Introduction to China REACH

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 regulation and is also known as "China REACH".

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 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.

Read more about IECSC and how to search.

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 all="" by-products="" content="" impurities="" li="" of="" or="" total="" w="" waste="">
• 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.

China New Substance Notification - Data Requirements and Estimated Duration

Regular Notification	Four levels: 1-10t/y, 10-100t/y, 100-1000t/y, 1000t/y+; Minimum data requirement increases with tonnage band; Risk assessment report required for all levels; Estimated duration: level I(1 year), level II(2 years), level III(3 years), level IV(4 years.)
Simplified Notification – General Conditions	Minimum physio-chemical data: melting point, partition coefficient n-octanol/water and water solubility; 1 of the following 3 eco-toxicology studies must be conducted in China : ready biodegradability or acute toxicity study with Chinese fish or acute toxicity test with earthworms; Estimated duration: 4-8 months;
Simplified Notification – Special Conditions	No minimum data requirement; Simplified notification form and supporting document required; Estimated duration: 2-3 months;
Scientific Research Record	Test data not required; Only application form needs to be submitted; Estimated duration: 3-10 working days.

Mandatory Eco-toxicology Studies in China

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.

Only Representative

Foreign companies may appoint a local Chinese agent to submit new chemical notifications on their behalf. China MEP Order 7 has set minimum requirement on the qualifications of a Chinese agent (for example, fixed office, minimum registered capital 3 million Yuan, etc.) 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

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 test reports, their manufactured or imported amount should be added to determine the right level of notification.

Adding Notified New Substances onto IECSC

IECSC is not a static inventory. General new substances will be added onto IECSC by government notice 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.

Post-notification Obligations

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.

- See more at: http://www.chemsafetypro.com/Topics/China/China_REACH_MEP_Order_7_New_Substance_Notification.html