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The Japanese “Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc.” is better known as the “Chemical Substance Control Law” (CSCL). Since its enactment in 1973, it has imposed strict pre-market evaluation of chemical substances to prevent environmental pollution and control chemical risks to human health, plants and animals. It has been amended 3 times in 1986, 2003 and 2009. Full implementation of amended CSCL started from April 1, 2011.
Read comprehensive introduction of Japan CSCL in ChemPedia
CSCL stipulates that potential revisions or amendments to the law should be assessed every 5 years to align legislation with industry status quo. So after the last amendment in 2011, the Japanese government held conferences in late 2016 and consulted with stakeholders on potential amendments to the current CSCL. And ongoing amendments have been conducted since Japan passed the revision to CSCL in Mar, 2017.
Live updates on the revision of Japan CSCL in Chronological order:
Mar 7, 2017 | Japanese government voted and passed the amendments to CSCL The concept “Environmental Release Amount” is introduced to solve the low volume threshold reported by the industry; “Specified General Chemicals” and “specified New Chemicals” are added as another two chemical categories in Japan to manage more stringent on those very toxic chemical substances, which under current regulation, are only regarded as “general chemicals” and regulated inconsistent with the reflection of hazards or risk level. More regulatory compliance requirements that general chemicals will be required. |
Dec 8, 2017 | Japan METI sets enforcement date for revised CSCL The revision for 2 added categories in managing chemicals will take effect from Apr 1, 2018 The revision for the “Environmental Release Amount” will take effect from Jan 1, 2019 |
Feb 7, 2018 | Japan METI details the determination of specified new chemicals The draft of the determination standards for “specified new chemicals” is on public consultation for a month. It is regulated that is a chemical meets any of the following 3 standards, then it would be regarded as a “specified new chemical”:
1. Below 3×10-4mg/L for All 3 chronic toxicity tests; or 2. Below 3×10-5mg/L for 2 chronic toxicity tests and 1 acute toxicity test; or 3. Below 3×10-5mg/L for 1 chronic toxicity test and 2 acute toxicity tests. The standard is expected to take effect along with the amendments on the same date. |
Jun 28, 2018 | Japan publishes table of Environmental Emission Factors for new chemical notification The 4 authorities jointly issued a draft of the environmental emission factors with consultation ended on Jul 27, 2018. It will be implemented on Jan 1, 2019. The [environmental emission amount= [manufacture or import amount]*[emission factor]. |
Jul 5, 2018 | Japan revises use categories under CSCL The 4 authorities jointly issued the drafts of revised use categories and emission factors for public consultation till Aug 4, 2018. The use category is set up to classify chemical substances by their usage, and an emission factor is provided for each use category. Enterprises are required to provide the precise usage of the chemicals for the annual report and the risk assessment. The values of this emission factors are not the same with the emission factors for new chemical notification as they are used for screening and risk assessments of the existing chemicals. |
Oct, 2018 | Supporting documents released for small volume substance/low volume notification as the implementation date closes. Five differences were summarized: 1. Submit certification of usage (Purchase order/ quality certification/ SDS with specific usage/ authorized confirmation for usage, etc.) 2. Electronics for chemical constitutional formula (In MOL format) 3. Numbers on official acceptance via e-application will add up to 10 times (acceptance for paper application remains as 4.) 4. Former e-certification to be repealed in electronic application (e-certification installed in the browser to clarify ….) 5. Application could be submitted via CD/DVD |
