US Cosmetic Safety Substantiation File (MoCRA)
The safety substantiation records MoCRA requires the responsible person to keep for each cosmetic product.
- Signed by a qualified safety assessor
- Regulator-ready, or we revise it free
- Delivered in 24, 48 or 72 hours
Trusted by brands including
Service details
Everything included, explained
Quick answer
MoCRA requires the responsible person to keep records showing adequate safety substantiation for each cosmetic sold in the US. FDA does not prescribe specific tests and does not require animal testing. We prepare a US safety substantiation file per product: £295 if we already hold your CPSR, or £650 standalone.
What's included in your safety substantiation file
| Document | What it is |
|---|---|
| Evidence review | Formula, ingredient safety data, test results and any existing CPSR |
| US ingredient check | Ingredients checked against FDA-prohibited and restricted substances and colour additive rules |
| Safety rationale | A written summary of why the product is safe under its labelled conditions of use |
| Regulatory watch notes | Current status of fragrance allergen labelling, talc and PFAS for your product |
| Record file | Organised for the responsible person to keep and provide if FDA asks |
Who this file is for
- Brands with a UK or EU CPSR expanding to the US
- Responsible persons who need substantiation records for each product
- Brands using our US Responsible Person service
What this file does not include
- Laboratory testing. If evidence is missing, tests are arranged and paid for separately.
- FDA approval. FDA does not approve cosmetics before sale, and this file is not submitted for approval.
- OTC drug products. Sunscreens and other OTC drugs follow drug rules.
- More than one formula. Each formula needs its own file.
How it works
- Choose your starting point We hold your CPSR, or New.
- Send your data Full formula, supplier data, test results and labels.
- Review and write We review the evidence and write the safety rationale.
- File delivered You receive the file to keep with your MoCRA records.
What is MoCRA safety substantiation?
MoCRA added section 608 to the FD&C Act: the responsible person must ensure, and keep records supporting, that each cosmetic has adequate safety substantiation. That means tests, studies, research, analyses or other evidence that qualified experts accept as showing the product is safe under its labelled or customary conditions of use. FDA does not require specific tests or animal testing. A UK or EU CPSR is often a strong starting point.
What we check
Ingredients:
- Prohibited and restricted substances under FDA rules.
- Colour additives: Only those FDA permits for the intended use.
Regulatory watch (status checked at order):
- Fragrance allergens: FDA has not yet proposed the MoCRA fragrance allergen labelling rule; the statutory deadline has passed and FDA's agenda lists a proposal for late 2026.
- Talc: FDA's 2024 proposed talc asbestos-testing rule was withdrawn in November 2025; a new proposal is expected but not yet published.
- PFAS: FDA's December 2025 PFAS report found the data insufficient for a full safety assessment; there is no federal PFAS ban in cosmetics, but some US states have their own laws.
What you receive
- US safety substantiation file for one product
- A safety rationale reviewed and signed by Syed Muhammad Shamuel Shees, US Regulatory Lead
- A list of evidence relied on and any gaps
Legal framework
- FD&C Act section 608 — adequate safety substantiation and records
- Section 604 — definition of responsible person
- 21 CFR Part 73, 74, 81, 82 — colour additives
- 21 CFR Part 700 — prohibited and restricted cosmetic ingredients
Official sources:
- Modernization of Cosmetics Regulation Act of 2022 (FDA)
- Registration and Listing of Cosmetic Product Facilities and Products (FDA)
Why brands choose Phoenix
- Builds on your CPSR — if we already hold it, the file costs less.
- Reviewed by Syed Muhammad Shamuel Shees, US Regulatory Lead.
- Clear about what is still pending at FDA.
Hold the evidence before FDA asks. Order above, or message us on WhatsApp on +44 7346 009332.
Frequently asked questions
What does MoCRA require for cosmetic safety?
The responsible person must keep records showing adequate safety substantiation for each cosmetic, under FD&C Act section 608.
Does FDA require specific safety tests?
No. FDA does not prescribe specific tests and does not require animal testing. The evidence must be accepted by qualified experts as showing the product is safe.
Can my CPSR be used for the US?
Often, yes, as a starting point. We check it against US ingredient and colour additive rules and add a US safety rationale.
Is fragrance allergen labelling required in the US?
Not yet. FDA has not yet proposed the MoCRA fragrance allergen labelling rule; the statutory deadline has passed and FDA's agenda lists a proposal for late 2026.
Is this file sent to FDA?
No. It is kept by the responsible person and provided if FDA requests records.
How much does the file cost?
£295 per product if we already hold your CPSR, or £650 standalone.