Understanding Japan Cosmetic Regulations

To be sold in Japan, cosmetics products and quasi-drugs must be compliant with:

• The Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics
• Standards for Cosmetics
• The Act Against Unjustifiable Premiums and Misleading Representations
• The High-Pressure Gas Safety Law
• Fair Competition Rules
• The Narcotics and Psychotropics Control Act

In order to sell cosmetics or quasi-drug products, the importer must have a manufacturing license and a marketing license for which a Responsible Person must be designated. The importer must also be compliant with Good Manufacturing Practices (GMP), Good Quality Practices (GQP) and Good Vigilance Practices (GVP).

Cosmetics vs. Quasi-Drugs

Japan makes the following distinction between cosmetics and quasi-drugs:

• Cosmetics (Article 2.3 of the Pharmaceuticals Affairs Law):

“The term “cosmetic” used in this law refers to articles with mild action on the human body which are intended to be applied through rubbing, sprinkling or other similar methods, and are used to clean, beautify and increase attractiveness, alter the appearance or to keep the skin or hair in good condition. Proviso: these articles shall exclude quasi-drugs and those intended concurrently for the uses specified in Paragraph 1, Item 2 or Item 3.”

The comprehensive Licensing Standards of Cosmetics by Category (released in 1999) indicated 11 distinct categories of cosmetic products.

• Quasi-Drugs

“Products with mild action on the human body, they are considered as cosmetics with mild pharmacological action.”

Quasi-drug categories have been specified in Announcement No. 25 of the Ministry of Health from February 6, 2009. There are currently 27 quasi-drug categories.

The following products are included in the quasi-drug category: anti-dandruff, whitening, anti-acne, anti-chapping, anti-dryness, deodorants, antiperspirants, hair-growth, hair dying, hair perming, toothpastes, bath salts, mouth washes, breath products, etc.

BIORIUS covers both cosmetic products and quasi-drugs, and can help cosmetics companies with regulatory revisions.

How does it work?

The process is the same for cosmetics and quasi-drugs, except for pre-approval dossier preparation for quasi-drugs. It can take up to six months to be reviewed by the Pharmaceuticals and Medical Devices Agency (PMDA).

BIORIUS’ experts analyze the formulas and review the labels for both cosmetics and quasi-drugs in addition to preparing the pre-approval dossier for quasi-drugs.

The preparation of the pre-approval dossier includes documentation to submit to the PMDA.

Regarding cosmetics, there is no cosmetics dossier to provide to the authorities. The importer is responsible for the safety of the product. BIORIUS can verify the safety of the finished product as well as compliance with required standards.

Regulatory revision consists of a formula review, a label and claims review and preparation of  a pre-approval dossier for quasi-drugs.

Formula Review

Toxicological and regulatory assessment of ingredients and impurities, establishment of the INCI and ingredients lists in Japanese, establishment of warnings and precautions for use.

The product category (cosmetic or quasi-drug) is determined during this first step.

A formula review report is issued, which highlights the following elements:

• Ingredients names (INCI and Japanese names)
• Percentage of each ingredient
• Regulations and restrictions
• Margins of safety
• Comments from the experts (amendments needed)

The Japanese ingredients list and INCI list as well as warnings and precautions for use are also provided upon conclusion of this step.

As an option, BIORIUS can verify the safety of the finished product as well as compliance with required standards.

Label & Claims Review

Evaluation of product labels (ingredients list, symbols, legal requirements, etc.) and claims substantiation.

The label and claims review consists of a report containing all the information that needs to appear on the labeling material:

• Required elements
• Presence of required elements (primary packaging, secondary packaging & leaflet)
• Claims
• Conclusions on each claim
• Final ingredients list in Japanese and INCI list
• Comments from the experts – strategic recommendations provided for updating the label

Pre-Approval Dossier Preparation for Quasi-Drugs

Evaluation of the documentation needed for pre-approval.

BIORIUS evaluates the following elements:

• Data regarding origin and background of use in foreign countries
• Data regarding physical and chemical properties, specifications and testing methods
• Data regarding stability
• Data regarding safety
• Data regarding efficacy or effect

The data required for registration will depend on the class of the quasi-drug (Notification No. 1121), and will be conclusive at this step.