Chemical Registration in Japan - Overview
Cleaning and disinfectant products are called/identified and regulated very differently across countries and regions making it very challenging for the industry to place these products in different markets.
In Japan, these products are regulated differently according to usage, product, or industry. In the case of disinfectants or biocides used for hands, it is classified into cosmetics/quasi-drugs/drugs in accordance with the PMD Act whereas other surface disinfectants/detergent household products do not need registration/notification by any authority/agency.
Additionally, chemicals in these product formulations/mixtures should comply with other relevant chemical-related legislations like:
- Act on Control of Household Products Containing Harmful Substances.
- Chemical Substances Control Law (CSCL).
Table 1: Chemical Regulation in Japan
| Categories | Biocide/Disinfectant | Detergents/Cleaning Products | General Consumer Products | Chemicals |
| Regulation | Regulated as per claims under the below acts/law:
| Household Goods Quality Labeling Law, Consumer Affairs Agency. Act on Control of Household Products Containing Harmful Substances - Ministry of Health, Labor, and Welfare of Japan. | Chemical Substances Control Law (CSCL). | |
| Registration Requirement | No | No | No | Yes |
| Process Brief | N/A | N/A | N/A | Online |
| Local Representative | Yes. Usually, there is a designated importer in Japan who can be designated as an "in-country caretaker" in most cases. | N/A | N/A | Yes |
| Key Data Requirements |
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GHS is implemented in Japan through Industrial Safety and Health Law (ISHL) by the Japanese Industrial Standard (JIS Z 7253:2012), which specifies chemical Regulatory requirements for elements of SDS/label to be consistent with the GHS.
Freyr Expertise
- Product Classification and Regulatory Guidance.
- Regulatory Strategies for Market Access/Product Launch.
- Develop Strategies for Product Notification/Chemical Registration in Japan.
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- Prepare Technical Data Files (Specifications, MSDS, etc.) including Registration/ Notification Dossiers.
- Application Preparation and Submission for Relevant Introductions and Renewals.
- Sustainability and Packaging Solutions.
- Regulatory Intelligence (RI) Services.
Freyr Advantages
- Local presence in the market with relevant expertise and experience.
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- Support for region-specific Regulatory complexities.
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- Quick turnarounds and faster time-to-market.
