Japan Regulatory News

In a significant move aimed at curbing environmental pollution, Japan has officially notified the World Trade Organization (WTO) of its intention to designate Perfluorohexane Sulfonate (PFHxS), its is...

In a significant move aimed at curbing environmental pollution, Japan has officially notified the World Trade Organization (WTO) of its intention to designate Perfluorohexane Sulfonate (PFHxS), its isomers, or salts as Class I Specified Chemical Substances on 1 September 2023. These substances will require special authorization for their manufacturing or importation within the country.

The decision, based on Article 24 of the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc., will also entail a ban on several products if they incorporate PFHxS, its isomers, or their salts. The proposed date for adopting these measures is set for November 2023, with the entry into force scheduled for January 2024 for chemical substances and May 2024 for the products affected.

The following products will be prohibited from being imported when containing PFHxS, its isomers, or salts:

1. Water-repellent textiles and oil-repellent textiles.

2. Etching agents used for metal processing.

3. Etchants used in the manufacture of semiconductors.

4. Surface treatment agents for plating or related additives.

5. Antireflection agents used in semiconductor manufacturing.

6. Resists for semiconductors.

7. Water repellent, oil repellent, and fabric protection agents.

8. Fire extinguishers, fire-extinguishing agents, and fire-extinguishing foam.

9. Water-repellent clothes and oil-repellent clothes.

10. Water-repellent floor coverings and oil-repellent floor coverings.

The move is driven by concerns over the environmental impact of PFHxS, its isomers, and their salts, which are known for their non-biodegradability, high potential for bioaccumulation, and chronic toxicity. The decision aligns with resolutions made during the 10th Conference of the Parties to the Stockholm Convention on Persistent Organic Pollutants in 2022, emphasizing the need for international action against hazardous substances.

The public and stakeholders are invited to provide comments on these proposed measures within 60 days from the date of notification.

The Manufacturing Industries Bureau of the Ministry of Economy, Trade and Industry (METI) has unveiled a groundbreaking decision to include three POPs (persistent organic pollutants) to the Class I Sp...

The Manufacturing Industries Bureau of the Ministry of Economy, Trade and Industry (METI) has unveiled a groundbreaking decision to include three POPs (persistent organic pollutants) to the Class I Specified Chemical Substances List. The announcement, issued on 10 August 2023, follows the eleventh meeting of the Conference of the Parties to the Stockholm Convention (SC COP-11).

Stockholm Convention COP-11

At the eleventh meeting of the Conference of the Parties (COP) to the Stockholm Convention on 5 May 2023, over 120 countries collectively agreed to include two plastic chemicals and a pesticide in the Convention's list of substances earmarked for global elimination (Annex A). The three substances—UV-328, Dechlorane Plus, and Methoxychlor—were identified as meeting the Convention's criteria for persistent organic pollutants (POPs), thereby necessitating a global prohibition.

Details of three POPs

This decision to add the three POPs to the Class I Specified Chemical Substances under the Chemical Substances Control Law (CSCL) was made after thorough discussions during the 229th meeting of the Chemical Review Committee held in July 2023.

Details of the three newly listed substances are:

Each of these substances has raised concerns due to their persistence, high bioaccumulation potential, and long-term toxicity. More information about the substances can be found here.

Future schedule

Specific measures such as the designation of import-prohibited products and restrictions on the use of the three substances other than for specific applications will be decided after a joint meeting between the Ministry of Health, Labor and Welfare (MHLW) and the Ministry of the Environment (MoE). The implementation of these measures is expected after the fall of 2024, providing industries and stakeholders with a transition period to adjust their practices accordingly.

Japan recently discovered sodium aluminate dioxide (CAS number: 1302-42-7) in some imported goods that included sodium aluminate (CAS number: 11138-49-1). According to an announcement dated 19 July 20...

Japan recently discovered sodium aluminate dioxide (CAS number: 1302-42-7) in some imported goods that included sodium aluminate (CAS number: 11138-49-1). According to an announcement dated 19 July 2023, from the Ministry of Health, Labour and Welfare (MHLW) in accordance with the Poisonous and Deleterious Substances Control Law (PDSCL), manufacturer, or marketers of items proven to contain aluminium sodium dioxide are required to register as poisonous and deleterious substance operators by 31 October 2023.

On 1 July 2018, the MHLW announced sodium aluminate dioxide as a deleterious substance under the Poisonous and Deleterious Substances Control Law (PDSCL). If a company engages in products containing sodium aluminate, they must notify the MHLW and are subject to requirements such as registration, provision of safety data sheets (SDSs), proper labelling and packaging. With these measures, the use of items containing sodium aluminate dioxide will be regulated in order to protect public health and the environment.

The government will continue to strengthen the regulation of deleterious substances to ensure that chemicals are used properly and handled safely.

In Japan, the classification of substances according to the Japan GHS is overseen by three key ministries: the Ministry of Economy, Trade and Industry (METI), the Ministry of Health, Labour and Welfar...

In Japan, the classification of substances according to the Japan GHS is overseen by three key ministries: the Ministry of Economy, Trade and Industry (METI), the Ministry of Health, Labour and Welfare (MHLW), and the Ministry of Environment (MOE). These ministries are responsible for categorizing substances, and their classifications serve as a reference for companies when preparing GHS labels and Safety Data Sheets (SDSs).

On 29 June 2023, Japan’s National Institute of Technology and Evaluation (NITE) announced the classification listings for 170 substances (47 newly classified and 123 reclassified substances) based on the JIS Z 7252-2019 standard that adopts the sixth revised edition of the UN Globally Harmonized System (GHS) of classification and labelling of chemicals. The updated list consists of a total 3,327 substances.

