Ecuador has recently updated its technical regulation on paints, replacing the existing standard with RTE 061 (2R). The new regulation, which addresses a wide range of paints and coatings, introduces updated requirements aimed at ensuring higher safety and quality standards for products manufactured or imported into the country. Companies operating in this sector, whether domestically or internationally, should be aware of the significant changes brought about by this regulation.

Key Changes in RTE 061 (2R)

1. Lead Content Limits
   One of the most important updates in RTE 061 (2R) is the establishment of stricter lead limits for paints. The regulation sets new maximum allowable concentrations of lead in paint formulations, aiming to reduce exposure to this hazardous substance. Companies will need to adjust their formulations to comply with these lower thresholds to avoid penalties and ensure consumer safety.

2. Labeling Requirements
   The revised Regulation introduces new labeling requirements for paints and coatings. Manufacturers and importers must ensure that their products display clear and accurate information, such as product composition, safety warnings, and instructions for use. The new labeling requirements aim to increase transparency and provide consumers with essential information to make informed choices.

3. Conformity Assessment Procedure
   The new conformity assessment procedure under RTE 061 (2R) outlines the steps that manufacturers and importers must follow to demonstrate compliance with the regulation. This process includes product testing and certification to confirm that paints meet the established standards for lead content and other safety criteria. Companies will need to familiarize themselves with the updated procedures to ensure seamless market access.

Implications for Paint and Coating Companies

The adoption of RTE 061 (2R) will have significant implications for paint manufacturers and importers in Ecuador. Companies should review their product formulations and labeling practices to ensure compliance with the revised regulation. Non-compliance could result in fines, product recalls, or market access restrictions.

For exporters, it is crucial to understand that these changes apply not only to locally produced paints but also to imported products. International manufacturers wishing to sell their paints in Ecuador will need to meet the same stringent standards as domestic companies.

Next Steps for Compliance

To comply with RTE 061 (2R), companies should:

• Review and adjust formulations to meet the new lead limits.

• Update product labels to reflect the revised requirements.

• Prepare for updated conformity assessment procedures, which may involve additional testing and certification processes.

The full text of RTE 061 (2R) can be accessed through the World Trade Organization's website here.

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.