May 4, 2020
On April 28, 2020, the names of 16 substances were published by Japan’s Ministry of Health, Labour and Welfare (MHLW) to be regulated under the Poisonous and Deleterious Substances Control Law (PDSCL). The substances are open for public comment until May 27, 2020. Once the public comment period is closed, the amendment to the Cabinet Order on the Designation of Poisonous and Deleterious Substances will designate these substances. The updated Order is expected to be published by mid-June and become effective on July 1, 2020.
Chemical suppliers have the opportunity to submit their comments; however, proposed amendments historically go into effect with little modification or revision. If you currently supply any of the proposed substances to Japan, you should start preparing for additional obligations today.
Additional obligations for each proposed substance include preparation and updating of hazard communication documents – labelling and SDS, as well as registration requirement for businesses and individuals manufacturing/importing and handling these substances. The amendment will impact not only chemical suppliers in Japan, but also foreign suppliers exporting their substances or mixtures containing these substances to Japan.
The 16 substances to be regulated as Poisonous Substances or Deleterious Substances are:
Proposed Poisonous Substances
Proposed Deleterious Substances
The proposed amendment also includes the following changes to the current list of Poisonous and Deleterious substances:
No longer designated as Deleterious Substances
|CAS Number||New Threshold|
|Lithium hydroxide monohydrate||1310-66-3||>0.5%
(Current threshold >0.3%)
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.
- 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. It is one of the most important responsibilities as a chemical supplier to notify the customer when regulatory status of your product is changed.