Global Cosmetics Regulatory Systems: A Comparative Analysis of India, The United States and Japan

Walk into a pharmacy in Mumbai, Minneapolis, or Tokyo and the shelves look broadly similar — moisturizers, shampoos, sunscreens, lipsticks. The regulatory systems keeping those products safe, however, look quite different. Grasping those differences is not merely an academic exercise.  For any manufacturer, brand owner, or importer trying to operate across these three markets, a misstep in product classification, form selection, or labeling language can mean years of market-entry delay, financial penalties, and reputational damage. The regulatory stakes are, in short, very real.  [1,4,7] India governs cosmetics under a statutory instrument originally enacted in 1940, substantially modernised through the Cosmetics Rules 2020 and the Cosmetics Amendment Rules 2025 — eight targeted reforms published in the Gazette of India on July 29, 2025. In October 2025, India's Drugs Controller General presented a draft Drugs, Medical Devices and Cosmetics Act 2025, proposing to replace the 1940 statute entirely, for introduction during the Winter session of Parliament. [2,5,8] The United States operated under essentially the same cosmetics legislation for eighty-four years before MoCRA was enacted on December 29, 2022, introducing mandatory facility registration, product listing, safety substantiation, and adverse event reporting. Implementation remains uneven: the GMP rule has slipped to a long-term actions list, the fragrance allergen rule is targeted for May 2026 at the earliest, and the FDA's December 2025 PFAS assessment — finding insufficient toxicological data for the majority of frequently used PFAS — has added momentum to a growing patchwork of state-level bans.  [3,6,9,10] Japan's system stands apart from both by virtue of its bifurcated product classification.  General cosmetics travel through a lightweight notification pathway; quasi-drugs- a uniquely Japanese category encompassing anti-dandruff shampoos, whitening preparations, antiperspirants, hair dyes, and twenty-three other product types — require something closer to a pharmaceutical marketing approval. The PMD Act amendments of May 14, 2025, have strengthened supply-chain obligations and adverse event systems, and the PMDA's April 2026 mandate for eCTD v4.0 electronic submissions makes Japan the first major regulatory authority globally to require that format.  [11,12,13]

Part I: India: Cosmetics Regulatory Framework

1. INDIA: COSMETICS REGULATORY FRAMEWORK
   1. Legislative Architecture
      1. Drugs and Cosmetics Act 1940

Drugs and Cosmetics Act, 1940 (1940 Act) is the basis of India’s cosmetics legislation. Section 3(aaa) describes the definition of a cosmetic, being any substance applied to the human body for the purposes of cleansing, beautification, promotion of attractiveness or changing appearance, and includes substances used in composition in this definition. The definition is technology agnostic and has proved flexible enough to allow the incorporation of products that could not even be thought of at the time the Act was introduced by Parliament. This Act is complemented by the Drugs and Cosmetics Rules, 1945, in Schedule M-II (Good Manufacturing Practice Requirements), Schedule Q (Permissible Colorant List) and Rules 134-145D. [14,15] In 2025, the CDSCO released new guidelines that established the distinction between cosmetic and drug products for borderline products. According to these guidelines, three criteria alone would qualify a product for being considered a drug, rather than a cosmetic, and hence be licensed through the drug pathway: an SPF rating greater than 30; a functional or medicinal claim such as "heals acne" or "restores the skin barrier"; or inclusion of any of the following scheduled active pharmaceutical ingredients: clindamycin, hydroquinone, or minoxidil. Aesthetic claims such as "even skin tone" and "radiance boost" would qualify for cosmetic classification. The upshot is that formulators of sunscreens or medically active skin care products have to consider India's classification guidelines as an active compliance issue right from the formulation stage. [16]

