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
South Asia 4
Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare; State Licensing Authorities for manufacturing
India
G.S.R. 763(E) of 2020-12-15; Cosmetics (Amendment) Rules 2025 notified 2025-07-29 · Cosmetics Rules, 2020 under the Drugs and Cosmetics Act, 1940 (as amended by the Cosmetics (Amendment) Rules, 2025)
- In force
- 2020-12-15
- Latest change
- Cosmetics (Amendment) Rules 2025 clarified 'use before' and 'date of expiry' definitions, allowed electronic batch records and shifted some powers to State Licensing Authorities; BIS revised IS 4707 Part 2 (list of substances) on 2025-08-21 and on 2026-07-02 proposed banning 64 fragrance raw materials (consultation to 2026-08-31).Sources
- Market entry
- Pre-market import registration: a Form COS-1 application via SUGAM leads to a COS-2 Import Registration Certificate (valid 5 years, product by product), while domestic manufacture needs a state licence.
- Responsible person
- A foreign manufacturer must appoint an Indian authorised agent, subsidiary or importer that holds the COS-2 registration and is named on the label.
- Safety file
- No PIF as such; the applicant submits product specifications, test methods, labels and an undertaking that the product conforms to the applicable BIS standard listed in the Ninth Schedule.
- Labeling
- English and/or Hindi label with product name, manufacturer and importer name/address (incl. 'Made in ...'), batch number, manufacturing and use-before/expiry date, net content, registration number and an 'INGREDIENTS' list (ingredients above 1% in descending order); no fragrance-allergen rule.
- Animal testing
- Animal testing of cosmetics banned in India (Rule 148-C, 2014) and import of cosmetics tested on animals prohibited since 2014-11-13 (Rule 135-B).
- Ingredient lists
- BIS standards in the Ninth Schedule of the Cosmetics Rules 2020, notably IS 4707 Part 1 (colourants) and Part 2 (prohibited/restricted substances, revised 2025), plus product-specific IS specifications.
- Notes
- The Gazette G.S.R. number of the 2025 amendment was not found; a CDSCO circular effective 2026-01-16 reportedly auto-rejects SUGAM applications whose queries stay unanswered for 90 days (consultancy source).
Drug Regulatory Authority of Pakistan (DRAP) for medicated cosmetics; Pakistan Standards and Quality Control Authority (PSQCA) for compulsory standards; Pakistan General Cosmetics Regulatory Authority (PGCRA) created by the General Cosmetics Act 2023 but not operational
Pakistan
General Cosmetics Act 2023 (Gazette of Pakistan Extraordinary, 7 Aug 2023); DRAP Act 2012; S.R.O. 412(I)/2014 · General Cosmetics Act 2023; DRAP Act 2012 with the Alternative Medicines and Health Products (Enlistment) Rules 2014 for medicated cosmetics; PSQCA compulsory Pakistan Standards
- In force
- 2023-08-07
- Latest change
- A government rightsizing committee decided to abolish the not-yet-operational PGCRA, leaving the General Cosmetics Act 2023 without a functioning regulator and rules.Sources
- Market entry
- No general-cosmetics notification system operates yet; medicated cosmetics, medicated soaps and shampoos need DRAP enlistment, and cosmetics on PSQCA's compulsory list (toilet soap, shampoo, skin cream PS 3228, hair dyes, shaving cream, skin powder, hair cream) need PSQCA conformity certification before import or sale.
- Responsible person
- DRAP enlistment and PSQCA licences are held by a Pakistan-registered importer or manufacturer acting as legal representative of the foreign maker.
- Safety file
- Formula with ingredient limits, CoA, Free Sale Certificate, GMP evidence and PSQCA laboratory test reports, plus safety/quality data for DRAP-enlisted medicated cosmetics.
- Labeling
- English labeling with ingredients, batch, expiry, manufacturer/importer and the PSQCA or DRAP number where applicable; halal claims must be substantiated.
- Animal testing
- No statutory ban identified.
