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Compliance Requirements for U.S. Food Products Commercialized in Mexico: NOM-051 and the Mandatory Evaluation Documents

Compliance Requirements for US Food Products Commercialized in Mexico

By María Fernanda Mandujano Morales, EAS Consulting Group Independent Consultant

Exporting food products from the United States to Mexico requires compliance with specific regulations—particularly NOM-051-SCFI/SSA1-2010, which governs front-of-pack and nutritional labeling for prepackaged foods and non-alcoholic beverages. This standard mandates warning seals, limits on marketing to children, and detailed ingredient and nutrition declarations, all designed to support public health and informed consumer choices.

Since 2021, all products subject to NOM-051 must undergo label evaluation by an Inspection Unit (Unidad de inspección UI). The UI must be accredited by the Mexican Accreditation Entity (EMA) and authorized by COFEPRIS, Mexico’s Federal Commission for Protection Against Sanitary Risks. There are two evaluation paths, depending on the product’s labeling status at import: the Dictamen de Cumplimiento and the Constancia de Cumplimiento.

Dictamen de Cumplimiento

This applies when the product enters Mexico without NOM-051-compliant labeling and will be labeled after import, within a registered warehouse in Mexico. The process is as follows:

  1. The importer registers a warehouse as part of their importation process.
  2. The product arrives in Mexico without NOM-051 labeling.
  3. Labeling is performed at the warehouse.
  4. An Inspection Unit evaluates the final label and issues a Dictamen de Cumplimiento.
  5. The Dictamen is presented to customs for product release.

The warehouse is not officially “authorized” by SAT, but must be registered under the importer’s records and comply with the procedures outlined in the Official Agreement on NOM Compliance at Point of Entry, issued by the Ministry of Economy (Secretaría de Economía). Some Inspection Units may also request proof of use or lease of the warehouse.

Agencies involved:

  • Secretaría de Economía (regulatory authority for NOM-051 compliance)
  • COFEPRIS (sanitary labeling review and UI authorization)
  • EMA (technical accreditation of UIs)
  • SAT (customs clearance, registry of importers and warehouses)

Constancia de Cumplimiento

This applies when the product arrives already labeled in accordance with NOM-051 from the country of origin. The process includes:

  1. The exporter designs NOM-051-compliant labels before shipping.
  2. The UI reviews the label and documentation.
  3. A Constancia de Cumplimiento is issued.
  4. It is submitted for customs clearance.

Both documents are mandatory, and must align with the product’s formulation, packaging, and artwork. Any change requires a new evaluation.

Recommendations for U.S. Exporters

  • Choose your strategy early: If labeling in the U.S., opt for a Constancia; if labeling in Mexico, prepare for a Dictamen.
  • Work only with accredited, authorized Inspection Units.
  • Have your documentation ready, including nutritional analysis and label design.
  • Consult experts familiar with both FDA and Mexican regulatory frameworks.

Conclusion

Compliance with NOM-051 is more than a technical step—it’s a strategic decision. Choosing the right path and understanding the roles of each authority ensures smoother access to the Mexican market and helps protect your brand from unnecessary delays or penalties.

¡Claro que sí, Mafer! Aquí tienes la lista de referencias bibliográficas actualizadas con la aclaración sobre la bodega, incluyendo el rol específico de la Secretaría de Economía, además de las otras agencias relevantes:

Referencias actualizadas – NOM-051 y cumplimiento en importación a México

  1. NOM-051-SCFI/SSA1-2010
    “Especificaciones generales de etiquetado para alimentos y bebidas no alcohólicas preenvasados – Información comercial y sanitaria”.
    Modificaciones relevantes:
    • 27 de marzo de 2020 (DOF) – Fase 1
    • 28 de diciembre de 2023 (DOF) – Fase 3
      Available at: https://www.dof.gob.mx
  2. Secretaría de Economía
    • Acuerdo por el que se establecen las mercancías sujetas al cumplimiento de normas oficiales mexicanas en el punto de entrada al país y en el punto de comercialización.
    • Publicado en el DOF el 1 de octubre de 2020 y actualizado en años posteriores.
      Available at: https://www.gob.mx/se
  3. COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)
    • Lineamientos sobre etiquetado sanitario y acreditación/autorización de Unidades de Verificación (UV).
      Available at: https://www.gob.mx/cofepris
  4. EMA (Entidad Mexicana de Acreditación)
    • Directorio actualizado de Unidades de Verificación acreditadas para evaluación conforme a NOM-051.
      Available at: https://www.ema.org.mx
  5. SAT (Servicio de Administración Tributaria)
    • Requisitos para el padrón de importadores y procedimientos aduanales.
    • Registro de domicilios fiscales y bodegas utilizadas para cumplimiento normativo.
      Available at: https://www.sat.gob.mx

Posted in Foods, Issue of the Month.