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Draft of the Revised Guidance for New Chemical Substance Notification in China was Published for Public Consultation

original article from CIRS

The Guidance for New Chemical Substance Notification in China (Guidance) was published in 2010 as the supplementary document for the Measures for New Chemical Substance Environmental Management (MEP Order 7). For the purpose of improving the management of the hazardous chemical substance, MEP decided to revise the Guidance to improve the notification processes and efficiency. The draft of the revised Guidance was published by MEP-SCC for public consultation. The comments shall be sent to the official email address before 31 July 2015.

There are some significant changes in the draft of the revised Guidance that enterprises should pay attention to. CIRS experts have analyzed the Guidance and compiled the following interpretations:

1. Revised contents for Oversea Notifier, Certificate Holder and Representative Agent (page 11)

Before revision: oversea notifier has to appoint a domestic representative to notify and the domestic representative who submitted the notification will be the certificate holder, who will carry all the responsibilities and obligations.

After revision: the oversea notifier will be the certificate holder but a domestic representative is also required to be appointed. Either the oversea notifier or the domestic representative will have to carry all the responsibilities and obligations.

2. Valid time period of the testing report is added (page 30)

The revised Guidance stipulates that the testing report shall be performed according to the testing methods that are currently effective. When submitting the notification, if the previous testing method has been updated and been more than 5 years, the tests shall be re-done using the updated testing methods. The previous testing report can be submitted as supplementary documents for expert review.

3. Revision for the data requirement of typical notification and notification exemption conditions (page 33-44)

Main revisions are made in the data requirement and exemption conditions of mutagenicity, repeated does study, toxicokinetics, carcinogenicity, fish 14-day toxicity study, etc. The details of the requirement changes and the influence on the enterprises will be described in another article that is compiled by CIRS experts, which will be published later.

4. More detailed requirements for risk assessment of typical notification are included (page 46)

It stipulates that enterprises, when manufacturing/importing/using new chemicals, shall know more details about the potential risks that the new chemicals will have. Relevant risk control measures shall be performed by enterprises.

The revised Guidance provides a template for Risk Assessment Report, which will improve the efficiency of the review process of the competent authorities.

5. Revision for the procedure of modification of certificate information (page 65)

The revision will simplify the review process for the modification of certificate information. The original certificate is not required to be changed after the certificate information modification, instead, a modification receipt will be sent to the certificate holder. This revision will be good for enterprises to perform new chemicals related activities more efficiently after the modification of the certificate information.

6. Revisions for the simplified notification of polymers (page 65)

There is no tonnage limit for the simplified notification of polymers, which means activities of any tonnage of the polymers can be performed after notification.

Exclusions for the simplified notification of polymers are published: 1. Unstable or degradable polymer; 2. Water-absorbing polymer.

The information mentioned above is some significant changes that enterprises shall pay attention to. The more detailed interpretation of the revisions will be analyzed and published by CIRS later. Please pay attention to our website for the updates.

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