By: Adriana Pérez and Olga Torres
Summary of Technical Standard 84-2021 Sanitary Registration of Repellent Products for External Use in Humans and Repellent Products for Use in Guatemalan Environments
On September 24, 2021, Technical Standard 84-2021 for the Sanitary Registration of Repellent Products for External Use in Humans and Repellent Products for Use in Environments in Guatemala came into effect. The purpose of this regulation is to establish the requirements for the registration of these products of natural or synthetic origin, based on the Toxicological Classification criteria of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).
Repellents must be recognized by institutions such as FAO, WHO, EPA, and/or European Union, and repellents/pesticides used in agricultural or gardening activities are not included in the standard. The products must be ready-to-use formulations without modification and comply with both oral and dermal Lethal Average Dose greater than 2000 mg/kg.
The procedure must be carried out by the responsible pharmacist, who will sign the corresponding form; the following must be submitted: proof of payment of the fee, application form, product safety data sheet, the qualitative and quantitative composition of the product, certificate of free sale, product sample, analytical methodology, and others. The requirements vary depending on whether the product is an insect repellent for external use in humans, for use in environments, of natural origin, or if it contains N, N-Diethyl-Toluamide-DEET.
The sanitary registration is valid for five years and can be renewed for similar periods. Any modification such as use, change in additives, brand, trade name, distributor, type of primary packaging and others, must be notified to the authority by submitting the requirements for a proper update.
During the registration or renewal process, the Ministry of Health has the authority to request from the registrant, additional scientific and technical documentation considered necessary to evaluate the risk to human or environmental health.