eBook Details
Title: New Chemical Substance Notification Guidance Document
Code: Ebook01
Language: English
Price: € 150
Format: Electronic Edition (Adobe PDF)
Pages: 53
Translated by: REACH24H Group
Released in Mandarin Chinese, there are a total of 6 chapters, including guidance on the scope of the regulation, notification types, procedures, requirements of new chemical substance notification, supplementary provisions for polymers, post-notification supervision. The aim of the document is to guide companies with new chemical substance notification and assist industry in complying with China REACh. We have translated the new guidance document into English and it is available for € 150.
Highlights
- For Non Chinese manufacturers, they must submit the notification through their Chinese legal entity or appoint an agent in China.
- There are qualification requirements for the agent.
- The data requirements for notification are greatly increased, particularly for eco-toxicology.
- Risk assessment report is required for Regular Notification.
- Supervision and inspection is stricter and will be enforced more rigourously.
Contents of Guidance for China REACh (English Translation)
1. Applicable Scope of New Chemical Substance Notification
1.1 Applicable Chemical Substances
1.2 Scope of Applicable Territories
1.3 Scope of Applicable Activities
1.4 Notifiers and Representative Agents
2. New Chemical Substance Notification Types and Submission Format
2.1 Notification Types
2.2 Special Regular Notification Submission
3. New Chemical Substance Notification Procedure
3.1 Notification Preparation
3.2 Regular Notification Procedure
3.3 Simplified Notification Procedure
3.4 Scientific Research Record Notification Procedure
3.5 Notification Withdrawal
4. New Chemical Substance Notification Material Requirements
4.1 Format Requirements of Notification Application Material
4.2 Requirements of Data Quality for Notification
4.3 Regular Notification Data Submission Requirements
4.4 Risk Assessment Report Requirements
4.5 Information Requirements for Special Regular Notification Submissions
4.6 Data Requirements for Simplified Notification
4.7 Requirements for Confidential Information
5. Special Provisions for Polymers
5.1 Naming of Polymers
5.2 Requirements for Simplified Notification of Polymers
5.3 Requirements for Regular Notification of Polymers
6. Post-registration Supervision and Management of New Chemical Substances
6.1 Post-registration communication of information
6.2 Modification of information on registration certificate
6.3 Reporting of new information
6.4 Communication of information, reporting and information storage
6.5 Acceptance of on-site supervision and inspection
6.6 Listing of registered substances in the IECSC
6.7 Cancellation and Withdrawal of Registration Certificate
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© 2010, All rights reserved. Copying of this document including electronic circulation is not permitted without consent of REACH24H Consulting Group.
