further environmental exposure studies and a follow up risk assessment (Tier 2). In some cases, the government might also request toxicity studies of the substances before a final risk assessment.

With the objective to help manufacturers comply with the Ministry of Health, Labour, and Welfare’s (MHLW) risk control requirements and to keep abreast of new regulations being introduced under the ...

With the objective to help manufacturers comply with the Ministry of Health, Labour, and Welfare’s (MHLW) risk control requirements and to keep abreast of new regulations being introduced under the Industrial Safety and Health Act (ISHA), Japan is going to launch a platform on chemical management.

The information portal will be set up on a test basis in the financial year 2023 which runs from 1 April 2023 to 31 March 2024 and will be updated later with the feedback received from user experience. Japan has implemented the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) through its ISHA regulatory framework. 

The Japan National Institute of Occupational Safety and Health (JNIOSH) is responsible for creating, running and upgrading the platform as per governmental policy on occupational safety and health. 

Currently, the website is under construction and will provide detailed information on:

• News on revisions to ISHA and enforcement schedules which includes updates on risk management provisions under the Act, such as changes to SDS, labelling and exposure limit requirements. 

• Chemical risk management requirements for consultants and managers 
• Risk assessment tools
• Guidelines for monitoring workers’ health

On 15 September 2022, the Ministry of Health, Labour, and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of Environment (MOE) jointly released a Notice to seek hazard ...

On 15 September 2022, the Ministry of Health, Labour, and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of Environment (MOE) jointly released a Notice to seek hazard information on three default candidate substances. The notice sets a deadline of 30 November 2022. Interested companies planning to conduct tests should notify the ministries and complete them by 31 December 2023.

A 'default candidate substance' is a general chemical substance for which the ministries have insufficient hazard data to conduct a screening assessment to designate it as priority assessment. The substances are: 

• tricyclo[5.2.1.0(2.6)]dec-3-en-8-yl acetate
• N, N-Dipolyoxyalkylene (C＝2, 3)-N-alkyl (C8-18, normal chain) amine;
• polyoxyalkylene (C 2-4,8) monoalkyl(or alkenyl) (C 1-24) ether (n=1-150)

The three ministries have requested the following data:

•  algae growth inhibition
•  daphnia acute immobilisation
•  fish acute toxicity

If the collected information is found to be insufficient or received and verified, but cannot be used for the screening assessment without test notifications, the ministries will classify the default candidate substance as:

• default hazard class I: for substances that potentially have an effect on the ecosystem
• default hazard class II: for substances that potentially have an effect on health

On the basis of hazard and toxicity levels, the substance’s hazard and exposure class will be estimated by the joint ministerial council to decide if it should be designated as a 'default priority assessment chemical'.