Some examples of the substances are:

All GHS-classified substances are searchable through the GHS Mixture Classification and SDS/Label Preparation Creation System (NITE-Gmiccs).

In June 2022 the Japanese Ministry for Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of the Environment (MOE) together with the National Institute of ...

In June 2022 the Japanese Ministry for Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of the Environment (MOE) together with the National Institute of Occupational Safety and Health (JNIOSH) and the National Institute of Technology and Evaluation (NITE) of Japan launched a project with the goal of collecting test results and hazard data on chemical substances from the private sector.  The data information will be collected by NITE via its online platform.

Since 2006 a government Globally Harmonised System (GHS) of classification and labelling of chemicals project has been run by the MHLW, METI, MOE, and other relevant ministries to implement classification of chemical substances. So far GHS classification results for 3,300 substances have been published based on the knowledge of experts who use evaluation documents and books prepared by public institutions such as international organizations and major countries as basis information for classification. It is the hope that the new project will enhance communication on hazards from private business operators and that the hazards of currently unclassified substances and substances whose hazards have not been determined due to lack of information will be properly understood.

On 1 June 2023, NITE changed some requirements for companies voluntarily submitting chemical hazard information, to improve risk management in the workplace. The changes are:

1. Test information sourced from non-GLP (Good Laboratory Practise) laboratories will now be accepted by the project. The following requirements must be met for test reports to be regarded extremely dependable.

• Physico-chemical hazards: Tests carried out in accordance with the test procedures outlined by international organisations and standard organisations like the International Organization for Standardization (ISO), Japanese Industrial Standards (JIS), and United Nations Recommendations on the Transport of Dangerous Goods (UNRTDG).
• Hazardous to human health: The test substance has a certain level of purity in accordance with internationally recognized test methods such as OECD test guidelines (preferably conducted in a GLP-compliant test facility).
• Environmental hazards: The test substance has a certain level of purity in accordance with internationally recognized test methods such as OECD test guidelines (preferably conducted in a GLP-compliant test facility).

2. Companies had the possibility to notify NITE of their intention to provide information by 30 June 2023 but were not required to do so.

3. NITE will advise companies on how to submit documents of 400 megabytes (MB) or more.

4. If a company chooses to submit information, it must do so by 31 October 2023, using the NITE platform.

In addition to test information, this project also collects safety data sheets (SDS) that reflect GHS classification results using test information. Submission of an SDS is not mandatory, but it will serve as a reference for actual classification in the government's GHS classification project. The provided SDS will be used as reference information in the GHS classification project by the government but will not be posted on the NITE website or made available to the public.

In a notice published in the official government gazette Kanpo on 26 May 2023, Japan’s Ministry of Health, Labour and Welfare (MHLW) added 3-Aminopropan-1-ol (CAS number 156-87-6) and mixtures there...

In a notice published in the official government gazette Kanpo on 26 May 2023, Japan’s Ministry of Health, Labour and Welfare (MHLW) added 3-Aminopropan-1-ol (CAS number 156-87-6) and mixtures thereof with a concentration of 1% or more to its list of poisonous and deleterious substances. The MHLW designated the substance, used in electronics, cosmetics, textiles, synthetic resin and pharmaceuticals, as 'deleterious' and the designation came into force on 1 June 2023.

The MHLW has classified 3-Aminopropan-1-ol as Category 1 Skin corrosion/irritation as well as serious eye damage/eye irritation in line with the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) standards established in Japan. These hazard classes are the primary considerations in selecting Deleterious Substances.

The amendment also includes the following changes, valid from 26 May 2023, to the list of Deleterious Substances:

• The concentration cut-off is changed from 10% to 15% for 2-Isobutoxyethanol (CAS number 4439-24-1), currently designated as a Deleterious Substance. 2-isobutoxyethanol mixtures with less than 15% are excluded from the list.
• Removal of diantimony tetraoxide (CAS number 1332-81-6) and its mixtures from the list of deleterious substances.

Manufacturers, importers, and distributors of Poisonous and Deleterious Substances have the obligation to register their substances with the MHLW and will be subject to SDS and labelling requirements. According to the government's Chemical Risk Information Platform (CHRIP), there are currently 585 substances on the poisonous and deleterious substance list.

On 1 June 2023, the Ministry of Land, Infrastructure, Transport, and Tourism (MLIT), the Ministry of Health, Labour, and Welfare (MHLW), and the Ministry of the Environment (MOE) of Japan jointly anno...

On 1 June 2023, the Ministry of Land, Infrastructure, Transport, and Tourism (MLIT), the Ministry of Health, Labour, and Welfare (MHLW), and the Ministry of the Environment (MOE) of Japan jointly announced the proposal to add cybutryne to the list of hazardous substances that need permission when dismantling a ship. Cybutryne is a biocide used in antifouling paints. The action comes after cybutryne was added to the standards for creating an inventory of hazardous elements in April 2023 by the International Maritime Organisation's subcommittee on pollution prevention and response.

The enforcement is anticipated to begin in the middle of July, and public comment is ongoing until 2 July 2023.

It becomes mandatory for ship owners to provide an inventory of any hazardous materials discovered in the ship's machinery and structure in accordance with the country's Proper Implementation of Ship Recycling and Dismantling Act. This act aspires to align with the Hong Kong International Convention for the Safe and Ecologically Sound Recycling of Ships (HKC). The HKC was adopted by the International Maritime Organisation (IMO) in 2009 and will enter into effect 24 months after 15 states have signed it and other prerequisites have been satisfied. The HKC is aimed at ensuring that ships, when being recycled after reaching the end of their operational lives, do not pose any unnecessary risk to human health and safety or to the environment.