China IECSC - Inventory of Existing Chemical Substances Produced or Imported in China (IECSC)

IECSC standards for the  Inventory of Existing Chemical Substances Produced or Imported in China (IECSC) . In Jan 2013, China MEP published the updated version of IECSC. There are 45,612 substances in IECSC (2013) among which 8,486 substances do not have CAS numbers. Any substance that is not listed on IECSC is regarded as a new substance in China and requires notification in accordance with China MEP Order 7 (China REACH).

There are 3,270 substances in the confidential section of IECSC. If a substance cannot be found in above list, you may submit a formal enquiry to MEP to check the confidential section to confirm whether your substance is a new substance. This enquiry costs approximately 100 USD per substance.

More info about China IECSC
http://www.chemsafetypro.com/Topics/China/China_IECSC_Inventory_Existing_Substances.html

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

Japan CSCL: Chemical Substances Control Law

The Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (hereinafter the "Chemical Substances Control Law" or "Japan CSCL") was firstly enacted in 1973 to prevent environmental pollution by chemical substances that pose a risk to human health or the environment. That latest amendment was made in 2009. Full implementation of amended CSCL started from 1 April 2011. 

Main Requirements of Japan CSCL 

Japan CSCL controls both new and existing substances. For new substances, a strict pre-manufacture evaluation system is implemented. For existing substances, manufacturers or importers are required to report their quantity and uses annually if the volume of manufacture (M) or importation (I) exceeds certain amount. CSCL also designates substances subject to priority risk assessment and prohibits some substances from M/I. 

New Substance Notification under Japan 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).

A new substance is defined as a chemical substance other than the following substances:

• A substance that is on the list of existing and new chemical substances (ENCS);
• Monitoring chemical substances;
• Priority assessment chemical substances;
• Class I or II specified chemical substance;

Japan ENCS consists of two parts:

• Existing chemical substances placed on Japanese market before 16 Oct 1973 (approximately 20,600 substances);
• New chemical substances that have been notified under the CSCL, determined to be "safe" and published on government Gazette((approximately 8,000 substances);

Note: Some substances are exempt from new substance notification. A new substance is also subject to notification under ISHL if it is not on ISHL list.

Read more about new substance notification in Japan.

Annual Reporting of General Chemical Substances and PACs

This is a new requirement for manufacturers and importers under amended CSCL. The main purpose of annual reporting is to provide the Japanese government with the information on the volume and uses of existing chemical substances placed on Japanese market. Based on the info received and available knowledge on chemical hazards, the Japanese government may take further regulatory actions against those existing substances by adding them onto different regulatory lists such as the list of priority assessment chemicals or the list of specified chemical substances.

More Info about Japan CSCL
http://www.chemsafetypro.com/Topics/Japan/Japan_CSCL_Chemical_Substance_Control_Law.html

Japan ISHL: Industrial Safety and Health Law

Industrial Safety and Health Law ("Japan ISHL") was firstly enacted in 1972 to ensure the safety and health of workers in workplaces. IHSL designates substances that are prohibited to manufacture or import, substances requiring permission and chemical substances requiring safety data sheets and labels. ISHL also controls new substances and requires manufacturers and importers to notify them to the Ministry of Labor and Welfare (MHLW) prior to production and importation.

New Substance Notification under Japan ISHL

Any substance that is not on ISHL list requires notification prior to manufacture or importation. ISHL list 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;

ISHL is available for search via the following link:

Note: Chemical Substance Control Law(CSCL) has its own definition of new substances and its own existing substance inventory ENCS. You should also check ENCS for your substance.

Read more about new substance notification in Japan.

ISHL and GHS

ISHL is one of the main laws for implementing GHS in Japan. The Article 57-2 of ISHL states that businesses are required to provide SDSs to their clients when transferring or providing any of the notifiable chemical substances(about 644) specified by ISHL. Even for hazardous chemicals not specified by ISHL, suppliers shall make reasonable efforts to comply with GHS requirements in Japan.

Read more about GHS in Japan.

More Info about Japan ISHL

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