Request a DemoUnder Japan's PMD Act, beauty and personal care products are divided into two regulatory categories: cosmetics and quasi-drugs. Cosmetics feature mild effects on the human body, are intended for appearance-related purposes, and follow a notification system. Quasi-drugs, positioned between cosmetics and pharmaceuticals, contain designated active ingredients and are intended for specific efficacies such as skin whitening, deodorization, and hair growth promotion. These products require pre-market approval from the Ministry of Health, Labour and Welfare (MHLW), following a scientific technical review conducted by the Pharmaceuticals and Medical Devices Agency (PMDA).
The Japanese Standards of Quasi-drug Ingredients (JSQI) is the primary technical standard governing ingredients used in quasi-drugs in Japan. By defining quality specifications and testing methods for quasi-drug ingredients, it provides the technical foundation for quasi-drug product development, regulatory submissions, and ongoing compliance. For overseas cosmetic companies seeking to enter the Japanese quasi-drug market, understanding and complying with JSQI is essential.
Part 1 Development History of JSQI
The JSQI has undergone continuous structural and technical evolution to accommodate the growing complexity of the industry. Its development is marked by three primary editions.
1.1 Major Editions
1.1.1 JSQI 1991
The inaugural edition of the JSQI was promulgated on May 14, 1991, via Notification No. 535 issued by the former Ministry of Health and Welfare. This milestone marked Japan's first unified, standalone technical standard exclusively dedicated to quasi-drug ingredients. It consolidated the "Ingredient Specification I" (for active ingredients) and "Ingredient Specification II" (for additives), which were originally presented in Attachments 2 and 3 of the Standards for Manufacturing (Importing) Approval of Hair Dyes. Between 1993 and 1998, JSQI 1991 underwent four partial amendments, broadening its regulatory scope beyond hair dyes to encompass other quasi-drug categories such as permanent wave agents, medicated toothpaste, and bath additives.
1.1.2 JSQI 2006
Enacted on March 31, 2006, via Notification No. 0331030 of the MHLW, JSQI 2006 officially superseded the 1991 framework. This edition incorporated into its Appendix II many ingredients previously listed under the Cosmetic Ingredient Standards and the Specifications for Cosmetic Ingredients not listed in the Cosmetic Ingredient Standards (both abolished in 2001). Appendix II primarily concerned ingredients other than quasi‑drug active ingredients, i.e., additives. Notably, Appendix I, which governed quasi‑drug active ingredients, remained unchanged from JSQI 1991. JSQI 2006 served as the operational standard for over a decade, undergoing multiple interim revisions between 2007 and 2019 before its eventual retirement.
1.1.3 JSQI 2021
Issued on March 25, 2021, the current JSQI 2021 represents the most profound structural and technical modernization of the standard to date. Designed to streamline compliance and eliminate historical regulatory redundancies, its key improvements include:
Restructured General Rules: The previous General Rules section—compartmentalized into "Common," "Appendix I," and "Appendix II"—was integrated into a single set of overarching provisions. This integration rescinded the former mandate requiring Appendix I active ingredients to strictly adhere to the Japanese Pharmacopoeia (JP), establishing the JSQI 2021's own General Rules and General Tests as the primary, self-contained authority for all quasi-drug raw materials.
Consolidated Testing Methodologies: Requirements for reagents, test solutions, and standard solutions for volumetric analysis were streamlined by integrating all definitions into the "General Tests" chapter. This revision resolves previous inconsistencies—such as redundant definitions, duplicate naming conventions, and conflicting specifications—that arose from having these items listed in both the General Tests and Appendix I. Furthermore, the JSQI 2021 established new specifications for substances formerly covered by abolished Japanese Industrial Standards (JIS).
Abolished Appendix Distinctions: JSQI 2021 eliminated the historical distinction between Appendix I (active ingredients) and Appendix II (additives). All ingredients are now consolidated into a single master inventory, systematically organized in Japanese syllabary (kana) alphabetical order.
Expanded Content: Two new general test methods were added and 17 existing methods revised, resulting in a total of 84 test methods. Concurrently, 1,453 ingredient specifications were updated and 1 specification removed, bringing the total number of listed ingredient monographs to 2,647.