1. 1. 2. Cosmetics Rules 2020

The Cosmetics Rules 2020, issued on December 15, 2020, marked the most comprehensive restructuring of India's cosmetics regulation system since the enactment of the 1940 Act. The five notable changes are as follows: First, the whole process of cosmetic importation was made electronic using the SUGAM portal (cdscoonline.gov.in). This is done by replacing the old paper-based process based on Form 42/43 with a new set of forms called COS-1 to COS-23. Second, the notion of "New Cosmetic," which applies where an ingredient is used in the product for which there has been no prior approval in India, was introduced along with the application form (COS-12) associated with the same. Third, the provision of cosmetic loan licensing was made using the new Form COS-8. Fourth, the classification of products was made under a Fourth Schedule categorizing fourteen categories of products eligible for registration for import. Fifth, a Ninth Schedule was introduced identifying Indian standards for cosmetics and a Tenth Schedule for permissible colorants. [14,17]

1. 1. 3. Cosmetics Amendment Rules 2025 — Eight Targeted Reforms

The latest amendment made to this law is the Cosmetics Amendment Rules, 2025, which were notified as Gazette Notification G.S.R. 513(E) on 29th July, 2025, using powers derived from Sections 12 and 33 of the 1940 Act, after consulting the Drugs Technical Advisory Board. The amendments came into force immediately after being notified and incorporated eight changes related to labeling regulations as well as enforcement actions.  [8,18,19]

• Limitation in Expiry Labeling (Rule 34 Amendment): Rule 34 has given clear statutory definitions for terms such as “use before” and “date of expiry.” ‘Use before’ means before the first day of the stated month; ‘date of expiry’ means the last day of that month. Removes ambiguity at customs and retail enforcement stages
• Rule 31A – Suspension or Cancellation of License: State Licensing Authorities may suspend or cancel a manufacturing licence for non-compliance after issuing a show-cause notice and opportunity for hearing. Appeal to State Government lies within 90 days.
• Change in Terminology: The term “Controlling Officer” has been replaced with “Controlling Authority” in several rules to improve regulatory clarity. Additionally, the term “license” was substituted with “approval” for recognized testing institutions, creating a distinction between manufacturing licenses and laboratory approvals.
• Rule 26 – Batch-wise Record Retention: Manufacturers are required to maintain batch-wise records of raw materials received and finished products manufactured for either three years from the date of manufacture or six months after the expiry date of the product, whichever is later. These records may be maintained in physical or electronic form. Soap manufacturers are exempted and may follow procedures approved by the licensing authority.
• Rule 11 – Central Cosmetics Laboratory: The Central Drugs Laboratory has been designated as the Central Cosmetics Laboratory responsible for routine testing, appellate testing of disputed samples, and other functions assigned by the Central Government.
• Rule 34(10) – Flexibility in Export Labeling: Cosmetics intended for export are permitted to comply with the labeling requirements of the importing country rather than domestic Indian labeling regulations. In cases where the foreign consignee requests confidentiality, the manufacturer’s name may be replaced with a code number approved by the State Licensing Authority.
• Rule 49 – Transportation of Samples: The provision allowing transportation of samples through courier services was removed to ensure that enforcement samples are transferred only through reliable and legally verifiable channels.
• Rule 53 – Disposal of Spurious Cosmetics: Rule 53 incorporated reference to Section 17D of the Drugs and Cosmetics Act, 1940, providing legal authority for the seizure and disposal of counterfeit or spurious cosmetics.

2.1.4 Proposed Drugs, Medical Devices and Cosmetics Act 2025:

The most significant regulatory initiative by India recently is the Drugs, Medical Devices and Cosmetics Act 2025. The draft bill was put forth in a high-level Union Health Ministry meeting presided over by Health Minister J.P. Nadda on October 15, 2025 by the Director-General of India. In case the legislation gets passed into law, it will mark an end to the 1940 Act for the first time in 85 years since that statute became the prevailing regulation. Some of the important characteristics of the new law include: conferring statutory authority on CDSCO for action against sub-standard or spurious cosmetics; digitization of all licensing procedures; greater coordination between the Central and State level regulatory agencies; and a Program to upgrade the testing lab facilities. [20]

