We assist the notification / application for new chemical substances under Chemical Substances Control Law in Japan.
Under " Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (Chemical Substances Control Law) (Act No. 117 of 1973) ", if a chemical substance is new, it is necessary to submit a notification / application in accordance with the regulations.
Based on our deep knowledge, experience, and achievements over many years, we, Sumika Chemical Analysis Service, can provide a consistent service (one-stop service) from test arrangement to notification / submission to the authorities.
Overview of CSCL
The aim of CSCL is to prevent environmental pollution caused by chemical substances that pose a risk of harming human health and disruption of habitat or development of flora and fauna.
l Came into effect in 1973, the world’s-first law for industrial chemicals.
l Amended several times: 1986, 1999, 2003, 2009 and 2017
Scope of Notification/Confirmation
Scope of Applications Chemical substances obtained by chemical reactions of elements or compounds Excluding; • Chemicals regulated by other laws (e.g. Agro-chemicals, Fertilizers, What shall be notified/Confirmed? New chemical substances ・General Chemicals / Priority Assessment Chemicals / Class I / Class II / Monitoring Chemicals (Former Existing Chemicals) ・ Reagents, Chemicals for Research and Test Purposes ・ Natural Products, NOT obtained by artificial chemical reactions Only Confirmation be needed for; ・ Intermediates, Closed System Applications, Intended Exclusively for Export, SQP (Small Quantity Permit), LVE (Low Volume Exemption)
Foodstuffs, Food additives, Pharmaceuticals, Quasi-drugs, Medical
equipment, Cosmetics, Specified Toxic Substance, etc.)
• Articles / Waste
No Notification/Confirmation are needed for;
Steps for Notification / Confirmation
Data requirement
Major points of the amendment of 2017
On June 7, 2017, the "Draft law for partial amendment of Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (CSCL)" was promulgated.
[Points of revision]
● Expansion of the national quantity limit for new chemical substances for small quantities (≤ 1 t/y) and low volumes (≤ 10 t/y) (enforced in January 2019)
● Introduction of specified new chemical substances / specified general chemical substances (enforced in April 2018)
● Review of the operation of CSCL (test method) (started operation in April 2018)
・ Introduction of degradation test OECD TG 301F
Expanded options for test conditions that are easier to degrade
・ Introduction of feed administration method for concentration test
Expansion of test condition options for poorly water-soluble substances
Our Services
We provide comprehensive and advanced contract services.
● Many years’ experience of compliance with CSCL
● Actual performance of compliance with CSCL for various chemical substances, from inorganic and organic to polymers (Especially, unstable substances with multiple components and substances that are difficult to test such as poor water solubility)
● Familiarity with the operational status and issues of the law
● Advanced analysis technology / sample synthesis technology
・ We have the latest analytical techniques and have many accomplishments in synthesizing samples of biodegradable intermediate decomposition products.
● Cooperation with affiliated test facilities
・ We have established partnerships with excellent test facilities in Japan and overseas, and it is possible to carry out various tests that are effective not only for CSCL but also for overseas registration.
・ Highly accurate testing and evaluation using the most-advanced techniques is possible.
● Strategic planning of efficient application
・ Based on a large number of registration experience including overseas, we have know-how for dealing with issues such as efficient application strategies and toxic substance as well as public information searches and prediction methods.
・ We have overseas affiliate companies (EU, China and Korea) and have many experience in simultaneous application of multiple countries in collaboration with our affiliated companies.
Related Informations
Contact Us for Services
For inquiries and requests concerning services of analysis, measurements, products and consulting, please contact us via inquiry form.