When MoCRA came along, it added something new to the U.S. cosmetic rules: you must have substantiation (proof) that your products are safe. Not just believe they’re safe—but have reasonable, science-based proof.
Surprisingly, before MoCRA, a cosmetic product was supposed to be safe, but there was no requirement for proof of its safety.
That doesn’t mean you need to hire a lab or pay thousands for testing. But it does mean keeping good records, understanding your ingredients. and being conscientious in your formulation.
Let’s go over what that really looks like in practice.
What “Adequate Safety Substantiation” Really Means
MoCRA defines adequate safety substantiation as data, research, or analysis that qualified experts would consider enough to be “reasonably certain” your product is safe when used normally.
That could include:
- Ingredient safety data from your suppliers
- Studies or reports on similar formulations
- Certificates showing compliance with standards (like IFRA or FDA color additive approvals)
- Preservative challenge testing or stability testing (if you’ve done them)
- Records showing you’re following good manufacturing practices (GMP)
In plain English: research and document that the ingredients you use and the final formulation are safe. Keep documentation that shows you made your products responsibly and know they won’t hurt anyone when used as intended.
Who’s Responsible?
The person or business named on the product label—the responsible person—must have and keep those records.
- If you make the product and your name is on the label: you’re responsible.
- If you manufacture for someone else: they’re responsible (but they’ll likely expect you to provide safety info).
- If you purchase white label products and put your name on the label: you’re responsible (but you should be able to get all the necessary information from the manufacturer).
You Don’t Have to Test Everything
There’s no official list of required tests under MoCRA. You just need documentation showing your ingredients and finished products are safe.
A challenge test is the gold standard, but if you use a proven preservative at the right level—and follow good manufacturing practices—documentation showing that can be enough.
In many cases, ingredient safety information can rely on existing data—and there is lots of data available!
Where to Find Ingredient Safety Information
You don’t have to start from scratch. Most of the safety data you need already exists—you just need to track it down and keep copies. Here are your best sources:
1. Supplier Documentation
Ask your ingredient suppliers for:
- Safety Data Sheets (SDS)
- Certificates of Analysis (COA)
- IFRA Conformity Certificates for fragrance oils
- Ingredient breakdowns (especially for blends, preservatives, or trademarked items)
- Test results for any ingredients that have been safety tested by the manufacturer.
Many suppliers catering to small makers are starting to offer these upon request or through product downloads.
2. Cosmetic Ingredient Review (CIR)
The CIR Expert Panel has published hundreds of reports summarizing ingredient safety research. You can search by ingredient name here: https://www.cir-safety.org/ingredients and reference the Expert Panel findings as part of your safety substantiation.
3. IFRA Standards
The International Fragrance Association (IFRA) publishes safe maximum use levels for fragrance ingredients (including those in essential oils). Having a copy of the standard that applies to fragrance components in your product and showing that you are within the allowed amount can prove safety. Keep a copy of the IFRA Standard that applies to your fragrance or essential oil.
https://ifrafragrance.org/safe-use/standards-documentation
4. FDA-Approved Color Additives
The FDA has already determined that certain color additives are safe to use in cosmetics. If you use those color additives, then you can use their approval as proof of safety (provided you are using them the way they were approved. Check the FDA’s list of approved color additives and keep your supplier’s Certificate of Analysis showing that the color additive you purchased meets the FDA specifications.
5. EU Annexes (for Reference)
The EU’s cosmetic regulations include annexes listing restricted ingredients, colorants, and preservatives. They don’t apply legally in the U.S., but they’re helpful for seeing what’s considered safe elsewhere. If an ingredient is restricted in the EU, and you are within those limitations, you can use those limits as part of your documentation.
6. Scientific Databases
If you like to dig deep:
- PubMed – https://pubmed.ncbi.nlm.nih.gov/
(For peer-reviewed toxicology and safety studies) - Google Scholar – https://scholar.google.com/
Add words like cosmetic or safety to narrow results.
7. MASTER YOUR LABELING Membership
As part of my MASTER YOUR LABELING Membership, I am developing a database of safety substantiation documentation for cosmetic ingredients. I currently have a substantial amount of information gathered. Until I have it published, members can request the data and I’ll provide what I have.
Keep Good Records
Documentation can go a long way toward showing you’ve done your homework, and it doesn’t need to be complicated. Keep a folder—digital or physical—with:
- Ingredient safety info from suppliers
- IFRA and color additive certificates
- Notes or reports on any testing you’ve done
- GMP checklists or SOPs showing how you keep products clean and stable
- Any correspondence confirming ingredient composition or safe levels
If any issues arise with the product or the FDA ever asks for proof of safety, having that documentation ready will make your life much easier.
Final Thoughts
Safety substantiation isn’t about red tape—it’s about knowing and having proof that your products are as safe as you believe they are. When you collect your documentation now, you protect both your business and your customers later.
If you’re not sure how to build or organize your safety records, I can help your through a MASTER YOUR LABELING Membership or private consulting.
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