Japan Categorizes NPE as Class II Specified Chemical Substance

Update: On 5 December 2024, Japan’s MHLW, METI and MOE notified the World Trade Organization (WTO) of the adoption of the Cabinet Order designating NPE as a Class II Specified Chemical Substance. This designation will come into force on 1 April 2025.   

Original Text: 

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: 1 October 2024 

• Date of Entry into Force: 1 April 2025 

• Deadline for Comments: 19 August 2024 

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