This page is a living resource — last updated July 2026. Regulations change. Always verify with official sources before shipping. Found an update or error? Let us know.
1. Comprehensive Regulatory Comparison: 5 Markets at a Glance
The table below compares cosmetic and eyelash regulations across the five major import markets. Use this as a quick reference when preparing your compliance documentation for each target region.
| Requirement | United States | European Union | Saudi Arabia | Brazil | Japan |
|---|---|---|---|---|---|
| 1. Regulatory Body | FDA (Food & Drug Administration) | European Commission + Member State competent authorities | SFDA (Saudi Food & Drug Authority) | ANVISA (Agência Nacional de Vigilância Sanitária) | PMDA (Pharmaceuticals and Medical Devices Agency) + MHLW |
| 2. Key Legislation | MoCRA 2022 (Modernization of Cosmetics Regulation Act), FD&C Act | EC 1223/2009 (EU Cosmetics Regulation) | SFDA Cosmetic Products Regulation, SASO standards | RDC 752/2022 (ANVISA Cosmetics Regulation) | PMD Act (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices) |
| 3. Facility Registration Required? | Yes — mandatory under MoCRA (renew every 2 years) | Yes — Responsible Person (RP) must be established in EU | Yes — SFDA e-Cosmetics system registration | Yes — ANVISA company registration + product notification | Import notification only (no pre-market facility registration for cosmetics) |
| 4. Product Registration / Notification | Product listing with FDA (product category, ingredients, responsible person) | CPNP notification before market placement (EU Cosmetics Regulation) | SFDA Cosmetic Product Notification (e-Cosmetics portal) | ANVISA product notification (RDC 752/2022 — simplified for low-risk cosmetics) | Import notification + ingredient labeling (cosmetics classified as quasi-drugs need pre-market approval) |
| 5. Responsible Person Requirement | "Responsible Person" must be a US address/entity | Responsible Person must be EU-based (manufacturer, importer, or designated third party) | Local agent or importer with SFDA registration | Local registration holder (Brazilian entity) | Importer or Marketing Authorization Holder (MAH) in Japan |
| 6. Ingredient Restrictions | No pre-market approval. FDA maintains prohibited/restricted ingredients list. No mandatory safety substantiation before MoCRA (now required) | Annex II (~1,700 prohibited substances), Annex III (restricted), Annex V (allowed preservatives). Full PIF required | Follows EU Annex II/III framework. Additional halal ingredient considerations | Mercosur harmonized lists; broadly aligned with EU. ANVISA negative list | Positive list for preservatives, UV filters, colorants. Negative list of prohibited ingredients |
| 7. Labeling Requirements | Product identity, net quantity, ingredients (INCI), responsible person name/address, warnings. English. | Product name, ingredients (INCI), net content, RP name/address, country of origin (if outside EU), batch number, PAO (Period After Opening) | Arabic + English labels mandatory. Ingredients (INCI), batch number, country of origin, manufacturer/importer name. Halal logo if applicable. | Portuguese labeling. Product name, ingredients (INCI), net content, manufacturer/importer, batch number, expiration date, ANVISA registration number. | Japanese labeling. Product name, ingredients (Japanese translation), net content, importer name/address, manufacturing number. Quasi-drugs require additional MHLW approval mark. |
| 8. Language on Label | English | Official language(s) of member state where sold | Arabic AND English (both mandatory) | Portuguese | Japanese |
| 9. Testing Requirements | Safety substantiation required under MoCRA. No specific test mandated. Industry standard: microbial, stability, challenge testing. | Full safety assessment by qualified safety assessor required. CPSR (Cosmetic Product Safety Report) mandatory. | Conformity assessment. Product testing per SASO standards (typically IEC/ISO standards recognized). SFDA may request test reports. | Stability testing, microbiological testing. Safety assessment required for registration. | Quasi-drugs: rigorous safety/efficacy data required. General cosmetics: manufacturer/importer responsible for safety. |
| 10. Good Manufacturing Practice (GMP) | GMP required under MoCRA (FDA establishing standards). ISO 22716 widely recognized. | ISO 22716 harmonized standard. GMP compliance mandatory. | ISO 22716 recognized. SFDA inspection may apply. | GMP certification required (RDC 48/2013). ISO 22716 accepted. | GMP required for quasi-drugs. Voluntary for general cosmetics. ISO 22716 recommended. |
| 11. Shelf Life / Expiration | Not mandatory for cosmetics with >30 month shelf life. PAO symbol if <30 months. | PAO symbol (open jar with number of months) if shelf life >30 months. Expiration date required if <30 months. | Expiration date required on label. | Expiration date required. | Manufacturing date or manufacturing code required. Expiration for quasi-drugs. |
| 12. Adverse Event Reporting | Mandatory under MoCRA. Serious events must be reported to FDA within 15 days. | Required under EU Cosmetics Regulation. Serious undesirable effects reported to competent authorities. | Required. SFDA adverse event reporting system. | Required. ANVISA pharmacovigilance system for cosmetics (notified products). | Required for quasi-drugs. Voluntary for general cosmetics. |
