Regulatory Developments

China Publishes Revised New Chemical Notification and Registration Guidance for Public Comment

July 1, 2015 PRINT

After over a year of review and revision, on June 25, 2015, the Chinese Ministry of Environmental Protection Solid Waste and Chemical Management Center (MEP-SCC) published the "Guidance for New Chemical Substance Notification and Registration (Draft)" (Guidance) for public comment. The deadline to submit comments to MEP-SCC regarding the Guidance is July 31, 2015. Comments should be submitted to MEP-SCC via e-mail (guidance@mepscc.cn). In addition, MEP-SCC will hold a meeting to explain the Guidance on the afternoon of July 9, 2015, at MEP-SCC in Beijing and participants are requested to register online. The Acta Group's (Acta®) business partner in China will attend the meeting and issue a memorandum on the meeting once it has occurred.

Background

Since "Provision on the Environmental Administration of New Chemical Substances" (Order No. 17) became effective on October 15, 2003, China has issued three supporting Guidance documents in the past 12 years: "Guidance for New Chemical Substance Notification" (Trial) was issued in December 2003; "Guidance for New Chemical Substance Notification" (1st edition) was issued in October 2004; and, with the release of revision of the Regulation (Order No. 7) on January 19, 2010, which came into effect on October 15, 2010, the corresponding "Guidance for New Chemical Substance Notification and Registration" was revised and re-issued in September 2010.

The intent of the new Guidance revision is to provide an update based on practical experiences and lessons learned since the implementation of Order No. 7. As with all documents issued by the MEP-SCC, the document is available in Chinese. We provide a brief summary of key elements in English, below.

Although the schedule for release of this Guidance revision was not stated, Acta anticipates that the revised Guidance will be issued in final soon.

What Is New?

The current guidance came into effect on October 15, 2010. The key provisions in the revised Guidance are summarized below:

  • Exempted Substances:
     
    • Enzymes (without treatment by chemical process) and fertilizers are added to the exemption list.
       
    • Articles containing a new chemical substance (NCS) that may be exposed to the environment and/or humans during use, e.g., surface coatings of articles, are not exempted.
       
  • Registration Agent, Only Representative (OR):
     
    • Overseas registrants shall still file the registration through an OR, but the overseas registrant is now the Certificate Holder, and the OR assumes the liability only if the overseas registrant cannot or will not carry out its obligations.
       
    • The OR will no longer have a registered capital requirement (the registered capita requirement for an OR is currently 3 million RMB).
       
  • Registration Hierarchy:
     
    • It clarifies that the hierarchy of registration from low to high is Scientific Record Notification → Simplified Registration → Regular Registration.
       
    • A higher hierarchy registration certificate will automatically abolish the lower hierarchy registration certificate, and thus, one registrant will have only one Certificate for one substance.
       
  • Registration Formality:
     
    • Registration documents shall be submitted electronically. Sending hardcopies of registration documents to MEP-SCC will no longer be required.
       
  • Simplified Registration:
     
    • It clarifies that if a NCS is imported into China in a quantity less than one ton per year, all of which is then exported from China, the NCS can submit a simplified registration for Export Only.
       
    • There will be no tonnage limits for polymers of simplified registration.
       
    • Special situation of simplified registration will not apply to unstable or degradable polymers or water absorbing polymers.
       
      • If a polymer is easily to degrade, decompose, or depolymerize, or if the polymer decomposes after production or usage, the polymer is not eligible for simplified registration.
         
      • Water absorbing polymers with Mn (number average molecular weight) greater than 10,000 daltons are not eligible for simplified registration, either.
         
  • Validity Period of Test Report:
     
    • If a revised test method/guideline has officially been published for five years, data gathered using the obsolete test method/guideline will not be accepted, and testing should be redone using the revised method/guideline.
       
  • Toxicology Tests:
     
    • Level 1 regular registration:
       
      • Acute dermal and acute inhalation toxicity tests can be exempted based on the NCS's physical-chemical properties and its low exposure potential; and
         
      • If any of the Ames (bacterial reverse mutation test) and in vitro chromosome aberration tests shows a positive result and the NCS has wide exposure potential, the mutagenicity tests for Level 2 are required.
         
    • Level 2 regular registration:
       
      • In addition to Ames and in vitro chromosome aberration tests, additional mutagenicity tests may be required for Level 2 and above (Table 1).
         
    • Table 1 Mutagenicity Tests for Level 2 and Above
      Condition Result Additional Tests Required
      a Bacterial reverse mutation (Ames test) - In vitro gene mutation test (mammalian?). If the in vitro gene mutation test shows a positive result, an in vivo gene mutation test (e.g., UDS) should be provided.
      In vitro chromosome aberration/micronucleus test -
      b Ames test - In vitro gene mutation test and in vivo chromosome aberration/micronucleus test. If the in vitro gene mutation test shows a positive result, an in vivo gene mutation test should be provided.
      In vitro chromosome aberration/micronucleus test +
      c Ames test + In vivo gene mutation test.
      In vitro chromosome aberration/micronucleus test -
      d Ames test + In vivo gene mutation test and in vivo chromosome aberration/micronucleus test.
      In vitro chromosome aberration/micronucleus test +

       
    • Level 3 regular registration:
       
      • Full toxicokinetics study shall be performed only if the NCS has any Globally Harmonized System of Classification and Labeling of Chemicals (GHS) health classification.
         
    • Level 4 regular registration:
       
      • Carcinogenicity study shall be performed only if the NCS has a widespread dispersive use or there is evidence of frequent or long-term human exposure, and the NCS is classified as germ cell mutagen category 2, or there is evidence from the repeated dose study(ies) that the NCS is able to induce hyperplasia and/or pre-neoplastic lesions. Otherwise, only carcinogenesis risk assessment should be provided.
         
  • Ecotoxicology Tests:
     
    • The current requirement for a fish 14-day prolonged toxicity test is removed for Level 2 regular registration.
       
    • An earthworm reproductive test shall be performed for Level 4 regular registration if the NCS has terrestrial organism acute toxicity classification.

Commentary

This revised Guidance would simplify the registration formality and adopt a weight of evidence approach for certain data requirements. The Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) approach on the carcinogenicity data requirement would, for example, be adopted. The carcinogenicity test decision for NCS manufactured and/or imported at quantities above 1,000 tons per year would be on a case-by-case basis. Human exposure and the inherent potential of the substance to induce genotoxicity and/or to induce hyperplasia and/or pre-neoplastic lesions in repeated dose toxicity studies should be evaluated. It should be noted that a daphnia reproduction test or a bioconcentration test would be conducted in China for Level 2 regular registration because the fish 14-day prolonged toxicity test would not be required.


 
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