Japan Regulatory News

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.

In a significant step to address environmental concerns, the Japanese Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of Environment (MoE) h...

In a significant step to address environmental concerns, the Japanese Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of Environment (MoE) have jointly issued a consultation, calling for the designation of methoxychlor, dechlorane plus, and UV-328 as Class I Specified Chemical Substances under the Chemical Substance Control Law (CSCL). The consultation was released on 12 December 2023.

Global Context

This announcement follows the Eleventh Meeting of the Conference of the Parties to the Stockholm Convention on Persistent Organic Pollutants, held in Geneva, Switzerland, from 1 May to 12 May 2023. During the conference, these three substances, methoxychlor, dechlorane plus, and UV-328, were added to Annex A of the Convention. The Stockholm Convention is a global treaty that aims to protect human health and the environment from chemicals that are persistent, geographically widespread, bioaccumulative, and harmful to human health or the environment.

Proactive Measures and Restrictions

As a party to the Stockholm Convention, Japan is now ready to take proactive measures to control and eliminate these Persistent Organic Pollutants (POPs). The plan is to prohibit the manufacture and import of methoxychlor, dechlorane plus, and UV-328, starting from the third quarter of 2024, with no plans to establish "essential use" exemptions. This means that the use of these substances in the production of other products will also be strictly prohibited.

Furthermore, Japan will implement import bans on specific products containing dechlorane plus and UV-328, to restrict their entry into the market. The affected product categories include flame retardant additives for resins, silicone rubber, lubricants, adhesives and tapes, as well as components, housings, wires, and cables of electrical and electronic products for dechlorane plus. For UV-328, the import bans will apply to paints and varnishes, lubricants, adhesives, tapes, sealants, and its use as a UV absorber in plastics.

Health and Environmental Effects of the Targeted Chemicals

Dechlorane Plus is a chlorinated flame retardant that is commonly used in electronics and automobiles. Human exposure to Dechlorane Plus has been linked to neurodevelopmental and reproductive disorders. UV-238 is an ultraviolet stabilizer that protects polymers from degradation. It has been associated with adverse liver and kidney effects in animals. Methoxychlor is an organophosphate pesticide that is banned in the United States and the European Union due to its toxicity to aquatic life, persistence, ability to bioaccumulate, and endocrine-disrupting activity.

The public is invited to comment on the proposed measures until 10 January 2024.

On 1 November 2023, Japan's Ministry of Economy, Trade and Industry (METI) issued a directive requiring companies to submit detailed information on two priority assessment chemicals (PACs) under t...

On 1 November 2023, Japan's Ministry of Economy, Trade and Industry (METI) issued a directive requiring companies to submit detailed information on two priority assessment chemicals (PACs) under the country's Chemical Substances Control Law (CSCL).

The substances in question, sodium alkenesulfonate and sodium hydroxyalkanesulfonate, have been listed as PACs, indicating their potential risks to the environment or human health. Companies are now required to submit comprehensive data with their annual reports for the financial year 2024. The information required includes:

Name and Contact Details of Notifier: Companies must provide their name and contact details as the notifier of the substances in question.

Name and CAS Number of the Substance: The specific identification of the substances with their Chemical Abstracts Service (CAS) numbers is crucial for accurate reporting.

Chemical Structure, Composition, and Weight Percentage: Detailed information about the chemical structure, composition, and weight percentage of the substances is required for a thorough assessment.

Volume: Companies are required to disclose the volume of the substances being manufactured or imported, especially if the volume exceeds one tonne per year.

Uses: METI is requesting information on the intended uses of sodium alkenesulfonate and sodium hydroxyalkanesulfonate, as understanding the potential exposure scenarios is essential for risk evaluation.

Priority assessment chemicals are subject to increased scrutiny due to their potential adverse effects. The National Institute of Technology and Evaluation’s (NITE) Chemical Risk Information Platform shows that there are currently 218 substances listed under the PAC category.

Companies engaging in the manufacture or import of these substances in quantities exceeding one tonne per year are required to submit their annual reports, ensuring compliance with METI regulations and contributing to the overall safety and accountability in the handling of chemicals.