Cosmetic Compliance in East Asia

Cosmetic regulation in East Asia

East Asia is four separate regimes with no mutual recognition between them. A dossier accepted in one market does not carry into the next, and each market requires a locally established entity to hold the filing. What the four share is a direction of travel: every one of them now puts a documented safety assessment, signed by a qualified assessor, at the centre of market access. China and Taiwan have made that assessment mandatory; South Korea is phasing the same requirement in; Japan places the safety responsibility on the local licence holder. The technical safety work is therefore the reusable core, even though the filings are not.

China is the most demanding of the four and is treated at length below, because its requirements (full safety assessment, a domestic responsible person, ingredient inventory control, and per-claim efficacy substantiation) are the ones brands most often underestimate.

China: the CSAR framework

The Cosmetic Supervision and Administration Regulation (CSAR) has governed cosmetics in mainland China since 1 January 2021, replacing the 1989 hygiene rules. It is administered by the National Medical Products Administration (NMPA), with the National Institutes for Food and Drug Control (NIFDC) providing the technical guidelines.

Classification. Products are either special cosmetics or general cosmetics. Special cosmetics, namely hair dyes, perming products, sunscreens, freckle and whitening products, anti-hair-loss products, and any product claiming a new function, require NMPA registration, with a certificate valid for five years. General cosmetics require notification, which does not expire. Toothpaste is regulated by reference to the general cosmetic rules and must be notified; ordinary soap sits outside the scope unless it makes a special-cosmetic claim.

The registrant or notifier is the responsible person. Under Article 6, the applicant for registration or notification is the responsible person, accountable for the product’s quality, safety, and efficacy. An overseas company cannot file directly: it must appoint a domestic responsible person, a China-established entity whose duties run across the whole lifecycle. The domestic responsible person signs the dossier, responds to NMPA audits, keeps import records, and carries the adverse-reaction monitoring and reporting obligation. This is a substantive legal role, not a mailing address.

Safety assessment. China has moved off the transitional regime. The simplified safety assessment report, allowed during the phase-in, has been withdrawn, and a full product safety assessment report is now required. The NIFDC submission guidelines of April 2024 set two dossier tiers: Category I, covering special cosmetics, infant and children’s cosmetics, and products containing a new ingredient still in its monitoring period, for which a full safety assessment report is mandatory; and Category II, covering everything else, where an assessment report or assessment conclusions with supporting materials may be submitted. The full report cannot rely on the historical-use concentration in the ingredient inventory as evidence, and it must include physical and chemical stability data, packaging compatibility, and preservative challenge testing. Under Article 21, the assessment must be performed by a person with cosmetics safety knowledge and at least five years of relevant experience.

Ingredient inventory and new ingredients. Ingredients already listed in the Inventory of Existing Cosmetic Ingredients in China (IECIC 2021) are treated as existing and need only be referenced. An ingredient used in cosmetics in China for the first time is a new cosmetic ingredient (NCI) under Article 11 and must clear one of two routes before use: registration for higher-risk functions (preservatives, colorants, sunscreen agents, freckle and whitening agents, and hair dyes), and the lighter filing route for the rest. An approved NCI enters a three-year monitoring period during which annual safety reports are required, after which, absent any concern, it is added to the inventory. The inventory itself was restructured into two lists in 2025.

Efficacy substantiation. Efficacy claims must be substantiated, with the permitted form of evidence (laboratory testing, human trials, consumer-use testing, or literature) depending on the claim, and a summary of the efficacy claim basis is published on the NMPA platform. Claims that cannot be substantiated must be revised or dropped.

Animal testing and the UK route. Imported general cosmetics can be exempt from mandatory animal testing where the applicant supplies a safety assessment and a good manufacturing practice certificate issued by the competent authority of the country of manufacture. The United Kingdom operates a system to issue that certificate, so a UK-manufactured general cosmetic can take the animal-test-free import route, which many exporting countries cannot. A March 2026 NMPA draft has proposed extending the exemption to special cosmetics and to products containing new ingredients, but at the time of writing this is a consultation draft and not yet in force.

Japan: cosmetics and quasi-drugs under the PMD Act

Cosmetics in Japan are regulated by the Ministry of Health, Labour and Welfare (MHLW) under the Pharmaceuticals and Medical Devices Act (the PMD Act, formerly the Pharmaceutical Affairs Law). The Pharmaceuticals and Medical Devices Agency (PMDA) reviews quasi-drug applications and the notifications of foreign manufacturers and importers; prefectural governments handle licensing and inspection.

The classification decision comes first. Japan splits products into cosmetics, which have only mild action, and quasi-drugs, which contain approved active ingredients and carry functional claims such as whitening, anti-wrinkle, anti-dandruff, deodorant, depilatory, and medicated effects. The two follow different routes, and misclassification costs months, so it is the first question to settle.

Cosmetics route. No product dossier is submitted to the authority for an ordinary cosmetic; the responsibility for safety rests with the local licence holder. To import and sell, a Japan-based entity must hold a cosmetics Manufacturing and Sales (marketing) Business Licence and act as the Marketing Authorisation Holder, together with a Manufacturing Business Licence covering the import and labelling acts. A foreign manufacturer must appoint a Japanese Marketing Authorisation Holder, who then files the manufacturing or marketing notification and the product import notification before the product enters Japan. The formula must conform to the MHLW Standards for Cosmetics, which operate as positive lists for permitted UV filters, preservatives, and tar colours alongside prohibited and restricted lists. An overseas manufacturing site may need accreditation under Japan’s foreign manufacturer accreditation framework, administered by the PMDA, and accreditation can affect launch timing.

