Global Cosmetic Regulatory Update

Regulatory activity in the cosmetics and personal care industry is accelerating across major markets. From new guidance under MoCRA in the United States to PFAS bans in France and emerging halal requirements in Indonesia, companies are navigating an increasingly complex compliance environment.

In our latest webinar, Ithos Global’s regulatory experts, joined by legal counsel, broke down what these updates mean for manufacturers, formulators, and brands. Below is a strategic overview of the most impactful developments so far this year, and what your team should be preparing for next.

United States: FDA Action Under MoCRA Is Picking Up

After a delayed rollout of some provisions, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is now actively shaping FDA enforcement and guidance priorities.

1. Draft Guidance on Mandatory Recalls

The U.S. FDA issued draft guidance outlining how it will determine when to use its new mandatory recall authority. The document clarifies:

  • How the FDA evaluates health risk and adverse event data in relation to recalls
  • The process for working with the “Responsible Person.”
  • Enforcement considerations
  • The opportunity for hearings

While recall authority may not be used frequently, the framework is now clearly defined. That alone changes risk exposure for brands.

2. Record Access & Adverse Event Documentation

The FDA also released guidance detailing its authority to access adverse event records. Companies must be prepared to provide:

  • Intake procedures for adverse event reporting
  • Documentation of how seriousness was determined
  • Evidence of serious adverse event reporting
  • Distribution and inventory records, among other documentation

If your documentation is fragmented across departments or systems, this is a red flag. The FDA’s expectations are explicit.

3. PFAS Safety Assessment

The agency’s PFAS safety review concluded that available data is insufficient to determine cosmetic safety risks. However, two important signals emerged:

  • Only a small percentage of cosmetic listings report intentionally added PFAS
  • International regulatory approaches and state-level restrictions were referenced

This issue remains active, especially as state-level bans move forward.

4. Upcoming Allergen Disclosure Proposal

The FDA is expected to publish its proposed mandatory allergen disclosure list in May 2026. While international harmonization may be considered, the final approach remains uncertain. Companies selling globally should closely monitor alignment with EU Annex III requirements.

5. Sunscreen Active Ingredient Review

The FDA is reviewing a new sunscreen active ingredient, a category historically slow to see approvals. If approved, this could signal a shift toward more modernized sunscreen regulation in the US.

California: Ingredient Bans and Prop 65 Litigation Continue

California remains one of the most aggressive regulatory environments in the US. Here are some updates:

The C.U.R.L. Act

The C.U.R.L. Act (Combatting Unsafe Relaxers Act) will prohibit nine intentionally added ingredients in hair relaxers starting January 1, 2030. It also authorizes laboratory testing and enforcement oversight by state authorities. Reformulation timelines may seem distant, but supply chain validation should begin early.

Musk Restrictions & Safe Cosmetics Updates

California expanded its ingredient restrictions under its existing cosmetic laws, including new musk limitations and reporting updates under the Safe Cosmetics Program. Fragrance compliance documentation is becoming increasingly critical.

Proposition 65 Trends

Under California Proposition 65, litigation continues around:

  • Titanium dioxide
  • Diethanolamine (DEA)
  • Phthalates in packaging
  • BPA/BPS in packaging components
  • Vinyl acetate copolymers
  • PFAS contamination

Even when safe harbor levels exist, litigation risk remains high. Companies must evaluate both exposure and enforcement trends, not just regulatory thresholds.

European Union & France: Deforestation and PFAS

EU Deforestation Regulation (EUDR)

The EU Deforestation Regulation implementation timeline has been pushed back, with obligations applying first to medium and large companies. This regulation requires supply chain due diligence for certain raw materials.

Compliance will depend heavily on supplier documentation readiness.

France’s PFAS Ban

France’s ban on intentionally added PFAS in cosmetics is now in effect, with a one-year sell-through period for products already on the market. Impurity thresholds reach parts-per-billion levels.

Testing capabilities and supplier certifications are becoming essential in this environment.

United Kingdom: Divergence from the EU

The UK continues to update its cosmetic regulation independently. Recent developments include:

  • New restriction levels for hexyl salicylate
  • Prohibition of certain CMR-classified substances
  • Guidance on cosmetic use in children issued by the Cosmetic, Toiletry and Perfumery Association

The children’s guidance is particularly relevant for brands marketing anti-aging or active skincare products that may appeal to younger consumers. Marketing language scrutiny is increasing.

Canada: Hotlist and Chemical Assessments

In Canada, regulators are reviewing updates to the Cosmetic Ingredient Hotlist and conducting safety assessments related to chemical use in plastics.

Health Canada continues to evaluate ingredient safety and regulatory controls. Companies selling into Canada should expect ongoing refinements to permissible ingredients and documentation requirements.

Global Developments: ANDEAN, Indonesia, China

ANDEAN Labeling

Countries in the Andean region have harmonized over-labeling allowances, providing some flexibility for imported products. This creates operational efficiencies for companies distributing regionally.

Indonesia Halal Proposals

Indonesia is considering supply chain segregation requirements for halal and non-halal products, potentially impacting raw material sourcing, production, and logistics.

If implemented, this would require significant planning for global manufacturers exporting into Indonesia.

China Ingredient Function Standardization

China is standardizing allowable ingredient functions to streamline registration and notification processes. While this increases clarity, it also demands strict alignment between formulation documentation and permitted ingredient uses.

Legal & Advertising Trends: Claims Under Scrutiny

Our legal expert highlighted several high-risk areas for cosmetic brands:

  • “Free-from” claims (e.g., PFAS-free, paraben-free)
  • Contaminant-related class actions
  • SPF efficacy challenges
  • Compostability and recyclability claims
  • Drug-adjacent “cosmeceutical” language
  • Sustainability marketing

The Federal Trade Commission and competitor challenges also remain active enforcement avenues.

AI in Regulatory Compliance: Opportunity With Guardrails

Artificial intelligence tools are increasingly used to:

  • Organize supplier documentation
  • Review claim substantiation
  • Assess retailer certification requests
  • Streamline regulatory workflows

However, companies must protect confidential information and understand how AI integrates into SOPs and GMP expectations. AI can support compliance, but it cannot replace regulatory accountability.

What This Means for Your Business

Across jurisdictions, three themes are clear:

  • Documentation readiness is essential
  • Ingredient transparency is expanding
  • Marketing claims are under legal pressure

Regulatory compliance is no longer a reactive function. It must be embedded into formulation, supply chain management, and brand positioning from the start.

In the full webinar, our experts walk through practical examples, common mistakes we are seeing in audits and litigation, and specific steps your team can take now to reduce risk and accelerate product approvals.

If your company operates across multiple markets, this session provides strategic context you cannot afford to miss.

Watch the full webinar to access the complete regulatory breakdown and actionable guidance from our experts.

Or, if you would like to see how Ithos Global simplifies raw material qualification and global compliance management, explore our solutions or schedule a demo with our team.

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