Compliance
Cosmetic regulations by market, with the latest amendments
42 markets, one card each: the authority, notification vs registration, who must be the local responsible person, what the safety file needs, key labeling rules, and the most recent change. Where a market's banned/restricted list is in our inventories, it links straight through.
Every entry cites an official or industry source; the official text of each market prevails and this is a factory-side digest, not legal advice. Data updated 2026-09-10.
Latest changes, 2025–2026
Newest first; only changes in force or with a published date.
European Union · Expanded EU fragrance-allergen labelling becomes mandatory for new products
Regulation (EU) 2023/1545 adds 56 allergens to Annex III; products placed on the market from 31 July 2026 must name them above 0.001% (leave-on) / 0.01% (rinse-off), with existing products to comply by 31 July 2028 — Switzerland applies the same annex and Canada mirrors the list.
SourcesMainland China · China NMPA Announcement No. 70 (2026) streamlines registration and filing
Eight measures: a first-launch-in-China commitment replaces home-market sale proof, animal-test exemptions widen, ingredient safety data are archived instead of submitted, similar formulas may share test reports, cross-border production transfers and domestic-responsible-person changes are simplified, and more efficacy-test methods are accepted.
SourcesUnited Kingdom (Great Britain) · UK SI 2026/23 and SI 2026/109 set GB-specific bans and dates
Great Britain bans 4-MBC and lowers the formaldehyde-releaser warning threshold to 0.001% from 15 July 2026, bans CMRs incl. TPO from 15 August 2026 (sell-through to 14 February 2027), restricts hexyl salicylate from 15 August 2026 and bans 17 more CMRs incl. nano silver from 23 March 2027, while still not adopting the EU 2023/1545 allergen expansion.
SourcesTaiwan · Taiwan makes PIF and GMP mandatory for all general cosmetics
The final phase of the Cosmetic Hygiene and Safety Act roll-out requires every general cosmetic (except exempt handmade soap) to hold a Product Information File with a safety assessment and to be manufactured under 化粧品優良製造準則, on top of the existing product notification.
SourcesASEAN (ASEAN Cosmetic Directive) · ASEAN releases revised ACD Annexes II, III, IV and VI
After the 43rd ACC meeting, bifonazole, clotrimazole, thiabendazole and tioconazole were banned, kojic acid capped at 1%/0.2%, BHT and verbena absolute restricted and chlorophene/2-chloroacetamide dropped as preservatives; Malaysia transposed the changes by NPRA Circular 2/2026 on 2026-07-06 and the Philippines had adopted the 40th–42nd ACC changes by FDA Circular 2026-0001 on 2026-04-22.
SourcesAustralia · Australia requires an AICIS assessment certificate for retinal in consumer products
Following evaluation EVA00186 (presumed developmental toxicant, Repr. 1B), retinal/retinaldehyde with any consumer end use can no longer be exempted or reported, so an assessment certificate is needed before import or manufacture of retinal serums, creams and moisturisers.
SourcesBangladesh · Bangladesh publishes draft Cosmetics (Licence and Registration) Rules 2026
The Health Services Division released for comment the draft rules that will operationalise cosmetics licensing and registration under the Drugs and Cosmetics Act 2023 (DGDA), which has so far run without detailed rules.
SourcesBrazil · Brazil issues RDC 1.029/2026 and 1.030/2026 ingredient lists after 2025 bans
ANVISA's new Mercosur-harmonised restricted list (part 1, 24-month adaptation) and prohibited list (12-month adaptation) follow RDC 995/2025's TPO and DMPT ban in force 2025-11-03 and Law 15.183/2025's animal-testing ban from 2025-07-31; consultation 1.399/2026 on the second restricted-list tranche ran until 8 September 2026.
SourcesUkraine · Ukraine adopts Resolution No. 737 amending the cosmetics Technical Regulation
Re-issues Annexes 2–6 to EU 1223/2009 levels, keeps 2026-08-03 as the date from which all newly placed cosmetics must be notified and fully compliant, allows legacy/non-notified stock to be sold until 2030-08-03, and enters into force six months after publication (2026-12-13).
SourcesEuropean Union · Regulation (EU) 2026/909 ('Omnibus Act 2') enters into force
Published 2026-04-28, it restricts fragrance allergens (benzyl salicylate, citral/geranial/neral, acetylated vetiver oil), aluminium compounds, zinc salts and several hair dyes and bans triphenyl phosphate, with a placing-on-market deadline of 2027-01-01 and sell-through to 2028-07-01 (citral 2028-08-01).