2.2 Regulatory Authority Structure

Authority flows along two parallel tracks: a central import registration track managed by CDSCO/DCGI, and a state manufacturing licensing track managed by individual State Licensing Authorities [14,15,17]

Figure: India cosmetics regulatory authority tree — Sources: [14, 15, 17]

2.3 Product Classification

Unlike Japan's two-tier cosmetics classification scheme, India's regulatory regime adheres to the "one cosmetics class" system. However, The Cosmetics Rules, 2020 further categorizes imports into fourteen specific groups under the Fourth Schedule: skin care preparations; hair care preparations; nail preparations; oral care preparations; eye preparations; shaving preparations; deodorants and antiperspirants; color cosmetics; bath and shower preparations; sun protection preparations; children's make-up preparations; insect repellent cosmetics; feminine hygiene preparations; and miscellaneous category. Each group serves as the basic unit for registration charges and certificate issuance. The "New Cosmetic" sub-category, launched in 2020, concerns products containing any substance that does not have a previous history of being regulated in India. These products are filed under Form COS-12, and need to be backed up by: reference safety data from the EU, USA, or Japan; complete toxicology studies conducted for the novel ingredients; and applicable BIS specifications. No marketing can be done before receiving CDSCO's approval. Such a route has been critical for introducing innovations in skincare active ingredients like peptides, growth factor analogues, or novel UV filters that might be common in other markets. [14,17]

2.4 Registration — Import Pathway (COS-1 to COS-2 Flowchart)

Figure maps the complete import registration pathway for cosmetics entering India under the Cosmetics Rules 2020, tracing each step from the initial appointment of an Indian representative through to customs clearance and the commencement of lawful marketing.  The decision node at Step 5 — where CDSCO determines whether the application is satisfactory — is the point at which most delays occur; brands that prepare comprehensive documentation from the outset avoid the iterative query-and-response cycle that can add months to the timeline.  [14,15,17]

STEP 1 — Appoint Indian Representative

Manufacturer / Authorised Agent / Indian Subsidiary / Importer

↓

STEP 2 — Classify Product (Fourth Schedule)

14 categories · New Cosmetic (Form COS-12) if novel ingredient

↓

STEP 3 — Compile Mandatory Documents

Free Sale Certificate · Manufacturer Authorization · Certificate of Analysis · IS 4011:2018 test report · Full ingredient list with % · Labels · No-animal-test self-declaration · Heavy metal declaration

↓

STEP 4 — Submit Form COS-1 via SUGAM Portal & Pay Fee

cdscoonline.gov.in · Government Fee: USD 1,000/category + USD 50/variant + USD 500/extra site · Pay via Bharatkosh gateway

↓

STEP 5 — CDSCO Scrutiny (Statutory Timeline: 180 Working Days)

Ingredient check vs IS 4707:2025 · Labeling review · Heavy metal limits · Safety data adequacy

↓

? Application Satisfactory?  ?

YES → Proceed | NO → Discrepancies notified via SUGAM → Applicant rectifies → Resubmit

↓

STEP 6 — COS-2 Import Registration Certificate Issued

Valid 5 years · Retention fee every 5 years · Late fee 2 %/month within 180-day grace period · COS-4 / COS-4A for secondary importers (valid 3 years)

↓

STEP 7 — Port Clearance (CDSCO Port Office)

Present COS-2 · Submit no-animal-test manufacturer undertaking to Customs · Confirm ≥ 30 % shelf life remaining

↓

STEP 8 — Marketing in India Commences

Label compliance (Rule 34) · GMP maintained · Immediate notification of any foreign market withdrawal to CDSCO

Figure: India imports registration flowchart (COS-1 → COS-2) — Sources: [14, 15, 17, 21]

2.5 Licensing — Domestic Manufacturing

2.5.1 Manufacturing License (Form COS-5)

Cosmetic manufacturers in India must obtain a manufacturing licence from the respective State Licensing Authority (SLA) under the Drugs and Cosmetics Act, 1940 and Cosmetics Rules, 2020. Under Rule 31, the SLA must decide on a complete application within 45 days, followed by a facility inspection within 30 days to validate the GMP self-declaration (Form COS-7). False declarations may result in licence cancellation; correctable flaws result in a stop-manufacture order. The licence is valid forever, subject to retention costs every five years; a 180-day grace period applies, with a 2%/month surcharge for late payment.  The licence remains valid subject to payment of retention fees every five years. [14,15,22,23]

