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
East Asia 5
National Medical Products Administration (NMPA)
Mainland China
State Council Decree No. 727 (promulgated 2020-06-16) · Regulations on the Supervision and Administration of Cosmetics (CSAR)
- In force
- 2021-01-01
- Latest change
- NMPA Announcement No. 70 (2026) introduced eight registration/filing optimisation measures, incl. wider animal-test exemptions, shared test reports for similar formulas and ingredient safety data kept on file instead of submitted.Sources
- Market entry
- Pre-market: 普通化妆品备案 (filing) for general cosmetics and 特殊化妆品注册 (NMPA registration) for special cosmetics (hair dye, perm, freckle-whitening, sunscreen, anti-hair-loss, new efficacy), under 化妆品注册备案管理办法 (SAMR Order No. 35, in force 2021-05-01).
- Responsible person
- Overseas registrants/filers must appoint a 境内责任人 (domestic responsible person, a Chinese legal entity) that files the product and bears joint liability for quality and safety.
- Safety file
- 产品安全评估报告 per 化妆品安全评估技术导则 (2021): simplified reports were accepted only until 2025-05-01 (NMPA Announcement 2024 No. 50); since then a full-version assessment is required, with eligible general cosmetics allowed to submit the 安全评估基本结论 and keep the full report on file for inspection.
- Labeling
- Chinese label mandatory under 化妆品标签管理办法 (in force 2022-05-01): full ingredient list in descending order using standard Chinese names, ingredients at or below 0.1% grouped under 其他微量成分; efficacy claims must be substantiated under 化妆品功效宣称评价规范; no fragrance-allergen naming rule.
- Animal testing
- Not required for domestic general cosmetics; imported general cosmetics have been exempt from toxicology tests since 2021-05-01 if the manufacturer holds a GMP certificate from its home authority and the safety assessment confirms safety, except children's products, products using new ingredients under monitoring, or firms under key supervision; NMPA No. 70 (2026) widened the exemptions.
- Ingredient lists
- 化妆品安全技术规范 (2015年版, continuously updated: prohibited, restricted, permitted preservatives/UV filters/colorants/hair dyes) plus 已使用化妆品原料目录 (2021年版, 5th adjustment 2026-08-19).Look up this inventory here: 中国 · Safety and Technical Standards for Cosmetics — prohibited and restricted
- Notes
- The full-version safety-assessment cut-off is 2025-05-01. Other 2026 items: NMPA Announcement No. 48 (2026-05-15, mercury standard effective 2026-07-01; o-phenylphenol and Acid Violet 43 from 2028-06-01), No. 51 (2026-05-29, eight test methods effective 2027-03-01), GACC Announcement No. 61 (2026-05-11, import/export inspection rules effective 2026-12-01), e-label pilots in Shanghai/Guangdong, and a draft mandatory national labelling standard under consultation.
Customs and Excise Department (C&ED); Department of Health for pharmaceutical-type products
Hong Kong SAR
Cap. 456 Laws of Hong Kong (general safety requirement, s.4) · Consumer Goods Safety Ordinance (Cap. 456) and Consumer Goods Safety Regulation (Cap. 456A); Trade Descriptions Ordinance (Cap. 362)
- Latest change
- Hong Kong Customs warned the public about a collagen cream containing banned Sudan red dye and lacking the required Chinese warning labelling (enforcement action under Cap. 456; no new legislation).Sources
- Market entry
- None: no pre-market registration, notification or import licence for general cosmetics; only products classified as pharmaceuticals (Cap. 138) or proprietary Chinese medicines (Cap. 549) need registration.
- Responsible person
- No statutory responsible person; the Hong Kong manufacturer, importer or supplier is liable for meeting the general safety requirement.
- Safety file
- No mandated dossier; suppliers must be able to show the product meets the general safety requirement (reasonable safety by reference to international or Hong Kong standards, test reports on request).
- Labeling
- No cosmetics-specific label law, but any warning or caution on safe keeping, use or disposal must be in both English and Chinese, legibly and conspicuously (Cap. 456A); descriptions must not be false or misleading (Cap. 362); no ingredient or allergen listing mandate.
- Animal testing
- No ban and no requirement.
- Ingredient lists
- No cosmetic-specific lists; C&ED judges safety against international standards (EU/ACD/China limits) and the Poisons List under the Pharmacy and Poisons Ordinance (Cap. 138) restricts substances such as hydroquinone and certain hair-dye amines.
- Notes
- Commencement date of Cap. 456 (commonly cited as 1995) could not be verified; bilingual warnings are the only language rule.
Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare
Taiwan
Promulgated 2018-05-02 by Presidential Order, replacing 化粧品衛生管理條例 · Cosmetic Hygiene and Safety Act
- In force
- 2019-07-01
- Latest change
- Third and final phase: all general cosmetics (except handmade solid soap exempt from factory registration) must hold a Product Information File (PIF) and be made under 化粧品優良製造準則 (GMP, ISO 22716-based).Sources
- Market entry
- Pre-market 產品登錄 (online product notification) for all cosmetics: general cosmetics since 2021-07-01 and 特定用途化粧品 (sunscreen, hair dye, perm, antiperspirant, tooth whitening) since 2024-07-01, when the former 查驗登記 licence system ended.