SourcesArgentina · Argentina adopts Mercosur GMC 27/25, 06/25 and 07/25 lists and deregulates imports
Disp. 2820/2026 bans TPO and N,N-dimethyl-p-toluidine with 60 days to adapt; Disp. 2599/2026 and 2601/2026 (BO 2026-05-21) replace the 2011/2014 restricted and prohibited lists; earlier Disp. 4033/2025 removed ANMAT prior intervention on cosmetic imports from 2025-07-10 and Disp. 7939/2025 allowed establishment enabling by sworn declaration.
SourcesEuropean Union · EU Omnibus VIII (Regulation (EU) 2026/78) applies
Published 2026-01-13, it bans nano and massive silver, restricts silver powder, hexyl salicylate and o-phenylphenol, and required withdrawal of non-compliant products by 1 May 2026 without a stock-clearance period.
SourcesCanada · Canada mandates fragrance-allergen disclosure on cosmetic labels
Under SOR/2024-63, 24 fragrance allergens must appear in the ingredient list above 0.001% leave-on / 0.01% rinse-off from 12 April 2026, expanding to 81 allergens for new products from 1 August 2026 and all products from 1 August 2028, with compliance promotion until 11 April 2027.
SourcesSouth Korea · Korea enacts a mandatory cosmetic safety assessment system (Act No. 21302)
Responsible sellers must prepare and retain a safety assessment reviewed by a qualified assessor before marketing; MFDS issued preparation guidelines on 2026-06-10 and draft Decree/Rule amendments on 2026-07-08, with phased application from 2028 and full enforcement around 2031.
SourcesIsrael · Israel proposes a 'U.S. track' and retailer duties for cosmetics
A Ministry of Health legislative memorandum would allow import of FDA-compliant cosmetics alongside the EU track, impose verification duties on retailers via the MoH cosmetics database, bring solid soap into scope and create a standing advisory committee; it remains a proposal.
SourcesUnited States · FDA withdraws talc-asbestos testing rule while other MoCRA rules stay pending
FDA withdrew the December-2024 proposed talc testing rule, issued its PFAS-in-cosmetics report (2025-12-29) and draft mandatory-recall guidance (2025-12-18); GMP, fragrance-allergen and formaldehyde hair-smoothing rules missed statutory deadlines with NPRMs now targeted for November 2026, and biennial facility-registration renewals began two years after each initial registration.
SourcesIndonesia · Indonesia issues PerBPOM 25/2025 on cosmetic ingredients ahead of the halal deadline
Issued in October 2025 (day inferred from its one-year transition ending 2026-10-03), PerBPOM 25/2025 replaced the 2019/2022 ingredient rules with tighter ACD-aligned limits; two weeks after that deadline, on 2026-10-17, BPJPH halal certification becomes mandatory for all cosmetics under PP 42/2024.
SourcesKazakhstan (EAEU member) · EEC Council Decision No. 74/2025 amends TR CU 009/2011 ingredient annexes
Published 2025-10-28 and applicable across the EAEU (incl. Kazakhstan) from 2026-10-28, it adds 14 prohibited substances, three restricted substances, a new UV filter (incl. nano form) and bans fluorides in liquid oral products for children under 6, with a 0.001% formaldehyde labelling threshold from 2027-01-01; EEC Board Decision No. 31 (2026-03-10) set transition periods.
SourcesSaudi Arabia · SFDA bans 21 more cosmetic ingredients
After a 2025-08-14 circular adding three restricted substances, SFDA added 21 substances (e.g. dibutyltin maleate, dibutyltin oxide, 4-nitrosomorpholine, 4-methylimidazole) to its prohibited list; import/manufacture of non-compliant products is banned from 2026-01-01 with sell-through allowed until 2028-01-01.
SourcesEuropean Union · EU Omnibus VII (Regulation (EU) 2025/877) bans TPO and other CMRs
TPO (UV nail-gel photoinitiator) and other newly classified CMR substances were added to Annex II with no sell-through: products may neither be placed nor made available on the EU market from 1 September 2025.
SourcesVietnam · Vietnam Circular 34/2025/TT-BYT takes effect; draft Cosmetics Decree in consultation
Circular 34/2025 (issued 2025-07-03) added online notification via the National Public Service Portal, while the MoH's draft Decree on Cosmetic Management (WTO G/TBT/N/VNM/349, redrafted 2026-02 and 2026-05) would replace Circular 06/2011 with mandatory CGMP-ASEAN, PIF and stricter claims rules.