2.5.2 Loan Licence (Form COS-8)

The Cosmetics Rules 2020 officially recognized the loan license scheme whereby the loan licensee obtains the right to use the premises and facilities owned by a licensed manufacturer, but the loan licensee is entirely responsible for ensuring regulatory compliance of the product manufactured through such an agreement. Both the manufacturing license of the loanor and the license of the loan licensee need to be in force at all times. [14,22]

2.6 Ingredient Safety Standards

2.6.1 IS 4707 Framework and the 2025 Revision

The framework for ingredient safety in India relies on BIS IS 4707, which categorizes cosmetic ingredients as GRAS (Generally Recognized as Safe) or GNRAS (Generally Not Recognized as Safe) and includes five schedules: banned compounds; restricted chemicals; authorised preservatives; approved colorants (IS 4707 Part 1, Schedule Q); and approved sunscreens. The D&C Rules 1945 include Rules 134–145-D, which impose extra legal restrictions. BIS made significant changes to IS 4707 in August 2025: On September 3, 2025, IS 4707 (Part 2):2025, the fifth revision of the GNRAS and restricted ingredient list, and IS 4707 (Part 3):2025, a new stand-alone preservative standard, were made publicly available. These additions bring India's ingredient governance closer to the detailed Annexes of the EU Cosmetics Regulation.  [2,15,24]

2.6.2 Specific Prohibitions and Concentration Limits

2.7 Good Manufacturing Practices

India's cosmetics GMP requirements derive from Schedule M-II of the Drugs and Cosmetics Rules 1945 and the Seventh Schedule of the Cosmetics Rules 2020. At the licence application stage, the manufacturer submits Form COS-7 — a structured GMP self-declaration covering premises, plant, equipment, and documentation systems. Post the Cosmetics Amendment Rules 2025, licensees must additionally maintain batch-wise records for raw materials and finished products for the longer of three years from manufacturing date or six months after expiry.  Records may be held in hard copy or electronic format. Inspectors appointed by both central and state governments audit licensed facilities at minimum once every three years or more frequently on a risk-informed basis. The Central Cosmetics Laboratory — formally redesignated under the 2025 amendments — holds appellate testing authority over disputed samples.  [14,17,18]

2.8 Labeling Requirements

Cosmetics labeling in India is governed by Rule 34 of the Cosmetics Rules 2020, the Legal Metrology (Packaged Commodities) Rules 2011, and any BIS standard referenced in the Ninth Schedule. A critical institutional point: neither the CDSCO nor the SLA formally approves product labels at the time of granting authorization. A product missing required declaration is "misbranded” under the 1940 Act, exposing the responsible party to licence suspension, cancellation of the import registration, or criminal prosecution.  [14,26] Mandatory labeling elements that must appear on both inner and outer packaging of all  cosmetics sold in India include: product name and brand; manufacturer's full name and  address (appreciable to principal location and postal code for containers of ≤ 60 ml  liquid or ≤ 30 g solid/semi-solid); import registration certificate number from Form  COS-2 (mandatory for all imports under Rule 34, Sub-Rule 9); manufacturing licence  number; net content in metric units; batch or lot number; expiry information; a full  ingredient list in descending order by weight/volume for components above 1%,  followed in any order by those at 1% or below, preceded by the word INGREDIENTS;  and applicable directions and warnings. All mandatory text must appear in English; Hindi and regional language translations may supplement, but cannot replace, English declarations.  [26,27] The Cosmetics Amendment Rules 2025 added precision to the expiry date obligation.  'Use before' now means the consumer must use the product before the first day of the stated month; 'date of expiry' means the product expires on the last day of that month.  Rule 34(10), also amended in 2025, allows cosmetics intended for export to carry labeling that complies with the destination country's requirements rather than India's domestic standards — a relief provision for contract exporters that closes a longstanding compliance gap.  [18,26]

