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

1. Background to the revision of the Cabinet Order

At the meeting of the Conference of the Parties to the Stockholm Convention on Persistent Organic Pollutants, perfluoro alkanoic acid (limited to those with a branched structure and 8 carbon atoms) (PFOA isomers) or their salts and PFOA related compounds were decided to come under the scope of elimination. In response, the Chemical Substances Council ^(*1) held a meeting and reached the conclusion that it is appropriate to designate these substances as Class I Specified Chemical Substances ^(*2) under Article 2 (2) of the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (hereinafter referred to as the “Act”). Based on this, the Cabinet Order designates the substances as Class I Specified Chemical Substances and makes the necessary revisions to the Order for Enforcement.

*Notes:

1. The meeting was jointly held by: the Chemical Substances Investigation and Survey Committee, Committee on Safety Measures for Chemical Substances under the Pharmaceutical Affairs Council; and the Subcommittee on Evaluation of Chemical Substances, Environmental Health Committee under the Central Environment Council.
2. The list of Class I Specified Chemical Substances covers chemical substances that are low degradable, highly accumulative and have long-term toxicity to human beings or other animals at the top of the food chain. Concerning these substances, businesses are required to receive permission to manufacture and import them (both of which are prohibited in principle), are limited in how they can use them, and are prohibited from importing products designated under the Cabinet Order.

2. Summary of the Cabinet Order

(1) Designation of Class I Specified Chemical Substances (Article 1 of the Order for Enforcement of the Act)

The Cabinet Order designates the following chemical substances as Class I Specified Chemical Substances under Article 2 (2) of the Act.

1. Perfluoro alkanoic acid (limited to those with a branched structure and 8 carbon atoms) (PFOA isomers) or their salts; and
2. PFOA related compounds (perfluorooctyl iodide, 8:2 fluorotelomer alcohol, and compounds designated by Ordinance of the Ministry of Health, Labor and Welfare, Ordinance of the Ministry of Economy, Trade and Industry, and Ordinance of the Ministry of the Environment).

(2) Designation of products that businesses are not permitted to import, in which any of the Class I Specified Chemical Substances are used (Article 7 of the Order for Enforcement of the Act)

The Cabinet Order is to designate water-repellent textiles and oil-repellent textiles as the products that businesses are not permitted to import if such products contain PFOA related compounds to be designated as Class I Specified Chemical Substances.

(3) Designation of applications and the period of time in which businesses are permitted to use the Class I Specified Chemical Substances (Article 3 of the Initial Supplementary Provisions to the Order for Enforcement of the Act)

The Cabinet Order is to stipulate the applications and the period of time in which businesses are permitted to use perfluorooctyl iodide and 8:2 fluorotelomer alcohol to be designated as Class I Specified Chemical Substances.

(4) Designation of products for which standards must be met in relation to handling in which any of the Class I Specified Chemical Substances are used (Article 4 of the Initial Supplementary Provisions to the Order for Enforcement of the Act)

For the time being, the Cabinet Order is to designate fire extinguishers, fire-extinguishing agents, and fire-extinguishing foam in which perfluoro alkanoic acid (limited to those with a branched structure and 8 carbon atoms) (PFOA isomers) or their salts, or PFOA related compounds are used as products for which standards specified by the government must be met when they are handled.

3. Future schedule (tentative)

Promulgation: July 10, 2024

Enforcement: September 10, 2024 (to be enforced two months after the promulgation): This is to designate the substances in Item 2 (1) [i] above.

Enforcement: January 10, 2025 (to be enforced six months after the promulgation): This is to designate the substances in Item 2 (1) [ii] and (2) to (4) above.

Note: In addition, related transitional measures under the Supplementary Provisions of the revised Order for Enforcement will come into force on the promulgation day or at any appropriate time two months or six months after the promulgation.

Related Materials (in Japanese)

• Bill of the Cabinet Order and the reasons(PDF:87KB)
• Outline(PDF:62KB)
• Comparison of the prior and revised provisions(PDF:1,424KB)
• Referential provisions(PDF:171KB)

Division in Charge

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