On 21 June 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI) and Ministry of the Environment (MOE) notified the World Trade Organization (WTO) of the designation of NPE (polyoxyethylene nonylphenyl ether) as a Class II Specified Chemical Substance under the Act on the Regulation of Manufacture and Evaluation of Chemical Substances (hereinafter referred to as the Act).

Class II Specified Chemical Substances are substances that are specified by Cabinet Order (Order for enforcement of the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc.), and that are believed to pose a risk of causing harm to humans or damage to flora and fauna in the human living environment, and a significant amount of the substance remains in the environment over a substantially extensive area, or it is reasonably likely that such a situation will arise in the near future.

Regulatory Requirements

This designation necessitates several regulatory requirements:

1. Notification Requirement:
   • Manufacturers and importers of NPE must notify the planned quantity of NPE to be manufactured or imported, as stipulated in Article 35, paragraphs 1 and 6 of the Act.
2. Technical Guidelines:
   • The handling of NPE and NPE-added water-based cleaning agents must comply with the measures outlined in the technical guidelines, as per Article 36, paragraph 1 of the Act.
3. Labelling Requirements:
   • Containers and packaging of NPE and NPE-added water-based cleaning agents must display labels indicating compliance with the prescribed measures, in accordance with Article 37, paragraph 1 of the Act.

Objective and Rationale:
The primary objective of this designation is to protect animal and plant life, ensure public health, and protect the environment. This action reflects Japan's extensive efforts to protect the environment and ensure public health.

Proposed Dates:

• Date of Adoption: October 2024
• Date of Entry into Force: April 2025
• Deadline for Comments: 60 days from notification

Companies are encouraged to review the proposed regulations and provide feedback within the specified comment period. This proactive step is critical to ensuring that the regulations are comprehensive and effective in achieving their intended protective measures.

On 21 June 2024, Japan took a significant step in chemical safety management by releasing an updated list of new and revised Globally Harmonized System (GHS) classifications for 160 chemical substances. This update was published by the National Institute of Technology and Evaluation (NITE) on behalf of the Ministry of Health, Labour and Welfare (MHLW), the Ministry of the Environment (MOE) and the Ministry of Economy, Trade and Industry (METI).

This GHS classification was performed based on the information sources and guidance for classification and evaluation which are described in the GHS Classification Guidance for the Japanese Government etc.

Details of the Update:

• New Classifications: The update includes 48 newly classified substances such as Oxiran-2-ylmethyl neodecanoate (CAS 26761-45-5) and Cycloaliphatic epoxy resin (CAS 2386-87-0).
• Revised Classifications: It also revises the classifications for 112 existing substances, including 1,2-Dichloropropane (CAS 78-87-5) and Cellosolve acetate (CAS 111-15-9).

Comprehensive Information:

The detailed list is available in both Japanese and English. It includes the following critical information for each substance:

• Hazard Class
• Pictogram
• Signal Word
• Hazard and Precautionary Statements
• Classification Rationale
• CAS Numbers
• Reference Materials

The classifications were finalized during the fiscal year 2023, from 1 April 2023, to 31 March 2024.

Implications for Companies:

While companies are encouraged to use this updated list as a reference when preparing GHS-based labels or Safety Data Sheets (SDS), it is not mandatory. Companies may choose to use other test results and information sources to support their labels and SDS content.

Japan follows the sixth revised edition of the UN Globally Harmonized System of Classification and Labelling of Chemicals. Currently, Japan's GHS list includes a total of 3376 substances. This update reinforces Japan's commitment to chemical safety and aligns with global standards for chemical classification and labelling. Companies involved in the production, handling or use of these substances should review the new classifications to ensure compliance and safety.