- Responsible person
- The Taiwan manufacturer or importer (化粧品製造或輸入業者) must complete the notification, hold the PIF and appear on the label, so a foreign brand needs a Taiwan-registered importer.
- Safety file
- PIF (產品資訊檔案, 16 items incl. formula, labels, test reports and a safety assessment signed by a qualified assessor) phased in on 2024-07-01 (specific-purpose), 2025-07-01 (infant, lip, eye, non-medicated toothpaste/mouthwash) and 2026-07-01 (all general cosmetics), with fines up to NT$1 million.
- Labeling
- Traditional-Chinese labelling with product name, use, directions, batch, shelf life, full ingredient list, manufacturer/importer and origin; specific-purpose actives must show content; no separate fragrance-allergen naming rule.
- Animal testing
- Animal testing for cosmetic or ingredient safety assessment banned in Taiwan since 2019-11-09 (Art. 6) with narrow TFDA-approved exceptions; imported animal-tested products are not banned.
- Ingredient lists
- 化粧品禁止使用成分表, 化粧品成分使用限制表, 化粧品防腐劑成分名稱及使用限制表, 化粧品色素成分使用限制表, 化粧品防曬劑成分使用限制表 and 化粧品微生物容許量基準表 (nine PFAS/allergen entries added to the prohibited list from 2025-01-01).
- Notes
- GMP phases mirror the PIF phases (2024-07-01, 2025-07-01, 2026-07-01) per TFDA and Taiwan press.
Ministry of Health, Labour and Welfare (MHLW) with PMDA; prefectural governments issue licences
Japan
Act No. 145 of 1960 (renamed PMD Act 2014); latest amendment Act No. 37 of 2025 · Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act)
- In force
- 1961-02-01
- Latest change
- PMD Act amendment (Act No. 37 of 2025) promulgated and phased in from 2025-11-20 and 2026-05-01, tightening MAH governance, quality and supply obligations (largely pharma-focused); separately MHLW's 2025-03-10 notice rewrote the 特記表示 (highlighted-ingredient) rules so that the ingredient's purpose must be stated.Sources
- Market entry
- No pre-market approval for cosmetics: the licensed MAH files a 化粧品製造販売届 (notification) per product before sale, whereas products with medicinal claims are 医薬部外品 (quasi-drugs) needing MHLW approval.
- Responsible person
- A Japan-licensed 製造販売業者 (Marketing Authorization Holder) must hold the product notification and bear full responsibility, and imported goods also need a licensed 製造業者 for labelling/storage.
- Safety file
- No statutory PIF; the MAH must ensure conformity with 化粧品基準 and the GQP/GVP ordinances and keep quality and safety records.
- Labeling
- Full ingredient list in Japanese using JCIA 表示名称 (mandatory since 2001-04-01) plus product name, MAH name/address, contents and lot; a highlighted ingredient (特記表示) must state its purpose (2025-03-10 notice); no fragrance-allergen labelling rule in force.
- Animal testing
- No statutory ban and no requirement for cosmetics; quasi-drug approvals may still rely on animal data.
- Ingredient lists
- 化粧品基準 (Standards for Cosmetics, MHW Notification No. 331 of 2000, last amended 2024-07-12): negative list plus positive lists for preservatives, UV filters and tar colours.Look up this inventory here: 日本 · Standards for Cosmetics — appended tables
- Notes
- Consultancy claims that Japan will mandate fragrance-allergen labelling from May 2026 could not be verified on MHLW's site and should be treated as unconfirmed; MHLW also introduced electronic export certificates for cosmetics on 2026-07-27 (ChemLinked).
Ministry of Food and Drug Safety (MFDS)
South Korea
Act No. 6025 (enacted 1999-09-07); latest amendment Act No. 21302 (2025-12-30) · Cosmetics Act
- In force
- 2000-07-01
- Latest change
- MFDS issued draft amendments to the Cosmetics Act Enforcement Decree and Rule setting detailed safety-assessment standards (assessor qualifications, record retention) and custom-cosmetics rules, implementing Act No. 21302 whose mandatory safety assessment phases in from 2028.Sources
- Market entry
- No pre-market approval for general cosmetics (the registered responsible seller reports production/import), while 기능성화장품 (functional cosmetics: whitening, anti-wrinkle, UV, hair etc.) need MFDS review or report before sale.
- Responsible person
- A Korea-registered 화장품책임판매업자 (cosmetic responsible seller) must register with MFDS, hold the product records and appear on the label.
- Safety file
- Currently product safety/efficacy data are kept by the responsible seller; Act No. 21302 (promulgated 2025-12-30) requires a safety assessment prepared and reviewed by a qualified assessor before marketing, with MFDS guidelines issued 2026-06-10 and phased mandatory application from 2028 (full by about 2031).
- Labeling
- Korean-language label with full ingredient list (전성분표시); 25 fragrance allergens must be named when above 0.01% in rinse-off or 0.001% in leave-on products (since 2020-01-01); the 2025-02-07 Enforcement Rule amendment revised how manufacturing number, expiry date, period-after-opening and precautions are shown.
