There is nothing more important than safety. If you can’t believe in a product or rely on it to do what it says, then nothing else matters. That’s why safety is a top priority for cosmetics and personal care products companies. The development of new cosmetics or personal care products involves numerous scientific disciplines. Chemists, biochemists, microbiologists, toxicologists, product formulators, engineers, packaging scientists, quality assurance professionals – and many more scientific and technical experts – work together to ensure the safety and efficacy of every new product brought to market.
Safe by Design – Right from the Start
Safety is considered throughout the product formulation process – from 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 products will be used by millions of individuals and families around the world.
DID YOU KNOW: All cosmetics and personal care product companies are required by federal law to demonstrate the safety of products and ingredients before they go to market.
Scientific advances and frequent changes in consumer preferences all play a role in how new products are developed. When a company creates a new product, it is guided by a complex list of scientific factors to make sure the product is safe for everyone who uses it.
Choosing Safe Ingredients
The first step is to make sure all the ingredients are safe on their own as well as when combined together. Part of this process is considering how, and how often, consumers use the product. It starts with a healthy dose of skepticism about the safety of all new ingredients. If ingredients cannot be proven to be cannot establish their safety and benefit to consumers, we will not use them.
Safety evaluation includes an assessment of an ingredient’s potential to cause both short-term (i.e., acute) and long-term effects (i.e., chronic, cumulative) that may only show up after repeated exposure. Scientists consider an ingredient’s potential for causing eye or skin irritation, allergic reactions, reproductive or fetal development effects, harm to the body’s DNA (i.e., genotoxicity), and cancer (i.e., carcinogenicity).
Defining a Safe Range
You may have heard the saying, “the dose makes the poison.” Water, for instance, is not only safe but essential to health and wellbeing. Drinking 10 liters or more, however, could result in “water intoxication” – a potentially life-threatening condition. Similarly, electricity at low levels powers our heart and brain, as well as 9-volt batteries. But an electrical current millions of times more powerful, like a bolt of lightning, can cause death.
Identifying potentially harmful scenarios and then determining a safe range for ingredients in cosmetics and personal care products is the next step in the safety assessment process.
To do this, a margin of safety must first be determined. Scientists set the maximum amount allowed in a product at a level many times lower than the amount which might cause harm. The difference, called the “safety factor,” may be a hundred-fold, a thousand-fold or even a million-fold, depending on the ingredient and potential for harm.
Cosmetics and personal care products companies do same assessment on every single ingredient used in products and 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 to produce additional data. This process is standardized across the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), European Union (EU), Health Canada and other organizations that evaluate safety.
Determining Safe Product Use
Cosmetics and personal care products companies take seriously their commitment to people and the planet. After ingredients are evaluated to confirm their real-world use is safe for both consumers and the environment, developers work with engineers and scientists to test how the new product reacts to light, temperature and transportation. This helps ensure products will remain stable and perform as expected throughout their lifetime. They also review which preservatives will work best, to make sure products don’t grow bacteria or other microorganisms, and how the packaging might affect the product’s shelf life. They look at whether the new formula can be manufactured safely in an existing facility and that quality is not compromised no matter where in the world the product is made or used. If the product formula is not safe, it will be reformulated, or not marketed.
Companies must ensure products comply with all government regulations. In the U.S., cosmetics and personal care products are regulated by the Food & Drug Administration (FDA) under the Food, Drug & Cosmetics Act and the Fair Packaging & Labeling Act. Sunscreens are considered over-the-counter (or OTC) drugs and are regulated accordingly. Each company is required to label products with safety information, including the list of ingredients and how best to use the product.
Cumulative Exposure
The average consumer uses multiple cosmetics and personal care products each day. Therefore, the assessment of cumulative exposure to product ingredients from multiple sources is an important component in the overall assessment of product safety. The methodology used to do safety assessments is very conservative, and includes the following steps:
- Assuming the highest possible concentration of an ingredient that would be used in a particular product type
- Assuming the highest possible consumer exposure during product use, etc.
- Adding additional 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 (NOAEL).
This process results in very large MOS – often hundreds- or thousands-fold – more than accounting for any potential concerns about cumulative exposure.
Post-Market Surveillance
Bringing a product from concept to market can take two to three years, or longer. Even after the product is available for sale, the commitment to safety and quality is far from over. Regulators and manufacturers constantly monitor the marketplace for reports of unexpected reactions to a product and other consumer feedback. As science advances and consumer preferences change, companies continually innovate to ensure the products – in stores, online and in your home – meet your expectations for safety and high quality.