eBook Details
Title: Measures on the Environmental Management of New Chemical Substances
Code: Ebook02
Language: English
Price: €100
Format: Electronic Edition (Adobe PDF)
Size: 266 Kb
Pages: 22
Translated by: REACH24H Group
Date of publication: May 1st, 2010
Since the EU first began debating REACH, there has been speculation that other countries would be forced by the globalised nature of the chemicals industry to introduce similar controls.
The revised version of 'Measures on the Environmental Management of New Chemical Substances' has been dubbed 'China REACh' -MEP (Order No. 7) since it draws on many elements of REACh, particularly those concerning risk assessment, risk management and data submission. It would expand on China's existing regime for new chemical substances by increasing the volume and complexity of data that must be supplied to the authorities before import or production. The manufacture, import or use of a new chemical substance that had not been properly notified is expressly prohibited.
The revised version will, similar to the 2003 Measures, apply only to substances that are not listed on the Inventory of Existing Chemical Substances Produced or Imported in China (IECSC). There were 45,355 substances listed on IECSC (2010). A specific requirement is that an eco-toxicological test report included in the notification dossier (where required), must include test data from Chinese target organisms tested within the territory of the People's Republic of China. The use of Chinese laboratories will therefore be mandatory in most cases. Notification of new chemicals may only be carried out by a registered Chinese entity.
Although to describe the revised version of the 'Measures on the Environmental Management of New Chemical Substances' as 'China REACh' is probably to overstate the case, it does represent a significant step towards introducing a REACh-style regime in China.
It is unlikely to mark the end of China's efforts to strengthen its chemical safety regime, particularly since it is administered by the new Ministry of Environmental Protection – a powerful 'super-ministry' created in 2008 from the State Environmental Protection Administration. Regulatory trends in such an important market will no doubt be watched with interest by all chemical companies. Sufficient understanding and accurate grasp of the real-time developments of China REACh will be of great help for trading in China.
Highlights
- For Non-CN manufacturers, they can only submit the notification by their Chinese legal entity or appoint an Only Representative in China.
- Only China-generated eco-toxicological data would be acceptable for notification;
- Joint-notification available by Chinese entities only and protecting confidential data which has always been an issue in China, may be difficult.
- Penalties for non compliance are high.
- Enforcement has already begun.
Key Issues
- There are over 80,000 existing substances listed by the IS chemical inventory, the TSCA and approximately 110,000 substances were pre-registered with the ECHA under REACh. However, only 45,355 substances are listed on the inventory of existing chemical substances in China (IECSC). Many substances may be identified as new substances, especially high-tech products imported from western countries.
- The manufacturers/importers of new substances have to submit new substances notification to CRC-MEP before these substances are offered on the market and there are strict penalties imposed for non compliance.
- Many Non-Chinese chemical manufacturers are not familiar with this new regulation and it's important to know your responsibilities and duties under China REACh.
Contents of CHINA REACh (English Version)
Chapter 1 General Provisions
Article 1 [Aim]
Article 2 [Scope]
Article 3 [Classification]
Article 4 [Main systems]
Article 5 [Registration Certificate]
Article 6 [Encourage advanced technology]
Article 7 [Confidentiality]
Article 8 [Public supervision]
Chapter 2 Notification Procedure
Article 9 [Type of Notification]
Article 10 [Regular Notification]
Article 11 [Tonnage Rank of Regular Notification]
Article 12 [Basic Case of Simplified Notification]
Article 13 [Special Case of Simplified Notification]
Article 14 [Requirements of Record Notification]
Article 15 [Serial Notification, Joint Notification and Repeat Notification]
Article 16 [Qualification of Applicant]
Article 17 [Report according to the facts]
Article 18 [Publish Environmental Information]
Article 19 [Testing Agency]
Chapter 3 Registration
Article 20 [Procedure of Regular Notification]
Article 21 [Procedure of Simplified Notification]
Article 22 [Procedure of Record Notification]
Article 23 [Registration Announcement]
Article 24 [Processing Timelines]
Article 25 [Contents of Registration Certificate]
Article 26 [New Property Report and Disposal Measures]
Article 27 [Repeat Notification]
Article 28 [Information Sharing]
Chapter 4 Tracking Control
Article 29 [Pre-condition on Examination and Approval of Environment Assessment]
Article 30 [Information Communication]
Article 31 [General Risk Control Measures]
Article 32 [Prior Risk Control Measures]
Article 33 [Forbid transferring]
Article 34 [Management Requirements for Research and Development]
Article 35 [Activities Report]
Article 36 [Annual Report]
Article 37 [Document Storage]
Article 38 [Notice for Supervision]
Article 39 [Supervision and Inspection]
Article 40 [Cancellation of Registration]
Article 41 [Procedures of Supplementing Existing Chemical Substances Inventory]
Article 42 [Regular Investigation]
Chapter 5 Legal Responsibilities
Article 43 [False Notification]
Article 44 [Penalties by MEP]
Article 45 [Penalties by Local Authorities 1]
Article 46 [Penalties by local authorities 2]
Article 47 [Penalties for evaluation expert's infringement]
Article 48 [Penalties for testing organization's infringement]
Article 49 [Penalties for abuse of power]Chapter 6 Supplementary Provisions
Article 50 [Glossary]
Article 51 [Document Format]
Article 52 [Implementation Date]
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