Simultaneously with the enactment of JSQI 2021, the MHLW promulgated two supplementary regulatory documents: the new List of Permitted Additives in Quasi-drugs and new Pre-market Application Rules for Quasi-drugs. Together with JSQI 2021, these instruments form a complete and coordinated regulatory framework for quasi-drug formulation and approval.
1.2 Ongoing Updates
The JSQI is a dynamic regulatory instrument, subject to continuous refinement to reflect scientific advancements, regulatory developments, and international harmonization. Since the implementation of the 2021 edition, the MHLW has issued the following updates:
October 18, 2021: Issuance of the first errata notice, correcting technical and typographical errors in 62 ingredient monographs.
March 27, 2023: The first partial revision, which revised six general test methods and nine ingredient specifications to improve alignment with related standards, including the JP, and adjusted licensing requirements for manufacturing and sales.
March 21, 2025: The second partial revision, promulgated alongside a second errata notice and updated administrative procedures for marketing approval applications. This revision amended 15 general testing methods and updated specifications for 222 quasi-drug ingredients.
Part 2 Overview of JSQI 2021
JSQI 2021 is structured into three main parts: General Rules, General Tests, and Individual Ingredient Monographs.
Key Components | Description |
|---|---|
General Rules | This section comprises 28 articles and lays down the foundational principles of the entire standard. It defines the scope of application, basic concepts, key terminology, judgement criteria for test results, units and symbols, as well as laboratory operation requirements. Regarding scope, JSQI 2021 compiles specifications for ingredients permitted in quasi-drugs, with the exception of ingredients derived via genetic engineering (unless otherwise stipulated) and substances already governed by the JP, Japan's Specifications and Standards for Food Additives (JSFA), or JIS. |
General Tests | This section contains 84 standardized analytical procedures that serve as the universal operational benchmarks referenced throughout the individual ingredient monographs. It also standardizes the use of reagents, reference substances, standard solutions and testing equipment to guarantee the consistency, reliability, and regulatory compliance of all laboratory testing activities. The testing techniques span the following major categories:
※ Note on Method Validation:
|
Individual Ingredient Monographs | Functioning as the technical core of the standard, this section details specifications for 2,647 quasi-drug ingredients. All monographs are now arranged in Japanese syllabary order within a single integrated system. Every monograph establishes the quality requirements applicable to a specific ingredient and adopts a standardized template with up to 16 specific data fields (not all fields apply to every substance):
※ Note on Heavy Metal Limits: While Japanese regulations typically do not prescribe overarching heavy metal impurity limits for finished quasi-drug formulations, control is strictly enforced upstream at the raw material level via the JSQI. For most quasi-drug ingredients, the total heavy metal content is capped at ≤20 ppm, and arsenic is limited to ≤2 ppm. |
Part 3 Quasi-drug Market Access
While JSQI 2021 does not independently establish market access requirements, it provides the official quality specifications and analytical methods that serve as the foundation for the regulatory review of marketing authorization applications. Pursuant to the PMD Act and MHLW administrative rules, applicants must provide comprehensive data regarding ingredient profiles, manufacturing processes, specifications and test methods, usage and dosage, function or efficacy.
For ingredients covered by JSQI 2021, manufacturers must adhere strictly to the corresponding monograph specifications and test methods. Applicants can simply mark "JSQI (外原規)" in the Ingredient and Content section of the application dossier, without elaborating full ingredient specification.
Where revisions to JSQI cause already-approved quasi-drugs to deviate from updated technical specifications, manufacturers should correspondingly update their ingredient specifications, test methods, and quality management procedures. Based on the nature of the changes, a partial or minor change application may be required.
Failure to monitor JSQI updates and maintain compliance may lead to regulatory inquiries, requests for additional testing or justification, and potential delays in the approval process.
Part 4 Other Quasi-drug Ingredient Lists
JSQI 2021 primarily establishes quality standards and testing requirements for quasi-drug ingredients. However, it does not prescribe the applicable product categories, concentration limits, or conditions of use for individual ingredients.
To determine whether a specific ingredient may be used in a particular quasi-drug category and to verify applicable use restrictions, companies should also consult the supplementary ingredient lists and standards issued by the MHLW.
Key references include:
| Permitted Active Ingredients | |
Permitted Additives |
Together with JSQI, these lists form an important part of Japan's quasi-drug ingredient management framework. Therefore, compliance assessments should consider both the quality requirements established under JSQI and the applicable ingredient restrictions and use conditions specified in the relevant category-specific lists.
