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
Southeast Asia 7
ASEAN Cosmetic Committee (ACC) and ASEAN Cosmetic Scientific Body (ACSB); enforced by each member state's regulator
ASEAN (ASEAN Cosmetic Directive)
Agreement signed 2003-09-02 in Phnom Penh at the 35th AEM Meeting · ASEAN Cosmetic Directive (Schedule B of the Agreement on the ASEAN Harmonized Cosmetic Regulatory Scheme)
- In force
- 2008-01-01
- Latest change
- Revised ACD Annexes II, III, IV and VI released after the 43rd ACC meeting: four azole antifungals banned, kojic acid limited to 1% (face/hand) and 0.2% (body), BHT and verbena absolute restricted, and chlorophene and 2-chloroacetamide removed as preservatives.Sources
- Market entry
- Pre-market product notification (not approval) to each member state's authority before the product is placed on that market (Art. 7).
- Responsible person
- The company or person responsible for placing the product on the market must be established in the member state where it is notified and is named on the label.
- Safety file
- Product Information File (Art. 8) with a safety assessment signed by a qualified assessor, kept at the responsible person's address for inspection.
- Labeling
- Art. 6 and Appendix I: product name and function, full ingredient list (INCI, descending), country of manufacture, responsible company name/address, contents, batch, manufacture/expiry dates and warnings, in the language accepted by each member state; allergen naming is not mandated by the ACD itself.
- Animal testing
- The ACD neither bans nor requires animal testing; safety is demonstrated through the PIF assessment.
- Ingredient lists
- ACD Annex II (prohibited), Annex III (restricted), Annex IV (colourants), Annex VI (preservatives) and Annex VII (UV filters), updated twice yearly by the ACC/ACSB.Look up this inventory here: 东盟 · ASEAN Cosmetic Directive — Annexes
- Notes
- Annex changes bind in each state only once transposed (e.g. Malaysia Circular 2/2026 of 2026-07-06; Philippines FDA Circular 2026-0001 of 2026-04-22 for the 40th–42nd ACC changes).
Health Sciences Authority (HSA), Cosmetics Control Unit
Singapore
Health Products Act (Cap. 122D); Cosmetic Products Regulations 2007 transposing the ACD · Health Products Act 2007 and Health Products (Cosmetic Products – ASEAN Cosmetic Directive) Regulations 2007
- In force
- 2008-01-01
- Latest change
- HSA published the June 2026 ACD annex revisions (Annexes II, III, IV, VI) that notifiers must check before submitting or re-notifying products.Sources
- Market entry
- Pre-market product notification via HSA's PRISM portal (CRIS account) for every product and variant, renewed annually, before supply.
- Responsible person
- The Singapore company or person responsible for placing the product on the market (a locally registered entity with a CRIS/CorpPass account) files the notification and is named on the label.
- Safety file
- Product Information File per ACD Art. 8, including a safety assessment, kept by the responsible company and produced to HSA on request.
- Labeling
- English labelling with product name/function, directions, full ingredient list, country of manufacture, responsible company name/address, contents, batch number, manufacturing/expiry date and ACD Annex III/VI/VII warnings; small packs may use leaflets or tags.
- Animal testing
- No ban and no requirement.
- Ingredient lists
- ACD Annexes II–VII as published on the HSA ACD page (June 2026 version).Look up this inventory here: 东盟 · ASEAN Cosmetic Directive — Annexes
- Notes
- No separate national cosmetic law change in 2025–26 beyond ACD annex adoption was found.
National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health
Malaysia
CDCR 1984, Regulation 18A (notified cosmetics) · Control of Drugs and Cosmetics Regulations 1984 (under the Sale of Drugs Act 1952) and the Guidelines for Control of Cosmetic Products in Malaysia
- In force
- 1984
- Latest change
- NPRA Circular No. 2/2026 revised the Guidelines' annexes (prohibited, restricted, colourants, preservatives) to adopt the 43rd ACC amendments, following Circular No. 1/2026 of 2026-01-26 and the 2025-07-10 revision that banned 2-ethylhexanoic acid and TMPTA and restricted salicylic acid.Sources
- Market entry
- Pre-market cosmetic notification via the QUEST 3+ online system; the notification is valid 2 years and must be renewed at least 1 month before expiry.
- Responsible person
- The Cosmetic Notification Holder (CNH) must be a Malaysian company or legal entity registered with the Companies Commission (SSM) with a permanent local address.
- Safety file
- Product Information File (ACD Art. 8) with safety assessment held by the CNH and made available to NPRA on request.