SourcesColombia / Andean Community (Bolivia, Colombia, Ecuador, Peru) · Andean Decision 944, mandatory labelling regulation and Colombia's animal-testing rule
Decision 944 removes the blanket Spanish-translation requirement for NSO technical files; the Andean Labelling Technical Regulation (Res. 2310) became mandatory on 2025-12-17 for Colombia, Peru, Ecuador and Bolivia; Colombia's Res. 0814/2026 (May 2026) requires a first-party no-animal-testing declaration with new and renewed NSOs.
SourcesMorocco · Morocco's AMMPS conditions cosmetic applications on updated establishment declarations
Applications filed since 2025-06-11 are processed only after the operator's cosmetics/body-hygiene establishment declaration is updated, part of the DMP-to-AMMPS transition aimed at tracing every product to a responsible operator.
SourcesJapan · Japan promulgates PMD Act amendment (Act No. 37 of 2025)
Phased in from 2025-11-20 and 2026-05-01, the amendment strengthens MAH quality/safety governance and supply obligations; the cosmetics-specific 2025 change was MHLW's 2025-03-10 notice rewriting the 特記表示 highlighted-ingredient rules to require the ingredient's purpose on packs and ads.
SourcesSri Lanka · Sri Lanka NMRA revises document requirements for new cosmetic registrations
A new 11-document checklist for importers (heavy-metal CoA, steroid-free declaration, ISO 22716/GMP certificate, Safety Assessment Report, embassy-attested FSC) applies from 2025-06-01.
SourcesMainland China · China stops accepting simplified safety assessment reports
The one-year transition under NMPA Announcement 2024 No. 50 ended, so every new registration or filing now needs a full-version safety assessment per the 2021 Technical Guidelines, with eligible general cosmetics submitting the basic conclusion and keeping the full report on file.
SourcesSouth Korea · Korea amends cosmetic packaging labelling rules
MFDS amended the Cosmetics Act Enforcement Rule (Annex 4) with immediate effect, revising how the manufacturing number, expiry date, period-after-opening and precautions must appear on all cosmetics made or imported after that date.
SourcesIsrael · Israel's 'What is good for Europe' cosmetics reform takes effect
Amendment No. 37 (2024) to the Pharmacists Ordinance replaced the cosmetic product licence (discontinued 2024-12-31) with notification of EU/UK/Swiss-compliant cosmetics by a registered Israeli responsible representative, while sensitive categories remain under approval.
Sources
East Asia 5
National Medical Products Administration (NMPA)
Mainland China
State Council Decree No. 727 (promulgated 2020-06-16) · Regulations on the Supervision and Administration of Cosmetics (CSAR)
- In force
- 2021-01-01
- Latest change
- NMPA Announcement No. 70 (2026) introduced eight registration/filing optimisation measures, incl. wider animal-test exemptions, shared test reports for similar formulas and ingredient safety data kept on file instead of submitted.Sources
- Market entry
- Pre-market: 普通化妆品备案 (filing) for general cosmetics and 特殊化妆品注册 (NMPA registration) for special cosmetics (hair dye, perm, freckle-whitening, sunscreen, anti-hair-loss, new efficacy), under 化妆品注册备案管理办法 (SAMR Order No. 35, in force 2021-05-01).
- Responsible person
- Overseas registrants/filers must appoint a 境内责任人 (domestic responsible person, a Chinese legal entity) that files the product and bears joint liability for quality and safety.
- Safety file
- 产品安全评估报告 per 化妆品安全评估技术导则 (2021): simplified reports were accepted only until 2025-05-01 (NMPA Announcement 2024 No. 50); since then a full-version assessment is required, with eligible general cosmetics allowed to submit the 安全评估基本结论 and keep the full report on file for inspection.
- Labeling
- Chinese label mandatory under 化妆品标签管理办法 (in force 2022-05-01): full ingredient list in descending order using standard Chinese names, ingredients at or below 0.1% grouped under 其他微量成分; efficacy claims must be substantiated under 化妆品功效宣称评价规范; no fragrance-allergen naming rule.
- Animal testing
- Not required for domestic general cosmetics; imported general cosmetics have been exempt from toxicology tests since 2021-05-01 if the manufacturer holds a GMP certificate from its home authority and the safety assessment confirms safety, except children's products, products using new ingredients under monitoring, or firms under key supervision; NMPA No. 70 (2026) widened the exemptions.
