Let’s dive right in: There are only 11 cosmetic ingredients banned by the Food and Drug Administration (FDA) in the United States, while there are more than 1,300 restricted ingredients in Europe. Although it may seem like I added two zeros to that last number, it’s true and we can explain why. Similar to Europe’s food ingredient regulations, Europe is more cautious when it comes to ingredients, while the U.S. is more open-minded. In this post, we will give a rundown on the several differences between the two markets in their health and beauty regulations.
Are There Ingredients Banned From Use In Cosmetics/Personal Care Products?
Yes, both U.S. and European regulations list ingredients that should not be used in cosmetics or personal care products.
- There are nine cosmetics ingredients restricted or prohibited by the Environmental Protection Agency (EPA).
- 11 additional cosmetics ingredients have been judged by the Cosmetic Ingredient Review Expert Panel (CIR) as not safe for use.
- The International Fragrance Association (IFRA) also sets safety standards for fragrance. For example, the IFRA banned 174 substances in the use of fragrance products.
- Under the law, cosmetic products and ingredients do not need Food and Drug Administration (FDA) premarket approval, with the exception of color additives.
- However, the FDA can pursue enforcement action against products on the market that are not in compliance with the law, or against firms or individuals who violate the law.
- 1938 was the last time the Food and Drug Administration (FDA) passed an act – the Federal Food, Drug, and Cosmetic Act (FDCA) which is aimed at supervising the cosmetic industry and cosmetic companies.
- The European Cosmetics Directive Annex II list has 1,378 banned substances. Yes, that’s A LOT, however 80% of the ingredients have not been used in cosmetic products and will not be used as cosmetic ingredients.
Why Are These Toxic Ingredients Legal in the United States?
There isn’t a clear answer to this question, but there is an obvious power struggle between U.S. regulation leaders and big-name cosmetic companies on what ingredients should or shouldn’t be regulated.
The Environmental Protection Agency (EPA) has had the power to regulate harmful ingredients under the Toxic Substances Control Act (TSCA) since 1976 but has only used this power a handful of times. The TSCA makes it complicated for the EPA to regulate the industry. The EPA can only test a potentially toxic chemical if companies have already shown the agency that the substance may cause harm. You can imagine that this does not happen frequently. Because of the self-policing nature of the industry, close-scrutiny requirements are practically non-existent, long-term health effects from various chemicals are unknown, and cosmetic companies are not legally required to report adverse product effects to the FDA.
In short, the mixture of a powerful industry’s influence with a regulatory system that demands a high level of proof of harm before any regulation is likely to blame for the lack of banned ingredients.
Are There Requirements to List Ingredients on the Product Label?
Yes, both the U.S. and Europe have requirements for listing ingredients on cosmetic and personal care products.
- The FDA has three main labeling requirements.
- Principal Display Panel (PDP): Must present an identity statement, net quantity, and any usage warnings.
- Information Panel (IP): Must be in the correct language, show name and place of business, distributor statement, cosmetic warning statements, ingredients declaration, ingredient names, ingredients listing, and material facts.
- Trade secret status: A trade secret may consist of any formula, pattern, device, or compilation of information used in one’s business that could potentially give one an opportunity to obtain an advantage over competitors who do not know or use it. Keep in mind that the FDA only granted this status once!
- Flavor and fragrance ingredients need to only be listed as “flavor” or “fragrance” on the label.
- The cosmetic regulation defines the mandatory information for a compliant cosmetic label to include:
- Name and address of the responsible person, country of origin, nominal content, date of minimum durability (DOMD) and period after opening (PAO), particular precautions of use and warnings, batch number, product function, and list of ingredients.
- Flavor and fragrance ingredients need to only be listed as “flavor” or “fragrance” on the label, except for 26 specific perfume ingredients, which must be included in the ingredient list.
Is Sunscreen Considered a Cosmetic or Drug Product?
- The FDA considers sunscreen as an Over-The-Counter (“OTC”) drug.
- Products claiming the prevention or treatment of disease or effect on a structure or function of the body are considered drugs.
- As a consumer you can buy sunscreen without a prescription, but as a manufacturer, you’ll have to follow the FD&C Act and drug regulations.
- Claims are restricted for sunscreen, so labeling regulations are different.
- Sunscreen meets the definition of a cosmetic product.
- UV filters require pre-market approval.
Why You Should Care.
As a consumer, when you buy a product from a retailer, you are sending a message of interest and support to a manufacturer. Now is the time to start paying attention to what you buy and understand the impact of what you buy. Similar to what we have seen in the food industry, the fewer people who purchase items with toxic ingredients, the less incentive there is for brands to make them and retailers to sell them.
As a supplier and retailer, it is critical to understand that consumers’ product interests are changing across the world. Unlike Europe, U.S. consumers won’t be able to entirely rely on regulations to bring attention to potentially harmful ingredients. As a manufacturer, suppliers should understand the influence and impact of what they sell. Certifications are a great way to instill trust and communication with your customers and RangeMe partners with certification providers and compliance specialists that can help you sell a safe product that is FDA approved and beyond.