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
Latin America 5
Brazilian Health Regulatory Agency (ANVISA)
Brazil
Lei nº 6.360/1976; RDC nº 752/2022 · Law No. 6.360/1976 on sanitary surveillance, implemented for cosmetics by RDC No. 752/2022 (classification, labelling, notification and registration)
- In force
- 2022-10-03
- Latest change
- RDC 1.030/2026 (new prohibited list internalising Mercosur GMC 07/25, 12-month adaptation) and RDC 1.029/2026 (restricted list part 1 per GMC 06/25, 24-month adaptation) were issued, following RDC 995/2025's TPO and DMPT ban (in force 2025-11-03) and Law 15.183/2025's animal-testing ban (2025-07-31).Sources
- Market entry
- Pre-market regularisation with ANVISA — electronic notification for most products and registration for higher-risk 'products subject to registration' (sunscreens, hair straighteners, repellents, hand sanitisers, children's products), filed by a Brazilian company holding an AFE.
- Responsible person
- A Brazilian legal entity with ANVISA operating authorisation (AFE) and state licence must be the product holder (detentora) named on the label; foreign manufacturers need a local importer/holder.
- Safety file
- Safety/efficacy dossier (formula, specifications, stability, microbiology, safety assessment and, for registered products, efficacy data) kept by the holder and submitted for registration.
- Labeling
- Portuguese labelling per RDC 752/2022 (name, INCI ingredients, holder and CNPJ, ANVISA notification/registration number, lot, validity, warnings, consumer service contact); no fragrance-allergen declaration requirement.
- Animal testing
- Law No. 15.183 of 2025-07-31 bans testing of cosmetics, perfumes and hygiene products or their ingredients on live vertebrates, with narrow CONCEA exceptions.
- Ingredient lists
- RDC 529/2021 (prohibited substances) as amended by RDC 995/2025 and RDC 1.030/2026; RDC 1.029/2026 (restricted substances, part 1); separate Mercosur-harmonised RDCs list permitted preservatives, UV filters and colorants.Look up this inventory here: 巴西 · ANVISA cosmetic ingredient restrictions and positive lists
- Notes
- RDC 1.029/1.030 are dated 2026-06-11 with DOU publication reported as 2026-06-15, and RDC 1.029's annexes were still to be released; a public consultation (1.399/2026) on the second part of the restricted list ran 2026-07-08 to 2026-09-08.
National Administration of Drugs, Food and Medical Technology (ANMAT) — INAME
Argentina
Resolución MSyAS 155/98; Disposiciones ANMAT 1107/99 and 1108/99; Ley 16.463 · Resolution (ex-MSyAS) No. 155/98 on personal hygiene products, cosmetics and perfumes, with ANMAT Dispositions 1107/99 and 1108/99 on product admission
- In force
- 1998
- Latest change
- Dispositions 2599/2026 and 2601/2026 (BO 2026-05-21) incorporated Mercosur GMC 06/25 (restricted list, replacing the 2011/2022 lists) and GMC 07/25, after Disposition 2820/2026 (BO 2026-05-15) banned TPO and N,N-dimethyl-p-toluidine with 60 days to adapt; 2025 deregulation removed ANMAT prior intervention on cosmetic imports (Disp. 4033/2025, from 2025-07-10) and allowed establishment enabling by sworn declaration (Disp. 7939/2025).Sources
- Market entry
- Pre-market product admission/inscription with ANMAT — Grade I (low-risk) products by automatic admission via sworn declaration and Grade II products (e.g., sunscreens, hair straighteners, antiperspirants, fluoride oral care) by evaluation — before manufacture or import.
- Responsible person
- The ANMAT-enabled Argentine manufacturer or importer (establishment with a registered technical director) is the product holder; foreign makers must work through such an importer.
- Safety file
- Formula, specifications, microbiological and stability data and safety substantiation kept by the holder and declared under oath for admission; no formal PIF/CPSR.
- Labeling
- Spanish labelling per Res. 155/98 and Mercosur rules (name, INCI ingredients, holder and technical director, ANMAT establishment and product admission numbers, lot, expiry, warnings); no fragrance-allergen declaration requirement.
- Animal testing
- No national ban in force; proposed bills have not been enacted.
- Ingredient lists
- Mercosur technical regulations internalised by ANMAT dispositions: GMC 27/25 and 07/25 prohibited list (Disp. 2820/2026 and 2601/2026), GMC 06/25 restricted list (Disp. 2599/2026), plus lists of permitted preservatives, UV filters and colorants.
- Notes
- official_url points to Disp. 1108/99 on Infoleg (Res. 155/98 text not fetched); the absence of a national animal-testing ban was not positively verified against a primary source.
