CRC-MEP instruction on FCC key points for Special Case of SN

According to an informal document on FCC Key Points which has been released in this July by CRC-MEP to the concerned parties, most commonly seen non-conformities in the Special Case of SN are those related to the notifier or agent’s name, Chinese and English substance name, the corresponding generic name, expression of the registered quantities and descriptions about substance use.

The instruction has repeated a principle of generic name nomenclature set in the 2010 China REACH Guidance book that Chinese generic name must be determined based on a national recommended industry standard HJ/T 420-2008, “The guidelines for the generic name of new chemical substances”. English generic name shall be translated faithfully from the Chinese one.

Generally, the omissible information when claiming a generic name includes the position of substituted groups, the number of functional groups, the length of carbon chain and other descriptors that demonstrate some specific chemical structure, source of substance and production process, etc. And the HJ/T 420-2008 has made clear that the notifier in general can only claim confidential for two specific descriptors in its generic name. However, if the notifier would like to claim more than two omissions, he shall supply a CBI paper explaining adequate reasons, signed or stamped, suggests CRC-MEP. This paper shall be submitted along with other notification documents to CRC-MEP.

For the special attention of Chinese domestic notifiers, the July CRC-MEP instruction has illustrated, via correct and false examples, the format and use of Chinese/English punctuations, capitalization, italic form, superscript & subscript, hyphen and blank space, etc.

There is another watchable advice for cross-national companies who choose the Chinese branch to be a domestic notifier: Chinese company name only for the part of notifier’s information, no need to add English names after the Chinese company name. In contrast, Chinese company names are not accepted for non-Chinese notifiers which appoint a Chinese based agent to do the notification, even if you may have got a Chinese branch.

What is Special Case of China REACH Simplified Notification?

In China REACH, a Special Case of Simplified Notification might be the easiest job second to the Scientific Research Record, as it waives all data requirements for toxicology and eco-toxicology.

If your new chemical substance is manufactured or imported in quantities less than 1 t/a, you should register it in the form of a Simplified Notification (usually in the general case). But if your new substance meets any of the following conditions, you would need to consider the special case of SN:

(i)     It is an intermediate or for the sole purpose of exporting from China, both in quantities < 1 t/a;

(ii)    It is a polymer of low concern (LCP) with low monomer concentration (<2% w/w);

(iii)   It is for the purpose of scientific research and development in quantities of 0.1-1 (not included)t/a;

(iv)   It is for purposes of product research or process technology, in quantities <10 t/a over a 2-year period.

Notification documents you need to prepare for Special Case of SN

1)      New chemical substance simplified notification application form;

2)      Relevant documentary evidence to prove your Special Case of SN. Yet luckily no eco-toxicological test report is necessary for SN Special Case.

Notes from REACH24H

We are not convenient to post directly the informal CRC-MEP instruction document on our website. If you want to know more about the FCC or TCC (Technical Completeness Check) requirements, please feel free to contact us by info@reach24h.com.