- Animal testing
- Sale of cosmetics tested on animals (finished products or ingredients) has been banned since 2017-02 under Art. 15-2, with limited exceptions such as tests required by foreign law.
- Ingredient lists
- 화장품 안전기준 등에 관한 규정 (MFDS Notification: Annex 1 prohibited ingredients, Annex 2 restricted ingredients incl. preservatives, UV filters and colorants) plus the functional-cosmetics standards.Look up this inventory here: 韩国 · Regulation on Safety Standards for Cosmetics
- Notes
- Exact effective dates of individual Act No. 21302 provisions were not verified from the statute text (ChemLinked gives a 2028 phase-in); a 2026-03-31 Enforcement Rule amendment also tightened supervision of directly-purchased overseas cosmetics.
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.
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.
Oceania 2
Australian Industrial Chemicals Introduction Scheme (AICIS) for ingredients; ACCC for labelling; TGA for sunscreens and therapeutic claims
Australia
Industrial Chemicals Act 2019 (Cth); Industrial Chemicals (General) Rules 2019 · Industrial Chemicals Act 2019 (AICIS) with the Consumer Goods (Cosmetics) Information Standard 2020 under the Australian Consumer Law
- In force
- 2020-07-01
- Latest change
- After evaluation EVA00186, retinal (retinaldehyde, CAS 116-31-4) for any consumer use can no longer be introduced as exempted or reported, so importers/manufacturers need an AICIS assessment certificate first (notice 2026-07-14); AICIS registration for the 2026–27 year is required before introducing chemicals on or after 2026-09-01.Sources
- Market entry
- No product registration: the Australian importer or manufacturer registers with AICIS each year (1 Sep–31 Aug) and categorises every ingredient introduction as exempted, reported or assessed, while sunscreens above SPF 4 and therapeutic-claim products are TGA-regulated.
- Responsible person
- The Australian entity that imports or manufactures (the 'introducer') must hold AICIS registration and keep categorisation records; an overseas OEM cannot register on a buyer's behalf.
- Safety file
- No PIF; the introducer keeps records supporting each AICIS category (ingredient identity, hazard data, exposure) for 5 years and obtains an assessment certificate for assessed introductions.
- Labeling
- Consumer Goods (Cosmetics) Information Standard 2020: full ingredient list in English on the container (INCI or common English names, descending order, colour additives last, 'may contain' allowed for colours); therapeutic/sunscreen labels follow TGA rules; no allergen-naming rule.
- Animal testing
- Since 2020-07-01 new animal test data (generated on or after that date) cannot be used to support AICIS categorisation or assessment of ingredients used solely in cosmetics, with narrow exceptions; sale of imported animal-tested products is not banned.
- Ingredient lists
- Australian Inventory of Industrial Chemicals (AIIC) for listed chemicals, Poisons Standard (SUSMP) schedules and the IChEMS register (PFOS/PFOA/PFHxS banned from 2025-07-01); no cosmetic-specific positive lists.
- Notes
- The 2025-07-01 PFAS ban sits under the IChEMS scheme (environment portfolio), not AICIS; the ACCC is reviewing the 2020 information standard (outcome not verified).
Environmental Protection Authority (EPA); Commerce Commission for Fair Trading Act claims; Medsafe for therapeutic products
New Zealand
Cosmetic Products Group Standard 2020 (HSNO group standard), amended by EPA decision APP204297 of 2024-01-30 · Cosmetic Products Group Standard 2020 under the Hazardous Substances and New Organisms Act 1996
- In force
- 2020
- Latest change
- The amended Cosmetic Products Group Standard 2020 applies: schedules aligned to the EU, PFAS added to the prohibited list (manufacture/import banned from 2027-01-01, sale from 2028-01-01, disposal by 2028-07-01), nanomaterial record-keeping and revised labelling incl. 'contains/releases formaldehyde' warnings.Sources
- Market entry
- None: no pre-market notification or registration, but products must comply with the Group Standard (ingredients, labelling, packaging) from the day they are imported or made.
- Responsible person
- No statutory responsible person, but the New Zealand importer or manufacturer is legally responsible and its NZ physical address must appear on the label.
- Safety file
- No PIF required; the importer/manufacturer must hold evidence of compliance with the Group Standard (formulation checked against the schedules, nanomaterial records) for the EPA on request.
- Labeling
- English label with product name, full ingredient list (INCI, descending order), batch code, NZ importer/manufacturer address, nano ingredients flagged and required warnings; hazardous formulations also need HSNO hazard labelling.
- Animal testing
- Animal testing of cosmetics or cosmetic-only ingredients in New Zealand banned since 2015 (Animal Welfare Act s.84A); imported animal-tested products are not banned.
- Ingredient lists
- Group Standard schedules for prohibited components (Schedule 4, incl. PFAS in Table 2), restricted components, permitted colourants, preservatives and UV filters, aligned to EU Regulation 1223/2009 annexes.
- Notes
- The original 2020 commencement month and the exact schedule numbering were not verified.
