United States · California · Washington
US cosmetics. MoCRA documentation.
Prepare product files, safety evidence and MoCRA workflows, with separate California and Washington appendices.
From your product basis to US documentation
Use the same formula for a US product file, separate MoCRA workflows and regional additions. This example follows a leave-on facial product.
Example: leave-on facial serum
One product basis, distinct documents and cases.
Shared product basis
Formula, INCI, product application and the companies involved provide the starting point for US documentation.
US product and safety file
- Formula version and application
- Safety evidence and original records
- Source versions and missing information
Prepare MoCRA cases
- Facility Registration
- Manage the facility and responsibilities separately.
- Product Listing
- Link the product version to the relevant facilities.
California
Supported substance findings, regional evidence and outstanding exposure questions. A separate appendix supplements the US file.
Washington state
Substance conditions within the supported TFCA assessment scope and missing information. Findings remain in a distinct regional appendix.
Next step: qualified review and the designated external submission channels. Preparation in INCIkit is separate from actual submission.
An illustrative workflow with selected content, not a confirmed submission or product approval.
Official information: FDA · MoCRAFDA · Registration & ListingCalifornia · Proposition 65Washington · TFCA
A clear workflow for your US documentation
Record your product and its use
Connect the formula, INCI information, product application and companies involved. Reuse your existing product information as a shared basis.
Bring safety evidence together
Associate original evidence, calculations and assumptions with your US product and safety file. See which information is missing or needs qualified review.
Keep MoCRA workflows separate
Manage facility registration and product listing as distinct cases. Keep responsibilities, product versions and documented external responses traceable.
Add California and Washington
Review supported regional substance findings and add the relevant appendices. Prepare documentation for professional assessment and external submission.
Less gathering. A clearer next step.
US product and safety documentation
Keep product information, application, sources and evidence linked to the relevant product version. Missing information stays part of the working record.
Distinguish facilities from listings
Manage site-specific registration separately from product-specific listing. Connect the appropriate versions and responsibilities.
Review regional findings separately
California and Washington supplement the federal basis with their own findings and appendices. Each regional appendix remains identifiable.
Hand over traceable versions
Save documentation with its product and source references. Use the available document outputs to share the specific working version.
How INCIkit supports your US documentation
INCIkit organises your product documentation and shows supported checks, source versions and missing evidence. California and Washington are selected regional additions; the scope does not cover every US rule or all states.
Facility registration, product listing and safety substantiation are different tasks. Authority submission and qualified assessment take place outside this preparation workflow. A saved case or technical acceptance is not FDA approval.
Editing and preparation depend on active access, team role and usage limits. Available PDF/ZIP output depends on document type, plan and export limit. The pricing page explains the scope.
Questions about MoCRA and US cosmetic documentation
How does INCIkit support MoCRA preparation?
Manage facility registration and product listing as separate cases, linked to the relevant company, site and product information. Case references, external responses and documented FDA status remain distinct. Applicable obligations or exemptions need assessment based on your specific circumstances.
Can INCIkit help document cosmetic safety substantiation?
The US product and safety file brings together product application, safety evidence, calculations and original records. Missing data and assumptions remain visible. This supports safety substantiation work; a generated report or saved upload alone does not establish scientifically adequate substantiation of safety.
What is supported for California and Proposition 65?
Add supported California substance findings and a separate regional appendix. California Safe Cosmetics Program and CFFIRKA reporting topics remain distinct from Prop 65 exposure and warning questions. A substance finding alone does not determine whether a warning is required; actual exposure and applicable risk conditions also need assessment.
What does the Washington support include?
Washington state has supported regional substance conditions and a separate appendix, including the stated assessment scope for the Toxic-Free Cosmetics Act. Source versions, missing information and special authority procedures remain identifiable; this is not a blanket TFCA clearance.
Does INCIkit submit my documentation to the FDA?
INCIkit prepares information and cases. Actual submission uses the designated external FDA channels. Facility registration and product listing are not product approval; the FDA does not issue registration or listing certificates.
Which plan do I need for US documentation?
Editing and preparation require active access, the appropriate team role and available usage limits. File output also depends on document type, plan and export limit. See the pricing page for editing, preparation and file output.