Mexico Cosmetics Labeling & GMP Compliance Guide 2026: COFEPRIS Regulatory Requirements For Cosmetic Products

Ensuring compliance with Mexico’s COFEPRIS cosmetics labeling standards and Good Manufacturing Practices (GMP) is essential for any company planning to manufacture, import, or sell cosmetic products in the Mexican market. With evolving regulatory expectations and increasing enforcement activity by COFEPRIS (Federal Commission for Protection against Health Risks), a proactive, structured compliance strategy is critical to avoid delays, penalties, or product seizures.

This comprehensive guide from Maven Regulatory Solutions outlines the mandatory labeling requirements under NOM-141-SSA/SCFI-2012, the GMP framework of NOM-259-SSA1-2022, detailed operational requirements, and key compliance strategies for cosmetic product success in Mexico.

Introduction to Mexico Cosmetics Regulation

Mexico regulates cosmetic products under the oversight of COFEPRIS, the national health authority responsible for public health risk protection. Two cornerstone standards govern cosmetics:

1. NOM-141-SSA/SCFI-2012 – Labeling Requirements
2. NOM-259-SSA1-2022 – Good Manufacturing Practices (GMP)

Together, these standards ensure that consumers receive safe, quality, and properly labeled cosmetics supported by traceable manufacturing practices.

1. COFEPRIS Cosmetic Product Labeling Requirements

Cosmetics sold in Mexico must comply with NOM-141-SSA/SCFI-2012. These requirements are designed to enhance consumer safety, promote transparency, and ensure accurate product information.

Key Mandatory Labeling Elements

Product-Specific Labeling Requirements

Certain cosmetics require specialized labeling elements:

• Sunscreens: Display SPF value, UVA protection level, and application instructions.
• Hair Dyes: Include allergy warnings and patch test instructions.
• Toothpastes: Show fluoride concentration where applicable.
• Children’s Products: Warn about accidental ingestion and safe storage.

Labeling Best Practices for COFEPRIS Compliance

To minimize regulatory risk:

• Use clear, readable Spanish language exclusively on all labels.
• Follow cosmetic-specific symbol and unit conventions.
• Ensure completeness and accuracy of ingredient listings and regulatory claims.
• Conduct regulatory review before launch to avoid administrative sanctions.

2. Mexico Cosmetic GMP: NOM-259-SSA1-2022

Effective from March 2, 2023, NOM-259-SSA1-2022 outlines manufacturing standards for cosmetics in both domestic and imported product contexts. It covers the entire value chain, from facility design to personnel hygiene, and quality control.

These GMP requirements reflect risk-based quality management systems, like internationally recognized frameworks like ISO and PIC/S but tailored to Mexican regulatory expectations.

GMP Core Areas of Compliance

Personnel Hygiene & Competency

Personnel involved in cosmetic production must follow strict guidelines:

• Clean uniforms and protective equipment
• Handwashing protocols
• No jewelry or personal items in production zones
• Restricted access for symptomatic individuals
• Documented training in hygiene and GMP principles

Facility and Physical Environment

Production and storage areas must be designed to prevent contamination and ensure traceability:

• Segregated zones for production, QC, storage and dispatch
• Cleanable surfaces for floors, walls, ceilings
• Proper ventilation, lighting, and drainage systems
• Designated sanitary facilities with hygiene stations

Sanitation, Utilities & Pest Control

A compliant cosmetic manufacturing facility must maintain:

• Potable water systems with documented quality checks
• Effective wastewater and effluent control
• Pest-free zones with documented pest control measures
• Organized waste disposal to prevent contamination

Equipment, Calibration & Maintenance

Production equipment must be:

• Designed to avoid product contamination
• Cleaned and disinfected per SOPs
• Calibrated regularly with documented results
• Maintained to prevent unexpected downtime

Unserviceable equipment must be clearly identified and segregated.

Raw Materials, Packaging & Traceability

All raw materials and packaging components must be:

• Inspected upon receipt
• Identified with lot numbers
• Stored under controlled conditions
• Processed based on documented acceptance criteria
• Released by qualified personnel

Inventory control using FIFO (first in, first out) must be documented.

3. Production, Quality Control & Release Criteria

Manufacturing operations must follow documented procedures ensuring:

• Materials verification before production
• Lot traceability codes for batch identification
• Defined acceptance criteria for finished cosmetics
• Strict out-of-specification (OOS) investigation processes
• Release authorization by trained quality personnel

Finished products must be clearly labeled, properly packaged, and stored under controlled conditions prior to distribution.

4. Transportation & Distribution Controls

Cosmetic products must be transported in ways that:

• Preventing contamination or degradation
• Preserve product integrity
• Comply with documented temperature or humidity requirements
• Use corrosion-resistant and clean vehicles

5. Complaints, Recalls, and Post-Market Obligations

Manufacturers must have procedures for:

• Handling product complaints
• Investigating defects, allergens, or safety issues
• Managing returns under controlled conditions
• Implementing recalls promptly and notifying COFEPRIS if safety is impacted

Trend analysis and corrective action planning are mandatory for continuous improvement.

6. Documentation, Recordkeeping & Spanish Requirements

All records must be:

• In clear, legible Spanish
• Retained for at least one year beyond relevant activities
• Signed, dated, and version controlled
• Readily available for COFEPRIS inspections

Handwritten entries must use permanent ink, with corrections documented transparently.

7. Labeling & GMP Integration A Compliance Checklist

FAQs – COFEPRIS Cosmetics Labeling & GMP

Q1. Is Spanish labeling mandatory?
Yes, all cosmetic labels and documentation must be in Spanish.

Q2. Can cosmetics claim health benefits?
No claims must be limited to cosmetic function, not medicinal treatment.

Q3. When does GMP NOM-259-SSA1-2022 apply?
It is in effect and applies to both domestic and imported products.

Q4. What happens if products don’t meet GMP standards?
COFEPRIS can conduct inspections, issue citations, or remove products.

Q5. Are safety data and labeling evaluated during GMP audits?
Yes dossier review and inspection include both manufacturing and labeling.