Overview

Under CAFTA-DR, it is not mandatory to provide a certificate of origin. However, the Government of Guatemala has asserted that a CAFTA-DR Certification of Origin must accompany the shipment to qualify for CAFTA-DR tariff benefits and provides a suggested form and filing instruction. It is strongly suggested to follow this format to avoid problems in the import process.

It is key to double check that the correct “preferential criteria” is included in space # 7 of the suggested form. Importers have been denied the preferential tariff for incorrect criteria designation.

The preferential criterion corresponds to letters “a”, “b”, or “c”, according to Chapter 4 - Rules of Origin.

If either the exporter or the importer does not know which criterion applies, the Ministry of Economy is willing to review the product description with the importer to determine the correct criterion. For rules regarding how to complete the CAFTA-DR Certification of Origin, please refer to the Directorate of Administration of Foreign Commerce (DACE) of the Ministry of Economy.

As of December 2005, the Guatemalan Ministry of Economy’s National Quality System became the standard setting body and manages the Guatemalan Accreditation Office (OGA) and the National Metrology Center (CEME). Prior to December 2005, the Guatemalan Norms Commission (COGUANOR) set standards, but when the National Quality System came on board, COGUANOR standards became voluntary. The Guatemalan Accreditation Office (OGA) is governed by Presidential Decree 145-2002 and is responsible for the accreditation of laboratories and certifying entities and inspection organizations.

Presidential Decree 78-2005 establishes official tariffs for the services provided by the OGA, which is a signatory to the “Multilateral Recognition of the Inter American Cooperation for Accreditation” (IAAC) and has been accepted in the “Mutual Agreement of Recognition of the International Accreditation for Laboratories” (ILAC).

Standards and regulations for both local and imported products are the same, except for public markets and other food serving locations that require sanitary licenses but no product registration.

Any local producer, processor, packer, or distributor needs to operate under a sanitary license issued by Food Control at the Ministry of Health. Importers need to be legally registered with an active sanitary license of operations and imported products need to be registered as well. Labeling is required and imported food products are marketed in Guatemala with a Spanish-language label in accordance with the food law. Stickers are also allowed. Stickers would be required to declare the name of the product, list of ingredients, and nutritional label if appropriate. Please ensure that the Spanish sticker is legible but does not block the front package or the ingredients list or the preparation instructions.  Furthermore, there have been situations where imports have had difficulty clearing customs when the labels have not been in Spanish.

MAGA maintains lists of approved companies (not plant facilities) that can export to Guatemala non-processed food products such as poultry, meats, and seafood. The pre-approved facilities’ requirement does not apply to the United States.  For the United States, the list of exporting companies is constructed and updated as exports come to the country, since the United States was granted food safety equivalence through CAFTA-DR. Not all importers are aware of this, so please clarify with your importer.

The Foreign Agricultural Service updates every year its GAIN Food and Agricultural Imports Regulations and Standards (FAIRS) Report, where detailed information is provided for exporting agricultural and food products to Guatemala. Please visit the latest GAIN FAIRS report for Guatemala.

To receive an import permit, all imported foods of animal or vegetable origin, fresh or processed, must comply with the following requirements:

a) Certificate of Origin for Sanitary Purposes:
i.    Plant health certificate (phytosanitary certificate) issued by APHIS if it is a fresh plant food product.
ii.    Sanitary certificate issued by the Food Safety Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA), if it is meat product, either fresh or processed
iii. Agricultural Marketing Service (AMS) Export Certificate for table eggs, low egg content process products (like omelets), and milk and dairy products.
iv. National Oceanographic and Atmospheric Agency (NOAA) seafood and fisheries Export Certificate.
b)     State Issued Certificate of Free Sale or Food and Drugs Administration (FDA) export certificate if it is a processed food product, either primary or end, which is not a meat product.
c) Commercial invoice.
d) Bill of lading
e) Certification of Origin for customs and tariff purposes. The CAFTA-DR proposed certificate of origin b the Government of Guatemala fulfills customs requirements so that preferential tariffs can be applied.
f) Re-Export Certificate if the product is re-exported from the country, but please note that it still requires the original sanitary or phytosanitary certificate.

