Modernising Sun Care: What the New U.S. Law Means for Chemistry, AI, and Sustainable Innovation
On November 12, 2025, the President signed into law—via H.R. 5371 (119th Congress)—a major reform of the over-the-counter (OTC) drug monograph system, creating ripple effects across the sun-care, UV-filter, formulation, and sustainability ecosystem.
Although the bill covers broader appropriations, its impact on our industry is clear:
the U.S. is modernising how it evaluates sunscreen ingredients, steering the FDA toward real-world evidence (RWE), non-animal testing methods, and updated efficacy frameworks for topical drugs.
This is a milestone for innovation in UV filters and formulation chemistry—and an opening for teams ready to modernise their testing and regulatory strategies.
What’s New — At a Glance
Streamlined GRASE determinations
The FDA must shift from decades-old paradigms toward “modern evidence standards” (including historical data, SPF efficacy outcomes, and RWE) to determine whether an OTC ingredient is Generally Recognised As Safe & Effective (GRASE).
User-fee programme extended to FY 2030
Industry contributions to the OTC Monograph User Fee Program continue, and the FDA must publish annual work progress reports, including activity on sunscreen monograph ingredients.
Shift toward non-animal testing
By November 2026, the FDA must publish draft guidance identifying validated in-vitro, in-silico, computational, and other alternative methods for topical drug safety/efficacy assessment.
Greater transparency & reporting from FY 2026
Annual reports must include:
Tier 1 GRASE submissions for sunscreen ingredients
timelines for Proposed Orders (POs) and Final Orders (FOs)
post-market safety activities
Sunset of user-fee authority
The user-fee framework ends October 1, 2030, and all mandated reporting ends January 31, 2031.
No fixed dates for existing UV filters
The mechanism is in place, but the law does not specify when the FDA will issue POs/FOs for current OTC sunscreen filters.
Why This Matters for Chemistry, Formulation & Sustainability Teams
1. Innovation unlocked for UV filters
The U.S. has long lagged behind other regions in approving next-generation UV filters. With a clearer monograph pathway, teams working on novel absorbers, stabilisers, hybrid filters, or photostable systems now have more regulatory visibility.
2. Alignment with global science
The mandated move toward non-animal, in-vitro, and in-silico approaches aligns the U.S. with global toxicology and sustainability trends.
This benefits formulation scientists and toxicologists seeking faster, more ethical, and more mechanistic testing frameworks.
3. Sustainability + performance
For companies pursuing green innovation, this shift supports:
safer, more eco-friendly UV filter chemistry
reduced reliance on animal testing
improved formulation feel and broad skin-type performance
transparent KPIs that feed into LCAs, CO₂ footprints, and ESG reporting
4. Advantage for early movers
Teams who start preparing alternative-method datasets, integrated safety–efficacy frameworks, RWE models, and digital data pipelines will be the fastest to respond once FDA issues draft and final orders.
| Milestone | What to watch | Implication for R&D / formulation teams |
|---|---|---|
| Draft guidance on nonclinical alternatives by Nov 2026 | FDA must issue draft guidance on validated alternative methods for topical drugs | Begin selecting in-vitro and computational methods; map in-vivo legacy data to alternative pathways |
| Annual performance reporting from FY 2026 | Progress on sunscreen monograph Tier 1 GRASE submissions, safety, timelines | Integrate submission tracking, review timelines, and safety KPIs into internal dashboards |
| User-fee authority sunset: Oct 1, 2030; reporting ends Jan 31, 2031 | Finite window for accelerated monograph operations | Align R&D and regulatory pipeline timing — early planning is critical |
| No fixed dates for POs/FOs for existing filters | Timelines for FDA actions remain unspecified | Monitor announcements closely; prepare for rapid dossier submission when the window opens |
Practical Guidance — How Chemcopilot Helps Sun-Care Innovation
1. Build Your Non-Animal Testing Strategy Now
The shift in regulatory focus necessitates a proactive approach to testing. Companies must immediately inventory all existing UV filters, excipients, and complete formulations to assess their compatibility with advanced, non-animal methodologies. This comprehensive review should focus on several key areas of alternative methods.
