The Retailer Spring Edition 2023

THE RETAILER

48

MAJOR REGULATORY CHANGES FOR THE US COSMETICS INDUSTRY IN 2023

Tracey Fanning Senior Managing Scientist Exponent International

Dr Claire Fordyce Senior Scientist Exponent International

Iain Brunning Principal Scientist, Head of Cosmetics Safety & Regulatory Affairs Exponent International

P REPARING FOR THE NEW US COSMETIC REGULATIONS: WHAT UK AND GLOBAL BUSINESSES NEED TO KNOW

KEY PROVISIONS OF MoCRA 1. Mandatory Site Registration & Product Listing By the end of December 2023, all facilities that manufacture or pro cess cosmetic products distributed in the U.S. must register with FDA. Registration must include the facility name and contact information (international facilities will require a specified U.S. agent) and a list of the brands that are produced or processed at the facility. The U.S. RP will also be required to list each product annually to FDA within 120 days of being placed on the market. This listing will include the facility registration code of the site of manufacture and a list of ingredients. As of March 2023, the FDA has ceased accepting submissions to the Voluntary Cosmetic Registration Program (VCRP) and will be imple menting a new system for facility registrations and cosmetic product listings. The FDA has advised that additional information on this new system will be available in the coming months. 2. Current Good Manufacturing Practice (cGMP) Requirements The FDA plans to introduce cosmetics GMP requirements in line with national and international standards in the next 2-3 years. Once enacted, any product processed or manufactured outside of the applicable cGMP standards will be deemed non-compliant. These new regulations will have significant implications for all UK and global compa nies selling cosmetic products in the U.S.” ‘‘

WHAT IS THE NEW MODERNIZATION OF COSMETICS REGULATION ACT?

In December 2022, President Biden signed into law the Modernization of Cosmetics Regulation Act (MoCRA), marking the first major update to the Food and Drug Administration's (FDA) cosmetics regulations since 1938. Starting in 2023, MoCRA will introduce significant changes to U.S. cosmetics regulations, including a new concept of a U.S. “Responsible Person” (RP), new labelling requirements, mandatory product listing and facility registration, reporting of serious adverse events, and finished product safety assessment. The regulation will also establish a new Good Manufacturing Practice (GMP) standard for cosmetic products manufactured in the U.S. Products that fail to comply with the new requirements will be prohibited. The FDA has been given additional enforcement authority where prod ucts may pose a significant risk to consumers. These include access to product information records, issuing mandatory recalls and suspension of facility registrations. These regulatory updates have been in progress for over a decade, and many of the changes bring U.S. cosmetics regulation closer to that of U.S. over-the-counter drugs and to the EU Cosmetics Regulation, widely considered the industry “gold standard.” Given the substantial implications of the new regulations, it is imperative for all global companies selling cosmetic products in the U.S. to begin preparing as soon as possible. The team of regulatory and safety experts at Exponent have compiled a summary of the key considerations and initial steps to take regarding these changes.