Japan ENCS: The Inventory of Existing and New Substances in Japan

The inventory of existing and new chemical substances(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);

ENCS is available for search or download from Chemical Risk Information Platform (CHRIP) via the link below.

How do I know if my substance is a new substance under CSCL in Japan?

Existing substances and notified chemical substances are assigned with METI numbers or Class reference numbers. A substance that does not have a METI number or Class reference number will be regarded as a new substance in Japan and require notification under CSCL.

It is not easy to search ENCS on CHRIP because ENCS listings are not based on CAS numbers. Each ENCS listing identified by one METI number may cover a number of similar substances. If you could not find a METI number or Class reference number for your substance on CHRIP, there are a number of options for you:

• Option 1: Download ENCS from CHRIP and check each entry one by one to determine which entry matches your substance.
• Option 2: Get a reference book called "Handbook of Existing and New Chemical Substances" published by the Chemical Daily in Japan. This reference book provides links between METI numbers and CAS numbers for many substances.
• Option 3: Ask for help from a consultant.

Note: Industrial Safety and Health Law(ISHL) has its own definition of new substances. You should also check ISHL list for your substance. A substance that is listed on ENCS but not listed on ISHL list is also subject to new substance notification under ISHL.

More info about Japan ENCS
http://www.chemsafetypro.com/Topics/Japan/Japan_ENCS_Inventory_of_Existing_and_New_Chemical_Substances.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