Ecuador Regulatory News

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 ...

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 produ...

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 ...

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.

Ecuador's National Agency for Health Regulation, Control, and Surveillance (ARCSA) has invited public feedback on a comprehensive proposal to revise labeling requirements for pesticides meant for ...

Ecuador's National Agency for Health Regulation, Control, and Surveillance (ARCSA) has invited public feedback on a comprehensive proposal to revise labeling requirements for pesticides meant for domestic, industrial, and public health use. The move, which aims to enhance transparency and safety standards, has been put forth in a notification to the World Trade Organization (WTO) dated September 19, 2023.

The proposed amendments to the existing resolution (ARCSA-DE-2021-004-AKGR) concerning registration and labeling stipulations for these pesticides seek to provide more clarity and bring about essential updates to labeling provisions. Notably, these changes aim to redefine the scope of pesticides intended for domestic use, now encompassing "products expressly authorized for use to prevent, destroy, control, or combat pests in the home," including those applied to wood.

One notable aspect that will remain unchanged is the requirement for sanitary certificates, often referred to as health notifications. These certificates will continue to be valid for a duration of five years. Companies will be obligated to apply for re-registration at least 90 days before the expiry of their product's certificate. Failure to adhere to this deadline would necessitate treating the product as new, requiring re-registration. It is important to note that the proposal does not alter certificate or registration prerequisites.

Once the proposal receives approval, it will come into effect immediately upon publication in Ecuador's Official Registry. Stakeholders and interested parties have until October 31, 2023, to submit their comments on the proposed changes.

Key Labelling Changes

One of the pivotal aspects of the proposal is the overhaul of labeling requirements. Under the revised guidelines, pesticide labels would be mandated to include the following information:

1. Active Ingredients: Labels must specify active ingredients by both their chemical and common names, referencing the International Union of Pure and Applied Chemistry (IUPAC) standards and Ecuadorian technical regulations.

2. Acute Toxicity: Pesticides will be categorized into four acute toxicity classes, providing consumers with a clear understanding of their potential harm:

   • Category III and U: Harmful if swallowed, in contact with fur, or inhaled.
   • Category II: Toxic if ingested, in contact with skin, or inhaled.
   • Category IB: Fatal if swallowed, in contact with skin, or inhaled.
   • Category IA: Fatal if swallowed, in contact with skin, or inhaled.

3. Specific Phrases: Specific phrases relevant to the product's formulation will also be mandated on labels.

In cases where active ingredients are not listed in either the IUPAC or Ecuadorian approved sources, those conforming to the International Organization for Standardization (ISO) guidelines applicable to pesticides will be considered acceptable.

Another significant requirement will be that products must be packaged with labeling and information sheets that are resilient to normal wear and tear, including transportation and storage.

These proposed changes reflect ARCSA's commitment to enhancing the safety and transparency of pesticide usage in Ecuador and ensuring that consumers have access to clear and essential information about the products they use.

As the deadline for public comments approaches on October 31, stakeholders are encouraged to participate actively in the process to help shape the future of pesticide regulation in Ecuador. The potential benefits include improved safety, more informed consumers, and a more sustainable approach to pest control in both domestic and industrial settings.

Ecuador has recently released a draft regulation for public scrutiny, outlining the procedures governing the issuance of toxicological evaluation reports, modifications to existing reports, and the al...

Ecuador has recently released a draft regulation for public scrutiny, outlining the procedures governing the issuance of toxicological evaluation reports, modifications to existing reports, and the alignment of labels with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) for agricultural pesticides.

The proposed changes regarding GHS-compliant labeling have far-reaching implications, as they will affect all registered chemical-based agricultural pesticides in the country. According to the draft, applicants seeking approval for their products will be required to pay a stipulated fee and furnish the specified information for evaluation.

This draft regulation is currently open for public input and feedback, providing a crucial opportunity for stakeholders and concerned citizens to contribute their insights. The public comment period spans a duration of sixty days, commencing from August 30th. Your input during this period can play a significant role in shaping the final regulations governing toxicological evaluations and labeling practices for agricultural pesticides in Ecuador.

Link to the draft in Spanish: 23_12073_00_s.pdf (wto.org)