Japan CSCL and ISHL

Background of Japan CSCL and ISHL

Japan was the first country in the world to establish a risk prevention and control system for new chemical substances. There are currently two laws governing new chemical substances in Japan: Japan Chemical Substances Control Law (CSCL) enacted in October 1973 and Industrial Safety and Health Control Law (ISHL) enacted in 1972. The main function of the CSCL is to evaluate new chemical substances before they are marketed, thereby preventing the risk of harm to human health and the ecological environment. And the main function of the ISHL is to establish a risk control and disaster prevention system to ensure a safe and healthy workplace and a convenient and comfortable work environment.

Although both the CSCL and ISHL impose regulatory requirements for the declaration of new chemical substances entering the Japanese market, the two regulations differ in terms of several specific requirements, such as the definition of new chemical substances, notification requirements, the subject of the declaration, and data requirements. For chemical manufacturers or suppliers doing business in Japan, it is necessary to clarify whether the products are new chemical substances under the two regulations and to respond to compliance according to the requirements of the two regulations respectively.

About Us

Our company collaborates with well-known leading chemical companies located in Japan to help you fulfill your regulatory obligations in Japan.

Our team of experts has spent a great deal of time carefully studying the Japanese CSCL and ISHL regulations and gaining a deep understanding of the differences between them. We are well-positioned to provide you with tailored regulatory solutions for your chemical products in terms of risk assessment, notification and testing strategies, and study monitoring in compliance with Japan's CSCL and ISHL requirements. And we provide targeted preparation of declarations to help you meet these obligations.

Our Services

We provide one-stop compliance services, including inquiring whether your chemical products belong to new chemical substances under ISHL and CSCL, determining the notification type, arranging the safety tests required, preparing the submission notification documents, and finally completing the notification. Our services include, but are not limited to:

• New chemical substance investigation service
• Review the need for notification and exemption possibilities
• Data gap analysis and customized notification strategies
• Arrangement and monitoring of test study required for notification
• Registration of new substances under CSCL and ISHL
• Chemical production/import notification and monitoring
• Application for registration of low-yield new chemical substances
• Pre-confirmation application for low-concern polymers
• Competent authority/expert communication and consultation
• Regulatory training services
• Preparation of Safety Data Sheets (SDSs) and labels in accordance with Japanese regulation (JIS.GHS)

Our Advantages

• Outstanding team of experts: We have a team of senior technical staff with academic backgrounds in biology, pharmacology, analytical chemistry, chemical engineering, environment, etc.
• Rich accumulation and experience: We have many years of practical experience in global chemical compliance services and technical consulting and have helped many companies to complete CSCL and ISHL compliance projects in Japan.
• Flexible strategy: We support operations, including risk evaluation in response to CSCL revisions.

If you need help or have a question, please feel free to contact us for more details.