In accordance with Chemical Substances Control Law (CSCL), Priority Assessment Chemicals (PACs) are substances jointly regulated and released by the Ministry of Economy, Trade and Industry (METI), the Ministry of Health, Labour and Welfare (MHLW), and the Ministry of the Environment (MOE). PACs refer to substances whose long-term toxicity to humans or to flora and fauna in the human living environment is unclear, that have been found, or are expected to be found, in considerable amounts over a substantially extensive area of the environment. They were therefore published based on the Chemical Substances Control Law. These substances are classified into three categories based on their characteristics: substances that pose risks to human health, substances that pose risks to ecosystems, and substances that pose risks to both human health and ecosystems.
► In accordance with CSCL,for chemical substances designated as priority assessment chemicals (PACs) in Japan,priority assessment on their potential risks as specified above is required. Annual reports shall be submitted before June 30 each year for chemical substances with an annual production/import volume of 1t or more. The deadline of submission is on July 31. Importers or manufacturers may be required to provide additional hazard data, and they shall transmit information to downstream parties/users.
► Chemical substances that are not designated as PACs are not subject to relevant obligations.
Click here to search for more details:
https://www.cirs-group.com/en/chemicals/japan-cscl-and-ishl
Regulations and standards
► Chemical Substances Control Law (Jun 17, 2022)
► Implementation of the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture (Dec 28, 2020)
► Guidelines for Filling in Manufacturing Quantity of General Chemical Substances, Priority Assessment Chemical Substances and Monitoring Chemical Substances (March 30, 2020)
► Basic Concepts of the Risk Assessment on Priority Assessment Chemical Substances under the Chemical Substance Control Law [3rd Revision] (July 7)
► Methods for the Risk Assessment of Priority Assessment Chemical Substances [3rd Revision] (July 7)
► Technical Guidance on the Risk Assessment of Priority Assessment Chemical Substances under the Chemical Substance Control Law
Regulatory authorities
► Ministry of Economy, Trade and Industry
► Ministry of Health, Labour and Welfare
► Ministry of the Environment
Exemptions
- Elements
- Naturally existing substances
- Radioactive substances
- Specified poisons in the Poisonous and Deleterious Substances Control Law
- Stimulants and precursor materials specified in the Stimulants Control Act
- Anesthetics specified in the Narcotics and Psychotropics Control Act
- Manufacturing or importing PACs for testing and research purpose
- Substances specified in the following regulations: ①food, food additives, containers and utensil, toys and detergents under the Food Sanitation Act; ②pesticides in the Pesticide Control Law; ③fertilizers in the Fertilizer Control Act; ④feed and feed additives under the Feeds Safety Act; ⑤pharmaceutical, cosmetics and medical devices under the Pharmaceutical and Medical Device Act.
- PACs as impurities whose weight is less than 1% (non-intentionally added substances: including raw materials not reacted, by-products, etc.)
- Articles purchased from Japan and sold in Japan.
- Chemical substances contained in products/articles for consumption.
How to obtain the list?
- Click here to search for the latest inventory
- Contact CIRS Group to purchase the latest version (in Excel)
Our services
- New Chemical Substance Search
- New Chemical Substance Notification
- Preparation of registration scheme (data evaluation and data analysis)
- Testing coordination and supervision
- Consultation with our experts or competent department
- Regulatory Training
- Preparation of SDS and label
If you have any questions, please contact us at chemicals@cirs-group.com.
