China's MEPSCC Publishes Draft Amendment to New Chemical Notification Guidelines
On June 25, 2015, the Solid Waste and Chemical Management Center of the Chinese Ministry of Environmental Protection (MEPSCC) published for public comment draft amendments to its Guidelines for Registration of New Chemical Substances ("Guidelines").[1] The current version of the Guidelines[2] was published in October 2010 and serves as the guidance document for implementation of the Provisions on the Environmental Administration of New Chemical Substances, commonly known as MEP Order 7.[3] Comments on the draft amendments must be submitted to MEPSCC by July 31, 2015. Key elements of the proposed revisions are discussed below.
1. Revised Scope, Exemptions
The draft amendment includes fertilizers as among the types of substances that are exempt from MEP Order 7, (fertilizers are subject to registration by the Chinese Ministry of Agriculture (MOA)). Enzymes, other than those that are chemically modified, are also explicitly identified naturally occurring substances that do not fall within the scope of MEP Order 7. The draft amendment also proposes a significant change to the "article" exemption, which would require that a new substance contained in an item be notified if it may result in exposure to the environment and/or humans during use. An example provided in the draft is an exterior surface coating of an item.
2. Changes to Domestic Notifier, Chinese Agent, and Certificate Holder Provisions
Under the draft amendment, a domestic notifier of a new chemical substance would no longer be required to be a legal entity registered with the Chinese Administration of Industry and Commerce (AIC). Under the proposed amendment, any AIC-registered entity would be allowed to submit a new chemical notification if it intends to manufacture or import a new chemical substance.
The current requirement that a Chinese notification agent have a minimum registered capital (RMB 3 million) also is proposed to be eliminated. Any AIC-registered legal entity, regardless of its registered capital, would be able to serve as an agent of an overseas notifier(s). The overseas notifier, however, could no longer simply issue an authorization letter to appoint its agent but would be required to execute a contract. The contract would have to explicitly state that the Chinese agent will perform all duties and obligations on behalf of the overseas notifier if the latter does not or cannot do so for any reason. Further, the Chinese agent must agree to be subject to joint liability.
The procedures for designation of the certificate holder would also be changed. The current practice is that: (1) a domestic notifier (manufacturer or importer) is designated both as the holder and notifier; and (2) an overseas notifier (exporter) is only designated as the notifier and the appointed Chinese agent holds the registration certificate. The draft amendment would designate the notifier as the certificate holder regardless of whether it is a domestic or an overseas entity.3. Test Data
The draft amendment would revise the types of toxicological test data required for Full Notifications. For instance, a notifier of a new substance for which the annual production volume falls within Tier 2 (i.e., 10-100 tons/year), or a new substance without a health hazard classification and for which the annual production volume is Tier 3 or above (i.e., 100 tons/year or more), would only be required to provide relevant toxicokinetics information but would not have to conduct a toxicokinetics study. The types of mutagenicity studies required for Tier 2 or above (i.e., 100 tons/year or more) also would be amended based on the results of the bacteria reverse mutation assay and in vitro chromosomal aberration assay. With respect to eco-toxicity information, the 14-day prolonged fish toxicity test would no longer be required for Tier 2.
One notable and significant revision is that a study would have to be re-conducted if the protocol that was used has been updated for more than 5 years. Earlier studies conducted using old protocols could only be submitted for the reference of the reviewers.
4. Modification of Risk Assessment Report
The draft amendment includes a more detailed description of the content and format of a risk assessment report required for a Full Notification. The main body of the risk assessment report would increase from seven sections to 13 sections, as follows:
1) Background;
2) Environment management classification and risk control measures;
3) Substance identity;
4) Data on properties;
5) Use;
6) Hazard classification, management category, and physical risk control;
7) Identification of PBT and vPvB substances;
8) Hazard assessment;
9) Exposure assessment;
10) Risk characterization and uncertainty analysis;
11) Conclusion of assessment;
12) References; and
13) Appendices.
The proposed amendment also requires that the hazard classification be performed based upon the new Chinese standards (i.e., "GB 30000" series), which adopt United Nations (UN) Globally Harmonized System (GHS) Rev. 4.
If you have questions, would like additional information, or would like assistance in submitting comments on the proposal (in Chinese), please do not hesitate to contact Tom Berger (Berger@khlaw.com) or Chen Hu (Hu@khlaw.com).
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[1] Available in Chinese at: http://www.mepscc.cn/tabid/75/InfoID/915/frtid/40/Default.aspx.
[2] Available in Chinese at: http://www.mep.gov.cn/gkml/hbb/bgt/201009/W020100921500388885939.pdf.
[3] Available in Chinese at: http://www.mep.gov.cn/gkml/hbb/bl/201002/t20100201_185231.htm.