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China REACH ( MEP Order 7)

By Little Pro on 2015-12-30 Views:  Update:2017-01-18

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".

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.

What is New about China REACH?

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.

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. Around 3,300 substances are listed in the confidential part of IECSC.

Read more about IECSC and how to search.

China REACH Exemptions

The following substances are exempt from China REACH.

  • 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 REACH - Types of New Substance Notification

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.

China REACH

China REACH - 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 Local Eco-toxicology Studies under China REACH

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.

China REACH Mandatory Eco-toxicology Studies

 

Only Representative under China REACH

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

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.

Adding Notified New Substances onto IECSC

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.

China REACH 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.

China REACH Post-notification Obligations

China REACH vs EU REACH

Items China REACH (MEP Order 7) EU REACH
Target of Registration
  • China: Only new substances, no volume exemption;
  • EU: All new and existing substances >=1t/y;
Polymer
  • China: Notification of polymer itself;
  • EU: Registration of monomers;
Applicant
  • China: Manufacturer, importer or only representative;
  • EU: Manufacturer, importer or only representative
Only Representative
  • China: Can be appointed by either manufacturer or trader outside of China;
  • EU: Can only be appointed by non-EU manufacturer;
Local Studies
  • China: Yes (some eco-toxicology studies);
  • EU: No;
Risk Assessment Report
  • China: Required for >=1t/y;
  • EU: Required for >=10t/y;
Testing Proposal
  • China: Not accepted;
  • EU: Accepted.
QSAR
  • China: Can only be used as supporting info;
  • EU: Accepted.
Joint Submission
  • China: Optional (Be careful with accumulated tonnage rules);
  • EU: Mandatory
Adding Notified New Substance to Inventory
  • China: Yes (5 years);
  • EU: No.
Article
  • China: Out of scope;
  • EU: Within its scope (restriction, SVHC, etc.).

Reference & Resources

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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