MoCRA Deadlines 2026: Complete Compliance Timeline

What Are the Key MoCRA Deadlines?

The Modernization of Cosmetics Regulation Act (MoCRA) established a phased rollout of requirements that began in late 2023 and extends into 2026 and beyond. Understanding the full timeline is critical for maintaining compliance and avoiding enforcement actions. For a complete overview of all MoCRA obligations, see our MoCRA compliance guide.

Below is the complete MoCRA deadline timeline, showing what has already passed, what is coming up, and what remains to be determined.

When Must Facilities Register?

Under FD&C Act Section 607 (as amended by MoCRA), cosmetics facility registration has been required since July 2024. FDA provided an extended compliance period through late 2024 for initial registrations.

Who Must Register?

• All facilities that manufacture or process cosmetics distributed in the US
• Contract manufacturers making cosmetics for other companies
• Foreign facilities exporting cosmetics to the United States

New Facilities

Any facility that begins manufacturing cosmetics after the initial deadline must register before commencing manufacturing operations. There is no grace period for new entrants -- registration must be completed through FDA's Cosmetics Direct portal prior to production. Our step-by-step MoCRA registration guide walks you through the process.

When Is the Product Listing Deadline?

Product listing requirements have been in effect since December 2024. This requirement is now fully in effect and is an ongoing obligation under FD&C Act Section 607 (as amended by MoCRA).

What Must Be Listed?

• Every cosmetic product distributed in the United States
• Products manufactured domestically and those imported from abroad
• Private label and contract-manufactured products
• Products sold through professional and retail channels

Ongoing Obligations

Product listings are not a one-time filing. You must update your listings within 60 days when a product is discontinued, its formulation significantly changes, or a new product is introduced. Failure to maintain current listings can trigger FDA enforcement.

What Is the Biennial Renewal Schedule?

The biennial renewal is the most critical upcoming MoCRA deadline in 2026. Unlike food facility registration, which renews in even-numbered years, cosmetics facility registration follows its own biennial cycle.

What You Need to Know

• Renewal window: FDA will open the renewal period approximately two years after initial registration became effective
• Process: Renewal is completed through FDA's Cosmetics Direct portal
• Updates required: You must verify and update all facility information, product categories, and brand names during renewal
• No fee: Registration renewal is free through FDA's electronic system

Consequences of Missing Renewal

If you fail to renew by the deadline, your facility registration will lapse. This means:

• Your facility will no longer appear as registered in FDA's database
• Products manufactured at the facility may be considered adulterated
• Import shipments from unregistered foreign facilities could be refused entry
• FDA may consider the lapse during any future inspection or enforcement action

When Do Adverse Event Reporting Rules Apply?

Mandatory serious adverse event (SAE) reporting has been required since March 2025. This is an ongoing obligation with no future deadline -- it applies every time a serious adverse event is reported to a responsible person.

What Qualifies as a Serious Adverse Event?

• Death or life-threatening experience
• Inpatient hospitalization
• Persistent or significant disability or incapacity
• Congenital anomaly or birth defect
• Significant disfigurement (including serious rash, burns, hair loss, or persistent skin discoloration)
• Medical or surgical intervention to prevent any of the above

Reporting Process

Reports must be submitted to FDA via the CFSAN Adverse Event Reporting System (CAERS). You must include product identification, a description of the adverse event, and contact information for the reporter. Follow-up information must be submitted within one year if new safety data becomes available.

Record Retention

All adverse event records -- including non-serious events -- must be maintained for 6 years and be available for FDA inspection upon request.

When Will GMP Rules Take Effect?

MoCRA requires cosmetics to be manufactured in accordance with Good Manufacturing Practice (GMP). However, FDA has not yet published a final GMP rule or Notice of Proposed Rulemaking (NPRM). The effective date remains To Be Determined (TBD).

What to Prepare

Even without a final GMP rule, you should be implementing these practices:

• Personnel: Training programs, hygiene protocols, and qualification records
• Facilities: Proper design, maintenance schedules, and sanitation procedures
• Equipment: Calibration, cleaning validation, and maintenance logs
• Raw materials: Supplier qualification, incoming testing, and storage controls
• Production: Batch records, in-process controls, and packaging validation
• Quality control: Finished product testing, specifications, and release procedures
• Documentation: SOPs, change control, and deviation management

What About Fragrance Allergen Disclosure?

MoCRA mandates that specific fragrance allergens be disclosed on product labels. However, FDA must first finalize the list of allergens that require disclosure. An FDA NPRM (Notice of Proposed Rulemaking) is anticipated around May 2026. This is a proposed rule -- not a compliance deadline. Once a final rule is published, companies will have a compliance period to update their labels.

What We Know

• FDA's allergen list is expected to closely mirror the EU's 26 fragrance allergens that require disclosure above certain concentration thresholds
• The NPRM is anticipated around May 2026; after public comment and finalization, there will be a compliance period (likely 1-2 years) for companies to update their labels
• The requirement applies to both leave-on and rinse-off cosmetics

How to Prepare

Even without the final list, proactive companies should take these steps now:

• Audit your fragrance formulations for known EU-regulated allergens
• Request allergen declarations from fragrance suppliers
• Assess label real estate -- you may need more space for allergen disclosures
• Begin planning label redesigns to accommodate the new requirements

What Are the Penalties for Missing Deadlines?

MoCRA gives FDA significant new enforcement authority over cosmetics. Failing to meet deadlines can result in consequences ranging from warning letters to product seizures.

Potential Consequences

How Can I Prepare for Upcoming Deadlines?

Staying ahead of MoCRA deadlines requires a structured approach. Use this checklist to ensure you are ready for every requirement.

How Does Assurentry Help with MoCRA Compliance?

MoCRA introduced the most sweeping changes to US cosmetics regulation in over 80 years. Keeping track of every deadline, maintaining registration status, filing product listings, and managing adverse event reporting is a substantial operational burden -- especially for companies managing multiple facilities or large product portfolios.