INVIMA (Colombia) and the other national competent authorities under Andean Community Decision 833
Colombia / Andean Community (Bolivia, Colombia, Ecuador, Peru)
Decisión 833 (Gaceta Oficial 3450, 2018-11-26), amended by Decisions 857 and 944; Resolución 2108 (implementing regulation); Resolución 2310/2022 (labelling) · Andean Community Decision 833 'Harmonisation of Legislation on Cosmetic Products'
- In force
- 2021-03-01
- Latest change
- Decision 944 amended Art. 9 of Decision 833 to drop the blanket Spanish-translation requirement for technical documentation; the Andean Labelling Technical Regulation (Res. 2310) became mandatory 2025-12-17 and Colombia's MinSalud Resolution 0814/2026 (May 2026) now requires a no-animal-testing conformity declaration with new and renewed NSOs.Sources
- Market entry
- Pre-market Notificación Sanitaria Obligatoria (NSO) — a code issued by the national authority (INVIMA in Colombia) after filing the technical dossier, valid 7 years and recognised across CAN member states.
- Responsible person
- A titular/holder domiciled in the member country (manufacturer, importer or authorised company) files the NSO and is the legal responsible party named on the label.
- Safety file
- Technical information per Decision 833: qualitative/quantitative INCI formula, specifications, safety and efficacy substantiation, stability and label art, plus GMP evidence under Res. 2108.
- Labeling
- Spanish labelling per Res. 2310 (name, INCI ingredients, NSO holder/importer, country of origin, NSO number, lot, expiry, warnings); no fragrance-allergen threshold rule.
- Animal testing
- Colombia's Law 2047/2020 bans testing, import, manufacture and sale of animal-tested cosmetics from 2024-08-10 (regulated by Res. 0814/2026); Ecuador has a similar ban, Peru and Bolivia do not yet.
- Ingredient lists
- Decision 833 accepts the EU Annexes II–VI, US FDA and Mercosur lists as reference lists for prohibited, restricted and permitted ingredients.
- Notes
- The Decision 833 reference-list wording (Art. 5) was not re-fetched; Res. 0814/2026's date is as reported by Infobae (2026-05-06); the Ecuador ban is cited from secondary reports.
Public Health Institute of Chile (ISP), Ministry of Health
Chile
DS 239/2002 (Diario Oficial 2003-06-20), as amended; Código Sanitario; Ley 21.646 · Supreme Decree No. 239/2002 — Regulation of the National Cosmetics Control System, under the Sanitary Code
- In force
- 2003-06-20
- Latest change
- Law 21.646 banning animal testing of cosmetics and their ingredients (and marketing of such products) entered into force; a March-2025 public consultation proposed amending DS 239 to implement it.Sources
- Market entry
- Pre-market ISP sanitary registration for cosmetics, while low-risk products (DS 239 Art. 5 b–c, e.g., solid soaps and ISP-listed categories) only require notification to ISP before sale.
- Responsible person
- A Chilean titular (manufacturer or importer with an ISP-authorised establishment and a technical director) holds the registration and is named on the label.
- Safety file
- Registration dossier with formula, specifications, stability and safety/efficacy evidence; special-purpose cosmetics such as sunscreens need efficacy data.
- Labeling
- Spanish labelling with ISP registration number, INCI ingredients, titular, lot, expiry and warnings; no fragrance-allergen declaration requirement.
- Animal testing
- Banned since 2025-01-27 under Law 21.646 — safety must be demonstrated with validated alternative methods.
- Ingredient lists
- DS 239 relies on ISP-adopted lists of prohibited/restricted substances, preservatives, colorants and UV filters, largely aligned with EU/Mercosur references.
- Notes
- Whether the DS 239 amendment implementing Law 21.646 has been published could not be confirmed; the ingredient-list instruments were not re-verified.
General Directorate of Medicines, Supplies and Drugs (DIGEMID), Ministry of Health
Peru
Ley 29459 (2009-11-26); DS 016-2011-SA; Decisión 833 · Law No. 29459 on Pharmaceutical Products, Medical Devices and Sanitary Products and its regulation DS 016-2011-SA, applying Andean Decision 833
- In force
- 2009-11-26
- Latest change
- Andean Decision 944 (in force 2025-06-24) relaxed Spanish-translation requirements for NSO technical files and the Res. 2310 labelling regulation became mandatory 2025-12-17; the bill to ban cosmetic animal testing (PL 7688/2023-CR) cleared the Agrarian Commission in Sept 2024 but had not been passed by the plenary as of 2026.Sources
- Market entry
- Pre-market NSO filed electronically with DIGEMID through the VUCE single window (procedure DGM013), valid 7 years, before import or sale.
- Responsible person
- A Peruvian titular (manufacturer or importer/droguería with DIGEMID establishment registration and a technical director) obtains the NSO and is named on the label.
- Safety file
- NSO dossier per Decision 833: INCI formula, organoleptic/physico-chemical/microbiological specifications, safety and efficacy substantiation, label art and GMP/free-sale evidence.
- Labeling
- Spanish labelling per Res. 2310 with NSO code, INCI ingredients, titular, origin, lot and expiry; no fragrance-allergen declaration requirement.
- Animal testing
- No ban yet — bill PL 7688/2023-CR is pending before Congress.
- Ingredient lists
- Andean Decision 833 reference lists (EU Annexes II–VI, US FDA, Mercosur) as applied by DIGEMID.
- Notes
- No Peru-specific 2025–2026 cosmetics instrument was found beyond the Andean Decisions; animal-testing bill status is per reports up to April 2026.
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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