Alert to Industry: China Releases Draft of Amended New Chemical Notification Regulations
On May 21, 2009, the Ministry of Environmental Protection (MEP) released its long-awaited draft of revised regulations for notification of new chemical substances in China (“Regulations on the Management of New Chemical Substances (Amended), Draft for Soliciting Opinions,” referred to here as the Draft Regulations). These Draft Regulations have been posted on MEP’s website in Chinese and are open for public comment until June 28, 2009.1
The New Chemical Substance Notification Guidelines, which are akin to technical implementing measures for the currently existing Regulations on the Management of New Chemical Substances, have not yet been revised. MEP anticipates that it will finalize revision of these guidelines only after completing revision of the Draft Regulations. As a result, there are a number of details associated with the Draft Regulations that may only be confirmed after the revision of the guidelines is complete.
Companies manufacturing new chemical substances in or exporting new chemical substances to China, or who wish to do so, should carefully review the Draft Regulations to determine how they may affect the company’s current or proposed operations, and determine whether they wish to comment. An English translation is available on request.
The summary below highlights certain of the key provisions of these Draft Regulations, a number of which are likely to be welcomed by industry.
Simplified Notification for Volumes Below One Tonne Per Year (Article 8(2)(1.)
The simplified notification for new chemical substances manufactured or imported at annual quantities of less than one tonne per year is one of the most notable features of the Draft Regulations. It appears to be specifically designed to respond to industry requests for a form of Low Volume Exemption (LVE) that could be used for any new chemical substance. According to the Draft Regulations, the documentation required under this filing category consists of the following: (1) the simplified filing form, and (2) an eco-toxicology test. As required under current regulations, the eco-toxicology test must be performed in China (i.e., by an approved Chinese test lab) on a Chinese test species.
The simplified low-volume filing category should allow many notifications that must now proceed as full notifications (general filings) to proceed under a more streamlined process. Notably, the Draft Regulations specify that the time for review of the filing by the expert committee is not to exceed 30 working days (Article 14).
Other Simplified Notifications (Article 8(2)(2.)
Four additional simplified filing categories are established in the Draft Regulations, and in some respects are likely to be viewed positively by industry. The documentation required for these filings includes: (1) the Simplified Filing Form, and (2) “relevant materials proving compliance with the condition(s)” of the filing category under which the application is being made.
Although the Simplified Filing Form is not set out in the Regulations, it is one of the forms MEP is specifically directed to create (Article 39). Substances notified by a simplified filing, including a low-volume filing, will not be entered on the Inventory of Existing Chemical Substances (Article 31), and thus these notifications will be specific to the registrant.
- Technological R&D: The Draft Regulations introduce welcome flexibility for new chemical substances being introduced solely for technological R&D. They raise the annual quantity eligible for this filing category from 1,000 kilograms per year, valid for one year, to quantities of more than one tonne but less than 10 tonnes per year and valid for up to (but less than) two years.
- Scientific Research: Two separate provisions are authorized for notifying new chemical substances for “scientific research.” The first provision is a simplified filing for quantities greater than 0.1 tonnes per year but less than one tonne per year.
The second provision is called a Record of Scientific Research. This filing category can be used for quantities up to 0.1 tonne per year and requires only the submittal of a Scientific Research Record Sheet for New Chemical Substances. Although not set out in the regulations, this form will be separately developed by MEP (Article 39).
- Use as Intermediate and Export Only: New chemical substances that will be produced or imported into China solely for use as an intermediate or solely for export qualify for a simplified notification if the volume produced or imported is less than one tonne per year.
- Polymers: Simplified notification is also available for new chemical substance monomers that form less than 2 percent of a polymer, and for polymers of low concern.2
New chemical substances to be manufactured or imported in an annual volume at or above one tonne per year are subject to the requirement for a General Notification. The Draft Regulations announce the principle that higher volumes will trigger greater requirements for testing and other data. The quantities that will trigger the need for additional data, and for re-registration if the registered quantity is proposed to be exceeded, are 10 tonnes, 100 tonnes, and 1000 tonnes, respectively. The additional data requirements that will be specified at each level are not set out in the Draft Regulations.
