by Yuko Howell
On October 31, 2018, Japan’s Ministry of Health, Labour and Welfare (MHLW) announced that it will amend the Cabinet Order on the Designation of Poisonous and Deleterious Substances and designate four new substances as deleterious substances. The amendment – which is expected to become effective as early as January 1, 2019 – will impact not only chemical suppliers of these substances in Japan, but also the suppliers exporting them to Japan.
Although three-month transitional measures will likely be given for these particular designated substances and mixtures, chemical manufacturers and suppliers of these substances are advised to start preparing now for additional obligations.
Which four substances are going to be regulated under Japan’s PDSCL Regulation?
The four substances to be regulated as Deleterious substances under Japan’s Poisonous and Deleterious Substances Control Law are:
|Dicyclohexylamine and preparations containing dicyclohexylamine||101-83-7||> 4%|
| 3-(Difluoromethyl)-1-methyl-N-[(3R)-1,1,3,- trimethyl-2,3-dihydro-1H-indane-4-yl]-1H- pyrazole-4-carboxamide
and preparations containing 3-(difluoromethyl)-1- methyl-N-[(3R)-1,1,3,-trimethyl-2,3-dihydro-1H- indane-4-yl]-1H-pyrazole-4-carboxamide
|Mercaptoacetic acid and preparations containing mercaptoacetic acid||68-11-1||>1%|
|Morpholine and preparations containing morpholine||110-91-8||>6%|
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.
[FREE WEBINAR] Japan’s PDSCL for Non-Japanese Chemical Suppliers
On December 6, 2018, UL Senior Regulatory Specialist Yuko (Asano) Howell will be hosting a FREE live webinar on Japan’s Poisonous and Deleterious Substances Control Law.
The webinar will provide an overview of PDSCL and discuss important compliance requirements. Special attention will be given to requirements that are relevant to non-Japanese chemical suppliers, and consequences of non-compliance will be addressed.
The PDSCL gets updated regularly with the addition of new poisonous and deleterious substances, so this is an essential webinar for any suppliers of toxic substances to understand the compliance implications, even if your substances are not currently listed.
Reserve your FREE spot here.
- 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.
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Japan’s Ministry of Health, Labor & Welfare is currently accepting public comments on the amendment. The details of the amendment and a comment submission form can be accessed here (available in Japanese only).
Japan, Poisonous and Deleterious Substance Control Law, PDSCL, SDS, Labelling, Supply Chain Communication, Poisonous Substances, Deleterious Substances, MLHW