COFEPRIS Compliance for Food & Beverage Manufacturers

1. Overview of Mexican Food Regulatory Framework

The Ley General de Salud (General Health Law) is the primary regulation for importing, exporting, and commercializing food products in Mexico. COFEPRIS, as a department within the Mexican Secretariat of Health, administers this framework and ensures food safety through a system of Mexican Official Standards known as NOMs (Normas Oficiales Mexicanas).^[2]

The FDA, SENASICA, and COFEPRIS have established a food safety partnership to strengthen food safety systems and protect public health through information sharing, technical cooperation, and coordinated regulatory approaches.^[3]

Key Mexican Official Standards (NOMs)

Several NOMs govern food manufacturing and labeling in Mexico:^[1]

• NOM-051-SCFI/SSA1-2010: Comprehensive guideline governing the labeling of prepackaged food and non-alcoholic beverages, including mandatory front-of-pack warning labels
• NOM-251-SSA1-2009: Technical standard on good manufacturing practices for food products, beverages, and dietary supplements
• NOM-120-SSA1-1994: Good manufacturing practices for food, beverages, and dietary supplements

2. NOM-051: Front-of-Pack Warning Label Requirements

NOM-051-SCFI/SSA1-2010 is a comprehensive guideline governing the labeling of prepackaged food and non-alcoholic beverages in Mexico. In March 2020, COFEPRIS introduced significant amendments to NOM-051, marking a pivotal moment in the regulation of food labeling in the country. These labeling changes are mandatory for both domestic and imported products, and aim to encourage Mexicans to adopt a healthier diet and fight diseases such as obesity and diabetes.^[4]

Octagonal Warning Labels

NOM-051, as amended, requires manufacturers to place octagonal warning symbols on certain consumer products that state, for example, "Excess Calories," "Excess Saturated Fat," "Excess Sugars," and "Contains Caffeine - Avoid in Children." Companies must review and update their product labeling and marketing strategies to align with the new requirements, including implementing front-of-pack labeling, incorporating graphic warning labels where necessary, and adjusting promotional tactics targeting children.^[5]

Three-Phase Implementation Timeline

The regulation has been implemented in three stages:^[4]

• First Stage: December 1, 2020 - September 30, 2023 (includes major changes). Some provisions came into effect on April 1, 2021.
• Second Stage: October 1, 2023 - September 30, 2025
• Third Stage: October 1, 2025 - onward. The third phase of implementation will also require octagonal warning labels when ingredients in the prepackaged products contain excess sugars, fats, and sodium.

The third phase, scheduled for implementation beginning October 1, 2025, stipulates that complementary information must be incorporated into the provisions outlined in NOM-051. This represents the final phase of Mexico's front-of-pack labeling law implementation.^[6]

Evaluation Criteria for Warning Labels

The warning labels are triggered based on specific thresholds for added ingredients. If added sugars are included during the production process, then sugars and energy/calories must be evaluated. If sodium is added during the production process, then only sodium must be evaluated. The thresholds become progressively stricter across the three implementation phases.^[4]

Mandatory Label Evaluation Process

Since 2021, all products subject to NOM-051 must undergo label evaluation by an Inspection Unit (Unidad de inspección UI), which must be accredited and authorized by COFEPRIS. There are two evaluation paths: the Dictamen de Cumplimiento and the Constancia de Cumplimiento, depending on whether products are labeled before or after import.^[6]

3. Mandatory Label Information Requirements

In Mexico, it is mandatory to prepare a label in Spanish language that complies with NOM-051-SCFI/SSA1-2010 outlining all requirements for label preparation. The original label in English may remain on the package if an additional one in Spanish is affixed, and adhesive tags/stickers with information in Spanish are permitted if they remain adhered until product reaches the end consumer.^[7]

Required Label Elements

The Sanitary Control Regulations require specific labeling elements:

• Product name (common or generic name)
• Complete ingredient list in descending order by proportion
• Nutritional information panel
• Manufacturer or distributor data (name and address)
• Lot number and production date
• Expiration date or best before date
• Net content declaration
• Precautionary statements (when applicable)
• Consumption or preparation instructions
• Octagonal warning labels (when thresholds are exceeded)
• Country of origin

Spanish Language Requirements

All mandatory information must be presented in Spanish. While the original English label may remain on the product, a compliant Spanish label must be affixed to meet COFEPRIS requirements. This ensures Mexican consumers can access critical product information in their native language.

4. Sanitary Registration and Import Permits

Based on health risks, COFEPRIS determines if imported food products require an import permit, which the importer must apply for in advance. For products requiring import permits from COFEPRIS, these need to arrive along with a Certificate of Analysis (COA) that must include physical, chemical, and microbiological analysis by an accredited laboratory, per product lot in the consignment.^[8]

Sanitary Import Permit (PSPI)

Dietary supplements and certain food products intended for import must have a prior Sanitary Import Permit (PSPI) issued by COFEPRIS, which allows health authorities to verify compliance with current sanitary legislation. This permit is product-specific and must be obtained before each importation.^[8]

Certificate of Analysis Requirements

The Certificate of Analysis must include physical, chemical, and microbiological analysis performed by an accredited laboratory. This documentation provides evidence that the product meets Mexican safety standards and quality specifications.