The Certificate of Free Sale can include a list of products to be registered, if all the products in that list are registered simultaneously. For example, if twenty products are to be registered at the same time, Food Control allows for one original certificate and nineteen copies to accompany the rest of the products, since one complete file is kept per registered product.

Central American Technical Regulations (RTCA) – As part of the Central American harmonization process, Ministries of Economy have published the RTCAs that spell out technical regulations for packaging, labeling, liquors and spirits, approved additives, infant food, sanitary license, and registration of products. Though the regulations are the same for all Central America, their implementation varies from country to country. Please, refer to FAS export certificate report to get more detailed information on the U.S. export certificates approved in Guatemala and additional information required to comply with Guatemala import requirements and standards.

Official Contacts 
Name:             Karla Tay
Title:                Agricultural Specialist
Institution:    Foreign Agricultural Service, U.S. Department of Agriculture
Address:         Blvd Austriaco 11-51 zona 16.  Edificio Embajada Americana
Telephone:   (502) 5326-0005
Email:              TayKM@state.gov

Name:             Evelyn Meneses
Title:                Director for Regulations
Institution:    Food Control Unit/Ministry of Health (MSPAS)
Address:         Avenida Bolivar, 28-07 Zona 8, 01008, Guatemala
Telephone:   (502) 22964026
Email:             emeneses@mspas.gob.gt

Name:             Jorge Gomez
Title:                Plant Health Director
Institution:    Norms and Regulations Unit/Ministry of Agriculture (MAGA) 
Address:         7 Avenida 3-67, Zona 13, 01013, Guatemala 
Telephone:   (502) 2413-7389
Email:              jgomez@maga.gob.gt

Name:             Nelson Ruano
Title:                Food Safety Director
Institution:    Norms and Regulations Unit/Ministry of Agriculture (MAGA) 
Address:         7 Avenida 3-67, Zona 13, 01013, Guatemala
Telephone:   (502) 2413-7389
Email:              mvnelsonru@yahoo.com

Name:             Khrista Polanco
Title:                Animal Health Director
Institution:    Norms and Regulations Unit/Ministry of Agriculture (MAGA) 
Address:         7 Avenida 3-67, Zona 13, 01013, Guatemala
Telephone:   (502) 2413-7389
Email:             kpolanco@maga.gob.gt

Name:             Rosario Gómez
Title:                Director OIRSA-SEPA-SITC
Institution:    Inter-Regional Body for Plant and Animal Health/Ministry of Agriculture (MAGA)
Address:         21 Avenida 3-12, Zona 15, Guatemala
Telephone:   (502) 2369-5900
Email:             rgomez@oirsa.org

Name:             Licda. Victoria Meza
Title:                CAFTA-DR Administrator
Institution:    Foreign Commerce Administration Direction/Ministry of Economy
Address:         6 Avenida 10-43 Zona 1, Guatemala
Telephone:   (502) 2412-0200
Email:              vmeza@mineco.gob.gt

Registration Requirements for Pharmaceutical Products  

Pharmaceutical products, including specialty drugs, biologicals, biotechnology-based products, homeopathic medicines, radiopharmaceuticals, dietary supplements, and allergen therapies – must obtain a sanitary registration from MAGA before being imported or sold in the country.  