2.9 Animal Testing, Post-Market Surveillance, and Enforcement

India maintains an absolute statutory ban on animal testing for cosmetic products and their ingredients. The prohibition operates at two procedural points: at registration or licensing, the applicant must submit a signed and stamped self-declaration confirming no animal testing; and at every port of importation, the manufacturer must separately provide a written undertaking to the Commissioner of Customs. Violations attract imprisonment for up to three years and a fine not exceeding INR 5,000 under the 1940 Act.  [2,15] Post-market surveillance depends on four mechanisms operating in parallel. Any regulatory action taken against a registered product anywhere in the world — market withdrawal, restriction, cancellation of authorization — must be reported to CDSCO immediately, with dispatch and marketing suspended pending resolution. State drug control offices inspect licensed factories at minimum once every three years under a risk-based Programme.  Consumer and industry complaints are managed through the SUGAM portal. The Central Cosmetics Laboratory — now formally designated under the 2025 amendments — provides an appellate testing mechanism for disputed samples. Rule 53, as amended in 2025, provides enforcement officers with an unambiguous statutory basis under Section 17D of the 1940 Act to seize and dispose of spurious cosmetics — closing a previous gap that had hampered action against counterfeits.  [14,18,19]

Part II: UNITED STATES: COSMETICS REGULATORY FRAMEWORK

2. UNITED STATES: COSMETICS REGULATORY FRAMEWORK

3.1 Legislative Architecture and MoCRA 2022

The United States constitutes the world's single largest national cosmetics market, with an estimated aggregate value in excess of USD 100 billion. For eighty-four years, it was regulated under a framework that had changed so little since 1938 that it had become something of a global outlier. The Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act) gave the FDA authority to pursue adulterated and misbranded cosmetics after they reached the market, but the pre-market toolkit was thin: facility registration was voluntary, ingredient listing was voluntary, adverse event reporting was voluntary, and there were no binding GMP regulations for cosmetics. The only pre-market approval requirement was for color additives, under the Color Additive Amendments Act of 1960.  [3,9,28] The Modernization of Cosmetics Regulation Act 2022 (MoCRA) changed that landscape.  Enacted on December 29, 2022 — as Section 3501 of the Consolidated Appropriations Act 2023 (H.R. 2617) — MoCRA added Sections 607 through 613 to the FD&C Act and established for the first time a comprehensive, mandatory national regulatory framework for cosmetics.  Its headline provisions are: mandatory facility registration (§607(a)); mandatory product listing with full ingredient disclosure (§607(c)); safety substantiation obligations; mandatory serious adverse event reporting within fifteen business days; FDA recall authority; a directive to promulgate binding GMP regulations; a fragrance allergen disclosure rule; and standardized asbestos testing methods for talc-containing cosmetics. [3,6,9,28]

3.2 Regulatory Authority Structure

Figure: USA cosmetics regulatory authority structure — Sources: [3, 6, 9, 28]

3.3 Registration, Listing, and Safety Substantiation

Section 607(a) of the FD&C Act requires every facility that manufactures or processes cosmetics for US distribution — domestic or foreign — to register with the FDA.  Registration is submitted electronically through the FDA's Cosmetics Direct portal using the Structured Product Labeling format; facilities must first obtain an FDA Establishment Identifier (FEI) number. Existing facilities had a July 1, 2024 enforcement deadline following an initial six-month grace period; new facilities must register within sixty days of commencing operations. Registrations are renewed biennially.  As of January 1, 2025, the system held 9,528 unique active facility registrations.  [3,6,9] Section 607(c) requires the "responsible person" — the manufacturer, packer, or distributor named on the label — to file a product listing for every marketed cosmetic, including a full ingredient disclosure. Products in commerce before December 29, 2022 were subject to a July 1, 2024 deadline; new products must be listed within 120 days of first entering interstate commerce. Listings are renewed annually, including formal notification of discontinuations. A single listing may cover products with identical formulations or formulations differing only in color, fragrance, flavor, or fill quantity.  As of January 1, 2025, the FDA database held 589,762 active product listings.  [9,28,29] More’s safety substantiation requirement obliges responsible persons to maintain adequate documentary evidence that each cosmetic product is safe before marketing begins.  The statutory standard for "adequate substantiation" requires tests, studies, research, analyses, or other evidence that qualified scientific experts would consider sufficient to establish a reasonable certainty of safety under normal conditions of use.  Products lacking adequate substantiation on file are deemed adulterated and cannot be lawfully sold. The FDA may inspect substantiation records during facility visits.  [3,9]

