According to Article 41【Procedures for entering into the Inventory of Existing Chemical Substances】 of Order No. 7 of Ministry of Ecology and Environment (hereafter referred to as Order No.7), the holder of registration certificate, at the expiration of 5 years from the date of the initial production or import of the substance, shall initiate the procedures for its entering IECSC. Specifically, different management categories would have varied access to entering IECSC.
 
Under the enforcement of Order No.7, the first approval general notification was announced on Jan 1^st, 2012 while throughout this year, 51 certificates of general notification were issued by MEPSCC. Therefore, since 2017, successively began many substances to carry out procedures for entering into IECSC, but till now, none of them have been included in this inventory.  BoardingCard thinks this may not due to compliant information provided by notifiers and on the other hand, it is related to the heavy workload, changes in personnel and working procedures of government.
 
For the issues that notifers concern, BoardingCard, based on the Order No.7 and the Guidance, would like to share some experience as follows:
 
Q1: Certificate has been obtained since 2013 with the management category classified as dangerous category.  After 5 years’ activity, will the substance automatically enter the inventory?
 
A1: Ministry of Ecology and Environment shall list general new chemical substances announcement into the Inventory after five years as of the date of the Registration Certificate holder firstly producing or importing the general new chemical substance. The Registration Certificate holder of hazardous new chemical substances (including chemical substances subject to key environmental management) shall, from the date of initial production and initial import activity to six months before reaching five years, submit actual activities report from initial activity to the Registration Center (MEESCC). After receiving actual activity report, the Registration Center shall submit registration data and annual reports of new chemical substances along with actual activity information report to Ministry of Ecology and Environment. Ministry of Ecology and Environment will organize review committee to retrospectively assess actual activity information of new chemical substances and propose retrospective assessment comments.
 
 
Q2: What documents are required when conducting IESCS Listing Petition?
A2: In the recent training conference held by MEPSCC in Suzhou, dossier requirements were explained clearly as below:

No.	Basic documents required MEPSCC	Detailed materials suggested by BC
1	IECSC Listing Petition Form	Standard Petition Form can be obtained by contacting BC
2	Appendix 1 Letter of Authorization	Please provide Letter of Authorization if the signatory is not the legal representative of notifier or certificate holder
3	Appendix 2 Copy of the Registration Certificate	Please provide the e-copy of the Registration Certificate
4	Appendix 3 First Activity Report	Please provide e-copy of the signed First Activity Report
5	Appendix 4 Actual Activity Report	Please provide annual report data； BC will assist to prepare this part based on the description on below information: production, transfer, delivery and exposure situation of the new chemical substance; practice and effects of waste accumulative treatment, review of implementation on risk control measures and administrative management requirements; new hazard information; supervision, inspection and rectification; environmental impact and changes around plant area for production or processing, and other information related to actual activities of new chemical substances. For Key Hazardous Chemicals, results or report on environment monitoring or evaluation shall also be submitted.
6	Appendix 5 Identification info protection application (If Any)	Only when the notifier wants to keep the confidentiality status of the new chemical’s identity.
7	Appendix 6 Identifying info changing application (If Any)	Only when characterization information changed, such as that a CAS No. was issued to the new chemical after notification.
8	Appendix 7 Classification and Administration category	Confirm GHS classification according to the corresponding information in notification dossier and new hazard information acquired after registration.
9	Appendix 8 Risk Controllable statement	Combined with Actual Activity Situation Report, elaborate t key risk control measure, and state that the risks are under control.
10	Appendix 9 Other	Other information needs to inform the authorities.

 
Q3: If identification protection was not chosen when conducting notification, can the notifier apply for confidentiality when conducting IECSC Listing Petition?
A3: No. If identification protection was not chosen when conducting notification, the notifier cannot apply for confidentiality when conducting IECSC Listing Petition. If the notifier has already chose identification protection in notification procedure and wants to keep the confidentiality statue, Appendix 5 Identification protection application shall be applied for; otherwise, the identification protection will lose efficacy.
 
Q4: After petition, how long can the chemical substance get listed in IECSC?
A4: In current Guidance, it is specified that after receiving actual activity report, MEESCC shall submit notification dossier and annual reports of new chemical substances along with IECSC Listing Petition to the MEE. MEE shall organize review committee to retrospectively assess actual activity information and give assessment comments. MEE will list the registered chemical into IECSC based on assessment comments, and in the form of official announcement. However, given the working status in MEE, notifiers cannot expect listing work to be finished within six months.  
 
 
 
Q5: What if the substance has met the time of entry, but the notifier does not submit corresponding applicant material voluntarily?
 
A5: Notifers think differently about the entry into IECSC, considering its properties and market situations. The case that the substance has arrived the time when it is able to enter the list while the notifer prefers not is not rare. At present, the government departments do not have a specific verification process for this part of the work or have any relevant penalty clauses. Therefore, to some extent, it depends on the willingness and initiative of the notifers to finish IESCS Listing Petition.
 
 
 
Q6: Would the new substances which were notified under Order No.17 be able to enter IECSC as well?
 
A6: Yes. On March 8^th,2016 , the former Ministry of Environmental Protection issued a bulletin on Inventory of Existing Chemical Substances in China (No. 20, 2016). In this bulletin, all 31 added new substances are from those notified under Oder No. 17. How substances under Order No. 17 enter IECSC please refer to Q2. It is worth noting that NO Risk Assessment Report was required under Order No.17. Then the dossier ready for petition would ask for more professional skills.  For more details, please contact us.
 
 
 
Above is a summary of concerned issues of notifers by Beijing BoadingCard. For any details or any specific cases, you are welcome to contact us.
 
 
 
Contact:
Beijing BoardingCard Chemical Regulatory Consulting Co., Ltd.
Tel: +86-10-87671126
Email: mialiu@bjboardingcard.com
Http://www.bjboardingcard.com