Interpretation of the Draft Revision of China’s New Chemical Management System

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MEP Order No.7
(Draft Revision)

China’s MEE published the draft revision of the Measures for the Environmental Management of New Chemical Substances (MEP Order No.7) on July 9, with public comments accepted until Aug 16, 2019. The release of the draft is another important event in the management of new chemical substances and follows shortly after the Notice of IECSC Supplementation issued by MEE (see relevant CL News) on June 21.

The key points of this draft echo and expand on the content outlined in the Regulation on Environmental Risk Assessment and Control of Chemical Substances issued by MEE on January 8, 2019, and thoroughly flesh out the mechanisms of China’s new chemical substance management scheme.

Below are the major amendments introduced in the draft revision.

Applicant & Guarantor

“The notifier” as defined within the original MEP Order No.7 has been changed into “the applicant” in the draft, and “the representative agent” has been changed into “guarantor”. The representative agent was required to assume the responsibilities and obligations of being a registration certificate holder, however the guarantor needs to only guarantee that the applicant will undertake responsibilities stipulated by the draft.

Processors can be applicants in circumstances where any pharmaceuticals, pesticides, veterinary drugs and cosmetics which are originally exempted from registration in accordance with relevant laws and regulations, are identified as new chemical substances and planned to be used in other industrial applications.

Scope of Application

• The free trade zones and other special customs supervision areas have been added into the scope of application. The draft specifies that imported goods which are temporarily stored at such special customs supervision areas and designated for export to other countries without any processing will be added into the scope of exclusion.

• Exemptions are newly offered to fertilizers.

• Exemptions are offered to new chemical substances imported or manufactured in volumes under 100kg a year for scientific research purposes.

Information Protection

The draft proposes a maximum 5-year limit, which is absent at present, with regard to how long the government would protect confidential business information of new substances.

Types of New Chemical Registration

Notes:

• Businesses do not need to conduct tests for record notification; instead, they need only to submit the known data concerning physicochemical properties, environmental health and toxicological properties and eco-toxicological properties of new chemical substances. They can engage in relevant activities immediately after submitting all materials required for record notification. Therefore, compared with requirements made by the MEP Order No.7 in force, and especially the basic case of simplified notification, the draft significantly reduces testing costs of enterprises as well as the time required for notification.  However, the draft revision does not detail the type of simplified notification (special case) which applies to substances for PPORD purpose in an annual manufacture/import volume of below 10 t for no more than two years. We assume that the details might be mistakenly omitted from the draft revision. Relevant enterprises should make comments on that, otherwise they will have to deal with that type in accordance with the requirements of simplified registration introduced by the draft revision.

• Compared with regular notification (1-10 t/y) in MEP Order No.7, the type of simplified registration introduced by the draft revision reduces the requirements on registration data by excluding toxicological data and terrestrial organism toxicity data. In addition, relevant enterprise still need to submit chronic toxicity data on aquatic environment for chemical substances that are persistent and bioaccumulative.

• The data requirements on regular registration will no longer simply set by tonnage, but focus on risk assessment and regulatory needs. Data requirements will be stratified based on hazards and exposure situations. Chronic toxicity test data is required only for new persistent or bioaccumulative substances with a risk of exposure.

Registration of Highly Hazardous New Chemical Substances: Materials Required to Prove Necessity of Application

Relevant enterprises should submit socio-economic analysis materials when applying for regular registration of PBT substances, vPvB substances, or substances with the same hazards as theirs. The materials should include an explanation on whether the new chemical substance has the same or evident advantages compared with chemical substances which are already used in its application, so as to clarify the necessity of applying for its registration.

This is a newly added requirement compared with MEP Order No.7; and the regular registration of new chemical substances with any high hazard will not be granted if the necessity of relevant activities is deemed as not acceptable.

New Specific Standards for “Registration not Granted”

Criteria for Regular Registration not Granted:

1. Chemical substances which still pose excessive risks to the environment and human health even after risk control measures are considered

2. New chemical substances with any high hazard, for which the necessity of relevant activities is deemed as not acceptable

Criteria for Simplified Registration not Granted:

1. Chemical substances which are persistent, bioaccumulative and toxic, or those with accumulative environmental risks.

Relevant enterprises will be allowed to provide more data, further assess risks and proceed with regular registration under the circumstance of simplified registration not granted. In addition, the draft specifies that applicants with unsettled environmental violations will not be granted registration approval prior to legal proceedings finishing. The time spent awaiting legal proceedings to finish will not be factored in when calculating the approval period.

Content of Registration Certificate

The certificate of regular registration should stipulate one or more environmental management requirements below for new chemical substances with any high hazard and new chemical substances are persistent and bioaccumulative (PB), persistent and toxic (PT) or bioaccumulative and toxic (BT), based on the MEP Order No.7:

• limit the emission and concentration of new chemical substances;

• implement new usage management upon being added into the IECSC;

• submit annual report;

• Other environmental management requirements.

The newly added requirements will strengthen environmental risk control. The environmental management requirements on new chemical substances with high hazards will focus on “limitation of emission and concentration”, “submission of annual report” and “implementation of new usage management upon being added into the IECSC”, etc.

Activities Report

The relevant requirements on each-activity report and five-year activity report have been deleted, and the system of first-activity report and annual report has been retained.

The deadline of submitting annual report has been changed from February 1 to April 30.

The scope of annual report submission has been changed. Only chemical substances for regular registration which are stipulated on the registration certificate to submit annual report should submit the annual report.

Procedures for Listing Registered Substances into IECSC  

As proposed, new chemical substances registered under regular registration will be added into the IECSC by the MEE five years after their registration. A registration certificate holder will no longer be required to submit the application for listing their substances into the IECSC.

The registered substances up listing into IECSC will no longer be classified as general or hazardous. New chemical substances with new usage management requirements specified in the registration certificate should be assigned new usage management requirements upon being added into the IECSC. The listing procedures will be optimized by cancelling the revaluation on the substance by the evaluation committee. 

Measures to Ensure Policy Continuity

• The draft revision will replace the original MEP Order No.7 when it comes into force.

• Regular notification certificates obtained under the current MEP Order No.7 shall continue to be valid, but they should be in line with relevant rules promulgated by the draft revision after the draft revision takes effect.

• Simplified notification (general case & special case) certificates obtained under current MEP Order No.7 are deemed as valid as the record notification receipts stipulated by the draft revision after it takes effect. Relevant enterprises should conduct record notification according to the draft revision, if any change occurs and impacts the accuracy of information specified on the original certificate.

• Applications for regular notification and simplified notification, which have been accepted but not approved before the draft revision takes effect, can still be proceeded with in line with relevant regulations of the original MEP No.7.

• The certificates for new chemical substances obtained under the normal notification of SEPA Order No.17 (precursor of MEP Order No.7) will remain effective after the draft revision takes effect, but they should be in line with relevant management rules of the draft revision.

• New chemical substances with a regular notification certificate under the current MEP Order No.7 will be added into the IECSC by the MEE five years after the first time of operation, or five years after the implementation of the draft revision; new chemical substances having finished normal notification under the SEPA Order No.17 will be added into the IECSC within 6 months after the implementation of the draft revision.

Have your say

The specific implementation details will only be clear when China finalizes the updates of China New Chemical Substances Notification Guidance. If you have any comments on the draft revision, please do not miss the deadline of August 16.

References:

1. Draft Revision

2. MEP Order No.7

3. CL News

4. newly drafted Regulation on environmental risk assessment and control of chemical substances

5. SEPA Order No.17