Japan Regulatory News

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.

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'.

On 9 September 2022, the Japanese Ministry of Health, Labour, and Welfare (MHLW), the Ministry of Economy, Trade, and Industry (METI), and the Ministry of Environment (MoE) jointly published the Notif...

On 9 September 2022, the Japanese Ministry of Health, Labour, and Welfare (MHLW), the Ministry of Economy, Trade, and Industry (METI), and the Ministry of Environment (MoE) jointly published the Notification Schedule for Manufacture and Import of New Chemical Substances for 2023.

The three ministries announced that companies must provide the necessary information via electronic notifications on the website of the National Institute of Technology and Evaluation (NITE). It is mandatory to include following information in the Notification:

• company name and address  
• the name of the responsible agent or notifier 
• the substance information such as name of substance or compound, chemical structure and formula, uses, expected volume of production or import for the next three years, relevant test results, etc. 

If companies need clarifications on any of the requirements, they can submit their request via enquiry forms on the METI and the NITE websites.

The Chemical Substances Control Law (CSCL) divides chemicals into existing and new chemicals. New chemicals must also be notified to, and evaluated by, METI for their biodegradation, bioaccumulation and toxicity to humans and the environment before and after they are placed on the market.

New Chemical Notification Schedule for 2023

Furthermore, the ministries said that they plan to release the 2024 schedule by September 2023. 

Japanese standards on chemical classification, labelling and safety data sheets (SDSs), JIS Z 7252 and JIS Z 7253, have been aligned with the Globally Harmonized System (GHS) Rev.6.Until May, 24, 2022...

Japanese standards on chemical classification, labelling and safety data sheets (SDSs), JIS Z 7252 and JIS Z 7253, have been aligned with the Globally Harmonized System (GHS) Rev.6.Until May, 24, 2022, chemical suppliers were given the time to arrange and update relevant SDSs and labels to adapt to new requirements. GHS labels and SDSs are mandatory for the chemicals regulated by the three main clauses for chemicals in Japan, that is, the Industrial Safety and Health Law (ISHL), the Pollutant Release and Transfer Register (PRTR) Law and the Poisonous and Deleterious Substances Control Law (PDSCL).

Whereas for other chemicals falling outside these regulatory categories, implementation of GHS classification and hazard communication elements is encouraged. Despite their different applicable scopes, these laws overall convey the same standards on the criteria for classification, labeling and SDS preparation for:

• JIS Z 7252:2019 Classification of chemicals based on GHS of Classification and Labelling of Chemicals, and
• JIS Z 7253:2019 Hazard Communication of Chemicals Based on GHS - Labelling and Safety Data Sheet.

The notable revision after these standards were published in May 2019, was the incorporation of an additional hazard class for desensitized explosives with new H statements, H206 to H208, into the standards. A sub-hazard category (i.e., Pyrophoric gas) was also introduced for flammable gases.

Noteworthily, the 3-year grace period expired on May 24, 2022. Therefore, individuals have to follow up with the new requirements to ensure compliance within the industry.

A new version of the Japanese online tool, Globally Harmonized System (GHS) Mixture Classification and Labelling Creation System (Nite-Gmiccs) from the National Institute of Technology and Evaluation ...

A new version of the Japanese online tool, Globally Harmonized System (GHS) Mixture Classification and Labelling Creation System (Nite-Gmiccs) from the National Institute of Technology and Evaluation (NITE) has been released.

The latest version comes with upgraded functions, such as assisting users to create safety data sheets (SDSs). The fixed bugs include issues relevant to systematic layout, SDS labels, Acute Toxicity Estimates (ATE) for mixtures and individual ingredients, and duplications of mixture identities when importing mixture composition information, etc. It is available as a free version via the NITE’s website. Information like the composition of chemical mixtures or the GHS classification of pure chemical substances is recommended for making relevant classification’ labels.

The new function for SDSs also allows users to directly transpose results from GHS classification as well as to classify mixtures and ingredients to SDSs into the required format. This new feature in the system eases previously existing administrative burdens substantially for either authorizing authorities or the SDSs creators.

Advantages of this function also include easier access for users’ reference to the applicable Nite Chemical Risk Information Platform (Chrip) law and regulation information from the Cas registry number of the composition component of the products. This can also at the same time be exported to the SDS formats. Timely updates on related regulatory changes and other news information regarding existing substances listed under the Ministry of Health, Labour and Welfare (MHLW)’s Industrial Safety and Health Act (ISHA) and the Ministry of Industry, Trade and Economy (Meti)'s Chemical Substances Control Law (CSCL) are also provided in version 2.0.2.

Other detailed upgrades include:

• To display "Non-medicinal Deleterious Substances" and "Non-medicinal Non-toxic Substances" required for labels under the Poisonous and Deleterious Substances Control Law, and
• To calculate the ATE even in cases where all the composition components of the mixture or product are shown as "Not applicable to the category".