USA

Close-up of SPF 60 UV protection cream for skincare, featuring floral accents and a natural setting.
USA

FDA Officially Approves Next-Generation Sunscreen Ingredient Bemotrizinol: A New Era for U.S. Sun Protection Begins

On June 10, 2026, the U.S. Food and Drug Administration (FDA) issued a landmark regulatory decision—Final Administrative Order OTC000039. This order officially amends Over-the-Counter (OTC) Sunscreen Monograph M020 to approve the use of the brand-new sunscreen active ingredient Bemotrizinol (Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine) in OTC sunscreens at a maximum allowable concentration of 6%. This marks the first time in over two decades that a truly modern, innovative chemical UV filter has been added to the U.S. sunscreen monograph, signaling a monumental milestone for the American sun care market. I. What Did the FDA Declare? According to the comprehensive 35-page final administrative order, the FDA thoroughly reviewed voluminous scientific safety data and public comments submitted by the requesting manufacturer, DSM Nutritional Products. The agency formally concluded that Bemotrizinol is Generally Recognized as Safe and Effective (GRASE) for use as a sunscreen active ingredient at concentrations up to 6%. II. Two Core Foundations […]

FDA Officially Approves Next-Generation Sunscreen Ingredient Bemotrizinol: A New Era for U.S. Sun Protection Begins Read More »

White cosmetic containers and small vase on a pink background showcasing modern design and simplicity.
USA

The Virginia State Humane and Toxin-Free Cosmetics Act: New Prohibitions on High-Risk Ingredients

The Virginia General Assembly introduced a significant legislative proposal designated as House Bill 122 (HB 122), titled the Virginia State Humane and Toxin-Free Cosmetics Act. This legislation amends existing trade laws to prohibit the manufacture, sale, and distribution of cosmetic products containing specific hazardous chemical substances within the Commonwealth. I. Core Legislative Provisions 1. Establishment of the “Toxin-Free Cosmetics” Article The bill introduces Article 2 (“Toxin-Free Cosmetics”) into Chapter 52 of Title 59.1 of the Code of Virginia, establishing a structured framework across the following statutory sections: 2. Schedule of Prohibited Chemical Substances Pursuant to § 59.1-574.2, no individual or corporate entity may manufacture, sell, deliver, offer for sale, or utilize in consumer transactions any cosmetic product containing the following intentionally added substances: No. Banned Substance Name CAS Registry Number 1 Dibutyl phthalate 84–74–2 2 Di(2-ethylhexyl) phthalate 117-81-7 3 Formaldehyde 50–00–0 4 Paraformaldehyde 30525-89-4 5 Methylene glycol 463-57-0 6 Quaternium-15

The Virginia State Humane and Toxin-Free Cosmetics Act: New Prohibitions on High-Risk Ingredients Read More »

USA

FDA Launches Unified Adverse Event Monitoring System (AEMS)

On March 11, 2026, the U.S. Food and Drug Administration (FDA) officially announced the launch of the Adverse Event Monitoring System (AEMS). This brand-new unified platform and interactive public data dashboard is designed to analyze and process adverse event reports with greater efficiency. The system is scheduled to be fully operational by the end of May 2026. This transition will bring significant changes to the industry landscape and the way the public accesses data. Here is the core information you need to know: A “Unified” Era: Covering All Regulated Products The launch of AEMS marks a major milestone in the FDA’s data integration efforts. It will provide real-time adverse event reporting across all FDA-regulated product categories, including: Retiring Legacy Systems To achieve this integration, the FDA will decommission several aging, decentralized reporting systems across various centers. The new AEMS will directly replace the following well-known platforms: By consolidating these systems

FDA Launches Unified Adverse Event Monitoring System (AEMS) Read More »

USA

FDA Issues Reports on PFAS and Records Access: Official Draft Guidance Must Be Reviewed!

Entering 2026, the regulatory hammer of the U.S. Food and Drug Administration (FDA) has fallen in rapid succession. Within just three weeks, the FDA released two critical documents targeting PFAS (“forever chemicals”) and records access authority. The release of these documents is no coincidence; they are direct products of the comprehensive implementation of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). For companies exporting to the U.S., the threshold for compliance has been raised once again. I. PFAS Investigation Report: 51 Ingredients Named, Data Gaps Remain a Challenge On December 29, 2025, the FDA submitted its highly anticipated report on PFAS in cosmetics to Congress. This authoritative conclusion was derived from the first wave of product listing data under MoCRA. Core Findings: II. Records Access Guidance: What’s in the FDA’s “Inspection Kit”? On January 21, 2026, the FDA issued draft industry guidance regarding records access authority under Sections 605

FDA Issues Reports on PFAS and Records Access: Official Draft Guidance Must Be Reviewed! Read More »