Japan Regulatory News

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".

The Ministry of Health, Labour and Welfare (MHLW) in Japan recently designated 4-methylbenzenesulfonic acid as a deleterious substance. This is an industrial substance widely used in coating prod...

The Ministry of Health, Labour and Welfare (MHLW) in Japan recently designated 4-methylbenzenesulfonic acid as a deleterious substance. This is an industrial substance widely used in coating products, polymers, lubricants, and greases. Most importantly, this restriction starts from April 30.

For manufacturers, importers, and end-users of this substance, you must notify the ministry. This notification also applies to preparations that contain about 5% of the substance. Starting from the application date, notification will also be subjected to the requirements of the Poisonous and Deleterious Substances Control Act, as relevant to the substance notification. 

These requirements include:

· business registration by manufacturers, importers, and sellers,

· appointment of qualified personnel to prevent health and hygiene hazards,

· labelling on substance packaging and containers,

· provision of a safety data sheet (SDS), 

· record keeping, and

· sound disposal management.

Last  Update: 2022-02-08

Japan is going forward with a global ban on the production, import, and use of Perfluorooctanoic acid (PFOA), its salts, and 2,2,2-Trichloro-1-(2-chlorophenyl)-1-(4-chlorophenyl) ethanol (also known as o,p’-Dicofol), as a part of its commitment announced at the 9th meeting of the Stockholm Convention on (POPs) in 2019.

In February 2021, the Ministry of Economy, Trade and Industry (METI), the Ministry of the Environment (MoE), and the Ministry of Health, Labour and Welfare (MHLW) announced an amendment to the Cabinet Order of the Act on the Evaluation of Chemical Substances and Regulation of their Manufacture, etc. In the proposal, PFOA, its salts, and o,p’-Dicofol will be added to the group of substances regulated as Class 1 Specified Chemical Substances. Class I specified chemical substances under the Chemical Substances Control Law (CSCL) are those substances that Japan has assessed as persistent, highly bioaccumulative, or which have a risk of long-term toxicity to humans.  Under Japan’s Act on the Evaluation of Chemical Substances and Regulation of their Manufacture, etc., manufacture and import of a Class 1 Specified Chemical Substance requires prior authorisation from METI. The use of the regulated substances is only authorised when there are no alternatives available and the use of the substances will not pose a risk to the environment or to human health.

Class 1 Specified Chemical Substances are listed in Article 1 of the Cabinet Order of the Act on the Evaluation of Chemical Substances and Regulation of their Manufacture, etc.

In addition, the following list of products is to be added to Article 7 of the Cabinet Order which prohibits the import of products containing PFOA and its salts.

• Water-resistant and oil-resistant paper
• Water-repellent and oil-repellent textiles
• Cleaning agents
• Anti-reflection agents used in the manufacture of semiconductors
• Paints and varnish
• Water and oil repellent
• Adhesives and sealing fillers
• Fire extinguishers, fire-extinguishing agents, and fire-extinguishing foam
• Toners
• Water-resistant and oil-resistant clothes
• Water-repellent floor and oil-repellent floor coverings
• Floor waxes
• Photographic paper

The amendment is expected to be finalised by April and come into force in mid-October.

Last update: 2021-04-21

Japan’s Ministry of Environment (MoE) in 2021 has published the schedule for companies to notify new chemical substances manufactured or imported in volumes of less than 10 tonnes/year, or a...

Japan’s Ministry of Environment (MoE) in 2021 has published the schedule for companies to notify new chemical substances manufactured or imported in volumes of less than 10 tonnes/year, or apply for the small volume chemical permits under the Chemical Substances Control Law (CSCL).

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

1. Online electronic submission.
2. Optical disc mailing.
3. By E-mail.

The Applicant willing to manufacture or import the chemicals must include all the relevant details about Company Name, Addresses, Notifier or Responsible Person with the amount of Volume and use of chemicals to be exported. The online electronic submission can be favorable in the time of Covid-19, which can be done by uploading the applications to the Ministry of Economy, Trade and Industry (METI).

The Ministry of Health, Labour and Welfare (MHLW), MoE and 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 50M Japanese yen.

Click here to see more Information (In Japanese)

Update: 2021-01-28