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International Regulatory Guide by Market
We provide the documentation and regulatory support you need to sell our products in any market worldwide. Select your target market below to see what's required and what we've already prepared for you.
Regulatory Requirements
- • AICIS (Australian Industrial Chemicals Introduction Scheme) compliance for all chemical ingredients
- • NICNAS/AICIS inventory listing or exemption for each ingredient
- • Product labelling per Australian Consumer Law and TGA (non-therapeutic cosmetics)
- • Compliance with the Competition and Consumer Act 2010
- • No mandatory pre-market registration for cosmetics
What We Provide
- ✓ All ingredients AICIS listed or exempt
- ✓ Safety Data Sheet (SDS) for each product
- ✓ Certificate of Analysis (CoA) per batch
- ✓ Certificate of Conformity
- ✓ Full INCI ingredient list for labelling
- ✓ Manufactured in accordance with ISO 22716 GMP principles
- ✓ Label design support and compliance review available
Regulatory Requirements
- • Regulation (EC) No 1223/2009 — the EU Cosmetics Regulation
- • Cosmetic Product Safety Report (CPSR) — Annex I Parts A & B
- • Product Information File (PIF) held by an EU Responsible Person
- • CPNP (Cosmetic Product Notification Portal) notification before first sale
- • EU Responsible Person (legal entity established in the EU)
- • Compliance with Annexes II–VI (restricted/prohibited substances)
- • Article 19 labelling requirements
What We Provide
- ✓ Complete CPSR (Parts A & B) — ready for assessor sign-off
- ✓ Full Product Information File (PIF) per Article 11
- ✓ Preservative Efficacy Testing (PET) — Ph. Eur. Criteria A pass
- ✓ Stability testing (real-time, accelerated, freeze-thaw)
- ✓ Microbiological testing per ISO 17516
- ✓ Toxicological profiles and Margin of Safety calculations
- ✓ SDS, CoA, Certificate of Conformity
- ✓ Guidance on appointing an EU Responsible Person
Regulatory Requirements
- • UK Cosmetics Regulation (retained EU law, UK-specific amendments)
- • CPSR equivalent required — same structure as EU
- • UK Responsible Person (must be established in the UK)
- • SCPN (Submit Cosmetic Product Notification) via UK OPSS portal
- • PIF held at UK RP address
- • UK-specific labelling (UK RP address on label)
What We Provide
- ✓ CPSR and PIF — identical structure accepted by UK authorities
- ✓ All EU-standard documentation transfers directly to UK requirements
- ✓ SDS, CoA, Certificate of Conformity
- ✓ Guidance on appointing a UK Responsible Person
- ✓ SCPN notification data package ready
Regulatory Requirements
- • FDA Cosmetic Regulations — 21 CFR Parts 700-740
- • MoCRA 2022 (Modernization of Cosmetics Regulation Act) — effective 2024+
- • Facility registration with the FDA
- • Product listing with the FDA
- • Adverse event reporting system
- • Good Manufacturing Practice (GMP) compliance
- • US Agent required for foreign manufacturers
- • Label compliance with Fair Packaging and Labeling Act
What We Provide
- ✓ Safety Data Sheet (SDS) — GHS compliant
- ✓ Certificate of Analysis (CoA) per batch
- ✓ Certificate of Conformity
- ✓ Manufacturing in accordance with ISO 22716 GMP principles
- ✓ Full ingredient listing (INCI format) for FDA labelling
- ✓ Microbiological and stability testing records
- ✓ Guidance on FDA facility registration and US Agent appointment
Regulatory Requirements
- • UAE: ECAS/ESMA product registration via Emirates Conformity Assessment System
- • Saudi Arabia: SFDA (Saudi Food & Drug Authority) cosmetic notification
- • GCC Standardization Organization (GSO) technical regulations
- • CoA and safety assessment documentation
- • Arabic language labelling requirements
- • Halal certification may be required or preferred
- • Free Sale Certificate from country of origin
What We Provide
- ✓ Certificate of Analysis (CoA) per batch
- ✓ Certificate of Conformity
- ✓ Safety Data Sheet (SDS)
- ✓ Product safety assessment documentation
- ✓ Microbiological and stability data for registration dossier
- ✓ Guidance on halal certification pathways
- ✓ Free Sale Certificate support (via Australian Chamber of Commerce)
Regulatory Requirements
- • China: NMPA registration or filing (general vs special-use cosmetics)
- • South Korea: MFDS notification and functional cosmetic review
- • Japan: PMDA classification (quasi-drug vs cosmetic)
- • ASEAN: Cosmetic Directive harmonised notification
- • India: BIS standards and CDSCO registration
- • Animal testing may be required in some markets (China general cosmetics exemption since 2021)
What We Provide
- ✓ Full product dossier for registration applications
- ✓ Safety Data Sheet, CoA, Certificate of Conformity
- ✓ Product safety assessment and toxicological data
- ✓ Preservative efficacy and microbiological testing data
- ✓ Stability testing reports
- ✓ Cruelty-free / no animal testing declaration (Article 18 compliant)
- ✓ Guidance on in-market regulatory partners for registration
Need help navigating the regulatory requirements for your market?
Contact Our Regulatory Team