Europe 4
European Commission (DG GROW) with Member State competent authorities
European Union
Regulation (EC) No 1223/2009 · Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
- In force
- 2013-07-11
- Latest change
- Commission Regulation (EU) 2026/909 ('Omnibus Act 2') published (in force 2026-05-18) restricting fragrance allergens such as benzyl salicylate and citral, aluminium compounds, zinc salts and hair dyes and banning triphenyl phosphate, with placing-on-market deadline 2027-01-01 and sell-through to 2028-07-01; Omnibus VIII (EU) 2026/78 applied from 2026-05-01 (nano/massive silver banned, hexyl salicylate and o-phenylphenol restricted).Sources
- Market entry
- Pre-market electronic notification of every product in the Cosmetic Products Notification Portal (CPNP) by the Responsible Person before placing on the market (Art. 13); no approval.
- Responsible person
- A Responsible Person established in the EU is mandatory — by default the EU manufacturer or importer, or a third party appointed by written mandate (Art. 4).
- Safety file
- Product Information File (PIF) kept 10 years, containing the Cosmetic Product Safety Report (CPSR, Annex I Parts A/B) signed by a qualified safety assessor, GMP (ISO 22716) statement, manufacturing description and proof of claims.
- Labeling
- Language(s) fixed by each Member State; INCI ingredient list; fragrance allergens named above 0.001% (leave-on) / 0.01% (rinse-off) — Regulation (EU) 2023/1545 adds 56 allergens to the historic 26, mandatory for products placed on the market from 2026-07-31 and for all products from 2028-07-31.
- Animal testing
- Full testing and marketing bans since 2013-03-11 (Art. 18): cosmetics or ingredients tested on animals for cosmetic purposes cannot be marketed in the EU.
- Ingredient lists
- Annex II (prohibited), Annex III (restricted), Annex IV (colorants), Annex V (preservatives), Annex VI (UV filters); CosIng database for INCI names.Look up this inventory here: 欧盟 · CosIng — European Commission cosmetic ingredient database
- Notes
- EUR-Lex pages for 2026/78 and 2026/909 were not machine-readable at fetch time; their OJ dates (2026-01-13 and 2026-04-28) and deadlines are taken from Complife and Cosmeservice regulatory bulletins and should be cross-checked against the OJ text. Omnibus VII = Regulation (EU) 2025/877 (TPO ban applied 2025-09-01, no sell-through).
Office for Product Safety and Standards (OPSS), Department for Business and Trade
United Kingdom (Great Britain)
Regulation (EC) No 1223/2009 (assimilated GB law); SI 2019/696 Schedule 34 · UK Cosmetics Regulation — assimilated Regulation (EC) No 1223/2009 as amended by Schedule 34 of the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019
- In force
- 2021-01-01
- Latest change
- SI 2026/23 bans 4-MBC (enzacamene) and cuts the 'contains formaldehyde' warning threshold to 0.001% released from 2026-07-15, and adds CMR substances incl. TPO to Annex II from 2026-08-15 (sell-through to 2027-02-14); SI 2026/109 (Mar 2026) restricts hexyl salicylate from 2026-08-15 and bans 17 further CMRs incl. nano silver from 2027-03-23 (sell-through 2027-09-22).Sources
- Market entry
- Pre-market notification on OPSS's Submit Cosmetic Product Notifications (SCPN) service by the UK Responsible Person before placing on the GB market; Northern Ireland stays under EU CPNP rules.
- Responsible person
- A Responsible Person established in the UK (manufacturer, importer or a company appointed by mandate) is mandatory and its address goes on the label; an EU RP is not accepted for GB.
- Safety file
- PIF with a Cosmetic Product Safety Report signed by a suitably qualified safety assessor (qualification recognised in the UK), kept 10 years and available in English on request.
- Labeling
- English labelling with UK RP name/address; INCI list; only the historic 26 fragrance allergens must be declared (>0.001% leave-on / >0.01% rinse-off) because GB has not adopted the EU 2023/1545 expansion; formaldehyde-releaser warning at ≥0.001% from 2026-07-15.
- Animal testing
- Testing and marketing bans carried over from EU law (Art. 18 of the assimilated regulation) remain in force.
- Ingredient lists
- Annexes II–VI of the UK Cosmetics Regulation (prohibited, restricted, colorants, preservatives, UV filters), now amended by UK statutory instruments on their own timetable.Look up this inventory here: 欧盟 · Regulation (EC) No 1223/2009 — Annexes II to VI
- Notes
- SI 2026/109 dates (hexyl salicylate 2026-08-15; 17 CMRs 2027-03-23) come from Cosmeservice/CIRS summaries, the legislation.gov.uk text could not be fetched; OPSS has not concluded any consultation on adopting the expanded allergen list as of Sept 2026.
Federal Food Safety and Veterinary Office (FSVO / BLV / OSAV) with cantonal enforcement authorities
Switzerland
SR 817.023.31 (Ordinance of 16 December 2016); LGV SR 817.02 Art. 54 · Ordinance of the FDHA on Cosmetics (VKos / OCos) under the Foodstuffs Act (LMG) and the Foodstuffs and Utility Articles Ordinance (LGV)
- In force
- 2017-05-01
- Latest change
- Amendment RU 2025 824 (adopted 2025-12-09) applies the 1 ppm furocoumarin limit to the sum of eight marker furocoumarins in leave-on products with sun exposure from 2026-01-01 without transition period; ingredient annexes follow EU 1223/2009 by dynamic reference, currently updated through Regulation (EU) 2026/909.Sources
- Market entry
- No pre-market notification or registration — products are placed on the market under the manufacturer's/importer's self-control (Selbstkontrolle) with cantonal market surveillance.
