Japan to Regulate Flupentiofenox as Deleterious Substance under PDSCL

By Yuko Howell, Regulatory Affairs Lead, Supply Chain team, UL Solutions

On January 22, 2024, Japan's Ministry of Health, Labour and Welfare (MHLW) issued a proposed update to the Cabinet Order on the Designation of Poisonous and Deleterious Substances. The proposal includes the designation of Flupentiofenox (CAS number 1472050-04-6) as a Deleterious Substance. Flupentiofenox and mixtures containing Flupentiofenox would be subject to SDS and labeling requirements under the Poisonous and Deleterious Substances Control Law (PDSCL). Manufacturers, importers, and distributors of Poisonous and Deleterious Substances also have the obligation to register this substance with the MHLW. 

According to the MHLW, its review of the LD50/LC50 values of Flupentiofenox indicated the acute toxicity level that is within the criteria for selecting Deleterious Substances.

The MHWL is accepting public comments on the proposal until February 21, 2024. The update to the Cabinet Order is expected to be finalized in the following May and become effective in early June.

The proposed amendment also includes the following changes to the list of Deleterious Substances:

• Explicit exclusion of Cyclopyranil (CAS number 1651191-47-7) from Organic cyanide compounds, which are collectively regulated as Deleterious Substances. Cyclopyranil will be no longer regulated under the PDSCL.
• Concentration cut-off change for Diazinon (CAS number 333-41-5) specifically applying to its mixture in a microcapsule, currently designated as a Deleterious Substance. The cut-off will be raised from 25% to 30%.

Japan’s PDSCL

Japan’s Poisonous and Deleterious Substances Control Law (PDSCL) designates poisonous and deleterious substances based on their acute toxicity level. The law and related regulations have legal and operational impacts on every entity in the supply chain, and in addition to manufacturers, importers, distributors, and retailers having to register with the Ministry of Health, Labour & Welfare (MHLW) and/or local governments, there are requirements for downstream users who must ensure that poisonous and deleterious substances are stored in locked storage cabinets. Having compliant safety data sheets (SDSs) and labels, ensuring proper record keeping, and following the transport standards are also necessary throughout the supply chain.

Next Steps

• Review your products and determine if any will be affected by this amendment.
• If you are manufacturing, importing, and/or selling any of the to-be-regulated substances in Japan, make sure you are registered as a Poisonous and Deleterious Substances Business Operator.
• If you are exporting any of the to-be-regulated substances to Japan, make sure your importer is registered as a Poisonous and Deleterious Substances Business Importer.
• Learn more about additional obligations and communicate them to your customers as new obligations might affect their operations as well. One of the most important responsibilities as a chemical supplier is to notify the customer when regulatory status of your product is changed.

Additional Information

Proposed amendment to the Cabinet Order on Designation of Poisonous and Deleterious Substances  (Available in Japanese only)

Public comment submission on the proposed amendment (Available in Japanese only)

Flupentiofenox (CAS Number 1472050-04-6) Information published by the MHLW (Available in Japanese only)