Japan Regulatory News

Japan will implement a ban on 21 products containing perfluorooctanoic acid (PFOA) isomers, their salts and PFOA-related compounds, as announced on 26 April 2024. This significant move by the Ministry...

Japan will implement a ban on 21 products containing perfluorooctanoic acid (PFOA) isomers, their salts and PFOA-related compounds, as announced on 26 April 2024. This significant move by the Ministry of Health, Labour and Welfare (MHLW), the Ministry of Economy, Trade and Industry (METI) and the Ministry of Environment (MOE) is a crucial step towards protecting the environment and public health.

Amendments to Chemical Substance Regulations

The proposal will amend the Order for Enforcement of the Act on the Evaluation of Chemical Substances and Regulation of their Manufacture to designate certain substances as Class I Specified Chemical Substances:

• PFOA with a branched structure and eight carbon atoms and its salts.

• PFOA-related compounds, including perfluorooctyl iodide (PFOI) and 8:2 fluorotelomer alcohol (8:2 FTOH).

• Compounds (with seven carbon atoms) containing a pentadecafluoroalkyl group directly bonded to a carbon atom and containing perfluorooctanoic acid or perfluoroalkane acid with a branched structure and eight carbon atoms as a result of a natural chemical reaction.

When a substance is designated as a Class 1 Specified Chemical Substance its manufacture, import, and use are generally prohibited in accordance with the provisions of the Cabinet Order.

Import Bans

The proposed ban will specifically prohibit the import of the following:

Transitional Measures

In order to facilitate a smooth transition, the proposal includes several measures:

• Medical Devices: The use of 8:2 FTOH for the manufacture of invasive and implantable medical devices will be allowed until 3 December 2025.

• Pharmaceutical Products: Use of PFOI for the manufacture of perfluorooctyl bromide (PFOB) allowed until 31 December 2036.

• Manufacturing Permits: Companies can apply for permits to manufacture PFOI and 8:2 FTOH before the enforcement date, effective upon approval.

• Permit the temporary use of fire extinguishers, fire extinguishing agents and fire extinguishing foam that contain PFOA isomers and salts.

Technical Standards and Environmental Protection

The proposal also stipulates technical standards for manufacturing facilities that handle PFOI and related substances. Additionally, companies will have to include environmental protection information on containers, packaging or invoices for these substances.

Consultation and Enforcement Timeline

The authorities plan to review feedback from Council members and other organizations before finalizing the draft Order for PFOA-related compounds. This review will take place after June but before the enforcement date.

Consultation Period: Ended on 25 May 2024

Public Notice Announcement: Expected in July

Enforcement Date: January 2025 for the general ban; September 2024 for PFOA with a branched structure and eight carbon atoms as a Class I Specified Chemical Substance.

Japan’s Ministry of the Environment (MOE) has allocated funding for three pioneering projects dedicated to understanding the health effects associated with per- and polyfluoroalkyl substances (PFAS)...

Japan’s Ministry of the Environment (MOE) has allocated funding for three pioneering projects dedicated to understanding the health effects associated with per- and polyfluoroalkyl substances (PFAS). The three projects were selected by the PFAS Research Steering Committee from a pool of 14 submissions received by the MOE following a call for proposals from 26 December 2023 to 5 February 2024.

Under the overarching theme of Comprehensive Research on PFAS, the selected projects are as follows:

1. Hyogo Medical University: This project aims to conduct experimental validation to shed light on the immunosuppressive and immune-promoting effects of PFAS in the context of immunological diseases.
2. National Institute of Health Sciences (NIHS): Focused on innovation, this project endeavors to develop a hazard assessment methodology grounded in gene expression analysis. Such an approach seeks to facilitate prioritization and holistic evaluation in the context of PFAS regulation.
3. Hokkaido University: Embarking on a multidimensional exploration, this comprehensive initiative aims to elucidate the health effects of PFASs, taking into account toxicological impacts, mechanisms of toxicity development and interspecies variations. This integrated study merges environmental epidemiology and toxicology to provide a deeper understanding of the subject matter.

On 12 April 2024, Japan's Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI) and Ministry of the Environment (MOE) formally notified the World Trade Orga...

On 12 April 2024, Japan's Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI) and Ministry of the Environment (MOE) formally notified the World Trade Organization (WTO) of the revision of the Order for Enforcement of the Act on the Regulation of Manufacture and Evaluation of Chemical Substances (the Act).

Key Revisions to the Act

5. Designation of Class I Specified Chemical Substances: Pursuant to Articles 17 and 22 of the Act, the following substances will now require authorization for manufacture or import:

   • PFOA isomers or their salts and PFOA related compounds.

5. Designation of Permitted Chemical Substances and Uses: Article 25 of the Act allows the use of the following substances for a specified period of time.

   • 8:2 fluorotelomer alcohol, used in the manufacture of invasive and implantable medical devices, permitted until 3 December 2025.

   • Perfluorooctyl iodide, for the manufacture of pharmaceutical products, permitted until 31 December 2036.

