The questions brands preparing to export to Japan ask most often — answered by OTC experts.
The key question is where the effect is expected to arise.
Products expected to have a general effect overall, such as cleansing or moisturizing the skin.
Japan operates a negative list of prohibited and restricted ingredients together with positive lists for certain permitted ingredients.
Products that, beyond cosmetic function, claim efficacy through specific active ingredients.
Typical examples include whitening, acne prevention, UV-related efficacy, deodorant and hair growth.
Both active ingredients and additives are controlled within permitted ranges.
No. They may be sold as either cosmetics or quasi-drugs.
Claims may focus on the physical blocking function of UV absorbers and scatterers.
UV-filter ingredients themselves are classified as additives, so the application must be made together with a separate active ingredient.
In that case the total amount of UV absorbers used as additives must not exceed 10%.
(Where a whitening active ingredient is included) Inhibits melanin production and prevents freckles and blemishes
SPF and PA testing is generally performed, but submission of the results is not mandatory for approval applications or notifications.
Separate test data may nevertheless be required depending on the sales strategy or customer requirements.
Whitening wording differs according to whether the product is a quasi-drug.
Active ingredients: arbutin, vitamin C derivatives, tranexamic acid, nicotinamide, kojic acid and others
Permitted wording: inhibits melanin production and prevents freckles and blemishes
Permitted wording: prevents freckles and blemishes caused by sunlight — mainly in connection with UV-protection function
The permitted scope differs between quasi-drugs and cosmetics.
Permitted wording: makes fine lines caused by dryness less noticeable. Using this wording may require evaluation testing in accordance with Japanese guidelines.
Yes. Naming systems can differ in particular between quasi-drugs and cosmetics.
Quasi-drug: nicotinamide (whitening or additive), niacinamide (wrinkle improvement)
When changing product type it is necessary to review the full ingredient list, approval documents and labeling wording together.
Note: this FAQ is general guidance for understanding the Japanese cosmetic and quasi-drug systems. Individual review is required for each product depending on its formulation, labeling, claims and sales format.
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