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
Africa 4
National Department of Health (Directorate: Food Control) under the FCD Act; SAHPRA only for products with medicinal claims
South Africa
Act 54 of 1972; draft Regulations relating to the Labelling, Advertising and Composition of Cosmetics (GN R.1469, 22 Dec 2017); SANS 289:2022 · Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972
- In force
- 1973-01-01
- Latest change
- Draft Regulations relating to the labelling, advertising and composition of cosmetics (R.1469) were published for comment and remain unfinalised and unenforced as of 2026.Sources
- Market entry
- None – no pre-market notification or registration; the market is self-regulated under the FCD Act with the CTFA Cosmetic Compendium as industry guidance.
- Responsible person
- No statutory local RP; the manufacturer/importer/distributor named on the label is liable under the Act, and the draft regulations would formalise a South African responsible person.
- Safety file
- No mandatory filing; industry practice and the draft regulations expect a PIF with safety assessment and GMP (ISO 22716).
- Labeling
- English at minimum with ingredient list, net content per SANS 289 / Legal Metrology Act, and no misleading claims under the ARB/CTFA Cosmetic Advertising Code.
- Animal testing
- No statutory ban on animal testing of cosmetics.
- Ingredient lists
- CTFA Cosmetic Compendium adopts EU 1223/2009 Annexes II–VI; the draft R.1469 Annexures I/II list prohibited (e.g. mercury, chloroform) and restricted substances.
- Notes
- Sources disagree on whether R.1469 (2017) is final; ChemLinked (updated 2026-08-18) and Chemycal treat it as an unenforced draft, so it is reported as draft here.
National Agency for Food and Drug Administration and Control (NAFDAC)
Nigeria
NAFDAC Act Cap N1 LFN 2004; Cosmetic Products Registration Regulations 2023; Cosmetics Products Labelling Regulations 2019 · NAFDAC Act Cap N1 LFN 2004 with the Cosmetic Products Registration Regulations 2023, Cosmetics Products Labelling Regulations 2019 and Cosmetics Products (Prohibition of Bleaching Agents) Regulations 2019
- In force
- 1993
- Latest change
- Cosmetic Products Registration Regulations 2023 (posted by NAFDAC in Feb 2024) restated mandatory registration; no new cosmetics regulation was found for 2025-2026, only enforcement actions.Sources
- Market entry
- Mandatory pre-market registration with NAFDAC via the NAPAMS e-portal (registration.nafdac.gov.ng), with the certificate valid 5 years and renewable.
- Responsible person
- Foreign manufacturers must appoint a Nigerian-incorporated local representative holding a Power of Attorney or contract-manufacturing agreement, in whose name the certificate is issued.
- Safety file
- Certificate of Manufacture and Free Sale, comprehensive Certificate of Analysis, GMP inspection of the factory, label artwork and NAFDAC laboratory analysis; skin-lightening agents require precautionary statements.
- Labeling
- English mandatory with INCI ingredients in descending order, NAFDAC registration number, batch, manufacturing/expiry dates, net content, manufacturer and country of origin, and warnings for skin-lightening agents.
- Animal testing
- No statutory ban identified.
- Ingredient lists
- NAFDAC prohibited/restricted substances, notably bleaching agents (mercury, corticosteroids, hydroquinone above the permitted limit) under the 2019 Bleaching Agents Regulations, with EU/ASEAN lists used as reference.
- Notes
- NAFDAC regulation PDFs could not be opened, so commencement dates are year-only (in_force_since is the year NAFDAC was created); the exact hydroquinone limit was not verified from an official text.
Kenya Bureau of Standards (KEBS) for standards and PVoC; Pharmacy and Poisons Board (PPB) for registration of cosmetics as health products (to become KHPTA)
Kenya
KS EAS 377-1:2013 et seq.; KS EAS 346; Legal Notice No. 100 of 2022 (commenced 2022-06-09) · Standards Act (Cap 496) with East African standards KS EAS 377 (ingredients) and KS EAS 346 (labelling); Pharmacy and Poisons Act (Cap 244) and the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules 2022
- In force
- 2022-06-09
- Latest change
- KEBS issued PVoC Manual Version 15 governing Certificates of Conformity for imports (including cosmetics); the KHPTA Bill covering cosmetics passed the National Assembly in Nov 2024 but has not been assented.Sources
- Market entry
- Imports need a KEBS Certificate of Conformity under the PVoC programme (issued pre-shipment by appointed agents) and the KEBS standardisation/import mark, while PPB registration under LN 100/2022 applies to cosmetics defined as health products, especially those with therapeutic claims.
- Responsible person
- Non-Kenyan applicants must appoint a local representative (Kenyan citizen/resident or Kenyan-incorporated company) for PPB registration, and PVoC/import permits run through the Kenyan importer.
- Safety file
- INCI formula, toxicological safety assessment, microbiological and stability data, Certificate of Free Sale and GMP evidence for KEBS/PPB review, with heavy-metal testing increasingly expected.
- Labeling
- English labelling per KS EAS 346 with INCI ingredients, batch, expiry, full manufacturer address, warnings and the KEBS mark; Kiswahili optional.
- Animal testing
- No statutory ban identified.
- Ingredient lists
- KS EAS 377 parts (prohibited, restricted, colorants, preservatives, UV filters) referencing EU 1223/2009 Annex II/III, with a DEAS 377-1:2020 revision drafted.
- Notes
- Division of labour between KEBS and PPB for ordinary cosmetics is in flux (KHPTA Bill pending in the Senate as of 2026); in_force_since refers to the PPB rules while the KEBS standards regime is older.
Moroccan Agency for Medicines and Health Products (AMMPS), successor to the Ministry of Health's Direction du Médicament et de la Pharmacie (DMP)
Morocco
Loi n° 17-04; Circulaire n° 48 DMP/20 (17 Aug 2012); Loi n° 10-22 promulgated by Dahir n° 1-23-54 (12 Jul 2023) · Law No. 17-04 (Code of Medicines and Pharmacy) with DMP Circular No. 48 DMP/20 establishing cosmetic product registration; Law No. 10-22 creating AMMPS
- In force
- 2012-08-17
- Latest change
- AMMPS now processes cosmetic applications filed since 2025-06-11 only after the operator's establishment declaration is updated, tightening traceability of manufacturers and importers during the DMP-to-AMMPS transition.Sources
- Market entry
- Pre-market registration of each cosmetic with AMMPS (ex-DMP): establishment declaration, product file submission and poison-centre (CAPM) code, yielding a temporary certificate (ATD, 1 year) then a definitive certificate valid 5 years.
- Responsible person
- A Moroccan-established manufacturer or importer declared as a cosmetics/body-hygiene establishment with qualified quality-control staff and compliant premises must hold the registration.
- Safety file
- Administrative and technical file with full INCI formula, raw-material and microbiological specifications, analytical and stability results, toxicologist safety assessment, claim substantiation and Free Sale Certificate.
- Labeling
- French and/or Arabic labeling with Arabic mandatory for precautions/warnings, importer name and address, INCI, batch and expiry; halal certification (IMANOR Label Halal Maroc, NM 08.0.802) voluntary.
- Animal testing
- No statutory ban identified.
- Ingredient lists
- Circular 48 DMP/20 references the EU cosmetics lists (prohibited and restricted substances, CMR ban) and AMMPS follows EU 1223/2009 annexes in practice.
- Notes
- A consultancy blog claims halal certification becomes mandatory for all imported cosmetics on 2026-10-17; no AMMPS/IMANOR source confirms this, so it is treated as unverified.
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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