In December 2022, U.S. Congress established the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) as a regulatory framework. MoCRA aims to improve cosmetic product safety and increase transparency in the cosmetics industry through increased requirements for aspects such as cosmetic formulations and Good Manufacturing Practices (GMPs).
MoCRA’s regulations will impact all facilities that manufacture or process cosmetic products for U.S. distribution. Cosmetic companies outside of the U.S. will need to comply with MoCRA’s regulations to export their products to the U.S. When the U.S. Food and Drug Administration (FDA) begins enforcing new requirements, non-compliant cosmetics will be refused entry into the U.S.
The act includes provisions that pertain directly to the cosmetic formulations and GMPs and will require cosmetics manufacturers to make significant changes to current practices and operations to comply with new regulations.
MoCRA’s Impact on Good Manufacturing Practices (GMPs)
MoCRA mandates that cosmetics companies, create and implement GMPs for their products, which aim to establish measures ensuring that cosmetics are produced in a safe and sanitary manner.
The act enables FDA to implement more extensive regulatory efforts, including:
- Conducting inspections of cosmetics facilities
- Accessing records it considers essential to verify adherence GMPs, which FDA will establish
- Deeming products adulterated if they are not manufactured in a manner that is consistent with GMP requirements
MoCRA also includes provisions for “simplified” (less stringent) GMPs for smaller businesses.
FDA will publish a notice of proposed rulemaking for GMPs within 2 years of MoCRA’s enactment and issue a final rule within 3 years.
How Will MoCRA Affect Cosmetic Formulations?
Under MoCRA, manufacturers must provide more detailed information to FDA about ingredients and product safety. Cosmetics manufacturers will have to disclose full ingredient lists, along with fragrance allergens declarations as determined by FDA.
Ingredients information will be accessible to the public through the Freedom of Information Act, unless FDA has approved an exemption due to trade secret status.
Many companies will need to obtain new systems and technologies to manage ingredients information and comply with MoCRA’s regulations. If safety can not be obtained or proven for specific ingredients, formulations may need to be revised to accommodate new safety requirements.
Solutions to MoCRA’s Challenges
Cosmetics companies will likely encounter challenges when adhering to new regulations and guidelines. Companies will need to establish a comprehensive approach to GMPs and a quality management system to comply with FDA’s standards.
Cosmetri’s GMP software is designed to help companies manage GMP requirements, enabling facilities to:
- Digitally store GMP documents
- Conduct internal audits
- Establish review cycles for GMP documents
- Expedite creation of Standard Operation Practices (SOPs) with a SOP template package
Cosmetri GMP is designed for ISO 22716 compliance, the EU compliance standard for cosmetics GMPs. FDA issued guidance to the industry in 2013 that closely follows the ISO 22716 standard.
While MoCRA’s regulations will require cosmetics companies to alter operations, MoCRA will ultimately help improve the safety and quality of cosmetic products for consumers.
Facilities with relaxed manufacturing habits need to obtain education on GMPs now. Companies can simplify adherence to GMP and cosmetic formulation requirements by operationalizing compliance with software designed for cosmetics.
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