On Chemical Regulatory Annual Conference 2017, Mr. Fukushima, the Ex-Director General of Chemical Management Center (NITE), along with Ms. Yoshida from National Institute of Technology and Evaluation (NITE), have given a full explanation on Japan New Chemical Substance Notification and Inventory.
In more than half-a-century circulation of CSCL, it has experienced four major revisions, aiming to manage and classify chemical substances in Japan. To further clarify the scope of notification to enterprises, Mr. Fukushima showed a graph illustrating the scope of the law and the judgment of new chemicals (see graph 1). According to graph 1, only substances that meet all the left-side conditions are new chemicals.
Graph 1
Despite the fact that there is not much data required for new chemical notification in CSCL, the official has been endeavored to decrease enterprises’ cost and reduce animal testing. In terms of degradation and accumulation assessment, both Qsar and Read-across (including Comparison of hydrophilicity and measured BCF) can be adopted.
Mr. Fukushima in his presentation explained exemption conditions of low, small volume and intermediate, as well as the new amendments on the calculation of the tonnage threshold regarding low volume and small volume notification. The new amendments introduce a new concept called “Environmental Release Amount”, which is calculated by the formula: [Environmental Release Amount] = [Manufacture or Import Amount] × [Release Factor]. The release factor is decided based on the specific use and application of the substance and varies among different industries.
Ms. Yoshida from National Institute of Technology and Evaluation (NITE), has further interpreted the relationships between MITI-number and CAS RN, and the methods to find MITI number. She started with the significance of MITI- number and the groupings of Existing Chemicals List. There are differences in classification rules of MITI-number and CAS RN. As a result: one MITI-number probably covers a number of substances with similar structures, meaning that one MITI-number may cover many different CAS RN; it is also possible that one CAS RN covers many MITI-number, or one MITI-number covers only a part of CAS RN. The search of MITI-number has become one of the most complicated processes in compliance.
In order to overcome this obstacle, Ms. Yoshida has given the users following suggestions and tips on the search of MITI-number: use the functional group name when it fails to use chemical names; use shorter name to cover possible chemical names (eg. "prop" for prop-2-en, 2-propene); use “Search by Category” filters of NITE-CHRIP; Hydrocarbons might be named with the generic chemical name; Polymers might be named from monomer names.
According to Ms. Yoshida, apart from the database J-check for CSCL, NITE has developed a database called CHRIP which includes Japan’s main inventories of chemical substances and public data published by the world's major economies and safety assessment organizations. Also, NITE and the authorities of ASEAN countries have collaboratively developed database AJCSD so as to help its users with their compliance in ASEAN countries.
