Chemical Substances Control Law (CSCL) and Industrial Safety Health Law (ISHL)
CSCL is a law aimed at ensuring preventionof environmental pollution caused by those chemical substances that pose a risk of impairing human health or interferes with the inhabitation and/or growth of flora and fauna. The competent authorities are Ministry of Economy, Trade and Industry (METI), Ministry of Health, Labour and Welfare (MHLW) and Ministry of the Environment (MOE). To achieve the above-mentioned aim, there is a registration system for new substances to the competent authorities prior to their manufacture and/or importation.
(1)Low Volume Exemption (LVE): Less than 1000kg/year (From 1st of April to 31th March next year)*1 Dossier
(2)Low Volume Notification (LVN): 1 to 10 ton/fiscal year *1*2 Dossier
Bioaccumulation test (or LogPow, if appropriate)
(3)Standard notification: 10 ton or more *3 Dossier
Bioaccumulation (or LogPow, if appropriate) AMES
28days repeat oral toxicity with recovery group
Algal growth inhibition
Acute fish toxicity
*1: It is not always that each notifier can get the full limit amount, for example, in a case where the full limit amount shall be shared with all notifiers in Japan. (As of April 2017)
*2: A substance notified in this category will not be listed on the inventory.
*3: A substance notified in this category will be listed on the inventory after 5 years from the completion of notification if it is judged as white substance.
The biodegradation test is required for LVN and standard notification at first. Then the result of this determines whether or not further tests are required. The test should be performed in accordance with CSCL biodegradation test guideline that is similar to OECD301C.
If degradants/metabolites are observed, identification of them is also required under CSCL.
One of important factor is a BCF of the bioaccumulation test. If BCF would be 5000 and above, it is judged as “high-bioconcentration” and such substances shall be practically banned for manufacturing / importing anymore. If BCF would be 1000 and above and less than 5000, it is comprehensively judged based on additional bioaccumulation study.
Definition of polymer under CSCL
Polymer means a substance consisting of:
(a) Molecules characterized by the sequence of one or more types of monomers units;
(b) A simple weight majority of molecules containing at least three monomer units that are covalently bound to at least one other monomer unit or reactant;
(c) Less than a simple weight majority of molecules of the same molecular weight; and
(d) Molecules distributed over a range of molecular weighs wherein difference in the molecular weights are primarily attributable to differences in the number of monomer units.
(Source: Introduction to new chemical substances evaluation under CSCL.
Chie Fujita. Chief，Safety Assessment Division Chemical Management Center National Institute of Technology and Evaluation(NITE))
Further to this, Mn must be equal to or more than 1000.
What is PFS?
Polymer Flow Scheme (PFS) is a scheme to reduce safety test requirement for a polymer.
It is required for both standard PFS notification and Polymer of Low Concern (PLC) application. In standard PFS notification, a polymer will be listed in the inventory after 5 years from the completion of the notification. On the other hand, in Polymer of Low Concern (PLC) application, a polymer will never be listed in the inventory.
・Stability test under acid and alkali (pH 1.2, 4.0, 7.0 and 9.0)
・Solubility test for five solvents (water, n-octanol, n-heptane, Tetrahydrofuran (THF) and Dimethyl formamide (DMF))
・Relative molecular weight distribution measured by Size Exclusion Chromatography
Minimum PFS criteria are as follows (judged as not-readily degradable and not-high bioaccumulation)
・Stable in acid and alkali (no change of weight, DOC, IR and molecular weight)
・Not soluble in water/solvent
・If soluble in any, the content of Mn<1000 is less than 1%
・If soluble in any and the content of Mn<1000 is more than 1%, no information to indicate high accumulation of the content of Mn<1000.
If you want no-limit PFS notification or PLC, there are more strict criteria.
ISHL is a law aimed at ensuring the safety and health of workers in the workplace and promoting the establishment of a comfortable working environment. It stipulates the safety and health management system, measures to protect workers from danger and health disorders, regulations on machinery and dangerous goods / harmful substances, safety and health education for workers, maintenance and promotion of workers' health Measures, etc.
To achieve the above-mentioned aim, there is a registration system for new substances to Ministry of Health, Labour and Welfare (MHLW), prior to their manufacture and/or importation.
(1) Less than 100kg/year
(2)100kg or more (Listed in the inventory within 1 year after the notification)
Polymer exemption is applied to a certain type of polymer.
Both CSCL and ISHL do not have confidential inventory and CBI system.
We can provide a full support for the notification including but not limited to determining whether your substance is regarded as a new chemical substance under CSCL and ISHL of Japan, presenting possible options with expected costs and time, arrangement of safety tests to be required for each option, preparation and submission of notification documents. A partial support that you may need from these services is also available.
For any enquiries,please contact us!