Ingresar
Partial Health Reform for Processed Foods
By Pedro Córdova Balda, Efrén Jurado & Daniela Coral, Robalino
The National Agency for Regulation, Control and Health Surveillance (ARCSA) issued Resolution ARCSA DE 2025 007 DASP, which amends the Technical Health Regulation for Processed Foods. The reform introduces stricter requirements for manufacturers and strengthens the authority’s sanctioning powers.
What changes?
Health Notification and Good Manufacturing Practices (GMP): Mandatory laboratory reports and stability studies are now required; companies have a maximum of one year to submit them with a letter of commitment.
Stronger enforcement powers: Immediate precautionary measures (closure, seizure) and suspension of certificates if inspections are obstructed.
Labeling and marketing: Oversight of combo products, minimum labeling requirements for bulk goods, compliance with the Organic Law on the Rationalization, Reuse and Reduction of Single-Use Plastics, the Ecuadorian Technical Regulation RTE INEN 022 (2R), among other national and international standards.
How does this impact companies in the sector?
Increased documentary and testing requirements to register or modify products.
Higher operational risk: immediate seizures or recalls in case of supplier non-compliance.
Need to strengthen traceability and review supply contracts.
Upcoming developments: ARCSA has announced the release of complementary technical guidelines for designing stability studies and validating laboratory methods. In addition, an online module is expected for submitting reports and letters of commitment.
Robalino
Robalino: Innovation and Excellence in Ecuador
Robalino stands out in the Ecuadorian legal advisory landscape as a pioneering firm in merging legal services with consulting. With a disruptive approach and a forward-thinking vision, the firm has quickly positioned itself as a strategic ally for businesses of all sizes and sectors, serving a broad range of clients, from startups to large multinational corporations.
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Robalino provides exceptional advisory services. Its commitment to excellence, innovation, and client satisfaction has established it as a market leader in Ecuador. The firm is also recognized internationally.