Nothing is more important to cosmetic and personal care products companies than ensuring the safety of their products that are trusted by millions of families every day. This commitment to safety is the industry’s cornerstone with companies employing thousands of scientific and medical experts who are devoted to studying the safety of human health as well as the environment in relation to products and the ingredients used in them.
The development of a new cosmetic or personal care product involves numerous scientific disciplines and multiple areas of expertise, including chemistry and biochemistry, microbiology, molecular modeling, engineering, formulation science, packaging science, safety science and quality assurance.
Safe by Design - Right from the Start
Safety is considered throughout the product formulation process – from product concept to design to finished product. It is considered at every stage of the development process – for every ingredient, every package, and every product – knowing that products will be used by millions of families.
DID YOU KNOW: That all cosmetic and personal care product manufacturers are required by federal law to demonstrate the safety of their products and ingredients before they go to market.
The safety assessment process is a multi-step process that includes:
Choosing Safe Ingredients
As one of the first steps, the safety process only allows consideration of new ingredients that are shown to be safe when used in a consumer product. It starts with a healthy dose of skepticism about the safety of all new ingredients. If we cannot establish their safety and benefit to consumers, we will not use them.
The safety evaluation includes an assessment of an ingredient’s potential to cause both short-term (i.e., acute) effects and long-term effects (i.e., chronic, cumulative) that only show up after longer, repeated exposures. Scientists consider an ingredient’s potential for causing eye or skin irritation, allergic skin reactions, reproductive or fetal development effects, harm to the body's DNA (i.e., genotoxicity), and its potential to cause cancer (i.e., carcinogenicity).
Defining a Safe Range
For example, drinking typical levels of water is safe and even essential to health, while drinking roughly 10 liters or more could result in "water intoxication" - a potentially life-threatening condition. It all depends on the amount of water you drink. Electricity at low levels powers our heart and brain as well as 9-volt batteries, but an electrical current millions of times more powerful from a bolt of lightning can cause death.
Identifying those potentially harmful scenarios and then determining a safe range for each cosmetic/personal care product ingredient is the next step in our safety assessment process.
To identify a safe range for an ingredient, a margin of safety is determined. This same process is used by scientists at the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), European Union (EU), Health Canada, and others that evaluate safety. As a first step, the amount which might cause harm is identified by scientists and then the maximum amount allowed in the product is set at a level many times lower. The difference, called the “safety factor” may be a 100-fold or 1000-fold depending on the type of harm, and these safety margins are all standardized across FDA, EPA etc. as well. In fact the amount used may be a significant amount lower than the allowable level, so that the actual safety factor can be 10,000 or even a million fold less than the safe level.
Cosmetics companies do this level of assessment on every ingredient that they use in their products. They avoid unsafe ranges. If there is not enough information to establish a safe range, companies will remove the ingredient from consideration, or investigate it further with additional data.
Determine Safe Product Use
All ingredients are evaluated in the final product to confirm that their actual use is within the safe range for both consumers and the environment. If the product formula is not safe, it will be reformulated, or not marketed. Our industry employs thousands of scientists and professionals who ensure that products meet safety and regulatory requirements around the world.
Cumulative exposure is evaluated as part of the overall product safety assessments. The methodology used to do safety assessments (which is the same scientific process used by regulatory agencies around the world like the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), World Health Organization (WHO), European Union (EU), etc.) includes the use of some very conservative steps, such as:
- Assuming the highest possible concentration of an ingredient that would be used in any particular product type
- Assuming the highest possible consumer exposure during product use, etc.
- Adding additional margins of safety (MOS) between what consumers might be exposed to and the levels that caused no harmful effects in safety tests (known as the No Observed Adverse Effect Level or NOAEL).
These conservative steps result in very large MOS -- often hundreds or thousands of fold. Therefore, these very large MOS more than account for any potential concerns about cumulative exposures.
Once a product is marketed, consumer use is monitored and scientific information continues to be collected. New safety methods are also considered as science evolves. As science advances and consumers' preferences change, the industry continually innovates to ensure millions of families have the safest, highest quality products that help enrich their lives.
The Scientists Behind Safe Products
Scientists who are educated and trained in many different disciplines are involved in the design, development, safety assurance and manufacture of cosmetic and personal care products, including chemistry and biochemistry, microbiology, molecular modeling, engineering, formulation science, technical packaging, and toxicology . While the activity of each of these scientists contributes to the safety profile of cosmetic and personal care products, it is the specific role of the toxicologist to design and interpret the tests that ensure the safety of cosmetic and personal care products and their ingredients.