Japan to Implement Comprehensive Ban on PFOA-related Products

Japan will implement a ban on 21 products containing perfluorooctanoic acid (PFOA) isomers, their salts and PFOA-related compounds, as announced on 26 April 2024. This significant move by the Ministry of Health, Labour and Welfare (MHLW), the Ministry of Economy, Trade and Industry (METI) and the Ministry of Environment (MOE) is a crucial step towards protecting the environment and public health.

Amendments to Chemical Substance Regulations

The proposal will amend the Order for Enforcement of the Act on the Evaluation of Chemical Substances and Regulation of their Manufacture to designate certain substances as Class I Specified Chemical Substances:

• PFOA with a branched structure and eight carbon atoms and its salts.

• PFOA-related compounds, including perfluorooctyl iodide (PFOI) and 8:2 fluorotelomer alcohol (8:2 FTOH).

• Compounds (with seven carbon atoms) containing a pentadecafluoroalkyl group directly bonded to a carbon atom and containing perfluorooctanoic acid or perfluoroalkane acid with a branched structure and eight carbon atoms as a result of a natural chemical reaction.

When a substance is designated as a Class 1 Specified Chemical Substance its manufacture, import, and use are generally prohibited in accordance with the provisions of the Cabinet Order.

Import Bans

The proposed ban will specifically prohibit the import of the following:

Transitional Measures

In order to facilitate a smooth transition, the proposal includes several measures:

• Medical Devices: The use of 8:2 FTOH for the manufacture of invasive and implantable medical devices will be allowed until 3 December 2025.

• Pharmaceutical Products: Use of PFOI for the manufacture of perfluorooctyl bromide (PFOB) allowed until 31 December 2036.

• Manufacturing Permits: Companies can apply for permits to manufacture PFOI and 8:2 FTOH before the enforcement date, effective upon approval.

• Permit the temporary use of fire extinguishers, fire extinguishing agents and fire extinguishing foam that contain PFOA isomers and salts.

Technical Standards and Environmental Protection

The proposal also stipulates technical standards for manufacturing facilities that handle PFOI and related substances. Additionally, companies will have to include environmental protection information on containers, packaging or invoices for these substances.

Consultation and Enforcement Timeline

The authorities plan to review feedback from Council members and other organizations before finalizing the draft Order for PFOA-related compounds. This review will take place after June but before the enforcement date.

Consultation Period: Ended on 25 May 2024

Public Notice Announcement: Expected in July

Enforcement Date: January 2025 for the general ban; September 2024 for PFOA with a branched structure and eight carbon atoms as a Class I Specified Chemical Substance.