- Responsible person
- The manufacturer or importer domiciled in Switzerland who places the product on the market is the responsible person for compliance and self-control; no separate RP designation exists.
- Safety file
- A product information file with a safety assessment/safety report equivalent to the EU PIF/CPSR must be kept and shown to authorities on request.
- Labeling
- Labelling in at least one official language (German, French or Italian); INCI ingredient list; fragrance allergens per the EU Annex III entries (0.001% leave-on / 0.01% rinse-off) because Swiss law refers to the EU annexes; Swiss-domiciled responsible party on the label.
- Animal testing
- Animal testing of cosmetics/ingredients and marketing of animal-tested cosmetics are prohibited in line with the EU ban (LGV Art. 59).
- Ingredient lists
- Annexes II–VI of Regulation (EC) No 1223/2009 apply by reference (LGV Art. 54); Switzerland keeps only stricter national deviations such as the furocoumarin limit.
- Notes
- Fedlex text is not machine-readable; article numbers (LGV Art. 59 animal testing, language rule) should be checked; Swiss transitional dates for the 2023/1545 allergen expansion could not be verified.
Turkish Medicines and Medical Devices Agency (TİTCK), Ministry of Health
Turkey (Türkiye)
Official Gazette No. 32184 (bis) of 8 May 2023, under Cosmetics Law No. 5324 · Cosmetic Products Regulation (Kozmetik Ürünler Yönetmeliği)
- In force
- 2023-11-08
- Latest change
- Amending regulation (Official Gazette No. 32480) revised the annexes and RP rules, including D5/D6 siloxane limits of 0.1% in rinse-off products from 2026-12-01 and in all products from 2027-06-06; separately, Ministry of Trade distance-selling rules (OG 2024-10-30) require Turkish labels, importer details and the ÜTS notification number in online listings from 2025-04-01.Sources
- Market entry
- Pre-market product notification in the Product Tracking System (ÜTS) by the Turkish Responsible Person before placing on the market; no approval but TİTCK may review the file.
- Responsible person
- A Responsible Person resident/established in Turkey (manufacturer, importer or a legal entity appointed by written agreement) must be designated and holds the PIF.
- Safety file
- Product Information File and cosmetic product safety assessment/report by a qualified assessor mirroring EU 1223/2009 Annex I; valid EU safety assessment reports are accepted without repetition.
- Labeling
- Turkish-language labelling (INCI names allowed for ingredients) with the Turkish RP name/address; fragrance allergens declared per Annex III thresholds (0.001% leave-on / 0.01% rinse-off); e-commerce listings must show legible Turkish label images and the ÜTS number.
- Animal testing
- Article 21 prohibits placing on the market cosmetics or ingredients tested on animals where validated alternative methods exist, mirroring the EU ban.
- Ingredient lists
- Annexes II–VI of the Cosmetic Products Regulation (prohibited, restricted, colorants, preservatives, UV filters), aligned to the EU annexes with a time lag.
- Notes
- Entry into force (six months after publication) is stated by two law-firm summaries; the Resmî Gazete text could not be fetched. Whether the October-2024 draft amendment (digital labels/QR codes, notification fees) was gazetted could not be confirmed.
Eurasia 3
Eurasian Economic Commission (EEC) sets the rules; national bodies enforce — in Russia Rospotrebnadzor (state registration, surveillance) and accredited certification bodies for declarations
Russia / Eurasian Economic Union (Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan)
TR CU 009/2011 (Customs Union Commission Decision No. 799 of 23 September 2011) · Technical Regulation of the Customs Union TR CU 009/2011 'On Safety of Perfumery and Cosmetic Products'
- In force
- 2012-07-01
- Latest change
- EEC Board Decision No. 87 of 2025-10-07 updated the lists of standards supporting TR CU 009/2011 (new test methods for formaldehyde, UV-A, water resistance and SPF; essential-oil safety standards) effective 2026-04-08; the last substantive annex revision (EEC Council Decision No. 64 of 2022-04-15, prohibited/restricted lists, colorants, preservatives, UV filters) took effect 2023-04-18.Sources
- Market entry
- Mandatory EAC conformity assessment before placing on the market — Declaration of Conformity for most cosmetics, or a State Registration Certificate (SGR) for higher-risk groups such as children's, intimate-hygiene, tanning, whitening, hair-dye/perm, chemical-peel and fluoride >0.15% products — recorded in the EAEU unified register.
- Responsible person
- The applicant for the declaration or state registration must be a legal entity or sole trader registered in an EAEU member state (manufacturer, its authorised representative or importer) and is named on the label.
- Safety file
- Technical evidence behind the declaration — test reports from accredited EAEU laboratories (physico-chemical, microbiological, toxicological/clinical) plus GMP evidence; no PIF/CPSR concept but equivalent documents are held by the applicant.
- Labeling
- Russian (plus the state language of the member state of sale) for product name, purpose, warnings, applicant/manufacturer details, shelf life and batch; the ingredient list may use INCI/Latin; EAC mark mandatory; no fragrance-allergen declaration requirement.
