China REACH - New Substance Notification

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.

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%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.

More Info about China REACH
http://www.chemsafetypro.com/Topics/China/China_REACH_MEP_Order_7_New_Substance_Notification.html

Japan New Substance Notification

Both Chemical Substance Control Law (CSCL) and Industrial Safety and Health Law (ISHL) require a new substance to be notified prior to its production and importation. There are many differences between notifying a new substance under CSCL and notifying a new substance under ISHL


New Substance Notification under CSCL
A person who intends to manufacture or import a new chemical substance shall notify it to three ministries at least three months prior to the manufacture or importation. The three ministries are the Ministry of Economy, Trade and Industry (METI), the Ministry of Labor and Welfare (MHLW), and the Ministry of the Environment (MOE). 

The picture below shows how to determine if a new substance requires notification under CSCL.

New Substance Notification under ISHL
ISHL requires manufacturers and importers to notify a new substance to the Ministry of Labor and Welfare (MHLW) prior to its production and importation. Any substance that is not on ISHL list will be subject to new substance notification under ISHL.

ISHL List also consists of two parts:

• Existing chemical substances under CSCL(in commerce in Japan before 1973)- approximately 20,600 substances;
• New substances notified under ISHL and published on government Gazette;

New Substance Notification - Exemptions and Data Requirements

Not all new substances require notification ISHL. The picture below shows how to determine if a substance requires notification under ISHL and which type of notification is applicable.

There are two types of notification under ISHL: standard notification and small volume notification. For standard notification, the information required is AMES study and other information such as manufacturing process, reaction formula, etc. For low volume notification(<100kg/y), no test data is required.

To find out their difference, please click the link below

http://www.chemsafetypro.com/Topics/Japan/Japan_New_Substance_Notification_CSCL_ISHL.html