3.4 PFAS Assessment, GMP Backlog, and Fragrance Allergen Rule

The FDA released its congressionally mandated PFAS cosmetics assessment on December 29, 2025, meeting that specific statutory deadline under MoCRA Section 3506. Based on mandatory product listing data submitted to the FDA, 51 distinct PFAS are intentionally incorporated as ingredients across 1,744 cosmetic formulations — approximately 0.41 percent of all products in the listing database as of August 30, 2024. Of the 25 most frequently used PFAS, representing about 96 percent of all PFAS use in cosmetics, the FDA found that toxicological data for a majority were incomplete or unavailable. Five PFAS appeared to present low safety concerns under intended use conditions; one PFAS was identified as having a potential safety concern with significant remaining uncertainty. [10,30] Several U.S. states, including California, Colorado, Maryland, Minnesota, and Washington, implemented bans on intentionally added PFAS in cosmetics from January 1, 2025, while additional restrictions are planned in other states between 2026 and 2032. In addition, California included vinyl acetate, N-methyl-N-formylhydrazine, and bisphenol S under Proposition 65, making warning labels mandatory for applicable cosmetic products from 2026. [10,31] MoCRA directed the FDA to issue proposed GMP regulations by December 29, 2024 and to finalize them by December 29, 2025. Both deadlines were missed. According to the Fall 2025 FDA Unified Agenda, the proposed GMP rule has been moved to the "long-term actions list," with no near-term publication date indicated. The regulatory home for cosmetics GMP is anticipated to be 21 CFR Part 711. ISO 22716:2007 (Cosmetics — Good Manufacturing Practices) operates as the industry's de facto standard in the interim.  [6,32,33] The fragrance allergen disclosure rule — which MoCRA directed the FDA to issue by June 2024 — has been repeatedly delayed. The FDA withdrew the December 2024 asbestos testing proposed rule for talc-containing cosmetics on November 28, 2025, further extending that compliance timeline. As of early 2026, the Spring 2025 Unified Agenda targets a fragrance allergen Notice of Proposed Rulemaking (NPRM) for May 2026; the final rule is unlikely before 2027. In a separate and more positive development, the FDA proposed on December 11, 2025 to add Bemotrizinol (Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine) at up to 6 percent to the OTC Monograph M020 for sunscreen — one of the advanced EU-approved UV filters that American consumers have long awaited.  [6,31,32,33]

3.5 Labeling, Adverse Events, and Animal Testing

In the U.S., cosmetic labelling is regulated by the FD&C Act, the Fair Packaging and Labelling Act, and 21 CFR Parts 701-740. Required labelling includes the product identity statement, name and address of the manufacturer, packer, or distributor, net quantity in metric and U.S. customary units, ingredient list in descending order using INCI nomenclature, and required warning statements. MoCRA also required the provision of contact information for reporting adverse events and “for professional use only” labelling for cosmetics that are solely for licensed professionals. [3,6,9] MoCRA's serious adverse event (SAE) reporting requirement obliges responsible persons to report SAEs to the FDA within fifteen business days. A SAE is defined as an event resulting in death, a life-threatening experience, inpatient hospitalisation, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an infection, as well as any event requiring medical or surgical intervention to prevent such an outcome. Additional medical information received within twelve months of the initial report must also be submitted within fifteen business days. Records of all adverse events — including non-serious ones — must be retained for six years, or three years for qualifying small businesses.  [3,9,29] The United States does not maintain a federal ban on animal testing for cosmetics.  MoCRA's legislative history reflects a normative preference against animal testing, but no enforceable prohibition was enacted at the federal level. Multiple states have filled that gap: California, Virginia, Nevada, Maryland, and Illinois each maintain their own cosmetics animal testing prohibitions. Arizona Senate Bill 1005, introduced in early 2026, would add a further state-level ban.  [9,29]

