The questions brands preparing to export to China, Japan and ASEAN ask most often — answered by OTC experts.
Many companies believe animal testing is unavoidable when exporting cosmetics to China, but the applicable requirements now differ according to product type and company qualifications.
China manages cosmetics as either general cosmetics or special cosmetics, and general cosmetics that meet certain conditions can be notified without submitting animal test data.
Special cosmetics, however, follow a separate approval and registration procedure, and additional documentation may be required depending on product safety and risk level. Chinese animal testing requirements must therefore be assessed comprehensively according to product type, company conditions and the registration route, rather than against a single standard.
China manages UV protection not as a simple topical cosmetic function but as an efficacy-driven function affecting the physiology of the skin.
Sunscreen products are therefore classified as special cosmetics rather than general cosmetics, and are subject to a stricter registration procedure and to submission of safety and efficacy documentation.
Even a sun care product distributed as a general cosmetic in the EU or ASEAN markets may be classified as a special cosmetic in China, so reviewing the product classification framework before market entry is essential.
China manages cosmetics as either general or special cosmetics. Special cosmetics include the following product groups:
sunscreens, whitening and blemish-improvement products, hair-loss prevention products, hair dyes and permanent wave products.
The same product may be classified differently under each country's regulatory framework, and classification as a special cosmetic can substantially increase the registration procedure, documentation and review period compared with a general cosmetic.
When exporting to China it is therefore important to review the regulatory classification criteria first, rather than the marketing wording.
Under the Standards for Cosmetic Efficacy Claim Evaluation, China requires submission of assessment documentation providing scientific support for the efficacy a product labels or advertises.
Depending on the type of claim — moisturizing, whitening, wrinkle improvement, UV protection and so on — the evidence may take the form of human application testing, consumer use testing, laboratory testing or literature-based documentation.
For certain claims, test data produced by a testing institution recognized by the Chinese authorities may be required, and the consistency between the claim and the study design is also reviewed.
Efficacy assessment documentation is not only a registration requirement but is also used as the basis for advertising and marketing wording, so it matters for advertising compliance after launch as well.
When entering the Chinese market it is therefore important to establish the claim strategy and the efficacy assessment strategy together from the earliest stage of product development.
Establishing a Chinese corporation is not necessarily required.
However, to register or notify a cosmetic in China you must appoint a Domestic Responsible Person in China.
The Domestic Responsible Person carries out product registration and notification on behalf of the overseas manufacturer, and bears responsibility across the product life cycle — including post-market safety management, adverse event reporting, product recall and dealing with the regulator.
They also retain product quality and safety documentation and act as the official channel of communication with the authorities, so they function as a core regulatory responsibility holder rather than a mere administrative agent.
Selecting the Domestic Responsible Person is therefore an important decision alongside the product registration strategy.
Since the Regulations on the Supervision and Administration of Cosmetics took effect, China has continuously strengthened its safety assessment system, institutionalizing an ingredient-based risk assessment framework in particular through the requirement to submit a Safety Assessment Report.
Product safety therefore no longer rests on finished-product test results alone; it is assessed comprehensively on scientific evidence including the toxicological information, human safety data, history of use and exposure assessment for each raw material.
Ingredient-level safety information is the key evidence used to prepare the Safety Assessment Report, so where that information is insufficient, requests for supplementary assessment may arise or the registration procedure may be delayed.
In the current Chinese regulatory environment, regulatory capability at the raw material selection and safety data stage — rather than at the finished product stage — has become the decisive factor in whether a product can be launched.
China applies safety management standards to cosmetics intended for children aged 12 and under that are stricter than those for general cosmetics.
Children's cosmetics are managed on a safety-first principle and may not claim adult functional efficacy such as whitening, acne improvement, body odour removal, hair removal, hair-loss prevention, hair dyeing or permanent waving.
New cosmetic ingredients, ingredients produced using genetic modification technology and nanomaterials are in principle restricted; where their use is necessary, scientific justification and safety substantiation are required.
China applies a minimum formula principle to children's cosmetics and also applies strict safety assessment criteria to the number and concentration of colorants, preservatives, surfactants and UV filters.
