On December 30, 2009, the Chinese Ministry of Environmental Protection (MEP) adopted the newly amended new chemical notification scheme “Measures on Environmental Management of New Chemical Substances” (新化学物质环境管理办法), Order 7. The new program enters into force on October 15, 2010. This memorandum provides a general overview of this critically important new program.
Background
The new regulation is intended in part to align China with other leading regulatory schemes such as the system in the United States and European Union (EU) under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). The expectation is that China will continue to evolve its new chemical program by updating/enhancing the current existing chemical lists and regulatory framework. This, however, remains to be seen, as modifications/enhancements are at the infancy of implementation.
Although the amendment offers the suggestion of a regulatory structure, the amendment lacks sufficient detail to provide meaningful guidance regarding actual implementation. Guidance documents are reportedly under development but are not anticipated to be published until sometime between April 2010 and July 2010. The MEP is expected to remain on target with an October 15, 2010, implementation date.
Scope
The new chemical notification scheme applies to “new” substances to be placed on the Chinese market and not those already listed on the Inventory of Existing Chemical Substances Manufactured or Imported in China (IECSC) list. The new notification scheme also includes provisions that new substances, such as raw materials and intermediates for pharmaceuticals, pesticides, veterinary medicine, cosmetics, and food and feed additives, must comply with the environmental management provisions as set out in the regulation. In addition, “items” (articles) that are designed to release the new chemical substance intentionally during the item’s life cycle are to be managed in accordance with the regulation.
A significant modification identified in the amendment that may be easily overlooked is the change regarding what constitutes the territorial boundaries of the People’s Republic of China. The amendment not only accounts for the customs territory of the People’s Republic of China, but now also includes bonded areas and export processing zones.
Overview of the New Chemical Notification Amendment
The amendment places a much greater emphasis on the need to assess the environmental and human health risk of registered substances, thus placing greater emphasis on risk management. At the time of notification, a risk assessment report which includes use details, exposure scenarios, environmental and health risk assessment, and risk control measures is to be submitted, along with a supporting dossier containing relevant data concerning physical/chemical properties and toxicity. Although the amendment specifies the need to include human health details within the risk assessment report, the focus of the amendment is on the impact of the chemical substance on the environment.
Substances will be categorized into three classifications: general new chemical substances; hazardous new chemical substances; and key hazardous new chemical substances for environmental management. Under the amendment, a new chemical substance will be identified as hazardous if the chemical substance shows physical, chemical, health, or environmental hazard (observed from test results), and if it reaches or exceeds the value specified in the relevant standards for the identification of hazardous characteristics and classification of chemical substances.
To assess the data requirements needed for submission, the amendment expands volume-based tiers (triggers), with the now familiar principle of “higher volume, more data.” These volume bands, in metric tons per year, are 0.1= – <1, 1= – <10, 10= – <100, 100= – <1000, and =1000. The information needed to comply per tier is discussed below.
One of the most significant changes is found in Article 16, which specifies that only a Chinese-registered entity can perform a submission and will be considered the registrant of the substance. Any non-Chinese entity will now have to rely on local agents or affiliates (Registration Agent) to perform a submission/registration. The non-Chinese company must choose its agent/affiliate carefully, as the registrant within China must not have a “bad record” of compliance with respect to any notification under the new chemical substance notification procedures. Violations remain on the record for a period of three years.
Consistent with the prior notification scheme of new chemical substance, certain ecotoxicological testing (biodegradation and acute fish toxicity) is required to be completed at an accredited Chinese testing laboratory by using species within domestic China. This testing must be completed by an MEP-approved testing laboratory within the territory of the People’s Republic of China that follows the Chinese Good Laboratory Practice (GLP) as developed by the MEP. Consistent with the prior new chemical substance scheme there remains the need to have a completed and accepted notification prior to import and/or manufacture, however, there are now four main notification types: (1) simplified notification (special); (2) simplified notification (general); and (3) regular notification, which all can be submitted individually or following the procedures outlined for joint, repeated, and serial notifications; and (4) scientific research record notification (SRRN). Each is discussed below.
Simplified Notification Special Circumstances
A simplified notification under special circumstances is applicable for substances where the new chemical substance is identified as an intermediate or only for export with annual production or import amount less than 1 ton, substances for scientific research purposes manufactured or imported at between 0.1 and 1 metric tons per annum, substances for R&D purposes for processes manufactured or imported in amounts <10 metric tons/year over a two-year period (<20 metric tons in total), and polymers, as new chemical substances, with a monomer concentration <2% or a low concern polymer. No ecotoxicity testing is required to submit this notification.
Upon submission of the simplified notification package under special circumstances to the MEP’s Chemical Registration Center (CRC-MEP), the MEP will receive a copy of the notification within 5 working days from the submission date. If the substance has been identified as non-hazardous, then the MEP will make its decision to accept or reject the notification within 15 working days. An additional 10 working days may be required for those cases that cannot be determined within 15 working days.
General Circumstances
A simplified notification under general circumstances is applicable to general chemical substances marketed at under 1 metric ton per year that do not meet the criteria for a special circumstances notification. To complete a simplified notification, a form must be completed and the testing requirements fulfilled. Testing is limited to ecotoxicological studies on Chinese organisms. Unlike the EU REACH scheme, however, the registrant can submit a copy of the test report, as opposed to completing and submitting “Robust Study Summaries.” There are advantages and disadvantages to this approach. The benefits include a reduction in work effort, cost, and notification preparation time. A key disadvantage is the fact that the data owner has now released proprietary data and information, in full, to the MEP. The information requirements needed to complete the simplified notification form, which is not yet available, remain unknown. It is anticipated that the data/information requirements will be minimal: CAS number, Chinese chemical name, chemical structure, applicant details, and related information.