- Animal testing
- No ban — animal testing is not prohibited and toxicological data may still be generated in vivo.
- Ingredient lists
- Annex 1 (prohibited), Annex 2 (restricted), Annex 3 (colorants), Annex 4 (preservatives), Annex 5 (UV filters) of TR CU 009/2011, plus the list of products subject to state registration (Annex 12).
- Notes
- Annex numbering for the state-registration product list (Annex 12) and the SGR product categories are summarised from certification-body guidance, not re-verified against the consolidated regulation text.
Ministry of Health of Kazakhstan – Committee for Sanitary and Epidemiological Control (state registration) and EAEU-accredited certification bodies (declarations), under rules set by the Eurasian Economic Commission
Kazakhstan (EAEU member)
TR CU 009/2011 (Customs Union Commission Decision No. 799 of 23 Sept 2011), as amended by EEC Council Decisions No. 64/2022, No. 114/2024 and No. 74/2025 · EAEU/Customs Union Technical Regulation TR CU 009/2011 'On Safety of Perfumery and Cosmetic Products', applied directly in Kazakhstan as an EAEU member state (no separate national cosmetics law)
- In force
- 2012-07-01
- Latest change
- EEC Council Decision No. 114 (29 Nov 2024) entered into force (new product categories, state-registration schemes with 5-year certificates, enhanced toxicology testing from 2026-07-01), while Decision No. 74 (12 Sept 2025) adds 14 prohibited substances, a new UV filter and a fluoride ban in children's liquid oral products from 2026-10-28 and a 0.001% formaldehyde labelling threshold from 2027-01-01.Sources
- Market entry
- Pre-market EAC conformity assessment: a Declaration of Conformity (max 5 years) registered by an EAEU-accredited body for most cosmetics, or a State Registration certificate (SGR, now max 5 years) for listed categories (children's, intimate, tanning, whitening, chemical peels, hair dyes, etc.), with documents issued in any EAEU state valid in Kazakhstan.
- Responsible person
- The applicant/declarant must be a legal entity registered in an EAEU member state (Kazakh importer or the manufacturer's authorised representative) whose name and address appear on the label.
- Safety file
- Test reports from accredited EAEU laboratories (microbiology, toxicology/safety, physico-chemical), formula, technical documentation and label samples, with foreign documents translated into Russian.
- Labeling
- Russian plus Kazakh (state language) labeling with the EAC mark, EAEU applicant name/address, ingredients, batch, shelf life and specific warnings (e.g. fluoride content), as Kazakhstan's Law on Languages requires Kazakh on labels.
- Animal testing
- No ban on animal testing under TR CU 009/2011.
- Ingredient lists
- TR CU 009/2011 Annexes 1–5 (prohibited substances, restricted substances, colorants, preservatives, UV filters), broadly aligned to EU lists and updated by Decisions 64/2022, 114/2024 and 74/2025.
- Notes
- The specific Kazakh committee issuing SGR certificates was not confirmed on an official page. EEC Board Decision No. 87 (7 Oct 2025) updated the standards lists from 2026-04-08 and Board Decision No. 31 (10 Mar 2026) set transition periods for Decision 74.
Ministry of Health of Ukraine (regulator and notification portal) and the State Service of Ukraine on Medicines and Drugs Control (market surveillance)
Ukraine
CMU Resolution No. 65 of 2021-01-20 (in force 2024-08-03), as amended by CMU Resolution No. 737 of 2026-06-04 · Technical Regulation on Cosmetic Products, approved by Cabinet of Ministers Resolution No. 65 of 20 January 2021 (aligned with EU Regulation (EC) No 1223/2009)
- In force
- 2024-08-03
- Latest change
- Resolution No. 737 re-issued Annexes 2–6 in line with EU lists and set staged deadlines: products placed on the market from 2026-08-03 must be notified and fully compliant, legacy/non-notified stock may be sold until 2030-08-03, and the amendment enters into force six months after publication (2026-12-13).Sources
- Market entry
- Mandatory pre-market notification through the Ministry of Health's electronic portal (CPNP-style) by the responsible person before placing on the market, fully enforced for products placed from 2026-08-03.
- Responsible person
- A responsible person established in Ukraine (manufacturer, importer or a third party mandated in writing) must be designated and named on the label.
- Safety file
- Product Information File with a Cosmetic Product Safety Report signed by a qualified assessor, kept 10 years at the responsible person's address.
- Labeling
- Ukrainian-language labeling with responsible person name/address, INCI ingredients, batch, durability/PAO, precautions and function, with internationally understood symbols allowed.
- Animal testing
- Banned – the regulation prohibits placing on the market cosmetics tested on animals, mirroring EU Article 18.
- Ingredient lists
- Annexes 2–6 of the Technical Regulation (prohibited, restricted, colorants, preservatives, UV filters) mirroring EU 1223/2009 Annexes II–VI as updated by Resolution 737/2026.
- Notes
- GlobalCosing reports publication of Resolution 737 on 2026-06-13 and entry into force on 2026-12-13; confirm against zakon.rada.gov.ua. The draft had been notified to the WTO on 2025-07-30 with comments to 2026-01-09.