5. Prohibition on Import of Products: Under Article 24 of the Act, the import of following products containing PFOA isomers or their salts, and PFOA-related compounds will be prohibited.

Addressing Environmental Concerns: Objective of the Revision

The objective of the revision is to address environmental concerns arising from the non-biodegradability, bioaccumulation potential and chronic toxicity of PFOA isomers or their salts and PFOA-related compounds. The decision is in line with the decisions taken at the Ninth Conference of the Parties to the Stockholm Convention on Persistent Organic Pollutants in 2019.

Timeline and Procedure:

Proposed Adoption Date: June 2024.

Proposed Entry into Force: The revised regulations will take effect in two phases. Firstly, the designation of PFOA isomers or their salts is proposed to take effect in August 2024. Subsequently, the designation of PFOA-related compounds and the addition of banned products are scheduled to take effect in December 2024.

Deadline for Comments: Stakeholders have 60 days from the date of notification to provide feedback.

The revision underscores Japan's commitment to environmental protection and public health by regulating hazardous chemical substances and their uses.

In a significant step to protect the environment and public health, Japan's Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of Environme...

In a significant step to protect the environment and public health, Japan's Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of Environment (MOE) have jointly initiated a consultation on the designation of certain perfluorooctanoic acid (PFOA) isomers, their salts, and PFOA-related compounds as Class I Specified Chemical Substances under the Chemical Substance Control Law (CSCL).

The proposed ban, if enacted, would affect the manufacture, import, and use of these substances throughout Japan. The consultation period commenced on 1 February 2024 and is set to conclude on 1 March 2024.

Details of the proposed ban and classification framework

Under the CSCL framework, chemicals are classified on the basis of their persistence, bioaccumulation, and toxicity upon continued exposure to the environment. The substances targeted in this proposal have been identified as exhibiting characteristics of being persistent, highly bioaccumulative, or toxic to humans over the long term.

Prohibited and exempted substances

Specifically, the proposal seeks to designate the following substances as Class I Specified Chemical Substances:

• Perfluoroalkane acid with a branched structure and eight carbon atoms and its salts.
• PFOA-related compounds including perfluorooctyl iodide, 8:2 fluorotelomer alcohol, and compounds with the pentadecafluoroalkyl group bonded directly to the carbon atom, resulting from natural chemical reactions with PFOA or perfluoroalkane acid with a branched structure and eight carbon atoms.

Highlights of the ban on specific products containing PFOA and PFOA-related compounds are summarized in table below:

Notably, the proposal includes exemptions for two essential uses of PFOA:

• Perfluorooctyl iodide (PFOI) intended for the production of perfluorooctyl bromide (PFOB) for pharmaceutical products.
• 8:2 fluorotelomer alcohol (8:2 FTOH) for the manufacture of invasive and implantable medical devices.

International alignment

Japan’s approach to regulation PFOA will be in line with international limits on PFOA under the UN's Stockholm Convention on Persistent Organic Pollutants (POPs).

On 9 January 2024, the Japanese Ministry of Health, Labour, and Welfare (MHLW) issued a key notice to guide companies in complying with new requirements for safety data sheets (SDSs) and Globally Harm...

On 9 January 2024, the Japanese Ministry of Health, Labour, and Welfare (MHLW) issued a key notice to guide companies in complying with new requirements for safety data sheets (SDSs) and Globally Harmonized System (GHS) based labels for hazardous substances under the Industrial Safety and Health Act (ISHA). These requirements are set to become mandatory from 1 April 2024.

Key requirements outlined by the MHLW include:

A. Safety Data Sheets (SDS) must include:

• CAS numbers and substance names
• Physical and chemical properties of the substance, including colour, odour, melting/freezing point, boiling point and flammability.
• Information on appropriate protective equipment and storage/handling precautions.
• Specific information on human health effects following exposure, such as acute toxicity, serious eye damage/irritation, respiratory/skin sensitization, reproductive toxicity, and germ cell mutagenicity.
• Accident and emergency management procedures in case of leakage and other incidents, including evacuation measures and use of protective equipment.
• Description of the content in terms of concentration or weight percentage, or provision of a conversion formula to enable users to convert to weight percentage.
• Recommended uses and restrictions on use including conditions to avoid and incompatible materials.
• Product ingredients classified as confidential must be clearly identified with a summary description; companies may use non-disclosure agreements for such information. Exceptions apply to substances regulated by specific ordinances.

B. Packaging labels must include:

• The name of the substance (must be identical to the name in the SDS). The product name may be used if it allows identification.
• GHS hazard classifications (according to standard JISZ7252:2019) with details for each substance in a mixture if the mixture itself is not classified
• Possible harmful effects on the human body
• Hazards with pictograms and warnings
• Storage and handling instructions, including measures to prevent exposure.
• Name, address, and telephone number of the person making the label and information on the domestic manufacturer/importer.
• Emergency contact telephone numbers
• Signal word
• Information on the stability and reactivity of the substance, including storage conditions, handling precautions, decomposition, and mixing with incompatible substances.