- Ingredient lists
- 化妆品安全技术规范 (2015年版, continuously updated: prohibited, restricted, permitted preservatives/UV filters/colorants/hair dyes) plus 已使用化妆品原料目录 (2021年版, 5th adjustment 2026-08-19).Look up this inventory here: 中国 · Safety and Technical Standards for Cosmetics — prohibited and restricted
- Notes
- The full-version safety-assessment cut-off is 2025-05-01. Other 2026 items: NMPA Announcement No. 48 (2026-05-15, mercury standard effective 2026-07-01; o-phenylphenol and Acid Violet 43 from 2028-06-01), No. 51 (2026-05-29, eight test methods effective 2027-03-01), GACC Announcement No. 61 (2026-05-11, import/export inspection rules effective 2026-12-01), e-label pilots in Shanghai/Guangdong, and a draft mandatory national labelling standard under consultation.
Customs and Excise Department (C&ED); Department of Health for pharmaceutical-type products
Hong Kong SAR
Cap. 456 Laws of Hong Kong (general safety requirement, s.4) · Consumer Goods Safety Ordinance (Cap. 456) and Consumer Goods Safety Regulation (Cap. 456A); Trade Descriptions Ordinance (Cap. 362)
- Latest change
- Hong Kong Customs warned the public about a collagen cream containing banned Sudan red dye and lacking the required Chinese warning labelling (enforcement action under Cap. 456; no new legislation).Sources
- Market entry
- None: no pre-market registration, notification or import licence for general cosmetics; only products classified as pharmaceuticals (Cap. 138) or proprietary Chinese medicines (Cap. 549) need registration.
- Responsible person
- No statutory responsible person; the Hong Kong manufacturer, importer or supplier is liable for meeting the general safety requirement.
- Safety file
- No mandated dossier; suppliers must be able to show the product meets the general safety requirement (reasonable safety by reference to international or Hong Kong standards, test reports on request).
- Labeling
- No cosmetics-specific label law, but any warning or caution on safe keeping, use or disposal must be in both English and Chinese, legibly and conspicuously (Cap. 456A); descriptions must not be false or misleading (Cap. 362); no ingredient or allergen listing mandate.
- Animal testing
- No ban and no requirement.
- Ingredient lists
- No cosmetic-specific lists; C&ED judges safety against international standards (EU/ACD/China limits) and the Poisons List under the Pharmacy and Poisons Ordinance (Cap. 138) restricts substances such as hydroquinone and certain hair-dye amines.
- Notes
- Commencement date of Cap. 456 (commonly cited as 1995) could not be verified; bilingual warnings are the only language rule.
Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare
Taiwan
Promulgated 2018-05-02 by Presidential Order, replacing 化粧品衛生管理條例 · Cosmetic Hygiene and Safety Act
- In force
- 2019-07-01
- Latest change
- Third and final phase: all general cosmetics (except handmade solid soap exempt from factory registration) must hold a Product Information File (PIF) and be made under 化粧品優良製造準則 (GMP, ISO 22716-based).Sources
- Market entry
- Pre-market 產品登錄 (online product notification) for all cosmetics: general cosmetics since 2021-07-01 and 特定用途化粧品 (sunscreen, hair dye, perm, antiperspirant, tooth whitening) since 2024-07-01, when the former 查驗登記 licence system ended.
- Responsible person
- The Taiwan manufacturer or importer (化粧品製造或輸入業者) must complete the notification, hold the PIF and appear on the label, so a foreign brand needs a Taiwan-registered importer.
- Safety file
- PIF (產品資訊檔案, 16 items incl. formula, labels, test reports and a safety assessment signed by a qualified assessor) phased in on 2024-07-01 (specific-purpose), 2025-07-01 (infant, lip, eye, non-medicated toothpaste/mouthwash) and 2026-07-01 (all general cosmetics), with fines up to NT$1 million.
- Labeling
- Traditional-Chinese labelling with product name, use, directions, batch, shelf life, full ingredient list, manufacturer/importer and origin; specific-purpose actives must show content; no separate fragrance-allergen naming rule.
- Animal testing
- Animal testing for cosmetic or ingredient safety assessment banned in Taiwan since 2019-11-09 (Art. 6) with narrow TFDA-approved exceptions; imported animal-tested products are not banned.
- Ingredient lists
- 化粧品禁止使用成分表, 化粧品成分使用限制表, 化粧品防腐劑成分名稱及使用限制表, 化粧品色素成分使用限制表, 化粧品防曬劑成分使用限制表 and 化粧品微生物容許量基準表 (nine PFAS/allergen entries added to the prohibited list from 2025-01-01).
- Notes
- GMP phases mirror the PIF phases (2024-07-01, 2025-07-01, 2026-07-01) per TFDA and Taiwan press.
