On Sep 20, the three competent authorities of Japan’s Chemical Substances Control Law (CSCL), namely METI, MHLW and MOE, jointly announced the schedule (Jan ~ Dec, 2017) for new chemical substance notification under the relevant articles in CSCL:
Ø Article 3(1) – Notification pertaining to the manufacture, etc. of a new chemical substance
Ø Article 5(1) – Request pertaining to confirmation of a low volume new chemical substance
Ø Article 5(7) – Continuation of the evaluation of a low volume new chemical substance
Ø Article 7(1) – Notification concerning the manufacture, etc. of a new chemical substance by foreign manufactures
A new chemical notification under CSCL usually goes through two rounds of evaluation, including the preliminary evaluation carried out by the 3 ministries independently (deadline specified as below) and the second evaluation by the joint reviewing committee (depending on the progress of preliminary evaluation).
However, for a same new chemical already notified under CSCL, the new notifier can apply for notification directly regardless of the above mentioned procedures if he can obtain relevant proof from the previous notifier.
The schedule for material submission is shown in the following table:
| Application deadline for preliminary evaluation | Application deadline for formal evaluation of a same new chemical notified before | |
| Jan | 2016/10/13 | 2017/1/17 |
| Feb | - | 2017/2/10 |
| Mar | 2016/12/14 | 2017/3/10 |
| Apr | 2017/1/16 | 2017/4/7 |
| May | 2017/2/17 | 2017/5/12 |
| Jun | 2017/3/14 | 2017/6/9 |
| Jul | 2017/4/18 | 2017/7/14 |
| Aug | - | 2017/8/4 |
| Sep | 2017/6/6 | 2017/9/8 |
| Oct | 2017/7/19 | 2017/10/13 |
| Nov | 2017/8/17 | 2017/11/10 |
| Dec | 2017/9/8 | 2017/12/8 |
The official instruction on preparation and submission of notification materials was slightly amended on Sep 16th 2016.
Reference Links
Notice of METI, MHLW and MOE on Schedule of New Chemical Substance Notification in 2017 (in Japanese) 2016-09-20
Manual on Preparation and Submission of Materials for New Chemical Substance Notification under Chemical Substance Control Law (in Japanese) 2016-09-16
