China's Ministry of Environmental Protection (MEP) announces today that certificates for 11 new chemical substances registered through regular notification under China New Chemical Substance Notification (China REACH) will be soon approved if no dissenting opinion is raised during the period of 30 May to 1 June. Most of these new substances are registered as hazardous ones. For certificate holders, they could expect more stringet post-registration obligations than the general type.
Depending on the actual environmental management intensity, New chemical substances registered through Regular Notification are divided in three environmental management categories: the general chemical substance; hazardous chemical substance and hazardous chemical substance of high environmental concern. According to the China MEP announcement, four of the published substances are classified as hazardous; six in the scope of hazardous chemical substance of high environmental concern; and only one dye chemical substance as the general one. Also, one alkyl ester substance has been registered through joint notification.
Earlier on 6 January this year, China MEP published two new substances that completed regular notification during 2011, both of which subject to the category of “hazardous chemical substance”. And one of them adopted joint notification.
Table of the first 11 new substances to be approved of 2012 China NCSN Regular Notification (RN)
Order | Chinese Chemical Name | Notifying Company | Notification Type | Environmental Management Category |
1 | 多氟化烷基醚 | 大金化学国际贸易（上海）有限公司 Daikin Industries International Trade (Shanghai) Ltd | RN | hazardous chemical substance of high environmental concern |
2 | 氨硫酰三卤甲基吡啶甲酸烷基酯 | 联化科技股份有限公司 Lianhe Chemical Technology Co., Ltd | RN | hazardous chemical substance of high environmental concern |
3 | 烷基-[(芳氧基氧膦基)氧基]-(羟基烷基)-氧代-氮杂二环烯羧酸(硝基芳烷基)酯 | 凯莱英生命科学技术（天津）有限公司/ 凯莱英医药化学（阜新）技术有限公司 Asymchem Laboratories, Inc (Tianjing) & Asymchem Laboratories, Inc (Fuxin) | Joint Notification | hazardous chemical substance of high environmental concern |
4 | 1-甲基-3-(三氟甲基)-1H-吡唑-4-甲酸 1-methyl-3-(trifluoromethyl)-1H-pyrazole-4-carboxylic acid CAS: 113100-53-1 | 联化科技股份有限公司 Lianhe Chemical Technology Co., Ltd | RN | hazardous chemical substance |
5 | 5-氨基-2,3-二氢-4-(2-甲基苯基)-3-氧代-1H-吡唑-1-基硫代羟甲酸(S-2-丙烯-1-基)酯 | 江苏联化科技有限公司 | RN | hazardous chemical substance |
6 | 2-氨基-5-氰基-N,3-二甲基苯甲酰胺 2-amino-5-cyano-N,3-dimethyl benzamide CAS: 890707-29-6 | 联化科技股份有限公司 Lianhe Chemical Technology Co., Ltd | RN | hazardous chemical substance |
7 | α-羟基-α-甲基-4-苯氧基苯乙酸乙酯 | 联化科技股份有限公司 Lianhe Chemical Technology Co., Ltd | RN | hazardous chemical substance of high environmental concern |
8 | (2E)-2-(2-氯甲基苯基)-3-甲氧基-2-丙烯酸甲酯 (2E)-2-(2-chloromethylphenyl)-3- methoxy-2-methyl acrylate CAS: 117428-51-0 | 上海试四化学品有限公司 Shanghai No. 4 Reagent & H.V. Chemical Co. Ltd | RN | hazardous chemical substance of high environmental concern |
9 | [(二芳基亚烷基)双(亚氨基亚烷基)]双(烷基酚) | 苏州雅本化学股份有限公司 Suzhou ABA Chemicals Co. Ltd | RN | hazardous chemical substance |
10 | 烷基-(烷基四唑基)吡唑磺酰胺 | 苏州雅本化学股份有限公司 Suzhou ABA Chemicals Co. Ltd | RN | hazardous chemical substance of high environmental concern |
11 | 染料绿 58 CAS: 128-58-5 | DNP Fine Chemicals Co.,Ltd. | RN | general chemical substance |
What is Regular Notification under the China NCSN?
China NCSN Regular Notification applies four stepwise levels of requirements for different tonnage manufactured or imported per year, starting from the lowest 1 t/a till more than 1000 t/a. The higher the tonnage, the more test data and the longer lead time. On average, the testing cycle of a regular notification could last two to three years or even longer. Companies subject to the NCSN Regular Notification shall prepare for submission of three main notification documents:
New chemical substance regular notification application form;
Risk assessment report of the notified new chemical substance; and
Testing reports of the corresponding physical-chemical properties, toxicology and eco-toxicology as well as other relevant testing documents and credentials of the testing institutions.
Companies need also to be aware that the eco-toxicological test report must be based on testing data acquired via a Chinese based laboratory and by using Chinese tested organisms.
Post-registration (/notification) obligations for the notifying companies
Companies who have completed regular notifications and received the registration certificates should notice several timelines concerned with their substances listing into IECSC. A new general substance registered under Regular Notification will be listed into the IECSC in 5 or above years since the first date of its manufacturing or import.
A new hazardous substance or substance with high environmental concern registered under regular notification is required to report CRC-MEP its actual activity submitted by the registration certificate holder within not less than 6 months before the end of the 5th year as of its first date of manufacturing or import. After that, a review evaluation on the substance hazard information will be conducted at the expert committee. At last, it is up to the MEP to incorporate the substance into IECSC based on the result agreed at the evaluation committee.
Chapter IV of MEP Order 7 (Measures for the Environmental Management of New Chemical Substance Notification 2010) explicates detailed post-notification obligations for the registration certificate holder. For new hazardous chemical substances, multiple obligations are typical of duties in hazard communication and hazard track control, such as proper fulfillment of the risk control measures indicated in the certificate, first-time activity report compilation, newly arising hazard reporting, hazard chemical substance registration in line with State Council Decree 591, next year activity plan, and the manufacturing/importing/use flow direction of the registered substance.
For more technical and regulatory keynotes of China NCSN compliance, please enter our Expert article.
