The National Agency for Regulation, Control, and Sanitary Surveillance (ARCSA) in Ecuador has released Version 2.0 of the External Instruction Document, detailing updated requirements for the registration, re-registration, and modification of sanitary notifications for industrial hygienic products, hospital disinfectants, and food-grade disinfectants. 

Expanded Scope and New Product Categories

The latest version introduces additional product categories under regulation:

• Hygienic disinfectant products for hospital use.
• Food-grade disinfectants. 

New Labeling and Reference Codes

To facilitate compliance, the guidelines now include a dedicated labeling guide for all regulated products:

• Industrial use: Reference Code N129PHI
• Hospital use: Reference Code N129PHHOP
• Food-grade use: Reference Code N129PHFV

This structured approach aims to simplify product identification and regulatory processes for manufacturers and importers.

Enhanced Compliance Requirements

Version 2.0 introduces stricter standards for product efficacy and stability studies:

• Efficacy Studies: Applicants must justify the properties of their products through comprehensive efficacy data.
• Stability Studies: The document mandates stability tests for three distinct product batches, alongside accelerated stability studies adhering to the latest norms.

These changes reflect ARCSA's focus on ensuring product safety and maintaining quality standards throughout a product’s lifecycle.

Evolution of Guidelines

The original guidelines were created in June 2020, but significant updates in December 2024 reflect an ongoing effort to improve regulatory oversight. Key changes include:

• Updated government branding on official documents.
• Clearer processes for modifying sanitary notifications.
• New labeling and study requirements to align with international best practices.

Regulatory Transparency and Accessibility

ARCSA emphasized that this document is solely for its intended purpose and that stakeholders must always consult the latest version available in the institutional repository. Printed or copied versions are considered uncontrolled and may lack the most recent updates.

A Step Forward in Hygiene and Safety

The revisions aim to streamline the registration process, enhance public safety, and provide clarity to stakeholders navigating the regulatory landscape. The agency encourages manufacturers, importers, and distributors to familiarize themselves with the updated requirements and ensure full compliance by referencing the institutional repository. For further details, External Instruction Document can be found here (in Spanish).

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.