On 13 October, Guatemala notified to the World Trade Organization (WTO) the draft Technical Standard for food supplements to be registered at the Food Regulation and Control department.
This document introduces clearer rules for products intended to be registered under the food law, considering that food supplements can be regarded as either foods or medicines depending on their composition. In summary, it proposes:
- Labelling provisions, based on the harmonized regulation for pre-packaged foods and nutrition labelling from the Secretariat for Central American Economic Integration (SIECA, per its Spanish acronym).
- Provisions regarding health claims (international references).
- Specific maximum levels of vitamins and minerals based on the Nutrient Reference Values (NRVs) that differ from those established for products falling in the medicine category (Technical Standard 14-2020) which are based on Tolerable Upper Intake Levels (ULs), No Observed Adverse Effect Levels (NOAEL) and the highest observed intake (HOI).
- Maximum levels for certain compounds such as caffeine and taurine, the amounts are lower than the ones established for products falling under the medicine law.
With this regulation the use of ingredients would be restricted to those listed in the corresponding annex while the use of other nutrients/substances (e.g., botanical extracts) would be not allowed.
Although the enforcement date notified by the Ministry of Health was 20 October 2021, the final text has yet to be issued. Furthermore, Technical Standard 002-2018 is no longer in force.
Please do not hesitate to contact us to learn more about food-related concerns or for advice on foods and food supplement regulations in Latin America and the Caribbean.
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October 21, 2021
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