Regulatory Reset: Key Compliance Deadlines

The personal care and cosmetics sector is experiencing the most significant regulatory overhaul since 1938, primarily driven by the implementation of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) in the US and the swift, complex evolution of the EU Cosmetics Regulation. For formulators, this means a dual focus on rigorous safety substantiation and immediate ingredient substitution.

Here is a recap of the critical regulatory shifts impacting cosmetics and personal care in 2025 and the major compliance challenges expected through 2026 and 2027.

I. Major Regulatory Changes in 2025: MoCRA, PFAS Bans, and Global Chemical Shifts

The year 2025 centered on the first major deadlines under MoCRA and the widespread enforcement of state-level chemical bans, forcing immediate formulation changes.

A. US: MoCRA Implementation Takes Effect

The FDA’s expanded oversight under MoCRA reached several critical compliance points:

Facility Registration & Product Listing: Most manufacturers were required to register facilities and submit complete product listings with full ingredient disclosure to the FDA, with compliance deadlines passing in mid-2024.
Safety Substantiation: All cosmetic products must have documented scientific evidence proving product safety under regular use, requiring robust testing and safety documentation for all components.
Adverse Event Reporting: Manufacturers must now report serious adverse events to the FDA within 15 business days and maintain records for six years, demanding new systems to track consumer complaints.
FDA Adverse Event Reporting System (FAERS): The FDA launched the FAERS Public Dashboard for Cosmetic Products in September 2025, an interactive tool to facilitate public querying of real-time adverse event data.

B. PFAS Bans & State-Level Chemical Restrictions

US state regulations continued to tighten, often moving faster than federal action, particularly on “forever chemicals”.

PFAS Bans Effective: Bans on the sale and distribution of cosmetic products containing intentionally added PFAS (Per- and Polyfluoroalkyl Substances) took effect in multiple states on January 1, 2025, including California, Colorado, Maryland, and Washington.
Formaldehyde Restrictions: Washington State notified the WTO of a new regulation restricting the manufacture, sale, and distribution of cosmetics containing intentionally added formaldehyde or formaldehyde releasers, effective September 28, 2025.
Toxic-Free Cosmetics Acts: Several states, including Washington, enacted laws banning numerous toxic chemicals, such as certain phthalates, formaldehyde-releasing preservatives, and mercury compounds, from cosmetics sold within the state.

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C. EU & Global Shifts

The EU continued its rapid phase-out of targeted ingredients and classes of substances.

Microplastics Restriction: New EU regulations began to restrict intentionally added microplastics in consumer products by July 2025, requiring formulators to use biodegradable or non-particulate alternatives.
4-Methylbenzylidene Camphor (4-MBC) Ban: The UK notified a ban on the UV filter 4-MBC, aligning with EU restrictions. Products placed on the UK market before July 15, 2026, have a sell-through period until January 2027.
GHS Revision 11: Effective February 2025, the Global Harmonized System (GHS) Revision 11 began to refine classification criteria for endocrine-disrupting chemicals and establish new hazard categories for persistent, mobile toxic substances, impacting Safety Data Sheet (SDS) creation.

II. What to Expect: 2026 and Beyond

The next two years will be defined by the finalization of key MoCRA rulemaking and the enforcement of expansive EU labeling and ingredient limits.

A. US MoCRA Finalization (2026-2027)

The FDA is moving forward with key product-safety rules, even as the final GMP rule is delayed.

Talc Testing Final Rule: The final rule establishing standardized testing methods for detecting asbestos in talc-containing cosmetic products is targeted for March 2026.
Fragrance-Allergen Labeling: The Notice of Proposed Rulemaking (NPRM) for the disclosure of fragrance allergens is anticipated in May 2026. This will be a major labeling overhaul, with the final rule likely not enforced until 2027 or later.
Formaldehyde Ban NPRM: The FDA’s Notice of Proposed Rulemaking to prohibit formaldehyde and formaldehyde-releasers in hair straightening products is targeted for December 2025.
Cosmetic GMP: The proposed rule for cosmetic Good Manufacturing Practices (GMP) has been moved to the FDA’s “Long-Term Actions” list, signaling that it is not expected within the next 12 months, despite the passing of the statutory deadline.

B. EU Labeling and Ingredient Limits (2026-2027)

Europe will significantly expand labeling requirements and continue to restrict broad classes of chemicals.

Expanded Allergen Labeling: New rules will mandate the on-pack labeling of approximately 60 additional fragrance allergens, a massive increase from the original 26. This is expected to take effect in phases between April 2026 and August 2028.
Siloxane Restrictions: The restriction limiting Cyclopentasiloxane (D5) and Cyclohexasiloxane (D6) to 0.1% in leave-on cosmetic products is expected to be fully enforced by June 2027.
New CMR Bans: New substances classified as Carcinogenic, Mutagenic, or Reprotoxic (CMR) under the GB and EU CLP regulations will be prohibited in cosmetics, with some UK restrictions starting in August 2026.

III. Actionable Steps

Centralize MoCRA Documentation: Use the delay in the final GMP rule to conduct a gap assessment and strengthen your documentation spine. Ensure all products have verifiable, centralized safety substantiation files ready for an FDA inspection.
Proactive Allergen and PFAS Substitution: Do not wait for the final MoCRA allergen rule. Begin auditing your fragrance blends now against the anticipated list of 82 EU allergens to prevent a massive, last-minute labeling overhaul in 2026. Also, ensure all formulations are free of intentionally added PFAS to comply with the 2025-effective state bans.
Monitor Global Chemical Lists: Regularly review updates to the EU’s Cosing database and California’s Proposition 65 list, as these often predict future federal and state restrictions.

Sources

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Regulatory Reset: Key Compliance Deadlines

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