Historically, sunscreen assessment has been complicated by diverse and even conflicting data requirements among regulatory authorities. In many countries, product developers are mandated to avoid animal testing whenever possible while other countries continue to require it.

As an example, the United States Food and Drug Administration (FDA), categorizes sunscreens as over-the-counter (OTC) drugs, not cosmetics. This means sunscreens sold in the US are subject to the same testing requirements as OTC pharmaceuticals which severely limits access to the UV-filter innovation found internationally.  However, with passage of the 2025 SAFE Sunscreens Act, the US Congress has directed the FDA to modernize sunscreen assessment, a move which aligns perfectly with FDA-wide efforts to replace animal testing with new approach methods (NAMs).

This webinar series, presented by NURA and ICCS, aims to identify practical solutions for UV-filter development and testing that improve predictivity while providing animal-free assessments of sunscreens. In the first session, experts will discuss the Global Perspectives on Sunscreen Regulation, covering unique experiences of implementing NAMs across Europe, the United States and Brazil. The second session will focus on Modern Safety Assessments for UV Filters, highlighting Next Generation Risk Assessment (NGRA) principles, systemic toxicity, carcinogenicity, developmental toxicity, and Read-Across approaches for sunscreens. The third session will tie everything together with a discussion of Policy and the Regulatory Path Forward for Sunscreen Safety.

REGISTER FOR SESSION 1

SESSION 1: GLOBAL PERSPECTIVES ON SUNSCREEN REGULATION

Tuesday, July 14, 2026
10:00 am – 12:00 pm ET / 14:00–16:00 UTC

FEATURING:

Sunscreen Regulation in a Global Context: Challenges and Opportunities in the U.S.
Kimberly Norman, PhD, DABT, ERT, Personal Care Products Council

• Summarize the global sunscreen regulatory landscape, identifying areas of convergence and divergence across international markets.
• Analyze the unique challenges within the U.S. regulatory system, including data requirements for GRASE determinations and barriers to market entry for new UV filters.
• Explore opportunities to modernize U.S. sunscreen regulation, with a focus on advancing science-based, efficient, and globally aligned approaches to safety assessment and innovation.

European Union UV Filter Safety Regulations: Raising the bar and setting the pace for the rest of the world
J Nash, MS, PhD, Procter & Gamble

• Finished products containing UV filters are cosmetics and subject to animal-testing bans
• Safety of UV filters is assessed by independent experts at the Scientific Committee on Consumer Safety (SCCS), according to their Notes of Guidance
• Efficacy and safety testing follow international standards

Human-based Approaches for Assessment of UV Filters
Warren Casey, PhD, DABT, US National Institute of Environmental Health Sciences (NIEHS)

• US NIH will discuss efforts to address the endpoints relevant to FDA concerns

Transitioning to NAMs for Sunscreens in Brazil
Damaris Cristine Marios Dos Santos, MS, Grupo Boticário

• Brazilian regulatory landscape regarding the acceptance and integration of New Approach Methodologies (NAMs) for environmental assessments in the cosmetics sector.
• Application of NAMs in environmental hazard and risk assessments from a cosmetic perspective - case study.
• Emerging environmental concerns, "coral-safe" claims, and how NAMs can be applied.

Discussion and Q&A
Dave Allen, PhD (moderator), International Collaboration on Cosmetics Safety
Eryn Slankster-Schmierer, MSc, PhD (moderator), Physicians Committee for Responsible Medicine
Shagun Krishna, PhD (moderator), Physicians Committee for Responsible Medicine

• Commonalities
• Shareable and adoptable concepts
• Identifying exiting barriers
• Actionable steps forward

Complete details on this series, including the latest updates on Sessions 2 and 3, are available at pcrm.org/Sunscreen.

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