Overview

The Measures for the Registration of Environmental Management of New Chemical Substances (Order No. 12 of the Ministry of Ecology and Environment, hereinafter referred to as the Measures) have been implemented since January 1, 2021. The New Chemical Substance Record Notification has provided important convenience for the compliance of enterprise activities due to its simple procedures, immediate receipt of receipts, and immediate activity upon receipt of receipts. Although the application process for registration is convenient, it does not mean that everything is settled once the application is completed. The competent authority for the Ministry of Ecology and Environment will organize its affiliated technical institutions for chemical substance environmental management to conduct random checks on the compliance of the Record Notification materials at irregular intervals. If the inspection determines that the Record Notification materials do not meet the requirements or are insufficient to determine whether they comply with the Record Notification conditions, the authority will send the applicant a "One-time Notice of Supplement for New Chemical Substance Record Notification", which is as follows:If a notified company receives the "One-time Notice of Supplement for New Chemical Substance Record Notification" and fails to submit the required supplementary materials without justifiable reasons for an extended period, it will trigger a "lockout" mechanism. This company will be unable to submit a new Record Notification and will receive an automatic "Rejection Notice" from the Government Service Hall when attempting to do so. This interlinked measure is a recent addition aimed at better standardizing and reminding applicants of the historical Record Notification to be supplemented. The "Rejection Notice" is as follows:Therefore, REACH24H reminds enterprises to regularly and continuously monitor the progress of completed New Chemical Substance Record Notifications. If they receive a "One-time Notice of Supplement for New Chemical Substance Record Notification", they should promptly submit the required supplementary materials according to the notice. The supplementary period is generally 5 working days. If this deadline cannot be met, an extension application should be sent to the case handler along with a reason. After the applicant submits complete, accurate, and compliant supplementary materials, the competent authority of the Ministry of Ecology and Environment will reorganize the compliance review of the Record Notification materials. In order to better assist relevant enterprises in completing the supplement of New Chemical Substance Record Notification, the following is a common supplement requirement of New Chemical Substance Record Notification and operation guide for the supplement of New Chemical Substance Record Notification combined based on our experience at REACH24H.

When the Supplementary Materials of New Chemical Substance Record Notification Are Required?

New Chemical Substance Record Notification includes two scenarios: 1) the annual production or import volume of a new chemical substance is less than 1 ton; 2) the polymer contains no more than 2% of monomers or reactants that are new chemical substances, or it belongs to low-concern polymers. Among these, the Record Notification of polymers is more complex due to stricter material requirements, making them more likely to require supplements. Common supplement requirements currently include:

1. The chemical identification information is incorrect or inconsistent, such as the name does not conform to the IUPAC or CAS naming rules, or the chemical name does not correspond to the CAS

2. The generic name for the confidential Record Notification does not meet the requirements of the guidelines for the preparation of generic name

3. The list of monomers/reactants of the polymer is incorrect

4. The GPC analysis report of molecular weight distribution of polymer is incomplete

5. The polymerization mechanism of polymer is not clear

6. The judgment material claiming that the polymer does not belong to the 5 exclusions is insufficient

How to Complete the Supplement of the New Chemical Substance Record Notification?

1. Log in to the Government Service Hall and enter the "history list of Record Notification"2. Click the [supplementation] button to modify and resubmit the required supplement3. Print the "Record Notification Application Form" into PDF document, sign and seal it, and submit it to complete the supplementIf you encounter any technical challenges during the process of completing the Record Notification supplement, REACH24H is here to assist you.