The Measures for Environmental Administration of New Chemical Substances (MEP Order 7) was issued in Jan 2010 by China MEP and came into force on 15 Oct 2010. This regulation is similar to EU REACH and is also known as "China REACH".
MEP Order 7 requires that manufacturers and importers submit new substance notifications and obtain approvals from China MEP prior to production or importation. A foreign exporter may appoint a Chinese agent to submit 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.
Inventory of Existing Chemical Substances Produced or Imported in China (IECSC)
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.
China New Substance Notification - Exemptions
The following substances are exempt from new substance notifications under MEP Order 7.
- Chemical substances subject to other existing laws and regulations (pharmaceuticals, pesticides, cosmetics, food additives, etc.);
- Naturally occurring substances;
- Impurities (content of a single impurity <10%w/w, total content of all impurities<20%w/w), waste or by-products;
- Special categories such as glass, cement, alloys, non-isolated intermediates (*), articles.
*On-site isolated intermediate is regarded as non-isolated intermediate in China and thus exempt.
China New Substance Notification - Types of Notification
There are 4 types of notifications 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.
http://www.chemsafetypro.com/Topics/China/China_REACH_MEP_Order_7_New_Substance_Notification.html
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