Product Safety Substantiation
MoCRA: This information is applicable to: All Cosmetic Manufacturers
Under the new MoCRA requirements, by December 29, 2023, you must ensure your product is safe and have records and documents to prove it.1
What is “safe”?
"Safe" means that the product, including any of the ingredients, will not harm or injure a person when used as directed. If the product or an ingredient causes minor or transient reactions or skin irritation in some users, it would not considered harmful or injurious.2
What is “adequate substantiation of safety”?
"Adequate substantiation of safety" means tests or studies, research, analyses, or other information that a qualified expert would consider supports a reasonable certainty that the product is safe.3
So far, what we have from the FDA is that you can use relevant safety data that is already available to support the safety of your products and ingredients.4 The good news is that there is a great deal of existing material that shows how safe most cosmetic ingredients are, especially those used by handcrafters.
Who is responsible for safety substantiation?
The "responsible person"5 is the person or company named on the label.
If you are making and selling the product, then your business name and address should be listed on the label. You are the person responsible for having adequate safety documentation.
If you make cosmetic products for someone else to sell under their own label, then their business would be on the label. Even though the product label should say “Manufactured for …” or “Distributed by …” and it’s clear that they didn’t actually make the product, they are still responsible for having safety substantiation. In all likelihood, they would expect you to provide the necessary documentation.
The same holds true if you buy cosmetic products and then sell them under your own label. If your business name and address are on the label, then you are responsible for having safety documentation. You should get that from the company formulating or making the product for you and keep it on file.
What should you do now?
Ideally, it would be great if you could actually have each of your product formulations tested for safety and effectiveness of the preservative system. However, that may cost prohibitive if you are just starting out.
As an alternative, gather the safety data for each ingredient used in each of the products you make. Organize and save the information in a way that it can be provided if you are asked for it.
You’ll need several bits of information for each ingredient:
- Safety assessments or other details that show the standards for the ingredient to be safe. Depending on the type of ingredient, that may include maximum levels of contaminants, usage levels, or restrictions on how the ingredient may be used.
- Certification or documentation from your supplier that the ingredient you purchased meets the standards for the ingredient. They should have some sort of “Certificate of Analysis” or “Certificate of Conformity” that states that what they are selling meets the standards or is the exact thing.
- Documentation that you used the ingredient in the way in which it has been determined to be safe.
Example: Ultramarines (color additive)
- Regulations: 21 CFR 73.2725 Ultramarines are approved for use in external use cosmetics, including in the eye area. Impurities must not exceed Lead 20 PPM, Arsenic 3 PPM, and Mercury 1 PPM.
- Manufacturer’s Certificate of Analysis (for an example, see Ultramarine Pink from MakingCosmetics.com)
- Show that you used it in a product that was for external use or around the eye area (but not for contact with mucous membranes, such as the lips).
You can use the HSCG’s sample Product Safety Substantiation Record, or create something of your own that works for you.
You should keep printed or electronic copies of any referenced safety data. A link to the item online would probably be sufficient if the information is available from a resource that is unlikely to change (such as articles published in journals).
In addition to any studies or safety assessments, you should also get and keep a Certificate of Analysis from your supplier showing that the product you purchased meets the safety standards.
Sources of safety data
Most likely, you use ingredients that are known to be safe. The HSCG will be releasing a compiled list of safety documentation for some of the more common ingredients in the very near future. If your ingredients are not on that list, you should be able to find actual safety data from the following places:
- General ingredients: Cosmetic Ingredient Review Expert Panel published articles on cosmetic ingredient safety. See https://www.cir-safety.org/ingredients to search for specific ingredient safety assessments. Their safety assessments are usually published in the International Journal of Toxicology.
- Blended Ingredients: Where the ingredient is a blend of several components, the manufacturer may have created documentation on the safety and usage levels (which you should be able to get from your supplier).
- Color Additives: FDA regulations which specify which color additives are safe when used as allowed. See Color Additives Permitted for Use in Cosmetics on the FDA website.
- Fragrances: Manufacturers’ IFRA Standards Conformity Certificates, which should be available from your fragrance supplier.
For blends of essential oils you create yourself, use the IFRA standards to calculate the acceptable usage level for any essential oils with restrictions or limitations.
- Preservatives: Manufacturer specifications and documentation that details the components in the preservative, the effective ranges for the preservative, and the maximum safe usage. Then show that your use preservative so it is both safe and effective.
1 21 USC 364d(a)
2 21 USC 364d(c)(2)
3 21 USC 364d(c)(1)
4 FDA. Modernization of Cosmetics Regulation Act of 2022
5 In legal terms, a "person" could be either a real person or a business entity such as an LLC, corporation or partnership.