Part III- Japan: Cosmetics Regulatory Framework

3. JAPAN: COSMETICS REGULATORY FRAMEWORK
   1. Legislative Foundation and 2025 PMD Act Amendments

Japan ranks as the world's third-largest cosmetics market, with an estimated value of approximately USD 35 billion and a projected CAGR of 3.12 percent between 2025 and 2030.  Japanese consumers are internationally recognised for their product sophistication — high expectations for formulation precision, evidence-based functional claims, and premium packaging — and the regulatory system reflects those expectations.  It is among the world's most technically demanding cosmetics frameworks.  [11,13,34] The statutory foundation is the Pharmaceutical and Medical Devices Act (PMD Act), formally titled the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145 of 1960, as substantially revised).  The Act came into force in its current consolidated form on November 25, 2014, replacing the older Pharmaceutical Affairs Law. It governs the full product lifecycle — from pre-market classification and marketing authorisation through manufacturing licensing, labeling, quality management, and post-market surveillance.  [11,34,35] On May 14, 2025, the National Diet of Japan approved amendments to the PMD Act after a five-year review period. The reforms increased adverse event reporting requirements for Marketing Authorisation Holders (MAHs), established a Supply System Manager to report supply disruptions to the MHLW and expanded conditional approval pathways for certain medical and quasi-drug products, with implementation continuing through May 2027. Meanwhile, the Pharmaceuticals and Medical Devices Agency announced that eCTD v4.0 electronic submissions will be mandatory from April 2026. [12,13,35]

4.2 Regulatory Authority Structure

The Japan Cosmetic Industry Association (JCIA) plays an influential advisory and standard-setting role, though it lacks statutory regulatory authority. [11,34,35]

Figure: Japan cosmetics regulatory authority tree — Sources: [11, 34, 35, 36]

4.3 Product Classification — Cosmetics vs Quasi-Drugs

Japan's most distinctive regulatory feature is its bifurcated product classification.  Under Article 2, Paragraph 3 of the PMD Act, cosmetics are defined as articles with mild action on the human body, applied by rubbing, sprinkling, or similar means, for the purpose of cleansing, beautifying, enhancing attractiveness, altering appearance, or maintaining the skin or hair in good condition. Six product categories are recognised under this definition: skin care; makeup; hair care; fragrances; bath products; and oral care without therapeutic claims.  [11,34,36] Quasi-drugs occupy the space between cosmetics and pharmaceuticals. They exhibit mild pharmacological activity for specific purposes designated by MHLW under Announcement No. 25 (February 6, 2009), which currently lists twenty-seven quasi-drug categories. These include:  anti-dandruff shampoos and conditioning products; skin-whitening preparations; anti-acne products; deodorants and antiperspirants; hair-growth stimulants; hair dyes; hair perming products; medicated toothpastes; bath agents with therapeutic claims; mouthwashes; topical antiseptics; wound disinfectants; preparations for chapped skin; treatments for heat rash; and several others. Efficacy must be achieved through active ingredients drawn from the MHLW-approved quasi-drug ingredient list.  [11,36,37]

The consequences of misclassifying a product in either direction is severe. A cosmetic that bears quasi-drug efficacy claims without the necessary marketing approval faces withdrawal, administrative penalties, and potential licence revocation. Getting the classification right requires a pre-launch evaluation based on three factors: the intended claims; whether the proposed active ingredients and additives conform to the MHLW-approved quasi-drug ingredient list; and precedent from comparable products already authorized on the Japanese market. Simple quasi-drug applications typically require nine to twelve months for approval; those involving new active ingredients take substantially longer.  [36,37]

