Reviewed and Approved by Paula Brock, PhD, MSCI, Senior Regulatory & Scientific Consultant, EAS Consulting Group, a Certified Group company.
1-Minute Summary
- MoCRA requires cosmetic manufacturers to substantiate product safety before market release.
- The first step in cosmetic safety substantiation is to identify and analyze all ingredients, including impurities.
- Begin with a literature review to evaluate safety data on ingredients, escalating to detailed analysis if data is lacking.
- Assess exposure by calculating how much of each ingredient consumers will be exposed to based on product use.
- Calculate the Margin of Safety (MoS) to confirm ingredients meet safety benchmarks, ensuring consumer protection.
MoCRA Introduced New Safety Substantiation Requirements
Imagine you’re getting ready to launch a new cosmetic product – a facial serum with cutting-edge ingredients promising hydration and anti-aging benefits. Your market research suggests that this product will be a big seller. But, before you can bring it to market, there’s one major hurdle: proving that your product is safe.
That’s where cosmetic safety substantiation comes in. Under the Modernization of Cosmetic Regulation Act (MoCRA) – an amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) – every cosmetic manufacturer is legally required to substantiate the safety of their products before selling them. This isn’t just about meeting regulatory requirements; it’s about protecting your brand, building trust with consumers, and avoiding serious consequences like recalls or lawsuits.
Now, let’s break down how to substantiate your product’s safety.
Legal and Regulatory Requirements of Cosmetic Safety Substantiation
First, we must understand MoCRA regulations.
Under this law, cosmetic manufacturers must have adequate substantiation of safety for each product before it hits the shelves. Here is the regulation as quoted in 21 USC 364d: Safety substantiation:
(a) Substantiation of safety
A responsible person for a cosmetic product shall ensure, and maintain records supporting, that there is adequate substantiation of safety of such cosmetic product.
(b) Coal-tar hair dye
Subsection (a) shall not apply to coal-tar hair dye that otherwise complies with the requirements of section 361(a) of this title. A responsible person for a coal-tar hair dye shall maintain records related to the safety of such product.
(c) Definitions
For purposes of this section:
(1) Adequate substantiation of safety
The term “adequate substantiation of safety” means tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.
(2) Safe
The term “safe” means that the cosmetic product, including any ingredient thereof, is not injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual. The Secretary shall not consider a cosmetic ingredient or cosmetic product injurious to users solely because it can cause minor and transient reactions or minor and transient skin irritations in some users. In determining for purposes of this section whether a cosmetic product is safe, the Secretary may consider, as appropriate and available, the cumulative or other relevant exposure to the cosmetic product, including any ingredient thereof.
The Regulation in Layperson’s Terms
So, what does this mean?
In plain terms, it means you need to provide scientific evidence showing that your product, when used as intended, is not harmful to consumers.
Let’s say your product is that new facial serum we mentioned earlier. You can’t assume it’s safe based on similar products; you need data to back up your claims, whether that’s from existing studies, validated testing methods, or documented safety information on each ingredient.
For example, if your serum contains hyaluronic acid – a common skincare ingredient – you could pull safety data from resources like the Cosmetic Ingredient Review (CIR) and have someone qualified to do the analysis. However, if your product includes a lesser-known botanical extract, you may need to dive deeper into toxicological studies or conduct specific tests to demonstrate its safety.
Essential References for Cosmetic Safety Substantiation under MoCRA
Where do you start gathering this data? Fortunately, you’re not navigating this alone. There are well-established methods and references you can rely on. Regulatory guidelines like FDA’s Cosmetic Safety Guidelines, ISO Standards, and international bodies such as ICCR and REACH offer comprehensive frameworks for safety assessments, depending on the markets where your products will be sold.
For example, your serum may need to undergo cosmetic stability testing to ensure it maintains its efficacy and safety over time. You may also need to perform cosmetic lab testing for microbial contamination, residual solvents, or heavy metal content, which can be done using ISO standards for microbial limits.
If you’re unsure what testing to perform, the experts at EAS Consulting Group, a Certified Group company, can provide guidance.
Ingredient Identification and Analysis
The next step is to identity every substance in your formulation that could pose a safety risk.
