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
North America 3
U.S. Food and Drug Administration (FDA)
United States
21 U.S.C. §§ 361–364k; MoCRA (Pub. L. 117-328, Div. FF, Title III, Subtitle E) · Federal Food, Drug, and Cosmetic Act (FD&C Act) Chapter VI as amended by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), plus the Fair Packaging and Labeling Act for labelling
- In force
- 2022-12-29
- Latest change
- FDA withdrew its Dec-2024 proposed rule on asbestos testing of talc-containing cosmetics; the statutory GMP and fragrance-allergen rules remain overdue (allergen and formaldehyde hair-smoothing NPRMs now targeted for Nov 2026), FDA issued its PFAS-in-cosmetics report on 2025-12-29 and first biennial facility-registration renewals fell due from Dec 2025.Sources
- Market entry
- No pre-market approval — MoCRA requires facility registration (renewed every two years) and product listing (updated annually) through FDA's Cosmetics Direct portal, enforced since 2024-07-01; color additives need FDA approval and sunscreens/anti-dandruff products are OTC drugs.
- Responsible person
- A 'responsible person' is the manufacturer, packer or distributor whose name appears on the label; a U.S. address is not mandated, but foreign facilities must name a U.S. agent and the responsible person must handle adverse-event reporting.
- Safety file
- Adequate safety-substantiation records (tests, studies or other evidence) must be kept for each product; serious adverse events must be reported to FDA within 15 business days and records kept 6 years.
- Labeling
- English labelling per 21 CFR 701 and the FPLA (identity, net contents, ingredients in descending order, warnings, responsible person name/address); MoCRA adds a domestic address/phone or e-mail for adverse-event contact and professional-use statements; fragrance-allergen disclosure starts only once FDA's pending rule is final.
- Animal testing
- No federal ban (FDA does not require animal testing); about a dozen states, e.g. California and New York, prohibit selling cosmetics newly tested on animals.
- Ingredient lists
- No annex system — 21 CFR 700 (prohibited/restricted ingredients such as mercury and chloroform), 21 CFR 73/74/82 approved color additives, plus MoCRA-mandated talc and fragrance-allergen rules still pending.Look up this inventory here: 美国 · FDA prohibited and restricted cosmetic ingredients; color additives
- Notes
- Rule status comes from FDA registration/renewal pages and a March-2026 Foley & Lardner review; NPRM target dates are Unified Agenda estimates, not published rules. MoCRA's main provisions took effect 2023-12-29.
Health Canada (Consumer Product Safety Directorate)
Canada
R.S.C. 1985, c. F-27; C.R.C., c. 869 as amended by SOR/2024-63 · Food and Drugs Act and the Cosmetic Regulations
- In force
- 1977
- Latest change
- Fragrance-allergen disclosure under SOR/2024-63 took effect: 24 allergens must be named in the ingredient list above 0.001% (leave-on) / 0.01% (rinse-off), expanding to 81 allergens for new products from 2026-08-01 and all products from 2028-08-01, with a compliance-promotion year to 2027-04-11.Sources
- Market entry
- Post-market notification — a Cosmetic Notification Form must be filed with Health Canada within 10 days after first sale in Canada; no licence or approval.
- Responsible person
- No mandatory Canadian RP; the label must carry the name and principal place of business of the manufacturer or the Canadian importer/distributor, and the notifier is accountable to Health Canada.
- Safety file
- No formal PIF — manufacturers/importers must be able to demonstrate safety on request, comply with the Cosmetic Ingredient Hotlist and may not rely on new animal-test data.
- Labeling
- Bilingual English/French mandatory statements; INCI ingredient list; fragrance allergens named above 0.001% leave-on / 0.01% rinse-off from 2026-04-12; metric net quantity and manufacturer/importer address.
- Animal testing
- Cosmetic animal testing and the sale of cosmetics relying on new animal-test data are banned since 2023-12-22 (Bill C-47 amendments to the Food and Drugs Act).
- Ingredient lists
- Cosmetic Ingredient Hotlist (administrative list of prohibited and restricted ingredients) backed by the Food and Drugs Act s.16 general safety prohibition.Look up this inventory here: 加拿大 · Cosmetic Ingredient Hotlist
- Notes
- SOR/2024-63 was published 2024-04-24 and its non-allergen provisions took effect 2024-10-09; the 81-allergen phase dates are from the canada.ca labelling guide; Health Canada clarified in 2026 that allergen concentrations in the CNF are optional.
Federal Commission for Protection against Sanitary Risks (COFEPRIS), Secretaría de Salud
Mexico
Ley General de Salud Arts. 269–272 and 271 Bis; Reglamento de Control Sanitario de Productos y Servicios; NOM-141-SSA1/SCFI-2012 · General Health Law (Ley General de Salud) and the Regulation on Sanitary Control of Products and Services, with NOM-141-SSA1/SCFI-2012 (labelling) and NOM-259-SSA1-2022 (GMP)
- In force
- 1984-07-01
- Latest change
- COFEPRIS published in the DOF an Acuerdo de simplificación merging, eliminating and fully digitising sanitary procedures (including notices) via its digital single window, effective 20–30 business days after publication; NOM-259-SSA1-2022 GMP became mandatory 2023-03-02 and the prohibited/restricted-substances Acuerdo (DOF 2010-05-21) was last amended 2014-03-11.Sources
- Market entry
- No product registration or notification — the manufacturer or importer files an Aviso de Funcionamiento (establishment operating notice) with COFEPRIS and compliant products can be sold; an Aviso de Publicidad is required for advertising.
- Responsible person
- No formal RP; the Mexican manufacturer or importer that files the Aviso de Funcionamiento is legally accountable and must appear on the label.
- Safety file
- No mandatory PIF — the manufacturer/importer must hold evidence of safety and of compliance with the substances Acuerdo and GMP (NOM-259) available to COFEPRIS on inspection.
- Labeling
- Spanish labelling per NOM-141-SSA1/SCFI-2012 (product name, INCI ingredient list, net content, responsible party, lot, warnings); no fragrance-allergen disclosure requirement.
- Animal testing
- Banned since 2021-10-15 — Art. 271 Bis of the General Health Law prohibits manufacturing, importing or marketing cosmetics tested on animals (decree DOF 2021-10-14).
- Ingredient lists
- Acuerdo por el que se determinan las sustancias prohibidas y restringidas en la elaboración de productos cosméticos (DOF 2010-05-21, amended 2014-03-11).
- Notes
- The DOF page for the 2025 simplification Acuerdo could not be fetched, so its cosmetic-specific effects are summarised from CIRS/Greenberg Traurig.
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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