Japan Regulatory News

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

Japan’s Chemical Substances Control Law (CSCL) goals to prevent environmental pollution caused by chemical substances that pose a risk to human health and interfere with the habitat and healthy ...

Japan’s Chemical Substances Control Law (CSCL) goals to prevent environmental pollution caused by chemical substances that pose a risk to human health and interfere with the habitat and healthy development of flora and fauna.  (Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture etc., Act No. 117 of 1973, art. 1 (provisional translation, for version in effect as of Apr. 1, 2011), Ministry of Economy, Trade and Industry (METI) website.)  The CSCL regulates chemicals that are not regulated by other laws such as the Poisonous and Deleterious Substitute Control Law and Pharmaceutical Affairs Law.  The CSCL was amended and the amendment was promulgated on June 7, 2017.

The CSCL requires prior risk assessment of new chemicals before they can be manufactured or imported. Currently, if the quantities of new chemicals to be manufactured or imported are below an amount set by Cabinet order and the chemicals are not harmful based on available knowledge, they will be exempted from all or part of the risk assessment process.

The amended law changes the calculation of the maximum permissible quantities.  The new measurement of quantity will be based on the level of harmful emissions released by the chemicals into the environment, not on the manufacturing or import of chemicals.

This increases the upper limit of the quantities of certain new chemicals that can be manufactured or imported without full assessment.  

As per article 2 of CSCL, Chemicals are currently classified into the following categories based on their level of persistency, bio-accumulativeness, and toxicity upon continuous exposure to the environment.

• Class I Specified Chemicals are persistent, bio-accumulative, and toxic after continuous exposure;
• Class II Specified Chemicals are accumulated or will be accumulated to some extent in the environment and are toxic after continuous exposure;
• Monitored? Chemicals are persistent and bio-accumulative, but whose toxicity after continuous exposure is unknown;
• Priority Assessment Chemicals are accumulated or will be accumulated to some extent in the environment, but whose toxic after continuous exposure is unknown; and
• General Chemicals.

The amendment adds a new category of chemicals, “Specified General Chemicals,” that are toxic after continuous exposure to the environment, to the above list. 

The government takes measures to control risks associated with a chemical after it is on the market. General Chemicals are the ones least regulated under the CSCL.  The amended CSCL adds the following management measures to be applied to Specified General Chemicals:

• the government will send a notification of the risk assessment to businesses that report holding them;
• the government will make public the results of assessments of the chemicals;
• the competent ministries will instruct and give advice to the businesses under their jurisdiction; and

the businesses dealing with such chemicals are obligated to expend effort in providing information on the chemicals to their clients.