Let’s go back to the hyaluronic acid in your serum. You’ll need to document its…
- INCI name (International Nomenclature Cosmetic Ingredient)
- CAS number (Chemical Abstracts Service)
These are unique identifiers used globally. This not only ensures compliance but also makes it easier to reference safety data across multiple sources.
But don’t stop there. Look at the ingredient’s physical form, stability, and solubility. Is it chemically similar to another well-studied substance? That could save you time, as you may be able to read across data from similar ingredients rather than conducting new tests.
And don’t forget the Certificate of Analysis (COA) for each ingredient. This document is your proof that the hyaluronic acid (or any other ingredient) you’re using meets purity standards and safe levels of impurities like heavy metals or microbial contamination, helping provide the documentation you need to substantiate the safety of your cosmetic products.
Literature Review and Tiered Approach
Another key step is to review the existing literature on your ingredients.
Let’s say your serum also contains bergamot oil for fragrance. A quick search may reveal it’s classified as a strong sensitizer and needs to be used within specific concentration limits. This information, from CIR monographs and the International Fragrance Association (IFRA Standards Library), can guide your usage level and formulation decisions.
If you can’t find enough data in the literature, that’s when you move to more complex analysis, perhaps conducting a Threshold of Toxicological Concern (TTC) evaluation to assess the ingredient’s risk based on exposure levels.
Toxicity Risk Assessment in Cosmetic Safety Substantiation
Once you’ve gathered the literature, it’s time for a toxicity risk assessment. This is where you determine how the ingredients in your serum might affect consumers.
One option is a New Generation Risk Assessment (NGRA), which relies on non-animal methods such as in vitro (lab-based) tests or in silico (computer modeling) techniques. These methods are becoming the gold standard in cosmetics safety substantiation because they’re more ethical and, often, more reliable than traditional animal testing.
If you’re using a new preservative, you might perform an in vitro test to assess whether it causes skin irritation. Alternatively, if you’re dealing with a well-known preservative like phenoxyethanol, you can refer to existing CMR (Carcinogenicity, Mutagenicity, and Reproductive Toxicity) data for your risk assessment.
Exposure Assessments
Even if an ingredient is safe in isolation, you still need to assess how much of it consumers will be exposed to when using your product. This is where exposure assessments come in.
Let’s break it down with your facial serum:
- Dermal Exposure: Most of your serum’s ingredients will be applied to the skin, but not all of them will be absorbed. For leave-on products, the retention factor is assumed to be 100%. But for rinse-off products, like face washes, the retention factor is much lower.
- Daily Effective Product Use: You’ll need to calculate how much of your product a consumer might apply in a day – maybe it’s 2 grams of serum per use. From there, you can estimate the exposure of each ingredient by multiplying the amount used with its concentration in the product.
You also need to consider special populations. For example, if you’re marketing the serum to pregnant women, certain ingredients might require closer scrutiny due to potential systemic exposure.
Margin of Safety (MoS) Calculations
Now, we’ve come to the crux of cosmetics safety substantiation: the Margin of Safety (MoS).
The goal here is to calculate the ratio of how much of an ingredient is safe versus how much the consumer will be exposed to.
To calculate the Margin of Safety (MoS), divide the Point of Departure (PoD) – like the NOAEL (No Observed Adverse Effect Level) – by the Systemic Exposure Dose (SED) or Local Exposure Dose (LED). A higher MoS indicates a safer ingredient, with a MoS of 100 or more typically considered safe for systemic exposures.
Again, if you need guidance, our experts at EAS Consulting Group can help.
Cosmetic Safety Substantiation Follows a Structured Process
Safety substantiation is a foundational step in your R&D process that ensures your cosmetic products meet the highest standards of safety and regulatory compliance. Regardless of the product, following a structured process that includes ingredient analysis, literature review, exposure assessment, and MoS calculations will help you protect your brand and your consumers.
For guidance in substantiating the safety of your products, reach out to EAS Consulting Group.
Certified Laboratories can help with cosmetic lab testing for microbial contamination, heavy metals, residual solvents, and other contaminants. We also provide cosmetic stability testing.