The legislation updating the hazardous chemical registration system in China, titled as “Measures for the Administration of Hazardous Chemicals Registration” or SAWS Order 53 has already entered into force since Aug 1st, 2012. However, there might still exist confusion over the answer to the key question “Should I get my substances registered according to the SAWS Order 53?”
According to the official statement, chemical substances listed in the Catalogue of Hazardous Chemicals (also referred as “Chinese C&L Inventory”) should get registered with the National Registration Center of China (NRCC), which seems pretty straightforward. What complicates the problem for companies is that the 2002 version is currently subject to major changes, with around 3,000 more substances to be added to the revised C&L inventory, which will be released in the next few years, very likely in several batches.
The recurring delay on the final release date of the inventory could be justified by the complexity extent of the work and the number of competent authorities in coordination. Recently, the official from the NRCC-SAWS (State Administration of Work Safety), Mr. Chen Jinhe confirmed that the revised Chinese C&L Inventory will be issued in several batches in the next few years, with the first batch released next spring earliest. An “initial proposal” has been drafted and agreed upon in the NRCC, claimed by Jinhe Chen, while the final version will only be released after review by several other relevant authorities, including SAWS, MIIT, AQSIQ, etc.
Meanwhile, for those chemicals with unknown hazard properties, companies should ask approved testing institutions to perform the hazard assessment. SAWS-certified labs could only be responsible for the physico-chemical hazard identification, while the Ministry of Health is responsible for human health hazard identification. The Ministry of Environmental Protection (MEP) is responsible for environmental hazard identification. However, this official statement just invites more questions to be answered, implying more detailed work needs to be done by the responsible Chinese authorities. As what Mr. Chen has pointed out in the webinar a “guidance-like” document will be prepared to help the affected companies with the registration.
Specifically, for chemicals of unknown hazardous properties, the need-to-be-clarified details consist of:
Definition of chemicals with “unknown hazards” (what should be classified as chemicals of unknown hazardous properties);
Identification procedure and Requirements;
List of the labs certified by multi relevant authorities (Will the foreign labs be qualified?); and
Company or the authority should conduct the hazardous classification (NRCC once claimed that it will be responsible for the classification of the chemicals instead of directly adopt the company’s self-classification result.)
The above questions pertaining to how to determine whether the substances are required to be registered or not are expected to be answered in this registration guidance, which was claimed to be published sometime next year.
Another major change that might affect the classification of the substance during registration is that Chinese authority is planning to update China GHS national standards for classification and labeling criteria, to bring them in accordance with the UN GHS 4th edition. Besides the 26 national standards, 2 more will be added, the aspiration hazard (still in draft stage) and the hazard to the ozone layer. A full set of 28 national standards will be published next summer, expressed by Mr. Chen.
The good news which might relieve the nerve of some of the potential registrants is that before the registration guidance is released, the chemical substances with “unknown hazard property” are “exempted” from the registration responsibility. Nevertheless, the situation will be changed once the guidance document is issued, clarifying the concrete steps to conduct the hazard assessment.
Furthermore, the potential registrants should always get well-prepared, the time for the updated registration online platform ready for practical use might not be too long. Mr. Chen mentioned the NRCC has recently accomplished the preparation work to upgrade the online registration system and other relevant documents.
Besides, the new legislation sets more detailed submission requirements. The regulatory compliance specialist from REACH24H said, unlike the old measures, which only require companies to upload the safe data sheet and labels as part of registration, the new measures ask companies to provide more detailed information, such as classification and labelling, physico-chemical data, information of main uses, hazard properties, safety precaution measures and emergency response measures even though a hazard identification report is no longer required. Due to enhanced complexity of the revised registration form, the capacity building program will be happening nationwide by the end of November to prepare qualified personnel efficient in handling the registration work.
