China’s Ministry of Environmental Protection (China MEP) yesterday published two statistic diagrams for the registered new chemical substances between January and June, 2012. During the first half 2012, nine registrant companies now are formally granted the registration certificate for 13 substances, in the type of new substance Regular Notification, following a MEP demonstration announcement three months ago; and in total 1,474 substances are announced registered in the type of new substance Simplified Notification (SN).
Among the 13 new substances that have been registered by Regular Notification, 2 are submitted through joint notification; 6 identified as new hazardous substances; 6 as new hazardous substances of high environmental concern; 1 as new general substance. This batch release has added two more new substances in addition to the 11 substances demonstrated by MEP on May 30, 2012 (see Chemlinked news on May 30). The two new ones are shown as below:
Nr | Chinese name | Notifying company | Notification type | Environmental management category |
1 | (取代的苯基)偶氮取代的碳多环酸金属盐 | 天津东洋油墨有限公司 | Regular Notification | new hazardous substances |
2 | (羟基烷基)-二氧代-氮杂二环烷羧酸(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 | Joint Notification | new hazardous substances |
In the regard of simplified notifications (SN), over 70%, that’s 1047 substances, are registered in a sub-category called “polymers with low monomer concentration”, P (M< 2%) in short, under the Special Case of SN. Ratio ranking of the other six types are respectively, the General Case of SN (198 substances; 13.43%); polymers of low concern (LCPs) (128; 8.68%); product research or process technology (<10 t/a over a 2-year period) (3.32%); only for exports (<1 t/a) (24; 1.63%); for scientific research and development (0.1-1 t/a) (15; 1.02%); and intermediates (<1 t/a) (13; 0.88%).
Type of Simplified Notification
Special case
1) intermediates (and manufactured/imported in quantities < 1 tonne per annum) (“Intermediate”);
2) only for the purpose of exporting from China, in quantities < 1 tonne per annum (“Only for export”);
3) for the purpose of scientific research and development, in quantities of 0.1-1 tonne (not included) per annum (“SR&D”);
4) polymers with low monomer concentration (<2 % w/w) (“P(M<2%)”);
5) polymers of low concern (“LCPs”);
6) for the purpose of product research or process technology,<10 tonnes per annum and over a 2-year period (“PROPT”);
General case
7) General case (or basic case)
Simplified notification statistics from 2011 till July 2012
SN type | First half 2011 | Later half 2011 | Full 2011 | First half 2012 |
P(M<2%) | 1308 | 2375 | 3683 | 1047 |
General case | - | 131 | 131 | 198 |
LCPs | 134 | 282 | 416 | 128 |
PROPT | 54 | 96 | 150 | 49 |
Only for export | 6 | 42 | 48 | 24 |
SR&D | 38 | 41 | 79 | 15 |
Intermediates | 30 | 30 | 60 | 13 |
In total | 1570 | 2997 | 4567 | 1474 |
Under the system of China’s new substance notification, manufacturers and importers when their product (substance) output reach above 1 tonner per year (Regular Notification) have to submit a great deal of registration documentation including substance risk assessment and corresponding test data reports. Yet, registration requirements can be less stringent to a differing extent if the substance is in quantities of less than 1 t/a (Simplified Notification). For instance, in the General Case of SN, the only difficult part in data collection is the ecotoxicological test report; when it comes to the Special Case of SN, such as P (M<2%) and LCPs, there’s even no requirement for ecotox data. It is for that reason and current industry situation that a majority of the registered new substances are fallen in the category of P (M<2%). Compared with the western interest in new intermediates registration, the Chinese one is anything but intent. This is because new intermediates in China do not enjoy that much exemption conditions like in REACH registration.
