A recent enforcement action in the United States has led to the high-profile recall of nail polish remover products following the detection of methylene chloride and chloroform. Both substances are strictly prohibited in cosmetic formulations globally due to their significant health risks.
Methylene chloride and chloroform are volatile organic compounds recognized for their hazardous profiles, including potential carcinogenicity and acute neurotoxicity. Methylene chloride, in cosmetics, is a concern because it has been shown to cause cancer in animals and is likely harmful to human health. Methylene chloride is a prohibited ingredient which is not allowed in cosmetics at any level under FDA regulations.
This incident serves as a critical warning for brand owners regarding supply chain integrity and raw material purity. Even in category-standard formulations like removers, the inadvertent use of industrial-grade solvents instead of high-purity cosmetic ingredients can lead to catastrophic regulatory failures.
Under modern cosmetic legislation, the brand owner, or the designated Responsible Person, is legally liable for ensuring that finished products are free from prohibited contaminants. To safeguard your brand and consumer health, we recommend implementing rigorous supplier audits and periodic “unannounced” laboratory testing for prohibited volatile impurities. Ensuring compliance at the source is the only way to prevent costly recalls and irreversible brand damage.
Need guidance on MoCRA compliance? Our team assists cosmetic brands with product listings, facility registration, ingredient review, and overall regulatory requirements to ensure smooth entry into the U.S. market. Explore our full MoCRA services to see how we can help.