- Ingredient lists
- DRAP permitted/prohibited ingredient and contaminant (heavy metal, microbial) limits for medicated cosmetics and PSQCA Pakistan Standards (e.g. PS 3228-2017 skin cream); no EU-style annex system yet.
- Notes
- Labeling-language requirement not verified from an official source; PGCRA status after Nov 2024 not confirmed.
Directorate General of Drug Administration (DGDA); Bangladesh Standards and Testing Institution (BSTI) for compulsory standards
Bangladesh
Act No. 29 of 2023 (18 Sept 2023); draft Cosmetics (Licence and Registration) Rules 2026; BSTI mandatory CM-licence product list · Drugs and Cosmetics Act 2023 (Act No. 29 of 2023)
- In force
- 2023-09-18
- Latest change
- The Health Services Division published the draft Cosmetics (Licence and Registration) Rules 2026 under the 2023 Act for public comment.Sources
- Market entry
- Cosmetics require a DGDA licence/registration (import registration valid up to 5 years) under the 2023 Act, with detailed rules still in draft, and a BSTI CM licence/port clearance certificate is mandatory for cosmetics on the compulsory standards list (328 products as of May 2026).
- Responsible person
- A Bangladesh-registered importer or manufacturer holding the DGDA and BSTI licences must be the applicant, so foreign brands need a local authorised importer.
- Safety file
- Product Information File (Annexure-I), GMP certificate, CoA, Free Sale Certificate, origin-country registration and a declaration of no harmful chemicals, plus a halal certificate if animal by-products are used.
- Labeling
- Bengali labeling required (supplementary Bengali label for imports) with ingredients, batch, expiry, price and importer details, plus a BSTI metrology certificate for net content.
- Animal testing
- No statutory ban identified.
- Ingredient lists
- No published national annex system; compliance is judged against the applicable Bangladesh Standard (BDS) for each product type and DGDA harmful-chemical declarations.
- Notes
- The draft-rules date (2026-06-24) comes from a search snippet because the hsd.gov.bd page could not be fetched; Bengali labeling and 5-year import-registration validity come from consultancy sources.
National Medicines Regulatory Authority (NMRA)
Sri Lanka
NMRA Act No. 5 of 2015; Extraordinary Gazette No. 2144/20 (9 Oct 2019); NMRA new-application checklist effective 2025-06-01 · National Medicines Regulatory Authority Act No. 5 of 2015 (replacing the Cosmetics, Devices and Drugs Act No. 27 of 1980) and the cosmetics regulations/gazettes made under it
- In force
- 2015
- Latest change
- NMRA issued a revised 11-document checklist for new cosmetic registrations by importers, effective 2025-06-01, including a heavy-metal CoA, steroid-free declaration, ISO 22716/GMP certificate and Safety Assessment Report.Sources
- Market entry
- Mandatory pre-market registration with NMRA – Provisional Registration (1–2 years) then Full Registration (5 years) – and imported consignments undergo sampling, testing and inspection for a Certificate of Conformity.
- Responsible person
- A Sri Lankan authorised agent/Marketing Authorisation Holder with an import licence and a brand-owner Letter of Authorization (not older than 3 years) must apply.
- Safety file
- Embassy-attested Free Sale Certificate, finished-product CoA with heavy metals (Pb, As, Hg, Cd) from accredited labs, full composition (INCI, CAS, %, function), steroid-free declaration for leave-on skincare, ISO 22716/GMP certificate and Safety Assessment Report.
- Labeling
- NMRA-approved label artwork with INCI ingredients, batch, expiry and manufacturer/importer details; English accepted, with Sinhala/Tamil rules not verified.
- Animal testing
- No statutory ban identified.
- Ingredient lists
- NMRA evaluates formulations against international references (EU/ASEAN lists) plus its own steroid and heavy-metal restrictions; no published national annexes were found.
- Notes
- NMRA pages could not be fetched; the title of the 2019 cosmetics gazette and label-language rules are unverified, and in_force_since is the year of the NMRA Act.
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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