Companies are urged to bring their practices into line with these regulations without delay to ensure compliance by the specified deadline. Failure to do so may result in penalties or legal consequences. The MHLW emphasizes the importance of these measures in improving workplace safety and minimizing the risks associated with hazardous substances.

In a major step forward for environmental protection and international collaboration, the Philippines and Thailand are preparing to initiate monitoring efforts for Persistent Organic Pollutants (POPs)...

In a major step forward for environmental protection and international collaboration, the Philippines and Thailand are preparing to initiate monitoring efforts for Persistent Organic Pollutants (POPs) later this year. This decision was a key outcome of the 15th East Asia Persistent Organic Pollutants (POPs) Monitoring Workshop, organized by Japan’s Ministry of Environment (MOE) in Manila, Republic of the Philippines in November 2023.

The workshop brought together experts from Japan, the UN Environment Programme (UNEP), the Secretariat of the Basel, Rotterdam, and Stockholm Conventions, as well as representatives from Environment and Climate Change Canada. Government officials from Cambodia, Indonesia, South Korea, Laos, Malaysia, Mongolia, the Philippines, Singapore, Thailand, Vietnam, and Japan actively participated in the event.

Background and Purpose:

The workshop aligns with the objectives of the Stockholm Convention on Persistent Organic Pollutants (POPs), adopted in 2001. The Convention, which entered into force on 17 May 2004, mandates participating countries to conduct national and international environmental monitoring to identify the presence of POPs in humans and the environment. The Japanese Ministry of the Environment has been organizing this workshop since 2002 to facilitate international cooperation and contribute to evaluating the effectiveness of the POPs Convention.

Workshop Overview:

1. Sponsorship and Cooperation:

                                          Sponsored by: Japanese Ministry of the Environment

Cooperation: Republic of the Philippines, Department of Natural Resources and Environment, Environmental Management Bureau

2. Participants:         Government officials from 11 East Asian countries

Representatives from the United Nations Environment Program (UNEP), the Secretariat of the Basel-Rotterdam-Stockholm Convention, Environment and Climate Change Canada, and Japanese experts.

3. Main Contents:  Chaired by Professor Reiko Sodeno, the workshop covered several topics:

1. Progress of evaluating the effectiveness of the POPs Convention
2. Analysis results and status report POPs monitoring in East Asia
3. Future monitoring plans
4. Framework for future East Asia POPs monitoring project

The press release issued by Japan’s Ministry of Environment on 12 January 2024, highlighted the following key results:

1. The Secretariat of the Basel-Rotterdam-Stockholm Convention presented the 3rd Global Monitoring Report, which evaluates the effectiveness of the POPs Convention, and discussed efforts for the next evaluation.
2. Reports on the status and results of cooperative monitoring efforts at priority survey points were presented. Agreements were made to continue monitoring in specific areas.
3. Future monitoring plans were discussed, confirming cooperative monitoring in the Republic of the Philippines and the Kingdom of Thailand in 2024, and arrangements for the Republic of Indonesia in 2025.
4. Several research institutions have been established to sustain and strengthen POPs monitoring in the East Asian region. Feasibility studies will be conducted with Mongolia as a candidate, following Japan, South Korea, the Republic of the Philippines, and the Kingdom of Thailand.

The workshop has laid the groundwork for continued international cooperation in monitoring and addressing the challenges posed by persistent organic pollutants in the East Asian region.

Japan's Ministry of Health, Labour and Welfare (MHLW) has taken a significant step towards improving transparency and accessibility by releasing an English version of its positive list of substanc...

Japan's Ministry of Health, Labour and Welfare (MHLW) has taken a significant step towards improving transparency and accessibility by releasing an English version of its positive list of substances assessed for safety in food contact materials (FCMs). The information made available on 25 December 2023, aims to provide clarity on permitted substances and additives used in food packaging.

Components of the published material

The English publication of the list is structured into three parts:

1. Table 1 - Polymers: This list categorizes polymers into five categories and explains the characteristics (i.e. glass transition temperature and melting point) of the five categories.

2. Table 2 – Additives: A comprehensive list of 827 additives. For each additive, the table includes its substance names in Japanese and English, CAS numbers, use limits according to polymer group, and associated requirements.

3. Essential Monomers: A detailed list comprising 21 Annexes for different types of essential monomers, their CAS numbers and requirements.

Additional resources and upcoming publications

In an effort to further assist stakeholders and the public, the MHLW is set to publish a list of frequently asked questions (FAQs) on its official website. These FAQs are intended to provide additional clarification on the requirements associated with the Positive List.

The Japanese version of the Positive List was initially published on 30 November 2023. However, in recognition of the global significance and the diverse audiences affected by these regulations, the English version is intended to facilitate a broader understanding and compliance.

Enforcement and legal amendments

Enforcement of the Positive List is scheduled to commence on 1 June 2025. This follows the MHLW’s earlier publication in April 2020 of the first draft positive list of substances assessed for safety in contact with utensils, containers, and packaging. The amendments to Article 18(3) of the Food Sanitation Act came into effect on 1 June 2020.