There are three types of new chemical substance notification, which are general notification, simplified notification, and scientific research record notification. Among the three types, general notification has bigger notification amount, more special cases, and is an important way to make the notified substance listed in the IECSC. Thus, general notification are more demanding in dossier requirements, which, before getting approved, should undergo the process of technical review from expert committee, technical review comments forwarded to MEP, and publication on official website of MEP. In addition, post-registration supervision on general notification is more rigorous than the other two types of notification.
For the above reasons, it is of great importance to conduct preliminary evaluation on a general notification program, which means identify the inherent properties of the chemical substance, potential exposure risks based on identification of the chemical substance, data from test reports, QSAR, database and websites etc., and customize notification scheme in line with the marketing plan of clients.
The importance of preliminary evaluation on a general notification program mainly reflects in the following aspects:
1. Data gap analysis and testing items arrangement.Summarize data gap and potential testing items according to the Guideline and the available information from QSAR and testing reports etc.
2. Notification scheme matches marketing plan. Because of the great amount of general notification and exiting marketing needs of the notified chemical substance, notification amount and timetable are becoming the concerns of the enterprises, thus it is crucial to make a perfect notification scheme which matches the market demand closely.
3. Program schedule. Testing and administrative approval are the two key factors which have great influence on the program schedule. Test duration depends on not only the business capacity, but also the software and hardware conditions of a testing agency, thus, it is crucial to choose a suitable laboratory. Dossier service is an important part for notification agencies to save time for their clients, and in Beijing BoardingCard, the time limit is one month, and usually within one week, from receiving all the final test reports to submitting to MEPSCC.
4. Program costs. Only a customized and perfect notification scheme can realize real cost-saving, not simple spending less.
5. Notification certificate approved. Preliminary evaluation on a general notification is the basis of predicting inherent properties of the chemical substance, data gap analysis, testing items arrangement, making risk assessment reports and dossier preparation, which are all the necessary conditions to pass the experts review and obtain the notification certificate.
In conclusion, a thorough preliminary evaluation on general notification is the important prerequisite for the notification program to be carried out smoothly, which helps to save expenditure, time, and unnecessary post-registration management cost. Beijing BoardingCard, with rich experience in preliminary evaluation on general notification and obtaining notification certificates successfully, is willingly to support enterprises in chemical regulatory compliance.