Chemical Substance Control Law（CSCL)
CSCL is a law aimed at ensuring prevention of 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 notification system for new substances to the competent authorities prior to their manufacture and/or importation.
A person who intends to manufacture or import a new chemical substance shall notify it to three ministries (METI, MHLW, MOE) prior to the manufacture or importation. Depending on the manufacture/import volume, there are various procedures for the new chemical notification.
| Type of Notification | Volume |
| Standard (full) notification *1 | More than 10 tons per year *2 |
| Low volume notification (LVN) | Not greater than 10 tons per year*3 |
| Small volume confirmation (Low volume exemption: LVE) |
Not greater than 1 ton per year*3 |
| Polymer of low concern | N/A |
*1: Only 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 a white substance.
*2: From 1st of April to 31st of March in the following year
*3:
Each applicant can apply for up to 10 ton/year (LVN) or 1 ton/year (LVE).
On the other hand, each usage code has each exposure factor. The authorities accumulate the value of quantity x exposure factor, and the total exposure amount in Japan per year is allowed up to 10 ton or 1btons.
For example, if Company A applies for 1 ton of a substance with an exposure factor of 0.9 and Company B also applies for 1 ton under LVE at the same time, the exposure amount in whole Japan will be 1 x 0.9 plus 1 x 0.9 = 1.8 tons.
In this case, each applicant would obtain 0.5 tons respectively.
Test requirement
Biodegradation test is required at first for low volume notification and standard (full) notification. 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 OECD 301C or OECD 301F.
If degradants/metabolites are observed, identification of them is also required under CSCL. The target of the studies subsequently required is remaining materials, meaning both parent material and degradants/metabolites.
One of important factors is a BCF of the bioaccumulation test. If the BCF would be 5000 and above, it is judged as “high bioaccumulation”and such substances shall be practically banned for manufacturing / importing anymore. If the BCF would be 1000 and above and less than 5000, it is comprehensively judged based on additional bioaccumulation test.
| Type of Notification | Data Requirement |
| Standard (full) notification * | Biodegradation test Bioaccumulation test (or LogPow, if appropriate) 28 days repeated dose toxicity study Bacterial reverse mutation assay (Ames test)Chromosome aberration test Algal growth inhibition study Daphnia acute immobilization study Acute fish toxicity studyOr PCF(Polymer Flow Scheme) |
| Low volume notification (LVN) * | Biodegradation test Bioaccumulation test (or LogPow, if appropriate)OrPCF(Polymer Flow Scheme) |
| Small volume confirmation (Low volume exemption: LVE) |
No testing data is required. |
| Polymer of low concern | PCF(Polymer Flow Scheme) |
* If the material is readily degradable under CSCL definition, no other studies are required.
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 not be listed in the inventory.
Requirements of PFS study
・Stability test under acid and alkali (pH 4.0 and 9.0)
・Solubility test for three solvents (water, 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
Or
・If soluble in any, the content of Mn<1000 is less than 1%
Or
・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.
Inventory
You can check the Japanese inventory from following link.
https://www.nite.go.jp/en/chem/chrip/chrip_search/systemTop (The link to NITE-CHRIP)
Information
https://www.nite.go.jp/en/chem/index.html (The link to Chemical Management Section of National Institute of Technology and Evaluation(NITE))