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.
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.
Middle East 5
GCC Standardization Organization (GSO) issues the Gulf Technical Regulation; national regulators (SFDA, MoIAT/municipalities, etc.) enforce it
GCC (Gulf Cooperation Council bloc: Saudi Arabia, UAE, Kuwait, Qatar, Bahrain, Oman)
GSO 1943:2024 (Edition 4, approved 2024-05-01); companions GSO 2528:2024 (claims), GSO 2636:2021 (PIF), GSO 2020:2010 (GMP) · GSO 1943:2024 Cosmetic Products – Safety Requirements of Cosmetics and Personal Care Products (Gulf Technical Regulation)
- In force
- 2009-10-17
- Latest change
- GSO 1943:2024 (Edition 4) and GSO 2528:2024 on cosmetic claims approved, replacing GSO 1943:2021/2022.Sources
- Market entry
- No bloc-level system: each member state runs its own pre-market notification/conformity scheme against GSO 1943 (SFDA GHAD/eCosma in KSA, MoIAT ECAS plus Dubai Montaji in UAE, etc.).
- Responsible person
- GSO 1943 requires the manufacturer or responsible person's name/address on the label, and in practice every member state requires a locally licensed importer/agent to notify products.
- Safety file
- Product Information File per GSO 2636:2021 with safety assessment, formula, test data and GMP (GSO 2020 / ISO 22716) evidence, available to authorities on request.
- Labeling
- Arabic mandatory (Arabic-only or bilingual Arabic/English) with INCI ingredients, batch, expiry/PAO, country of origin and manufacturer/RP; products must be free of pork derivatives and must not carry imagery contrary to Islamic/GCC values; halal certification voluntary.
- Animal testing
- No GCC-wide ban on animal testing of cosmetics identified.
- Ingredient lists
- GSO 1943 annexes of prohibited substances, restricted substances, permitted colorants, preservatives and UV filters, aligned to EU Regulation (EC) No 1223/2009.
- Notes
- GSO 1943 is adopted nationally (SFDA.CO/GSO 1943, UAE.S GSO 1943) and enforced by national authorities; consultancy claims of a 'unified GCC regulation 2026' cite no official GSO document, so no 2025-2026 bloc-level change is verified.
Saudi Food and Drug Authority (SFDA)
Saudi Arabia
Royal Decree No. M/49 dated 18/6/1436H (2015-04-07); Implementing Regulation of the Cosmetic Products Law; SFDA.CO/GSO 1943:2024; SFDA.CO/GSO 2528:2024 · Cosmetic Products Law (Royal Decree No. M/49 of 18/6/1436H) and its Implementing Regulation, with technical requirements SFDA.CO/GSO 1943
- In force
- 2015-10-04
- Latest change
- SFDA added 21 substances to its prohibited list (after a 2025-08-14 circular adding three restricted substances); import/manufacture of non-compliant products is banned from 2026-01-01 with sell-through allowed until 2028-01-01.Sources
- Market entry
- Mandatory pre-market product notification (listing) in the SFDA GHAD unified e-platform (eCosma module; GHAD replaced eCosma on 2023-03-30), decided within 15 days and valid 5 years, plus a shipment Certificate of Conformity via FASEH before customs clearance.
- Responsible person
- Only an SFDA-licensed Saudi establishment (importer/distributor or local manufacturer) can notify products, so foreign brands must appoint such a local agent.
- Safety file
- Product Information File per GSO 2636 with safety assessment, formula, test reports and GMP (GSO 2020 / ISO 22716) evidence held for SFDA inspection; local factories need an SFDA technical licence.
- Labeling
- Arabic labeling mandatory (bilingual Arabic/English accepted) with INCI list, function, batch, expiry or PAO, responsible party, net content, warnings and country of origin; must be free of pork derivatives; halal certification not legally mandatory.
- Animal testing
- No statutory ban on animal testing of cosmetics identified.
- Ingredient lists
- SFDA lists of prohibited and restricted substances and permitted colorants, preservatives and UV filters (SFDA.CO/GSO 1943 annexes aligned to EU 1223/2009), amended by SFDA circulars of Feb, Aug and Sep 2025.
- Notes
- SFDA's own site blocked fetching, so the 2025 circular dates rely on SGS/Cotecna summaries; Cotecna's Feb-2025 item describes an earlier restricted-substances circular with separate deadlines of 2026-12-01 (production/import) and 2028-12-01 (market).
Ministry of Industry and Advanced Technology (MoIAT, successor of ESMA) for ECAS conformity; Dubai Municipality (Montaji) and other emirate municipalities for product registration
United Arab Emirates
Cabinet Decision No. 18 of 2014; UAE.S GSO 1943:2024; GSO 2528:2024; Cabinet Decision No. 5 of 2014 (fragrances) · Cabinet Decision No. 18 of 2014 on the UAE Regulation for the Control of Cosmetics and Personal Care Products, applying UAE.S GSO 1943
- In force
- 2014-04-29
- Latest change
- MoIAT updated its Technical Guidelines for Cosmetics and Personal Care Products and adopted GSO 1943:2024 / GSO 2528:2024 (effective 2024-05-01); no new federal cosmetics decision found for 2025-2026.Sources
- Market entry
- Two-layer pre-market system: MoIAT ECAS Certificate of Conformity (valid 1 year) against GSO 1943 for import/customs, plus product registration in Dubai Municipality's Montaji system (valid 5 years) before retail sale.