- Labeling
- Labels in Bahasa Malaysia and/or English with product name, function, full ingredient list (INCI), country of manufacture, CNH name/address, contents, batch, manufacturing/expiry date and required warnings; halal claims only with JAKIM certification.
- Animal testing
- No ban and no requirement.
- Ingredient lists
- Guidelines for Control of Cosmetic Products in Malaysia, Annex I Parts 1–7 (ACD Annexes II–VII as adopted by NPRA).Look up this inventory here: 东盟 · ASEAN Cosmetic Directive — Annexes
- Notes
- CDCR dates from 1984; the notification regime under Reg. 18A has applied since ACD implementation on 2008-01-01.
Thai Food and Drug Administration (Thai FDA), Cosmetic Control Group, Ministry of Public Health
Thailand
Cosmetics Act B.E. 2558 (Royal Gazette, in force 2015-09-09) · Cosmetics Act B.E. 2558 (2015), as amended by Cosmetics Act (No. 2) B.E. 2565 (2022)
- In force
- 2015-09-09
- Latest change
- Thai FDA opened consultation (to 2026-07-08) on six draft notifications adding 10 prohibited substances (Quaternium-15, benzophenone, phenacetin, azole antifungals, etc.) and 3 restricted ones (BHT, Acid Yellow 3, verbena absolute) to align with the ACD, and on 2026-07-07 published a reference list of fragrance allergens based on EU Regulation 2023/1545.Sources
- Market entry
- Pre-market notification (จดแจ้ง) filed electronically with Thai FDA before manufacture or import; the notification receipt is valid 3 years.
- Responsible person
- A Thai-registered manufacturer or importer (the notifier) with a registered place of business in Thailand holds the notification and appears on the label.
- Safety file
- Product Information File per ACD Art. 8 (with safety assessment) kept by the notifier for inspection.
- Labeling
- Thai-language label required (applied within 30 days of import): product name and type, notification number, ingredient list, importer/manufacturer name and address, batch, manufacturing/expiry date, net content and warnings, with foreign text allowed alongside Thai.
- Animal testing
- No ban and no requirement.
- Ingredient lists
- Ministry of Public Health notifications on prohibited substances, restricted substances, permitted preservatives, colourants and UV filters, aligned to ACD Annexes II–VII.Look up this inventory here: 东盟 · ASEAN Cosmetic Directive — Annexes
- Notes
- The June 2026 ingredient changes were still drafts at the consultation deadline and their adoption status as of 2026-09-11 was not verified.
Indonesian Food and Drug Authority (BPOM); BPJPH for halal certification
Indonesia
PerBPOM No. 21/2022 (notification); PerBPOM No. 25/2025 (ingredients); PP No. 42/2024 (halal) · Health Law No. 17/2023 and Government Regulation No. 28/2024, implemented by BPOM Regulation No. 21/2022 (cosmetic notification), No. 25/2025 (technical requirements for cosmetic ingredients), No. 18/2024 (labelling, promotion and advertising) and No. 8/2026 (CPKB/GMP certification)
- In force
- 2022
- Latest change
- BPOM announced PerBPOM No. 8/2026 (set 2026-04-21) simplifying CPKB/GMP certification; in parallel PerBPOM 25/2025 ingredient limits must be met by 2026-10-03, BPJPH halal certification becomes mandatory for all cosmetics from 2026-10-17 (PP 42/2024), and BPJPH Regulation 3/2026 (2026-07-23) requires a red 'NON HALAL' mark on non-halal cosmetics after a 12-month transition.Sources
- Market entry
- Pre-market notification (notifikasi kosmetika) through BPOM's Notifkos e-system per product and variant, with fees of IDR 500,000 (ASEAN-made) or IDR 1,500,000 (non-ASEAN) and a 3-year validity.
- Responsible person
- The applicant must be an Indonesian legal entity (local manufacturer, importer or licence holder) with a BPOM account and, for imports, a letter of authorisation from the foreign manufacturer.
- Safety file
- Dokumen Informasi Produk (DIP, the ACD Art. 8 PIF) with safety assessment kept by the notifier, plus a BPJPH halal certificate from 2026-10-17.
- Labeling
- Bahasa Indonesia is mandatory at least for benefits, directions and warnings (PerBPOM 18/2024, in force 2024-11-15), plus full ingredient list, notification number, batch, expiry, manufacturer/importer and halal or 'NON HALAL' marking.
- Animal testing
- No ban and no requirement.
