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Notification of New Chemicals in Japan

There are various regulations on chemicals in Japan such as Chemical Substances Control Law, Industrial Safety and Health Law, Agricultural Chemicals Regulation Law, Food Sanitation Law, Poisonous and Deleterious Substances Control Law, etc.

For industrial chemicals, the two laws, Chemical Substances Control Law (CSCL) and Industrial Safety and Health Law (ISHL) require the notification of new chemicals.

CSCL has been amended in 2017, and the amendments already came into force. The main points in relation to the new chemical notification requirements are the calculation method of amount for Low volume notification and Low volume exemption (introduction of the concept of environmental emission volume), the new biodegradation guideline (similar to OECD 301F) and the streamline of the PFS (polymer flow scheme) test.


Chemical Substances Control Law (CSCL)

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.

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
(per notifier and across Japan *3)
Small volume confirmation
(Low volume exemption: LVE)
Not greater than 1 ton per year
(per notifier and across Japan *3)
Polymer of low concern N/A
Other confirmation:
Intermediates
N/A

*1: A substance notified in this category only will be listed on the inventory after 5 years from the completion of notification if it is judged as white substance.

*2: From 1st of April to 31st of March next year

*3: For low volume notification and small volume confirmation, there is the upper volume limit not only for a notifier but also for the total volume across Japan.
(The exemption rule for small and low volume chemicals was amended in 2017, and the total amount across Japan is calculated by sum of the environmental emission volume of all the notifiers for a same chemical substance, and not sum of the manufacture/import volume.)

The 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 material (both parent material and degradants/metabolites.

One of important factor is a BCF of the bioaccumulation test. If BCF would be 5000 and above, it is judged as “high bioaccumulation”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.

Type of Notification Data Requirement
Standard (full) notification * Biodegradation test
Bioaccumulation (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 study
Low volume notification (LVN) * Biodegradation test
Bioaccumulation (or LogPow, if appropriate)
28 days repeated dose toxicity study
Small volume confirmation
(Low volume exemption: LVE)
No testing data is required.
Polymer of low concern Polymer flow scheme
Other confirmation:
Intermediates
No testing data is required.

* Readily biodegradable substances require the biodegradation test data only.

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 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.


Industrial Safety and Health Law (ISHL)

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
Dossier
(2)100kg or more (Listed in the inventory within 1 year after the notification)
Dossier
AMES

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!