China REACH Takes Effect for New Chemicals


China’s new Measures on Environmental Management Registration of New Chemical Substances went into effect earlier this year and have an aim to streamline the registration process for new chemicals going into the country.

Passed by China’s Ministry of Ecology and Environment last spring, the new measures, known as China REACH, are the second amendment passed since the regulation’s adoption in 2003.

About China REACH

The new measures reduced requirements for some new chemical substances; exemptions are applicable most notably to the fertilizer industry. However, now, new substances are subject to three types of registrations and are determined primarily by the annual tonnage of the chemical.

The registrations types are as follows.

Regular Registration – New substances with annual volume that exceeds 10 tons. Submitted materials should include the application form, physicochemical, toxicological and ecotoxicological test reports, an environmental risk assessment report and a commitment letter on the implementation or transmission of environmental risk control measures.

Simplified Registration – New substances with annual volumes above one ton but less than 10 tons. Submitted materials should include the application form, the physicochemical properties and ecotoxicological study reports, and a commitment letter on the implementation or transmission of environmental risk control measures. Toxicological data is no longer mandatory for Simple Registrations.

Filing – All substances for which the annual volume is less than one ton, as well as qualified polymers, including for which new monomers are no more than 2% and polymers of low concern. The new measures also state that registrants of Filings will only receive a notice of reception and can start activities immediately after the Filings are submitted. Previously, reception took several months.

There are other changes that impact the post-registration management of the chemicals, including:

  • The first-activity report is required for both Simplified Registrations and Regular Registrations and should be submitted within 60 days since the first manufacture or the first transfer to customers after import;
  • The annual activity report will only be mandatory for Regular Registrations, unless the authority otherwise exempts this requirement in the registration certificates (this deadline was extended from Feb. 1 to April 30);
  • The requirement to file a five-year report before a new substance is added to the IECSC no longer exists;
  • A new substance that is the subject of a Regular Registration will be automatically added to the inventory in five years since its first approval;
  • Simplified Registrations or Filings will not lead to listings in the IECSC;
  • In the case that a new substance is notified with a generic name, its chemical identity will be made public in five years since the substance is added in the IECSC; and
  • That provision also will apply to the substances currently listed in the confidential portion of IECSC, as well as those notified under MEP Order 7 and the prior SEPA Order 17.

Tagged categories: AS; Asia Pacific; Coating chemistry; Construction chemicals; Good Technical Practice; Government; Laws and litigation; Polymers; Regulations

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