Due to recent procedural delays and backlogs, applicants should anticipate extended processing times and plan submissions well in advance of intended commercialization. Complete guidance and official registration forms can be accessed at: MSPAS  

Basic Documentation Requirements*

1. Completed applications forms (original and duplicate) 
2. Product composition and formula (common and scientific names)
3. Valid foreign sanitary license (e.g. FDA or PAHO)
4. Legalized trademark registration
5. Free Sale Certificate from the country of origin; must be certified by WHO or equivalent authority
6. Monograph (if applicable for new products)
7. Detailed product description
8. Product specifications and manufacturing standards
9. Description of analytical methods used
10. Packaging materials (samples required)
11. Spanish-language labeling and instructions
12. Manufacturing contract (for maquila or toll production arrangements)
13. Stability data (for products with shelf life of 24 months or more)
14. Product samples
15. Bioequivalence studies (if applicable)
16. Specifications of active pharmaceutical ingredients (API) for new molecules
17. Copy of the sanitary license of the local distributor
18. All documents in foreign language must be officially translated into Spanish.

*This is a general summary of the key documentation.  U.S. exporters are strongly advised to consult official sources and local regulatory experts to ensure compliance with the most recent requirements and procedures.  

Registration Requirements for Medical Devices, Dental Materials, and Laboratory Reagents

Sanitary registration is required for certain medical devices and related products, such as dental materials and laboratory reagents, before they can be imported and sold in Guatemala. The DRCPFA under the Ministry of Health is the responsible authority for managing these registrations. 
Registration forms and documentation guidelines can be found at the official portal:  MSPAS

For medical devices and related products, refer specifically to: “F-AS-f-08: Solicitud de Inscripción Sanitaria de Productos Afines”

Registration Requirements for Cosmetic Products  

All cosmetic products intended for commercial sale in Guatemala must obtain a sanitary registration from the Ministry of Health. Importantly, the holder of the sanitary registration must be a Guatemalan entity, which means U.S. exporters must work with a local company or representative to manage their product registrations. If a product is registered under a distributor’s name and the U.S. company wishes to change the distributor, both parties must sign a formal agreement to transfer the registration, which is then submitted to the Ministry of Health. However, if the U.S. company holds the registrations through a local representative (not the distributor), changing the distributor is a much simpler notification process.  

Key registration requirements for cosmetics include: 

• Good Manufacturing Practices: Issued by the health authority in the country of origin.  If not available, a sanitary license from the manufacturer may be accepted.
• Qualitative and Quantitative Formula: Signed by a qualified professional from the manufacturer.
• Finished Product Specifications: Including physical characteristics (color, odor, texture) and chemical/microbiological properties.  Often provided with a certificate of analysis.
• Labels and Packaging:  Labels must be in Spanish.  If originally in another language, a certified legal translation is required and must be physically attached to the product.  
• Power of Attorney:  Must be apostilled or legalized at a Guatemalan consulate in the U.S.  It must also designate a responsible person in Guatemala for sanitary compliance.
• Apostille:  U.S. public documents must be apostilled through the Secretary of State.  More information is available here:  Travel State
• Additional Requirements:  If the product contains active ingredients exceeding Guatemalan legal thresholds, a declaration from the manufacturer must be provided indicating whether the ingredient is pure or part of a compound.  

The local distributor must have appropriate storage facilities and a valid sanitary license to handle cosmetic imports. Forms and further details are available at:  Details and registration forms for cosmetic products may be found in the following link: MSPAS  
Refer to: “F-AS-f-08: Solicitud de Inscripción Sanitaria de Productos Afines”

Validity and Renewal of Sanitary Registrations

All sanitary registrations in Guatemala are valid for five years and may be renewed for an additional five years.   Renewal must be initiated before the expiration date. Forms for renewal or updates are available at the same registration portal under:  

• “F-AS-f-09: Solicitud Actualización de Registro” (First-time Registrations)
• “F-AS-f-05: Solicitud Renovación de Registro” (Renewals)

Additional Guidance and Points of Contact

The Ministry of Health’s regulatory offices typically do not respond to inquiries by email or phone.  Companies are encouraged to request an in-person appointment when possible. Having a knowledgeable and experienced local representative is the most effective way to ensure a smooth registration process. For more information, contact: MSPAS