For the simplified notification package under general circumstances, the technical dossier is submitted to the CRC-MEP. The CRC-MEP thereafter forwards the submission to the Review Committee (RC), which is comprised of experts. The RC has 30 working days to issue its opinion. Once the RC has issued its opinion, it will inform the MEP, which has up to 15 working days to accept or decline the notification. An additional 10 working days may be required for cases that cannot be determined within 15 working days. In total, from submission to acceptance, a Chinese simplified notification will take between 4 to 10 weeks, depending upon the type of simplified notification performed. If MEP accepts the notification, the registrant will receive a Registration Certificate, which signifies the ability to initiate manufacture or import of the notified substance.
Regular Notification
A regular notification is applicable for substances manufactured or imported at levels exceeding 1,000kg (1 metric ton) per annum. The grades for a regular notification are as follows:
- Grade 1: 1 = – < 10 metric tons per annum;
- Grade 2: 10 = – < 100 metric tons per annum;
- Grade 3: 100 = – < 1,000 metric tons per annum; and
- Grade 4: = 1,000 metric tons per annum.
Following the principle of “higher volume, more data,” a regular notification requires more data than are required for the simplified notification submission. A regular notification form must accompany the applicable registration and includes appendices supporting the classification and labelling of the substance supported by a Material Safety Data Sheet (MSDS). To date, a standard form is not yet available, but is expected to be published by MEP soon. It is expected to be comprehensive and include requirements for all data necessary to support a regular notification and then some. A risk assessment report must accompany the registration, and include information on hazard assessment, exposure estimates, risk control measures, and the registrant’s results of an environmental and human health risk assessment. Copies of all relevant study reports on the physical-chemical, toxicological, eco-toxicological and environmental properties of the substance must also be submitted. These study reports must include a quality assurance certificate and GLP certification statement. In the case of eco-toxicological studies completed within the People’ Republic of China, they must be performed in an MEP approved laboratory and under GLP conditions as defined by MEP. When eco-toxicological data are submitted using an overseas testing institution, the test data must have passed the inspection of the competent department of its home county or comply with GLP qualification requirements. Documentation supporting this fact must accompany the submission package.
Upon submission of the regular notification forms to the CRC-MEP, within 5 working days of receipt, all files will be forwarded to the RC for review. The RC will complete its review process within 60 working days. The RC will review the substance identity, the risk assessment, and the proposed classification/labelling of the substance. If the RC determines details are missing from the notification, it may delay the proceedings and request the missing data via the CRC-MEP.
The legislation does not specify the timeframe within which the registrant must provide any missing details. It is assumed, however, that the RC will request/assign a reasonable timeframe. Once the RC is satisfied with the notification package, it informs the MEP of its opinion. The MEP has up to 15 working days to accept or decline the notification. In total, from submission to acceptance, a Chinese regular notification will take approximately 16 weeks. If acceptance by the MEP is granted, the registrant will receive a Registration Certificate, permitting manufacture or import of the notified substance.
Joint, Repeated, and Serial Notifications
Under the amendment, an applicant may submit the joint, repeated, and serial notifications in four different ways: on their own (i.e., a single notification with a single applicant); as part of a joint notification; as a repeat notification; or as a serial notification. Please note that procedures for submitting an individual notification are located above in each respective section
A joint notification can be submitted if there are two or more companies applying for a notification for the same substance. All applicants must submit their notification at the same time. This is in contrast to REACH, which allows submission of a “Lead” notification with multiple smaller joint submissions. At this time, it remains unknown how other potential applicants will be identified, complicating the process considerably.
A repeat notification is more similar to the REACH joint registration process. If a notification has already been performed by one registrant, another registrant may submit a repeat notification, which includes the testing data from the original notification. It will remain the original registrant’s responsibility to negotiate any data sharing agreement(s) along with compensation with subsequent registrants wishing to submit a repeat notification. According to the amendment, this would need to be “determined discretionally.”
Finally, a serial notification enables a registrant to submit several notifications in one serial notification for substances with a similar molecular structure, same or similar use patterns, and similar testing data. This approach is similar to the principles of establishing a chemical category (or groupings) by providing sufficient justification and evidence that the substance(s) can be grouped together in a category for data evaluation purposes. The substances included within these categories can be included in a serial notification and therefore be registered within China.
Scientific Research Record Notification
A SRRN is applicable for substances manufactured or imported for scientific research purposes at amounts of <0.1 ton per annum. Typically, ecotoxicological testing is required for a regular notification and simplified notification (general circumstances).
This notification type addresses the import of a new chemical substance for the purpose of scientific research. In this case, only a SRRN form needs to be completed. The form will likely include information on the purpose of the research, i.e., new use of a substance, and an outline of the process in which this will be completed. If a registrant is submitting a SRRN for the purpose of completing ecotoxicological testing to ensure compliance for a regular or simplified notification, this will need to be stated.
Compared with the submission process and timing of the regular and simplified notifications, the SRRN submission is relatively simple and quick. Substance shipments can occur once the submission is performed. Formal approval is not provided. Upon submission, the CRC-MEP collects all record notifications and, on a monthly basis, reports them to MEP. MEP regularly updates the Chinese government website with the information.
At this time, the type and level of detail that will be published remains unknown. The amendment specifically states: “No new chemical substance without the registration certificate or without being recorded and notified shall be allowed to be used in scientific researches.”