Japan Regulatory News

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.

On 27 October 2023, the Japanese Ministry of Economy, Trade and Industry (METI) issued a proposal to classify poly(oxyethylene) nonylphenyl ether (NPE) as a Class II specified chemical substance accor...

On 27 October 2023, the Japanese Ministry of Economy, Trade and Industry (METI) issued a proposal to classify poly(oxyethylene) nonylphenyl ether (NPE) as a Class II specified chemical substance according to its Chemical Substance Control Law (CSCL). The proposal mandates that manufacturers and importers to label their packaging with environmental protection guidelines and to submit reports detailing both expected and actual annual quantities.

Class II specified chemicals are chemicals that have been detected (or are expected to be detected) in significant amounts in the environment and are believed to represent a risk of long-term adverse effects to humans and/or the ecosystem. Currently, there are 23 substances in this class, including trichloroethylene, tetrachloroethylene, carbon tetrachloride, and triphenyltin N,N-dimethyldithiocarbamate.

In Japan, NPE is widely used as:

• Wetting, emulsifying, and dispersing agent in textile processing.
• Detergents, dishwashing liquids, and floor cleaners in household and industrial cleaning products.
• Defoaming agent in paper and pulp production.
• Emulsifier and wetting agent in the production of pesticides and herbicides.
• Emulsifier and surfactants in cosmetic products such as shampoos, body washes, facial cleansers, etc.

The consultation on the draft will end on 26 November 2023.

On September 25, 2023, Japan’s National Institute of Technology and Evaluation (NITE) amended the recommended classifications of six substances based on the sixth revised edition of the UN Globally ...

On September 25, 2023, Japan’s National Institute of Technology and Evaluation (NITE) amended the recommended classifications of six substances based on the sixth revised edition of the UN Globally Harmonized System (GHS) of Classification and Labelling of Chemicals. 

The six substances are:

The Ministry of Economy, Trade and Industry (METI), the Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Environment (MoE) are responsible for classifying substances, according to the Japanese GHS and have been publishing recommended classifications since 2006. To date, more than 3000 substances have been classified.

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

The notice can be downloaded here in Japanese.

In Japan, the Ministry of Health, Labour and Welfare (MHLW) has taken significant steps to improve workplace safety by updating the list of substances that require safety data sheets (SDSs) and labels...

In Japan, the Ministry of Health, Labour and Welfare (MHLW) has taken significant steps to improve workplace safety by updating the list of substances that require safety data sheets (SDSs) and labels in accordance with the United Nations Globally Harmonized System of classification and labelling (GHS). This move, in line with Japan's Industrial Safety and Health Act (ISHA), aims to improve the transparency of hazard information throughout the supply chain.

Revised list

On 31 August 2023, the MHLW published the revised list, which now includes a total of 667 substances. These substances are listed in both Japanese and English, along with their Chemical Abstracts Service (CAS) numbers and specified cut-off values. The cut-off value, designates the concentration threshold of a chemical substance within a product. If a listed chemical falls below this threshold, companies are exempt from providing SDSs and GHS-based labelling.

The revised list of substances requiring SDSs and GHS-based labels can be found here.

Manufacturers and importers are urged to thoroughly examine their products to determine whether they contain any of the listed chemicals above the specified cut-off values, thereby requiring SDSs or GHS-based labelling. Compliance with these regulations is essential to maintaining a safe and transparent working environment in Japan.

Earlier announcement

This development follows an earlier announcement on 16 March 2023, when Japan said it would add an additional 1,469 substances to the list, further strengthening the country's commitment to workplace safety and risk assessment. The 1,469 substances will be added in two stages in April 2025 and April 2026. More details on this addition can be found here. Transparent dissemination of hazard information throughout the supply chain remains a cornerstone of Japan's strategy.

Implementation of GHS in Japan

In Japan, the GHS is implemented under three laws, which include the Industrial Safety and Health Act (ISHL), the Pollutant Release and Transfer Register (PRTR) Law, and the Poisonous and Deleterious Substances Control Act (PDSCL).

As Japan continues to refine its workplace safety measures, the aim is to create a safer, more transparent environment for workers and companies alike, to encourage responsible handling of hazardous substances and to promote global harmonization of safety standards.

On 20 September 2023, the Ministry of Health, Labour, and Welfare (MHLW), the Ministry of Economy, Trade and Industry (METI), and the Ministry of Environment (MOE) jointly issued a Notice requestin...

On 20 September 2023, the Ministry of Health, Labour, and Welfare (MHLW), the Ministry of Economy, Trade and Industry (METI), and the Ministry of Environment (MOE) jointly issued a Notice requesting hazard information on a ‘default candidate substance’. The notice sets a deadline of 30 November 2023 for submitting hazard information or an offer to conduct a study. Companies planning to conduct studies in 2024 should also notify the ministries by the same deadline.

A 'default candidate substance' refers to a general chemical substance for which the government ministries lack sufficient hazard data to carry out a screening assessment for its classification as a priority assessment chemical (PAC).

The three ministries have requested the following hazard information on the substance alpha-(2-ethylhexanoyl)-omega-[(2-ethylhexanoyl)oxy]poly(oxyethylene) (CAS no: 9004-93-7):

•  Algae growth inhibition test
•  Daphnia magna acute swimming inhibition test
•  Fish acute toxicity test

 If the collected information is found to be insufficient or the obtained data is deemed unreliable for the screening assessment, the ministries will classify the substance under the default hazard class, with hazard class 1 for ecological effects and hazard class 2 for human health effects.

Subsequently, a joint ministerial council will assess the hazard and toxicity of the substance and use this information to determine whether it should be officially designated as a priority assessment chemical. This thorough evaluation process is essential to protect both the environment and public health by ensuring proper attention and scrutiny for potentially hazardous substances.

The full Japanese text of the Ministerial Notice which includes guidelines for submitting hazard information and conducting studies can be found here.