Cosmetic Regulatory Compliance Navigator
Navigate cosmetic regulatory requirements across FDA, EU, China, and global markets
What You Can Do
You can generate comprehensive regulatory roadmaps for cosmetic products across FDA, EU, China, Canada, and other key markets. This skill maps ingredient restrictions, allowed claims, labeling requirements, and safety documentation needs for each jurisdiction, then produces market-specific checklists, technical file templates, and submission packages that accelerate your approval timeline and eliminate costly compliance gaps.
Features
Automatically identifies ingredient restrictions, claim limitations, and documentation requirements for FDA, EU, China, Canada, Japan, and other target markets
Generates Ingredient Safety Summaries (ISS), stability protocols, and safety data requirements tailored to each jurisdiction
Creates pre-submission checklists that track all required documentation, testing, and certifications for each target market
Compares regulations across jurisdictions side-by-side to identify overlaps and streamline global dossier preparation
Evaluates proposed marketing claims against jurisdiction-specific regulations and flags non-compliant or risky language
Generates market-specific label requirements including language mandates, warning statement formats, and ingredient disclosure rules
Cross-references your formula against banned/restricted substances lists for each jurisdiction with compliance status
Outlines the sequence and timing of submissions, approvals, and post-market reporting for multi-market launches
Example Output
FDA Submission Checklist for New Skincare Serum:
- ✓ Cosmetic Facility Registration (Form FDA 3537)
- ✓ Ingredient Safety Summary (all components listed in CosIng or INCI)
- ✓ Manufacturing process validation
- ✓ Stability data (6-month minimum)
- Estimated timeline: 4-8 weeks
EU vs. China Requirement Comparison:
| Requirement | EU | China |
|---|---|---|
| Safety Assessment | Required (ISS) | Required (CSAR) |
| Animal Testing | Prohibited | Not required for imported products |
| Color Additives | Restricted list | Different restricted list |
| Preservatives | Maximum levels set | Maximum levels set |
Ingredient Restriction Alert:
- Titanium Dioxide: FDA allows; EU restricts in powder form; China allows with limits
- Hydroquinone: FDA banned; EU banned; China restricted to OTC products
What's Included
- SKILL.md: Complete regulatory navigation instructions and workflow
- Jurisdiction Requirement Map Template: Pre-built comparison framework for FDA, EU, China, Canada, Japan
- Safety Assessment Checklist Suite: ISS, stability testing, and safety data templates for each market
- Multi-Market Submission Tracker: Timeline planner and status dashboard for managing multiple submissions
- Ingredient Restriction Database Prompt: Query-based tool to cross-check formulas against global banned/restricted substance lists
- Label Compliance Builder Template: Language-specific label requirement generator
- Claims Substantiation Framework: Marketing claim evaluator with jurisdiction-specific compliance rules
Who It's For
- Cosmetic chemists and R&D teams preparing products for multi-market launches
- Regulatory affairs specialists managing FDA, EU, China, and international submissions
- Brand founders and product managers expanding into new geographic markets
- Contract manufacturers and CMOs coordinating compliance across client requirements
- Quality assurance teams conducting pre-launch regulatory audits and risk assessments
Best For
- Pre-launch regulatory roadmapping for new cosmetic formulations
- Multi-market expansion planning when launching existing products in new jurisdictions
- Dossier preparation and technical file compilation for regulatory submissions
- Ingredient reformulation impact assessments and compliance verification
- Marketing claims validation and substantiation across different regulatory environments
- Label design and compliance verification for global product packaging
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