Global Cosmetic Compliance
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Group Buy: Japanese Standards of Quasi-drug Ingredients 2021 (JSQI 2021)
English Translation
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Summary
In Japan, cosmetics are regulated under two categories: cosmetics and quasi-drugs. Quasi-drugs are a unique product class positioned between pharmaceuticals and cosmetics. The Japanese Standards of Quasi-drug Ingredients 2021 (JSQI 2021), issued by the Ministry of Health, Labour and Welfare (MHLW), is the core technical standard that specifies the quality specifications and test methods for ingredients used in quasi-drugs. It serves as an essential reference for manufacturers and importers to ensure their products comply with Japan’s safety and efficacy standards.

Effective from March 25, 2021, JSQI 2021 replaced the previous 2006 edition. Since its introduction, it has been revised several times—October 2021, March 2023, and March 2025—to strengthen quality control and align with evolving regulatory requirements.

In response to the growing number of translation requests for JSQI 2021 from our users, ChemLinked is considering translating the document into English.
Details

JSQI 2021 is structured into three main parts: General Rules, General Testing Methods, and Individual Ingredient Specifications.

  • General Rules: Contains 28 foundational provisions that define the standard's scope and application. It covers essential terminology, general testing principles, and the criteria used to determine the quality and acceptability of quasi-drug ingredients.

  • General Testing Methods: Includes a comprehensive set of analytical procedures and foundational guidelines for testing quasi-drug ingredients. It contains around 78 specific test methods, such as the Residual Acrylic Monomer Test Method, Acrylonitrile Test Method, and Amine Value Determination Method. The section also sets out standardized requirements for the use of reagents, reference standards, standard solutions, and measuring instruments—ensuring consistency, reliability, and regulatory compliance in all testing processes.

  • Ingredient Specifications: Lists 2,647 ingredients, each described with some or all of the following information (not every ingredient contains all items):

    1. Japanese name (official ingredient name)

    2. English name (chemical name)

    3. Japanese alias

    4. English alias

    5. Structural or rational formula

    6. Molecular formula and molecular weight

    7. Origin, the regulations of ingredients’ content and label

    8. Characteristics

    9. Identification tests

    10. Characteristic values

    11. Purity tests

    12. Loss on drying, ignition loss, and moisture

    13. Ignition residue or evaporation residue

    14. Special tests

    15. Quantitative methods

    16. Others

Payment and Product Delivery

We plan to offer the English version of JSQI 2021 through the following two options:

Option 1: Purchase/Upgrade to ChemLinked Cosmetic Corporate Membership Service (4,999 USD/year)

Option 2: Purchase the document separately at 2,699 USD


Notes:
1. The translation will only proceed if 30 or more clients would like to purchase the translation via either option.

2. For option 1, the English translation will be provided as an exclusive bonus for Corporate Membership subscribers. If the group buying campaign is successful, existing ChemLinked Corporate Members will also receive the translated version.

3. Should you have any doubts, please contact us via [email protected].

User Guide