Registration Timeline

Registration consists of two phases: (1) obtaining a food supplement classification letter and (2) obtaining a food supplement advertising permit, with phase (1) taking about 5-7 months and phase (2) taking two months. You must have a legally constituted company in Mexico, as COFEPRIS does not grant registrations to foreign companies directly.^[8]

5. Notice of Operation (Aviso de Funcionamiento)

A Notice of Operation must be filed with COFEPRIS by any business that intends to operate involving the production, distribution, or sale of food, beverages, or other products that could pose a risk to public health. Businesses must file a Notice of Operation within 30 days of starting operations in Mexico.^[9]

This notification establishes the legal foundation for operating a food business in Mexico and allows COFEPRIS to maintain oversight of facilities that manufacture, process, pack, or distribute food products.

Sanitary Responsible Person

Companies must appoint a Sanitary Responsible Person, typically a qualified professional (e.g., a chemist or biologist), who is legally responsible before COFEPRIS for the quality and compliance of products. This individual ensures that manufacturing practices, quality control procedures, and regulatory requirements are properly implemented and maintained.^[8]

6. Good Manufacturing Practices (NOM-251)

COFEPRIS regulates activities carried out by employers involving obtaining, processing, preparing, preserving, mixing, packaging, handling distribution of food products, food supplements, herbal remedies, beverages, and related products. Companies must comply with NOM-251-SSA1-2009, which establishes good hygiene practices in the manufacture of products.^[1]

Key GMP Requirements

NOM-251 addresses:

• Facility design, construction, and maintenance
• Equipment sanitation and calibration
• Personnel hygiene and training
• Process controls and documentation
• Raw material sourcing and verification
• Finished product testing and release
• Traceability and recall procedures
• Pest control and waste management
• Water quality and environmental monitoring

Compliance with NOM-251 demonstrates that a manufacturer has implemented appropriate controls to ensure food safety throughout the production process, from raw material receipt to finished product distribution.

7. Advertising Permits

An advertising permit from COFEPRIS is required to avoid misleading claims. An advertising permit from COFEPRIS is mandatory for marketing food supplements, and failure to obtain this permit exposes products to sanctions outlined in the General Health Law.^[8]

Advertising Restrictions

NOM-051 amendments include restrictions on marketing products with warning labels to children. Companies must adjust promotional tactics to comply with regulations that limit advertising of products containing excess calories, sugars, saturated fats, trans fats, or sodium to children under 12 years of age.

Products displaying warning seals cannot include child-directed marketing elements such as cartoon characters, celebrity endorsements targeting children, toys, or interactive games on packaging or in promotional materials.

8. Product Classification and Consultation

Dietary supplements do not require sanitary registration, though a product classification consultation can be requested from COFEPRIS to verify compliance with applicable legal framework. This consultation helps manufacturers understand which regulatory pathway applies to their specific product and what compliance requirements must be met.^[8]

Classification Categories

COFEPRIS classifies products into different categories that determine regulatory requirements:

• Food products (general)
• Food supplements
• Dietary products for special medical purposes
• Modified foods
• Beverages (alcoholic and non-alcoholic)

9. Compliance and Enforcement

COFEPRIS uses a comprehensive enforcement approach to ensure compliance with food safety and labeling requirements. NOM-051 entered into force on January 1, 2011, and was last amended on March 27, 2020, and is jointly enforced by PROFECO (Federal Consumer Protection Agency) and COFEPRIS.^[7]

Enforcement Actions

• Facility inspections: Verification of GMP compliance, sanitation practices, and documentation
• Product sampling and testing: Laboratory analysis to verify safety and quality claims
• Label compliance reviews: Verification of NOM-051 compliance including warning labels and Spanish language requirements
• Import inspections: Border verification of import permits, certificates of analysis, and label compliance
• Warning letters and sanctions: Formal notifications of violations and penalties
• Product detention and seizure: Removal of non-compliant products from commerce
• Facility closure: Suspension of operations for serious or repeated violations

Failure to obtain required permits, maintain proper labeling, or follow GMP requirements can result in significant penalties, product recalls, and loss of market access. Proactive compliance reduces regulatory risk and protects brand reputation in the Mexican market.

How Launch™ Simplifies COFEPRIS Compliance

COFEPRIS compliance involves navigating complex Spanish-language labeling requirements, octagonal warning label thresholds, import permits, sanitary registrations, GMP standards, and advertising restrictions. For food and beverage manufacturers, these requirements create significant regulatory complexity and can delay market entry into Mexico.

Launch™ turns COFEPRIS compliance into executable workflows by:

• Centralizing product data and Mexican regulatory requirements into a single execution-ready workspace
• Validating formulations against NOM-051 thresholds to determine required warning labels
• Generating compliant Spanish-language labels with proper octagonal warning symbols
• Checking ingredient compliance against permitted additives and maximum levels
• Preparing documentation for COFEPRIS import permits and sanitary registrations
• Organizing certificates of analysis and laboratory testing requirements
• Compiling submission-ready dossiers for inspection unit evaluation
• Maintaining traceability records aligned with NOM-251 GMP requirements
• Capturing regulatory decisions in a Compliance Context Graph that preserves the "why" behind every approval

Every execution is reviewable and adjustable by your team. Launch™ keeps humans firmly in control while automating the heavy lifting - ensuring compliance is accurate, auditable, and aligned with COFEPRIS expectations.