Japan Detergent Market: Quasi-Drug & MHLW Regulatory Guide

Market Access in Japan for Detergents: Key Regulatory Insights

Why Japan?

• Japan is a highly regulated and quality-conscious market.

• Compliance with safety, labeling, and regulatory classification is crucial for both importers and local manufacturers.

Detergent Classification

Detergents in Japan are categorized based on function and composition:

Category	Regulation	Examples
Quasi-drugs	PMD Act (Pharmaceutical and Medical Device Act)	Antibacterial, deodorizing, disinfectant
Household Products	Household Goods Quality Labeling Act	Dishwashing, laundry detergents
Chemical Substances	Poisonous and Deleterious Substances Control Act	Products with regulated ingredients

Governing Authorities

Agency	Role
MHLW	Approves quasi-drugs, ensures product safety
CAA (Consumer Affairs Agency)	Enforces labeling standards under Quality Labeling Act
METI	Regulates chemical substances
NITE	Conducts chemical risk assessments

Pre-Market & Labeling Requirements

For Quasi-Drugs:

• Mandatory MHLW approval before market entry

• Submit: product composition, efficacy, safety, stability data, and Japanese labeling

For General Detergents:

• No pre-approval needed

• Must comply with labeling and safety standards

Labeling Must Include:

• Japanese language

• Product name, ingredients, usage, precautions

• Manufacturer/importer details

• GHS hazard labeling if applicable

Technical Documentation Required

• Full ingredient list with concentrations

• Japanese SDS for hazardous/industrial use

• Efficacy, toxicology, and safety data (mainly for quasi-drugs)

Legal Representation in Japan

Product Type	Required Representation
Quasi-drugs	Marketing Authorization Holder (MAH)
General Detergents	Importer of Record (IOR) or Japanese entity

Timelines & Market Expansion

Category	Approval Time	Reuse Potential
Quasi-drugs	6–12 months	Data often reusable in Korea, China, ASEAN
General Detergents	Minimal (labeling only)	Ideal for broader APAC entry path

Conclusion

Success in Japan’s detergent market hinges on:

• Accurate product classification

• Clear regulatory pathway

• Local representation

• Japanese labeling and documentation

With the right partner (like Freyr), manufacturers can efficiently navigate Japan’s regulatory maze and unlock broader Asia-Pacific opportunities.