- Ingredient lists
- PerBPOM No. 25/2025 on Technical Requirements for Cosmetic Ingredients (prohibited, restricted, permitted preservatives/colourants/UV filters aligned to the ACD), replacing PerBPOM 23/2019 and 17/2022.Look up this inventory here: 东盟 · ASEAN Cosmetic Directive — Annexes
- Notes
- The exact promulgation day of PerBPOM 25/2025 (October 2025) and the reported e-Notifikasi mandate with 3-year validity from 2026-10-03 come from consultancy sources; a draft revision of PerBPOM 21/2022 was consulted in September 2025 and its adoption was not confirmed.
Drug Administration of Vietnam (DAV), Ministry of Health; provincial Departments of Health for domestic products
Vietnam
Circular 06/2011/TT-BYT dated 2011-01-25; Circular 34/2025/TT-BYT dated 2025-07-03 · Circular No. 06/2011/TT-BYT on Cosmetic Management (amended by Circulars 32/2019/TT-BYT and 34/2025/TT-BYT) and Decree 93/2016/NĐ-CP on cosmetic manufacturing conditions
- In force
- 2011
- Latest change
- Circular 34/2025/TT-BYT took effect, adding online notification via the National Public Service Portal with e-signatures, while the MoH's comprehensive draft Government Decree on Cosmetic Management (WTO G/TBT/N/VNM/349, redrafted 2026-02-02 and 2026-05-29) to replace Circular 06/2011 remained in consultation.Sources
- Market entry
- Pre-market product notification (công bố sản phẩm mỹ phẩm): imports to DAV and domestic products to provincial health departments, with a receipt number valid 5 years before circulation.
- Responsible person
- The organisation or individual responsible for placing the product on the market must be a Vietnam-established entity holding the notification receipt, so foreign manufacturers appoint a Vietnamese importer or authorised entity.
- Safety file
- Product Information File per ACD Art. 8 with safety assessment kept by the responsible organisation for inspection.
- Labeling
- Vietnamese-language label (Decree 43/2017 as amended by Decree 111/2021, plus Circular 06/2011): product name, function, ingredients, net content, manufacturer and responsible party, batch, production/expiry date, origin and warnings, with supplementary Vietnamese labels allowed on imports.
- Animal testing
- No ban and no requirement.
- Ingredient lists
- ACD Annexes II–VII as applied through Circular 06/2011/TT-BYT, with ACC updates implemented nationally (e.g. DEET ban effective 2025-11-15).Look up this inventory here: 东盟 · ASEAN Cosmetic Directive — Annexes
- Notes
- Whether the draft Decree was promulgated between June and 2026-09-11 could not be confirmed (latest found: second draft of 2026-05-29 on chinhphu.vn, originally targeted for 2026-07-01).
Food and Drug Administration (FDA Philippines), Center for Cosmetics Regulation and Research
Philippines
RA 9711 (2009); AO 2005-0025; FDA Circular 2023-001 (PIF) · Republic Act No. 9711 (FDA Act of 2009) amending RA 3720, with the ASEAN Cosmetic Directive adopted by DOH Administrative Order No. 2005-0025
- In force
- 2008-01-01
- Latest change
- FDA Circular No. 2026-0001 consolidated ACD amendments from the 40th–42nd ACC meetings, adding TMPTA to Annex II, amending the benzophenone entry (effective 2026-11-19) and restricting BHT with a 24-month grace period.Sources
- Market entry
- Pre-market Cosmetic Product Notification via the FDA eServices portal (with PIF upload) before distribution, valid 1–3 years and renewable.
- Responsible person
- A Philippine company holding an FDA License to Operate (LTO) as manufacturer, importer or distributor must file the notification and appear on the label.
- Safety file
- Product Information File per ACD Art. 8 under FDA Circular 2023-001, kept by the LTO holder for inspection.
- Labeling
- ACD Appendix I labelling in English or Filipino: product name and function, full ingredient list, country of manufacture, LTO holder name/address, contents, batch, manufacturing/expiry date and precautions, with claims following the ACD claims guidelines.
- Animal testing
- No ban and no requirement.
- Ingredient lists
- ACD Annexes II–VII as adopted through FDA circulars (latest FDA Circular 2026-0001; FDA Circular 2025-002 of 2025-03-18 adopted the 39th ACC changes such as the DEET ban).Look up this inventory here: 东盟 · ASEAN Cosmetic Directive — Annexes
- Notes
- ACD applied from 2008-01-01 while RA 9711 itself dates from 2009; notification validity (1–3 years) is from consultancy sources.
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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