Applying Generic Names in Your China New Substance Notification

What is a Generic Name?

Among all formats of confidentiality claiming, giving generic name for a notified new substance is a most popular form. If you would like to keep confidential the full chemical name of your notified substance during a Simplified or Regular Notification, you should submit a generic name for the substance so that the generic name will appear in all disseminated materials instead of the full chemical name. Without your written consent, the confidential information will not be published on any official announcement or registration certificate issued by the MEP. Yet the real substance information still needs to be delivered to the authority.

What is the Role of a Generic Name?

As the “stand-in” of the full chemical name, a generic name is usually used on the registration certificate of Simplified Notification and Regular Notification, the MEP-issued announcements for approved Simplified Notifications and Regular Notifications, in an attempt to protect CBI. You may also apply confidential claiming during a Scientific Research Record Notification (SRRN) but there is no need to submit a generic name as new substances submitted through the SRRN will not be granted any registration certificate and the MEP’s approval announcements regarding SRRN do not present a full chemical name or any generic names.

Requirements of Applying the Generic Name

Before August 2011, the actual application of generic name in China’s new substance notification could be described as “chaos” because there had been no clear official guidance released on this at that time, and the industry had insufficient knowledge of substance identification. One company registrant even adopted a single generic name, as “polymer resin”, for different notified new substances.

To solve this problem, the Chemical Registration Centre of the Ministry of Environmental Protection (CRC-MEP) finally published on August 23, 2011, a normative document calling the industry to act in compliance of specific technical requirements for the submission of substance identification information.

The CRC-MEP notice specified that registrants should comply with a nationwide technical standard coded as HJ/T 420-2008 in order to give a generic name for a new notified substance. Incompliant notification dossiers due to non-standard generic name will be returned to the registrant for correction; sometimes, a non-standard generic name could even lead to repeated notification submission and delayed notification cycle.

Examples of Giving Generic Names

Here are two examples of giving generic names, based on Appendix A of HJ/T 420-2008.

Example I: New chemical substance with particular structure

Molecular formula: CF₃CF₂CF₂CF₂CF₂CH₂N(CH₂CH₂OH)₂

Full chemical name: 2,2,3,3,4,4,5,5,6,6,6-Undecafluoro-N,N-bis(2-ethoxyl)hexylamine

This new substance can be provided with the following generic names:

• 2,2,3,3,4,4,5,5,6,6,6-Undecahalogenatd-N,N-bis(2-ethoxyl) hexylamine or 2,2,3,3,4,4,5,5,6,6,6-Undecasubstitued-N,N-bis(2-ethoxyl)hexylamine, by making confidential the fluorine atom (one descriptor is kept secret);

• Multifluoro-N,N-bis(2-ethoxyl)hexylamine, by making confidential the number of fluorine atoms (one descriptor is kept secret);

• 2,2,3,3,4,4,5,5,6,6,6-Undecafluoro-N,N-bis(2-substitutedethyl) hexylamine, by making confidential the hydroxyl group (one descriptor is kept secret);

• Undecafluoro-N,N-bis(2-ethoxyl)hexylamine, by making confidential the hexane structure and the molecular formula finder (two descriptors are kept secret).

Example II: New chemical substance without particular structure

Molecular formula: Not applicable

Full chemical name: Fatty acids, linseed-oil, polymer with ethylene glycol, fumaric acid and maleic anhydride

This new substance can be provided with the following generic names:

• Fatty acids, linseed-oil, polymer with ethylene glycol, fumaric acid and maleic anhydride, by making confidential the linseed-oil (one descriptor is kept secret);

• Fatty acids, linseed-oil, polymer with ethylene glycol, dicarboxylic acid and maleic anhydride, by making confidential the fumaric acid (one descriptor is kept secret).

Chemlinked Advice

1. Before carrying out your Simplified or Regular Notification, it’s important to first evaluate the necessity of applying generic names. Because once you choose the path of confidentiality, it means more efforts to compile a compliant generic name but this would increase the risk that your notification dossier will fail in the first-round expert evaluation.

2. If you’ve made up your mind to give generic names, please consult professional service agencies or check up relevant technical standards such as the HJ/T 420.

3. As to the number of confidential descriptors, the CRC-MEP generally accepts no more than two descriptors. If you plan to conceal more than two descriptors in the molecular formula, you are required to submit an additional self-statement describing your confidential reasons in detail.

• This article is contributed by Martin Hu and Lizzy Liu.