| 13. Animal Testing | Not banned federally. Some states (CA, NY, VA, etc.) have state-level bans. | Banned since 2013 (testing ban + marketing ban) | No specific ban. Halal certification typically requires cruelty-free claims. | Animal testing for cosmetics banned in several states. Federal movement toward ban. | Not banned. Alternatives encouraged. Quasi-drug testing may require animal data. |
| 14. Import Documentation | Commercial invoice, packing list, Bill of Lading, FDA product listing confirmation. MoCRA compliance cert recommended. | Commercial invoice, packing list, CPNP notification confirmation, CPSR (on request), GMP certificate. REACH compliance for adhesives. | Commercial invoice (legalized), packing list, Certificate of Origin, SFDA product notification, SASO Certificate of Conformity, Halal certificate (if applicable) | Commercial invoice, packing list, ANVISA product notification, GMP certificate, Free Sale Certificate from country of origin. | Commercial invoice, packing list, import notification form, ingredient list (Japanese). Quasi-drugs: MHLW approval certificate. |
| 15. Eyelash Adhesive Specifics | Cyanoacrylate-based adhesives regulated as cosmetics. Latex-free labeling recommended. No specific adhesive regulation. | Adhesives must comply with EC 1223/2009 + REACH. Cyanoacrylate restrictions. Formaldehyde content limits. | SASO standards apply. Cyanoacrylate adhesives require SDS documentation. | Adhesives considered Grade 2 cosmetics. Additional safety data may be required. | Adhesives regulated as cosmetics or quasi-drugs depending on claims. Cyanoacrylate subject to MHLW evaluation. |
| 16. Cost Estimate (First Registration) | FDA registration free. Product listing free. Costs: safety testing $500-3,000 per product. | CPNP notification free. RP service: €200-800/year. Safety assessment: €300-2,000 per product. | SFDA registration fee ~SAR 500-2,000. SASO CoC: $100-400 per shipment. Local agent: $500-2,000/year. | ANVISA fee ~R$500-2,000 per product. Local registration holder: $1,000-5,000/year. | Import notification: ¥10,000-50,000. MAH service: ¥50,000-200,000/year. Quasi-drug approval: ¥500,000-2,000,000. |
| 17. Typical Timeline (First Entry) | 2-4 weeks (registration + product listing) | 4-12 weeks (safety dossier, CPSR, CPNP) | 4-8 weeks (SFDA registration + SASO CoC) | 8-16 weeks (ANVISA registration + GMP certification) | 4-8 weeks (import notification). Quasi-drugs: 6-18 months. |
| 18. Key Compliance Risk | MoCRA enforcement ramping up. Late registration penalties up to $15,000/day. | Market surveillance by member states. Non-compliance = product withdrawal from 27 countries. | Customs rejections common without SASO CoC. Border holds can take weeks. | ANVISA increasing enforcement. Unregistered products seized at border. | Quasi-drug misclassification = customs rejection + re-export or destruction. |
2. Quick-Reference: Which Regulation Applies to Eyelashes?
Eyelash product classification varies by market. Understanding whether your product is a cosmetic, quasi-drug, or medical device is the critical first step in compliance planning.
Eyelash Classification by Market:
- US: Eyelashes (non-adhesive) = cosmetics. Eyelash adhesive = cosmetic. Both subject to MoCRA.
- EU: Eyelashes = cosmetic product (EC 1223/2009, Annex I scope). Adhesive containing cyanoacrylate = cosmetic with REACH.
- Saudi Arabia: Eyelashes = cosmetics (SFDA Cosmetics Regulation). No separate medical device classification.
- Brazil: Eyelashes = Grade 1 cosmetics (low risk, simplified notification). Adhesive = Grade 2 (higher risk).
- Japan: Eyelashes = cosmetics. Adhesive with active claims = quasi-drug (stricter regulation).
3. Pre-Export Compliance Checklist
A practical checklist for brands preparing to export eyelashes to any of the five regulated markets. Complete each step before booking your first shipment.
Export-Ready Compliance Checklist
Before shipping eyelashes to any of the five regulated markets:
- Confirm product classification — Is your product a cosmetic, quasi-drug, or medical device in the target market?
- Register facility — Complete facility/establishment registration if required by target market.
- Notify/register product — Submit product notification/registration in the target market's system.
- Prepare safety dossier — Safety assessment report, CPSR (EU), or equivalent.
- Verify ingredient compliance — Check all ingredients against target market's prohibited/restricted lists.
- Design compliant labels — Language, INCI ingredients, batch number, PAO/expiration, responsible person.
- Obtain GMP certification — ISO 22716 or equivalent accepted in target market.
- Secure import documents — Certificate of Conformity, Free Sale Certificate, Halal cert (if applicable).
- Designate responsible person/agent — Local entity in the target market.
- Ship with complete paperwork — Commercial invoice, packing list, compliance certificates, test reports.
4. Download & Share This Cheat Sheet
This regulatory reference is maintained by the Aurevia Lashes compliance team. Share it with your sourcing partners, regulatory consultants, or internal quality team.
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Last updated: July 2026. Found an update or error? Let us know.