4.4 Registration and Notification Pathways:

Figure illustrates the two regulatory pathways in Japan: the simplified notification system for cosmetics, which does not require pre-market approval from the MHLW, and the stricter premarket approval process for quasi-drugs under Article 14 of the PMD Act. Selecting the correct pathway is a key consideration before entering the Japanese market. [11,36,37]

4.5.1 Manufacturing Licence

Any entity — domestic or foreign — that manufactures, packages, stores, or applies Japanese-language labels to cosmetics within Japan must hold a Cosmetics Manufacturing Licence from the prefectural Pharmaceutical Affairs Division with jurisdiction over the relevant facility. Foreign brands that arrange for third-party warehousing or labeling within Japan must ensure those third-party operators hold the appropriate licence. The application requires: corporate registration documents; evidence of the responsible engineer's qualifications; testing laboratory contracts where applicable; and detailed facility floor plans. The entire process is conducted in Japanese, and initial licensing typically takes more than two months. The licence is valid for five years.  [36,37,38]

4.5.2 Marketing Authorization Holder Licence

In Japan, all entities promoting cosmetics commercially must possess a Cosmetics Manufacturing and promoting Licence, also known as a Marketing Authorisation Holder licence.  Foreign corporations cannot hold this licence directly; instead, they must nominate a Japanese corporation to serve as the MAH. The MAH bears the entire regulatory burden, including filing all notifications, verifying ingredient compliance with the Standards for Cosmetics, maintaining GQP and GVP systems, reporting potential harmful effects to MHLW within thirty days of awareness, responding to consumer enquiries, and managing product recalls. The MAH shall also select a qualified Marketing Supervisor-General with established academic and professional credentials under the PMD Act.  Both licences have five-year durations.  [11,36,37] For quasi-drugs created outside, the foreign producer must also become an "Accredited Foreign Manufacturer" with MHLW. The application is submitted to PMDA's Administrative Division II and must include: the curriculum vitae of the manufacturing establishment's responsible person; a list of products to be manufactured for import into Japan; manufacturing process documentation; and building and facility documents. There are three accreditation categories: full sterile quasi-drug manufacture, full non-sterile quasi-drug manufacturing, and packing, labelling, and storage operations only.  [36,38]

1. 6. Ingredient Standards, GQP, GVP, and Labeling

Japan's ingredient governance follows a hybrid positive/negative list approach under the Standards for Cosmetics (September 2000 Ministerial Notification). Preservatives, UV absorbers, and tar colors are subject to a positive list with maximum concentration limits. Other ingredients may be freely used following the MAH's safety assessment, provided they are absent from the negative list of 30 prohibited substances — including mercury, cadmium, strontium, and selenium compounds — and the list of 18 restricted ingredients with defined use conditions. For quasi-drugs, the JSQI governs all active ingredient specifications, concentration limits, and testing methods.  [11,36,39,40] The GQP Ordinance 2005 mandates documented quality systems, delivery and recall procedures, and consumer inquiry systems for all MAH holders — a prerequisite for the MAH licence. The GVP Ordinance 2005 mandates active collection of safety signals and reporting to MHLW within 30 days of awareness of any potential harm.  [11,36] Japanese-language labeling is mandatory for all cosmetics and quasi-drugs. The JCIA publishes the standardised Japanese INCI ingredient label names that manufacturers must follow. A total of 56 MHLW-sanctioned efficacy claim wordings are available for cosmetics; quasi-drug claims are strictly limited to those approved during the marketing approval process. Revised Special Labeling Rules of March 10, 2025 replaced the 1985 framework, requiring scientific substantiation whenever specific ingredients are highlighted in any product communication.  [36,41]

4. GLOBAL COSMETIC REGULATORY SYSTEMS: COMPARATIVE ANALYSIS