Ministry of Health, Labour and Welfare (MHLW) with PMDA; prefectural governments issue licences
Japan
Act No. 145 of 1960 (renamed PMD Act 2014); latest amendment Act No. 37 of 2025 · Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act)
- In force
- 1961-02-01
- Latest change
- PMD Act amendment (Act No. 37 of 2025) promulgated and phased in from 2025-11-20 and 2026-05-01, tightening MAH governance, quality and supply obligations (largely pharma-focused); separately MHLW's 2025-03-10 notice rewrote the 特記表示 (highlighted-ingredient) rules so that the ingredient's purpose must be stated.Sources
- Market entry
- No pre-market approval for cosmetics: the licensed MAH files a 化粧品製造販売届 (notification) per product before sale, whereas products with medicinal claims are 医薬部外品 (quasi-drugs) needing MHLW approval.
- Responsible person
- A Japan-licensed 製造販売業者 (Marketing Authorization Holder) must hold the product notification and bear full responsibility, and imported goods also need a licensed 製造業者 for labelling/storage.
- Safety file
- No statutory PIF; the MAH must ensure conformity with 化粧品基準 and the GQP/GVP ordinances and keep quality and safety records.
- Labeling
- Full ingredient list in Japanese using JCIA 表示名称 (mandatory since 2001-04-01) plus product name, MAH name/address, contents and lot; a highlighted ingredient (特記表示) must state its purpose (2025-03-10 notice); no fragrance-allergen labelling rule in force.
- Animal testing
- No statutory ban and no requirement for cosmetics; quasi-drug approvals may still rely on animal data.
- Ingredient lists
- 化粧品基準 (Standards for Cosmetics, MHW Notification No. 331 of 2000, last amended 2024-07-12): negative list plus positive lists for preservatives, UV filters and tar colours.Look up this inventory here: 日本 · Standards for Cosmetics — appended tables
- Notes
- Consultancy claims that Japan will mandate fragrance-allergen labelling from May 2026 could not be verified on MHLW's site and should be treated as unconfirmed; MHLW also introduced electronic export certificates for cosmetics on 2026-07-27 (ChemLinked).
Ministry of Food and Drug Safety (MFDS)
South Korea
Act No. 6025 (enacted 1999-09-07); latest amendment Act No. 21302 (2025-12-30) · Cosmetics Act
- In force
- 2000-07-01
- Latest change
- MFDS issued draft amendments to the Cosmetics Act Enforcement Decree and Rule setting detailed safety-assessment standards (assessor qualifications, record retention) and custom-cosmetics rules, implementing Act No. 21302 whose mandatory safety assessment phases in from 2028.Sources
- Market entry
- No pre-market approval for general cosmetics (the registered responsible seller reports production/import), while 기능성화장품 (functional cosmetics: whitening, anti-wrinkle, UV, hair etc.) need MFDS review or report before sale.
- Responsible person
- A Korea-registered 화장품책임판매업자 (cosmetic responsible seller) must register with MFDS, hold the product records and appear on the label.
- Safety file
- Currently product safety/efficacy data are kept by the responsible seller; Act No. 21302 (promulgated 2025-12-30) requires a safety assessment prepared and reviewed by a qualified assessor before marketing, with MFDS guidelines issued 2026-06-10 and phased mandatory application from 2028 (full by about 2031).
- Labeling
- Korean-language label with full ingredient list (전성분표시); 25 fragrance allergens must be named when above 0.01% in rinse-off or 0.001% in leave-on products (since 2020-01-01); the 2025-02-07 Enforcement Rule amendment revised how manufacturing number, expiry date, period-after-opening and precautions are shown.
- Animal testing
- Sale of cosmetics tested on animals (finished products or ingredients) has been banned since 2017-02 under Art. 15-2, with limited exceptions such as tests required by foreign law.
- Ingredient lists
- 화장품 안전기준 등에 관한 규정 (MFDS Notification: Annex 1 prohibited ingredients, Annex 2 restricted ingredients incl. preservatives, UV filters and colorants) plus the functional-cosmetics standards.Look up this inventory here: 韩国 · Regulation on Safety Standards for Cosmetics
- Notes
- Exact effective dates of individual Act No. 21302 provisions were not verified from the statute text (ChemLinked gives a 2028 phase-in); a 2026-03-31 Enforcement Rule amendment also tightened supervision of directly-purchased overseas cosmetics.
Where this sits in the chain
Stage 6, QC & compliance: check ingredients against each market inventory first, read the market rules here once the formula is set, then run QC and the compliance file before shipping. ASEAN notification accounts have their own page.
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