SmartSafety™ for Cosmetics: Compliant Record-Keeping and MoCRA‑Ready Reporting

With the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the FDA has introduced sweeping new requirements for cosmetics sold in the U.S. These include mandatory facility registration, product listing, safety substantiation, GMP adherence, adverse event reporting, and future fragrance allergen disclosure. To comply, companies must maintain organized, secure, and reliable documentation for each cosmetic product.

Global Compliance Gaps in Mid‑2025

As of January 1, 2025, the FDA had logged 9,528 active facility registrations and nearly 590,000 product listings worldwide getsignify.com+5Retail & Consumer Products Law Observer+5ChemLinked+5noviconnect.com+9getsignify.com+9U.S. Food and Drug Administration+9. Yet a substantial number of international brands—especially those based in China, South Korea, India, and Europe—have not met these requirements:

• A Registrar Corp. analysis found that 48% of imported cosmetics sold via the top 25 U.S. retailers remain non-compliant with MoCRA, representing approximately 135,000 products CosmeticsDesign.com+1PR Newswire+1.

• Many companies assume EU or Asian compliance translates to U.S. compliance, but MoCRA has distinct registration, listing, and reporting mandates not covered by other jurisdictions.

Challenges Facing Brands in Europe & Asia

• Regulatory fragmentation: Products compliant under EU Regulation 1223/2009 or China’s CSAR still need a separate MoCRA facility and product listings.

• Data infrastructure gaps: According to industry research, only ~63% of regulatory teams trust their compliance data, underscoring challenges around data reliability and accessibility CosmeticsDesign.com.

• Resource constraints: Smaller brands or those working with overseas manufacturers often lack visibility into ingredient safety substantiation and could struggle to implement GMP controls without proper systems.

What Companies Risk Under MoCRA

Non-compliant companies may face:

• Product import refusals or detentions at U.S. borders

• FDA warning letters or public enforcement actions

• Mandatory recalls or seizures for unsafe or misbranded items (FDA now has recall authority under MoCRA) datafoundry.ai+8The Regulatory Review+8Global Compliance News+8PR NewswireU.S. Food and Drug Administration+2getsignify.com+2Retail & Consumer Products Law Observer+2ecomundo.euhbfuller.com+15U.S. Food and Drug Administration+15Vogue Business+15

• Civil financial penalties, either standalone or tied to enforcement

• Heightened inspection frequency for longstanding registrants or repeat offenders

Why It's Crucial Now—Mid‑2025 Update

• MoCRA enforcement: Facility registration and product listing deadlines have passed; FDA continues compliance ramp-up in 2025 Allure+7U.S. Food and Drug Administration+7Retail & Consumer Products Law Observer+7.

• Draft GMP rules are expected to become final by December 29, 2025, making GMP readiness more urgent than ever Global Compliance News.

• Ingredient bans and ESG pressures continue to grow—nearly 46% of regulatory professionals expect more bans by the end of 2025 CosmeticsDesign.com.

Trusted, Efficient, Worldwide Compliance

SmartSafety offers a unified system already used in FDA‑accepted regulatory submissions and is aligned with global industry trends. It helps companies:

• Align with MoCRA enforcement and future GMP standards

• Avoid border blocks, recalls, or enforcement actions

• Replace fragmented compliance data with a centralized, auditable system

How SmartSafety™ Helps Cosmetic Companies Comply with MOCRA - Step by Step

• Centralized Formula & Ingredient Tracking SmartSafety stores all your formulations and ingredient lists in one place — with version control, history, and flagging of restricted substances for US markets.

• Built-In Safety Assessment Support You can link toxicological data and safety justifications directly to each ingredient, helping support the “adequate substantiation” MOCRA requires.

• Digital Safety File Management Upload and maintain required documentation (SDS, safety reports, expert assessments) in one location — easy to update and retrieve during audits.

• Adverse Event Logging & Reporting Track and log customer complaints or serious adverse events directly in SmartSafety, with structured fields aligned to FDA expectations.

---

• Curious how it works for your brand? Request a SmartSafety Demo.

Stay tuned for our next post with a step-by-step guide on how SmartSafety™ can help make your cosmetics MoCRA-compliant.