Japan Industrial Safety and Health Act (ISHA) - New Chemical Substance Notification Support Service

Expert One-Stop Support for ISHA Notifications in Japan

Under the Industrial Safety and Health Act (ISHA), companies planning to manufacture or import chemical substances in Japan that do not qualify as “existing chemical substances” are required to notify the Ministry of Health, Labour and Welfare (MHLW) before starting manufacture or importation.

Sumika Chemical Analysis Service, Ltd. (SCAS) brings extensive expertise, with over 30 years of experience and more than 500 successful ISHA notifications. Leveraging this knowledge, we provide seamless, end-to-end support from test arrangement to document preparation, submission, and communication with authorities. Because ISHA requires local applicants, we facilitate collaboration between overseas manufacturers and Japanese importers, ensuring compliance and smooth market entry.

Industrial Safety and Health Act (ISHA)

To ensure worker safety and health, prevent occupational accidents, and promote a comfortable working environment.

Established in 1972; notification system for new chemical substances introduced in the 1977 amendment.

Ministry of Health, Labour and Welfare (MHLW)

New chemical substances (those not listed as existing chemical substances)

Manufacturers or importers located in Japan

Prior to the commencement of manufacturing or importation

• Notification must be made by manufacturers or importers in Japan; entities located outside Japan are not eligible.
• ISHA differs from the Chemical Substances Control Law (CSCL) in scope and definition of existing chemical substances.
• Under ISHA, intermediates, by-products, and wastes are also subject to notification.
• Substances publicly listed under CSCL before June 29, 1979 are also considered existing chemicals under ISHA. After this date, the two laws are managed separately, requiring compliance with both as applicable.
• Under the CSCL, notifications are submitted per company (legal entity). In contrast, under the ISHA, notifications must be submitted per site or facility (e.g., each headquarters, factory, or business location), even if operated by the same company. Each relevant site is therefore required to submit its own notification under ISHA.

For annual manufacturing or import volumes of 100 kg or less per site.
No test data required.

For annual manufacturing or import volumes exceeding 100 kg per site.
Requires hazard assessment data, specifically an Ames test conducted under GLP (Good Laboratory Practice) conditions.

Note: The Ames test methodology under ISHA differs slightly from the OECD test guideline.

Polymers meeting all of the following criteria are exempt from new chemical substance notification under ISHA, as they are regarded as existing chemical substances:

• Composed exclusively of monomers that are existing chemical substances
• Number-average molecular weight of 2,000 or higher
• Do not meet any of the following conditions:

• 1.
  Possess a net positive charge
• 2.
  Carbon content less than 32% of total weight
• 3.
  Contain covalent bonds with elements other than sulfur, silicon, oxygen, hydrogen, carbon, or nitroge
• 4.
  Contain ionic bonds with metal ions (including complex metal ions) other than aluminum, potassium, calcium, sodium, or magnesium
• 5.
  Derived from biological materials or have similar structures
• 6.
  Derived from compounds containing halogen or cyano groups
• 7.
  Contain reactive functional groups (e.g., isocyanate) with a molecular weight per group of 10,000 or less
• 8.
  Prone to decomposition or depolymerization under normal temperature and pressure

SCAS provides comprehensive support throughout the entire notification process.

We offer clear guidance on regulatory requirements and help you develop optimal notification strategies, and identify any data gaps that need to be addressed.

We coordinate with partner laboratories to plan, manage, and monitor all required testing activities.

We create application documents that meet regulatory standards, conduct thorough content reviews, and provide support in English.

We submit applications to the MHLW on your behalf and handle all communications, including responses to questions and additional requests from authorities.

We provide continuous support after submission, addressing all feedback and additional requests from the authorities until the application is approved, ensuring a smooth and successful process.

• Over 30 years of experience and more than 500 successful notification projects
• Regulatory experts with deep knowledge of both Japanese and international chemical regulations
• Full support in English
• Extensive network of partner testing laboratories

• SCAS provides notification and consulting services for chemical regulations in Japan and internationally.

Japan, European Union, United Kingdom, United States, Canada, Australia, New Zealand, China, South Korea, Taiwan, Philippines, Turkey

• Consulting services for food packaging material regulations
• SDS (MSDS) authoring services
• Safety testing services