by Yuko Howell
On April 19, 2019, in a proposed amendment to the Cabinet Order on the Designation of Poisonous and Deleterious Substances, Japan’s Ministry of Health, Labour and Welfare (MHLW) published a list of eight substances to be added to the Deleterious Substances List. The amendment is expected to become effective as early as July 1, 2019 and will impose labelling and SDS requirements as well as registration obligations for businesses and individuals producing and handling these substances. The amendment will impact not only chemical suppliers in Japan, but also those exporting the substances or mixtures containing these substances to Japan.
Chemical suppliers have opportunities to submit their comments until May 18, 2019; however, proposed amendments historically go into effect with little modification or revision. With this in mind, if you currently supply any of the new deleterious substances to Japan, you should start preparing for additional obligations today.
The eight substances to be regulated as Deleterious Substances under Japan’s Poisonous and Deleterious Substances Control Law are:
|Substance Name||CAS Number||Threshold|
|Aluminum chloride and preparations containing aluminum chloride||7446-70-0||None|
|Cyclohex-4-ene-1,2-dicarboxylic anhydride and preparations containing cyclohex-4-ene-1,2-dicarboxylic anhydride||85-43-8||None|
|Didecyl(dimethyl)ammonium chloride and preparations containing didecyl(dimethyl)ammonium chloride||173-51-5||>0.4 %|
|2-(Dimethyl)aminoethanol and preparations containing 2-(dimethyl)aminoethanol||108-01-0||>3.1%|
|Hexanoic acid and preparations containing hexanoic acid||142-62-1||>11%|
|Heptanoic acid and preparations containing heptanoic acid||111-14-8||>11%|
|Pentanoic acid and preparations containing pentanoic acid||109-52-4||>11%|
|Butylic acid and preparations containing butylic acid||107-92-6||>3%|
The proposed amendment also includes new threshold values of 6.4% and 0.3%, respectively, for 2-(Dimethylamino)ethyl methacrylate (CAS Number 2867-47-2) and Lithium hydroxide monohydrate (CAS Number 1310-66-3).
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.
Recommended Action Items:
- 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. New obligations might affect their operations, and one of the most important responsibilities as a chemical supplier is to notify the customer when the regulatory status of your product(s) is changed.
Resource (available in Japanese only):
MHLW is currently accepting public comments on the amendment until May 18, 2019 The details of the amendment and a comment submission form can be accessed via the link below:
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Japan, Poisonous and Deleterious Substance Control Law
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