On July 24, 2024, Ecuador's regulatory authority, the Agency for Regulation, Control, and Sanitary Surveillance (ARCSA), introduced a new resolution amending its 2018 regulations on disinfectant products. These changes affect the process for obtaining Sanitary Notifications for several categories, including:
Hygiene products for industrial use
Hospital disinfectants
Food-grade disinfectants
Key Changes to the Regulations
The revised regulations also establish procedures for obtaining the Certificate of Free Sale and the Sanitary Certificate of Export, while outlining specific requirements for the supervision of the products. These new criteria apply to the manufacturing, storage, distribution, sale, and import of disinfectant products, ensuring stricter control and monitoring.
The updated regulations will officially come into force on January 24, 2025, allowing a six-month transition period for businesses to adapt to the new requirements.
Impact on Businesses
These changes aim to improve product safety and quality by ensuring that disinfectants used in industrial, hospital, and food-related environments meet Ecuador's public health standards. Companies involved in the manufacture or distribution of these products should familiarize themselves with the new regulations and ensure compliance to avoid disruptions to their operations.
For additional guidance, businesses can contact ARCSA or seek regulatory assistance to effectively manage these adjustments.