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In recent years there has been a significant increase in the volume of inquiries and demands to include notified new chemical substance into the IECSC from eligible notifiers who have completed notification under SEPA Order 17(replaced by MEP Order 7 in 2010). Although earmarked as a priority task by policymakers, the formulation of a specific guidance document to standardize IECSC inclusion procedures has been a long time coming (ChemLinked news). At the start of July 2014, the procedures were finalized and the practical listing work is now underway.
According to statistics from the authority, about 474 notifications were approved under the SEPA Order 17. Most of the original notifications (about 350 notifications) are already qualified to have their substances included into the IECSC (as five years have passed since the first date of actual manufacturing or import activities).
The qualified original notifiers can now prepare relevant material according to the IECSC inclusion procedures and apply for IECSC inclusion. For the actual activities report, as stipulated it should be compiled in compliance with the Guidance Document (2010). This requirement has great influence on the substance notified under the SEPA Order 17 when it is classified as hazardous, or even as hazardous of priority environmental concern, as more information should be provided compared to chemicals classified as general new chemicals.
As stipulated in the Guidance Document (2010), for hazardous new chemical substances, the report is to detail the production, transfer, release, exposure, waste accumulation and handling/management of the substance. For hazardous new chemical substances of priority environmental concern, the outcomes of a report on environmental monitoring or environmental assessment should also be provided.
The actual activities report is a demanding part of the application process, especially under the condition that the concept of classification of administrative management categories is not adopted by the SEPA Order 17. Therefore companies intending to include their notified new chemical substance into the IECSC should additionally identify the physical hazards, health hazards and environmental hazards according to the Guidelines for Hazard Identification of New Chemical Substances (Draft, 2011). Based on this assessment, companies should undertake self-classification under the various environmental management categories, namely general, hazardous new chemical substances or new chemical substance of priority environmental concern.
However, only testing reports are qualified as data for hazard classification. Non-testing data, such as MSDS, is not eligible. The hazard classification should comply with Rules for Classification and Labeling of Chemicals (GB 30000-2013 series) and the Guidelines for Hazard Identification of New Chemical Substances.
Mr. Yingxin Gao, the Director of the SCC-MEP (the original CRC-MEP) guarantees that the original notifiers are not required to generate additional data for hazard classification. For testing endpoints, if no data is available or there is no adequate data for classification, the classification result should be “classification is not possible”. However, if additional data is available and the hazard classification is made based on other testing reports excluded from the notification dossier submitted previously under SEPA Order 17, the testing report should be attached with the inclusion application form. Based on the hazard classification, the substance’s corresponding management category will be identified. For the Classification criteria of “Chemicals’ Administrative Management Category” you can refer to ChemLinked expert article.
When the notified substance gets listed into the IECSC, it will be exempt from regulatory supervision given the fact that China currently has no management over all existing chemical substances. Even if it is hazardous or hazardous of priority environmental concern, there may be no discernable increase in regulatory requirements unless it is specifically listed in other inventories. However, the government has made clear that C-REACH is currently being drafted to regulate all existing and new chemicals in China. The plan is hugely ambitious given that most of the tasks specified in the 12th Five-Year Plan issued by the MEP in 2011 have still not even begun.
