Article

Japan Nominates 9 Substances as Candidates for Poisonous and Deleterious Substances

Posted on: August 21, 2018

Poisonousby Yuko Howell

On July 30, 2018, an advisory committee of the Ministry of Health, Labour, and Welfare (MHLW) published the following list of 9 substances that are to be regulated as poisonous substances or deleterious substances under the PDSCL regulation. Industry still has a means to influence the final decision.

 

 Substance name CAS No.  Committee’s decision
 Cobalt(II) oxide  1307-96-6  Poisonous
 2-Furanmethanol  98-00-0  Poisonous
 Oxiran-2-ylmethyl methacrylate  106-91-2  Deleterious
 2,6-Dimethylphenol  576-26-1  Deleterious
 3,5-Dimethylphenol  108-68-9  Deleterious
 Sodium fluoride  7681-49-4  Deleterious
 Methanesulfonic acid  75-75-2  Deleterious
 Sodium hydrosulfide  16721-80-5  Deleterious
 2-Furaldehyde  98-01-1  Poisonous or Deleterious*

*The advisory committee is to review after further toxicity data is obtained.

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.

MHLW is accepting appeals from manufacturers and suppliers challenging the decisions until the deadline of August 31, 2018. The circular notice containing the list of the 9 substances includes a form that can be used in an appeal. The form asks for the following information, and is to be either faxed or e-mailed to MHLW:

  1. Name of manufacturer or supplier
  2. Name of chemical substance
  3. Specific issues to be considered for further review
  4. Proposed cut-off
  5. Availability of current toxicity data
  6. Propose testing method(s)
  7. In case no test is planned, state whether or not any toxicity information can be provided
  8. In case no test is planned, propose a way to provide toxicity information
  9. Name of contact person
  10. Telephone number, FAX number, and/or e-mail address

Companies who submit appeals by August 31, 2018 will then have an opportunity to submit to the advisory committee any toxicity data and information that is currently available, and conduct additional testing and provide the results by July 31, 2019. If there is no submission from industry, it is anticipated that – after a public comment process – the candidate substances will be added to the PDSCL as early as July or August 2019. A provisional period will be given for certain requirements, and companies typically have three months to comply.

Continue to watch this space for information regarding developments in this situation by subscribing to our fortnightly Regulatory Round-Up Newsletter.

Next Steps

  • Consider submitting comment(s) on the substances if this amendment affects you and/or you have relevant data.
  • If substance(s) in your products would be affected by this amendment, consider proactively developing SDSs and labels and learning about related obligations.

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Useful Information

Ministry of Health, Labour and Welfare. Pharmaceutical Affairs and Food Sanitation Council, Circular Notice No. 0730-4 (30 July 2018) (Available in Japanese only)

Keywords

Japan, Poisonous and Deleterious Substance Control Law, PDSCL, SDS, Labelling, Poisonous Substances, Deleterious Substances