Overview of the different labeling and marking requirements, including any restrictive advertising or labeling practices and where to get more information.
Under CAFTA-DR, a certificate of origin is not required. However, the GOG has asserted that a CAFTA-DR Certification of Origin must accompany the shipment to receive CAFTA-DR preferences and provides a suggested form and filing instruction.
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.
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.
MAGA accepts the export certificates issued by the Food Safety Inspection Service (FSIS), which is the FSIS 9060-5 form for poultry, meat, and meat products. Guatemala recently granted the United States market access for table eggs and egg products. FSIS also issues export certificates for pasteurized eggs and related products. The Agricultural Marketing Service (AMS) issues export certificates for table eggs and processed products like omelets; AMS also issues dairy export certificates. The National Oceanographic and Atmospheric Agency (NOAA) issues the negotiated Codex certificate to export seafood and products to Guatemala. All exports certificates are available online.
The Ministry of Health (MSPAS) requires that all processed food products be registered in Guatemala. The registration is unique for each product and importer; therefore, the same product can be registered by different importers, unless there is a previous legal representation established. For registration, MSPAS requires samples of the product and a government Certificate of Free Sales (CFS). This certificate does not need to be federal and can be issued at the state level by different government agencies, depending on the product. However, some states like Florida, are no longer issuing those certificates. Please note that the Food and Drug Administration (FDA) issues export certificates online. A new CFS is needed every 5 years, which is the period that the registration is valid. This document is a commercial document and does not need to have consular stamps.
MSPAS issues a sanitary registration number after a laboratory test has been performed on animal products. This registration number is also valid for five years and in the case of animal products, takes at least 8 weeks to be issued. For other processed products not of animal origin, the registration takes approximately 3 weeks. Laboratory tests will take place routinely and are scheduled once a year per product category. If products do not comply with labeling standards or food safety parameters, importers will be notified, as necessary.
In addition to the laboratory analysis for animal products, (for the wholesomeness of the product) the law requires inspections at the point of entry, wholesale and retail levels. Non-processed foods and food additives do not require registration. There is no environmental legislation that affects the importation of food products. The cost of registration and analysis of a product is about USD 215, independent of its category, and independent of registering it for the first time or requesting an extension of an already existing registration.
To receive an import permit, all imported foods of animal or vegetable origin, fresh or processed, must comply with the following requirements:
1) Certificate of Origin for Sanitary Purposes:
- Plant health certificate (phytosanitary certificate) issued by APHIS if it is a fresh plant food product;
- 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
- Agricultural Marketing Service (AMS) Export Certificate for table eggs, low egg content process products (like omelets), and milk and dairy products.
- National Oceanographic and Atmospheric Agency (NOAA) seafood and fisheries Export Certificate.
2) 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;
3) Commercial invoice.
4) Bill of lading
5) 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.
6) 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 Central American Technical Regulations to verify compliance.
Interested parties may contact Agricutural Specialist Karla Tay at KayTM@state.gov
Medical Devices, Pharmaceutical Products and Cosmetics
The Division of Registration and Control of Medicines and Foods of the Ministry of Health issues import permits for medical devices, pharmaceutical products and cosmetics.
Some products require an inscription (registration) at the registration office of the Ministry of Health. The approximate amount of time for the registration of a medical device is between 2-3 weeks and for pharmaceuticals and 4-6 months for cosmetics. These inscriptions need to be renewed every five years.
Surgical devices that require an inscription are intended for cutting the skin or a membrane, or which touch blood, such as syringes or finger pricks. Devices such as anesthetics and asthmatic inhalers, high pressure measuring apparatus, laser-guided apparatus and others do not require an inscription. These would be classified under medical equipment and supplies and undergo normal customs clearance procedures.
The Central American Technical Regulations, CATR (RTCA in Spanish) have been recently issued and published for processed food products, pharmaceuticals and cosmetics, among others. The CATR established unified standards and requirements for commercializing agricultural products, pharmaceuticals, cosmetics, healthcare products and others within the Central America and Panama region. Compliance with these technical regulations assures that products may be imported without major complications.
Interested parties may contact Commercial Specialist Antonio Prieto at email@example.com
Registration Requirements for Pharmaceutical Products:
Pharmaceutical products, including but not limited to specialty pharmaceuticals, homeopathic, radiopharmaceutical, supplements, biological, biotechnology and allergens require a sanitary permit to be imported and commercialized in Guatemala.
Details and registration forms for pharmaceutical products and renewal process may be found in the following link: here.
A simplified list of requirements for obtaining a sanitary permit is below: *
1. Fill and submit the appropriate forms in original and duplicate
2. Product formula and composition (mention both common and scientific names) (using appropriate form)
3. Sanitary license, valid or prior license (usually from FDA or PAHO)
4. Legalized copy of the Trademark registry
5. Free Sale Certificate from the country of origin; CBL approved by a recognized organization such as the OMS
6. Monograph study, when it is a new product
7. Product description
8. Product specifications
9. Method of analysis used
10. Packaging materials used (a sample), originals and copy
11. Instructions on label in Spanish
12. Copy of contract (in case of manufacture under drawback or “maquila” law)
13. Stability study for products with 24 months life expectancy or more, according to product
15. Bio-equivalence study, when applied
16. Standard of raw material of active principle/s for new molecules
17. Copy of the Sanitary License of the local distributor
18. All foreign language documents must be legally translated into Spanish.
*This is a simplified guide; it is recommended that the U.S. Company visits the appropriate links to obtain updated and specific guidance on how to register products.
Authorization to commercialize cosmetic products in Guatemala is required.
In Guatemala, the owner of the sanitary registration must be a local company. It is recommended that the U.S. exporter find local representation to take care of the ownership of its sanitary registrations.
When products are registered under a distributor’s name, and the U.S. Company determines that there is a need to change the distributor, it is necessary to present a document or contract, signed by both parties to the Ministry of Health.
If the U.S. Company owns the sanitary registrations through a local representative or company and chooses to change a distributor, such change must be notified to the Ministry of Health; this is a simple procedure.
Interested parties may contact Commercial Assistant Karla Salas at firstname.lastname@example.org