This includes evaluating the in-vitro efficacy of UV filters, which provides data on how well a filter absorbs and scatters UV radiation without using live subjects. Furthermore, it means exploring mechanistic toxicology endpoints by using high-throughput screening and other advanced cellular assays to understand the precise biological mechanisms of a substance's potential toxicity. Computational tools are also vital; companies should employ computational absorption/penetration models to predict how compounds interact with and move through the skin layers. Finally, the strategy must integrate tiered assessments using in-silico prediction methods combined with vast stores of historical safety data. Chemcopilot is uniquely positioned to assist by helping to integrate these diverse datasets, systematically identify data gaps that need to be addressed, and structure the entire package for future regulatory submission.
2. Leverage Real-World Evidence (RWE) Correctly
The FDA's increasing interest signals an expanding role for Real-World Evidence (RWE) in regulatory submissions. It is important to emphasize a key clarification: Chemcopilot does not function as a data collector for RWE. Its strength lies in utilizing the usage datasets that companies already possess or actively collect.
When companies provide this essential usage data—such as application behavior, field-test conditions, records of post-market consumer complaints, and the results of stability/wear tests—Chemcopilot can transform this raw information into valuable regulatory intelligence. Specifically, the platform is able to structure robust RWE frameworks, run sophisticated predictive models on the data, and crucially, integrate the outcomes into Life Cycle Assessments (LCAs), ongoing safety monitoring reports, and formal regulatory dossiers. This capability allows teams to scientifically and regulatory connect RWE back to their core formulation and toxicology models. This architecture ensures that teams gain the scientific and regulatory value of RWE while keeping Chemcopilot strictly as an analysis and integration engine, not a primary data source.
3. Align Sustainability and Performance Strategy
The regulatory reform presents a significant opportunity to fundamentally reinvent sun-care development. This is the moment to build formulations that deliver superior performance while inherently promoting sustainability.
This strategic alignment means prioritizing the development and use of safer filters that have demonstrably stronger safety profiles—which simultaneously reduces dependencies on animal testing. It also entails designing for a lower environmental footprint, resulting in reduced CO₂ footprints and more eco-compatible profiles across the product lifecycle. Moreover, this comprehensive approach should lead to product improvements for the consumer, such as achieving improved skin-type diversity and enhanced aesthetic textures. Chemcopilot supports this dual focus by employing its CO₂-calculation engine, which helps formulators accurately quantify the full environmental impact of different formulation choices across the entire product lifecycle.
4. Update Your Formulation and Regulatory Roadmap
Given the regulatory shifts, immediate action is required to structure future dossiers and roadmaps. Teams should begin now by meticulously detailing and organizing their upcoming work.
This preparation involves creating comprehensive evidence maps that outline the entire body of supporting data for a product, alongside well-defined alternative-method testing plans to replace legacy studies. A key piece of this strategy is developing a global filter strategy that accounts for varying international regulatory statuses. Furthermore, the internal organization of data must be refined, requiring a new data-package architecture designed for the modern regulatory environment, supported by a clear plan for resource allocation. Chemcopilot acts as the central unifying layer in this process: it unifies R&D workflows, regulatory parameters, toxicology rules, and vast formulation libraries into a single, cohesive digital R&D ecosystem, ensuring all parts of the organization are working from a synchronized, regulatory-ready foundation.
Industry Caveats
While the new legislation signals a positive change, certain industry caveats must be understood. This law is not a blanket guarantee; it does not guarantee the immediate approval of any new filter, and the FDA maintains full discretion over all submissions. Furthermore, many key timelines remain officially unspecified, which mandates that companies maintain a high level of organizational agility. The process of non-animal method validation will inherently take time and will require significant, cross-industry collaboration to establish accepted standards. Finally, the sun-care market remains globally diverse, meaning regional regulatory differences (e.g., EU/US/Asia) continue to be a vital factor in product development and market access.
Conclusion — A New Era for Sun-Care Innovation
The signing of H.R. 5371 represents a fundamental turning point for every professional involved in sun care: chemists, formulators, toxicologists, sustainability teams, and regulatory professionals. This moment marks the convergence of modern evidence, validated non-animal testing, and accelerated FDA processes.
This convergence directly aligns with the core capabilities of Chemcopilot, enabling:
Greener chemistry practices.
The deployment of truly intelligent workflows.
Significant digital R&D acceleration.
The creation of regulatory-ready data pipelines.
If your sun-care product pipeline is still reliant on legacy testing and outdated development frameworks, now is the critical moment to pivot. Early movers who adopt these modern approaches will secure a material competitive advantage. Chemcopilot is fully prepared to help you rapidly modernize your R&D infrastructure and expertly navigate this complex, new regulatory landscape—doing so safely, smartly, and sustainably.
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