Little Pro on 2015-12-30
The Measures for Environmental Administration of New Chemical Substances (China MEP Order 7) was issued in Jan 2010 by the Chinese Ministry of Environmental Protection (MEP) and came into force on 15 Oct 2010. This regulation is similar to EU REACH regulation and is also known as "China REACH".
Latest update: This regulation has been replaced by MEE Order 12 - The Measures for the Environmental Management Registration of New Chemical Substances issued by the Chinese Ministry of Ecology and Environment since 1 Jan 2021.
China MEP Order 7 requires that manufacturers and importers submit new substance notifications and obtain approvals from the Solid Waste and Chemical Management Centre of China MEP (MEP-SCC) prior to production or importation. A foreign exporter may appoint a local Chinese agent to submit new substance notifications.
The notification requirement not only applies to new substance on its own, in preparation or articles intended to be released, but also applies to new substances used as ingredients or intermediates for pharmaceuticals, pesticides, cosmetics, food additives and feed additives, etc.
Currently, China MEP Order 7's guidance document on new substance notification is being revised. There are some big changes with data requirements and notification procedure. The new guidance is expected to be published in the first half of 2016.
A new substance is defined as a substance other than those listed on the Inventory of Existing Chemical Substances Produced or Imported in China (IECSC). There are 45,612 substances in IECSC (updated in 2013) among which 8,486 substances do not have CAS numbers. Around 3,300 substances are listed in the confidential part of IECSC.
Read more about IECSC and how to search.
The following substances are exempt from China REACH.
*On-site isolated intermediate is regarded as non-isolated intermediate in China and thus exempt.
There are 4 types of notifications under China REACH which depend on the use and volume of a new substance: scientific research record, simplified notification ? special conditions, simplified notification ? general conditions and regular notification.
The table below shows how to determine which type of notification is applicable.
Regular Notification |
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Simplified Notification ? General Conditions |
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Simplified Notification ? Special Conditions |
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Scientific Research Record |
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For simplified notification under general conditions and regular notification, some eco-toxicology studies must be done locally in MEP-approved labs. The picture below shows which eco-toxicology studies must be conducted in China and the estimated duration of such studies in China.
Foreign companies may appoint a local Chinese agent to submit new chemical notifications on their behalf. The role of this agent is very similar to the role of "only representative" under EU REACH regulation. One big difference is that China MEP Order 7 allows traders to appoint Only Representatives while EU REACH only allows non-EU manufacturers to appoint Only Representatives.
Joint submission of new substance notification under China MEP Order 7 is possible and not mandatory. However, if several registrants notify a new substance jointly or share study reports, their manufactured or imported amount should be added to determine the right level of notification.
IECSC is not a static inventory. General new substances will be added onto IECSC 5 years since the date of the first commencement of manufacturing or importation. Whether hazardous new chemicals substances will be added onto IECSC depends on the review of technical committee. New substances that have gone through simplified notification or scientific research record cannot be added onto IECSC.
Getting a registration certificate is not the end. Certificate-holders have to fulfill post-notification obligations based on the category of management stated on the certificate.
New substances will be categorized as general new chemical substances or hazardous new chemical substances based on their hazard properties. Hazardous new chemical substances possessing persistent, bioaccumulative properties or are harmful to ecological environment and human health will be further classified as priority hazardous new chemical substances for environmental management and subject to additional post-notification requirements.
The picture below summarizes main post-notification obligations associated with different category of new substances.
Items | China REACH (MEP Order 7) | EU REACH |
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Target of Registration |
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Polymer |
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Applicant |
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Only Representative |
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Local Studies |
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Risk Assessment Report |
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Testing Proposal |
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QSAR |
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Joint Submission |
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Adding Notified New Substance to Inventory |
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Article |
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Note:There is no China SVHC list yet. However, there is Chinese version of REACH restricted substances list.
Click here to access all references and resources for China including the English translation of regulations, regulatory lists and useful links to the websites of competent authorities.
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Tags: Topics - China, REACH-like Regulation and Registration