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.

The Ecuadorian Institute of Standardization (INEN) has implemented Technical Regulation 089, "Toy Safety," to improve the safety of toys in the country. This regulation applies to all new toys, both locally manufactured and imported, intended for children under the age of 14.

RTE INEN 089 sets strict guidelines to ensure that toys meet essential safety requirements, focusing on mechanical and physical properties, flammability and migration of certain elements. The regulation requires clear and accurate labelling, including product name, manufacturer and importer details, country of origin and safety warnings.

This initiative aims to protect children from potential hazards associated with substandard or unsafe toys and to prevent misleading practices. The regulation is in line with international standards such as NTE INEN-ISO 8124.

By adhering to these guidelines, manufacturers and distributors will demonstrate their commitment to child safety and potentially gain greater consumer trust and market differentation.