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  5. Cabinet Decision on the Cabinet Order for the Partial Revision of the Order for Enforcement of the Act on the Regulation of Manufacture and Evaluation of Chemical Substances

Cabinet Decision on the Cabinet Order for the Partial Revision of the Order for Enforcement of the Act on the Regulation of Manufacture and Evaluation of Chemical Substances

September 24, 2024

Joint press release with the Ministry of Health, Labor and Welfare and the Ministry of the Environment

On September 24, 2024, a Cabinet Decision was made on the Cabinet Order for the Partial Revision of the Order for Enforcement of the Act on the Regulation of Manufacture and Evaluation of Chemical Substances.
The Cabinet Order designates poly (oxyethylene)=alkyl phenyl ether (where the alkyl consists of 9 carbon atoms; hereinafter referred to as “NPE”) as a Class II Specified Chemical Substance, and it makes necessary revisions to the Order for Enforcement of the Act.

1. Background to the revision of the Cabinet Order

A joint meeting of the Ministry of Health, Labor and Welfare, the Ministry of Economy, Trade and Industry, and the Ministry of the Environment*1 held in September 2023 concluded that it is appropriate to designate NPE as a Class II Specified Chemical Substance*2 as well as to require businesses to label NPE-added water-based cleaning agents and designate the agents as a product regarding which businesses should comply with technical guidelines. In light of this, the Cabinet Order designates NPE as a new Class II Specified Chemical Substance under the Order for Enforcement of the Act on the Regulation of Manufacture and Evaluation of Chemical Substances (Cabinet Order No. 202 of 1974; hereinafter referred to as the “Order for Enforcement of the Act”), and it makes necessary revisions to the Order for Enforcement of the Act.

*Notes:
  1. The meeting was jointly held by: the Chemical Substances Investigation and Survey Committee, Committee on Safety Measures for Chemical Substances, Pharmaceutical Affairs Committee under the Pharmaceutical Affairs and Food Sanitation Council; the Safety Measures Committee of the Chemical Substances Council; and the Subcommittee on Evaluation of Chemical Substances, Environmental Health Committee under the Central Environment Council.
  2. A Class II Specified Chemical Substance is designated under the Cabinet Order as a chemical substance that is thought to pose a risk of causing damage to human health or damage to the inhabitation and/or growth of flora and fauna in the human living environment due to a considerable amount of the chemical substance remaining in the environment over a substantially extensive area or because it is likely that such a situation will arise in the near future. In response to the designation, additionally, manufacturers and importers of a Class II Specified Chemical Substance are required to submit a prior notification of planned production and import quantities, while businesses handling a Class II Specified Chemical Substance are required to label on containers, packaging, etc. accordingly. All these businesses must comply with the technical guidelines.

2. Summary of the Cabinet Order

1. Designation of a Class II Specified Chemical Substance (Article 2 of the Order for Enforcement of the Act)

The Cabinet Order designates NPE as a Class II Specified Chemical Substance under the provisions of Article 2(3) of the Act on the Regulation of Manufacture and Evaluation of Chemical Substances (Act No. 117 of 1973).

2. Designation of a product regarding which the competent ministers should publish technical guidelines on the measures to be taken by business operators handling the Class II Specified Chemical Substance (Article 9 of the Order for Enforcement of the Act)

The Cabinet Order requires business operators handling NPE and NPE-added water-based cleaning agents to take measures under the technical guidelines and to label on containers, packaging, etc..

3. Transitional measures

Other necessary transitional measures will be established.

3. Future schedule (tentative)

Promulgation:
September 27, 2024
Enforcement:
April 1, 2025

Related Materials (in Japanese)

Division in Charge

Chemical Safety Office, Chemical Management Policy Division, Industrial and Product Safety Policy Group