Chemical Regulatory Services 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 disinfectant or biocide to hands, it is classified into cosmetics/quasi-drugs/drugs in accordance with 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)

Summary Table

Categories

Biocide/Disinfectant

Detergents/Cleaning Products

General Consumer Products

Chemicals

Regulation

Regulated as per claims under the below acts/law:

  • Pharmaceutical and Medical Device Act
  • 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.

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

  • Product labels
  • Safety Data Sheet (SDS) of the product or all ingredients declared in the product formula
  • Efficacy test results (For Pesticides, Disinfectants, and Bleaches)

 

 

 

 

 

 

 

 

 

  • R & D report

 

 

 

 

GHS is implemented in Japan through Industrial Safety and Health Law (ISHL) by the Japanese Industrial Standard (JIS Z 7253:2012), which specifies requirements for elements of SDS/label to be consistent with the GHS.

Expertise

Freyr Expertise

  • Product classification and Regulatory Guidance
  • Regulatory Strategies for Market Access/Product Launch
  • Develop Product Notification/Registration Strategies
  • Regulatory Applicability Review and Interpretation
  • Prepare Technical Data Files (specification, MSDS, etc.) including Registration/ Notification Dossiers
  • Application Preparation and Submission for Relevant Introductions and Renewals
  • Sustainability and Packaging Solutions
  • Regulatory Intelligence (RI)
Freyr Advantages
Advantages

Freyr Advantages

  • Local presence in the market with relevant expertise and experience
  • End-to-end Regulatory consultation
  • Easily navigate the complexities of Regulatory authorities
  • Support for region-specific Regulatory complexities
  • A structured and cost-effective approach to ensure compliance in the multi-market scenario
  • Quick turnarounds and faster time-to-market