Quasi-drug route. Quasi-drugs require pre-market approval under Article 14, on a dossier comparable to a pharmaceutical filing, with physicochemical, stability, toxicological, and efficacy data and an ingredient-level review.

Labelling is in Japanese, using the Japanese ingredient nomenclature.

South Korea: general and functional cosmetics under the Cosmetics Act

South Korea’s Ministry of Food and Drug Safety (MFDS) regulates cosmetics under the Cosmetics Act, in force since 2000. For imported products, the Korea Pharmaceutical Traders Association evaluates and issues the import entry approval.

Categories. Products are general cosmetics, functional cosmetics, or customised cosmetics. Functional cosmetics, which include whitening, anti-wrinkle, UV protection, hair colouring, and hair-loss relief products (with newer additions such as products to reduce the redness of pregnancy stretch marks), require a pre-market review and an approval letter from the MFDS before manufacture or import; where the functional ingredient is already in the Korean Functional Cosmetics Codex, a lighter notification route may apply. General cosmetics are managed by post-market surveillance and need no registration.

The responsible distributor. Anyone manufacturing, importing, or selling must register with the MFDS as a Responsible Cosmetic Distribution Business; for imports, the importer takes this role. Korea prohibits 1,032 ingredients and restricts preservatives, UV filters, and hair-dye ingredients to defined conditions; use of a restricted ingredient outside those conditions requires MFDS approval.

The incoming safety assessment system. A partial amendment to the Cosmetics Act (Law No. 21302), promulgated on 30 December 2025, establishes a mandatory product safety assessment. Responsible distributors will have to prepare and retain, product by product, a safety assessment reviewed by a qualified safety assessor before distribution; the report is not filed in advance but must be produced on MFDS request. Notably, the MFDS has signalled that safety reports already prepared under foreign regimes, such as a US MoCRA assessment or an EU/UK CPSR, may be accepted where they meet Korean standards. Implementation is phased: a pilot in 2026, application from 2028 to companies with annual production or import above KRW 1 billion and to newly approved functional and infant or children’s products, and full enforcement by around 2031. The MFDS published its preparation guidance for the new documentation on 10 June 2026.

Taiwan: notification and the Product Information File

Taiwan regulates cosmetics through the Taiwan Food and Drug Administration (TFDA) under the Cosmetic Hygiene and Safety Act, in force since 1 July 2019. The Act imposes three core obligations: product notification, establishment of a Product Information File, and compliance with cosmetics good manufacturing practice.

Notification has replaced registration. The older pre-market registration system for specific-purpose cosmetics was retired on 1 July 2024, and Taiwan now runs a single notification system. Online notification has been mandatory for general cosmetics since 1 July 2021 and for specific-purpose cosmetics (including sunscreens, hair dyes, and similar) since 1 July 2024. Notification must be filed by a Taiwan-based legal entity, so an overseas brand files through a local importer or agent rather than directly.

The Product Information File. The PIF comprises sixteen documents, including the product particulars, ingredient names and concentrations, the manufacturing process, toxicological data, stability test reports, and a comprehensive safety assessment signed by a qualified safety assessor. It may be kept in Chinese or English, must be updated when the product changes, and must be retained for at least five years after the product was last on the market. The PIF requirement is being phased in by category, and from 1 July 2026 every cosmetic, other than certain handmade solid soaps from operators exempt from factory registration, must have a PIF established before it is marketed. For brands selling in Taiwan, that deadline is imminent.

The common thread: a defensible safety assessment

Across all four markets the reusable asset is the same: a rigorous, defensible safety assessment by a qualified assessor. China’s Article 21 sets an experience bar; Taiwan requires a named safety assessor’s signature on the PIF; Korea’s incoming system turns on an assessor-reviewed report and has signalled it may accept a conforming foreign report; Japan places the safety burden on the local licence holder, who needs the technical basis to carry it. Our CPSR provides that technical core. A CPSR is a reasoned judgement about how a substance behaves in contact with the human body, and clinical pharmacology is the science of exactly that, how chemicals are absorbed, distributed, metabolised and act, which makes it the ultimate qualification for the work. Ours is led by a Clinical Pharmacologist who holds an MSc with Distinction in Clinical Pharmacology and Experimental Therapeutics from the University of Oxford. The local filings, the domestic responsible entity, and any market-specific testing are then built around it rather than from scratch.

How Oxford Biosciences helps

We prepare the safety documentation that each East Asian filing is built on: a CPSR-grade safety assessment, an ingredient review against the relevant market inventory and restricted lists, and a market-specific assessment summary for inclusion in the local dossier or Product Information File. In-country registration or notification, the appointment of a domestic responsible person, Marketing Authorisation Holder, responsible distributor, or local agent, and any registration testing at recognised laboratories are separate engagements, which we coordinate with established local partners. East Asia engagements are quoted on application. All fees are exclusive of VAT.