The definition of a serial notification

According to the definition of serial notification of new chemical substances in Article 15 of the Measures, ‘it usually refers to the notification of two or more new chemical substances of similar molecular structure, identical or similar uses and similar testing date, which are notified together by the same notifier’.

Note:

A joint serial notification could be simply explained that ‘Joint serial notification of new chemical substances refers to the notification of a series of new chemical substances, which qualify for serial notification, and are notified by two or more notifiers simultaneously’ according to Article 15 of the Measures.

Make the idea easier to understand

if company ‘A’ has now one new substance to notify without certain data as support according to the regular requirements for data collections generated by toxicological and eco-toxicological tests, they may have an alternative rather than directly carrying out the corresponding experiments by the accredited laboratory, should the data gap be filled in by using the existent data obtained in one or more other new substances, also waiting for notification, which share the similar molecular structure, identical or similar uses, and also testing data.

In short, except the physicochemical data which each of the substances is not allowed any vacancy, one intact set of toxicological and eco-toxicological data is enough to meet the lowest submission requirement, as the example shows in the following table:

×: no necessary | √: necessary

According to the table, three new substances are to be notified with data gapsexist:

The intact toxicological data can be collected by using the Data A from Substance A, Data B from Substance B, and Data C from Substance C; the intact eco-toxicological data can be collected by using the Data A from the Substance B, Data B from Substance A or Substance C, and Data C from Substance B or Substance C. The Physicochemical Data as explained before are due to be in full existence in each of the notifying substance’s data preparation. Therefore, the data collection has met the lowest requirements of serial notification submission and can be submitted.

Serial notification may fit your needs, but if your case fit for it?

The immediate effect of completion of serial notification would be the notifier shall obtain one registration certificate for each new chemical substance. It greatly reduces the cost and time during the entire notification procedure, however, the early stated requirements in the definition must be met as prerequisites, should the serial notification proceeds.

To arrange serial notification submission, it requires company to pay keen attention to the data matching while preparing the notification dossiers. The latest incidents involving several companies who resort to serial notification to handle the responsibilities under CR, tell us the following information deserve to be acutely aware of:

1. Chinese and English name, CAS number, molecular formula, molecular weight, structural formula;

2. The information of purity and impurity;

3. Physicochemical data;

4. Information of hydrolysis product;

5. The detailed use description with Chinese territory, including the process flow diagram (a must for risk assessment);

6. Tonnage of notified substance;

7. Any attainable data of toxicological, eco-toxicological and physicochemical literature or data of none test method;

9. The status quos of these notifying new substances in other countries or their classifications;

10. The literature of toxicokinetics of the notifying new substances or the data of none-test method.

The information before mentioned are immensely important, due to various cases on serial notification submissions as concluded that the experts from the CRC-MEP would usually put more weight upon them.

For companies who have been in the forefront of producing or exporting substances recognized as new substance under China REACH, the serial notification would be a relatively ideal choice. However, the uncertainty exists when, during the expert review, no one as yet could ensure a serial notification submission would be successfully approved.

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How to know if your substance is identified as a new substance in China?

Visit the following website for instruction:

https://www.reach24h.com/en/rscc/china-chemicals-inventory-toolbox.html

About REACH24H

REACH24H is a China-based chemical regulatory consulting company, specializing in providing professional regulatory consultancy, agency and technical support for companies from around the world. Over the years since its inception, the company has established its fame in assisting over 6000 thousand companies to fulfill the obligation under the famous EU REACH, and expands its focus on critical regulatory barriers in other regions. It has now a professional team, with seasoned toxicological and eco-toxicological experts who have years’ involvement in both scientific research and regulatory affairs. Their main focus on the newly emerged chemical regulations in China, such as China Reach, China GHS, and the hazardous chemical control laws, have demonstrated itself in providing consultation for Fortune 500 global chemical giants. On the other hand, the company also maintains cutting-edge technology in regulatory IT solutions, either by developing its unique ‘RSCC’ system which serves as platform for manufacturers, importers and downstream users to effectively monitor their EU REACH documents and communication within supply chain, or by building comprehensive partnerships with the globally famous regulatory technology providers such as WERCS and ChemADVISOR.