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.
ASEAN (Association of Southeast Asian Nations) is an economic community of ten Southeast Asian countries.
The member states are Singapore, Malaysia, Thailand, Indonesia, Vietnam, the Philippines, Brunei, Cambodia, Laos and Myanmar, together forming one of the world's major consumer markets with a population of around 700 million.
In the cosmetics field, regulatory harmonization between member states is pursued on the basis of the ASEAN Cosmetic Directive (ACD), with a common framework covering prohibited substances, restricted substances, preservatives, colorants and UV filters.
Product registration, labeling, advertising control and post-market surveillance are nevertheless operated individually by each national authority, so country-specific rules must also be reviewed when entering ASEAN.
Many companies think of ASEAN as one market, but in practice the characteristics of each country are very distinct.
ASEAN shares a basic framework of cosmetic regulation through the ASEAN Cosmetic Directive (ACD), but product registration procedures, labeling, advertising control, import rules and post-market surveillance are operated separately by each national authority.
Consumer preferences and distribution environments also differ by country. In Indonesia, for example, halal-related enquiries are frequent, whereas Singapore has a relatively large premium beauty segment.
Rather than approaching ASEAN with a single strategy, it is therefore important to consider both the regulatory environment and the market characteristics of each target country.
Halal is one of the factors that cannot be left out when discussing the ASEAN market.
Indonesia in particular has the world's largest Muslim population, and Malaysia is also known for high consumer awareness of and market demand for halal. In practice it is not unusual to be asked for documentation on the origin of raw materials, the use of animal-derived ingredients, alcohol content and manufacturing processes, even where the product has no halal certification. Increasingly, consumers also consider halal as an indicator of product transparency and trustworthiness rather than for religious reasons alone.
If you are planning to enter the ASEAN market, reviewing raw materials and manufacturing processes from the product development stage can therefore help with later market expansion.
Driven by the Korean Wave and the growth of K-Beauty, Korean cosmetics have built strong recognition and trust in the ASEAN market. Many consumers associate Korean cosmetics with a trendy image and good quality.
As the market matures, however, it is becoming harder to compete on "Made in Korea" alone. Competition has intensified not only among Korean brands but with Japanese, European, American and local brands, and consumers increasingly compare ingredients, efficacy, sensory experience and price competitiveness in detail.
Even so, Korean cosmetics retain clear strengths in areas such as sun care, cushions and skincare, and positive perceptions of K-Beauty persist. Successful entry into ASEAN therefore calls for a strategy that uses the strength of "Korean cosmetics" while also taking local consumer needs and market characteristics into account.
Southeast Asia experiences strong ultraviolet radiation and high temperatures year round, and its sun care market continues to grow. Preference is high for light textures, formulations with little white cast, and sunscreens that layer well with make-up. Korean sunscreens attract steady interest in the ASEAN market on the strength of their sensory quality and range of formulations.
Interest in environmental impact is also increasing. Thailand, for example, restricts the use of sunscreens containing certain UV filters in some marine national parks in order to protect coral reefs. The policy covers products containing oxybenzone, octinoxate, 4-methylbenzylidene camphor and butylparaben, and is operated to protect marine ecosystems.
It is frequently cited as a trigger for the wider trend toward environmentally conscious product development such as reef-friendly sun care.
For sun care products aimed at ASEAN it is therefore important to review not only UV-protection efficacy but also the ingredients used, consumer perceptions on environmental matters and regulatory trends in each country.
Yes. ASEAN operates common principles for cosmetic advertising through the ASEAN Cosmetic Claims Guideline, and expressions of product efficacy must be based on objective evidence.
Because advertising and labeling control is administered by each national authority, however, additional requirements may arise.
Some ASEAN countries require the product notification number to be displayed (Indonesia, Thailand), and others require disclosure of animal-derived ingredients (Malaysia, Brunei, Vietnam). Thailand also requires nanomaterial labeling, and Indonesia operates a 2D barcode scheme for cosmetic packaging.
So although ASEAN operates on a common framework, additional country-specific requirements exist in practice, and country-by-country review is needed across advertising wording, labeling, product information and marketing materials as a whole.
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