Standards and Technical Regulations
In general, U.S. standards set the pace for Guatemalan standards. Many products made in the U.S. already meet Guatemala’s standards. The main area of difference is found in items intended for human consumption, such as pharmaceuticals and food. For these categories, U.S. exporters must adhere strict local registration and labeling requirements specific to Guatemala.
The United States actively serves as a resource to assist Guatemala in developing or streamlining standards ensuring they are aligned and facilitative of trade. One of the critical components of the CAFTA-DR agreement is Chapter 7, which addresses Technical Barriers to Trade (TBT). The objective outlined withing its chapter focuses on increasing and facilitating trade by improving existing TBT agreement, the chapters aim to streamline processes that can often pose obstacles to trade, eliminating unnecessary barriers and enhancing bilateral cooperation. Read more on Technical Barriers to Trade under CAFTA-DR.
Currently, the approved Central American Technical Regulations concerning agricultural and food standards can potentially act as a technical barrier to trade. Specifically, concerns arise when these standards are established without a foundation of science-based evidence. Such measures can create unnecessary hurdles for exporters, particularly if they do not align with widely accepted international standards.
Food Products
Products labeled as “diet supplements”, “homeopathic”, “and prophylactic” or “phyto-therapeutic.” These products are classified as medicines and must be registered accordingly. All products seeking registration must be tested by the Health National Laboratory (LNS), which is the only laboratory authorized by the Ministry of Health, Product samples must be submitted along with the registration application.
Processed food products need to be registered on a product-by-product basis, paying the equivalent of USD 230 per registry, and the process is bureaucratic with potential delays extending over a year before approval. The Food and Drug Administration (FDA) does not require product-by-product registration for processed food.
Testing, Inspection and Certification
While many products can enter the market, those containing processed animal origin must undergo rigorous testing at the Ministry of Health’s official laboratory before they can be marketed. This test may take 1-3 months after which a registration will be issued. The registration allows for commercialization of the product and needs to be renewed every five years. Processed food products are subject to random inspections at the point of sale to ensure compliance with health standards. However, Guatemala does not conduct inspections or certifications at the origin of the products. For fresh produce or non-processed meat, the Regional International Organization for Plant Protection, OIRSA carries out inspections at the port of entry if fresh or refrigerated, mostly for quarantine pests or ISMF-15 stamp. No food safety inspection is carried out at the port of entry for these categories
The regulatory environment for food products in Guatemala requires thorough registration and testing processes to ensure compliance with health and safety standards. While certain food items enter the market more freely, those that are considered at higher risk, especially processed animal origin products, face more stringent requirements. Understanding these protocols is crucial for U.S. exporters seeking to navigate the Guatemalan market effectively.
Publication of Technical Regulations
Members of the World Trade Organization (WTO) are required under the Agreement on Technical Barriers to Trade (TBT Agreement) to notify the WTO of proposed technical regulations and conformity assessment procedures that could affect trade. Notify U.S. (www.nist.gov/notifyus) is a free, web-based e-mail registration service that captures and makes available for review and comment key information on draft regulations and conformity assessment procedures. Users receive customized e-mail alerts when new notifications are added by selected countries and industry sectors of interest and can also request full texts of regulations. This service and its associated website are managed and operated by the USA WTO TBT Inquiry Point housed within the National Institute of Standards and Technology, part of the U.S. Department of Commerce.”
Use ePing to review proposed technical regulations and conformity assessment procedures.
The ePing SPS&TBT platform (https://epingalert.org/), or “ePing”, provides access to notifications made by World Trade Organization (WTO) Members under the Agreements on Sanitary and Phytosanitary Measures (SPS) and Technical Barriers to Trade (TBT), distributed by the WTO from January 16, 1995, to present.
ePing is available to all stakeholders free of charge and is a versatile tool that can be used to:
- Follow and review current and past notifications concerning regulatory actions on products, packaging, labeling, food safety and animal and plant health measures in markets of interest,
- Receive customized e-mail alerts when new notifications are distributed,
- Find information on trade concerns discussed in the WTO SPS and TBT Committees.
Per obligation under the TBT Agreement, each WTO Member operates an Enquiry Point. National TBT Enquiry Points are authorized to accept comments and official communications from other national TBT Enquiry Points, which are NOT part of the WTO or the WTO Secretariat. All comment submissions from U.S. stakeholders, including businesses, trade associations, U.S domiciled standards development organizations and conformity assessment bodies, consumers, or U.S. government agencies on notifications to the WTO TBT Committee should be sent directly to the USA WTO TBT Enquiry Point. Refer to the comment guidance at https://www.nist.gov/notifyus/commenting for further information.
This guidance is provided to assist U.S. stakeholders in the preparation and submission of comments in response to notifications of proposed foreign technical regulations and conformity assessment procedures.
Contact Information
Entity: Guatemalan Standards Commission
Contact: Pablo Pineda, Director
Email: info@dsnc.gt