- Responsible person
- Only a UAE-incorporated entity (local manufacturer, importer or distributor) may hold ECAS certificates and Montaji registrations, so foreign brands need a local agent.
- Safety file
- Dossier with Free Sale Certificate, full ingredient report, GMP evidence and accredited lab test reports (microbiology, heavy metals), with a PIF per GSO 2636 held by the local registrant.
- Labeling
- Arabic labeling mandatory (bilingual Arabic/English accepted) per Cabinet Decision 18/2014 and GSO 1943 with INCI, batch, expiry/PAO, warnings and allergen declaration; pork-free and no imagery contrary to Islamic values; halal certification voluntary but required if halal is claimed.
- Animal testing
- No formal ban on animal testing of cosmetics in the UAE.
- Ingredient lists
- UAE.S GSO 1943 annexes (prohibited, restricted, colorants, preservatives, UV filters) aligned to EU 1223/2009.
- Notes
- Consultancy reports say the Emirates Drug Establishment (Federal Decree-Law 28/2023) took over medicated-product registration from MOHAP at end-2025 while ordinary cosmetics stayed with Montaji; not verified on an official page. Montaji covers Dubai only; other emirates use their own municipal systems.
Ministry of Health – Pharmaceutical Division (Cosmetics Department)
Israel
Pharmacists Ordinance (Amendment No. 37), 2024; Pharmacists' Regulations (Cosmetics) 5783-2022 (WTO G/TBT/N/ISR/1279) · Pharmacists Ordinance [New Version] 1981 as amended by Amendment No. 37 (2024) ('What is good for Europe is good for Israel' cosmetics reform), with the Pharmacists' Regulations (Cosmetics)
- In force
- 2025-01-01
- Latest change
- MoH legislative memorandum proposes a parallel 'U.S. track' for FDA-compliant cosmetics, retailer verification duties against the MoH cosmetics database, and adding solid soap to the cosmetic definition (proposal, not yet law).Sources
- Market entry
- Since 2025-01-01 the old Cosmetic Product Licence (discontinued 2024-12-31) is replaced by online notification to the MoH (Notification Track) by a registered dealer/responsible representative; EU-, UK- or Swiss-compliant products qualify, while 'sensitive' cosmetics (children under 12, sunscreens, nano, hair straighteners, etc.) stay under stricter approval.
- Responsible person
- An Israel-resident Responsible Person/representative registered in the MoH database must be appointed and is legally liable for the PIF and product safety.
- Safety file
- EU-style Product Information File with Cosmetic Product Safety Report by a qualified assessor, GMP (ISO 22716) and test data, kept 10 years.
- Labeling
- Hebrew labeling mandatory (English/Arabic optional) with INCI, batch, expiry/PAO, responsible person details and warnings, traceable to the MoH notification/database entry.
- Animal testing
- Banned: testing cosmetics on animals in Israel since 2007 and import/marketing of animal-tested cosmetics since 2013-01-01.
- Ingredient lists
- Annexes aligned to EU Regulation 1223/2009 (prohibited, restricted, colorants, preservatives, UV filters).
- Notes
- gov.il pages could not be fetched; the 2026 transition deadline for legacy licences and the Hebrew/English/Arabic label statement come from consultancy pages.
Egyptian Drug Authority (EDA) – General Administration for Cosmetic Products Registration
Egypt
Law No. 151/2019; EDA Decree No. 122/2022 (effective 2022-02-27); Regulatory Guide for Cosmetics Notification (2023) · Law No. 151 of 2019 establishing the Egyptian Drug Authority, with EDA Chairman Decree No. 122 of 2022 on the listing (notification) and circulation of cosmetic products
- In force
- 2022-02-27
- Latest change
- EDA issued the Regulatory Guide for Cosmetics Notification (2023), followed by a Claims Guide (EDREX:GL.CAPP.010), product-naming rules (reported effective 2025-01-01) and a variations-documents guide.Sources
- Market entry
- Mandatory pre-market notification on the EDA EgyCosm portal; a notification number is issued within 10 working days (3 days fast track) and is valid 10 years.
- Responsible person
- Notification is filed by an Egyptian company registered with the EDA (local manufacturer, importer or scientific office holding a brand-owner authorization letter).
- Safety file
- Composition form with INCI percentages, CoA, stability/shelf-life, Free Sale Certificate for imports, claim substantiation and clarification letters, with cosmetovigilance reporting within 20 days.
- Labeling
- Arabic mandatory (Arabic plus English artwork) showing product name, notification number/barcode, INCI list and usage instructions; advertising must be primarily Arabic.
- Animal testing
- No statutory ban identified.
- Ingredient lists
- EDA adopts the five EU 1223/2009 annexes (prohibited, restricted, colorants, preservatives, UV filters) plus EDA-specific limits.
- Notes
- EDA PDFs/announcement pages could not be opened; guide dates are unverified. The 10-year notification validity comes from consultancy 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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