Risk Classification of New Chemical Substances
The Draft Regulations announce a “policy of prevention at the source, classified management, and follow-up control in the environmental risk management” of new chemical substances. They establish a three-tiered risk classification system for new chemical substances being notified:
(1) general chemical substances, (2) harmful (hazardous) substances, and (3) chemical substances of environmental concern based on their inherent hazardous characteristics and degrees of exposure (Article 4).
Consistent with the above policy, this risk classification and risk controls are a central aspect of the Draft Regulations, from initial review of the substance through post-registration risk controls. Thus the focus is not merely on hazard but, rather, on resultant risk and whether appropriate risk controls are available. In reviewing applications for general registration, the expert review committee is to consider not only the inherent hazard characteristics of the substance, but also the degree of exposure and environmental risk posed by the substance and the “appropriateness of the measures for controlling the environmental risks of the chemical substance” (Article 13 (1)(2)). For chemicals classified as substances of environmental concern, MEP is to approve issuance of the registration if it determines that appropriate risk control measures are available and otherwise to deny it (Article 13(1)(3)). All registration certificates issued for new chemical substances are to list not only the usage and quantity level of the substance registered but also its risk classification. Certificates for a general registration are to “clearly indicate the measures for controlling environmental risks and administration management requirements” (Article 15).
Subsequent to registration, registrants and those who use the substance in processing are expected to undertake specified risk of controls keyed to the risk classification of the substance applied during registration and specified in the registration certificate for the substance. (Articles 19–21). Finally, in evaluating post-registration information received from a registrant about “new harmful [hazardous] characteristics” or about the environmental risks of a registered substance, MEP is directed either to revise the registration certificate if MEP determines that the newly disclosed risks can be adequately controlled through risk control measures, or to revoke the registration certificate if MEP determines that appropriate risk controls are not available (Article 28).
Entry of Registered Substances on the Inventory
The Draft Regulations now specify when chemical substances that have been approved for general registration will be entered on China’s Inventory of Existing Chemical Substances. Entry onto the inventory will now occur five years after the date of first import or manufacture of these substances. However, an “early application” for listing also may be made by a registrant after three years upon submittal of “relevant materials such as records of actual activities [with the registered substance] and risk control measures.”
The Draft Regulations also call for a five-year review of existing substances, during which any chemical substances found by MEP to have been produced or imported into China prior to October 15, 2003, are also to be entered onto the inventory. This provision reflects the process that MEP established in MEP Announcement No. 12 (2007) to enable “grandfathering” of chemical substances produced or used in China prior to October 15, 2003 (the effective data of the original Regulations on the Environmental Management of New Chemical Substances).
Enforcement and Penalties
The Draft Regulations underscore the essential obligation of compliance under the new chemicals registration regime, i.e., that producers and importers must make filings for new chemical substances and obtain their registration certificates prior to production or import (Article 5). The provisions for fines and penalties in Articles 35 and 36 of the Draft Regulations now list numerous specific offenses for which MEP or the local environmental protection agency is to mandate correction, assess penalties, publically announce the violations and enter them into the record. Parties that have a record of being sanctioned for a violation of the regulations are not permitted to file for registration of a new chemical substance for a period of three years (Article 9).
The Draft Regulations represent an important development in China’s regulatory regime for new chemical substances. We look forward to assisting our clients in reviewing their impact and, if appropriate, preparing comments.
1 We note that these draft regulations are not “China REACH,” although apparently they have been so described in certain media and other reports. They are as titled an amendment to China’s current chemical notification law. They do not, for example, contain REACH type provisions for manufactured articles, nor do they establish a system for prioritized review of all existing chemical substances.
2 The Draft Regulations do not define “polymers of low concern.” The existing definition of this term appears in section 7.2 of the existing New Chemical Substance Notification Guidelines (as amended 2004), published by the Chemical Registration Center of the then State Environmental Protection Agency.